阅读说明：本技术 用于影响心脏收缩性和/或松弛性的系统和方法 (System and method for influencing cardiac contractility and/or relaxation ) 是由 G·C·莫尔纳 S·D·格德克 M·L·肯内菲克 D·C·奥尔森 S·L·瓦尔德豪泽 T· 于 2019-08-12 设计创作，主要内容包括：一种用于施加神经刺激的系统,包括：外部护套；细长内部构件,该内部构件在外部护套中并且能够相对于外部护套移动。内腔具有远端。可扩张构件耦接到内部构件的远端并且位于外部护套中。可扩张构件从在外部护套中的压缩状态自扩张到在外部护套之外的扩张状态。可扩张构件包括：远端部分,该远端部分包括多根编织在一起的丝线；以及近端部分,该近端部分包括平行于纵向轴线延伸的多根丝线。该系统包括多个电极组件,该多个电极组件在可扩张构件的外部并且围绕可扩张构件在周向上间隔开。每个电极组件耦接到平行于纵向轴线延伸的两根丝线。每个电极组件包括多个在纵向上间隔开的电极。(A system for applying neural stimulation, comprising: an outer sheath; an elongate inner member within and movable relative to the outer sheath. The lumen has a distal end. An expandable member is coupled to the distal end of the inner member and is located in the outer sheath. The expandable member self-expands from a compressed state in the outer sheath to an expanded state outside the outer sheath. The expandable member includes: a distal portion comprising a plurality of filaments braided together; and a proximal portion including a plurality of filaments extending parallel to the longitudinal axis. The system includes a plurality of electrode assemblies external to and circumferentially spaced around the expandable member. Each electrode assembly is coupled to two wires extending parallel to the longitudinal axis. Each electrode assembly includes a plurality of longitudinally spaced electrodes.)

1. A partially braided expandable member for supporting an electrode array, the expandable member being self-expanding between a compressed state and an expanded state, the expandable member comprising:

a proximal end;

a distal end;

a longitudinal axis;

a distal section comprising a plurality of wires, each wire of the plurality of wires having a flexure comprising a wire section on each side of the flexure,

the flexure defines the distal end of the expandable member,

the wire section is braided from the distal end of the expandable member toward the proximal end of the expandable member; and

a proximal section proximate the distal section, the proximal section comprising a plurality of filaments,

the plurality of wires extend parallel to the longitudinal axis,

half of the wires of the plurality of wires are severed distal of the proximal end of the expandable member and the other half of the wires of the plurality of wires define the proximal end of the expandable member,

the other half of the plurality of wires is flexed toward the longitudinal axis to form a spoke and flexed parallel to the longitudinal axis to attach to an elongated member.

2. The expandable member of claim 1, wherein the distal segment comprises a first portion having a braided characteristic and a second portion having a second braided characteristic different from the first braided characteristic.

3. The expandable member of claim 2, wherein the first braiding characteristic comprises a braiding angle and the second braiding characteristic comprises a braiding angle, and wherein second braiding angle is greater than first braiding angle.

4. The expandable member of claim 1, wherein the distal segment has a uniform braid angle.

5. The system of claim 1, wherein end portions of the plurality of filaments in the proximal end section are positioned in side-by-side pairs parallel to the longitudinal axis.

6. The system of claim 5, further comprising a polymer tube covering at least a portion of each pair of side-by-side filaments.

7. The system of claim 5, wherein one end portion of each pair of side-by-side wires is truncated distal to the proximal end of the expandable member, and wherein the other end portion of each pair of side-by-side wires extends radially inward toward a proximal hub system to form a spoke.

8. The expandable member of claim 1, wherein the spokes are perpendicular to the longitudinal axis.

9. A catheter system, comprising:

a distal portion configured to be inserted into the vasculature of a subject, the distal portion comprising:

the expandable member according to any one of claims 1 to 8; and

a plurality of electrode assemblies.

10. The system of claim 9, wherein the other half of the plurality of wires extends to a proximal hub system.

11. The system of claim 10, wherein the proximal hub system comprises:

an outer belt;

an inner band radially inward of the outer band; and

an adapter comprising a first longitudinal section radially inside the outer band and a second longitudinal section radially inside the inner band, the other end portion of the wire being radially inside the inner band.

12. The system of claim 10, wherein the proximal hub system comprises:

a metal outer band;

a polymer adapter inside the outer band, and comprising:

a distal section comprising a plurality of radial projections, a channel between pairs of the radial projections of the plurality configured to receive one of the other half of the plurality of wires; and

A proximal section proximal to the distal section of the polymeric adapter, the proximal section of the polymeric adapter being free of radial protrusions;

a central lumen extending through the distal section of the polymeric adapter and the proximal section of the polymeric adapter; and

a metal inner band surrounding the proximal section of the polymeric adapter and inboard of the outer band, an arcuate space between the inner band and the proximal section of the polymeric adapter configured to receive the other half of the plurality of wires, at least one of the inner band or the outer band being radiopaque.

13. The system of claim 9, further comprising:

an outer sheath; and

an inner member radially inward of the outer sheath, the hub system coupled to the inner member.

14. The system of claim 13, wherein the outer sheath is configured to hold the expandable member in a compressed state.

15. The system of claim 14, wherein the expandable member is configured to expand from the compressed state toward the expanded state upon relative longitudinal movement of the outer sheath toward the proximal end of the inner member, and wherein the expandable member is configured to compress toward the compressed state upon relative longitudinal movement of the outer sheath toward the distal end of the inner member.

16. The system of claim 13, wherein the inner member comprises:

an elongated tube including a sidewall surrounding a lumen;

a first radiopaque marking;

a second radiopaque marker distal to the first radiopaque marker;

a first port through the sidewall, the first port being proximal to the first radiopaque marking; and

a second port through the sidewall, the second port distal to the first port, the second port proximal to the second radiopaque marking, the second port circumferentially spaced from the first port,

the system comprises:

a first pressure sensor in fluid communication with the first port; and

a second pressure sensor in fluid communication with the second port.

17. The system of claim 9, wherein each of the plurality of electrode assemblies comprises:

a first insulating layer;

a second insulating layer;

a plurality of electrodes between the first insulating layer and the second insulating layer; and

a plurality of conductors between the first insulating layer and the plurality of electrodes, each conductor of the plurality of conductors electrically connected to one electrode of the plurality of electrodes.

18. The system of claim 17, wherein the first insulating layer comprises a bevel.

19. The system of claim 17, wherein the second insulating layer comprises a bevel.

20. The system of claim 17, wherein at least one of the first and second insulating layers has a shore hardness of between 55D to 63D.

21. The system of claim 17, wherein the total thickness of the first and second insulating layers is between 0.004 inches (approximately 0.1mm) and 0.012 inches (approximately 0.3 mm).

22. The system of claim 17, wherein at least one of the plurality of electrodes is recessed into the second insulating layer.

23. The system of claim 17, wherein at least one of the plurality of electrodes is flat.

24. The system of claim 17, wherein at least one of the plurality of electrodes comprises a distal tab coupled to a conductor on a side opposite an active surface of the electrode.

25. The system of claim 17, wherein at least one of the plurality of electrodes comprises an oblong shape comprising:

A first semi-circular portion;

a second semi-circular portion; and

a rectangular portion longitudinally between the first and second semi-circular portions.

26. The system of claim 25, wherein a ratio of a length of the rectangular portion to a diameter of the first and second semi-circular portions is between 1: 3 to 3: 1.

27. The system of claim 9, wherein the plurality of electrodes are on a first side of a plane that intersects the longitudinal axis of the expandable member.

28. The system of claim 27, further comprising a radiopaque marker on a second side of the plane.

29. The system of claim 9, wherein each of the plurality of electrode assemblies comprises:

a first insulating layer comprising a tube having an open proximal end and an open distal end;

a second insulating layer coupled to the first insulating layer, the first and second insulating layers forming a channel in fluid communication with the tube, the channel having a closed proximal end and a closed distal end;

a plurality of electrodes between the first and second insulating layers, each electrode of the plurality of electrodes having an oblong shape and comprising a proximal tab and a distal tab; and

A plurality of conductors in the channel, each of the plurality of conductors electrically connected to an inner side of a distal tab of one of the plurality of electrodes.

30. The system of claim 9, wherein the plurality of electrode assemblies are circumferentially nested when the expandable member is in a compressed state.

31. The system of claim 9, wherein the plurality of electrode assemblies are shaped as a parallelogram when the expandable member is in a compressed state.

32. The system of claim 9, further comprising a nose distal to the expandable member, the nose comprising:

a distal section including a plurality of projections at least partially defining a plurality of channels; and

a proximal section without a protrusion.

33. An electrode assembly configured to be coupled to an expandable structure and to apply electrical nerve stimulation; the electrode assembly includes:

a first insulating layer comprising a tube having an open proximal end and an open distal end;

a second insulating layer coupled to the first insulating layer, the first and second insulating layers forming a channel in fluid communication with the tube, the channel having a closed proximal end and a closed distal end;

A plurality of electrodes between the first and second insulating layers, each electrode of the plurality of electrodes having an oblong shape and comprising a proximal tab and a distal tab; and

a plurality of conductors in the channel, each conductor of the plurality of conductors electrically connected to an inner side of the distal tab of one of the plurality of electrodes.

34. The assembly of claim 33, wherein the first insulating layer comprises a bevel.

35. The assembly of claim 33, wherein the second insulating layer comprises a bevel.

36. The assembly of claim 33, wherein at least one of the first and second insulating layers has a shore hardness of between 55D to 63D.

37. The assembly of claim 33, wherein the total thickness of the first and second insulating layers is between 0.004 inches (approximately 0.1mm) and 0.012 inches (approximately 0.3 mm).

38. The system of any one of claims 33-37, wherein at least one of the plurality of electrodes comprises a distal tab coupled to a conductor on a side opposite an active surface of the electrode.

39. The system of claim 38, wherein at least one of the plurality of electrodes comprises an oblong shape comprising:

a first semi-circular portion;

a second semi-circular portion; and

a rectangular portion longitudinally between the first semi-circular portion and the second semi-circular portion.

40. The system of claim 39, wherein the ratio of the length of the rectangular portion to the diameter of the first and second semi-circular portions is in the range of 1: 3 to 3: 1.

41. A system for applying neural stimulation through an anatomical blood vessel, the system comprising:

an outer sheath;

an elongate inner member within and movable relative to the outer sheath, the inner member having a distal end;

an expandable member coupled to the distal end of the inner member and located in the outer sheath, the expandable member self-expanding from a compressed state in the outer sheath to an expanded state outside the outer sheath, the expandable member having a longitudinal axis and comprising:

a distal portion comprising a plurality of filaments braided together to form a plurality of cells; and

A proximal portion proximal to the distal portion, the proximal portion comprising a plurality of wires extending parallel to the longitudinal axis; and

a plurality of electrode assemblies external to and circumferentially spaced around the expandable member, each electrode assembly of the plurality of electrode assemblies coupled to two of the wires extending parallel to the longitudinal axis, each electrode assembly of the plurality of electrode assemblies including a plurality of longitudinally spaced electrodes facing away from the expandable member.

42. A system for applying neural stimulation, the system comprising:

an outer sheath;

an elongate inner member within and movable relative to the outer sheath;

an expandable member coupled to the inner member, the expandable member self-expanding from a compressed state in the outer sheath to an expanded state outside the outer sheath; and

a plurality of electrode assemblies external to and circumferentially spaced around the expandable member, each electrode assembly of the plurality of electrode assemblies having a proximal end and a distal end, the plurality of electrode assemblies forming a parallelogram shape, wherein the proximal end of each electrode assembly is distal to the proximal end of a circumferentially adjacent electrode assembly, and wherein the distal end of each electrode assembly is distal to the distal end of a circumferentially adjacent electrode assembly.

43. A hub system for coupling a plurality of filaments to an elongate member, the hub system comprising:

a metal outer band;

a polymer adapter on an inner side of the outer band, the polymer adapter comprising:

a distal section comprising a plurality of radial projections, a channel between a pair of radial projections of the plurality of radial projections configured to receive a filament of a plurality of filaments; and

a proximal section proximal to the distal section, the proximal section being free of radial protrusions;

a central lumen extending through the distal segment and the proximal segment; and

a metal inner band surrounding the proximal segment and inboard of the outer band, an arcuate space between the inner band and the proximal segment configured to receive a plurality of filaments, at least one of the inner band or the outer band being radiopaque.

44. A catheter for measuring the pressure of a body lumen, the catheter comprising:

an outer sheath; and

an inner member within the outer sheath and movable relative to the outer sheath until a portion of the inner member is outside of the outer sheath, the inner member comprising:

An elongated tube comprising a sidewall surrounding a lumen;

a first radiopaque marking;

a second radiopaque marker distal to the first radiopaque marker;

a first port through the sidewall, the first port being proximal to the first radiopaque marking; and

a second port through the sidewall, the second port distal to the first port, the second port proximal to the second radiopaque marking, the second port circumferentially spaced from the first port;

a first pressure sensor in fluid communication with the first port; and

a second pressure sensor in fluid communication with the second port.

45. A housing for a filter assembly, the housing configured to affect an ECG signal, the housing comprising:

a plurality of electrode pads configured to be coupled to a plurality of ECG leads, the plurality of electrode pads being color coded and marked with at least one of a numeric or alphabetical designation, the plurality of electrodes being in positions mimicking the position of the electrode pads on the chest and periphery of a subject, the plurality of electrode pads comprising at least ten electrode pads; and

a plurality of ECG lead inputs configured to be coupled to ECG leads coupled to electrode pads on a subject.

46. A method of monitoring the effect of neurostimulation applied to a subject using a neurostimulator to move the neurostimulator, the method comprising:

stopping application of the neural stimulation;

monitoring signal decay to baseline after cessation of application of the neural stimulation;

resuming neural stimulation after monitoring signal decay to the baseline; and

after resuming neural stimulation, the signal is monitored to detect movement of the neural stimulator.

47. A method of monitoring the effect of neurostimulation applied to a subject using a neurostimulator to move the neurostimulator, the method comprising:

applying a neural stimulation comprising a parameter at a first value;

modifying the parameter of the neural stimulation to a second value different from the first value and continuing to apply the neural stimulation;

monitoring the signal after modifying the parameter of the neural stimulation;

after monitoring the signal, resuming neural stimulation that includes the parameter at the first value; and

after resuming neural stimulation including the parameter at the first value, monitoring the signal to detect movement of the neural stimulator.

48. A method of manufacturing an electrode assembly, the method comprising:

Coupling a conductor to a first side of a tab of an electrode;

positioning the electrode between a first insulating layer and a second insulating layer, the first insulating layer including a channel through which a conductor extends, the electrode including a second side exposed through the second insulating layer.

Technical Field

The present disclosure relates generally to methods and systems for facilitating modulation (e.g., electrical neuromodulation), and more particularly, to methods and systems for facilitating therapy of and calibrating electrical neuromodulation of one or more nerves in and around the heart.

Background

Acute heart failure is a cardiac condition in which a problem with the structure or function of the heart impairs its ability to provide adequate blood flow to meet physical needs. This symptom reduces quality of life and is a major cause of hospitalization and mortality in the western world. Treatment of acute heart failure is typically directed to removing causes, preventing deterioration of cardiac function, and controlling the congestive state of a patient.

Disclosure of Invention

Treatment of acute heart failure involves the use of inotropic agents such as dopamine and dobutamine. However, these agents have a chronotropic and inotropic effect and characteristically increase cardiac contractility at the expense of significantly increased oxygen consumption secondary to an increase in heart rate. As a result, although these inotropic agents increase myocardial contractility and increase hemodynamics, clinical trials have consistently demonstrated that increased cardiac arrhythmia and myocardial consumption lead to excessive mortality.

As such, there is a need to selectively and locally treat acute heart failure and otherwise obtain hemodynamic control without causing unwanted systemic effects. Thus, in some examples, no inotropic agent is used. In other examples, a reduced dose of a inotropic agent may be used, as, for example, a synergistic effect is provided by the various examples herein. By reducing the dose, side effects can also be significantly reduced.

Several examples of the present disclosure provide methods of tissue modulation (e.g., neuromodulation) of cardiac and other disorders. For example, some examples provide methods and apparatus for neuromodulating one or more nerves in or around a heart of a patient. Several methods of the present disclosure may be useful, for example, for electrical neuromodulation of patients with cardiac disease (e.g., patients with acute or chronic cardiac disease). Several methods of the present disclosure include, for example, neuromodulation of one or more target sites of the autonomic nervous system of the heart. In some examples, the sensed characteristic of non-electrical cardiac activity is used to adjust one or more characteristics of electrical neuromodulation delivered to the patient. Non-limiting examples of medical conditions that may be treated according to the present disclosure include cardiovascular medical conditions.

As discussed herein, the configuration of the catheter and electrode system of the present disclosure may advantageously allow for positioning a portion of the catheter within the vasculature of a patient, in one or both of the main and/or pulmonary arteries (right and left pulmonary arteries). Once positioned, the catheter and electrode system of the present disclosure may provide electrical stimulation energy (e.g., electrical current or electrical pulses) to stimulate autonomic nerve fibers around one or both of the main and/or pulmonary arteries in order to provide assisted cardiac therapy to the patient.

The catheter may include an elongated body having a first end and a second end. The elongated body may include an elongated radial axis extending through the first and second ends of the elongated body, and a first plane extending through the elongated radial axis. At least two elongate stimulation members may extend from the elongate body, wherein each of the at least two elongate stimulation members is bent into a first volume defined at least in part by the first plane. In one example, at least one electrode is on each of the at least two elongate stimulation members, wherein the at least one electrode forms an electrode array in the first volume. The electrically conductive element may extend through and/or along each of the elongate stimulation members, wherein the electrically conductive element conducts electrical current to a combination of two or more of the electrodes in the electrode array.

In one example, the at least two elongated stimulation members may be curved only in a first volume at least partially defined by the first plane, and a second volume at least partially defined by the first plane and opposite the first volume does not contain electrodes. The second plane may intersect the first plane perpendicularly along the elongated radial axis of the elongated body to divide the first volume into a first quadrant volume and a second quadrant volume. The at least two elongated stimulation members may comprise a first elongated stimulation member and a second elongated stimulation member, wherein the first elongated stimulation member is bent into the first quadrant volume and the second elongated stimulation member is bent into the second quadrant volume.

Each of the at least two elongate stimulation members may comprise a stimulation member elongate body and a filament extending longitudinally through the elongate body and the stimulation member elongate body, wherein pressure exerted by the filament against the stimulation member elongate body at or near its distal end causes the filament to deflect, imparting a bend into each of the at least two elongate stimulation members into a first space defined at least in part by the first plane. The catheter may further include an anchor member extending from the elongate body into a second volume at least partially defined by the first plane and opposite the first volume, wherein the anchor member does not contain an electrode.

In additional examples, the catheter may further comprise a structure extending between at least two of the at least two elongate stimulation members. An additional electrode may be positioned on the structure, the additional electrode having a conductive element extending from the additional electrode through one of the elongate stimulation members, wherein the conductive element conducts electrical current to the combination of the additional electrode and at least one of the at least one electrode on each of the at least two elongate stimulation members. An example of such a structure is a grid structure.

The catheter may further include a position measurement instrument including an elongated instrument body having a first end and a bumper end distal to the first end. The elongate body of the catheter may include a first lumen extending from the first end through the second end of the elongate body. The bumper end may have a shape with a surface area no less than a surface area of the distal end of the elongate body taken perpendicular to the elongate radial axis, and the elongate gauge body may extend through the first lumen of the elongate body to position the bumper end beyond the second end of the elongate body. In one example, a first end of the positioning and measuring instrument extends from a first end of an elongated body, the elongated measuring instrument body having markings indicating a length between a second end of the elongated body and a bumper end of the positioning and measuring instrument.

The present disclosure also includes a catheter system including a catheter and a pulmonary artery catheter having a lumen, wherein the catheter extends through the lumen of the pulmonary artery catheter. The pulmonary artery catheter can include an elongate catheter body having a first end, a second end, a peripheral surface, and an inner surface opposite the peripheral surface defining a lumen extending between the first end and the second end of the elongate catheter body. An inflatable balloon may be positioned on the outer peripheral surface of the elongated catheter body, the inflatable balloon having a balloon wall with an inner surface that defines a fluid-tight volume along with a portion of the outer peripheral surface of the elongated catheter body. An inflation lumen extends through the elongate catheter body, the inflation lumen having a first opening into the fluid-tight volume of the inflatable balloon and a second opening proximal to the first opening to allow fluid to move into and out of the fluid-tight volume to inflate and deflate the balloon.

The present disclosure also provides a catheter including an elongated catheter body having a first end, a second end, a peripheral surface, and an inner surface defining an inflation lumen extending at least partially between the first end and the second end of the elongated catheter body; an inflatable balloon on the outer peripheral surface of the elongate catheter body, the inflatable balloon having a balloon wall with an inner surface defining a fluid-tight volume with a portion of the outer peripheral surface of the elongate catheter body, wherein the inflation lumen has a first opening into the fluid-tight volume of the inflatable balloon and a second opening proximal to the first opening to allow fluid to move into the volume to inflate and deflate the balloon; a plurality of electrodes positioned along an outer surface of the elongate catheter body, the plurality of electrodes positioned between the inflatable balloon and the first end of the elongate catheter body; a conductive element extending through the elongate catheter body, wherein the conductive element conducts electrical current to a combination of two or more of at least one of the plurality of electrodes; and a first anchor extending laterally from the peripheral surface of the elongate body, the first anchor having struts forming an open frame having a peripheral surface with a maximum outer dimension greater than a maximum outer dimension of the inflatable balloon.

In one example, the first anchor is positioned between the inflatable balloon and a plurality of electrodes positioned along a peripheral surface of the elongate catheter body. The portion of the elongated catheter body including the plurality of electrodes may bend in a predetermined radial direction when placed under longitudinal compression. In another example, the first anchor is positioned between a plurality of electrodes positioned along a peripheral surface of the elongated catheter body and the first end of the elongated catheter body.

The elongate catheter body can further include a second inner surface defining a shaped lumen extending from the first end toward the second end. The forming wire has a first end and a second end, the forming wire being passable through the forming lumen, wherein the first end of the forming wire is proximal to the first end of the elongate catheter body and the second end of the forming wire is connected to the elongate catheter body such that the forming wire imparts a bend into the portion of the elongate catheter body having the plurality of electrodes when tension is applied to the forming wire.

The example catheter may also include an elongate catheter body having a first end, a second end, a peripheral surface, and an inner surface defining an inflation lumen extending at least partially between the first end and the second end of the elongate catheter body; an inflatable balloon on the outer peripheral surface of the elongate catheter body, the inflatable balloon having a balloon wall with an inner surface defining a fluid-tight volume with a portion of the outer peripheral surface of the elongate catheter body, wherein the inflation lumen has a first opening into the fluid-tight volume of the inflatable balloon and a second opening proximal to the first opening to allow fluid to move into the volume to inflate and deflate the balloon; a first anchor extending laterally from a peripheral surface of the elongate catheter body, the first anchor having struts forming an open frame, the open frame having a peripheral surface with a diameter greater than a diameter of the inflatable balloon; an electrode catheter having an electrode elongate body and a plurality of electrodes positioned along a peripheral surface of the electrode elongate body; a conductive element extending through the electrode elongate body of the electrode catheter, wherein the conductive element conducts electrical current to a combination of two or more of at least one of the plurality of electrodes; and an attachment loop connected to the electrode catheter and positioned around a peripheral surface of the elongated catheter body proximal of both the first anchor and the inflatable balloon.

The catheter system of the present disclosure may also include an elongate catheter body having a first end, a second end, a peripheral surface, and an inner surface defining an expansion lumen extending at least partially between the first end and the second end of the elongate catheter body, wherein the elongate catheter body includes an elongate radial axis extending through the first end and the second end of the elongate body, and wherein the first plane extends through the elongate radial axis; an inflatable balloon on the outer peripheral surface of the elongate catheter body, the inflatable balloon having a balloon wall with an inner surface defining a fluid-tight volume with a portion of the outer peripheral surface of the elongate catheter body, wherein the inflation lumen has a first opening into the fluid-tight volume of the inflatable balloon and a second opening proximal to the first opening to allow fluid to move into the volume to inflate and deflate the balloon; an electrode holder having two or more ribs extending radially away from a peripheral surface of the elongate catheter body toward the inflatable balloon, wherein the two or more ribs of the electrode holder curve into a first volume defined at least in part by a first plane; one or more electrodes on each of the ribs of the electrode holder, wherein the one or more electrodes on each of the ribs form an electrode array in the first volume; a conductive element extending through the two or more ribs of the electrode holder and the elongate catheter body, wherein the conductive element conducts electrical current to a combination of one or more electrodes in the electrode array; and having two or more rib anchoring cages, the ribs extending radially away from the outer peripheral surface of the elongate catheter body towards the inflatable balloon, wherein the two or more ribs of the anchoring cages curve into a second volume at least partially defined by the first plane and opposite the first volume, wherein the two or more ribs of the anchoring cages do not comprise electrodes.

In one example, a catheter includes an elongated body having a first end and a second end. The elongated body includes a longitudinal central axis extending between a first end and a second end. The elongated body also includes three or more surfaces defining a convex polygonal cross-sectional shape taken perpendicular to the longitudinal central axis. The catheter also includes one or more (but preferably two or more) electrodes on one of the three or more surfaces of the elongate body through which the conductive element extends. The conductive element may conduct current to a combination of one or more, or in the case of a single electrode, a second electrode may be provided elsewhere in the system to enable current flow. For example, the surface defining the convex polygonal cross-sectional shape of the elongated body may be rectangular. Other shapes are possible. In one example, the one or two or more electrodes are located on only one of the three or more surfaces of the elongated body. The one or more electrodes may have an exposed face that is coplanar with the one of the three or more surfaces of the elongated body. The one surface of the three or more surfaces of the elongated body may also include an anchoring structure extending over the one surface. In addition to the surfaces defining the convex polygonal cross-sectional shape, the elongated body of the catheter may also have a portion with a circular cross-sectional shape taken perpendicular to the longitudinal central axis. The catheter of this example may also include an inflatable balloon on a peripheral surface of the elongate body. The inflatable balloon includes a balloon wall having an inner surface that defines, along with a portion of the peripheral surface of the elongate body, a fluid-tight volume. An inflation lumen extends through the elongate body, the inflation lumen having a first opening into the fluid-tight volume of the inflatable balloon and a second opening proximal to the first opening to allow fluid to move into the fluid-tight volume to inflate and deflate the balloon.

In another example, a catheter includes an elongated body having a peripheral surface and a longitudinal central axis extending between a first end and a second end. The elongate body of this example has an offset region defined by a series of predefined bends along the longitudinal central axis. The predefined curve includes a first portion having a first curve and a second curve on the longitudinal center axis, a second portion following the first portion, wherein the second portion has zero curvature (e.g., a straight portion), and a third portion following the second portion, the third portion having a third curve and a fourth curve. An inflatable balloon is positioned on the peripheral surface of the elongated body, the inflatable balloon having a balloon wall with an inner surface that defines, along with a portion of the peripheral surface of the elongated body, a fluid-tight volume. An inflation lumen extends through the elongate body, the inflation lumen having a first opening into the fluid-tight volume of the inflatable balloon and a second opening proximal to the first opening to allow fluid to move into the fluid-tight volume to inflate and deflate the balloon. One or more electrodes are positioned on the elongated body along a second portion of the offset region of the elongated body. A conductive element extends through the elongated body, wherein the conductive element conducts electrical current to the combination of one or more electrodes. The portions of the elongated body of this example of the catheter may have various shapes. For example, the second portion of the elongated body may form a portion of a helix. The elongated body may also have three or more surfaces defining a convex polygonal cross-sectional shape taken perpendicular to the longitudinal central axis, wherein the one or more electrodes are located on one of the three or more surfaces of the elongated body. For this example, the convex polygonal cross-sectional shape may be rectangular. The one or more electrodes are located on only one of the three or more surfaces of the elongated body. The one or more electrodes may have an exposed face that is coplanar with the one of the three or more surfaces of the elongated body.

In another example, a catheter includes an elongated body having a peripheral surface and a longitudinal central axis extending between a first end and a second end. The elongated body includes a surface defining a deflection lumen, wherein the deflection lumen includes a first opening and a second opening in the elongated body. An inflatable balloon is positioned on the peripheral surface of the elongated body, the inflatable balloon having a balloon wall with an inner surface that defines a fluid-tight volume with a portion of the peripheral surface of the elongated body. An inflation lumen extends through the elongate body, the inflation lumen having a first opening into the fluid-tight volume of the inflatable balloon and a second opening proximal to the first opening to allow fluid to move into the fluid-tight volume to inflate and deflate the balloon. One or more electrodes are positioned on the elongate body, wherein the second opening of the deflection lumen is opposite the one or more electrodes on the elongate body. A conductive element extends through the elongated body, wherein the conductive element conducts electrical current to the combination of one or more electrodes. The catheter also includes an elongated deflection member, wherein the elongated deflection member extends through the second opening of the deflection lumen in a direction opposite the one or more electrodes on the one surface of the elongated body.

In another example, a catheter includes an elongated body having a peripheral surface and a longitudinal central axis extending between a first end and a second end. The elongate body includes a surface defining an electrode lumen, wherein the electrode lumen includes a first opening in the elongate body. The catheter also includes an inflatable balloon on the peripheral surface of the elongated body, the inflatable balloon having a balloon wall with an inner surface that defines a fluid-tight volume with a portion of the peripheral surface of the elongated body. An inflation lumen extends through the elongate body, the inflation lumen having a first opening into the fluid-tight volume of the inflatable balloon and a second opening proximal to the first opening to allow fluid to move into the fluid-tight volume to inflate and deflate the balloon. The catheter also includes an elongate electrode member, wherein the elongate electrode member extends through the first opening of the electrode lumen of the elongate body, wherein the electrode member includes one or more electrodes and a conductive element extending through the electrode lumen, wherein the conductive element conducts electrical current to a combination of the one or more electrodes. The elongate electrode member may form a loop extending away from the outer peripheral surface of the elongate body. The elongate electrode members forming the loop may lie in a plane collinear with the longitudinal central axis of the elongate body. Alternatively, the elongate electrode members forming the loop lie in a plane perpendicular to the longitudinal central axis of the elongate body.

According to some methods of the present disclosure and as discussed more fully herein, a catheter having an electrode array is inserted into the pulmonary trunk and positioned at a location such that the electrode array is positioned with its electrodes in contact with the posterior, superior, and/or inferior surfaces of the right pulmonary artery. From this location, electrical current may be delivered to or from the electrode array to selectively modulate the autonomic nervous system of the heart. For example, electrical current may be delivered to or from the electrode array to selectively modulate the autonomic cardiopulmonary nerves of the autonomic nervous system, which may modulate cardiac contractility and/or relaxation, in some examples beyond heart rate. Preferably, the electrode array is positioned at a location along the posterior and/or superior wall of the right pulmonary artery such that the electrical current delivered to or from the electrode array results in the greatest effect on cardiac contractility and/or relaxation and the least effect on heart rate and/or oxygen consumption compared to the electrical current delivered at other locations in the right and/or left pulmonary artery. In some examples, the effect on cardiac contractility is to increase cardiac contractility. In some examples, the effect on cardiac relaxivity is to increase cardiac relaxivity.

As used herein, the current delivered to or from the electrode array may be in the form of a time-varying current. Preferably, such a time-varying current may be in the form of one or more of a pulse of current (e.g., at least one pulse of current), one or more waveforms (e.g., a continuous wave of current), or a combination thereof.

As discussed herein, the present disclosure provides methods for treating a patient having a heart (the heart having a pulmonary trunk). Portions of the pulmonary trunk may be defined by a right lateral plane passing along a right luminal surface of the pulmonary trunk and a left lateral plane parallel to the right lateral plane passing along a left luminal surface of the pulmonary trunk. The right and left lateral planes extend in directions generally aligned with the anterior and posterior directions of the body of a subject (e.g., a patient). The branch point is positioned between the right and left lateral planes, wherein the branch point helps define the beginning of the left and right pulmonary arteries of the heart. The method further comprises moving a catheter having an electrode array comprising one or more, preferably two or more electrodes through the pulmonary trunk towards the bifurcation point. The electrode array is positioned in the right pulmonary artery on the left lateral planar right side, wherein one or more electrodes contact a posterior surface, an upper surface, and/or a lower surface of the right pulmonary artery on the left lateral planar right side. In additional examples, an electrode array may be positioned in the right pulmonary artery to the right of the right lateral plane, with one or more electrodes contacting a posterior surface, an upper surface, and/or a lower surface of the right pulmonary artery to the right of the right lateral plane. This example of a method also includes contacting one or more electrodes on a posterior, superior, and/or inferior surface of the right pulmonary artery at a location superior (e.g., above) the branch point. It is also possible to position at least a portion of the catheter in contact with a portion of the surface defining the branch point. In this example, the portion of the catheter may be provided with a shape that provides an increase in surface area that may help hold the portion of the catheter against the branch point.

In an additional example, the pulmonary artery trunk has a diameter taken on a plane perpendicular to the left and right lateral planes, wherein the electrode array is positioned in the right pulmonary artery to extend from a point to the right of the left lateral plane to a point approximately three times the diameter of the pulmonary artery trunk to the right of the branching point. The right pulmonary artery may further include a branch point that divides the right pulmonary artery into at least two additional arteries distal to the branch point that helps define the beginning of the left and right pulmonary arteries. The electrode array may be positioned in the right pulmonary artery between a branch point that helps define the beginning of the left and right pulmonary arteries and a branch point that divides the right pulmonary artery into at least two additional arteries. Once in place, electrical current may be provided to or from one or more electrodes of the electrode array. Values of a cardiac parameter of a patient may be measured in response to currents from or to one or more electrodes of an electrode array. Depending on the value of the cardiac parameter, changes may be made to which electrodes are used to provide current in response to the value of the cardiac parameter. The nature of the current provided in response to the value of the cardiac parameter may also be varied. Such changes include, but are not limited to, changes in voltage, amperage, waveform, frequency, and pulse width, for example. Further, an electrode of the one or more electrodes on the posterior, superior, and/or inferior surfaces of the right pulmonary artery may be moved in response to the value of the cardiac parameter. The current provided to or from one or more electrodes of the electrode array may be provided as at least one pulse of current to or from one or more electrodes of the electrode array. Examples of such cardiac parameters include, but are not limited to, measuring pressure parameters, acoustic parameters, acceleration parameters, and/or electrical parameters (e.g., ECG) of the patient's heart as cardiac parameters.

Several methods of the present disclosure allow for electrical neuromodulation of a patient's heart, including, for example, delivering one or more electrical pulses through a catheter positioned in a pulmonary artery of the patient's heart, sensing one or more characteristics of cardiac activity (e.g., non-electrical cardiac activity characteristics) responsive to the one or more electrical pulses from at least a first sensor positioned at a first location within a vasculature of the heart, and adjusting characteristics of the one or more electrical pulses delivered through the catheter positioned in the pulmonary artery of the heart responsive to the one or more characteristics of cardiac activity. The method may provide assisted cardiac therapy to a patient.

Sensing from at least a first sensor positioned at a first location may include sensing from the vasculature of the heart one or more of: pressure characteristics, acceleration characteristics, acoustic characteristics, temperature, and blood chemistry characteristics. The first sensor may be located in one of a left pulmonary artery stem, a right pulmonary artery, a pulmonary artery branch vessel, or a pulmonary artery stem of the heart, among other locations. One or more electrical pulses may optionally be delivered through a catheter positioned in one of the left pulmonary artery, the right pulmonary artery, or the pulmonary trunk of the heart that does not contain the first sensor. The first sensor may also be positioned in a pulmonary trunk of the heart.

Other locations for the first sensor may include in the right ventricle of the heart and in the left atrium of the heart. When positioned in the right atrium of the heart, the first sensor may optionally be positioned on a septal wall of the right atrium of the heart. The first sensor may also be positioned on the septal wall of the right ventricle. The right ventricle and the left ventricle share the septal wall, so a sensor in the right ventricle or on the septal wall of the right ventricle may be advantageously used to detect a characteristic indicative of the left ventricle. In some examples, the effect on cardiac contractility is to increase cardiac relaxation, contractility, and/or cardiac output. Additional locations for positioning the first sensor include in the superior vena cava of the heart, the inferior vena cava of the heart, and in the coronary sinus of the heart. The first sensor may be for sensing at least one of temperature or blood oxygen level when positioned in the coronary sinus of the heart.

In some examples, the first sensor may be positioned in the left atrium (e.g., by forming a hole in the septal wall between the right atrium and the left atrium, or by using a Patent Foramen Ovale (PFO) or Atrial Septal Defect (ASD)). A sensor in the left atrium may be useful for detecting a characteristic indicative of the left ventricle. If the left atrium has been accessed, in some examples, the sensor may be positioned in the left ventricle itself, which may provide the most direct measurement of the characteristics associated with the left ventricle. In some examples, the sensor may be positioned downstream of the left ventricle, including the aorta, aortic branch arteries, and the like. When the procedure is complete, any holes created or present may be closed using a closure device such as Amplatzer, Helex, CardioSEAL or other device. Other measurements of left ventricular contractility may include invasive methods, such as positioning strain gauges on the myocardium to measure changes in myocardial relaxation, positioning electrodes near the left stellate ganglion to measure single or multiple unit activity, and/or positioning skin electrodes around sympathetic nerve fibers to measure neural activity, such as compound action potentials.

Some methods may include sensing one or more cardiac characteristics from a skin surface of a patient, and adjusting a characteristic of one or more electrical pulses delivered through a catheter positioned in a pulmonary artery of the heart in response to one or more cardiac activity characteristics (e.g., a non-electrical characteristic) from a first sensor positioned at a first location in a vasculature of the heart and/or one or more cardiac characteristics from a skin surface of the patient. The one or more cardiac properties sensed from the skin surface of the patient may include, for example, electrocardiogram properties.

Some methods may include sensing, from at least a second sensor positioned at a second location in the vasculature of the heart, one or more characteristics of cardiac activity (e.g., non-electrical cardiac activity characteristic) responsive to one or more electrical pulses, and adjusting characteristics of the one or more electrical pulses delivered through a catheter positioned in a pulmonary artery of the heart responsive to the one or more characteristics of cardiac activity from the first sensor and/or the one or more characteristics of cardiac activity from the second sensor.

Adjusting the characteristics of one or more electrical pulses may include various responses. For example, adjusting the characteristics of the one or more electrical pulses may include changing which of the electrode or electrodes on the catheter is used to deliver the one or more electrical pulses. For another example, adjusting the characteristics of the one or more electrical pulses may include moving the catheter to reposition one or more electrodes of the catheter in a pulmonary artery of the heart. For yet another example, adjusting the characteristics of the one or more electrical pulses may include changing at least one of: electrode polarity, pulse pattern, pulse width, amplitude, frequency, phase, voltage, current, duration, inter-pulse interval, duty cycle, dwell time, sequence, wavelength, and/or waveform of one or more electrical pulses.

A level of electrode configuration from which one or more electrical pulses are transmitted may be assigned. The one or more electrical pulses may be delivered based on a hierarchy of electrode configurations, wherein one or more cardiac activity characteristics sensed in response to the one or more electrical pulses may be analyzed, and the electrode configuration may be selected for delivery of the one or more electrical pulses through a catheter positioned in a pulmonary artery of a heart of the patient based on the analysis. The hierarchy may be assigned to each characteristic of one or more electrical pulses delivered through a catheter positioned in a pulmonary artery of the heart, wherein the one or more electrical pulses are delivered based on the hierarchy of each characteristic. One or more non-electrical heart activity characteristics sensed in response to the one or more electrical pulses are analyzed, and based on the analysis, an electrode configuration may be selected for delivery of the one or more electrical pulses through a catheter positioned in a pulmonary artery of the patient's heart. Analyzing the one or more cardiac activity characteristics may include analyzing a predetermined number of the one or more cardiac activity characteristics.

In some examples, a method of facilitating therapeutic neuromodulation of a heart of a patient includes positioning an electrode in a pulmonary artery of the heart and positioning a sensor in a right ventricle of the heart. The method also includes transmitting the first series of electrical signals to the electrode via the stimulation system. The first series includes a plurality of first electrical signals. Each of the first plurality of electrical signals includes a plurality of parameters. Each of the first plurality of electrical signals of the first series differs from each other only in a magnitude of a first parameter of the plurality of parameters. The method also includes, after delivering the first series of electrical signals to the electrodes, delivering a second series of electrical signals to the electrodes via the stimulation system. The second series includes a second plurality of electrical signals. Each of the second plurality of electrical signals includes a plurality of parameters. Each of the second plurality of electrical signals of the second series differs from each other only in a magnitude of a second parameter of the plurality of parameters. The second parameter is different from the first parameter. The method also includes determining, via the sensor, sensor data indicative of one or more non-electrical cardiac activity characteristics responsive to the delivery of the first series of electrical signals and the second series of electrical signals, and delivering a therapeutic neuromodulation signal to the pulmonary artery using the selected electrical parameter. The selected electrical parameter includes a selected magnitude of the first parameter and a selected magnitude of the second parameter. The selected magnitudes of the first and second parameters are based at least in part on the sensor data. The therapeutic neuromodulation signals increase cardiac contractility and/or relaxation, in some examples beyond heart rate.

The method also includes transmitting a third series of electrical signals to the electrodes via the stimulation system. The third series includes a third plurality of electrical signals. Each of the third plurality of electrical signals includes a plurality of parameters. Each of the third plurality of electrical signals of the third series differs from each other only in a magnitude of a third parameter of the plurality of parameters. The third parameter is different from the first parameter and the second parameter. The method also includes determining, via the sensor, sensor data indicative of one or more non-electrical cardiac activity characteristics responsive to transmitting the third series of electrical signals. The selected electrical parameter may comprise a selected magnitude of the third parameter. The selected magnitude of the third parameter is based at least in part on the sensor data.

The method may further include determining a desired hierarchy between the first series and the second series. The pulmonary artery may include a right pulmonary artery. The one or more non-electrical cardiac activity characteristics may include at least one of a pressure characteristic, an acceleration characteristic, an acoustic characteristic, a temperature, and a blood chemistry characteristic. Determining the sensor data may include determining, via a second sensor on the skin surface, sensor data indicative of an electrocardiogram property in response to transmitting the first series of electrical signals and the second series of electrical signals.

The first parameter may be one of the following: polarity, pulse pattern, pulse width, amplitude, frequency, phase, voltage, current, duration, inter-pulse interval, duty cycle, dwell time, sequence, wavelength, waveform, or electrode combination, and optionally, the second parameter may be a different one of: polarity, pulse pattern, pulse width, amplitude, frequency, phase, voltage, current, duration, inter-pulse interval, duty cycle, dwell time, sequence, wavelength, waveform, or electrode combination. The second parameter may be one of the following: polarity, pulse pattern, pulse width, amplitude, frequency, phase, voltage, current, duration, inter-pulse interval, duty cycle, dwell time, sequence, wavelength, waveform, or electrode combination. The first parameter may include a current, and the second parameter may include a timing-related parameter (e.g., one of a frequency and a duty cycle).

In some examples, a method of facilitating therapeutic neuromodulation of a heart of a patient includes positioning an electrode in a pulmonary artery of the heart, positioning a sensor in a right ventricle of the heart, communicating a first electrical signal of a series of electrical signals to the electrode via a stimulation system, and after communicating the first electrical signal, communicating a second electrical signal of the series of electrical signals to the electrode via the stimulation system. The second electrical signal differs from the first electrical signal by a magnitude of a first parameter of the plurality of parameters. The method also includes determining, via the sensor, sensor data indicative of one or more non-electrical cardiac activity characteristics responsive to the delivery of the series of electrical signals, and delivering a therapeutic neuromodulation signal to the pulmonary artery using the selected electrical parameter. The selected electrical parameter comprises a selected magnitude of the first parameter. The selected magnitude of the first parameter is based at least in part on the sensor data. The therapeutic neuromodulation signals increase cardiac contractility and/or relaxation, in some examples beyond heart rate.

The pulmonary artery may include a right pulmonary artery. The pulmonary artery may include the left pulmonary artery. The pulmonary artery may include a pulmonary trunk. The one or more non-electrical cardiac activity characteristics may include at least one of a pressure characteristic, an acceleration characteristic, an acoustic characteristic, a temperature, and a blood chemistry characteristic. Determining the sensor data may include determining, via a second sensor on the skin surface of the patient, sensor data indicative of an electrocardiogram property in response to transmitting the series of electrical signals. The first parameter may be one of the following: polarity, pulse pattern, pulse width, amplitude, frequency, phase, voltage, current, duration, inter-pulse interval, duty cycle, dwell time, sequence, wavelength, waveform, or electrode combination.

In some examples, a method of facilitating therapeutic neuromodulation of a heart of a patient includes communicating a first series of electrical signals to an electrode in a first anatomical location, and after communicating the first series of electrical signals to the electrode, communicating a second series of electrical signals to the electrode. The first series includes a plurality of first electrical signals. Each of the first plurality of electrical signals includes a plurality of parameters. Each of the first plurality of electrical signals of the first series differs from each other only in a magnitude of a first parameter of the plurality of parameters. The second series includes a second plurality of electrical signals. Each of the second plurality of electrical signals includes a plurality of parameters. Each of the second plurality of electrical signals of the second series differs from each other only in a magnitude of a second parameter of the plurality of parameters. The second parameter is different from the first parameter. The method also includes sensing, via a sensor in a second anatomical location different from the first anatomical location, sensor data indicative of one or more non-electrical cardiac activity characteristics responsive to transmitting the first series of electrical signals and the second series of electrical signals, and providing a therapeutic neuromodulation signal to the first anatomical location using the selected electrical parameter. The selected electrical parameter includes a selected magnitude of the first parameter and a selected magnitude of the second parameter. The selected magnitudes of the first and second parameters are based at least in part on the sensor data. Treating neuromodulation signals increases cardiac contractility and/or relaxation.

The method may further include transmitting a third series of electrical signals to the electrodes. The third series includes a third plurality of electrical signals. Each of the third plurality of electrical signals includes a plurality of parameters. Each of the third plurality of electrical signals of the third series differs from each other only in a magnitude of a third parameter of the plurality of parameters. The third parameter is different from the first parameter and the second parameter. The method may further include sensing, via the sensor, sensor data indicative of one or more non-electrical cardiac activity characteristics in response to transmitting the third series of electrical signals. The selected electrical parameter may comprise a selected magnitude of the third parameter. The selected magnitude of the third parameter is based at least in part on the sensor data.

The method may further include determining a desired hierarchy between the first series and the second series. The first anatomical location may include the right pulmonary artery. The pulmonary artery may include the left pulmonary artery. The pulmonary artery may include a pulmonary trunk. The one or more non-electrical cardiac activity characteristics may include at least one of a pressure characteristic, an acceleration characteristic, an acoustic characteristic, a temperature, and a blood chemistry characteristic. Sensing the sensor data may include determining, via a second sensor on the skin surface, sensor data indicative of an electrocardiogram property in response to transmitting the first series of electrical signals and the second series of electrical signals.

The first parameter may be one of the following: polarity, pulse pattern, pulse width, amplitude, frequency, phase, voltage, current, duration, inter-pulse interval, duty cycle, dwell time, sequence, wavelength, waveform, or electrode combination, and optionally, the second parameter may be a different one of: polarity, pulse pattern, pulse width, amplitude, frequency, phase, voltage, current, duration, inter-pulse interval, duty cycle, dwell time, sequence, wavelength, waveform, or electrode combination. The second parameter may be one of the following: polarity, pulse pattern, pulse width, amplitude, frequency, phase, voltage, current, duration, inter-pulse interval, duty cycle, dwell time, sequence, wavelength, waveform, or electrode combination. The first parameter may include a current, and the second parameter may include a timing-related parameter (e.g., one of a frequency and a duty cycle).

In some examples, a method of facilitating therapeutic neuromodulation of a heart of a patient includes transmitting a first electrical signal of a series of electrical signals to an electrode in a first anatomical location, and after transmitting the first electrical signal, transmitting a second electrical signal of the series of electrical signals to the electrode. The second electrical signal differs from the first electrical signal by a magnitude of a first parameter of the plurality of parameters. The method also includes sensing, via a sensor in a second anatomical location different from the first anatomical location, sensor data indicative of one or more non-electrical cardiac activity characteristics in response to the delivery of the series of electrical signals, and providing a therapeutic neuromodulation signal to the first anatomical location using the selected electrical parameter. The selected electrical parameter comprises a selected magnitude of the first parameter. The selected magnitude of the first parameter is based at least in part on the sensor data. Treating neuromodulation signals increases cardiac contractility and/or relaxation.

The first anatomical location may include the right pulmonary artery. The first anatomical location may include the left pulmonary artery. The first anatomical location may include a pulmonary trunk. The one or more non-electrical cardiac activity characteristics may include at least one of a pressure characteristic, an acceleration characteristic, an acoustic characteristic, a temperature, and a blood chemistry characteristic. Sensing the sensor data may include sensing, via a second sensor on the skin surface of the patient, sensor data indicative of an electrocardiogram property in response to the delivery of the series of electrical signals. The first parameter may be one of the following: polarity, pulse pattern, pulse width, amplitude, frequency, phase, voltage, current, duration, inter-pulse interval, duty cycle, dwell time, sequence, wavelength, waveform, or electrode combination.

In some examples, a neuromodulation system for facilitating delivery of electrical signals to a heart of a patient includes a catheter and a stimulation system. The catheter includes a catheter body comprising: a proximal end, a distal end, a lumen extending from the proximal end toward the distal end, and an outer surface. The catheter also includes an electrode on the outer surface. The electrode is configured to transmit an electrical signal to a pulmonary artery of a patient. The catheter also includes a sensor on the outer surface. The sensor is configured to sense a cardiac activity characteristic from a location in the vasculature of the patient. The stimulation system includes a pulse generator configured to deliver a first series of electrical signals and a second series of electrical signals to the electrodes. The first series includes a plurality of first electrical signals. Each of the first plurality of electrical signals includes a plurality of parameters. Each of the first plurality of electrical signals of the first series differs from each other only in a magnitude of a first parameter of the plurality of parameters. The second series includes a second plurality of electrical signals. Each of the second plurality of electrical signals includes a plurality of parameters. Each of the second plurality of electrical signals of the second series differs from each other only in a magnitude of a second parameter of the plurality of parameters. The second parameter is different from the first parameter. The stimulation system also includes a non-transitory computer-readable medium configured to store sensor data indicative of one or more non-electrical cardiac activity characteristics responsive to communicating the first series of electrical signals and the second series of electrical signals to the electrode, and a processor configured to determine a selected magnitude of the first parameter and a selected magnitude of the second parameter based at least in part on the sensor data. The non-transitory computer readable medium is configured to store a selected electrical parameter that includes a selected magnitude of a first parameter and a selected magnitude of a second parameter. The pulse generator is configured to transmit a therapeutic neuromodulation signal to the electrode using the selected electrical parameter.

In some examples, a neuromodulation system for facilitating delivery of electrical signals to a heart of a patient includes a catheter and a stimulation system. The catheter includes a catheter body comprising: a proximal end, a distal end, a lumen extending from the proximal end toward the distal end, and an outer surface. The catheter also includes an electrode on the outer surface. The electrode is configured to transmit an electrical signal to a pulmonary artery of a patient. The catheter also includes a sensor on the outer surface. The sensor is configured to sense a cardiac activity characteristic from a location in the vasculature of the patient. The stimulation system includes a pulse generator configured to deliver a series of electrical signals to the electrodes. The series includes a first electrical signal and a second electrical signal. The second electrical signal differs from the first electrical signal by a magnitude of a first parameter of the plurality of parameters. The stimulation system also includes a non-transitory computer-readable medium configured to store sensor data indicative of one or more non-electrical cardiac activity characteristics responsive to communicating the series of electrical signals to the electrodes, and a processor configured to determine a selected magnitude of the first parameter based at least in part on the sensor data. The non-transitory computer readable medium is configured to store a selected electrical parameter, the selected electrical parameter comprising a selected magnitude of the first parameter. The pulse generator is configured to transmit a therapeutic neuromodulation signal to the electrode using the selected electrical parameter.

In some examples, a neuromodulation system for facilitating delivery of electrical signals to a heart of a patient includes a catheter and a shaping wire. The catheter includes a catheter body comprising: a proximal end, a distal end, a lumen extending from the proximal end toward the distal end, and an outer surface. The catheter also includes an electrode on the outer surface. The electrode is configured to transmit an electrical signal to a pulmonary artery of a patient. The shaping wire is configured to be positioned within the lumen of the catheter body. The forming wire includes a buckling portion. The catheter body includes a curved portion corresponding to the buckling portion of the shaping wire when the shaping wire is inserted into the lumen of the catheter body.

The cardiac activity characteristic may include a non-electrical cardiac activity characteristic. The non-electrical cardiac activity characteristic may include at least one of a pressure characteristic, an acceleration characteristic, an acoustic characteristic, a temperature, and a blood chemistry characteristic. The electrodes may be configured to transmit electrical signals to the right pulmonary artery of the patient. The electrodes may be configured to be positioned in a different location than the sensor. The catheter system may comprise a plurality of electrodes including said electrode. The location may be a pulmonary trunk, a right ventricle, a septal wall of the right ventricle, a right atrium, a septal wall of the right atrium, a superior vena cava, a pulmonary branch vessel, an inferior vena cava, or a coronary sinus. The neuromodulation system may also include a skin sensor configured to sense a cardiac characteristic from a skin surface of the patient. The cardiac activity characteristic may comprise a non-electrical cardiac activity characteristic, and wherein the cardiac characteristic comprises an electrical cardiac characteristic. The electrical cardiac property may comprise an electrocardiogram property.

In some examples, a method of neuromodulation of a heart of a patient includes positioning a catheter including electrodes in a pulmonary artery of the patient, positioning a sensor in a location in a vasculature of the heart, delivering a first set of one or more electrical pulses to the electrodes via a stimulation system, the first set of one or more electrical pulses having a first pulse characteristic, and after delivering the first set of one or more electrical pulses to the electrodes, delivering a second set of one or more electrical pulses to the electrodes via the stimulation system. The second set of one or more electrical pulses has a second pulse characteristic different from the first pulse characteristic. The method also includes conveying the therapeutic electrical pulses to the pulmonary artery using an electrode configuration selected by analyzing one or more characteristics of cardiac activity sensed via the sensor in response to the delivery of the first and second sets of electrical pulses. The electrode configuration includes a first pulse characteristic or a second pulse characteristic based at least in part on the analysis. The therapeutic neuromodulation signals increase cardiac contractility and/or relaxation, in some examples beyond heart rate.

In some examples, a method of modulation (e.g., electrical neuromodulation) of a patient's heart includes delivering one or more electrical pulses through a catheter positioned in a pulmonary artery of the patient's heart, sensing, from at least a first sensor positioned at a first location in a vasculature of the heart, one or more non-electrical cardiac activity characteristics responsive to the one or more electrical pulses, and adjusting, responsive to the one or more non-electrical cardiac activity characteristics, a characteristic of the one or more electrical pulses delivered through the catheter positioned in the pulmonary artery of the heart.

In some examples, sensing from at least a first sensor positioned at a first location may include sensing from the vasculature of the heart one or more of: pressure characteristics, acceleration characteristics, acoustic characteristics, temperature, or blood chemistry characteristics.

In one example, the first sensor is placed in one of a left pulmonary artery, a right pulmonary artery, or a pulmonary trunk of the heart. One or more electrical pulses are delivered through a catheter positioned in one of the left pulmonary artery, the right pulmonary artery, or the pulmonary trunk of the heart that does not contain the first sensor.

The first sensor may be positioned in the left pulmonary artery. The first sensor may be positioned in the right pulmonary artery. The first sensor may be positioned in other vessels in and around the heart, including but not limited to: pulmonary trunk, pulmonary artery branch vessel, right ventricle, septal wall of right ventricle, right atrium, septal wall of right atrium, superior vena cava, inferior vena cava, or coronary sinus. The first sensor (e.g., in the coronary sinus) may sense at least one of temperature or blood oxygen level.

In a number of examples, the method can include sensing one or more cardiac characteristics from a skin surface of a patient, and adjusting characteristics of one or more electrical pulses delivered through a catheter positioned in a pulmonary artery of the heart in response to the one or more non-electrical cardiac activity characteristics and the one or more cardiac characteristics from the skin surface of the patient. The one or more cardiac characteristics sensed from the skin surface of the patient may include electrocardiogram characteristics. The method may include sensing, from at least a second sensor positioned at a second location in the vasculature of the heart, one or more non-electrical cardiac activity characteristics responsive to the one or more electrical pulses, and adjusting characteristics of the one or more electrical pulses delivered through a catheter positioned in a pulmonary artery of the heart in response to the one or more non-electrical cardiac activity characteristics received by the first sensor and the second sensor. In several examples, adjusting the characteristics of the one or more electrical pulses may include one or more of: (i) changing which electrode on the catheter is used to deliver one or more electrical pulses; (ii) moving the catheter to reposition the electrodes of the catheter in the pulmonary artery of the heart; (iii) altering at least one of: electrode polarity, pulse pattern, pulse width, amplitude, frequency, phase, voltage, current, duration, inter-pulse interval, duty cycle, dwell time, sequence, wavelength, waveform, or electrode combination of one or more electrical pulses.

In a number of examples, the method may include assigning a hierarchy of electrode configurations from which to transmit one or more electrical pulses, transmitting the one or more electrical pulses based at least in part on the hierarchy of electrode configurations, analyzing one or more non-electrical cardiac activity characteristics sensed in response to the one or more electrical pulses, and selecting an electrode configuration for transmission of the one or more electrical pulses through a catheter positioned in a pulmonary artery of a heart of a patient based at least in part on the analysis. The method may include assigning a hierarchy to each characteristic of one or more electrical pulses delivered through a catheter positioned in a pulmonary artery of a heart, delivering the one or more electrical pulses based at least in part on the hierarchy of each characteristic, analyzing one or more non-electrical cardiac activity characteristics sensed in response to the one or more electrical pulses, and selecting an electrode configuration for delivery of the one or more electrical pulses through a catheter positioned in a pulmonary artery of a heart of a patient based at least in part on the analysis. Analyzing the one or more non-electrical cardiac activity characteristics may include analyzing a predetermined number of the one or more non-electrical cardiac activity characteristics.

In several examples, no therapeutic neuromodulation is provided. Rather, several examples are provided for the purpose of calibrating or optimizing signals (e.g., diagnostic or calibration purposes).

In some examples, a non-therapeutic calibration method includes positioning an electrode in a pulmonary artery of a heart and positioning a sensor in a right ventricle of the heart. The system also includes transmitting the first series of electrical signals to the electrode via the stimulation system. The first series includes a plurality of first electrical signals. Each of the first plurality of electrical signals includes a plurality of parameters. Each of the first plurality of electrical signals of the first series differs from each other only in a magnitude of a first parameter of the plurality of parameters. The method also includes, after delivering the first series of electrical signals to the electrodes, delivering a second series of electrical signals to the electrodes via the stimulation system. The second series includes a second plurality of electrical signals. Each of the second plurality of electrical signals includes a plurality of parameters. Each of the second plurality of electrical signals of the second series differs from each other only in a magnitude of a second parameter of the plurality of parameters. The second parameter is different from the first parameter. The method also includes determining, via the sensor, sensor data indicative of one or more non-electrical cardiac activity characteristics responsive to transmitting the first series of electrical signals and the second series of electrical signals. The method also includes determining a therapeutic neuromodulation signal to be delivered to the pulmonary artery using the selected electrical parameter. The selected electrical parameter includes a selected magnitude of the first parameter and a selected magnitude of the second parameter. The selected magnitudes of the first and second parameters are based at least in part on the sensor data.

In some examples, a non-therapeutic calibration method includes communicating a first electrical signal of a series of electrical signals to an electrode in a first anatomical location, and after communicating the first electrical signal, communicating a second electrical signal of the series of electrical signals to the electrode. The second electrical signal differs from the first electrical signal by a magnitude of a first parameter of the plurality of parameters. The method also includes sensing, via a sensor in a second anatomical location different from the first anatomical location, sensor data indicative of one or more non-electrical cardiac activity characteristics in response to the delivery of the series of electrical signals, and determining, using the selected electrical parameter, a therapeutic neuromodulation signal to be delivered to the first anatomical location. The selected electrical parameter comprises a selected magnitude of the first parameter. The selected magnitude of the first parameter is based at least in part on the sensor data.

In some examples, an apparatus comprises or consists essentially of a first portion and a second portion. The first portion includes a first annular portion having a first diameter and a first plurality of splines extending distally from the first annular portion. The second portion includes a second annular portion having a second diameter and a second plurality of splines extending distally and radially outward from the second annular portion. The second diameter is smaller than the first diameter. The second annular portion is capable of telescoping within the first annular portion. Each of the first plurality of splines is coupled to one of the second plurality of splines. The first portion expands from the collapsed state to the expanded state upon distal longitudinal advancement of the second portion relative to the first portion. The first plurality of splines are circumferentially spaced in the expanded state. The first portion collapses from an expanded state to a collapsed state upon proximal longitudinal retraction of the second portion relative to the first portion.

The distal end of each of the first plurality of splines may be coupled to one of the second plurality of splines.

The distal end of each of the first plurality of splines may be coupled to one of the second plurality of splines at the distal proximal end of the one of the second plurality of splines. The distal ends of the second plurality of splines may include fixation elements. At least some of the first plurality of splines may include electrodes. Each spline of the first plurality of splines may include a plurality of electrodes. The plurality of electrodes may at least partially form an electrode matrix.

The apparatus may further include a membrane coupled to the first plurality of splines, the membrane including a plurality of electrodes that at least partially form an electrode matrix. A longitudinal length from a proximal end of a most proximal electrode of the plurality of electrodes to a distal end of a most distal electrode of the plurality of electrodes may be between 20mm and 40 mm. The first plurality of splines may have a diameter in the expanded state of between 15mm and 35 mm.

The device may further include a catheter coupled to the first annular portion and an inner member within an inner lumen of the catheter and coupled to the second annular portion. The inner member may be movable relative to the catheter to distally advance and proximally retract the second portion. The proximal end of the first annular portion may be coupled in the distal end of the lumen of the catheter. A proximal end of the second annular portion may be coupled in a distal end of the lumen of the inner member. The inner member may be trackable over a guidewire.

The device may further include a holder coupled to the inner member, a spring engaging the holder, and a handle element coupled to the inner member. Upon distal advancement of the handle element, the spring may be longitudinally expanded, the inner member may be longitudinally advanced distally, the second portion may be longitudinally advanced distally, and the first portion may expand from the collapsed state to the expanded state. Upon proximal retraction of the handle element, the spring may be longitudinally compressed, the inner member may be proximally longitudinally retracted, the second portion may be proximally longitudinally retracted, and the first portion collapses from the expanded state to the collapsed state. The spring may be configured to retract the handle element at least partially proximally.

The device may further include a locking mechanism configured to maintain the handle element in the distally advanced state. The locking element may include a plurality of arms having open proximal ends. The handle element may be configured to extend through the open proximal end as the distal end is advanced. The locking element may include a plurality of arms having a closed proximal end. The handle element may be configured to engage the closed proximal end as the distal end is advanced. The plurality of arms may comprise leaf springs. The leaf spring may be configured to at least partially proximally retract the handle element.

The first plurality of splines may not be self-expanding. The first plurality of splines may be self-expanding. The first plurality of splines may comprise a non-tapered shape in the expanded state. The first portion may include a first cutting hypotube. The first loop portion may include a hypotube and the first plurality of splines may include a plurality of wires. The second portion may comprise a second cut hypotube.

In some examples, an apparatus includes or consists essentially of a plurality of splines, a structure coupled to at least one of the plurality of splines, and an electrode coupled to the structure.

The apparatus may include a plurality of electrodes coupled to the structure. The plurality of electrodes may be the electrodes. The plurality of electrodes may at least partially form an electrode matrix. The electrode matrix may comprise a 3 x 4 matrix.

The structure may be coupled to at least two splines of a plurality of splines. The electrode may be circumferentially located between two splines of the plurality of splines. The electrode may be circumferentially aligned with a spline of the plurality of splines.

The apparatus may further include a second electrode coupled to one of the plurality of splines. The structure may include a plurality of flexible strands (strands) connected to form a pattern of openings. The structure may comprise a grid. The structure may comprise a woven or knitted membrane. The structure may include a shape memory material having an expanded shape when unconstrained. The structure may comprise an insulating material.

In some examples, the apparatus comprises or consists essentially of a first sidewall, a second sidewall spaced from the first sidewall, and a third sidewall between the first sidewall and the second sidewall. The first, second, and third sidewalls at least partially define a U-shaped channel. The device also includes a plurality of conductors and an electrode electrically connected to one of the plurality of conductors in the slot.

The device may comprise a plurality of electrodes including said electrode. The plurality of electrodes may at least partially form an electrode matrix. Each of the plurality of electrodes may be electrically connected to one of the plurality of conductors. The electrode may have a dome shape.

The device may further comprise an insulating material between the plurality of conductors and the electrodes. The apparatus may further include an insulating material between the plurality of conductors and the third sidewall. The device may further comprise an insulating material extending at least over the bottom of the electrode. The insulating material may comprise a dome shape. The insulating material may include a planar upper surface. The insulating material may include a raised surface. An insulating material may cover the sharp edges of the electrodes.

The electrodes may not have uninsulated sharp edges. The electrodes may be configured to be spaced from a vessel wall surface.

In some examples, a system includes a plurality of the apparatus. The plurality of devices may at least partially form an electrode matrix.

In some examples, the device comprises or consists essentially of a catheter including a lumen, a fixation structure, and a fixation element. The fixing structure comprises a first side, a second side and a torsion part. The fixation element is coupled to a first side of the fixation structure. The first side faces radially inward when the fixation structure is inside the catheter lumen and faces radially outward when the fixation structure is outside the catheter lumen.

The lumen may be shaped to correspond to the shape of the fixation structure and fixation element. The twist may be 180 °. The fixation structure may comprise a ribbon (ribbon). The securing structure may include a post. The fixation structure may be configured to flex radially outward when deployed from the catheter. The fixation structure may include a conical spike (conical spike).

In some examples, the device may include or consist essentially of a fixation structure, a fixation mechanism, and an attachment point coupling the fixation structure to the fixation mechanism. The fixation mechanism is configured to rotate radially outward when the fixation structure is expanded. The securing mechanism is configured to rotate radially inward when the securing mechanism is collapsed. In the expanded state, the fixation mechanism extends radially outward of the fixation structure.

The securing mechanism may comprise an aperture. The device may also include a radiopaque marker coupled to the fixation mechanism.

The device may also include a tether extending distally from the attachment point. The tether may include a bend along the longitudinal length of the securing mechanism. The flexure may be between 30% and 70% of the longitudinal length of the fixation mechanism. The tether may include an angled portion having a wide edge coupled to the attachment point. The tether may include a twist proximal to the attachment point.

The device may further include a second fixation mechanism extending distally from the fixation structure. The fixation structure, fixation element, and attachment point may be integrally cut from the same hypotube. The fixed structure may comprise an electrode. The fixation structure may comprise a plurality of electrodes including said electrode. The plurality of electrodes may at least partially form an electrode matrix.

In some examples, a method of forming a device includes or consists essentially of cutting a hypotube to form a fixation structure, a fixation mechanism, and an attachment point coupling the fixation structure and the fixation mechanism, and shape setting an expanded shape. The expanded shape includes the fixation mechanism flexing radially outward of the fixation structure. After the shape sets the expanded shape, the securing mechanism is configured to rotate radially outward when the securing structure is expanded and the securing mechanism is configured to rotate radially inward when the securing structure is collapsed.

Cutting the hypotube may also include laser cutting the hypotube. Cutting the hypotube may include forming a tether extending proximally from the attachment point. The shape setting may include flexing the tether along a longitudinal length of the securing mechanism. The tether may be flexed between 30% and 70% of the longitudinal length of the securing mechanism. The shape setting may include flexing the tether at a proximal end of the attachment point. The shape setting may include forming a twist in the tether proximal to the attachment point.

In some examples, the device includes or consists essentially of a fixation structure, a fixation arm, and a fixation mechanism coupled to the fixation arm. The fixation structure includes an aperture, a first surface, and a second surface opposite the first surface. The securing arm is coupled to the interior of the aperture of the securing structure. The fixing arm does not protrude above the first surface in the first state.

The fixation arms may be configured to flex radially outward when unconstrained by the catheter. The securement mechanism may protrude above the first surface when the securement arm is unconstrained by the catheter. The fixation arm may be configured to remain stationary when unconstrained by the catheter. The securing mechanism may not protrude above the first surface when the securing arm may not be constrained by the catheter.

The securing structure and the securing arm may be formed from the same piece of material. The aperture may extend from the first surface to the second surface. The aperture may extend from the first surface to a point above the second surface. The securing mechanism may include a tapered spike. The securing mechanism may include a textured surface.

In some examples, the device comprises or consists essentially of a catheter including a lumen, a first loop longitudinally movable from within the lumen of the catheter out of the lumen of the catheter, and a second loop longitudinally movable from within the lumen of the catheter out of the lumen of the catheter. At least one of the catheter, the first loop, and the second loop includes a first electrode. At least one of the first and second loops may be a tap (pigtail) at the finger end.

The first ring may include a first plurality of electrodes including the first electrode. The first plurality of electrodes may at least partially form a first electrode matrix. The second ring may include a second plurality of electrodes. The second plurality of electrodes may at least partially form a second electrode matrix. The second ring may include a second electrode.

The first ring may include a first portion and a second portion, the first portion including an electrode of the first plurality of electrodes and the second portion including an electrode of the first plurality of electrodes. The second portion may be spaced from the first portion. The second portion may be parallel to the first portion.

The first ring may include an undulating section including peaks and valleys. The undulating section may comprise a first plurality of electrodes. The undulating section may comprise an electrode of the first plurality of electrodes near the peak and an electrode of the first plurality of electrodes near the trough.

The catheter may comprise a plurality of electrodes including said first electrode. The first plurality of electrodes may at least partially form a first electrode matrix.

The first and second rings may be configured to be deployed from the lumen of the catheter at least partially simultaneously. The first and second rings may be configured to be sequentially deployed from the lumen of the catheter.

The device may also include a securing feature extending radially outward from the conduit. The fixation feature may comprise an atraumatic hard ring.

In some examples, a method of using the device includes advancing a catheter distal to a pulmonary valve, advancing the catheter distal to the pulmonary valve, deploying the first and second rings, advancing the catheter distal to a pulmonary artery bifurcation after deploying the first and second rings. The first and second loops are self-orienting such that one of the first and second loops extends into the right pulmonary artery and the other of the first and second loops extends into the left pulmonary artery.

The method may include advancing the catheter distally until advancement may be limited by a pulmonary artery bifurcation. The method may further include extending a fixation feature proximally of the pulmonary valve. The method may further include attempting to capture the target nerve with the first electrode.

The method may further comprise: if the target nerve cannot be captured, the first and second rings are withdrawn into the lumen of the catheter, the catheter is proximally withdrawn, the catheter is rotated, after the catheter is rotated, the first and second rings are redeployed, and, after the first and second rings are redeployed, the catheter is distally advanced toward the pulmonary artery bifurcation. The first and second loops are self-orienting such that one of the first and second loops extends into the right pulmonary artery and the other of the first and second loops extends in an opposite direction into the left pulmonary artery. The method may further comprise: if the target nerve cannot be captured, an attempt is made to capture the target nerve with the second electrode.

In some examples, the device comprises or consists essentially of a catheter comprising a lumen and a ring that is longitudinally movable from within the lumen of the catheter to outside the lumen of the catheter. At least one of the catheter and the ring includes a first electrode.

The ring may comprise a first plurality of electrodes including said first electrode. The first plurality of electrodes may at least partially form a first electrode matrix.

The ring may include a first portion and a second portion, the first portion including an electrode of the first plurality of electrodes and the second portion including an electrode of the first plurality of electrodes. The second portion may be spaced from the first portion. The second portion may be parallel to the first portion.

The ring may include an undulating section including peaks and valleys. The undulating section may comprise a first plurality of electrodes. The undulating section may comprise an electrode of the first plurality of electrodes near the peak and an electrode of the first plurality of electrodes near the trough.

The catheter may include a first plurality of electrodes including the first electrode. The first plurality of electrodes may at least partially form a first electrode matrix.

The loop may be configured to deploy the distal end of the catheter out of the lumen of the catheter. The loop may be configured to deploy one side of the catheter out of the lumen of the catheter.

The device may also include a securing feature extending radially outward from the conduit. The fixation feature may comprise an atraumatic hard ring.

The ring may be tapped at the finger ends.

Methods of using the device may include deploying a ring out of a lumen of a catheter; advancing a catheter in the first branch vessel toward the main vessel after deploying the loop; allowing the loop to radially expand at a bifurcation comprising a first branch vessel, a main vessel, and a second branch vessel; and after allowing the ring to radially expand, proximally retracting the catheter until the ring contacts the second branch vessel.

The first branch vessel may include a left internal jugular vein (left internal jugular vein), the main vessel may include a left brachiocephalic vein, and the second branch vessel may include a left subclavian vein.

The method may further comprise extending the fixation feature.

The method may further include attempting to capture the target nerve with the first electrode. The target nerve may include a thoracic cardiac branch nerve. The target nerve may include a cervical cardiac nerve.

The catheter may include a curvature configured to flex toward the target nerve.

In some examples, a device comprises or consists essentially of a catheter including a lumen, a first sinusoidal wire, a second sinusoidal wire radially spaced from the first sinusoidal wire, and a plurality of electrodes.

Each of the plurality of electrodes may be coupled to at least one of the first and second sinusoidal wires.

The device may also include a membrane coupled to the first sinusoidal wire and the second sinusoidal wire. Each of the plurality of electrodes may be coupled to the membrane. The membrane may be configured to have a curved shape in the expanded state. The film may include a flexible circuit including conductive lines.

The plurality of electrodes may include button electrodes (button electrodes). The plurality of electrodes may include a tube electrode (barrel electrode). The plurality of electrodes may include cylindrical electrodes. The plurality of electrodes may include a directional electrode. The centers of the plurality of electrodes may be longitudinally offset.

The catheter may include a first section and a second section distal to the first section. The first section may have a circular cross-section. The second section may have an oval cross-section. The second section may be configured to contain a first sinusoidal wire and a second sinusoidal wire.

The first and second sinusoidal wires may be planar in the expanded state. The first and second sinusoidal wires may be angled in the expanded state. The first and second sinusoidal wires may include a shape memory material.

In some examples, the device includes or consists essentially of a handle, a sheath, and an electrode system that can move in and out of the sheath. The handle includes a repositioning system. The repositioning system includes a track and a grip (knob) slidable within the track. The electrode system is configured to move longitudinally when the grip moves longitudinally in the track and to move rotationally when the grip moves laterally or rotationally in the track.

The track may include a longitudinal section, a first transverse section extending from the longitudinal section in a first direction, and a second transverse section extending from the longitudinal section in a second direction opposite the first direction. The first transverse section may be longitudinally offset from the second transverse section. The first transverse segment may be longitudinally aligned with the second transverse segment.

The electrode system may be configured to move a longitudinal distance when the grip moves the same longitudinal distance in the track. The electrode system may be configured to rotate through a circumferential angle as the grip is moved laterally or rotationally in the track. The apparatus may further comprise a rotation stop to limit rotation of the electrode system to the circumferential angle.

The device may further include a detent and a groove configured to interact with the detent when the grip is moved. The detent may be configured to produce an audible indicia.

The device may also include a physical barrier configured to prevent accidental movement of the grip.

In some examples, a device includes or consists essentially of an expandable structure having a collapsed state and an expanded state. The expandable structure, in an expanded state, comprises a plurality of splines, each spline comprising a proximal section comprising a first portion, a second portion distal to the first portion, and a third portion distal to the second portion; an intermediate section distal to the proximal section; and a distal section distal to the intermediate section, the distal section including a fourth portion, a fifth portion distal to the fourth portion, and a sixth portion distal to the fifth portion. The first portion is parallel to the longitudinal axis. The second portion extends radially outward from the first portion. The third portion extends radially outward from the second portion and transverse to the longitudinal axis to the intermediate section. The fourth portion extends radially inward from the intermediate section and transverse to the longitudinal axis. The fifth portion extends radially inward from the fourth portion. The sixth portion extends from the fifth portion parallel to the longitudinal axis. At least two intermediate segments of the plurality of splines are circumferentially spaced and include a plurality of electrodes forming an electrode matrix.

The expandable structure may be self-expanding. The expandable structure may be expandable upon operation of the actuation mechanism.

In the expanded state, the at least two intermediate sections may be parallel to the longitudinal axis. In the expanded state, the at least two intermediate sections may be concave relative to the longitudinal axis. In the expanded state, the at least two intermediate sections may be convex with respect to the longitudinal axis.

Pairs of the first portions of the plurality of splines may be parallel. Pairs of the sixth portions of the plurality of splines may be parallel. Pairs of the first portions of the plurality of splines may be twisted. The pair of sixth portions of the plurality of splines may be twisted.

The proximal ends of the mid-sections of the plurality of splines may be longitudinally aligned. The proximal ends of the mid-sections of the plurality of splines may be longitudinally offset. The distal ends of the mid-sections of the plurality of splines may be longitudinally aligned. The distal ends of the mid-sections of the plurality of splines may be longitudinally offset.

The plurality of splines may also include splines located circumferentially between at least two mid-sections.

The plurality of splines may comprise a plurality of wires. A plurality of splines may be formed from the cut hypotube.

The expandable structure may further include a membrane coupled to the at least two intermediate sections. The membrane may comprise a matrix of electrodes.

The device may further include a proximal portion and a catheter shaft coupled to the proximal portion and to the expandable structure. The device may also include an actuator wire. The proximal portion may include an actuator mechanism. The actuator wire may be coupled to the actuator mechanism and to the expandable structure. The expandable structure may be configured to expand upon operation of the actuator mechanism. The proximal portion may include a Y-connector including a first branch configured to receive a guidewire and a second branch configured to electrically connect the electrode matrix to a stimulation system.

The device may further include a strain relief (strain relief) between the catheter shaft and the expandable structure. The strain relief means may comprise a spring. The strain relief device may comprise a cut hypotube. The cut hypotube may comprise a plurality of helices having the same chirality (sense).

The expandable structure may include a distal hub (hub) comprising a plurality of channels. The distal segments of the plurality of splines are slidable in the channels of the distal hub. The distal section may include a distal end having a dimension greater than a dimension of the channel.

In some examples, the device comprises or consists essentially of an expandable structure having a collapsed state and an expanded state. The expandable structure, in an expanded state, includes a plurality of arms, each arm including a proximal segment, an intermediate segment distal to the proximal segment, and a distal segment distal to the intermediate segment. The intermediate section of the plurality of arms includes an opening. At least two intermediate sections of the plurality of splines include a plurality of electrodes forming an electrode matrix.

The expandable structure may be self-expanding. The expandable structure may be expanded upon operation of an actuation mechanism.

In the expanded state, the at least two intermediate sections may be parallel to the longitudinal axis. In the expanded state, the at least two intermediate sections may be concave relative to the longitudinal axis. In the expanded state, the at least two intermediate sections may be convex with respect to the longitudinal axis.

Pairs of the first portions of the plurality of splines may be parallel. Pairs of the sixth portions of the plurality of splines may be parallel. Pairs of the first portions of the plurality of splines may be twisted. The pair of sixth portions of the plurality of splines may be twisted.

The proximal ends of the mid-sections of the plurality of splines may be longitudinally aligned. The proximal ends of the mid-sections of the plurality of splines may be longitudinally offset. The distal ends of the mid-sections of the plurality of splines may be longitudinally aligned. The distal ends of the mid-sections of the plurality of splines may be longitudinally offset.

The plurality of splines may further comprise splines located circumferentially between the at least two mid-sections.

The plurality of splines may comprise a plurality of wires. A plurality of splines may be formed from the cut hypotube.

The expandable structure may further include a membrane coupled to the at least two intermediate sections. The membrane may comprise a matrix of electrodes.

The device may also include a proximal portion and a catheter shaft coupled to the proximal portion and to the expandable structure. The device may also include an actuator wire. The proximal portion may include an actuator mechanism. The actuator wire may be coupled to the actuator mechanism and to the expandable structure. The expandable structure may be configured to expand upon operation of the actuator mechanism. The proximal portion may include a Y-connector including a first branch configured to receive a guidewire and a second branch configured to electrically connect the electrode matrix to a stimulation system.

The device may further include a strain relief between the catheter shaft and the expandable structure. The strain relief means may comprise a spring. The strain relief device may include a cut hypotube. The cut hypotube may include multiple helices having the same chirality.

The expandable structure may include a distal hub including a plurality of channels. The distal segments of the plurality of splines are slidable in the channels of the distal hub. The distal section may include a distal end having a dimension greater than a dimension of the channel.

In some examples, the device comprises or consists essentially of an expandable structure having a collapsed state and an expanded state. The expandable structure, in an expanded state, comprises a plurality of splines, each spline comprising a proximal section comprising a first portion, a second portion distal to the first portion, and a third portion distal to the second portion; an intermediate section distal to the proximal section; a distal section distal to the intermediate section, the distal section including a fourth portion, a fifth portion distal to the fourth portion, and a sixth portion distal to the fifth portion. The first portion is parallel to the longitudinal axis. The second portion extends radially outward from the first portion. The third portion extends radially outward from the second portion and transverse to the longitudinal axis to the intermediate section. The fourth portion extends radially inward from the intermediate section and transverse to the longitudinal axis. The fifth portion extends radially inward from the fourth portion. The sixth portion extends from the fifth portion parallel to the longitudinal axis. The mid-segments of the plurality of splines have an undulating shape with respect to the longitudinal axis. At least two intermediate sections of the plurality of splines include a plurality of electrodes forming an electrode matrix.

The expandable structure may be self-expanding. The expandable structure may be expandable upon operation of the actuation mechanism.

Pairs of the first portions of the plurality of splines may be parallel. Pairs of the sixth portions of the plurality of splines may be parallel. Pairs of the first portions of the plurality of splines may be twisted. The pair of sixth portions of the plurality of splines may be twisted.

Proximal ends of the mid-sections of the plurality of splines may be longitudinally aligned. The proximal ends of the mid-sections of the plurality of splines may be longitudinally offset. Distal ends of the mid-sections of the plurality of splines may be longitudinally aligned. The distal ends of the mid-sections of the plurality of splines may be longitudinally offset.

The intermediate section may include peaks and valleys. The peaks and valleys of the at least two intermediate sections may be longitudinally aligned. The peaks and troughs of the at least two intermediate sections may be longitudinally offset.

The plurality of splines may comprise a plurality of wires. A plurality of splines may be formed from the cut hypotube.

The expandable structure may further include a membrane coupled to the at least two intermediate sections. The membrane may comprise a matrix of electrodes.

The device may also include a proximal portion and a catheter shaft coupled to the proximal portion and to the expandable structure. The device may also include an actuator wire. The proximal portion may include an actuator mechanism. The actuator wire may be coupled to the actuator mechanism and to the expandable structure. The expandable structure may be configured to expand upon operation of the actuator mechanism. The proximal portion may include a Y-connector including a first branch configured to receive a guidewire and a second branch configured to electrically connect the electrode matrix to a stimulation system.

The device may further include a strain relief between the catheter shaft and the expandable structure. The strain relief means may comprise a spring. The strain relief device may comprise a cut hypotube. The cut hypotube may include multiple helices having the same chirality.

The expandable structure may include a distal hub including a plurality of channels. The distal segments of the plurality of splines are slidable in the channels of the distal hub. The distal section may include a distal end having a dimension greater than a dimension of the channel.

In some examples, the device comprises or consists essentially of an expandable structure having a collapsed state and an expanded state. The expandable structure, in an expanded state, includes a plurality of arms, each arm including a proximal segment, an intermediate segment distal to the proximal segment, and a distal segment distal to the intermediate segment. The intermediate sections of the plurality of arms comprise a sinusoidal shape. At least two intermediate sections of the plurality of splines include a plurality of electrodes forming an electrode matrix.

The expandable structure may be self-expanding. The expandable structure may be expandable upon operation of the actuation mechanism.

Pairs of the first portions of the plurality of splines may be parallel. Pairs of the sixth portions of the plurality of splines may be parallel. Pairs of the first portions of the plurality of splines may be twisted. The pair of sixth portions of the plurality of splines may be twisted.

The proximal ends of the mid-sections of the plurality of splines may be longitudinally aligned. The proximal ends of the mid-sections of the plurality of splines may be longitudinally offset. The distal ends of the mid-sections of the plurality of splines may be longitudinally aligned. The distal ends of the mid-sections of the plurality of splines may be longitudinally offset.

The intermediate section may include peaks and valleys. The peaks and valleys of the at least two intermediate sections may be longitudinally aligned. The peaks and troughs of the at least two intermediate sections may be longitudinally offset

The plurality of splines may comprise a plurality of wires. A plurality of splines may be formed from the cut hypotube.

The expandable structure may further include a membrane coupled to the at least two intermediate sections. The membrane may comprise a matrix of electrodes.

The device may also include a proximal portion and a catheter shaft coupled to the proximal portion and to the expandable structure. The device may also include an actuator wire. The proximal portion may include an actuator mechanism. The actuator wire may be coupled to the actuator mechanism and to the expandable structure. The expandable structure may be configured to expand upon operation of the actuator mechanism. The proximal portion may include a Y-connector including a first branch configured to receive a guidewire and a second branch configured to electrically connect the electrode matrix to a stimulation system.

The device may further include a strain relief between the catheter shaft and the expandable structure. The strain relief means may comprise a spring. The strain relief device may comprise a cut hypotube. The cut hypotube may include multiple helices having the same chirality.

The expandable structure may include a distal hub including a plurality of channels. The distal segments of the plurality of splines are slidable in the channels of the distal hub. The distal section may include a distal end having a dimension greater than a dimension of the channel.

In some examples, the device comprises, or consists essentially of, a longitudinal axis and a distal portion. The distal portion includes a first expandable structure and a second expandable structure distal to the first expandable structure. The first expandable structure has a collapsed state and an expanded state. In the expanded state, the expandable structure includes a plurality of arms, each arm including a proximal segment, an intermediate segment distal to the proximal segment, and a distal segment distal to the intermediate segment. The plurality of arms are located on a first side of a plane including the longitudinal axis. At least two intermediate sections of the plurality of splines comprise a plurality of electrodes forming an electrode matrix; and

the second expandable structure may comprise a Swan-Ganz balloon. The second expandable structure may be between 0.25cm and 5cm distal to the first expandable structure.

The first expandable structure may be self-expanding. The first expandable structure may be expandable upon operation of the actuation mechanism.

The plurality of splines may comprise a plurality of wires. A plurality of splines may be formed from the cut hypotube.

The first expandable structure may further include a membrane coupled to the at least two intermediate sections. The membrane may comprise a matrix of electrodes.

The device may also include a proximal portion and a catheter shaft coupled to the proximal portion and to the expandable structure. The catheter shaft may be configured to be proximate to a (appose) body lumen wall. The device may also include an actuator wire. The proximal portion may include an actuator mechanism. An actuator wire may be coupled to the actuator mechanism and to the first expandable structure. The first expandable structure may be configured to expand upon operation of the actuator mechanism. The proximal portion may include a Y-connector including a first branch configured to receive a guidewire and a second branch configured to electrically connect the electrode matrix to a stimulation system.

The first expandable structure may include a distal hub including a plurality of channels. The distal segments of the plurality of splines are slidable in the channels of the distal hub. The distal section may include a distal end having a dimension greater than a dimension of the channel.

The device may further include a tubular member extending from the proximal end portion to the second expandable structure. The tubular member may include a lumen configured to inflate the second expandable structure when a fluid is injected into the lumen. The tubular member may be coupled to the distal sections of the plurality of arms. The first expandable structure is expandable upon proximal retraction of the tubular member.

In some examples, a method of processing an electrocardiogram signal including P-waves and S-waves comprises or consists essentially of: detecting the end of the first S-wave, estimating the start of the first P-wave, and providing an artificial signal during a stimulation duration between detecting the end of the first S-wave and the estimated start of the first P-wave. A non-transitory computer readable medium may store executable instructions that when executed perform the method.

The artificial signal may comprise a straight line. The straight line may be a negative value. The straight line may be a positive value.

In some examples, the electrocardiogram signal includes or consists essentially of a first portion that is indicative of electrical activity of the heart during a first duration and a second portion that is not indicative of electrical activity of the heart during a second duration that is subsequent to the first duration. The first duration is less than the sinus rhythm. A non-transitory computer readable medium may be configured to store a signal.

The first portion may comprise a QRS complex (complex). The first portion may include PR intervals. The second portion may include an ST segment. The second portion may comprise a straight line. The straight line may be a negative value. The straight line may be a positive value.

In some examples, a method of processing an electrocardiogram signal comprises, or consists essentially of: detecting a first condition of a first type of wave selected from the group consisting of a P-wave, a Q-wave, an R-wave, an S-wave, and a T-wave; monitoring a monitoring duration of a second condition of a second type of wave selected from the group consisting of a P-wave, a Q-wave, an R-wave, an S-wave, and a T-wave after a stimulation duration that begins after detecting a first condition of the first type of wave. The second type of wave is different from the first type of wave; and triggering a physical event if a second condition of a second type of wave may not be detected during the monitoring duration. A non-transitory computer readable medium may store executable instructions that when executed perform the method.

The first condition may include the start of a first type of wave. The first condition may include an end of the first type of wave. The first condition may include a peak of the first type of wave. The second condition may include the start of a second type of wave. The second condition may include an end of the second type of wave. The second condition may include a peak of the second type of wave. The second condition may include a peak of the second type of wave. The first type of wave may comprise an S-wave. The second type of wave may include a P-wave. The second type of wave may include a Q-wave. The second type of wave may include an R-wave. The physical event may include terminating the stimulus. The physical event may include issuing an alarm.

In some examples, a method of processing an electrocardiogram signal comprises, or consists essentially of: providing a first portion indicative of electrical activity of the heart during a first duration, the first portion comprising a true P-wave, a true Q-wave, a true R-wave, a true S-wave, and a true T-wave; and providing a second portion that is not indicative of electrical activity of the heart during a second duration after the first duration, stimulation of the heart being performed during the second duration. A non-transitory computer readable medium may store executable instructions that when executed perform a method.

The portion may comprise a straight line. The straight line may be at zero. The straight line may be at a negative value. The straight line may be at a positive value.

The second portion may comprise a copy of the first portion.

The second portion may include at least a portion of the artificial sinus rhythm. The portion of the artificial sinus rhythm may include at least one of an artificial P-wave, an artificial Q-wave, an artificial R-wave, an artificial S-wave, and an artificial T-wave. At least one of the artificial P-wave, the artificial Q-wave, the artificial R-wave, the artificial S-wave and the artificial T-wave may be shaped like a real wave. At least one of the artificial P wave, the artificial Q wave, the artificial R wave, the artificial S wave, and the artificial T wave may be formed like a square wave.

In some examples, the electrocardiogram signal includes or consists essentially of a first portion that is indicative of electrical activity of the heart during a first duration and a second portion that is not indicative of electrical activity of the heart during a second duration that is subsequent to the first duration. The first portion includes true P-waves, true Q-waves, true R-waves, true S-waves, and true T-waves. Stimulation of the heart occurs at a second duration. A non-transitory computer readable medium may be configured to store a signal.

The second portion may comprise a straight line. The straight line may be at zero. The straight line may be at a negative value. The straight line may be at a positive value.

The second portion may comprise a copy of the first portion.

The second portion may include at least a portion of the artificial sinus rhythm.

The portion of the artificial sinus rhythm may include at least one of an artificial P-wave, an artificial Q-wave, an artificial R-wave, an artificial S-wave, and an artificial T-wave. At least one of the artificial P-wave, the artificial Q-wave, the artificial R-wave, the artificial S-wave and the artificial T-wave may be shaped like a real wave. At least one of the artificial P-wave, the artificial Q-wave, the artificial R-wave, the artificial S-wave and the artificial T-wave may be shaped like a square wave.

In some examples, the device includes or consists essentially of a handle, an expandable structure, an outer tube, and a shaft. The expandable structure has a collapsed state and a self-expanded state. The expandable structure includes a plurality of splines extending from the proximal hub to the distal hub. Each spline of the plurality of splines includes a proximal segment, an intermediate segment distal to the proximal segment, a distal segment distal to the intermediate segment, and a first electrode on a first spline of the plurality of splines. The intermediate section is configured to extend radially outward in a self-expanding state. The outer tube includes a proximal end coupled to the handle and a distal end coupled to the proximal hub. The shaft includes a proximal end and a distal end. A shaft extends through the outer tube from the handle to the distal hub. The handle is configured to retract the shaft. The intermediate section is configured to extend further radially outward upon retraction of the shaft.

At least one of the plurality of splines may be devoid of an electrode. The intermediate segment of each of the plurality of splines may form a first angle with the proximal segment and/or a second angle with the distal segment. The proximal segment and the distal segment of each of the plurality of splines may be devoid of electrodes. The first spline may include a first plurality of electrodes including a first electrode. The first plurality of electrodes may form an electrode array. The apparatus may further include a second electrode on a second spline of the plurality of splines. The first spline may include a first plurality of electrodes including a first electrode. The second spline may comprise a second plurality of electrodes including a second electrode. The first plurality of electrodes may include five electrodes. The second plurality of electrodes may include five electrodes. The first plurality of electrodes and the second plurality of electrodes form an electrode array. The second spline may be circumferentially adjacent to the first spline. The first spline and the second spline may form a first spline pair. The apparatus may also include a second spline pair. The second spline pair may include a third spline including a third plurality of electrodes and a fourth spline including a fourth plurality of electrodes. The fourth spline may be circumferentially adjacent to the third spline. The second spline pair may be circumferentially adjacent to the first spline pair. The first plurality of electrodes, the second plurality of electrode electrodes, the third plurality of electrodes, and the fourth plurality of electrodes may form an electrode array. The electrode array may comprise a 4 x 5 array. At least four circumferentially adjacent splines of the plurality of splines may each include a plurality of electrodes. At least one of the plurality of splines may be devoid of an electrode. The proximal and distal segments of each spline may be straight. The mid-section of each spline may be concave. The proximal and distal segments of each spline may be straight. The mid-section of each spline may be convex. The proximal and distal segments of each spline may be straight. The mid-section of each spline may be straight. Each spline of the plurality of splines may further comprise a proximal transition section connecting the proximal section and the intermediate section and a distal transition section connecting the intermediate section and the distal section. The splines may be grouped into circumferentially adjacent spline pairs. Each spline of the spline pair may be parallel to the other spline of the spline pair along the proximal segment, the intermediate segment, and the distal segment. Each spline of the spline pair may be non-parallel to the other spline of the spline pair along the proximal transition section and the distal transition section. The intermediate segment of each spline pair may be spaced further apart from each other than the proximal and distal segments. The expandable structure may include a longitudinal axis between the proximal hub and the distal hub. The proximal segment of each of the plurality of splines may diverge radially from the longitudinal axis and the distal segment of each of the plurality of splines may converge radially toward the longitudinal axis.

The outer tube may include a proximal portion and a distal portion. The proximal portion may have a higher durometer than the distal portion. The outer tube may include a plurality of longitudinal portions along the length of the outer tube. Each of the plurality of longitudinal portions may have a higher stiffness than a longitudinal portion of the plurality of longitudinal portions at a distal end thereof. At least one of the plurality of longitudinal portions may be configured with a length and stiffness for positioning the at least one longitudinal portion in a particular anatomical structure. The particular anatomical structure may include a heart chamber. The particular anatomical structure may include a blood vessel. The blood vessel may include the right pulmonary artery. The outer tube may include a first outer diameter at a proximal end of the outer tube and a second outer diameter at a distal end of the outer tube. The first outer diameter may be greater than the second outer diameter. The proximal portion of the outer tube may comprise a first plurality of layers, wherein the distal portion of the outer tube may comprise a second plurality of layers. The first plurality of layers may include more layers than the second plurality of layers. The outer tube may include a hinge connected to the proximal hub. The hinge may be configured to resist kinking when the device is flexed transverse to the longitudinal axis of the outer tube. The articulation may include a coil including a proximal end and a distal end, the proximal end of the coil surrounding a portion of the tube (tubing) and the distal end of the coil surrounding a portion of the proximal hub. The articulation may comprise a first wire comprising a helical winding, a second wire comprising a helical winding and occupying the space between the helices of the first wire, and a third wire comprising a helical winding and occupying the space between the helices between the first wire and the second wire. The outer tube may comprise a tube. The tubing may include an inner diameter configured to mate with an outer diameter of the proximal hub. The tube may be configured adjacent the proximal end of the end hub. The tubing may form a fluid seal between the outer tube and the proximal hub.

The splines comprising electrodes may comprise spline tubes, the electrodes being located on the outer surface of the spline tubes. The apparatus may further include a spline tube at least partially covering two circumferentially adjacent splines of the plurality of splines. The spline tube may be configured to inhibit two circumferentially adjacent splines from rotating relative to each other. The spline tube may be divided into two spatially separated tubular channels along the mid-sections of two circumferentially adjacent splines. Circumferentially adjacent splines of the plurality of splines may be grouped into spline pairs, each spline pair comprising a proximal tube at least partially covering the proximal section and a distal tube at least partially covering the distal section. The proximal and distal tubes may be configured to inhibit rotation of the splines of each spline pair relative to each other. Each of the proximal and distal tubes may comprise heat shrink tubing. Circumferentially adjacent splines of the plurality of splines may be grouped into spline pairs, each spline pair including a wire that buckles at a proximal end and may have a wire tip that terminates at a distal end.

The proximal hub may include a proximal end, a distal end, a central lumen, a plurality of peripheral lumens, and/or a plurality of spline channels. The central lumen may extend from a proximal end of the proximal hub to a distal end of the proximal hub. The shaft may slidably extend through the central lumen of the proximal hub. A plurality of peripheral lumens may be radially outward from the central lumen of the proximal hub. The plurality of peripheral lumens may be configured to communicate fluid flowing through the outer tube to the distal end of the proximal hub. A plurality of spline channels may extend proximally from the distal end of the proximal hub into the distal portion of the proximal hub. One spline of the plurality of splines may be in each spline channel of a plurality of spline channels of the proximal hub. A plurality of spline channels may extend through the distal portion of the proximal hub. Circumferentially adjacent splines of the plurality of splines may be grouped into spline pairs, each spline pair including a wire that buckles at the proximal end. The proximal hub may include a plurality of recesses proximal of the distal portion of the proximal hub. The flexed proximal end of the wire of each spline pair may be in a recess of the plurality of recesses. The plurality of recesses may be configured to inhibit movement of the plurality of splines at the proximal end of the recesses. At least one of the plurality of peripheral lumens may be configured to receive an electrical conductor extending from the handle to the electrode.

The distal hub may include a proximal end, a distal end, a central lumen, and/or a plurality of spline channels. The central lumen may extend from a proximal end of the distal hub to a distal end of the distal hub. The shaft may be fixably coupled to the central lumen of the distal hub. A plurality of spline channels may extend distally into the distal hub from the proximal end of the distal hub. One of the plurality of splines may be in each of a plurality of spline channels of the distal hub. Each spline channel of the plurality of spline channels of the distal hub may terminate near the distal end of the distal hub. The proximal end of the distal hub may include a tapered surface. The tapered surface of the proximal end of the distal hub may include openings to the plurality of spline channels. The tapered surface of the proximal end of the distal hub may be configured to facilitate buckling of the splines in a radially outward direction. The distal end of the distal hub may include an atraumatic configuration.

The handle may include a handle base and an actuator. The handle base may include a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The proximal end of the outer tube may be coupled to the lumen of the handle base through which the shaft slidably extends. An actuator may be attached to the proximal end of the shaft, the actuator being movable in a proximal direction and a distal direction relative to the handle base. The actuator may be configured to expand the expandable structure when moved in the distal direction and compress the expandable structure when moved in the proximal direction. The handle may also include an external handle, a securing member and/or a locking member. The outer handle may extend from the handle base. The fixation member may include a proximal end attached to the actuator. The locking member may be positioned along the securing member between the outer handle and the actuator. The locking member may be configured to move along a longitudinal axis of the fixation member and be fixed at a position along a length of the fixation member to prevent movement of the actuator in the distal direction. The securing member may include a threaded shaft and the locking member may be a threaded passage. The locking member may be moved longitudinally along the fixation member by rotating the locking member about the threaded shaft.

The handle may include a locking member having a locked configuration and an unlocked configuration. The locking member may include a body including a proximal end and a distal end, a channel extending from the proximal end to the distal end, and a protrusion extending into the channel of the locking member. The actuator may extend through the passage of the locking member. The protrusion may be configured to prevent movement of the actuator relative to the handle base in at least one of the proximal direction and the distal direction when the locking member is in the locked configuration. The actuator is movable in a proximal direction and a distal direction when the locking member is in the unlocked configuration. The actuator may include an elongated body and a textured surface along a length of the elongated body. The locking member is movable between the locked and unlocked configurations by rotating the locking member about the elongate body of the actuator. The protrusion may be configured to engage the textured surface in a locked position and configured not to engage the textured surface in an unlocked position. The locking member may further include a tab extending away from the body, the tab being positionable in a first position relative to the handle base when the locking member is in the locked configuration and a second position when the locking member is in the unlocked configuration. The textured surface may comprise a series of ridges, the protrusions of the locking member being configured to cooperate with the recesses between the ridges. The channel of the locking member may be oblong (oblong). The locking member may be configured to be switched between the locked configuration and the unlocked configuration by rotating the locking member approximately a quarter of a turn. The handle base may further include an aperture in the sidewall extending into the lumen of the handle base and near the proximal end of the outer tube. The electrical conductors may extend from the electrical socket into the outer tube through the aperture of the handle base.

The shaft may include an inner lumen. The lumen of the shaft may be configured to receive a guidewire. The proximal end of the shaft may be configured to receive a fluid. The proximal end of the shaft may be connected to a fluid valve. The shaft may include a sidewall and an aperture in the sidewall configured to allow fluid to flow out of the lumen of the shaft and to the proximal hub. The device may be configured to transmit fluid injected into the shaft to the distal hub and through the outer tube to the proximal hub. The shaft may include a plurality of hypotubes. The plurality of hypotubes may include a first hypotube having a proximal end and a distal end and a second hypotube having a proximal end and a distal end. The distal end of the first hypotube may be located proximal to the second hypotube. The proximal end of the second hypotube may be located distal to the first hypotube. The plurality of hypotubes may include three hypotubes. At least one hypotube of the plurality of hypotubes may include a proximal portion having a first outer diameter and a distal portion having a second outer diameter that is less than the first outer diameter. At least one hypotube of the plurality of hypotubes may include a sidewall and a bore through the sidewall.

In some examples, a method of modulating a nerve comprises or consists essentially of: the method includes inserting a distal portion of a device including an expandable structure into the vasculature, allowing the expandable member to self-expand, actuating a handle of the device to further expand the expandable structure to anchor the expandable structure in the vasculature, and activating a first electrode of the device to stimulate a nerve. The device includes a proximal portion including a handle and a distal portion including an expandable structure. The expandable structure has a collapsed state and a self-expanded state. The expandable structure includes a plurality of splines extending from the proximal hub to the distal hub. Each spline of the plurality of splines comprises a proximal segment, an intermediate segment distal to the proximal segment, and a distal segment distal to the intermediate segment. The intermediate section is configured to extend radially outward in a self-expanding state. The expandable structure includes a first electrode on a first spline of the plurality of splines.

The device may include an outer tube and a shaft. The outer tube may include a proximal end coupled to the handle and a distal end coupled to the proximal hub. The shaft may include a proximal end and a distal end and may extend through the outer tube from the handle to the distal hub. The handle may be configured to retract the shaft in a proximal direction relative to the outer tube when the handle is actuated such that the distal hub and the proximal hub move closer together.

The method may further comprise accessing the vasculature with a needle and syringe. The method may further comprise inserting a guidewire into the vasculature. The shaft of the device may include a lumen extending from the proximal portion of the device to the distal portion of the device. Inserting the distal portion of the device into the vasculature may include inserting the device over a guidewire such that the guidewire may be slidably received within the lumen of the shaft. The method may also include tracking the guidewire to a target location in the vasculature. The method may further include inserting a swan-ganz catheter into the vasculature. The swan-ganz catheter may include an inflatable balloon at the distal end of the catheter. The method may further include inflating the inflatable balloon, allowing the balloon to be carried to a target location by blood flow, inserting a guidewire into the target location through a lumen in the swan-ganz catheter, deflating the inflatable balloon, and retracting the swan-ganz catheter from the vasculature. The target site may be the right pulmonary artery.

The method may further include inserting an introducer into the vasculature. Inserting the distal portion of the medical device into the vasculature may include inserting the device through a sheath of an introducer. The method may further comprise retracting the distal end of the introducer sheath from the distal portion of the device and/or pushing the distal portion of the device beyond the distal end of the sheath to self-expand the expandable structure. The method may further include actuating a locking member on the handle to prevent the expandable structure from being compressed. The method may further include positioning the expandable structure in the right pulmonary artery. The nerve may be a cardiopulmonary nerve. The expandable structure may further include a second electrode on a second spline of the plurality of splines, the expandable structure being positioned such that the nerve may be positioned along the first spline, along the second spline, or between the first spline and the second spline. The method may further comprise activating the second electrode. The first spline may be circumferentially adjacent to the second spline. The first spline may include a first plurality of electrodes including a first electrode, and the second spline may include a second plurality of electrodes including a second electrode. The first plurality of electrodes may include five electrodes and the second plurality of electrodes may include five electrodes. The first spline and the second spline may form a first spline pair. The first plurality of electrodes and the second plurality of electrodes may form an electrode array. The expandable structure may further include a second spline pair including a third spline and a fourth spline, the third spline including a third plurality of electrodes and the fourth spline including a fourth plurality of electrodes. The first plurality of electrodes, the second plurality of electrodes, the third plurality of electrodes, and the fourth plurality of electrodes may form an electrode array. The electrode array may comprise a 4 x 5 array. The method may further include positioning the expandable structure against tissue in the vasculature such that the nerve may be positioned between at least two electrodes that are against the tissue. The nerve may be located between at least three electrodes that rest on the tissue. The nerve may be located between at least four electrodes that rest on the tissue. Activating the first electrode may include applying a voltage pulse of a first polarity. The method may further include applying a pre-pulse of voltage to tissue surrounding the nerve prior to activating the first electrode, the pre-pulse being of a second polarity opposite the first polarity. The method may further include measuring a pressure in the right ventricle and approximating the pressure in the left ventricle from the measured pressure in the right ventricle. The method may further include positioning a return conductor in the vasculature or on the skin, the return conductor configured to conduct current from the activated electrode.

In some examples, a device for increasing cardiac contractility and/or relaxation to treat heart failure includes or consists essentially of a handle and an expandable structure. The expandable structure has a collapsed state and a self-expanded state. The expandable structure includes a plurality of splines extending from the proximal hub to the distal hub. The device also includes a first electrode on a first spline of the plurality of splines, an outer tube extending from the handle to the proximal hub, and a shaft extending through the outer tube from the handle to the distal hub. The handle is configured to retract the shaft. The device is configured to be placed in a pulmonary artery and to deliver energy from the first electrode to a target tissue to increase cardiac contractility and/or relaxation to treat heart failure.

At least one of the plurality of splines may be devoid of an electrode.

The first spline may include a first plurality of electrodes including a first electrode. The first plurality of electrodes may form an electrode array.

The apparatus may further include a second electrode on a second spline of the plurality of splines. The first spline may include a first plurality of electrodes including a first electrode. The second spline may include a second plurality of electrodes including a second electrode. The first plurality of electrodes may include five electrodes. The second plurality of electrodes may include five electrodes. The first plurality of electrodes and the second plurality of electrodes may form an electrode array. The second spline may be circumferentially adjacent to the first spline. The first spline and the second spline may form a first spline pair. The apparatus may further include a second spline pair, the second spline pair including a third spline and a fourth spline, the third spline including a third plurality of electrodes and the fourth spline including a fourth plurality of electrodes. The fourth spline may be circumferentially adjacent to the third spline. The second spline pair may be circumferentially adjacent to the first spline pair. The first, second, third, and fourth pluralities of electrodes form an electrode array. The electrode array may comprise a 4 x 5 array. Each of at least four circumferentially adjacent splines of the plurality of splines may include a plurality of electrodes.

Each spline of the plurality of splines may include a proximal segment, an intermediate segment distal to the proximal segment, and a distal segment distal to the intermediate segment. The intermediate section may be configured to extend radially outward in a self-expanding state. The intermediate section may be configured to extend further radially outward when the shaft is retracted. The intermediate segment of each of the plurality of splines may form a first angle with the proximal segment and a second angle with the distal segment. The intermediate segment of each of the plurality of splines may be bent to the proximal segment and the distal segment.

The proximal segment and the distal segment of each of the plurality of splines may be devoid of electrodes.

The proximal and distal segments of each spline may be straight. The mid-section of each spline may be concave. The mid-section of each spline may be convex. The mid-section of each spline may be straight. The mid-section of each spline may be straight. Each of the proximal, distal and intermediate segments of each spline may be arcuate.

Each spline of the plurality of splines may further comprise a proximal transition section connecting the proximal section and the intermediate section, and a distal transition section connecting the intermediate section and the distal section. Each spline of the spline pair may be non-parallel to the other spline of the spline pair along the proximal transition section and the distal transition section.

A first spline and a second spline of the plurality of splines may form a first spline pair. The second spline may be circumferentially adjacent to the first spline. The apparatus may also include a second spline pair including a third spline of the plurality of splines and a fourth spline of the plurality of splines. The fourth spline may be circumferentially adjacent to the third spline. Each spline of the spline pair may be parallel to the other spline of the spline pair along the mid-section. Each spline of the spline pair may be parallel to the other spline of the spline pair along the proximal segment and the distal segment. The intermediate segment of each spline pair may be spaced further apart from each other than the proximal and distal segments.

At least one of the plurality of splines may be devoid of an electrode.

The expandable structure may include a longitudinal axis between the proximal hub and the distal hub. The proximal segment of each of the plurality of splines may diverge from the longitudinal axis and the distal segment of each of the plurality of splines may radially converge toward the longitudinal axis.

The plurality of splines may be configured to extend outwardly on one side of a plane that passes through a longitudinal axis of the expandable structure. A spline of the plurality of splines comprising an electrode may be configured to extend outward on one side of a plane that passes through a longitudinal axis of the expandable structure. The splines of the plurality of splines including the electrode may occupy 100 ° to 120 ° in the circumferential direction. Splines of the plurality of splines that do not include an electrode may be configured to extend outward on a second side of a plane that passes through a longitudinal axis of the expandable structure. The second side may be opposite the one side.

The outer tube may include a proximal portion and a distal portion. The proximal portion may have a higher durometer than the distal portion. The outer tube may include a plurality of longitudinal portions along the length of the outer tube. Each of the plurality of longitudinal portions may have a higher stiffness than a longitudinal portion of the plurality of longitudinal portions distal thereto. At least one of the plurality of longitudinal portions may be configured with a length and stiffness for positioning the at least one longitudinal portion in a particular anatomical structure. The specific anatomical structure may comprise a heart chamber. The specific anatomical structure may comprise a blood vessel. The blood vessel may include the right pulmonary artery.

The outer tube may include a first outer diameter at a proximal end of the outer tube and a second outer diameter at a distal end of the outer tube. The first outer diameter may be greater than the second outer diameter.

The proximal portion of the outer tube may include a first plurality of layers. The distal portion of the outer tube may include a second plurality of layers. The first plurality of layers may include more layers than the second plurality of layers.

The outer tube may include a hinge connected to the proximal hub. The hinge may be configured to resist kinking when the device is flexed transverse to the longitudinal axis of the outer tube. The articulating member may include a coil including a proximal end and a distal end. The proximal end of the coil may surround a portion of the tube and the distal end of the coil may surround a portion of the proximal hub. The articulation may comprise a first wire comprising a helical winding, a second wire comprising a helical winding and occupying the space between the helices of the first wire, and a third wire comprising a helical winding and occupying the space between the helices between the first wire and the second wire.

The outer tube may comprise a tube (tubing). The tubing may include an inner diameter configured to mate with an outer diameter of the proximal hub. The tube may be configured adjacent the proximal end of the end hub. The tubing may form a fluid seal between the outer tube and the proximal hub.

The first spline may comprise a spline tube. The first electrode may be located on the outer surface of the spline shaft.

The apparatus may also include a spline tube at least partially covering two circumferentially adjacent splines of the plurality of splines. The spline tube may be configured to inhibit rotation of the two circumferentially adjacent splines relative to each other. The spline tube may be divided into two spatially separated tubular channels along the mid-sections of two circumferentially adjacent splines.

Circumferentially adjacent splines of the plurality of splines may be grouped into spline pairs. Each spline pair may include a proximal tube at least partially covering the proximal segment and a distal tube at least partially covering the distal segment. The proximal and distal tubes may be configured to prevent the splines of each spline pair from rotating relative to each other. Each of the proximal and distal tubes may comprise a heat shrink tube.

Circumferentially adjacent splines of the plurality of splines may be grouped into spline pairs. Each spline pair may comprise a wire that is proximally flexed and has a wire tip that terminates at a distal end.

The proximal hub may include a proximal end, a distal end, and a central lumen extending from the proximal end of the proximal hub to the distal end of the proximal hub. The shaft may slidably extend through the central lumen of the proximal hub. The device may further include a plurality of peripheral lumens radially outward from the central lumen of the proximal hub. The plurality of peripheral lumens may be configured to communicate fluid flowing through the outer tube to the distal end of the proximal hub. At least one of the plurality of peripheral lumens may be configured to receive an electrical conductor extending from the handle to the first electrode. The device may also include a plurality of spline channels extending proximally from the distal end of the proximal hub to the distal portion of the proximal hub. One spline of the plurality of splines may be located in each spline channel of the plurality of spline channels of the proximal hub. A plurality of spline channels may extend through the distal portion of the proximal hub. Circumferentially adjacent splines of the plurality of splines may be grouped into spline pairs. Each spline pair may comprise a wire that is bent at the proximal end. The proximal hub may include a plurality of recesses proximal of the distal portion of the proximal hub. The flexed proximal end of the wire of each spline pair may be in a recess of the plurality of recesses. The plurality of recesses may be configured to inhibit movement of the plurality of splines at the proximal end of the recesses.

The distal hub may include a proximal end, a distal end, and a central lumen extending from the proximal end of the distal hub to the distal end of the distal hub. The shaft may be fixably coupled to the central lumen of the distal hub. The device may also include a plurality of spline channels extending distally from the proximal end of the distal hub into the distal hub. One of the plurality of splines may be located in each of a plurality of spline channels of the distal hub. Each spline channel of the plurality of spline channels of the distal hub may terminate near the distal end of the distal hub. The proximal end of the distal hub may include a tapered surface. The tapered surface of the proximal end of the distal hub may include openings to the plurality of spline channels. The tapered surface of the proximal end of the distal hub may be configured to facilitate buckling of the splines in a radially outward direction. The distal end of the distal hub may be non-invasively configured.

The handle may include a handle base including a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The handle may also include a proximal end of an outer tube coupled to the lumen of the handle base. The shaft may slidably extend through the lumen of the handle base. The handle may also include an actuator attached to the proximal end of the shaft. The actuator may be movable in a proximal direction and in a distal direction relative to the handle base. The actuator may be configured to expand the expandable structure when moved in the distal direction and compress the expandable structure when moved in the proximal direction. The handle may also include an outer handle extending from the handle base, including a securing member attached to the proximal end of the actuator, and a locking member positioned along the securing member between the outer handle and the actuator. The locking member may be configured to move along a longitudinal axis of the fixation member and be fixed at a position along a length of the fixation member to prevent movement of the actuator in the distal direction.

The securing member may include a threaded shaft and the locking member may be a threaded passage. The locking member may be moved longitudinally along the fixation member by rotating the locking member about the threaded shaft.

The handle may also include a locking member having a locked configuration and an unlocked configuration. The locking member may include a body including a proximal end and a distal end, a channel extending from the proximal end to the distal end, and a protrusion extending into the channel of the locking member. The actuator may extend through the passage of the locking member. The protrusion may be configured to prevent movement of the actuator relative to the handle base in at least one of the proximal direction and the distal direction when the locking member may be in the locked configuration. The actuator is movable in a proximal direction and a distal direction when the locking member may be in the unlocked configuration. The actuator may include an elongated body and a textured surface along a length of the elongated body of the actuator, the locking member being movable between the locked and unlocked configurations by rotating the locking member about the elongated body of the actuator. The protrusion may be configured to engage the textured surface in a locked position and configured not to engage the textured surface in an unlocked position.

The locking member may also include a tab extending away from the body. The tab is positionable in a first position relative to the handle base when the locking member is in the locked configuration. The tab may be in the second position when the locking member is in the unlocked configuration. The textured surface may comprise a series of ridges. The protrusion of the locking member may be configured to mate with the recess between the ridges. The channel of the locking member may be rectangular. The locking member may be configured to be switched between the locked configuration and the unlocked configuration by rotating the locking member a quarter turn.

The handle base may further include an aperture in the sidewall extending into the lumen of the handle base and near the proximal end of the outer tube. The electrical conductors may extend from the electrical socket into the outer tube through the aperture of the handle base.

The shaft may include an inner lumen. The lumen of the shaft may be configured to receive a guidewire. The proximal end of the shaft may be configured to receive a fluid. The proximal end of the shaft may be connected to a fluid valve. The shaft may include a sidewall and a hole in the sidewall. The bore may be configured to allow fluid to flow out of the lumen of the shaft and to the proximal hub.

The device may be configured to transmit fluid injected into the shaft through the shaft to the distal hub and through the outer tube to the proximal hub. The shaft may include a plurality of hypotubes. The plurality of hypotubes may include a first hypotube having a proximal end and a distal end, and a second hypotube having a proximal end and a distal end. The distal end of the first hypotube may be located proximal to the second hypotube. The proximal end of the second hypotube may be located distal to the first hypotube. The plurality of hypotubes may include three hypotubes. At least one hypotube of the plurality of hypotubes may include a proximal portion having a first outer diameter and a distal portion having a second outer diameter that is less than the first outer diameter. At least one hypotube of the plurality of hypotubes may include a sidewall and a bore through the sidewall.

The device may further comprise an expandable member. The device may also include an inflation lumen in fluid communication with the expandable member.

In some examples, the device includes, or consists essentially of, a handle and an expandable structure. The expandable structure has a collapsed state and a self-expanded state. The expandable structure includes a plurality of splines extending from the proximal hub to the distal hub. The device also includes an energy delivery neuromodulator on a first spline of the plurality of splines, an outer tube extending from the handle to the proximal hub, and a shaft extending through the outer tube from the handle to the distal hub, the handle configured to retract the shaft. The energy delivery neuromodulator may include an electrode. The neuromodulator may include a transducer.

In some examples, the device includes, or consists essentially of, a handle and an expandable structure. The expandable structure has a collapsed state and a self-expanded state. The expandable structure includes a plurality of splines extending from the proximal hub to the distal hub. The device also includes a neuromodulator located on a first spline of the plurality of splines, an outer tube extending from the handle to the proximal hub, and a shaft extending through the outer tube from the handle to the distal hub. The handle is configured to retract the shaft. The neuromodulator may include a radiofrequency electrode, an ultrasound element, a laser element, a microwave element, a cryogenic element, a thermal transfer device, or a drug delivery device.

The use of the device may be for neuromodulation. The use of the device may be for the treatment of cardiovascular conditions. The use of the device may be for the treatment of acute heart failure. The use of the device may be for the treatment of shock. The use of the device may be for the treatment of valvular diseases. The use of the device may be for the treatment of angina pectoris. The use of the device may be for the treatment of microvascular ischemia. The use of the device may be for the treatment of myocardial contractile disorders. The use of the device may be for the treatment of cardiomyopathy. The use of the device may be for the treatment of hypertension. The use of the device may be for the treatment of pulmonary hypertension. The use of the device may be for the treatment of systemic hypertension. The use of the device may be for the treatment of orthostatic hypertension. The use of the device may be for the treatment of orthopnea. The use of the device may be for the treatment of dyspnea. The use of the device may be for the treatment of autonomic nerve dysfunction. The use of the device can be used to treat syncope. The use of the device may be for treating a vasovagal reflex. The use of the device may be for the treatment of carotid sinus allergy. Use of the device may be for treating pericardial effusion. The use of the device may be for the treatment of structural abnormalities of the heart.

In some examples, a method of modulating a nerve comprises or consists essentially of: the method includes inserting a distal portion of the device into the vasculature, allowing the expandable member to self-expand, actuating the handle to further expand the expandable structure to anchor the expandable structure in the vasculature, and activating the first electrode to stimulate the nerve.

The method may further comprise accessing the vasculature with a needle and syringe. Access to the vasculature may be at the jugular vein. Access to the vasculature may be at the left jugular vein.

The method may further comprise inserting a guidewire into the vasculature. The shaft may include a lumen extending from a proximal portion of the device to a distal portion of the device. Inserting the distal portion of the device into the vasculature may include tracking the device over a guidewire to position the expandable structure at a target location in the vasculature. The guidewire may be slid through the lumen of the shaft.

The method may further include inserting a swan-ganz catheter including a distal end including a balloon into the vasculature, inflating the balloon, allowing the balloon to be carried to a target location by blood flow, inserting a guide wire through a lumen in the swan-ganz catheter, deflating the balloon, and retracting the swan-ganz catheter from the vasculature.

The target site may be a pulmonary artery. The target site may be the right pulmonary artery. The target location may be a pulmonary trunk. The target site may be the left pulmonary artery.

The method may further include inserting an introducer into the vasculature. Inserting the distal portion of the device into the vasculature may include inserting the device through a sheath of an introducer. The method may further comprise proximally retracting at least one of the distal end of the introducer sheath and the distal portion of the distal advancement device, allowing the expandable structure to self-expand. The method may also include actuating a locking member on the handle.

The nerve may comprise the cardiopulmonary nerve. The nerve may include the medial right dorsal CPN. The nerve may include a right dorsal CPN. The nerve may comprise a right star CPN. The nerve may include the right vagus nerve or the vagus nerve. The nerve may comprise the right intracranial vagal CPN. The nerve may include the right caudal vagus nerve CPN. The nerve may comprise the right coronary heart nerve. The nerve may comprise the left coronary heart nerve. The nerve may comprise a left lateral centripetal nerve. The nerve may comprise the left recurrent laryngeal nerve. The nerve may include the left vagus nerve or the vagus nerve. The nerve may comprise a left star CPN. The nerve may include a left dorsal lateral CPN. The nerve may include the left dorsolateral CPN.

The method may include positioning an expandable structure against tissue in the vasculature such that a nerve is located between a first electrode and a second electrode.

Activating the first electrode may include applying a voltage pulse having a first polarity. The method may further include applying a pre-pulse of voltage to tissue surrounding the nerve prior to activating the first electrode. The pre-pulse may have a second polarity opposite the first polarity.

The method may further include measuring a pressure in the right ventricle and approximating the pressure in the left ventricle from the measured pressure in the right ventricle.

The method may further include positioning a return conductor in the vasculature. The return conductor may be configured to conduct current from the activated electrode.

The current vector from the first electrode to the return electrode may be away from at least one of the heart and the trachea. Positioning the return conductor in the vasculature can include positioning the return electrode at least 5mm from the first electrode. Positioning the return conductor in the vasculature may include positioning the return electrode in the right ventricle. Positioning the return conductor in the vasculature may include positioning the return electrode in the superior vena cava. Positioning the return conductor in the vasculature may include positioning the return electrode in a brachiocephalic vein.

In some examples, the means for increasing cardiac contractility and/or relaxation may comprise or alternatively consist essentially of an expandable structure and a plurality of electrodes. The expandable structure has a collapsed state and an expanded state. The expandable structure includes an inflatable structure. The expandable structure may be configured for placement in a pulmonary artery. The expandable structure may be configured to deliver energy from at least one of the plurality of electrodes to increase contractility and/or relaxation of the heart.

The expandable structure may include at least one electrode of the plurality of electrodes. The expandable structure may include a first expandable member and a second expandable member. The first expandable member may include a first balloon. The first balloon of the first expandable member may include at least one electrode of the plurality of electrodes. The first balloon of the first expandable member may include at least two electrodes of the plurality of electrodes. At least two electrodes may be circumferentially spaced apart on the first balloon. The first expandable member may include a second balloon. The second balloon of the first expandable member may include at least one electrode of the plurality of electrodes. The second balloon of the first expandable member may include at least two electrodes of the plurality of electrodes. At least two electrodes may be circumferentially spaced apart on the second balloon. The first expandable member may include a valley between the first balloon and the second balloon. The valley may include at least one electrode of the plurality of electrodes. The second expandable member may include a first balloon. The first balloon of the second expandable member may include at least one electrode of the plurality of electrodes. The first balloon of the second expandable member may include at least two electrodes of the plurality of electrodes. At least two electrodes may be circumferentially spaced apart on the first balloon. The second expandable member may include a second balloon. The second balloon of the first expandable member may include at least one electrode of the plurality of electrodes. The second balloon of the first expandable member may include at least two electrodes of the plurality of electrodes. At least two electrodes may be circumferentially spaced apart on the second balloon. The second expandable member may include a valley between the first balloon and the second balloon. The valley may include at least one electrode of the plurality of electrodes. The first expandable member may comprise a balloon. The second expandable member may comprise a balloon. The third expandable member may comprise a balloon. The fourth expandable tension element may comprise a balloon. The first expandable member may comprise a balloon. The second expandable member may comprise a balloon. The third expandable member may comprise a balloon. The fourth expandable member may comprise a balloon. The first expandable member may be circumferentially spaced 90 ° from the second expandable member. The second expandable member may be circumferentially spaced 90 ° from the third expandable member. The third expandable member may be circumferentially spaced 90 ° from the fourth expandable member. The fourth expandable member may be circumferentially spaced 90 ° from the first expandable member. The third expandable member may be circumferentially spaced 90 ° from the fourth expandable member. The fourth expandable member may be circumferentially spaced 90 ° from the first expandable member. The expandable structure may include a fifth expandable member and a sixth expandable member. The expandable element may comprise a balloon. The second expandable member may comprise a balloon. The third expandable member may comprise a balloon. The fourth expandable member may comprise a balloon. The fifth expandable member may comprise a balloon. The sixth expandable member may comprise a balloon. The first expandable member may be circumferentially spaced 60 ° from the second expandable member. The second expandable member may be circumferentially spaced 60 ° from the third expandable member. The third expandable member may be circumferentially spaced 60 ° from the fourth expandable member. The fourth expandable member may be circumferentially spaced 60 ° from the fifth expandable member. The fifth expandable member may be circumferentially spaced 60 ° from the sixth expandable member. The sixth expandable member may be circumferentially spaced 60 ° from the first expandable member. The expandable member may include a lumen. The lumen may extend in a direction parallel to the longitudinal axis of the device. The expandable structure may include a plurality of struts. The plurality of pillars may include at least one electrode of the plurality of electrodes. At least one strut of the plurality of struts can be circumferentially located between the first edge of the first expandable member and the second edge of the second expandable member. At least one other strut of the plurality of struts can be circumferentially located between the second edge of the first expandable member and the first edge of the second expandable member. The at least one pillar may comprise at least one electrode. At least one other pillar may not include an electrode. In a number of examples, none of the plurality of struts are circumferentially located between the second edge of the first expandable member and the first edge of the second expandable member. The device may further comprise a guidewire lumen. The device may further comprise a swan-ganz balloon. At least one of the plurality of electrodes may be laser ablated to increase surface area. At least two of the plurality of electrodes are overmolded to form an electrode assembly. The apparatus may further comprise a first pressure sensor. The first pressure sensor may comprise a MEMS sensor. The first pressure sensor may be configured for placement in a pulmonary artery. The apparatus may further comprise a second pressure sensor. The second pressure sensor may comprise a MEMS sensor. The second pressure sensor may be configured for placement in the right ventricle.

In some examples, the means for increasing cardiac contractility and/or relaxation may comprise or alternatively consist essentially of an expandable structure. The expandable structure has a collapsed state and an expanded state. The expandable structure includes a plurality of struts, an open distal end in an expanded state, and a plurality of electrodes. The expandable structure may be configured for placement in a pulmonary artery. The expandable structure may be configured for use. The expandable structure may be configured to deliver energy from at least one of the plurality of electrodes to increase contractility and/or relaxation of the heart. At least two struts of the plurality of struts may be connected at a first point at the proximal end of the expandable structure. At least two other struts of the plurality of struts may be connected at a second point of the proximal end of the expandable structure. The device may further include a first tether coupled to the first point. The device may further include a second tether coupled to the second point. The expandable structure may be configured to change from an expanded state to a collapsed state when the first tether and the second tether are retracted proximally toward the catheter. At least one of the first tether and the second tether may include a bundled electrical connector electrically coupled to the plurality of electrodes. At least two of the plurality of pillars may include a plurality of electrodes. A first strut of the at least two struts may include a first electrode assembly including at least two electrodes of the plurality of electrodes. A second strut of the at least two struts may comprise a second electrode assembly comprising at least two electrodes of the plurality of electrodes. A first pillar of the at least two pillars may include at least two electrodes of the plurality of electrodes. Each of the at least two electrodes may be independently coupled to the first leg. The at least two electrodes may be longitudinally spaced apart. A second pillar of the at least two pillars may include at least two electrodes of the plurality of electrodes. Each of the at least two electrodes may be independently coupled to the second leg. The at least two electrodes may be longitudinally spaced apart. The at least two struts of the first strut and the at least two struts of the second strut may be configured to nest when the expandable structure is in the collapsed state. At least four of the plurality of pillars include a plurality of electrodes. A first strut of the at least four struts may include a first electrode assembly including at least two electrodes of the plurality of electrodes. A second strut of the at least four struts may comprise a second electrode assembly comprising at least two electrodes of the plurality of electrodes. A third strut of the at least four struts may comprise a second electrode assembly comprising at least two electrodes of the plurality of electrodes. A fourth strut of the at least four struts may comprise a second electrode assembly comprising at least two electrodes of the plurality of electrodes. A first pillar of the at least four pillars may include at least two electrodes of the plurality of electrodes. Each of the at least two electrodes may be independently coupled to the first leg. The at least two electrodes may be longitudinally spaced apart. A second strut of the at least four struts may comprise at least two electrodes of the plurality of electrodes. Each of the at least two electrodes may be independently coupled to the second leg. The at least two electrodes may be longitudinally spaced apart. A third strut of the at least four struts may comprise at least two electrodes of the plurality of electrodes. Each of the at least two electrodes may be independently coupled to the third leg. The at least two electrodes may be longitudinally spaced apart. A fourth strut of the at least four struts may comprise at least two electrodes of the plurality of electrodes. Each of the at least two electrodes may be independently coupled to the fourth leg. The at least two electrodes may be longitudinally spaced apart. The at least two electrodes of the first strut, the at least two electrodes of the second strut, the at least two electrodes of the third strut, and the at least two electrodes of the fourth strut are configured to nest when the expandable structure may be in the collapsed state. The expandable structure may include a closed proximal end in an expanded state. The expandable structure may include additional struts distal to the plurality of struts. The expandable structure may include additional struts proximal to the plurality of struts. The plurality of electrodes may be located on a strut of the plurality of struts on a first side of a plane passing through a longitudinal axis of the expandable structure. In several examples, the second side of the plane does not include an electrode. In several examples, the second side of the plane does not include struts for the longitudinal length of the plurality of electrodes.

The device may further include a guidewire sheath on one side of the expandable structure. The plurality of struts may taper at the proximal end of the guidewire sheath. The plurality of struts may include six struts. The four pillars may include a plurality of electrodes. The two struts may be devoid of multiple electrodes. In the expanded state, the four struts may be on a first side of a plane bisecting the expandable structure. The two struts may be on opposite sides of the plane. The proximal ends of the plurality of struts may be coupled to the hub. The expandable structure may include a proximal portion including a plurality of electrodes and a distal portion including an open distal end in an expanded state. The proximal and distal portions may be unitary. The proximal portion may be coupled to the distal portion. The proximal portion may have a first radial stiffness. The distal portion may have a second radial stiffness greater than the first radial stiffness. In the expanded state, the proximal portion may have a first diameter. The distal portion may have a second diameter that is less than the first diameter. The first diameter may be 2mm to 8mm larger than the second diameter. The proximal portion may include a branched post. The proximal portion may include an S-shaped feature at the proximal end of the plurality of struts.

The expandable structure may include a guidewire sheath including at least some of the plurality of electrodes. The guidewire sheath can have a distal end coupled to the distal portion. The guidewire sheath can be configured to flex radially outward in response to distal advancement of the guidewire sheath. The apparatus may further comprise a spline (spline) comprising at least some of the other electrodes of the plurality of electrodes. The spline may have a distal end coupled to the distal portion. The splines may be configured to flex radially outward in response to distal advancement of the splines.

In some examples, the means for increasing cardiac contractility and/or relaxation may comprise, or alternatively consist essentially of, an expandable structure. The expandable structure has a collapsed state and an expanded state. The expandable structure includes a first wire, a second wire, and a guidewire sheath. The guidewire sheath includes a plurality of electrodes. The guidewire sheath is configured to flex radially outward in response to distal advancement of the guidewire sheath. The first wire, the second wire, and the distal end of the guidewire sheath are coupled together. The expandable structure is configured for placement in a pulmonary artery. Energy delivery from at least one of the plurality of electrodes is configured to increase cardiac contractility and/or relaxation.

The apparatus may further comprise a spline comprising a plurality of second electrodes. The spline may have a distal end coupled to the first wire, the second wire, and the distal end of the guidewire sheath. The splines may be configured to flex radially outward in response to distal advancement of the splines. The guidewire sheath and splines may be configured to operate independently. The guidewire sheath and splines may be configured to operate independently. The guidewire sheath and splines may be configured to nest in an advanced state. In some examples, a method of positioning the device comprises, or alternatively consists essentially of: the expandable structure is advanced into the left pulmonary artery in a collapsed state and expanded to an expanded state. The first wire may be preloaded onto a first sidewall of the left pulmonary artery. The second wire may be preloaded onto the opposing wall of the left pulmonary artery. The method may further include proximally retracting the expandable structure in the expanded state. During retraction, the second wire may be snapped into the ostium of the right pulmonary artery. The method may further comprise distally advancing a guidewire sheath. The guidewire sheath can be bent radially outward into the right pulmonary artery.

In some examples, a method of detecting catheter movement comprises, or alternatively consists essentially of: placing a first sensor in a first body cavity; monitoring a first parameter profile of a first body lumen; placing a second sensor in a second body cavity; monitoring a second parameter profile of a second body lumen; and taking a catheter movement action when the second parameter profile is the same as the first parameter profile at a second time after the first time. The second parameter profile is different from the first parameter profile at the first time.

The first sensor may comprise a first pressure sensor. The first pressure sensor may comprise a MEMS sensor. The first parameter profile may include a pressure range. The second sensor may comprise a second pressure sensor. The second pressure sensor may comprise a MEMS sensor. The first parameter profile may include a pressure range. The first body cavity may include a pulmonary artery and the second body cavity may include a right ventricle. The first body cavity may include the right ventricle and the second body cavity may include the right atrium. The first body cavity may comprise the right atrium and the second body cavity may comprise the vena cava. The catheter movement action may include sounding an alarm. The catheter movement action may include stopping nerve stimulation. The catheter movement action may include collapsing an expandable element.

In some examples, a method of detecting catheter movement comprises, or alternatively consists essentially of: a sensor is positioned in the right ventricle and monitors whether a change in a parameter profile of the right ventricle is greater than a threshold.

The threshold may indicate movement of the sensor against the tricuspid valve. The threshold may indicate movement of the sensor near the tricuspid valve. The parameter may include pressure. The sensor may comprise a MEMS sensor. The method may further include detecting a change above a threshold and taking a catheter movement action. The catheter movement action may include sounding an alarm. The catheter movement action may include stopping nerve stimulation. The catheter movement action may include collapsing the expandable element. The catheter may include a sensor. Positioning the sensor in the right ventricle may include providing slack to the catheter. As the catheter is retracted proximally, the catheter may be tensioned and/or the sensor may move toward the annulus of the tricuspid valve.

In some examples, the method of setting a stimulation vector comprises or consists essentially of: the first electrode is provided as a cathode and the second electrode is provided as an anode. The line between the first electrode and the second electrode is a first stimulation vector. The method further includes providing a third electrode as an anode. The line between the first electrode and the third electrode is a second stimulation vector. The method also includes selecting as the stimulation vector one of the first stimulation vector or the second stimulation vector that is most orthogonal to a primary Electrocardiogram (ECG) vector between the first ECG lead and the second ECG lead.

The selected stimulation vector may reduce the amount of stimulation noise interference on the ECG signal. The first ECG lead and the second ECG lead can be coupled to an implantable cardiac defibrillator. The method may further comprise establishing the first electrode to be capable of capturing a nerve when used as a cathode. The method may further comprise providing a fourth electrode as an anode. The line between the first electrode and the fourth electrode may be a third stimulation vector. Selecting a stimulation vector may include selecting one of the first, second, or third stimulation vectors that is most orthogonal to the primary ECG vector. The method may further comprise applying the stimulation vector to therapeutic stimulation.

In some examples, the method of setting a stimulation vector comprises or consists essentially of: the first electrode is provided as a cathode and each of the plurality of other electrodes is provided as an anode. The plurality of other electrodes do not include the first electrode. The line between the first electrode and each of the plurality of other electrodes is a potential stimulation vector. The method also includes selecting as the stimulation vector a potential stimulation vector of the potential stimulation vectors that is most orthogonal to a primary Electrocardiogram (ECG) vector between the first ECG lead and the second ECG lead.

The selected stimulation vector may reduce the amount of stimulation noise interference on the ECG signal. The first ECG lead and the second ECG lead can be coupled to an implantable cardiac defibrillator. The method may further comprise establishing the first electrode to be capable of capturing a nerve when used as a cathode. The plurality of other electrodes may be comprised between 2 electrodes and 19 electrodes. The plurality of other electrodes may be included between 2 electrodes and 11 electrodes. The plurality of other electrodes may be comprised between 2 electrodes and 8 electrodes. A plurality of other electrodes may be rotated 360 ° around the first electrode. The method may further comprise applying the stimulation vector to therapeutic stimulation.

In some examples, a system for blanking neural stimulation from an Electrocardiogram (ECG) includes or alternatively consists of: an ECG blanker configured to communicate with an ECG system configured to monitor a subject; an ECG amplifier configured to receive signals from an ECG system; and a neurostimulation system configured to apply stimulation to the subject. The ECG blanking device is configured to instruct the neurostimulation system to not apply neurostimulation during a heartbeat and to blank signals from the ECG system during neurostimulation by the neurostimulation system.

The ECG blanking unit may be configured to predict when a heartbeat will occur. The ECG blanker may use deterministic timing to predict when a heartbeat will occur. Blanking the signal from the ECG system can include manipulating data from the ECG system and sending the manipulated data to the ECG amplifier. Blanking the signal from the ECG system may include maintaining the ECG signal at a constant voltage during the stimulation pulses. The neurostimulation system may include an ECG blanking device.

In some examples, a method of modifying an Electrocardiogram (ECG) waveform comprises or consists essentially of: detecting an R-wave of the ECG for a first duration; measuring an R-to-R interval of the ECG for a first duration; calculating a weighted sum average of the R to R intervals; predicting a window for a next heartbeat using the weighted sum average; and blanking the neural stimulation during the predicted window.

Calculating the weighted sum-sum average may include excluding outliers. The method may include calculating a weighted sum-sum average based on the second duration. The second duration may overlap the first duration. Blanking the neural stimulation may include allowing the neural stimulation to occur between the expected T wave and the expected Q wave. Blanking the neural stimulation may include allowing neural stimulation between the expected S-wave and the expected Q-wave. Blanking the neural stimulation may include allowing neural stimulation between the expected S-wave and the expected P-wave. Blanking the neural stimulation may include setting a blanking period using the predicted window. The blanking period may comprise 300 milliseconds after the predicted R-wave. The blanking period may comprise 700ms after the predicted R-wave. The blanking period may comprise 300ms before the next predicted R-wave. The blanking period may comprise 700 milliseconds before the next predicted R-wave. The blanking period may comprise 30% of the prediction window after the predicted R-wave. The blanking period may comprise 70% of the prediction window after the predicted R-wave. The blanking period may comprise 30% of the prediction window before the next predicted R-wave. The blanking period may comprise 70% of the prediction window before the next predicted R-wave.

In some examples, a system for filtering noise from an Electrocardiogram (ECG) includes or optionally consists essentially of: a filter component configured to communicate with an ECG lead configured to monitor a subject; an ECG system configured to receive a signal from an ECG lead; and a neurostimulation system configured to apply stimulation to the subject. The filter component is configured to generate a noise filtered signal comprising subtracting noise from the neurostimulation system from the signal from the ECG lead and transmit the noise filtered signal to the ECG system.

The filter assembly may include: an ECG input configured to be coupled to an ECG lead; an ECG output configured to be coupled to an ECG system; and a filter communicatively located between the ECG input and the ECG output. The filter may comprise a low pass filter. The filter may include a cutoff frequency that is less than the neural stimulation frequency. The filter may comprise a notch filter. The filter may be tuned to a frequency. The neuromodulation system may be configured to set the frequency. The filter assembly may include an input for setting the frequency manually or electronically. The frequency may be 20 Hz. The frequency may be 10 Hz. The ECG output may include a wire that mimics an ECG lead. The filter component may further include an analog-to-digital converter communicatively located between the ECG input and the ECG output, and a digital-to-analog converter communicatively located between the filter and the ECG output. The neurostimulation system can include a filter component.

In some examples, a neuromodulation system for matching a neural stimulation frequency to an Electrocardiogram (ECG) monitoring frequency includes or consists essentially of: an input configured to receive an ECG system operating frequency; and a neural stimulation frequency that is adjustable to match the operating frequency of the ECG system.

The ECG system operating frequency may be 50 Hz. The ECG system operating frequency may be 60 Hz. The system may be configured to adjust at least one stimulation parameter. The at least one stimulation parameter may include amplitude, pulse width, duty cycle, or waveform. The system may be configured to determine a treatment frequency. The adjustment of the at least one stimulation parameter may approximate the neural stimulation at the treatment frequency.

In some examples, the electrode assembly comprises or consists of: a portion of a strut including a first side, a second side opposite the first side, and a thickness between the first side and the second side; a hole in a portion of the post; an electrically insulating material on the first side of the pillar and the second side of the pillar; an electrode inserted through the first side of the pillar and removed from the second side of the pillar; and a conductor electrically coupled to the electrode. The electrode includes a swaged portion on a first side of the post.

The struts may be laser cut struts. The holes may be laser cut. The first side of the strut may include a channel. The conductor may be located in the channel. The assembly may further include an electrically insulating material over the swaged portion of the electrode. The assembly may further include a plurality of holes in the portion of the pillar and one electrode in each of the plurality of holes, and includes a swaged portion on the first side of the pillar. The assembly may further include a plurality of strut portions, each strut portion including at least one electrode in the bore of one strut and including a swaged portion on the first side of one strut.

In some examples, a method of monitoring an effect of neural stimulation applied to a subject using a neural stimulator to move the neural stimulator, the method comprising: stopping application of the neural stimulation; monitoring the signal that decays to baseline after cessation of the application of the neural stimulation; resuming neural stimulation after monitoring the signal decaying to baseline; and after resuming neural stimulation, monitoring the signal to detect movement of the neural stimulator.

Monitoring the signal after resuming neural stimulation may include monitoring a change in direction of the signal. Changes in the favored direction can confirm binding of the nerve. The method may include detecting a change in a favorable direction, and titrating (titrating) the neurostimulator. A change in an adverse direction may confirm that the nerve is not engaged. The method may include detecting a change in the adverse direction and evaluating a position of the neurostimulator. Assessing the location of the neurostimulator may include fluoroscopy. The method may further comprise using different electrodes of the neurostimulator. The method may further include moving the neurostimulator. Monitoring the signal after resuming neural stimulation may include monitoring a change in a magnitude of the signal.

A change above the threshold may confirm engagement of the nerve. The method may include detecting a change in the favored direction, and titrating the neurostimulator. A change less than the threshold may confirm that the nerve is not engaged. The method may include detecting a change in the adverse direction and evaluating a position of the neurostimulator. Assessing the location of the neurostimulator may include fluoroscopy. The method may further comprise using different electrodes of the neurostimulator. The method may further include moving the neurostimulator.

Ceasing application of neural stimulation may include reducing the stimulation to a subthreshold level. When the subject is in a steady state, application of neural stimulation is stopped. Stopping the application of the neural stimulation or modifying a parameter of the neural stimulation once a day. The application of neural stimulation may be stopped or parameters of the neural stimulation modified while the subject is in the evening. The application of the neural stimulation may be stopped or parameters of the neural stimulation modified while the subject is asleep. The application of neural stimulation or the modification of parameters of neural stimulation is intermittently stopped at prescribed time intervals throughout the day.

In some examples, a method of monitoring an effect of neural stimulation applied to a subject using a neural stimulator to move the neural stimulator includes: applying neural stimulation including a parameter of a first value; modifying the parameter of the neural stimulation to a second value different from the first value and continuing to apply the neural stimulation; monitoring the signal after modifying the parameter of the neural stimulation; resuming neural stimulation containing the parameter at the first value after monitoring the signal; and after resuming neural stimulation containing the parameter at the first value, monitoring the signal to detect movement of the neural stimulator.

The parameter may comprise an amplitude. The parameter may comprise a pulse width. The parameter may include a frequency. The parameter may comprise a duty cycle. The parameter may include a waveform. The first value may be less than the second value. The first value may be greater than the second value.

Monitoring the signal after resuming neural stimulation that includes the parameter at the first value may include monitoring a change in direction of the signal. Changes in the favored direction can confirm binding of the nerve. The method may include detecting a change in the favored direction, and titrating the neurostimulator. A change in an adverse direction may confirm that the nerve is not engaged. The method may include detecting a change in the adverse direction and evaluating a position of the neurostimulator. Assessing the location of the neurostimulator may include fluoroscopy. The method may further comprise using different electrodes of the neurostimulator. The method may further include moving the neurostimulator.

Monitoring the signal after resuming neural stimulation may include monitoring a change in a magnitude of the signal. A change above the threshold may confirm engagement of the nerve. The method may include detecting a change in the favored direction, and titrating the neurostimulator. A change less than the threshold may confirm that the nerve is not engaged. The method may include detecting a change in the adverse direction and evaluating a position of the neurostimulator. Assessing the location of the neurostimulator may include fluoroscopy. The method may further comprise using different electrodes of the neurostimulator. The method may further include moving the neurostimulator.

Ceasing application of neural stimulation may include reducing the stimulation to a subthreshold level. The application of neural stimulation may be stopped when the subject is in a steady state. The application of neural stimulation may be stopped or parameters of the neural stimulation may be modified once a day. The application of neural stimulation may be stopped or parameters of the neural stimulation modified while the subject is in the evening. The application of the neural stimulation may be stopped or parameters of the neural stimulation modified while the subject is asleep. The application of neural stimulation or the modification of parameters of neural stimulation is intermittently stopped at prescribed time intervals throughout the day.

In some examples, the catheter system includes a distal portion configured to be inserted into the vasculature of a subject. The distal portion includes an expandable structure and a plurality of electrode assemblies. The expandable structure has a compressed state and an expanded state. The expandable structure includes a plurality of intertwined wires.

Each wire of the plurality of intertwined wires may be bent at the distal end of the intertwined expandable structure towards the proximal end of the expandable structure. The plurality of intertwined threads may be braided. The end portions of the plurality of entangled filaments on each side of the crimp may be arranged in side-by-side pairs parallel to the longitudinal axis. The system may further include a polymer line covering at least a portion of each pair of side-by-side filaments. One end portion of each pair of side-by-side wires may be truncated away from the proximal end of the expandable structure. The other end portion of each pair of side-by-side wires may extend radially inward toward the proximal hub system to form a plurality of spokes (spokes).

The proximal hub system may include an outer band, an inner band radially inward of the outer band, and an adapter including a first longitudinal segment radially inward of the outer band and a second longitudinal segment radially inward of the inner band. The other end portion of the filament may be radially inward of the inner band. The adapter may include a plurality of radial projections and a plurality of channels. The other end portions of the wire may be respectively located in a plurality of channels (e.g., one wire end portion in each channel). At least one of the inner and outer bands may include a radiopaque material.

The system may further include an outer sheath and an inner member radially inward of the outer sheath. The hub system may be coupled to the inner member. The outer sheath may be configured to maintain the expandable structure in a compressed state. The expandable structure may be configured to expand from the compressed state toward the expanded state upon relative longitudinal movement of the outer sheath toward the proximal end of the inner member. The expandable structure may be configured to compress toward a compressed state upon relative longitudinal movement of the outer sheath toward the distal end of the inner member.

The inner member may include a first port and a second port proximate the first port. The first port may be circumferentially offset relative to the second port. The inner member may include a radiopaque marker proximate the first port. The inner member may include a radiopaque marker proximate the second port.

The expandable structure may have a first longitudinal section and a second longitudinal section. At least one characteristic of the first longitudinal section may be different from a characteristic of the second longitudinal section. The characteristic may include a braid angle. The characteristic may include a radial force.

Each of the plurality of electrode assemblies may include a first insulating layer, a second insulating layer, a plurality of electrodes between the first insulating layer and the second insulating layer, and a plurality of conductors between the first insulating layer and the plurality of electrodes. Each conductor of the plurality of conductors may be electrically connected to one electrode of the plurality of electrodes.

In some examples, the electrode assembly includes or alternatively consists of the following structure: the device includes a first insulating layer, a second insulating layer, a plurality of electrodes between the first insulating layer and the second insulating layer, and a plurality of conductors between the first insulating layer and the plurality of electrodes. Each of the plurality of conductors may be electrically connected to one of the plurality of electrodes.

The first insulating layer may include a longitudinal channel. The first insulating layer may include a tube having an inner lumen. The lumen of the tube may be in fluid communication with the channel. The first insulating layer may comprise a hole in the side of the tube. The bore may be at the proximal end of the channel. A plurality of conductors may extend through the lumen of the tube. Pairs of the plurality of wires may extend into the proximal ends of the lumens of the tubes of the plurality of electrode assemblies. The proximal ends may be longitudinally offset. The plurality of electrode assemblies may form a rectangle. The proximal end may be gradually longitudinally offset such that the plurality of electrode assemblies form a parallelogram. The system may further include a nose distal to the expandable member. The nose may include a cone. The nose may include: a distal section including a plurality of projections at least partially defining a plurality of channels; and a proximal section, the proximal section being free of protrusions.

A plurality of conductors may extend through the channel. The first insulating layer may include a plurality of holes. Pairs of multiple wires may extend through the apertures into the channel. The plurality of holes may be on an inner surface of the first insulating layer. The plurality of holes may be on a side surface of the first insulating layer.

The first longitudinal segment of each electrode assembly adjacent to the plurality of holes may be coupled to the expandable structure. A second longitudinal segment of each electrode assembly distal to the plurality of apertures may be movable relative to the expandable structure.

The first longitudinal segment may comprise at least one electrode. The second longitudinal segment may comprise at least one electrode. The first longitudinal segment may include a plurality of electrodes. The second longitudinal segment may comprise a plurality of electrodes.

On the inner surface, the first insulating layer may include a plurality of holes. Pairs of a plurality of wires may extend into the channel through one of the apertures. Each of the plurality of apertures may be longitudinally spaced from an adjacent aperture of the plurality of apertures.

The plurality of apertures may include a proximal aperture and a distal aperture. A first pair of the plurality of filaments may extend into the proximal aperture of a first electrode assembly of the plurality of electrode assemblies. A second pair of the plurality of wires may extend into the distal end aperture of a second electrode assembly of the plurality of electrode assemblies. The first electrode assembly may be circumferentially adjacent to the second electrode assembly. A third pair of the plurality of filaments may extend into a proximal aperture of a third electrode assembly of the plurality of electrode assemblies. A fourth pair of the plurality of wires may extend into a distal end aperture of a fourth electrode assembly of the plurality of electrode assemblies. The second electrode assembly may be circumferentially adjacent to the third electrode assembly. The third electrode assembly may be circumferentially adjacent to the fourth electrode assembly. A plurality of electrode assemblies may be circumferentially nested when the expandable structure is in a compressed state.

The first insulating layer may include a plurality of longitudinally spaced recesses. The plurality of electrodes may be located in a plurality of longitudinally spaced recesses.

The second insulating layer may include a longitudinal channel. The second insulating layer may include a plurality of longitudinally spaced recesses. The plurality of electrodes may be located in a plurality of longitudinally spaced recesses.

At least one of the first insulating layer and the second insulating layer may include a slope (e.g., a circle, a cone, etc.). The first insulating layer may include a slope. The second insulating layer may include a slope.

At least one of the first and second insulating layers has a shore hardness between 55D and 63D. The total thickness of the first and second insulating layers is between 0.004 inches (about 0.1mm) and 0.012 inches (about 0.3 mm).

At least one of the plurality of electrodes may be raised above the second insulating layer. At least one of the plurality of electrodes may be recessed over the second insulating layer. At least one of the plurality of electrodes may be flat. At least one of the plurality of electrodes may be dome-shaped. The at least one dome electrode may be hollow. At least one dome electrode may be solid. At least one of the plurality of electrodes may include a first tab coupled to the conductor. The first tab may be vertically offset.

The first tab may be vertically offset from the active surface of the electrode. The thickness of the first tab may be between 1/4 and 3/4 of the thickness of the at least one electrode. The first tab may include a distal tab. The conductor may be coupled to the first tab on a side opposite the active surface of the electrode.

At least one of the plurality of electrodes may include a second tab interlocked with the second insulating layer. The second tab may include an aperture. The second tab may be vertically offset. At least one of the plurality of electrodes may be part of an electrode subassembly that includes at least one electrode and an insulator. At least one of the electrodes may be made of an insulator. At least one electrode may be recessed into the insulator.

Each of the plurality of electrode assemblies may include a distal tab. Each electrode assembly of the plurality of electrode assemblies may include a proximal tab.

At least one of the plurality of electrodes may include an oblong shape including a first semi-circular portion, a second semi-circular portion, and a rectangular portion longitudinally between the first semi-circular portion and the second semi-circular portion. The ratio of the length of the rectangular portion to the diameter of the first and second semi-circular portions may be in the range of 1: 3 to 3: 1. At least one of the plurality of electrodes may include an elliptical shape.

The plurality of electrodes may be on a first side of a plane that intersects a longitudinal axis of the expandable structure. The system may further include a radiopaque marker on a second side of the plane.

In some examples, a housing for a filter assembly includes a plurality of electrode pads having at least one of a color coding and a label. The plurality of electrode pads are configured to be attached to a plurality of leads having at least one of the same color coding or the same label.

The housing may further include indicia to indicate where the plurality of electrode pads are to be located on the subject. The housing may further include a plurality of inputs configured to be coupled to the ECG leads. The housing may further include a connector port configured to couple to a plurality of ECG leads. The housing may further comprise a plurality of integral ECG leads.

In some examples, a method of manufacturing an electrode assembly includes: a plurality of electrodes is positioned between the first insulating layer and the second insulating layer, and the first insulating layer is coupled to the second insulating layer.

The first insulating layer may include a channel. One conductor of the plurality of conductors may extend from each electrode of the plurality of electrodes through the channel. Each of the plurality of electrodes may include a tab. The method may include coupling one conductor to the tab. The tab may comprise a distal tab. Coupling one conductor to the tab may include coupling one conductor to a side of the tab opposite the active electrode surface. The channel may include a sealed distal end. The method may include occluding the proximal end of the channel. The method may include filling the channel with an adhesive.

In some examples, a method of manufacturing an electrode assembly includes: a conductor is coupled to a first side of a tab of an electrode, and the electrode is positioned between a first insulating layer and a second insulating layer. The first insulating layer includes a channel. The conductor extends through the passage. The electrode includes a second side exposed through the second insulating layer.

The tab may be on a distal side of the electrode. The first insulating layer may include an electrode recess. Positioning the electrode may include placing the electrode in the recess. The second insulating layer may include an electrode recess. Positioning the electrode may include placing the electrode in the recess. The first insulating layer may include a tube in fluid communication with the channel. The method may include extending a conductor through a proximal portion of the tube. The channel may include a sealed distal end. The method may include occluding a proximal end of the passage. The method may include filling the channel with an adhesive.

The methods outlined above and set forth in further detail below describe certain acts that an implementer would take; however, it should be understood that they may also include instructions for other parties to perform these actions. Thus, for example, an action such as "position an electrode" includes "indicate a position an electrode".

For the purpose of summarizing the invention and the advantages that may be achieved, certain objects and advantages are described herein. Not all of these objects or advantages need be achieved in accordance with any particular example. In some examples, the invention may be implemented or realized in the following manner: an advantage or set of advantages can be obtained or optimized without obtaining other objects or advantages.

The examples disclosed herein are intended to be within the scope of the invention disclosed herein. These and other examples will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, and the invention is not limited to any particular disclosed example. The optional and/or preferred features described with reference to some examples may be combined with and included in other examples. All references, including patents and patent applications, cited herein are hereby incorporated by reference in their entirety.

In some embodiments, a partially braided expandable member for supporting an electrode array (the expandable member self-expanding between a compressed state and an expanded state) comprises or consists essentially of: a proximal end; a distal end; a longitudinal axis; a distal section; and a proximal end section. The distal section comprises or alternatively consists essentially of a plurality of wires. Each wire of the plurality of wires has a flexure that includes a wire segment on each side of the flexure. The flexure defines or at least partially defines the distal end of the expandable member. The wire segments are braided from a distal end of the expandable member toward a proximal end of the expandable member. The proximal section is proximal to the distal section. The proximal end section includes a plurality of filaments. The plurality of wires extend parallel to the longitudinal axis. Half of the wires of the plurality of wires are severed distal of the proximal end of the expandable member, and the other half of the wires of the plurality of wires define the proximal end of the expandable member. The other half of the plurality of wires are bent toward the longitudinal axis to form a spoke and bent parallel to the longitudinal axis to attach to the elongated member.

The distal section may include a first portion having a braiding characteristic and a second portion having a second braiding characteristic different from the first braiding characteristic. The first braiding characteristic may include a braiding angle, and the second braiding characteristic may include a braiding angle. The second braid angle may be greater than the first braid angle. The distal section may have a uniform braid angle. The end portions of the plurality of filaments in the proximal end section may be positioned in side-by-side pairs parallel to the longitudinal axis. The system may further include a polymer line covering at least a portion of each pair of side-by-side filaments. One end portion of each pair of side-by-side wires may be truncated distal to the proximal end of the expandable member. The other end portion of each pair of side-by-side wires may extend radially inward of the proximal hub system to form a spoke. The spokes may be perpendicular to the longitudinal axis.

In some embodiments, the catheter system includes a distal portion configured to be inserted into the vasculature of a subject. The distal portion may include a partially braided expandable member and a plurality of electrode assemblies.

The other half of the plurality of wires may extend to a proximal hub system, which may include or consist essentially of: an outer belt; an inner band radially inward of the outer band; and an adapter including a first longitudinal section radially inward of the outer band and a second longitudinal section radially inward of the inner band. The other end portion of the filament may be radially inward of the inner band. The proximal hub system may comprise or consist essentially of: a metal outer band; a polymer adapter inside the outer band; and a metal inner band. The polymeric adapter can include a distal section and a proximal section proximal to the distal section of the polymeric adapter. The distal section may include a plurality of radial projections. The channel between a pair of the plurality of radial projections may be configured to receive one of the other half of the plurality of wires. The proximal section of the polymeric adapter may be free of radial protrusions. The central lumen may extend through the distal section of the polymeric adapter and the proximal section of the polymeric adapter. The metal inner band may be around the proximal section of the polymeric adapter and inside the outer band. The arcuate space may be located between the inner band and the proximal segment of the polymeric adapter. The arcuate space may be configured to receive another half of the plurality of wires. At least one of the inner band or the outer band may be radiopaque.

The system may further include an outer sheath and an inner member radially inward of the outer sheath. The hub system may be coupled to the inner member. The outer sheath can be configured to maintain the expandable member in a compressed state. The expandable member may be configured to expand from the compressed state toward the expanded state upon proximal relative longitudinal movement of the outer sheath toward the inner member. The expandable member may be configured to compress toward a compressed state when the outer sheath is moved distally relative longitudinally toward the inner member.

The inner member may comprise an elongated tube comprising: a sidewall surrounding the interior cavity; a first radiopaque marking; a second radiopaque marker distal to the first radiopaque marker; a first port through the sidewall, the first port adjacent the first radiopaque marker; and a second port through the sidewall. The second port may be distal to the first port. The second port may be adjacent the second radiopaque marking. The second port may be circumferentially spaced from the first port. The system may include a first pressure sensor in fluid communication with the first port and a second pressure sensor in fluid communication with the second port.

Each of the plurality of electrode assemblies may include a first insulating layer, a second insulating layer, a plurality of electrodes between the first insulating layer and the second insulating layer, and a plurality of conductors between the first insulating layer and the plurality of electrodes. Each conductor of the plurality of conductors may be electrically connected to one electrode of the plurality of electrodes. The first insulating layer may include a slope. The second insulating layer may include a slope. At least one of the first and second insulating layers may have a shore hardness of between 55D and 63D. The total thickness of the first and second insulating layers may be between 0.004 inches (about 0.1mm) and 0.012 inches (about 0.3 mm). At least one of the plurality of electrodes may be recessed into the second insulating layer. At least one of the plurality of electrodes may be flat. At least one electrode of the plurality of electrodes may include a distal tab coupled to the conductor on a side opposite the active surface of the electrode. At least one of the plurality of electrodes may include an oblong shape including a first semicircular portion, a second semicircular portion, and a rectangular portion longitudinally between the first and second semicircular portions. The ratio of the length of the rectangular portion to the diameter of the first and second semi-circular portions may be in the range of 1: 3 to 3: 1.

The plurality of electrodes may be on a first side of a plane that intersects the longitudinal axis of the expandable member. The system may further include a radiopaque marker on a second side of the plane.

Each of the plurality of electrode assemblies may include: a first insulating layer comprising a tube having an open proximal end and an open distal end; a second insulating layer coupled to the first insulating layer; and a plurality of electrodes between the first insulating layer and the second insulating layer. The first and second insulating layers may form a channel in fluid communication with the tube. The channel may have a closed proximal end and/or a closed distal end. Each of the plurality of electrodes may have an oblong shape. Each electrode of the plurality of electrodes may include a proximal tab and/or a distal tab. A plurality of conductors may be located in the channel. Each conductor of the plurality of conductors may be electrically connected to an inner side of the distal tab of one of the plurality of electrodes.

The plurality of electrode assemblies may be circumferentially nested when the expandable member is in a compressed state. The plurality of electrode assemblies may be alternately longitudinally offset when the expandable member is in a compressed state. The plurality of electrode assemblies may be shaped as a parallelogram when the expandable member is in a compressed state.

In some embodiments, a partially braided expandable member for supporting an electrode array (the expandable member self-expanding between a compressed state and an expanded state) comprises or consists essentially of: a proximal end; a distal end; a longitudinal axis; a distal section; and a proximal end section. The distal section comprises or alternatively consists essentially of a plurality of wires. Each wire of the plurality of wires has a flexure that includes a wire segment on each side of the flexure. The flexure defines or at least partially defines the distal end of the expandable member. The wire segments are braided from the distal end of the expandable member toward the proximal end of the expandable member. The proximal section is proximal to the distal section. The proximal end section includes a plurality of filaments. The plurality of wires extend parallel to the longitudinal axis. At least some of the plurality of wires are bent toward the longitudinal axis to form spokes and are bent parallel to the longitudinal axis to attach to the elongated member.

In some embodiments, a partially braided expandable member for supporting an electrode array (the expandable member self-expanding between a compressed state and an expanded state) comprises or consists essentially of: a proximal end; a distal end; a longitudinal axis; a distal section; and a proximal end section. The distal section comprises or alternatively consists essentially of a plurality of wires. Each wire of the plurality of wires has a flexure that includes a wire segment on each side of the flexure. The flexure defines or at least partially defines the distal end of the expandable member. The wire segments are braided from a distal end of the expandable member toward a proximal end of the expandable member. The proximal section is proximal to the distal section. The proximal end section includes a plurality of filaments. The plurality of wires extend parallel to the longitudinal axis.

In some embodiments, an electrode assembly configured to be coupled to an expandable structure and to apply electrical nerve stimulation comprises or consists essentially of: a first insulating layer comprising a tube having an open proximal end and an open distal end; a second insulating layer coupled to the first insulating layer; and a plurality of electrodes between the first insulating layer and the second insulating layer. The first and second insulating layers form a channel in fluid communication with the tube. The channel has a closed proximal end and a closed distal end. Each of the plurality of electrodes has an oblong shape. Each electrode of the plurality of electrodes includes a proximal tab and a distal tab. A plurality of conductors are located in the channel. Each conductor of the plurality of conductors is electrically connected to an inner side of the distal tab of one of the plurality of electrodes.

The first insulating layer may include a slope. The second insulating layer may include a slope. At least one of the first and second insulating layers may have a shore hardness of between 55D and 63D. The total thickness of the first and second insulating layers may be between 0.004 inches (about 0.1mm) and 0.012 inches (about 0.3 mm). At least one electrode of the plurality of electrodes may include a distal tab coupled to the conductor on a side opposite the active surface of the electrode.

At least one of the plurality of electrodes may include an oblong shape including a first semi-circular portion, a second semi-circular portion, and a rectangular portion longitudinally between the first semi-circular portion and the second semi-circular portion. The ratio of the length of the rectangular portion to the diameter of the first and second semi-circular portions may be in the range of 1: 3 to 3: 1.

In some embodiments, an electrode assembly configured to be coupled to an expandable structure and to apply electrical nerve stimulation comprises or consists essentially of: a first insulating layer comprising a tube having an open proximal end and an open distal end; a second insulating layer coupled to the first insulating layer; and a plurality of electrodes positioned between the first insulating layer and the second insulating layer. The first and second insulating layers form a channel in fluid communication with the tube. The channel has a closed proximal end and/or a closed distal end. Each of the plurality of electrodes has an oblong shape. Each electrode of the plurality of electrodes includes a proximal tab and a distal tab. A plurality of conductors are located in the channel. Each conductor of the plurality of conductors is electrically connected to an inner side of the distal tab of one of the plurality of electrodes.

In some embodiments, an electrode assembly configured to be coupled to an expandable structure and to apply electrical nerve stimulation comprises or consists essentially of: a first insulating layer comprising a tube having an open proximal end and an open distal end; a second insulating layer coupled to the first insulating layer; and a plurality of electrodes between the first insulating layer and the second insulating layer. The first and second insulating layers form a channel in fluid communication with the tube. A plurality of conductors are located in the channel. Each conductor of the plurality of conductors is electrically connected to one electrode of the plurality of electrodes.

In some embodiments, a system for applying neural stimulation through an anatomical blood vessel comprises or consists essentially of: an outer sheath; an elongate inner member located within and movable relative to the outer sheath; an expandable member coupled to the distal end of the inner member and located in the outer sheath; and a plurality of electrode assemblies external to and circumferentially spaced around the expandable member. The lumen has a distal end. The expandable member self-expands from a compressed state in the outer sheath to an expanded state outside the outer sheath. The expandable member has a longitudinal axis. The expandable member includes: a distal portion comprising a plurality of filaments braided together to form a plurality of cells; and a proximal portion adjacent to the distal portion. The proximal portion includes a plurality of wires extending parallel to the longitudinal axis. Each electrode assembly of the plurality of electrode assemblies is coupled to two of the wires extending parallel to the longitudinal axis. Each electrode assembly of the plurality of electrode assemblies includes a plurality of longitudinally spaced electrodes facing away from the expandable member.

In some embodiments, a system for applying neural stimulation through an anatomical blood vessel comprises or consists essentially of: an outer sheath; an elongate inner member located within and movable relative to the outer sheath; an expandable member coupled to the distal end of the inner member; and a plurality of electrode assemblies circumferentially spaced around the expandable member. The expandable member self-expands from a compressed state in the outer sheath to an expanded state outside the outer sheath. The expandable member includes: a distal portion comprising a plurality of wires braided together to form a plurality of cells; and a proximal end portion proximal to the distal end portion. The proximal portion includes a plurality of wires extending parallel to the longitudinal axis. Each electrode assembly of the plurality of electrode assemblies is coupled to the wire extending parallel to the longitudinal axis. Each of the plurality of electrode assemblies includes a plurality of electrodes.

In some embodiments, a system for applying neural stimulation through an anatomical blood vessel comprises or consists essentially of: an expandable member; and a plurality of electrode assemblies circumferentially spaced around the expandable member. The expandable member includes: a distal portion comprising a plurality of filaments braided together to form a plurality of cells; and a proximal portion including a plurality of filaments extending parallel to the longitudinal axis.

In some embodiments, a system for applying neural stimulation comprises or consists essentially of: an outer sheath, an elongate inner member located within the outer sheath and movable relative to the outer sheath; an expandable member coupled to the inner member; and a plurality of electrode assemblies located outside of the expandable member and spaced circumferentially around the expandable member. The expandable member self-expands from a compressed state in the outer sheath to an expanded state outside the outer sheath. Each electrode assembly of the plurality of electrode assemblies has a proximal end and a distal end. The plurality of electrode assemblies form a parallelogram shape with the proximal end of each electrode assembly distal to the proximal end of a circumferentially adjacent electrode assembly, and with the distal end of each electrode assembly distal to the distal end of a circumferentially adjacent electrode assembly.

In some embodiments, a system for applying neural stimulation comprises or consists essentially of: an expandable member; and a plurality of electrode assemblies external to and circumferentially spaced around the expandable member. Each electrode assembly of the plurality of electrode assemblies has a proximal end and a distal end. The plurality of electrode assemblies form a parallelogram shape with the proximal end of each electrode assembly distal to the proximal end of a circumferentially adjacent electrode assembly, and with the distal end of each electrode assembly distal to the distal end of a circumferentially adjacent electrode assembly.

In some embodiments, a system for applying neural stimulation comprises or consists essentially of: an expandable member; and a plurality of electrode assemblies located outside the expandable member and spaced circumferentially around the expandable member. The plurality of electrode assemblies form a parallelogram shape.

In some embodiments, a method of deploying a system for applying neural stimulation, wherein the system comprises an expandable member and a plurality of electrodes located outside of and circumferentially spaced around the expandable member, and wherein the plurality of electrode assemblies form a parallelogram shape including a distal-most electrode, the method comprising or consisting essentially of: rotationally aligning a distal-most electrode with a superior aspect (superior) of the right pulmonary artery; longitudinally aligning the distal-most electrode with the carina or the left edge of the trachea; and rotating the expandable member after rotationally aligning the distal-most electrode.

In some embodiments, a method of deploying a system for applying neural stimulation, wherein the system comprises an expandable member and a plurality of electrode assemblies located outside of and circumferentially spaced around the expandable member, and wherein the plurality of electrode assemblies form a parallelogram shape including a distal-most electrode, the method comprising or consisting essentially of: rotationally aligning the distal-most electrode with the superior aspect of the right pulmonary artery; or the distal-most electrode is longitudinally aligned with the carina or left edge of the trachea.

In some embodiments, a method of deploying a system for applying neural stimulation, wherein the system comprises an expandable member and a plurality of electrode assemblies located outside of and circumferentially spaced around the expandable member, and wherein the plurality of electrode assemblies form a parallelogram shape including a distal-most electrode, the method comprising or consisting essentially of: the distal-most electrode is rotationally aligned with the superior view of the right pulmonary artery.

In some embodiments, a method of deploying a system for applying neural stimulation, wherein the system comprises an expandable member and a plurality of electrode assemblies located outside of and circumferentially spaced around the expandable member, and wherein the plurality of electrode assemblies form a parallelogram shape including a distal-most electrode, the method comprising or consisting essentially of: the distal-most electrode is rotationally longitudinally aligned with the carina or left edge of the trachea.

In some embodiments, a hub system for coupling a plurality of filaments to an elongate member comprises or consists essentially of: a metal outer band and a polymer adapter located inside the outer band. The polymeric adapter includes a distal section having a plurality of radial projections and a proximal section proximal to the distal section. The proximal section is free of radial protrusions. The channel between a pair of the plurality of radial projections is configured to receive a filament of the plurality of filaments. A central lumen extends through the distal segment and the proximal segment. The hub system further includes a metal inner band surrounding the proximal segment and inside the outer band. The arcuate space is located between the inner band and the proximal end segment and is configured to receive a plurality of filaments. At least one of the inner band or the outer band is radiopaque.

In some embodiments, a hub system for coupling a plurality of filaments to an elongate member includes or consists essentially of an outer band and an adapter inside the outer band. The adapter includes a distal section having a plurality of radial projections and a proximal section proximal to the distal section. The proximal section is free of radial protrusions. The channel between a pair of the plurality of radial projections is configured to receive a filament of the plurality of filaments. The hub system further includes an inner band surrounding the proximal segment and inside the outer band. The arcuate space is located between the inner band and the proximal end segment and is configured to receive a plurality of filaments.

In some embodiments, a hub system for coupling a plurality of filaments to an elongate member includes or consists essentially of an adapter including a distal section having a plurality of radial protrusions and a proximal section proximal of the distal section. The proximal section is free of radial protrusions. The channel between a pair of the plurality of radial projections is configured to receive a filament of the plurality of filaments. The hub system further includes an inner band surrounding the proximal segment and inside the outer band. A space is between the inner band and the proximal segment, the space configured to receive a plurality of filaments.

In some embodiments, a hub system for coupling a plurality of filaments to an elongate member comprises or consists essentially of: an outer band and an adapter located inside the outer band. The adapter includes a distal section having a plurality of radial projections and a proximal section proximal to the distal section. The proximal section is free of radial protrusions. The channel between a pair of the plurality of radial projections is configured to receive a filament of the plurality of filaments.

In some embodiments, a catheter for measuring pressure of a body lumen comprises or consists essentially of: an outer sheath; and an inner member positioned within the outer sheath, the inner member being movable relative to the outer sheath until a section of the inner member is positioned outside of the outer sheath. The inner member includes an elongate tube including a sidewall surrounding a lumen, a first radiopaque marker, a second radiopaque marker distal to the first radiopaque marker, a first port through the sidewall, and a second port through the sidewall. The first port is proximate the first radiopaque marking. The second port is distal to the first port. The second port is proximal to the second radiopaque marking. The conduit further includes a first pressure sensor in fluid communication with the first port and a second pressure sensor in fluid communication with the second port.

In some embodiments, a catheter for measuring pressure of a body lumen comprises or consists essentially of an elongate tube including a first port through a sidewall and a second port through the sidewall. The second port is distal to the first port. The second port is circumferentially spaced from the first port. The conduit further includes a first pressure sensor in fluid communication with the first port, and a second pressure sensor in fluid communication with the second port.

In some embodiments, a housing for a filter assembly configured to affect an ECG signal comprises or consists essentially of: a plurality of electrode pads configured to be coupled to a plurality of ECG leads; and a plurality of ECG lead inputs configured to be coupled to ECG leads coupled to electrode pads on the subject. The plurality of electrode pads are color coded and marked with at least one of a number or a letter designation. The plurality of electrodes are in positions similar to the positions of the electrode pads on the chest and periphery of the subject. The plurality of electrode pads may include at least ten electrode pads. The plurality of electrode pads may include at least six electrode pads. The plurality of electrode pads may include at least four electrode pads.

Drawings

Figure 1 schematically illustrates a system that may be used to apply electrical neuromodulation to one or more nerves in and around a subject's heart.

Fig. 2A schematically shows the heart and surrounding area.

Fig. 2B to 2D are schematic views of the heart and the peripheral region at various perspective angles.

Fig. 2E and 2F are schematic diagrams of the heart and peripheral nerves.

Fig. 2G and 2H are schematic diagrams of the vasculature and electrode matrix.

Fig. 2I is a schematic diagram of the cardiac vasculature and peripheral nerves.

Fig. 2J is a schematic diagram of the vasculature and peripheral nerves.

Fig. 2K is another schematic diagram of the heart and peripheral nerves.

Fig. 2L illustrates an exemplary stimulation device.

Fig. 3A is a side perspective and partial cross-sectional view of an example of a catheter.

Fig. 3B is a distal end view of the catheter of fig. 3A, as viewed along line 3B-3B of fig. 3A.

Fig. 4A is a side perspective and partial cross-sectional view of another example of a catheter.

Fig. 4B is a distal end view of the catheter of fig. 4A, as viewed along line 4B-4B of fig. 4A.

Fig. 4C is a side perspective view of an example of a portion of a catheter.

Fig. 5 and 6 show examples of catheters.

Fig. 7A and 7B illustrate an example of a pulmonary artery catheter that may be used with a catheter according to the present disclosure.

Fig. 8A and 8B show an example of a catheter.

Fig. 8C shows the catheter of fig. 8A positioned within a main pulmonary artery.

Figure 8D shows the catheter of figure 8B positioned within a main pulmonary artery.

Fig. 9 and 10 show additional examples of catheters.

Fig. 11 shows an example of a catheter system.

Fig. 12A to 12D show various examples of catheters.

FIG. 13 is a perspective view of a catheter positioned in a patient's heart.

Fig. 14A, 14B, 15A, 15B, 16 and 17 show examples of catheters.

Fig. 18A-18C are side partial cross-sections and perspective views of an exemplary catheter suitable for performing the methods of the present disclosure.

Fig. 18D shows the catheter of fig. 18A-18C positioned in the right pulmonary artery of the heart.

FIG. 19 is a partial cross-section and perspective view of an exemplary catheter positioned in a patient's heart.

Fig. 20 is a side partial cross section and perspective view of an exemplary first catheter and an exemplary second catheter suitable for performing the methods of the present disclosure.

Fig. 21 shows an example of a stimulation system for use with the catheter or catheter system of the present disclosure.

Fig. 22A is a perspective view of an example of a portion of a catheter.

Fig. 22B is a side elevational view of a portion of fig. 22A.

Fig. 22C is a distal end view of a portion of fig. 22A.

Fig. 22D is a proximal end view of a portion of fig. 22A.

Fig. 22E to 22G are side partial cross-sectional views of an example of a catheter including a portion of fig. 22A.

Fig. 22H-22L are side elevation and partial cross-sectional views of an example of a catheter deployment system.

Fig. 22M illustrates exemplary components of a portion of fig. 22A.

Fig. 23A is a perspective view of an exemplary section of a strut.

Fig. 23B is a transverse cross-sectional view of an example of a strut.

Fig. 23C is a transverse cross-sectional view of an example of a strut.

Fig. 23D is a transverse cross-sectional view of another example of a strut.

Fig. 23E is a transverse cross-sectional view of yet another example of a strut.

Fig. 23F is a transverse cross-sectional view of yet another example of a strut.

Fig. 23G is a top partial cross-sectional view of an exemplary section of a strut.

Fig. 23H shows an example of a stanchion system.

Fig. 23I shows an example in which the distance between the first pillar and the second pillar is smaller than the distance between the third pillar and the second pillar.

Fig. 23J shows an example in which the distance between the first and second struts is substantially the same as the distance between the third and second struts.

Fig. 23K shows an example of an electrode on a wire system.

Figure 23L is a cross-sectional view of the electrode spaced from the vessel wall.

Fig. 23M illustrates an exemplary electrode matrix.

Fig. 23Ni to 23Nix show an exemplary method of fabricating a component on a substrate.

Fig. 24A shows an example of a fixation system.

Fig. 24B and 24C show the fixation system of fig. 24A interacting with a catheter.

Fig. 25A is a perspective view of another example of a fixation system.

Fig. 25B is a side elevation view of the fixation system of fig. 25A.

Fig. 25C is an end view of the fixation system of fig. 25A.

Fig. 25D and 25E show the fixation system of fig. 25A interacting with a catheter.

Fig. 25F shows an example of a catheter including a shaped lumen.

Fig. 25G-25J show example deployments out of the lumen of the catheter of fig. 25F.

Fig. 26A is a side elevation view of an example of a catheter system 2600.

Fig. 26B-26H illustrate an exemplary method of deploying the catheter system 2600 of fig. 26A.

Fig. 27A is a perspective view of another example of a fixation system.

Fig. 27B is an elevation view of a portion of the fixation system of fig. 27A.

Fig. 27C-27F illustrate the fixation system of fig. 27A retracted after engagement with tissue.

Fig. 27G is a perspective view of yet another example of a fixation system.

Fig. 27H is a side view of the fixation system of fig. 27G.

Fig. 27I is a side view of yet another example of a fixation system.

Fig. 28A is a side view of an example of a fixation system.

Fig. 28B is an enlarged view of the dashed circle 28B in fig. 28A.

Fig. 28C is an enlarged view of the dashed box 28C in fig. 28A.

Fig. 28D shows an example of a radiopaque marker coupled to a proximal fixation mechanism.

Fig. 28E shows an example of a hole in the proximal fixation mechanism.

Fig. 28F is an expanded view (flattened view) of an example of a hypotube (hypotube) cutting pattern.

Fig. 28G is an enlarged view of the dashed box 28G in fig. 28F.

Fig. 28H is a side view of the strut of fig. 28G.

Fig. 28I is a side view of the proximal fixation mechanism flexed radially outward.

Fig. 28J is a side view of the proximal fixation mechanism flexed radially outward and the strut flexed at a flex point.

Figure 28K is a side view of a strut flexed at a flex point.

Fig. 28L to 28O show the proximal fixation mechanism rotated inwards during retrieval into the catheter.

Fig. 29A shows an example of a catheter system.

Fig. 29B-29F illustrate an exemplary method of deploying the catheter system of fig. 29A.

Fig. 29G shows an example of a catheter system.

Fig. 29H shows another example of a catheter system.

Fig. 29I shows yet another example of a catheter system.

Fig. 29J shows yet another example of a catheter system.

Fig. 29K shows yet another example of a catheter system.

Fig. 29L-29N illustrate an exemplary method of deploying the catheter system of fig. 29K.

Fig. 30A is a perspective view of an example of an electrode system.

Fig. 30B is a top plan view of a portion of the electrode system of fig. 30A.

Fig. 30C is a perspective view of another example of an electrode system.

Fig. 30D is a distal end view of the electrode system of fig. 30C in a collapsed state.

Fig. 30E is a distal end view of the electrode system of fig. 30C in an expanded state.

Fig. 30F is a plan view of yet another example of an electrode system.

Fig. 30G is a distal end view of the electrode system of fig. 30F.

Fig. 31A and 31B show an exemplary electrode combination of nine electrodes in a 3 × 3 matrix.

Fig. 31Ci to 31Cxi show an exemplary method of setting a stimulation vector.

Fig. 32A to 32D show exemplary electrode combinations of twelve electrodes in a 3 × 4 matrix.

Fig. 33A is a plot of contractility versus stimulation.

Fig. 33B is another plot of contractility versus stimulation.

FIG. 34 is an exemplary process flow that may be used to implement the duty cycle method.

FIG. 35A schematically illustrates a mechanically repositionable electrode catheter system.

Fig. 35B shows the catheter system of fig. 35A after longitudinal advancement.

Fig. 35C shows the catheter system of fig. 35A after longitudinal advancement and rotation.

FIG. 35D is a cross-sectional view taken along line 35D-35D of FIG. 35C.

Fig. 36A is a perspective view of an example of a catheter system.

Fig. 36B is a perspective view of a portion of the catheter system of fig. 36A in a collapsed state.

Fig. 36C is a side view of a portion of the catheter system of fig. 36A in an expanded state.

FIG. 36D schematically illustrates a side view of an example of an expandable structure.

FIG. 36E schematically illustrates a side view of another example of an expandable structure.

FIG. 36F schematically illustrates a side view of yet another example of an expandable structure.

FIG. 36G schematically illustrates a perspective view of yet another example of an expandable structure.

Fig. 36H schematically illustrates an example of an expandable structure pattern.

Fig. 36I schematically illustrates another example of an expandable structure pattern.

Fig. 36J schematically illustrates yet another example of an expandable structure pattern.

Fig. 36K schematically illustrates yet another example of an expandable structure pattern.

Fig. 36L schematically illustrates yet another example of an expandable structure pattern.

Fig. 36M schematically illustrates another example of an expandable structure pattern.

FIG. 36N schematically illustrates an example of an expandable structure.

Fig. 36O schematically illustrates an example of an expandable structure pattern.

FIG. 36P schematically illustrates a side view of an example of an expandable structure.

FIG. 36Q is a proximal end view of the expandable structure of FIG. 36P.

Fig. 37A is a perspective view of an example of a catheter system.

Fig. 37B is a side view of an example of an expandable structure.

FIG. 37C is a proximal end view of the expandable structure of FIG. 37B.

Fig. 37D is a perspective view of a wire bent to form a spline pair.

Fig. 37E is a perspective view of a spline pair including electrodes.

Fig. 37F is an enlarged perspective view of the distal ends of the spline pairs of fig. 37E.

Fig. 37Fi-37Fiii show examples of electrical movement of the electrodes.

Fig. 37G is a perspective view of an example of a proximal hub of an expandable structure.

Fig. 37H schematically illustrates a side cross-sectional view of the proximal hub of fig. 37G.

Fig. 37I is a perspective view of the distal end of the proximal hub of fig. 37G.

Fig. 37J schematically illustrates a side cross-sectional view of an example of a distal hub of an expandable structure.

Fig. 37K is a side view of an example of the proximal end of the catheter system of fig. 37A.

Fig. 37L is a side cross-sectional view of the proximal end of fig. 37K.

Fig. 37Li through 37Liii illustrate an exemplary method of operating the handle to radially expand the expandable member.

Fig. 37Li and 37Liv illustrate another exemplary method of operating the handle to radially expand the expandable member.

Fig. 37M is a side cross-sectional view of an example component of a handle base.

Fig. 37N is a perspective view of an example proximal end of a catheter shaft assembly and a support tube.

FIG. 37O is a side cross-sectional view of an exemplary connection between the distal end of the catheter shaft assembly and the proximal hub of the expandable structure.

Fig. 37P is a perspective view of an end of an example of a hinge.

Fig. 37Q is a perspective view of an exemplary handle of a catheter system in an unlocked configuration.

FIG. 37R schematically illustrates a perspective cross-sectional view of the handle of FIG. 37Q along line 37R-37R.

Fig. 37S is a perspective view of an example of a locking member.

Fig. 37T schematically shows an enlarged perspective cross-sectional view of the handle of fig. 37Q in an unlocked configuration in the area of circle 37T of fig. 37R.

Fig. 37U is a perspective view of the handle of fig. 37Q in a locked configuration.

FIG. 37V schematically illustrates a perspective cross-sectional view of the handle of FIG. 37U along line 37V-37V.

Fig. 38A is a perspective view of an example of a catheter system.

Fig. 38B is a perspective view of a portion of the catheter system of fig. 38A in a collapsed state.

Fig. 38C is a side view of a portion of the catheter system of fig. 38A in an expanded state.

FIG. 38D is a partial side cross-sectional view of the expandable structure.

FIG. 38E is a partial side cross-sectional view of the expandable structure.

FIG. 39A is a side view of an example of an expandable structure.

FIG. 39B is an end view of an example of another expandable structure.

FIG. 39C is an end view of an example of yet another expandable structure.

FIG. 39D is an end view of an example of yet another expandable structure.

Fig. 40A is a perspective view of an example of a strain relief device for a catheter system.

Fig. 40B is a perspective view of an example of another strain relief device for a catheter system.

Fig. 41A is a perspective view of an example of a catheter system.

Fig. 41B is a perspective view of a portion of the catheter system of fig. 41A in a collapsed and compacted state.

Fig. 41C is a transverse cross-sectional side view of a portion of fig. 41B.

FIG. 41D is a side view of a portion of FIG. 41B in a compacted state.

FIG. 41E is a perspective view of a portion of FIG. 41B in an expanded state.

Fig. 41F schematically illustrates the expandable structure expanded within the vasculature.

FIG. 41G schematically illustrates yet another example of an expandable structure expanded within the vasculature.

Fig. 42A is a side view of an example of an electrode structure.

Fig. 42B is a side view of another example of an electrode structure.

Fig. 43A is a side view of an example of an electrode.

Fig. 43B is a side view of another example of an electrode.

Fig. 44A is a side view of an example of an electrode.

Fig. 44B is a side view of another example of an electrode.

FIG. 45 is a diagram of nerve stimulation of nerves proximate to a vessel wall.

Fig. 46A is a graph illustrating monitoring left ventricular contractility and right ventricular contractility over time.

Fig. 46B is another graph illustrating monitoring of left ventricular contractility and right ventricular contractility over time.

Fig. 47A schematically shows an exemplary electrocardiogram.

Fig. 47B is an example of a modified electrocardiogram.

Fig. 47C is an example of a monitored electrocardiogram.

Fig. 47D is an example of a modified electrocardiogram.

Fig. 47E is another example of a modified electrocardiogram.

Fig. 47F is yet another example of a modified electrocardiogram.

Fig. 47G is still another example of a modified electrocardiogram.

Fig. 47Hi schematically illustrates an example system for blanking nerve stimulation from an ECG.

FIG. 47Hii schematically illustrates an example method of modifying an ECG waveform.

Fig. 47Hiii schematically shows an example ECG waveform, which is not corrupted by the application of neural stimulation.

Fig. 47I schematically illustrates an example system for filtering noise from an ECG signal.

Fig. 47J schematically illustrates an example notch filter.

Fig. 47Ki to 47Kvii schematically show an example effect of filtering noise from an ECG signal.

Fig. 47L schematically illustrates an example system for matching a neural stimulation frequency to an ECG monitoring frequency.

Fig. 48A illustrates insertion of a needle into the vasculature.

Fig. 48B illustrates insertion of an introducer and guidewire into the vasculature.

Fig. 48C shows a swan-ganz catheter and guidewire positioned in the right pulmonary artery.

Fig. 48D illustrates an exemplary catheter system positioned in the right pulmonary artery in an expanded state.

Fig. 48E shows the catheter system of fig. 48D in a further expanded state.

Fig. 48F is a side view of a portion of a catheter system inserted into an introducer.

Fig. 48G is a fluoroscopic image of the catheter system positioned in the right pulmonary artery.

Fig. 48H schematically shows stimulation of the target nerve by electrodes of the catheter system positioned in the right pulmonary artery.

Fig. 49A is a perspective view of an example expandable structure in an expanded state.

Fig. 49Ai is a perspective view of an example expandable structure in an expanded state.

Fig. 49Aii is a perspective view of an example expandable structure in an expanded state.

Fig. 49B is a perspective view of an example expandable structure in an expanded state.

Fig. 49C is a perspective view of an example expandable structure in an expanded state.

Fig. 49Ci is a perspective view of an example expandable structure in an expanded state.

FIG. 49Cii is a perspective view of an example expandable structure in an expanded state.

Fig. 49D is a perspective view of an example expandable structure in an expanded state.

FIG. 50A is a perspective view of an example expandable structure in an expanded state.

Fig. 50B is a perspective view of an example expandable structure in an expanded state.

Fig. 50C is a perspective view of an example expandable structure in an expanded state.

FIG. 51A is a perspective view of an example expandable structure in an expanded state.

Fig. 51B is a perspective view of an example expandable structure in a collapsed state.

Fig. 51C is a perspective view of an example expandable structure in an expanded state.

Fig. 51D is a cross-sectional view of an example catheter for receiving an expandable structure in a collapsed state.

Fig. 51Ei through 51Ev illustrate an example method of retrieving an expandable structure.

Fig. 51Fi is a perspective view of an example expandable structure in an expanded state.

Fig. 51Fii is a side view of the example expandable structure of fig. 51 Fi.

Fig. 52Ai is a perspective view of an example expandable structure in an expanded state.

Fig. 52Aii is a side view of the expandable structure of fig. 52Ai in an expanded state.

Fig. 52Aiii is an end view of the expandable structure of fig. 52Ai in an expanded state.

Fig. 52Aiv illustrates the expandable structure of fig. 52Ai positioned in the right pulmonary artery.

Fig. 52Bi is a perspective view of an example expandable structure in an expanded state.

Fig. 52Bii is an end view of the expandable structure of fig. 52Bi in an expanded state.

Fig. 52Ci is a perspective view of an example expandable structure in an expanded state.

FIG. 52Cii is a side view of the expandable structure of FIG. 52Ci in an expanded state.

FIG. 52Ciii shows the expandable structure of FIG. 52Ci in the right pulmonary artery.

Fig. 52Di is a perspective view of an example expandable structure in an expanded state.

Fig. 52Dii is a side view of the expandable structure of fig. 52Di in an expanded state.

Fig. 52Diii is an end view of the expandable structure of fig. 52Di in an expanded state.

FIG. 52E is a perspective view of an example expandable structure in an expanded and advanced state.

Fig. 52Fi and 52Fii illustrate an example method of using the expandable structure of fig. 52E.

Fig. 52Gi is a perspective view of an example expandable structure in a collapsed state.

FIG. 52Gii is a perspective view of the example expandable structure of FIG. 52Fii in an expanded state.

Fig. 52Giii through 52Gv illustrate an example method of using the expandable structure of fig. 52 Gi.

Fig. 52Gvi illustrates an example method of using a form of expandable structure 5260 that includes electrode splines.

Fig. 53A is a perspective view of an example electrode assembly.

Fig. 53B is a scanning electron microscope image at 3560 times magnification of the electrode area in circle 53B of fig. 53A.

Fig. 53Ci to 53Ciii-2 schematically illustrate an example method of manufacturing an electrode assembly such as that of fig. 53A.

Fig. 53Di and 53Dii schematically illustrate another example method of manufacturing an example electrode assembly, such as the electrode assembly of fig. 53A.

Fig. 53Ei schematically illustrates another example electrode assembly, such as the electrode assembly of fig. 53A.

Fig. 53Eii schematically illustrates another example electrode assembly, such as the electrode assembly of fig. 53A.

Fig. 53F is an external perspective view of an example electrode.

Fig. 53G is an internal perspective view of the example electrode of fig. 53F.

Fig. 54A is a schematic view of a heart with an example catheter system including an expandable structure deployed in the right pulmonary artery.

FIG. 54B is a perspective view of an example pressure sensor.

Fig. 54C is a diagram illustrating an example use of a pressure sensor for monitoring catheter movement.

Fig. 54Di and 54Dii illustrate example methods and systems for detecting movement of a catheter.

Fig. 54E illustrates, in a single diagram, example methods and systems for detecting movement of a catheter.

Fig. 55 is a front view of an example stimulation system.

FIG. 56A shows a screen of an example user interface.

FIG. 56B illustrates another screen of the example user interface of FIG. 56A.

Fig. 57A is a perspective view of an example of a catheter system.

Fig. 57B is a side view of the example expandable structure of the catheter system of fig. 57A in an expanded state.

Fig. 57C is a side view of the expandable structure of fig. 42B in an expanded state without an electrode assembly.

Fig. 57Di is an end view of the example expandable structure of fig. 57B.

FIG. 57Dii is an end view of another example expandable structure.

FIG. 57E is a proximal and side perspective view of the example hub system of the example expandable structure of FIG. 57B.

Fig. 57F is a distal end view of the example hub system of fig. 57E.

FIG. 57G is a proximal and lateral perspective view of a portion of the expandable structure of FIG. 57B and a portion of the example hub system of FIG. 57E.

FIG. 57H is a side view of a portion of the expandable structure of FIG. 57B and a portion of the example hub system of FIG. 57E.

FIG. 57I is a cross-sectional view of the example hub system of FIG. 57E taken from a lateral side of an inner band of the hub system.

Fig. 57J is an exploded proximal and side perspective view of the example hub system of fig. 57E.

Fig. 57K is a top plan view of an example electrode assembly of the example expandable structure of fig. 57B.

Fig. 57L is a partially transparent distal end and top perspective view of the example electrode assembly of fig. 57K.

Figure 57M is a cross-sectional view of the example electrode assembly of figure 57K taken along line 57M-57M of figure 57L.

FIG. 57N is a partially cut-away proximal end and top perspective view of the example electrode assembly of FIG. 57K.

Fig. 57O is a bottom perspective view of the example electrode assembly of fig. 57K.

Fig. 58A is a top and side perspective view of an example electrode of the example electrode assembly of fig. 57K.

Fig. 58B is a top plan view of the example electrode of fig. 58A.

Fig. 58C is a side view of the example electrode of fig. 58A.

Fig. 58Ci shows another example of the electrode.

FIG. 58D is a cross-sectional view of the example electrode of FIG. 58A taken along line 58D-58D of FIG. 58B.

Fig. 58E is a cross-sectional view of another example electrode of the example electrode assembly of fig. 57K.

Fig. 58Fi through 58Fiv are side views of other example electrodes of the example electrode assembly of fig. 57K.

Fig. 58G is a top and side perspective view of an example electrode subassembly of the example electrode assembly of fig. 57K.

Fig. 58Hi through 58Hiii are side cross-sectional views of other example electrode subassemblies of the example electrode assembly of fig. 57K.

Fig. 59A is a side view of a section of an example inner member of the example catheter system of fig. 57A.

Fig. 59B is a perspective view of a portion of the example inner member of fig. 59A.

Fig. 59C is a perspective view of another portion of the example inner member of fig. 59A.

Fig. 60A is a perspective view of a portion of a distal portion of the example catheter system of fig. 57A.

Fig. 60Bi is a distal and side perspective view of another example of a nose portion.

Fig. 60Bii is a distal end view of the nose portion of fig. 60 Bi.

Fig. 60Biii is a perspective view of an example distal end of a system including the nose of fig. 60 Bi.

Fig. 60Biv is a distal and side perspective view of an example distal end of a system including the nose of fig. 60 Bi.

Fig. 61A is a bottom and proximal perspective view of another example electrode assembly of the example expandable structure of fig. 57B.

Fig. 61B is a bottom and distal perspective view of the example electrode assembly of fig. 61A.

Fig. 61Ci is a top, side, and proximal perspective view of another example electrode assembly.

Fig. 61Ci is a rear, side, and proximal perspective view of the example electrode assembly of fig. 61 Ci.

Fig. 61Ciii is a bottom plan view of an example upper insulator and an example electrode of the example electrode assembly of fig. 61 Ci.

Fig. 61Civ is a side view of a plurality of the example electrode assemblies of fig. 61Ci coupled to an example expandable structure.

Fig. 61Cv is a bottom plan view of the plurality of example electrode assemblies of fig. 61Ci in example alignment for coupling to an expandable structure.

Fig. 61Di is a top plan view of an example electrode.

Fig. 61Dii is a top plan view of another example electrode.

FIG. 61Ei is a top, side, and proximal perspective view of yet another example electrode assembly.

FIG. 61Eii is a rear, side and distal perspective view of the example electrode assembly of FIG. 61 Ei.

Fig. 61eii is a top, side and distal perspective exploded view of the example electrode assembly of fig. 61 Ei.

FIG. 61Eiv is a top and side elevational view in longitudinal cross section of an example upper insulator of the electrode assembly of FIG. 61 Ei.

FIG. 61Ev is an enlarged top and side elevation cross-sectional view of the insulator on the example of FIG. 61 Eiv.

Fig. 61Evi is a top and side longitudinal sectional view of an example lower insulator of the electrode assembly of fig. 61 Ei.

Figure 61eviii is a top and distal longitudinal cross-sectional view of the electrode assembly of figure 61 Ei.

Figure 61Eviii is an enlarged top and distal longitudinal cross-sectional view of the electrode assembly of figure 61 Ei.

FIG. 61Eix is a proximal perspective view of the plurality of example electrode assemblies of FIG. 61Ei coupled to an example expandable structure.

Fig. 61Ex illustrates the expandable structure of fig. 61Eix and a plurality of example electrode assemblies positioned in a blood vessel.

Fig. 61Fi is a schematic side view of an example of an undersized blood vessel relative to an expandable structure and/or an oversized expandable structure relative to a blood vessel.

Fig. 61Fii is another schematic side view of an example of a blood vessel undersized relative to an expandable structure and/or an expandable structure oversized relative to the blood vessel.

Fig. 61Gi to 61Giv show schematic side or sectional views of the upper and lower insulators.

Fig. 62A illustrates an example housing for a filter assembly.

Fig. 62B illustrates another example housing for a filter assembly.

Detailed Description

Several examples of the present disclosure provide methods and systems that can be used to apply electrical neuromodulation to one or more nerves in or around a heart of a subject (e.g., a patient). For example, several examples may be useful for electrical neuromodulation of patients with cardiovascular medical symptoms (e.g., patients with acute or chronic cardiac disease). As discussed herein, several examples allow a portion of a catheter to be positioned within a vasculature of a patient in at least one of a right pulmonary artery, a left pulmonary artery, and a pulmonary trunk. Once positioned, the electrode system of the catheter may provide electrical energy (e.g., electrical current or electrical pulses) to stimulate the autonomic nervous system around (e.g., proximate to) the pulmonary artery to provide assisted cardiac therapy to the patient. The sensed cardiac activity characteristic (e.g., the non-electrical cardiac activity characteristic) may be used as a basis for: one or more characteristics of one or more electrical pulses delivered through a catheter positioned in a pulmonary artery of a heart are adjusted to provide assisted cardiac therapy to a patient.

Certain groups of the drawings showing similar items follow a numbering convention in which the first digit or digits correspond to the drawing figure number and the remaining digits identify an element or component in the drawing. Like elements or components between such groups of figures may be identified by the use of like numerals. For example, 336 may represent element "36" in FIG. 3A, and a similar element "36" may be represented as 436 in FIG. 4A. As will be appreciated, elements shown in the various examples herein can be added, exchanged, and/or deleted so as to provide any number of additional examples of the present disclosure. Components or features described with respect to previous figures may not be described in detail with respect to subsequent figures; however, the examples shown in subsequent figures may include any one of the components or combinations of the components or features of the previous examples.

The terms "distal" and "proximal" are used herein with respect to a position or orientation relative to a treating clinician employed along the devices of the present disclosure. "distal" or "distaily" is the position taken along the catheter that is distant from the clinician or in a direction away from the clinician. "proximal" and "proximally" are positions taken along the catheter near the clinician or in a direction toward the clinician.

The catheter and electrode systems of the present disclosure may be used to treat patients with various cardiac conditions. Such cardiac conditions include, but are not limited to, inter alia, acute heart failure. Several examples of the present disclosure provide methods that may be used to treat acute heart failure, also known as decompensated heart failure, by modulating the autonomic nervous system around pulmonary arteries (e.g., right pulmonary artery, left pulmonary artery, pulmonary trunk) in order to provide assisted cardiac therapy to a patient. Neuromodulation therapy may provide assistance by affecting cardiac contractility and/or relaxation, in some examples, beyond heart rate. The autonomic nervous system can be modulated to collectively affect cardiac contractility and/or relaxation, in some examples beyond heart rate. The autonomic nervous system can be affected by electrical modulation, which includes stimulating and/or inhibiting nerve fibers of the autonomic nervous system.

As described herein, one or more electrodes present on the catheter may be positioned within one or both of the main pulmonary artery and/or the right and left pulmonary arteries. According to several examples, one or more electrodes are positioned to contact a luminal surface of the main and/or right or left pulmonary artery (e.g., in physical contact with a posterior surface of the main pulmonary artery). As will be discussed herein, one or more electrodes on a catheter and/or catheter system provided herein may be used to provide pulses of electrical energy between the electrodes and/or a reference electrode. The electrodes of the present disclosure may be used in any of monopolar, bipolar, and/or multipolar configurations. Once positioned, the catheters and catheter systems of the present disclosure may provide electrical stimulation energy (e.g., electrical current or electrical pulses) to stimulate autonomic nerve fibers around one or both of the main and/or pulmonary arteries in order to provide assisted cardiac therapy to the patient.

In some examples, systems other than intravascular catheters may be used according to the methods described herein. For example, electrodes, sensors, etc. are implanted during open heart surgery or without introduction through the vasculature.

Several examples, as discussed more fully herein, may allow for electrical neuromodulation of a patient's heart, including delivering one or more electrical pulses through a catheter positioned in a pulmonary artery of the patient's heart, sensing one or more cardiac activity characteristics (e.g., non-electrical cardiac activity characteristics) from at least a first sensor positioned at a first location in a vasculature of the heart in response to the one or more electrical pulses, and adjusting characteristics of the one or more electrical pulses delivered through the catheter positioned in the pulmonary artery of the heart in response to the one or more cardiac activity characteristics to facilitate providing assisted cardiac therapy to the patient.

The catheter may comprise a plurality of electrodes, optionally inserted into the pulmonary trunk, and positioned such that the electrodes are preferably in contact with the posterior, superior and/or inferior surfaces of the pulmonary artery. From such a location, electrical pulses may be delivered to or from the electrodes to selectively modulate the autonomic nervous system of the heart. For example, electrical pulses may be transmitted to or from one or more of the electrodes to selectively modulate the autonomic cardiopulmonary nerves of the autonomic nervous system, which may modulate cardiac contractility and/or relaxation beyond heart rate in some examples. Preferably, the plurality of electrodes are positioned at locations along the posterior and/or superior wall of a pulmonary artery (e.g., the right or left pulmonary artery). From such a location in the pulmonary artery, one or more electrical pulses may be delivered through the electrodes, and one or more cardiac activity characteristics (e.g., non-electrical cardiac activity characteristics) may be sensed. Based at least in part on the sensed cardiac activity characteristics, characteristics of one or more electrical pulses delivered to or out of electrodes positioned in pulmonary arteries of the heart may be adjusted so as to positively affect cardiac contractility and/or relaxation while reducing or minimizing the effect on heart rate and/or oxygen consumption. In some examples, the effect on cardiac contractility is to increase cardiac contractility. In some examples, the effect on cardiac relaxivity is to increase cardiac relaxivity.

Fig. 1 schematically illustrates a system 100 that can be used to apply electrical neuromodulation to tissue (e.g., which includes one or more nerves) in and around a heart of a subject. The system 100 includes a first component 102 and a second component 104. The first component 102 can be positioned in a pulmonary artery (e.g., shown in fig. 1 as a right pulmonary artery, a left pulmonary artery, and/or a pulmonary trunk). The first component 102 can be positioned within a blood vessel via a minimally invasive, percutaneous procedure, such as being delivered through the vasculature from a remote location (e.g., the jugular vein (e.g., the internal jugular vein, as shown in fig. 1), the axial subclavian vein, the femoral vein, or other blood vessel). Such methods may be through wire (over-the-wire), using a swan-ganz floating catheter, combinations thereof, and the like. In some examples, the first component may be invasively positioned, for example, during a routine procedure (e.g., open heart procedure), placement of another device (e.g., coronary bypass, pacemaker, defibrillator, etc.), or as a stand-alone procedure. As described in further detail herein, the first component includes a neuromodulator (e.g., an electrode, transducer, drug, ablation device, ultrasound, microwave, laser, cryogenic, combinations thereof, etc.), and may optionally include a stent or frame, an anchoring system, and/or other components. The first component 102 may be acutely positioned in the pulmonary artery for 24 to 72 hours. In some examples, the first component 102 modulates the terminal branch nerve within the cardiac plexus, which may increase left ventricular contractility and/or relaxation. The increase in left ventricular contractility and/or relaxivity may not be accompanied by an increase in heart rate, or may be more than the increase in heart rate (e.g., based on a percentage change). In some examples, the first component 102 can be adapted to ablate tissue, including nerves, in addition to or instead of modulating tissue (e.g., nerves).

First component 102 is electrically coupled to second component 104 (e.g., via wires or conductive elements conveyed through the catheter and/or wirelessly, as shown in fig. 1). The second component 104 can be positioned outside the body (e.g., strapped to the arm of the subject, strapped to another part of the subject (e.g., leg, neck, chest), placed on a bedside table, etc., as shown in fig. 1). In some examples, the second component 104 may be temporarily implanted in the subject (e.g., in a blood vessel, in another body cavity, in the chest cavity, etc.). The second component 104 includes electronics (e.g., a pulse generator) configured to operate the electrodes in the first component 102. The second component 104 may include a power source or may receive power from an external source (e.g., a wall socket, a separate battery, etc.). The second component 104 may include electronics configured to receive sensor data.

The system 100 may include a sensor. The sensors may be positioned in one or more of a pulmonary artery (e.g., right pulmonary artery, left pulmonary artery, and/or pulmonary trunk), an atrium (e.g., left and/or right), a ventricle (e.g., left and/or right), a vena cava (e.g., superior vena cava and/or inferior vena cava), and/or other cardiovascular locations. The sensor may be part of the first component 102, part of the catheter, and/or separate from the first component 102 (e.g., an electrocardiograph chest monitor, pulse oximeter, etc.). The sensor can be in communication (e.g., wired and/or wireless) with the second component 104. The second component 104 can initiate, adjust, calibrate, terminate, or otherwise act on neuromodulation based on information from the sensor.

The system 100 may comprise an "all-in-one" system in which the first component 102 is integral or unitary with the target catheter. For example, the first component 102 may be part of a catheter that is inserted into an internal jugular vein, an axial subclavian vein, a femoral vein, etc., and is guided to a target location (e.g., a pulmonary artery). The first component 102 may then be deployed from the catheter. Such a system may reduce the number and/or complexity of procedural steps and catheter exchanges for locating the first component 102. For example, the length of the guidewire may be twice the length of the target catheter, which may be difficult to control in a sterile field. Because the repositioning system is already in place, such a system may make it easier to reposition the first component 102 after initial deployment.

The system 100 may include a telescopic (telescoping) and/or a through-the-wire system in which the first component 102 is distinct from the target catheter. For example, a target catheter (e.g., swan-ganz catheter) may be inserted into the internal jugular vein, axial subclavian vein, femoral vein, etc., and guided to a target location (e.g., pulmonary artery) (e.g., by floating). A guidewire may be inserted through a target catheter to a target location to a proximal hub (e.g., with the hardest portion exiting the distal end of the target catheter), and the first member 102, which is part of a separate catheter from the target catheter, may be tracked to the target location over the guidewire or using a telescoping system (e.g., other guidewires, guide catheters, etc.). The first component 102 may then be deployed from a separate catheter. Interventional cardiologists know that such systems make multiple exchanges without problems. Such a system may allow customization of certain specific functions. Such a system may reduce the overall catheter diameter, which may increase trackability and/or allow additional features to be added, for example because not all functions are integrated into one catheter. Such a system may allow multiple catheters to be used (e.g., removing a first individual catheter and positioning a second individual monotube without having to reposition the entire system). For example, catheters with different types of sensors may be positioned and removed as desired. The system 100 can be steerable (e.g., include a steerable catheter) without a swan-ganz tip. Some systems 100 may be compatible with one or more of the described types of systems (e.g., a steerable catheter with an optional inflatable balloon for swan-ganz flotation, a steerable catheter that may be telescoped over a guidewire and/or over a catheter, etc.).

Fig. 2A schematically shows a heart 200 and surrounding areas. The main or trunk pulmonary artery 202 begins at the exit of the right ventricle 204. In adults, the pulmonary trunk 202 is a tubular structure having a diameter of about 3 centimeters (cm) (about 1.2 inches (in)) and a length of about 5cm (about 2.0 in). The main pulmonary artery 202 branches into a left pulmonary artery 208 and a right pulmonary artery 206, and the left and right pulmonary arteries 208 and 206 deliver hypoxic blood to the respective lungs. As shown in fig. 2A, the main pulmonary artery 202 has a posterior surface 210 that arches above the left atrium 212 and is adjacent to the pulmonary veins 213. As described herein, the neural stimulator may be positioned at least partially in the pulmonary arteries 202,206,208, for example, where the neural stimulator is in contact with the posterior surface 210. In some examples, the preferred location for locating the neurostimulator is the right pulmonary artery 204. PCT patent application No. PCT/US2015/047780 and U.S. provisional patent application No.62/047,313 are incorporated by reference herein in their entirety, and more particularly, the description disclosed therein as being located in the right pulmonary artery is incorporated by reference herein. In some examples, a preferred location for positioning the neural stimulator is in contact with the posterior surface 210 of the pulmonary arteries 202,206, 208. From such a location, the stimulation electrical energy delivered from the electrodes may, for example, be better able to treat and/or provide treatment (including adjuvant treatment) to a subject experiencing various cardiovascular medical conditions (e.g., acute heart failure). Other locations of the neurostimulator within the pulmonary arteries 202,206,208 are also possible.

The first component 102 (fig. 1) can be positioned in a pulmonary artery 202,206,208 of a subject, wherein the neurostimulator of the first component 102 is in contact with a luminal surface of the pulmonary artery 202,206,208 (e.g., in physical contact with or proximate to a surface of a posterior portion 210 of the pulmonary artery 202,206, 208). The neurostimulator of the first component 102 may be used to deliver stimulation to the autonomous cardiopulmonary fibers surrounding the pulmonary arteries 202,206, 208. The stimulation electrical energy may elicit a response from the autonomic nervous system, which may help regulate the subject's cardiac contractility and/or relaxation. The stimulation may affect contractility and/or relaxation beyond heart rate, which may improve hemodynamic control while may reduce unwanted systemic effects.

In some examples, neuromodulation of a target nerve or tissue described herein may be used to treat cardiac arrhythmias, atrial fibrillation or flutter, diabetes, eating disorders, endocrine diseases, genetic metabolic syndrome, hyperglycemia (including anti-glucose), hyperlipidemia, hypertension, inflammatory diseases, insulin resistance, metabolic diseases, obesity, ventricular tachycardia, symptoms affecting the heart, and/or combinations thereof.

Fig. 2B to 2D are schematic views of the heart 200 and the peripheral region at various perspective angles. Portions of the heart 200 including portions of the pulmonary trunk 202 (e.g., other structures, particularly the aorta, superior vena cava, among others) have been removed to allow details discussed herein to be shown. Fig. 2B provides a perspective view of the heart 200 as seen from the front of the subject or patient (from a front-to-back direction), while fig. 2C provides a perspective view of the heart 200 as seen from the right side of the subject. As shown, the heart 100 includes a pulmonary trunk 102 from the base of a right ventricle 104. In adults, the pulmonary trunk 102 is a tubular structure approximately 3 centimeters (cm) in diameter and 5cm in length. The pulmonary trunk 202 branches into a left pulmonary artery 206 and a right pulmonary artery 208 at a branch point or bifurcation 207. The left and right pulmonary arteries 106 and 108 are used to deliver hypoxic blood to each corresponding lung.

The branch point 207 includes a ridge 209 extending from the posterior portion of the pulmonary trunk 202. As shown, the branching point 207 and the ridge 209 together provide a "Y" or "T" shaped structure that helps define at least a portion of the left and right pulmonary arteries 208 and 206. For example, from the ridge 209, the branching point 207 of the pulmonary trunk 202 slopes in the opposite direction. In a first direction, the pulmonary trunk 202 transitions into the left pulmonary artery 208, and in a second direction, opposite the first direction, the pulmonary trunk 202 transitions into the right pulmonary artery 206. The branch point 207 may not need to be aligned along the longitudinal centerline 214 of the pulmonary trunk 202.

As shown in fig. 2B, portions of the pulmonary trunk 202 can be defined by a right lateral plane 216 and a left lateral plane 220 parallel to the right lateral plane 216, the right lateral plane 216 passing along a right luminal surface 218 of the pulmonary trunk 202, wherein the left lateral plane 220 passes along a left luminal surface 222 of the pulmonary trunk 202. The right and left lateral planes 216, 220 extend in a posterior direction 224 and an anterior direction 226. As shown, the ridge 209 of the branch point 207 is located between the right lateral plane 216 and the left lateral plane 220. The branch point 207 is positioned between the right lateral plane 216 and the left lateral plane 220, wherein the branch point 207 can help to at least partially define the beginning of the left and right pulmonary arteries 208, 206 of the heart 200. The distance between the right lateral plane 216 and the left lateral plane 220 is approximately the diameter of the pulmonary trunk 202 (e.g., about 3 cm).

As discussed herein, the present disclosure includes methods for neuromodulating a heart 200 of a subject or patient. For example, as discussed herein, a catheter positioned in the pulmonary artery 202 may be used to deliver one or more electrical pulses to the heart 200. For example, as discussed herein, a first sensor positioned at a first location within the vasculature of the heart 200 senses a characteristic of cardiac activity in response to the neural stimulation. The characteristics of the neurostimulator may be adjusted in response to the sensed cardiac activity characteristics to provide assisted cardiac therapy to the patient.

Fig. 2D provides additional views of the posterior surface 221, superior surface 223, and inferior surface 225 of the right pulmonary artery 206. As shown, the view of the heart 200 in fig. 2D is from the right side of the heart 200. As shown, the posterior surface 221, the upper surface 223, and the lower surface 225 occupy approximately three-quarters of the luminal perimeter of the right pulmonary artery 206, with the anterior surface 227 occupying the remainder. In some implementations, the electrodes of the nerve stimulation device can be positioned adjacent to the anterior surface 227. The electrodes of the neurostimulation device may span a portion of the circumference, and that portion may span (e.g., only span) or be configured to span, for example, the anterior surface 227 and/or the superior surface 223. The electrodes may cover or span between about 10% to about 50% of the circumference of the device and/or artery (e.g., anterior surface 227 and/or superior surface 223) (e.g., about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, ranges between these values, etc.). The electrodes may cover or span between about 10mm and about 40mm (e.g., about 10mm, about 15mm, about 20mm, about 25mm, about 30mm, about 35mm, about 40mm, ranges between these values, etc.) of the circumference of the device and/or artery (e.g., anterior surface 227 and/or superior surface 223). In certain such embodiments, the electrodes of the nerve stimulation device may also or alternatively be positioned adjacent the upper surface 223. Fig. 2D also shows the aorta 230, the pulmonary veins 213, the Superior Vena Cava (SVC)232, and the Inferior Vena Cava (IVC) 234.

Fig. 2E and 2F are schematic views of heart 200 and peripheral nerves. The cardiovascular system is rich in autonomic fiber nerves. Sympathetic nerve fibers originate from the stellate and thoracic sympathetic ganglia and are responsible for increasing the chronotropic (heart rate), flaccidity (relaxation) and inotropic (contractile) states of the heart. Human autopsy studies have shown that the fibers responsible for the relaxed and inotropic states of the ventricles pass along the posterior surface of the right pulmonary artery 206 and the pulmonary trunk 202. Fig. 2E shows the approximate locations of the right dorsal medial common fibular (CPN)240, right dorsal lateral CPN 242, right asteroid CPN 244, right vagus (vagal nerve) or vagus (vagus)246, right intracranial vagus CPN 248, right caudal vagus CPN 250, right coronary heart 252, left coronary heart 254, left centripetal 256, left recurrent laryngeal 258, left vagus (vagal nerve) or vagus (vagus)260, left asteroid CPN 262, left dorsal lateral CPN 264, and left dorsal medial CPN 266. These and/or other nerves surrounding (e.g., in the vicinity of) heart 200 may be targeted for neurostimulation by the systems and methods described herein. In some examples, at least one of the right dorsal medial common peroneal nerve 240, the right stellate CPN 244, and the left centripetal nerve 256 is targeted for and/or affected for neuromodulation, although other nerves shown or not shown in fig. 2E may also be targeted and/or affected.

Fig. 2E and 2F also schematically show an air tube 241. As best seen in fig. 2F, the trachea 241 bifurcates into a right pulmonary artery bronchus 243 and a left pulmonary artery bronchus 241. The bifurcation of the trachea 241 can be considered to be along a plane 245. Plane 245 is along the right pulmonary artery 206. The bifurcation of the pulmonary artery can be viewed as along plane 247, with plane 247 spaced from plane 245 by gap 249. Gap 249 spans right pulmonary artery 206. A large number of cardiac nerves cross the right pulmonary artery 206 along the gap 249 indicated by the circled region 251, and these nerves may advantageously be the target of some of the systems and methods described herein. In some such examples, the bifurcation of the trachea 241 and/or the pulmonary artery 202 may provide a landmark for system and/or component localization. The stimulation electrodes may be spaced from the trachea 241, for example, to reduce coughing and other possible respiratory side effects. In some examples, the stimulation electrodes are spaced between about 2mm to about 8mm from the trachea 241 or plane 245 (e.g., about 2mm, about 3mm, about 4mm, about 5mm, about 6mm, about 7mm, about 8mm, ranges between such values, etc.). In some examples, the stimulation electrodes are spaced from the trachea 241 or plane 245 by a percentage (e.g., about 10%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 75%, about 100%, a range between such values, etc.) of the length of the right pulmonary artery 206 between about 10% and about 100%.

Fig. 2G and 2H are schematic diagrams of the vasculature and electrode matrix 201. Most of the electrode matrix 201 is located in the right pulmonary artery 206, but some of the electrode matrix 201 may be considered to be located in the pulmonary trunk 202. The electrode array is shown as a 4 x 5 matrix of electrodes 203. As described in further detail herein, the electrodes 203 may be positioned on a spline, on a membrane or mesh coupled to the spline, or the like. For example, four splines may contain five electrodes 203 per spline. In some examples, the electrodes 203 comprise bipolar electrodes with controllable polarity, allowing configurability of the electrode matrix 201. In some examples, the edge-to-edge spacing of the electrodes 203 is between about 3mm to about 7mm (e.g., about 3mm, about 4mm, about 5mm, about 6mm, about 7mm, ranges between such values, etc.). In some examples, the electrode 203 has about 0.5mm²To about 5mm²Surface area in between (e.g., about 0.5 mm)²About 1mm²About 1.5mm²About 2mm²About 2.5mm²About 3mm²About 3.5mm²About 4mm²About 4.5mm²About 5mm²A range between such values, etc.). The electrodes 203 are generally longitudinally and circumferentially aligned, but offset electrodes 203 are also possible. The coverage of the right pulmonary artery provided by electrode array 201 is between about 25mm to about 35mm in the longitudinal direction (e.g., about 25mm, about 28mm, about 31mm, about 35mm, ranges between such values, etc.) and between about 80 ° to about 120 ° in the circumferential direction (e.g., about 80 °, about 90 °, about 100 °, about 110 °, about 120 °, ranges between such values, etc.). The electrode array 201 may cover, for example, between about 25% to about 50% of the circumference of the blood vessel (e.g., about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, ranges between such values, etc.). In some examples, the electrode array 201 includes a 3 × 3 matrix, a 3 × 4 matrix, a 3 × 5 matrix, a 4 × 4 matrix, a 4 × 5 matrix, or a 5 × 5 matrix. A larger matrix may be more likely to pass through at least one of the electrodes 203 One combination captures the target nerve, and a smaller matrix can be more easily delivered to the target site. Referring again to fig. 2D, in some embodiments, an electrode array having features described herein can be positioned adjacent to the front surface 227. In certain such embodiments, the electrode array may also or alternatively be positioned adjacent to the upper surface 223.

Fig. 2I is a schematic diagram of the cardiac vasculature and peripheral nerves. Similar to fig. 2G and 2H, fig. 2I shows a pulmonary trunk 202, a right pulmonary artery 206, and a left pulmonary artery 208. Fig. 2I also shows the traces of the interventricular sulcus nerves 215,217 along the approximate crossing location of the right pulmonary artery 206 and pulmonary trunk 202. Stimulation of one or both of the nerves 215,217 may increase contractility and/or relaxation, e.g., beyond heart rate or without affecting heart rate. The electrode matrix 201 (including electrodes 203a,203b, 203c,203d, 203e,203f, etc.) is shown in phantom in the approximate positions of fig. 2G and 2H.

In some examples, a particular electrode may be selected to target or capture one or more nerves. The electrodes 203a,203b may be used, for example, to target the nerve 215 in a generally lateral manner. The electrodes 203a,203c may be used to target the nerve 215, for example, in a substantially parallel manner. The electrodes 203c,203d may be used to target the nerve 215 and the nerve 217, for example, in a generally lateral manner. The electrodes 203e,203f may be used, for example, to target the nerve 217 in a substantially mixed lateral-parallel manner. In some examples, two electrodes may be used in a bipolar manner, where one of the two electrodes is positive and the other of the two electrodes is negative. In some examples, more than two electrodes may be used, where two or more electrodes are positive electrodes and two or more electrodes are negative electrodes.

As described in further detail herein, after placement of the electrode array, the electrode combination may be activated to test its effect. Some combinations may produce better results but are more likely to cause side effects, some combinations may produce better results but may be less reproducible, some combinations may affect one nerve but not multiple nerves, etc. In some examples, multiple electrode combinations or independent outputs may be used in parallel or in series. For example, electrodes 203a,203b may be used to target nerve 215 for a first duration of time, and electrodes 203e,203f may be used to target nerve 217 for a second duration of time. The second duration may at least partially overlap the first duration, fully overlap the first duration (e.g., begin at the same time, end at the same time, begin after the first duration begins, end before the first duration ends, and combinations thereof), or may be separated in time from the first duration by a third duration. The third duration may be zero (e.g., the second duration begins when the first duration ends).

In several cadaver studies, the mean diameter 206d of the right pulmonary artery 206 near the branching point 207 was about 26.5mm with a standard deviation of about 4.6 mm. Assuming a circular vessel, the average circumference of the right pulmonary artery 206 near the branch point 207 is about 83 mm. If a 30% coverage of the circumference is aimed at, the electrode matrix should have a circumferential length of about 25mm (83mm x 30%). Other electrode matrix dimensions may be estimated or calculated based on other dimensions (e.g., vessel diameter at other points, measured vessel diameter, diameters of other vessels, vessel length, etc.), target coverage percentage, nerve location variability, placement accuracy, stimulation parameters, etc.

Fig. 2J is a schematic diagram of the vasculature and peripheral nerves. The superior vena cava 232 supplies blood to the right atrium of the heart, as described above. The blood vessels that supply blood to the superior vena cava 232 include the right innominate or right brachiocephalic vein 253 and the left innominate or left brachiocephalic vein 255. The blood vessels supplying blood to the right brachiocephalic vein 253 include the right subclavian vein 257 and the right internal jugular vein 259. The blood vessels supplying blood to the left brachiocephalic vein 255 include the left subclavian vein 261 and the left internal jugular vein 263. The hypothyroid vein 265 also supplies blood to the superior vena cava 232. The right vagus nerve is shown as an example, although other nerves are present around the vasculature shown in fig. 2F. The left vagus nerve extends adjacent to the left internal jugular vein 263 and common carotid artery, and then across the left brachiocephalic vein 255. The thoracic sympathetic branch also crosses the left brachiocephalic vein 255 closer to the aortic crown and more medial, approximately between the junction of the left subclavian and internal jugular veins 263 and about half the length of the left brachiocephalic vein 253. Vasculature that may not be generically delineated as cardiovascular may also be used in accordance with certain methods and systems described herein.

Fig. 2K is another schematic diagram of the heart 200 and peripheral nerves. As described in detail herein, neuromodulation may be performed by targeting nerves affecting contractility and/or relaxivity (e.g., left ventricular contractility and/or relaxivity) by positioning a catheter in a pulmonary artery (e.g., right pulmonary artery, pulmonary trunk, left pulmonary artery). In some examples, for example, the right star-shaped CPN 244 may also or alternatively be targeted by positioning the device at location 272 in the left subclavian artery 274 or at location 276 in the descending aorta 278. Positioning in the left common carotid artery 280 is also possible. In fig. 2K, an exemplary stimulation device 282 is shown at locations 272, 276. Other stimulation devices are also possible. In examples including multiple stimulation devices, the stimulation devices may be the same, different, or similar (as non-limiting examples, having the same structure but different dimensions).

Fig. 2L illustrates an exemplary stimulation device 282. The stimulation device 282 may be used, for example, to target stimulation of the right star-shaped CPN 244 or another nerve. Device 282 includes a skeletal structure 284, such as a stent, a loop, or the like. Skeletal structure 284 may include a self-expanding shape memory material (e.g., nitinol). The device 282 also includes a mesh or membrane 286 attached to the skeletal structure 284. The grid 286 may, for example, includeOne side of the device 282 includes an array of electrodes 288. The electrode array 288 may have a width of about 0.5cm²To about 3cm²Area in between (e.g., about 0.5 cm)²About 1cm, of²About 1.5cm²About 2cm, of²About 2.5cm²About 3cm²A range between such values, etc.). The electrode array 288 may be powered by implantable electronics 290. The electronic device 290 may include, for example, a non-volatile memory (e.g., storing electrode combinations and parameters), an ASICStimulation engines and logic, RF engines, battery power and sensors (e.g., pressure sensors, contractility sensors, combinations thereof, etc.). The device 282 may be positioned via a catheter delivered through the vasculature (e.g., from the femoral artery or the radial artery). The device 282 may be capable of being positioned until the target nerve is stimulated. In some examples, the electrode array 288 can be electronically repositioned (e.g., as described with respect to fig. 32A-32D). In some examples, an external device (e.g., worn by the subject) may power and/or control the device 282. In examples where electronics 290 may power and/or control device 282, device 282 may be fully implantable. In some such examples, the device 282 may be combined with a pacemaker, defibrillator, or other implantable stimulation device.

Fig. 3A is a side perspective and partial cross-sectional view of an example of a catheter 300. Fig. 3B is a distal end view of the catheter 300 of fig. 3A, as viewed along line 3B-3B of fig. 3A. The catheter 300 includes an elongated body 302 having a first or proximal end 304 and a second or distal end 306. The second end 306 is distal to the first end 304. The elongated body 302 includes a longitudinal axis 308 extending through the first end 304 and the second end 306 of the elongated body 302. A first plane 310 extends through the longitudinal axis 308 over the length of the elongated body 302. As used herein, a plane is a virtual flat surface on which a straight line connecting any two points thereon will lie entirely, and is used herein to help locate the relative position of a structure on the catheter 300. The first plane 110 is used herein to help illustrate the relative positions of the electrodes, among other reasons. The catheter 300 further includes at least two elongated stimulation members 314 (illustrated as 314a and 314B in fig. 3A and 3B). A stimulation member 314 extends from the elongate body 302. Each of the at least two elongated stimulation members 314a,314b is bent into a first volume 316 at least partly defined by the first plane 310. For example, at least two elongated stimulation members 314 extend from about the second end 306 of the elongated body 302 into the first volume 316.

Each of the at least two elongate stimulation members 314 comprises at least one electrode 318. At least one electrode 318 on each of the elongated stimulation members 314 forms an electrode array in a first volume 316 at least partially defined by the first plane 310. The at least one electrode 318 on each of the stimulation members 314 is electrically isolated from each other. In some examples, stimulation member 314 comprises an electrically insulating material.

Each of the at least one electrode 318 is coupled to a corresponding conductive element 320. The conductive elements 320 are electrically isolated from each other and extend from each respective electrode 318 through the first end 304 of the elongate body 302, through the stimulation member 314, and/or along the stimulation member 314. The conductive elements 320 terminate at connector ports, wherein each conductive element 320 is releasably coupleable to a stimulation system, e.g., as described herein. In some examples, the conductive element 320 is permanently coupled to the stimulation system (e.g., non-releasably coupled). The stimulation system may be used to provide stimulation electrical energy that is conducted through the conductive element 320 and delivered to the combination of electrodes 318 in the electrode array.

Each of the at least two elongate stimulation members 314 includes a stimulation member elongate body 322 having a distal end 324. The distal end 324 of the stimulation member elongate body 322 of each of the elongate stimulation members 314 extends from the elongate body 302. Each of elongate body 302 and stimulation member elongate body 322 includes a surface defining a lumen 328 through which a filament 326 may extend. A filament 326 is connected to its respective stimulation member elongate body 322 at or near the distal end 324 of the stimulation member elongate body 322, wherein the filament 326 thereby extends freely through a lumen 328 in the elongate stimulation member 314 through the first end 304 of the elongate body 302. The lumen 328 is sized to allow the wire 326 to move longitudinally within the lumen 328. The portion of the filament 326 extending from the first end 304 may be used to apply pressure to the stimulation member elongate body 322 at or near the distal end 324 of the stimulation member elongate body, where the filament 326 may deflect or buckle under such pressure, which may impart a bend into each of the at least two elongate stimulation members 314 entering the first volume 316 defined at least in part by the first plane 310. The at least two elongated stimulation members 314 extend radially away from the elongated body 302 over a range of distances depending on how much pressure is applied on the filament 326. The curvature of the at least two elongate stimulation members 314 may have a radius of curvature that varies along the length of the stimulation member elongate body 322 (e.g., as shown in fig. 3A).

In some examples, the at least two elongated stimulation members 314 are only bent into the first volume 316 at least partially defined by the first plane 310. A second volume, opposite the first volume and defined at least in part by the first plane 310, may not contain an electrode. In some examples, the at least two elongate stimulation members 314 include a first elongate stimulation member 314a and a second elongate stimulation member 314 b. The second plane 312 intersects the first plane 310 along the longitudinal axis 308 of the elongate body 302. The first plane 310 and the second plane 312 divide the first volume 316 into a first quadrant volume 332 and a second quadrant volume 334. In some examples (e.g., as shown in fig. 3A and 3B), the first elongate stimulation member 314a is bent into the first quadrant volume 332 and the second elongate stimulation member 314B is bent into the second quadrant volume 334.

The catheter 300 may include an anchor member 336 extending from the elongate body 302 into the second volume 330. The anchor member 336 may or may not include an electrode. The anchor member 336 does not occlude and/or promote thrombosis or blood clotting within the vasculature. The anchor member 336 and the elongate body 302 include surfaces that define a lumen 338 through which a wire 340 may pass. A wire 340 is connected to the anchor member 336 at or near the distal end 342 of the member 336, wherein the wire 340 extends freely through the lumen 338 of the anchor member 336 through the first end 304 of the elongate body 302. The lumen 338 is sized to allow the lead 340 to move longitudinally within the lumen 338. The portion of the wire 340 extending from the first end 304 may be used to apply pressure to the anchor member 336 at or near the distal end 342 of the anchor member 336, where the wire 340 may deflect or buckle under such pressure, which may impart a bend to the anchor member 336. The anchor member 336 may extend radially away from the elongate body 302 over a range of distances depending on how much pressure is applied to the wire 340. The anchor member 336 can be used to bring the electrodes 318 into contact with the luminal surface of the blood vessel (e.g., the posterior surface of one or both of the main and/or pulmonary arteries), for example, by applying various pressures as described herein. Optionally, the anchor member 336 may be configured to include one or more electrodes.

Each of the wires 326 and 340, after being used to impart a bend into its respective member, may be releasably locked in place by inhibiting or preventing longitudinal movement of the wire 326,340 relative to the elongate body 302. For example, a clip or other device may be used to bring the wire 326,340 into contact with the surface of the lumen 328,338 sufficient to inhibit or prevent relative movement of the wire 326,340 with respect to the surface of the lumen 328,338. This clamping action may also act as a hemostatic valve to reduce or minimize blood loss.

Fig. 3A and 3B also show a pulmonary artery catheter 344 (shown partially to show details of the catheter 300) that may be used with the catheter 300 in a catheter system. The pulmonary artery catheter 344 includes an elongate catheter body 346, the elongate catheter body 346 having a first or proximal end 348, a second or distal end 350, a peripheral surface 352, and an inner surface 354 opposite the peripheral surface 352. The inner surface 354 at least partially defines a lumen 356 extending between the first end 348 and the second end 350 of the elongate catheter body 346. The lumen 356 is sized and shaped to accommodate at least a portion of the catheter 300 within the lumen 356 during delivery of the catheter 300. For example, the anchor member 336 and at least two elongate stimulation members 314 and at least a portion of the elongate body 302 can be at least partially positioned within the lumen 356. The anchor member 336, the at least two elongate stimulation members 314, and at least a portion of the elongate body 302 can be deployed from the distal end 350 of the pulmonary artery catheter 344 during delivery and implantation of the catheter 300.

The pulmonary artery catheter 344 can also include an inflatable balloon 358 on the peripheral surface 352 of the elongate catheter body 346. The inflatable balloon 358 includes a balloon wall 360 having an inner surface 362, the inner surface 362 at least partially defining a fluid-tight volume 364 along with a portion of the outer peripheral surface 352 of the elongate catheter body 346. The pulmonary artery catheter 344 also includes an inflation lumen 366 extending through the elongate catheter body 346. The inflation lumen 366 includes a first opening 368 into the fluid tight volume 364 of the inflatable balloon 358 and a second opening 370 proximal to the first opening 368 to allow fluid to move into and out of the fluid tight volume 364 to inflate and deflate the balloon, respectively. A syringe or other such device containing a fluid (e.g., saline, contrast, gas (e.g., oxygen)) may be used to inflate and deflate balloon 358. Fig. 3A shows the balloon 358 in an expanded state, while fig. 3B shows the balloon 358 in a deflated state.

For example, as described herein, the catheter system may be used to position the catheter 300 in one or both of the patient's main and/or pulmonary arteries. With catheter 300 positioned within lumen 356, pulmonary artery catheter 344 may be introduced into the vasculature through a percutaneous incision and directed to the right ventricle. For example, the catheter 300 may be inserted into the vasculature via a peripheral vein of the arm (e.g., like a peripherally inserted central catheter). Changes in the subject's electrocardiogram and/or pressure signals from the vasculature can be used to guide and position the catheter 300 within the subject's heart. Once in place, the balloon 358 may be inflated to allow the pulmonary artery catheter 344 and catheter 300 to be carried from the right ventricle to the main pulmonary artery and/or one of the pulmonary arteries by the flow of blood. Optionally, various imaging modalities may be used in positioning the catheter 300 and/or the catheter system in one of the main and/or pulmonary arteries. Such imaging modalities include, but are not limited to, fluoroscopy, ultrasound, electromagnetic and potentiometric modalities.

The catheter system can be advanced along the main pulmonary artery until the distal end 350 of the pulmonary artery catheter 344 contacts the top of the main pulmonary artery (e.g., at a location distal to the pulmonary valve and adjacent to both pulmonary arteries). Advancement may be performed with balloon 358 in an inflated or deflated state. Once the distal end 350 of the pulmonary artery catheter 344 reaches the top of the main pulmonary artery, the elongate catheter body 346 can be moved relative to the catheter 300 to deploy the catheter 300 from the lumen 356 of the pulmonary artery catheter 344.

The outer peripheral surface of the catheter body 302 may include markings, for example, beginning at the first end 304 and extending to the second end 306 of the catheter 300. The distance between the markers may have a few units (e.g., millimeters, inches, etc.), which may allow the length between the distal end 350 of the pulmonary artery catheter 344 and the top of the main pulmonary artery to be determined. Indicia may also or alternatively be provided on the peripheral surface of the catheter body 302 that indicate when the distal end 350 of the pulmonary artery catheter 344 is free of the anchor member 336 and the elongate stimulation member 314. In some examples, a positioning measurement instrument may be used to position catheter 300 within the main pulmonary artery, for example, as discussed in further detail herein.

The ability to measure the distance from the top of the main pulmonary artery may facilitate placement of the electrode 318 in a desired location of the main pulmonary artery. In addition to or instead of measuring the distance from the top of the main pulmonary artery from which the second end 306 of the elongate body 302 is placed, the elongate body 302 may also be used to identify or map the location (e.g., desired or optimal location) of the electrode 314 within the vasculature. For example, using indicia on the peripheral surface of the catheter body 302, the second end 306 of the elongate body 302 can be positioned at a desired distance from the top of the main pulmonary artery. The wires 326 and 340 may then be used to impart a bend into the elongate stimulation member 314 and the anchor member 336. Using the filament 326 and the filament 340, the elongate stimulation member 314 and the anchor member 336 can be imparted with a bend that is large enough to contact a surface of a main pulmonary artery, such as an anterior surface of the main pulmonary artery, which can bring the electrode 318 into contact with the main pulmonary artery or one of the pulmonary arteries (left or right pulmonary artery). It will be appreciated that the anchors 336 are offset and help anchor the electrodes 318 along the surface of the blood vessel (e.g., along the posterior surface of the main pulmonary artery or one of the pulmonary arteries (left or right pulmonary artery)).

Due to its adjustable nature (e.g., depending at least in part on how much pressure or longitudinal force is applied to the filament 340), the anchor member 336 can be used to bring the electrode 318 into contact with the luminal surface of the main or one of the pulmonary arteries with a variety of different pressures. For example, the anchor member 336 can contact the electrode 318 with the luminal surface of one of the main pulmonary artery or the pulmonary artery with the first pressure. Using a stimulation system, for example, stimulation electrical energy may be delivered over a combination of two or more of the at least one electrode 318 in the electrode array, as described herein. The subject's cardiac response to the stimulation electrical energy may be monitored and recorded for comparison with other subsequent tests.

For any of the catheters and/or catheter systems discussed herein, any combination of electrodes positioned in or on the body of the subject, including a reference electrode (e.g., a reference electrode as discussed herein), can be used to provide stimulation to the subject and sense cardiac signals from the subject.

The pressure can be reduced and the elongate body 302 can be rotated in a clockwise or counterclockwise direction to reposition the electrode 318 into contact with the luminal surface of the main pulmonary artery or one of the pulmonary arteries. The stimulation system may be used to transmit stimulation electrical energy over a combination of two or more of the at least one electrode 318 in the electrode array. The subject's cardiac response to the test can then be monitored and recorded for comparison with prior and/or subsequent tests. In this manner, a preferred location of the luminal surface positioning electrode 318 along one of the main pulmonary artery or pulmonary artery can be identified. Once a preferred location for positioning the electrode 318 has been identified, the wire 340 may be used to increase the pressure applied by the anchoring member 336, which may help further anchor the catheter 300 in the patient.

Fig. 4A is a side perspective and partial cross-sectional view of another example of a catheter 400. Fig. 4B is a distal end view of the catheter 400 of fig. 4A, as viewed along line 4B-4B of fig. 4A. Catheter 400 includes at least the structures discussed herein with respect to catheter 300, and thus a detailed discussion of shared or similar elements is not repeated, but rather the element numbers are incremented in the hundreds in fig. 4A and 4B, with the understanding that the discussion of these elements is implicit.

Each of the at least two elongate stimulation members 414 includes a plurality of electrodes (e.g., three electrodes 418 shown in fig. 4A and 4B, although other numbers (e.g., 1, 2, 4, 5, or more) are possible). Electrodes 418 on the elongate stimulation member 414 form an electrode array. The electrodes 418 on each of the stimulation members 414 are electrically isolated from each other.

The catheter 400 also includes a structure 472 extending between at least two of the at least two elongate stimulation members 414. The structure 472 is flexible such that it can be transitioned between a delivery or low-profile state (radially collapsed state) that allows the structure 472 to be delivered into one of the main and/or pulmonary arteries, and a deployed or expanded state (radially expanded) as shown in fig. 4A. For example, the filament 426 and at least two elongate stimulation members 414 may be used to bring the structure 472 into its deployed or expanded state, as described herein. An example of structure 472 is a mesh structure.

Structure 472 includes a plurality of flexible strands connected to form a pattern of openings between the strands. One or more electrodes 474 may be present at one or more connections of the strands. The electrodes 474 may themselves form an electrode array, or may form an electrode array with the electrodes 418. In examples including a plurality of electrodes 474, the electrodes 474 may be arranged (e.g., as shown in fig. 4A) in a two-dimensional pattern, a three-dimensional pattern (e.g., to account for curvature of the stimulation member elongate body 422), or dispersed without a particular order. The strands may comprise the same material as the elongate body 402 and/or the elongate stimulation member 414, or a different material than the elongate body 402 and/or the elongate stimulation member 414. The strands may comprise an insulating material. Examples of insulating materials for one or more portions of the conduits and structures provided herein may include, but are not limited to: medical grade polyurethanes, in particular, for example, polyester-based polyurethanes, polyether-based polyurethanes and carbonate-based polyurethanes; polyamides, polyamide block copolymers, polyolefins (e.g., polyethylene (e.g., high density polyethylene, low density polyethylene)), and polyimides.

The structure 472 may have a predetermined shape that facilitates placement or positioning of at least one of the elongate stimulation member 414 and the electrode 418 thereon. For example, the structure 472 may be used to adjust and/or maintain the distance between electrodes 418 on adjacent stimulation members 414.

Structure 472 may include one or more additional electrodes 474. The additional electrode 474 may be positioned on the structure 472 or formed as an integral part of the structure 472. Each of the additional electrodes 474 may be electrically isolated from each of the other electrodes 474 and/or the electrodes 418. The additional electrodes 474 may each include a conductive element 476. Each of the conductive elements 476 is electrically isolated from one another and may extend from each respective additional electrode 474 through the strands of the structure 472, through the stimulation member 414 and the elongate body 402 to the first end 404. The conductive element 476 terminates at a connector port, where each of the conductive elements 420 and 476 can be releasably coupled to a stimulation system, e.g., as described herein. In some examples, the conductive element 420 may be non-releasably or permanently coupled to the stimulation system. The stimulation system may be used to provide stimulation electrical energy that is conducted through the conductive element 420,476 to the at least one additional electrode 474 and/or the combination of at least one electrode 418.

Fig. 4C is a side perspective view of an example of a portion 401 of a catheter. Portion 401 may be used with catheters 300,400, other catheters described herein, and the like. The portion 401 comprises a plurality of elongate splines 471. The splines 471 may include an elastic or shape memory material configured to form an expanded shape (e.g., the tapered shape shown in fig. 4C or other shape) when unconstrained in the catheter body, for example. The portion 401 includes a structure 472 extending between at least two of the elongate splines 471. One or more electrodes 474 may be coupled to the structure 472 (e.g., by adhesion, soldering, welding, tying, combinations thereof, etc.). The electrodes 474 may be aligned with the splines 471, arranged between the splines 471, and combinations thereof. For example, in portion 401, structure 472 is over three circumferentially offset splines 471. The middle set of four electrodes 474 is aligned with the middle spline 471 and the outer sets of four electrodes 474 are between the middle spline 471 and the outer spline 471, forming a 3 x 4 array or matrix of electrodes 474. In examples including a plurality of electrodes 474, the electrodes 474 may be arranged (e.g., as shown in fig. 4C) in a two-dimensional pattern, a three-dimensional pattern (e.g., taking into account the curvature of the expanded shape of the splines 471), or dispersed without a particular order. The electrodes 474 may themselves form an electrode array, or may form an electrode array with other electrodes (e.g., electrodes on splines 471).

Structure 472 may include a woven or knitted mesh or film. The structure may include an insulating material, such as medical grade polyurethane, e.g., polyester-based polyurethane, polyether-based polyurethane, and carbonate-based polyurethane; polyamides, polyamide block copolymers, polyolefins (e.g., polyethylene (e.g., high density polyethylene, low density polyethylene)), and polyimides, and the like.

In some examples, the structure 472 may be slid over the spline 471. For example, the lateral edge or middle portion of structure 472 may include a ring configured to slide over splines 471. Although shown in fig. 4C as being arcuate over a portion of the circumference of portion 401, structure 472 may be arcuate around the entire circumference of portion 401. In some such examples, the structure 472 can be slid over the splines 471 as a telescoping tube. The structure 472 may be coupled to splines 471 and/or tethered to a catheter.

In some examples, multiple structures 472 may be used. For example, multiple partially arcuate structures may be positioned around the spline 471 (e.g., at different circumferential locations, at overlapping circumferential locations, and/or at the same circumferential location (e.g., with different patterns of electrodes 474)). For another example, the structure 472 may be substantially tubular such that it can be slid over a single spline, or multiple such structures 472 may be used over different splines or even the same spline.

Forming an electrode on structure 472 may facilitate manufacturing. For example, the electrodes 474 may be coupled to the structure 472 independently of forming splines 471 (e.g., as opposed to forming electrodes in or on the splines 471). In some examples, electrode 474 may be formed on structure 472, e.g., like flex circuit fabrication. Structure 472 can also help position the conductive elements that electrically connect electrode 474 to the stimulation system.

The catheter 400 optionally includes an anchoring wire 478 extending longitudinally through the elongate body of the stimulation member. The elongate body 402 and the member elongate body 422 include surfaces that at least partially define a lumen having a first opening at the proximal end 404 and a second opening at or near the distal end 424 of the stimulation member elongate body 422. The anchoring wire 478 passes freely through the lumen with the first end 480 extending from the elongate body 422 at the proximal end 404 of the elongate body 402 and the second end 482 including an anchoring structure (e.g., barb) extending from a second opening at or near the distal end of the elongate body 422 of the stimulation member. The anchor wire 478 may be advanced through the lumen (e.g., a longitudinal force may be applied to the first end 480 of the anchor wire 478) to extend the anchor structure away from the stimulation member elongate body 414. For example, as discussed herein, the anchor member 436 may help anchor the catheter 400 in the subject. The anchoring wire 478 may also or alternatively be used to help secure the catheter 400 at a desired location in a subject. The catheter 300 may also include one or more of an anchoring wire 478 and associated structure. Optionally, the anchoring wire 478 may be configured and used with the electrodes of the stimulation system of the present disclosure. For example, the anchoring filaments 478 may be configured as anodes and one or more of the electrodes 418,474 may be configured as cathodes and/or anodes, and/or the anchoring filaments 478 may be configured as cathodes and one or more of the electrodes 418,474 may be configured as anodes and/or cathodes.

Fig. 4A also shows a pulmonary artery catheter 444 (shown partially to show details of the catheter 400), which is similar to, for example, the pulmonary artery catheter 344 discussed herein. For example, as described herein, a catheter system including a pulmonary artery catheter 444 can be used to position the catheter 400 in one of the patient's major and/or pulmonary arteries. With the catheter 400 positioned within the lumen 454, the pulmonary artery catheter 444 is introduced into the vasculature through a percutaneous incision and directed to the right ventricle. The balloon 458 is inflated through the inflation lumen, allowing the pulmonary artery catheter 444 and catheter 400 to be carried from the right ventricle to the main pulmonary artery or one of the pulmonary arteries by the flow of blood.

The catheter system shown in fig. 4A and 4B includes an optional position measurement instrument 484. The positioning gauge 484 includes an elongated gauge body 486 having a first end 488 and a bumper end 490 distal to the first end 488. The elongate measurement instrument body 486 is longitudinally movable within the inner lumen 492, the inner lumen 492 being at least partially defined by a surface extending through the elongate body 402 from the first end 404 through the second end 406 of the elongate body 402. The bumper end 490 may have a shape with an exemplary surface area that is not less than the surface area of the distal end 406 of the elongate body 402 taken perpendicular to the longitudinal axis 408. An elongated measurement instrument body 486 extends through the inner lumen 492 to locate a bumper end 490 distal of the second end 406 of the elongated body 402. A first end 488 of the positioning gauge 484 extends proximally from the elongated body 402. The elongated gauge body 486 may include indicia 494, the indicia 494 indicating a length between the second end 406 of the elongated body 402 and the bumper end 490 where the gauge 484 is positioned.

During guiding of the catheter 400, the bumper end 490 of the positioning gauge 484 may be longitudinally approximately flush with the distal end 424 of the stimulation member elongate body 422, the distal end 442 of the anchor member 436, and the distal end 450 of the pulmonary artery catheter 444 (e.g., the elongate body 402, the anchor member 436, and the elongate stimulation member 444 are positioned in the lumen 456 of the pulmonary artery catheter 444). In this configuration, the catheter system may be advanced along the main pulmonary artery until the bumper end 490 of the positioning gauge 484 contacts the top of the main pulmonary artery (e.g., at a location distal to the pulmonary valve and adjacent to both pulmonary arteries). With the balloon 458 in the inflated or deflated state, the catheter system may be advanced distally beyond the pulmonary valve.

Once the bumper end 490 contacts the top of the main pulmonary artery, the pulmonary artery catheter 444 (with the catheter 400 positioned within the lumen 456) can be moved relative to the bumper end 490 (e.g., the pulmonary artery catheter 444 and the catheter 400 can be moved away from the bumper end 490). As the pulmonary artery catheter 444 and the catheter 400 are moved relative to the bumper end 490, the markings 494 on the elongate gauge body 486 may be used to indicate the length between the distal end 224 of the stimulation member elongate body 422, the distal end 442 of the anchor member 436, the distal end 450 of the pulmonary artery catheter 444, and the bumper end 490 of the positioning gauge 484. The distance between the markings 494 may be in specific units (e.g., millimeters, inches, etc.), which may allow the length between the distal end 424 of the stimulation member elongate body 422, the distal end 442 of the anchor member 436, and the distal end 450 of the pulmonary artery catheter 444 to be determined. Once the desired length is achieved, the pulmonary artery catheter 444 can be moved relative to the catheter 400 to deploy the anchor member 436 and the elongate stimulation member 414 with the electrodes 418 within one of the main pulmonary artery or pulmonary artery.

The ability to measure the distance from the top of the main pulmonary artery may facilitate placement of the electrode 418 in a desired location of one of the main pulmonary artery or the pulmonary artery. For example, the distal end 424 of the stimulation member elongate body 422 and the distal end 442 of the anchor member 436 may be positioned at a desired distance from the top of the main pulmonary artery using the indicia 494 on the peripheral surface of the positioning gauge 484. The filament 426,440 may be used to impart a bend into the elongate stimulation member 414 and the anchor member 436, respectively. Using the filament 426 and the filament 440, the elongate stimulation member 414 and the anchor member 436 may be provided with a bend that is large enough to contact the anterior surface of the main pulmonary artery and may bring the electrodes 418 into contact with the luminal surface of the main pulmonary artery. The anchor member 436 may bias and help anchor the electrode 418 along the vessel surface (e.g., along the posterior surface of the main pulmonary artery). Optionally, the anchor member 436 may be configured to include one or more electrodes 418, e.g., as described herein.

Due to its adjustable nature (e.g., changing the proximate pressure depending on the amount of longitudinal force or applying pressure to the filament 440), the anchor member 436 may be used to bring the electrode 418 into contact with the luminal surface of the main or one of the pulmonary arteries at a variety of different pressures. For example, the anchor member 436 may contact the electrode 418 with the luminal surface of one of the main pulmonary artery or the pulmonary artery at a first pressure. Using the stimulation electrical energy from the stimulation electrodes, electrical energy may be delivered across a combination of two or more of the electrodes 418,474. The subject's cardiac response to the stimulation electrical energy may then be monitored and recorded for comparison with subsequent tests. If desired, the longitudinal pressure applied to the anchor member 436 can be reduced and the elongate body 402 can be rotated in a clockwise or counterclockwise direction and/or the elongate body 402 can be rotated lengthwise relative to the top of the main pulmonary artery or one of the pulmonary arteries to reposition the electrode 418 in contact with the luminal surface of the one of the main pulmonary artery or pulmonary artery. The stimulation system may again be used to transmit stimulation electrical energy over a combination of two or more of the electrodes 418,474. The subject's cardiac response to this subsequent test can then be monitored and recorded for comparison with the previous and subsequent tests. In this manner, a preferred location of the luminal surface positioning electrode 418 along the main pulmonary artery or one of the pulmonary arteries can be identified. Once identified, the wire 440 may be used to increase the pressure applied by the anchoring member 436, thereby helping to better anchor the catheter 400 in the patient.

Referring now to fig. 5, an example of a catheter 500 is shown, where the catheter 500 may include the structures and features of other catheters discussed herein. As shown, the catheter 500 includes an elongate body 502 having a first end 504 and a second end 506 distal to the first end 504. As shown, the elongate body 502 includes an elongate radial axis 508 extending through the first end 504 and the second end 506 of the elongate body 502. As shown, the first plane 510 extends through the elongate radial axis 508 over the length of the elongate body 502. The second plane 512 intersects the first plane 510 along the longitudinal axis 508 of the elongate body 502. The first plane 510 and the second plane 512 divide the first volume 516 into a first quadrant volume 532 and a second quadrant volume 534. The catheter 500 also includes at least two elongate stimulation members 514, as discussed herein, extending from the elongate body 502. Each of the at least two elongate stimulation members 514-1 and 514-2 is bent into a first volume 516 at least partially defined by the first plane 510. For example, at least two elongate stimulation members 514 may extend from about the second end 506 of the elongate body 502 into the first volume 516.

Fig. 5 also shows at least one electrode 518 on each of the at least two elongate stimulation members 514. At least one electrode 518 on each of the elongated stimulation members 514 forms an electrode array in the first volume 516. The at least one electrode 518 on each of the elongate stimulation members 514 may be electrically isolated from each other and/or may comprise an electrically insulating material. Catheter 500 also includes a conductive element 520 that extends through each elongate stimulation member 514 and/or along each elongate stimulation member 514. As described herein, the conductive element 520 can conduct electrical current to a combination of two or more of the electrodes 518. The conductive elements 520 may be electrically isolated from each other. The conductive elements 520 may terminate at connector ports, wherein each conductive element 520 may be releasably coupled to a stimulation system, e.g., as described herein. In some examples, the conductive element 520 is permanently coupled to the stimulation system (e.g., non-releasably coupled). The stimulation system may be used to provide stimulation electrical energy that is conducted through the conductive element 520 and delivered to the combination of electrodes 518 in the electrode array.

Each of the at least two elongate stimulation members 514 includes a stimulation member elongate body 522 having a distal end 524 that is movable relative to each other. In other words, the distal ends 524 of each of the stimulation member elongate bodies 522 are free from each other. As shown in fig. 5, the at least two elongated stimulation members 514 are only bent in a first volume 516 at least partly defined by the first plane 510. Fig. 5 also shows a second volume 530 (opposite the first volume 516) at least partially defined by the first plane 510 that does not contain electrodes. Fig. 5 also shows an example where the at least two elongated stimulation members 514 comprise a first elongated stimulation member 514-1 and a second elongated stimulation member 514-2, where the first elongated stimulation member 514-1 is bent into the first quadrant volume 532 and the second elongated stimulation member 514-2 is bent into the second quadrant volume 534, as previously described herein. The catheter 500 also includes an anchor member 536 that extends from the elongate body 502 into the second volume 530. As shown, the anchor member 536 does not include an electrode. The anchor member 536 includes an elongate body 538 as previously discussed with respect to the previous figures. Optionally, the anchor member 536 may be configured to include one or more electrodes 518, as described herein.

Each of the at least two elongate stimulation members 514 and the anchor member 536 can further include a filament 566 that extends longitudinally through the stimulation member elongate body 522 and elongate body 538, respectively. The filaments 566 may provide a predetermined shape to each of the at least two elongated stimulation members 514 and the anchor member 536. For example, the filaments 566 in each of the at least two elongate stimulation members 514 and the anchor member 536 may have a coiled or helical configuration that imparts a bend to the stimulation member elongate body 522 and elongate body 538, respectively. The filament 566 may also impart a stiffness to the stimulation member elongate body 522 that is sufficient to maintain a predetermined shape in a condition within the vasculature of a patient. As such, for example, the filaments 566 provide sufficient stiffness and flexibility to the stimulation member elongate body 522 to cause the at least two elongate stimulation members 514 to resiliently return to their bent configuration when placed in the vasculature of a patient.

The wire 566 may be formed from a variety of different metals or metal alloys. Examples of such metals or metal alloys include surgical grade stainless steel, such as austenitic 516 stainless steel and nickel titanium alloys known as Nitinol (Nitinol), among others. Other metals and/or metal alloys may also be used as needed and/or desired. The predetermined shape may be adapted to conform to a particular anatomical structure (e.g., the right or left pulmonary artery or other portion of the pulmonary trunk).

The at least two elongate stimulation members 514 may also include an anchor wire 514, as described herein, that extends longitudinally through the stimulation member elongate body 522 and a lumen in the elongate body 502. The anchoring wire 544 includes a first end 546 extending from the elongate body 502 and a second end 548 having an anchoring structure (e.g., a barb). The anchor filament 544 may be advanced through the lumen (e.g., a longitudinal force may be applied to the first end 546 of the anchor filament 544) to extend the anchor structure away from the stimulation member elongate body 514. In addition to using the anchor member 536 to help better anchor the catheter 500 in the patient, the anchor wire 544 may also be used to secure the catheter 500 at a predetermined location in the patient, as described herein. Optionally, the anchor wire 544 may be configured and used for the electrodes of the stimulation system of the present disclosure.

According to several examples, the catheter 500 further includes a pulmonary artery catheter 591, as described herein. As shown, a pulmonary artery catheter 591 (shown partially to illustrate details of the catheter 300) may be used with the catheter 500 to provide a catheter system. The pulmonary artery catheter 591 includes an elongated catheter body 5100, the elongated catheter body 5100 having a first end 5102, a second end 5104, a peripheral surface 5106, and an inner surface 5108 opposite the peripheral surface 5106. The inner surface 5108 defines an inner cavity 5110 extending between a first end 5102 and a second end 5104 of the elongate catheter body 5100. The lumen 5110 is sized and shaped to accommodate at least a portion of the catheter 500 within the lumen 5110 during delivery of the catheter 500. For example, the anchor member 536 and at least two elongate stimulation members 514 and at least a portion of the elongate body 502 can be positioned within the lumen 5110 during delivery. The anchor member 536, the at least two elongate stimulation members 514, and at least a portion of the elongate body 502 may be deployed from the distal end 5104 of the pulmonary artery catheter 591 during delivery and implantation of the catheter 500.

The pulmonary artery catheter 591 can also include an inflatable balloon 5112 on the peripheral surface 5106 of the elongate catheter body 5100. The inflatable balloon 5112 includes a balloon wall 5114 having an inner surface 5116, the inner surface 5116 defining a fluid-tight volume 5118 with a portion of the peripheral surface 5106 of the elongate catheter body 5100. The pulmonary artery catheter 591 further includes an inflation lumen 5120, the inflation lumen 5120 extending through the elongate catheter body 5100, wherein the inflation lumen 5120 has a first opening 5122 into the fluid-tight volume 5118 of the inflatable balloon 5112 and a second opening 5124 proximal of the first opening 5122 to allow fluid to move into the fluid-tight volume 5118 to inflate and deflate the balloon 5112 as described herein. The catheter system described in fig. 5 may be used, for example, to position the catheter 500 in one or both of the patient's main pulmonary artery 202 and/or pulmonary arteries 206,208, e.g., as described herein. The at least two elongate stimulation members 514 and anchor members 536 may be repositioned within the lumen 5110 of the pulmonary artery catheter 591 by moving the elongate catheter body 5100 back over the at least two elongate stimulation members 514 and anchor members 536 relative to the elongate body 502. The catheter system shown in fig. 5 may optionally include a positioning measurement instrument such as described with respect to fig. 4A and 4B.

Referring now to fig. 6, another example of a catheter 600 is shown. As shown, the catheter 600 includes an elongate body 602 having a first end 604 and a second end 606 distal to the first end 604. As shown, the elongate body 602 includes an elongate radial axis 608 extending through the first end 604 and the second end 606 of the elongate body 602. As shown, the first plane 610 extends through the elongate radial axis 608 over the length of the elongate body 602. The second plane 612 intersects the first plane 610 along the longitudinal axis 608 of the elongate body 602. The first plane 610 and the second plane 612 divide the first volume 616 into a first quadrant volume 632 and a second quadrant volume 634. The catheter 600 includes at least two elongate stimulation members 614 extending from the elongate body 602. Each of the at least two elongate stimulation members 614-1 and 614-2 is bent into a first volume 616 at least partially defined by the first plane 610. For example, at least two elongate stimulation members 614 extend from about the second end 606 of the elongate body 602 into the first volume 616.

Fig. 6 also shows at least one electrode 618 on each of the at least two elongate stimulation members 614. The plurality of electrodes 618 on the elongate stimulation member 614 may form an array of electrodes in the first volume 616. Catheter 600 also includes an electrically conductive element 620 that extends through each elongate stimulation member 614 and/or along each elongate stimulation member 514. As previously described herein, the conductive element 620 can conduct electrical current to a combination of two or more of the electrodes 618.

Each of the at least two elongate stimulation members 614 includes a stimulation member elongate body 622 each having a distal end 624 extending from the elongate body 602. In some examples (e.g., as shown in fig. 6), the at least two elongate stimulation members 614 are only curved in a first volume 616 at least partially defined by the first plane 610. Fig. 6 also shows a second volume 630 (opposite the first volume 616) at least partially defined by the first plane 610 that does not contain electrodes. Fig. 6 also shows an example where the at least two elongated stimulation members 614 include a first elongated stimulation member 614-1 and a second elongated stimulation member 614-2, where the first elongated stimulation member 614-1 is bent into the first quadrant volume 632 and the second elongated stimulation member 614-2 is bent into the second quadrant volume 634, e.g., as previously described herein. The catheter 600 also includes an anchor member 636 that extends from the elongate body 602 into the second volume 630. As shown, the anchor member 636 does not include electrodes. The anchor member 636 includes an elongate body 638 such as previously discussed. Optionally, the anchor member 636 may be configured to include one or more electrodes 618.

Each of the at least two elongate stimulation members 614 and anchor members 636 can further include a filament 666 extending longitudinally through and/or along the stimulation member elongate body 622 and elongate body 638, respectively. The filament 666 may provide each of the at least two elongated stimulation members 614 and the anchor member 636 with a predetermined shape. For example, the filaments 666 in each of the at least two elongate stimulation members 614 and the anchor member 636 can have a coiled or helical configuration that imparts a bend to the stimulation member elongate body 622 and the elongate body 638, respectively. The wire 666 may also impart a stiffness to the stimulation member elongate body 622 that is sufficient to maintain a predetermined shape in a condition within the vasculature of a patient. As such, for example, the wire 666 may provide the stimulation member elongate body 622 with sufficient stiffness and flexibility to cause the at least two elongate stimulation members 614 to resiliently return to their bent configuration when placed in the vasculature of a patient. The wire 666 may be formed from a variety of different metals or metal alloys (e.g., those discussed herein with respect to other examples).

The at least two elongate stimulation members 614 may also include an anchor wire 644 that extends longitudinally through and/or along the stimulation member elongate body 622. The anchor wire 644 includes a first end 646 extending from the elongate body 602 and a second end 648 having an anchoring structure (e.g., barb). A longitudinal force applied to the first end 646 of the anchor wire 644 advances the anchor wire 644 through the stimulation member elongate body 614 to extend the anchor structure away from the stimulation member elongate body 614. Optionally, the anchoring wire 644 may be configured and used for the electrodes of the stimulation system of the present disclosure.

The catheter 600 also includes a pulmonary artery catheter 691, as previously described herein. As shown, a pulmonary artery catheter 691 (shown partially to illustrate details of catheter 600) may be used with catheter 600 to provide a catheter system. The pulmonary artery catheter 691 includes an elongate catheter body 670, the elongate catheter body 670 having a first end 680, a second end 682, a peripheral surface 676, and an inner surface 672 opposite the peripheral surface 676. The inner surface 672 defines a lumen 674 extending between the first end 680 and the second end 682 of the elongate catheter body 670. The lumen 674 can be sufficiently sized and shaped to accommodate at least a portion of the catheter 600 within the lumen 674 during delivery of the catheter 600. For example, the anchor member 636 and at least two elongate stimulation members 614 and at least a portion of the elongate body 602 can be positioned within the lumen 674. The anchor member 636, the at least two elongate stimulation members 614, and at least a portion of the elongate body 602 can be deployed from the distal end 682 of the pulmonary artery catheter 691 during delivery and implantation of the catheter 600.

The pulmonary artery catheter 691 can also include an inflatable balloon 668 on a peripheral surface 676 of the elongate catheter body 670. The inflatable balloon 668 has a balloon wall 688 with an inner surface 690 that, along with a portion of the outer peripheral surface 676 of the elongate catheter body 670, defines a fluid sealed volume 692. The pulmonary artery catheter 691 further includes an inflation lumen 694 extending through the elongate catheter body 670, wherein the inflation lumen 694 has a first opening 696 into the fluid-tight volume 692 of the inflatable balloon 668 and a second opening 698 distal to the first opening 696 to allow fluid to move into the fluid-tight volume 692 to inflate and deflate the balloon 668, for example, as previously described herein. The catheter system shown in fig. 6 may be used to position the catheter 600 in one or both of the main and/or pulmonary arteries of a patient, e.g., as described herein. The at least two elongate stimulation members 614 and the anchor member 636 may be repositioned within the lumen 694 of the pulmonary artery catheter 691 by moving the elongate catheter body 670 back over the at least two elongate stimulation members 614 and the anchor member 636 relative to the elongate body 602. The catheter system shown in fig. 6 may optionally include a positioning measurement instrument such as described with respect to fig. 4A and 4B.

Referring now to fig. 7A and 7B, an alternative example of a pulmonary artery catheter 791 that may be used with any of the catheters described herein (e.g., catheters 300, 400, 500, or 600) is shown. As shown, the pulmonary artery catheter 791 includes an elongate catheter body 7100 having a first end 7102, a second end 7104, a peripheral surface 7106, and an inner surface 7108 opposite the peripheral surface 7106. The inner surface 7108 defines a lumen 7110 extending between a first end 7102 and a second end 7104 of the elongate catheter body 7100. The inner chamber 7110 is sufficiently sized and shaped to accommodate at least a portion of a catheter (e.g., the catheter 300, 400, 500, or 600) within the inner chamber 7110 during delivery of the catheter. For example, the anchor member and at least two elongate stimulation members and at least a portion of the elongate body can be positioned within the inner lumen 7110. The anchor member, the at least two elongate stimulation members, and at least a portion of the elongate body may be deployed from the distal end 7104 of the pulmonary artery catheter 791 during delivery and implantation of the catheter (e.g., catheter 300, 400, 500, or 600).

The pulmonary artery catheter 791 includes an inflatable balloon 7112. As shown, the inflatable balloon 7112 is positioned over an elongate inflation catheter body 7300 that passes through a balloon lumen 7302. The balloon lumen 7302 is defined by a lumen face 7304 that may extend from the first end 7102 through the second end 7104 of the elongate catheter body 7100. The balloon lumen 7302 has a cross-sectional dimension that allows the elongate inflation catheter body 7300 to move longitudinally within the balloon lumen 7302. In this way, the inflatable balloon 7112 may be moved relative to the distal end 7104 of the pulmonary artery catheter 791.

The inflatable balloon 7112 has a balloon wall 7114 with an inner surface 7116, the inner surface 7116, along with a portion of a peripheral surface 7106 of the elongate inflation catheter body 7300, defines a fluid-tight volume 7116. The elongate inflation catheter body 7300 further includes an inflation lumen 7120, the inflation lumen 7120 extending through the elongate inflation catheter body 7300, wherein the inflation lumen 7120 has a first opening 7122 into the fluid-tight volume 7116 of the inflatable balloon 7112 and a second opening 7124 proximal to the first opening 7122 to allow fluid to move into the fluid-tight volume 7116 to inflate and deflate the balloon 7112. A syringe or other known device containing a fluid (e.g., saline or a gas (e.g., oxygen)) may be used to inflate and deflate the balloon 7112. The balloon lumen 7302 has a cross-sectional dimension sufficient to allow the inflatable balloon 7112 to be received within the lumen 7302 in its fully deflated state. The inflatable balloon 7112 along with at least a portion of the elongate inflation catheter body 7300 may extend from the second end 7104 when the inflatable balloon 7112 is to be inflated.

Fig. 7B illustrates an alternative example of a pulmonary artery catheter 791 that may be used with any catheter (e.g., catheter 300, 400, 500, or 600) according to the present disclosure. Like the pulmonary artery catheter 791 shown in fig. 7A, the pulmonary artery catheter 791 includes an elongate catheter body 7100 having a first end 7102, a second end 7104, a peripheral surface 7106, and an inner surface opposite the peripheral surface 7106. The inner surface defines a lumen 7110 extending between a first end 7102 and a second end 7104 of the elongate catheter body 7100. The inner chamber 7110 is sufficiently sized and shaped to accommodate at least a portion of a catheter (e.g., the catheter 300, 400, 500, or 600) within the inner chamber 7110 during delivery of the catheter. For example, the anchor member and at least two elongate stimulation members along with at least a portion of the elongate body can be positioned within the lumen 7110 (the example shown in fig. 7B has a catheter (e.g., catheter 300, 400, 500, or 600) completely inside the lumen 7110). The anchor member, the at least two elongate stimulation members, and at least a portion of the elongate body may be deployed from the distal end 7104 of the pulmonary artery catheter 791 during delivery and implantation of the catheter (e.g., catheter 300, 400, 500, or 600).

The pulmonary artery catheter 791 shown in fig. 7B includes two inflatable balloons 7112 (shown as 7112-1 and 7112-2 in fig. 7B). As shown, each of the inflatable balloons 7112-1 and 7112-2 is positioned over a separate elongate inflation catheter body 7300-1 and 7300-2, where each of the elongate inflation catheter bodies 7300-1 and 7300-2 passes through the balloon lumens 7302-1 and 7302-2, respectively. As shown, each balloon lumen 7302-1 and 7302-2 is defined by a lumen face 7304-1 and 7304-2, respectively, that may extend from the first end 7102 through the second end 7104 of the elongate catheter body 7100. Balloon lumens 7302-1 and 7302-2 each have a cross-sectional dimension that allows the elongate inflation catheter bodies 7300-1 and 7300-2 to move longitudinally within their respective balloon lumens 7302-1 and 7302-2. In this way, each of the inflatable balloons 7112-1 and/or 7112-2 may be independently moved relative to the distal end 7104 of the pulmonary artery catheter 791. As with fig. 7A, the cross-sectional dimensions of each balloon lumen 7302-1 and 7302-2 may be sufficient to allow each respective inflatable balloon 7112-1 and 7112-2 to be received within each respective balloon lumen 7302-1 and 7302-2 in its fully deflated state. Each inflatable balloon 7112-1 and 7112-2, along with at least a portion of the elongate inflation catheter bodies 7300-1 and 7300-2, may independently extend from the second end 7104 when the inflatable balloon 7112-1 and/or 7112-2 is to be inflated.

Each of the inflatable balloons 7112-1 and 7112-2 has a balloon wall 7114-1 and 7114-2 with an inner surface 7116-1 and 7116-2, respectively, the inner surfaces 7116-1 and 7116-2, along with a portion of the peripheral surface 7106 of the elongate inflation catheter bodies 7300-1 and 7300-2, define fluid tight volumes 7118-1 and 7118-2, respectively. The elongate inflation catheter body 7300 further includes inflation lumens 7120-1 and 7120-1, the inflation lumens 7120-1 and 7120-1 extending through the elongate inflation catheter bodies 7300-1 and 7300-2, respectively, wherein the inflation lumens 7120-. Each of the inflatable balloons 7112-1 and 7112-2 may be independently movable and independently inflatable relative to the second end 7104 of the elongate body 7100, as described elsewhere herein.

The pulmonary artery catheter 791 also includes a positioning measurement instrument 752. The position measurement instrument 752 includes an elongated measurement instrument body 754 having a first end 756 and a bumper end 758 distal to the first end 756. The elongate measurement instrument body 754 is longitudinally movable within a lumen 750 defined by a surface extending through the elongate catheter body 7100. The elongate measurement instrument body 754 extends through the inner lumen 75 of the elongate catheter body 7100 to position the bumper end 758 beyond the second end 7104 of the elongate catheter body 7100. The first end 756 of the positioning and measurement instrument 752 extends from the first end 7102 of the elongate catheter body 7100, wherein the elongate measurement instrument body 754 includes indicia that indicate a length between the second end 7104 of the elongate catheter body 7100 and the bumper end 758 of the positioning and measurement instrument 752.

The pulmonary artery catheter 791 can also include a first anchor 729 extending laterally from the peripheral surface 7106 of the elongate catheter body 7100. As shown, the first anchor 729 has a strut 731 forming an open frame. The struts 731 have a peripheral surface 733, the peripheral surface 733 having a maximum outer diameter that allows the first anchor 729 (when deployed) to engage a surface of one or both of the main and/or pulmonary arteries. The sheath can cover and maintain the first anchor 729 in a non-deployed state while the pulmonary artery catheter 791 and a catheter (e.g., catheter 300, 400, 500, or 600) are being introduced into a patient.

The catheter systems shown in fig. 7A and 7B may be used to position a catheter (e.g., catheter 300, 400, 500, and/or 600) in one or both of the main pulmonary artery and/or the right or left pulmonary artery of a patient, e.g., as described herein. To do so, the pulmonary artery catheter 791 is introduced into the vasculature through a percutaneous incision with the catheter positioned within the internal cavity 7110, and is directed to the right ventricle (e.g., using the swan-ganz approach through an incision in the neck). For the catheter system of fig. 7A, the balloon 7112 is inflated (as described) to allow the pulmonary artery catheter 791 and catheter to be carried from the right ventricle into one of the main pulmonary artery or the right or left pulmonary artery by the flow of blood. Once the pulmonary artery catheter 791 and catheter (e.g., catheters 300, 400, 500, and/or 600) have been carried from the right ventricle into one of the main pulmonary artery or the right or left pulmonary artery, the sheath can be retracted, allowing the first anchor 729 to be deployed within the main pulmonary artery. The first anchors 729 can be returned to their undeployed state by positioning (e.g., advancing) the sheath back over the first anchors 729.

With the first anchor 729 in its undeployed position, the positioning measurement instrument 752 can be used to determine the length between the second end 7104 of the elongate catheter body 7100 and the top of the main pulmonary artery (e.g., at a location distal to the pulmonary valve and adjacent to the right and left pulmonary arteries). Up to this length, the catheter (catheter 300, 400, 500, 600) may be advanced from the inner lumen 7110 of the elongate catheter body 7100 to a position between the second end 7104 of the elongate catheter body 7100 and the top of the main pulmonary artery. This position may be determined, for example, using indicia on a portion of the elongate body of the catheter extending proximally from the first end 7102 of the elongate catheter body 7100 (e.g., indicia providing a length, for example, in millimeters).

Referring now to fig. 8A-8D, additional examples of a catheter 800 according to the present disclosure are shown. Catheter 800 includes an elongated catheter body 801 having a first end 803 and a second end 805. The elongate catheter body 801 further includes an outer peripheral surface 807 and an inner surface 809 defining an inflation lumen 811 (shown in phantom) extending at least partially between the first end 803 and the second end 805 of the elongate catheter body 801.

The catheter 800 includes an inflatable balloon 813 on the outer peripheral surface 807 of the elongate catheter body 801. The inflatable balloon 813 includes a balloon wall 815 having an inner surface 817 that, along with a portion of the outer peripheral surface 807 of the elongate catheter body 801, defines a fluid-tight volume 819. The inflation lumen 811 includes a first opening 821 into the fluid-tight volume 819 of the inflatable balloon 813 and a second opening 823 proximate the first opening 821 to allow fluid to move into and out of the volume 819 to inflate and deflate the balloon 813.

The catheter 800 also includes a plurality of electrodes 825 positioned along the outer peripheral surface 807 of the elongate catheter body 801. A plurality of electrodes 825 are located between the inflatable balloon 813 and the first end 803 of the elongate catheter body 801. An electrically conductive element 827 extends through the elongate catheter body 801, wherein the electrically conductive element 827 conducts an electrical current to a combination of two or more of the plurality of electrodes 825.

The catheter 800 further includes a first anchor 829 extending laterally from the peripheral surface 807 of the elongate body 801, the first anchor 829 having a strut 831 forming an open frame. In the illustrated example, the struts 831 have a peripheral surface 833, the peripheral surface 833 having a maximum outer dimension that is greater than the maximum outer dimension of the inflatable balloon 813 (e.g., its maximum diameter). As shown, the first anchor 829 has a center point 835 relative to the peripheral surface 833, the center point 835 being eccentric relative to a center point 837 of the elongate catheter body 801 relative to the peripheral surface 807.

Fig. 8A and 8B show a first anchor 829. Fig. 8A shows the first anchor 829 positioned between the inflatable balloon 813 and the plurality of electrodes 825 positioned along the peripheral surface 807 of the elongate catheter body 801. Figure 8B shows the first anchor 829 positioned between the plurality of electrodes 825 positioned along the peripheral surface 807 of the elongate catheter body 801 and the first end 803 of the elongate catheter body 801.

For the catheter 800 shown in fig. 8A, a portion 839 of the elongate catheter body 801 including the plurality of electrodes 825 may bend in a predetermined radial direction when placed under longitudinal compression. To achieve bending of the portion 839 including the plurality of electrodes 825, the elongate catheter body 801 may be pre-stressed and/or the wall may have a thickness that allows the elongate catheter body 801 to bend in a predetermined radial direction when under longitudinal compression. Additionally or alternatively, structures such as coils or helical wires having a different number of turns per unit length may be located within the elongated catheter body 801 in section 839. One or more of these structures may be used to allow longitudinal compression to produce a bend in the portion 839 in a predetermined radial direction. To obtain longitudinal compression, the first anchor 829 may be deployed in the vasculature of a patient (e.g., in a pulmonary artery), wherein the first anchor 829 provides a location or point of resistance against longitudinal movement of the elongate body 801. This therefore allows for the generation of a compressive force in the elongate catheter body 801 sufficient to bend a portion 839 of the elongate catheter body 801 (along which portion 1854 there are a plurality of electrodes 825) in a predetermined radial direction.

Figure 8C provides an illustration of a portion 839 of the elongate catheter body 801 being bent in a predetermined radial direction when placed under longitudinal compression. The catheter 800 shown in fig. 8C is representative of the catheter shown in fig. 8A and is discussed herein. As shown, the catheter 800 has been positioned at least partially in the main pulmonary artery 8500 of the patient's heart (the catheter 800 may also be positioned at least partially within the right pulmonary artery 8504 as shown), with the balloon 813 and the first anchor 829 located in the lumen of the left pulmonary artery 8502. From this position, a compressive force applied to the elongate catheter body 801 can cause a portion 839 of the elongate catheter body 801 having the plurality of electrodes 825 to bend in a predetermined radial direction, thereby allowing (e.g., causing) the plurality of electrodes 825 to extend toward and/or contact a luminal surface of the main pulmonary artery 8500. According to several examples, the plurality of electrodes 825 are brought into position and/or contact with the luminal surface of the main pulmonary artery 8500.

Providing a rotational torque at the first end 803 of the elongate catheter body 801 can help move the plurality of electrodes 825 relative to the luminal surface, thereby allowing a practitioner or clinician to "sweep" the plurality of electrodes 825 to different locations along the luminal surface of the main pulmonary artery 8500. This allows the patient's cardiac response to the stimulating electrical energy to be monitored and recorded at various different locations along the luminal surface of the main pulmonary artery 8500, as described herein. In this manner, a preferred location of the luminal surface localizing electrode 825 along the main pulmonary artery 8500 can be identified. According to other examples, the plurality of electrodes 825 can be brought into position or otherwise in contact with the luminal surface at the left or right pulmonary artery 8502, 8504, or otherwise, as needed and/or desired.

Alternatively, for catheter 800 shown in fig. 8B, elongate catheter body 801 can include a second inner surface 841 defining a shaped lumen 843 extending from first end 803 toward second end 805. The catheter 800 of fig. 8B may also include a forming wire 845 having a first end 847 and a second end 849. In one example, the forming lumen 843 has a size (e.g., diameter) sufficient to allow the forming wire 845 to pass through the forming lumen 843, wherein a first end 847 of the forming wire 845 is proximal to the first end 803 of the elongate catheter body 801 and a second end 849 of the forming wire 845 is connected to the elongate catheter body 801 such that the forming wire 845 imparts a bend into a portion 839 of the elongate catheter body 801 having the plurality of electrodes 825 when tension is applied to the forming wire 845.

Fig. 8D provides an illustration of a portion 839 of the elongate catheter body 801 being bent in a predetermined radial direction when using the shaping lumen and shaping wire discussed herein (the catheter 800 shown in fig. 8D is the catheter shown in fig. 8B and described herein). As shown, the catheter 800 has been positioned at least partially in the main pulmonary artery 8500 of the patient's heart with the balloon 813 located in the lumen of the left pulmonary artery 8502 and the first anchor 829 located in the main pulmonary artery 8500. From this position, when tension is applied to the shaping wire 845, the shaping wire 845 may serve to impart a bend into the portion 839 of the elongate catheter body 801 having the plurality of electrodes 825, thereby allowing (e.g., causing) the plurality of electrodes 825 to extend toward and/or contact the luminal surface of the main pulmonary artery 8500 (the catheter 800 may also be positioned at least partially in the right pulmonary artery 8504 as shown). According to several examples, the plurality of electrodes 825 are brought into position and/or contact with the luminal surface of the main pulmonary artery. According to other examples, the plurality of electrodes 825 can be brought into position or otherwise in contact with the luminal surface at the left or right pulmonary artery 8502, 8504, or otherwise, as needed and/or desired.

Providing a rotational moment at the first end 803 of the elongate catheter body 801 can help move the plurality of electrodes 825 relative to the luminal surface of the main pulmonary artery 8500 (and/or the right or left pulmonary artery), thereby allowing a practitioner or clinician to "sweep" the plurality of electrodes 825 along the luminal surface of the main pulmonary artery 8500 (and/or the right or left pulmonary artery) to different locations, as described herein, in order to identify preferred locations for positioning the electrodes 825 along the luminal surface of the main pulmonary artery (and/or the right or left pulmonary artery).

As shown, the catheter 800 of fig. 8A and 8B each include an elongate delivery sheath 851 having a lumen 853 extending over the outer peripheral surface 807 of the elongate body 801. The elongate delivery sheath 851 may have first anchors 829 positioned within the lumen 853 of the elongate delivery sheath 851 in the first position. The first anchors 829 extend from the peripheral surface 807 of the elongate body 801 as the elongate delivery sheath 851 is moved relative to the peripheral surface 807 of the elongate body 801.

Referring now to fig. 9, an additional example of a catheter 900 is shown. As described with respect to catheter 800, catheter 900 includes an elongate catheter body 901, the elongate catheter body 901 having a first end 903 and a second end 905, a peripheral surface 907, and an inner surface 909 defining an inflation lumen 911, the inflation lumen 911 extending at least partially between the first end 903 and the second end 905 of the elongate catheter body 901. The catheter 900 includes an inflatable balloon 913 on the peripheral surface 907 of the elongate catheter body 901, the inflatable balloon 913 having a balloon wall 915, the balloon wall 915 having an inner surface 917, the inner surface 917 defining a fluid-tight volume 919 along with a portion of the peripheral surface 907 of the elongate catheter body 901. The inflation lumen 911 includes a first opening 921 into a fluid-tight volume 919 of the inflatable balloon 913 and a second opening 923 proximate the first opening 921 to allow a fluid (e.g., a liquid or gas) to move into and out of the volume 919 to inflate and deflate the balloon 913.

Catheter 900 includes a plurality of electrodes 925 positioned along a peripheral surface 907 of elongated catheter body 901. As shown, a plurality of electrodes 925 are positioned between the inflatable balloon 913 and the first end 903 of the elongate catheter body 901. A conductive element 927 extends through the elongate catheter body 901, wherein the conductive element 927 conducts electrical current to a combination of one or more of the plurality of electrodes 925.

The catheter 900 further includes a first anchor 929 and a second anchor 955, both the first anchor 929 and the second anchor 955 extending laterally from the peripheral surface 907 of the elongated body 901. Both the first anchor 929 and the second anchor 955 have struts 931 forming an open frame for the anchors. The struts 931 have an outer peripheral surface 933, the outer peripheral surface 933 having a maximum outer dimension that is greater than the maximum outer dimension (e.g., the maximum diameter) of the inflatable balloon 913. As shown, first anchor 929 has a center point 935 relative to peripheral surface 933, center point 935 being off-center relative to a center point 937 of elongated catheter body 901 relative to peripheral surface 907. In contrast, second anchor 955 has a center point 935 relative to peripheral surface 933, center point 935 being concentric relative to a center point 937 of elongate catheter body 901 relative to peripheral surface 907. In some examples, the first anchor 929 may have a center point 935 relative to the peripheral surface 933, the center point 935 being concentric relative to a center point 937 of the elongated catheter body 901 relative to the peripheral surface 907, and/or the second anchor 955 may have a center point 935 relative to the peripheral surface 933, the center point 935 being eccentric relative to the center point 937 of the elongated catheter body 901 relative to the peripheral surface 907.

Catheter 900 includes an elongate delivery sheath 951 having a lumen 953 extending over a peripheral surface 907 of elongate body 901. The elongate delivery sheath 951, in a first position, can have a first anchor 929 and a second anchor 955 positioned within the inner lumen 953 of the elongate delivery sheath 951. As the elongate delivery sheath 951 is moved relative to the peripheral surface 907 of the elongate body 901, the first anchors 929 extend from the peripheral surface 907 of the elongate body 901. As the elongate delivery sheath 951 is moved further away from the inflatable balloon 913 relative to the peripheral surface 907, the second anchors 955 extend from the peripheral surface 907 of the elongate body 901.

As shown, the plurality of electrodes 925 are positioned between the first anchor 929 and the second anchor 955. The portion 939 of the elongate catheter body 901 that includes the plurality of electrodes 925 can be curved in a predetermined radial direction in a variety of different ways. For example, a portion 939 of the elongate catheter body 901 that includes the plurality of electrodes 925 can be caused to bend in a predetermined radial direction when placed under longitudinal compression (as described herein). Like the catheter 800, to cause the portion 939 including the plurality of electrodes 925 to bend, the elongate catheter body 901 may be pre-stressed and/or the wall may have a thickness that allows the elongate catheter body 901 to bend in a predetermined radial direction when placed under longitudinal compression. Additionally or alternatively, structures such as coils having a different number of turns of the helical wire per unit length may be located within the elongated catheter body 901 in the portion 939. One or more of these structures may be used to allow longitudinal compression to produce bending in the portion 939 in a predetermined radial direction.

To achieve longitudinal compression, the first anchor 929 can be deployed in the vasculature of a patient (as described herein), wherein the first anchor 929 provides a location or point of resistance against longitudinal movement of the elongate body 901. As described herein, this can be accomplished, for example, by moving the elongate delivery sheath 951 relative to the peripheral surface 907 of the elongate body 901 so as to allow the first anchors 929 to extend from the peripheral surface 907 of the elongate body 901. Once deployed, the first anchor 929 allows a compressive force to be generated in the elongate catheter body 901 sufficient to bend a portion 939 of the elongate catheter body 901 (along which portion 1854 there are a plurality of electrodes 925) in a predetermined radial direction. Once the bend is formed in the predetermined radial direction, the elongate delivery sheath 951 is moved further away from the inflatable balloon 913 relative to the peripheral surface 907 so as to allow the second anchors 955 to extend from the peripheral surface 907 of the elongate body 901.

Alternatively, the elongate catheter body 901 of the catheter 900 can include a second inner surface 941 defining a shaped lumen 943 extending from the first end 903 toward the second end 905. The catheter 900 may also include a forming wire 945 having a first end 947 and a second end 949, wherein the forming lumen 943 has a size (e.g., diameter) sufficient to allow the forming wire 945 to pass through the forming lumen 943, wherein the first end 947 of the forming wire 945 is proximal to the first end 903 of the elongate catheter body 901 and the second end 949 of the forming wire 945 is connected to the elongate catheter body 901 such that the forming wire 945 imparts a bend into the portion 939 of the elongate catheter body 901 having the plurality of electrodes 925 when tension is applied to the forming wire 945.

Referring now to fig. 10, an additional example of a catheter 1000 is shown. As described above, the catheter 1000 includes an elongate catheter body 1001, the elongate catheter body 1001 having a first end 1003, a second end 1005, a peripheral surface 1007, and an inner surface 1009 defining an expansion lumen 1011, the expansion lumen 1011 extending at least partially between the first end 1003 and the second end 1005 of the elongate catheter body 1001. The catheter 1000 further includes an inflatable balloon 1013 on a peripheral surface 1007 of the elongate catheter body 1001, wherein the inflatable balloon 1013 has a balloon wall 1015, the balloon wall 1015 having an inner surface 1017, the inner surface 1017 together with a portion of the peripheral surface 1007 of the elongate catheter body 1001 defines a fluid-tight volume 1019. The inflation lumen 1011 includes a first opening 1021 into a fluid-tight volume 1019 of the inflatable balloon 1015 and a second opening 1023 proximate the first opening 1021 to allow fluid to move into and out of the volume 1019 to inflate and deflate the balloon 1015.

The elongate catheter body 1001 also includes a first anchor 1029 that can extend laterally from a peripheral surface 1007 of the elongate catheter body 1001. As described herein, the first anchors 1029 include struts 1031 that form an open frame having a peripheral surface 1033, the peripheral surface 1033 having a maximum outer dimension that is greater than the maximum outer dimension of the inflatable balloon 1013 (e.g., its maximum diameter). As shown, the first anchor 1029 has a center point 1035 relative to the peripheral surface 1033, the center point 1035 being eccentric relative to the elongated catheter body 1001 relative to the center point 1037 of the peripheral surface 1007.

Catheter 1000 also includes an electrode catheter 1057 having an electrode elongate body 1059 and a plurality of electrodes 1025 positioned along a peripheral surface 1061 of electrode elongate body 1059. Conductive element 1063 extends through electrode elongate body 1059 of electrode catheter 1057 and/or along electrode elongate body 1059 of electrode catheter 1057, wherein conductive element 1063 conducts electrical current to a combination of one or more of plurality of electrodes 1025. As shown, the first anchor 1029 is positioned between the inflatable balloon 1013 and a plurality of electrodes 1025 positioned along a peripheral surface of the electrode elongate body 1059.

The catheter 1000 also includes an attachment loop 1065 connected to the electrode catheter 1057 and positioned around the peripheral surface 1061 of the elongate catheter body 1001 at the distal end of the first anchor 1029 and the inflatable balloon 1013. In one example, the attachment ring 1065 holds the distal end 1067 of the electrode catheter 1057 in a static relationship to the elongate catheter body 1001. From this position, the portion 1039 of the electrode elongate body 1059 comprising the plurality of electrodes 1025 can be caused to bend in a predetermined radial direction, as previously described. The configuration of the portion 1039 of the bent electrode elongate body 1059 that includes the plurality of electrodes 1025 can have any of the configurations and bending mechanisms described herein.

Fig. 10 also shows an elongate delivery sheath 1051 having a lumen 1053 extending over the outer peripheral surfaces of the elongate catheter body 1001 and electrode catheter 1057. The elongate delivery sheath 1051 can have a first anchor 1029 positioned within the lumen 1053 of the elongate delivery sheath 1051 in the first position. As the elongate delivery sheath 1051 is moved relative to the peripheral surface 1007 of the elongate body 1001 and the peripheral surface 1061 of the electrode catheter 1057, the first anchor 1029 extends from (e.g., away from) the peripheral surface 1007 of the elongate body 1001.

Referring now to fig. 11, two catheter systems 1169 are shown in accordance with a disclosed example. The catheter system 1169 includes an elongate catheter body 1102, the elongate catheter body 1102 having a first end 1104, a second end 1106, a peripheral surface 1176, and an inner surface 1184 defining an inflation lumen 1194, the inflation lumen 1194 extending at least partially between the first end 1104 and the second end 1106 of the elongate catheter body 1002. The elongate catheter body 1102 includes an elongate radial axis 1108 defined by the intersection of a first plane 1110 and a second plane 1112 perpendicular to the first plane 1110, wherein the elongate radial axis 1108 extends through the first end 1104 and the second end 1108 of the elongate catheter body 1102.

The catheter system 1169 also includes an inflatable balloon 1178 on a peripheral surface 1176 of the elongate catheter body 1102. The inflatable balloon 1178 has a balloon wall 1188 with an inner surface 1190, the inner surface 1190 defining, along with a portion of the peripheral surface 1176 of the elongate catheter body 1102, a fluid-tight volume 1192. The inflation lumen 1194 includes a first opening 1196 into a fluid-tight volume 1192 of the inflatable balloon 1178 and a second opening 1198 proximate the first opening 1196 to allow fluid to move into and out of the volume 1192 to inflate and deflate the balloon 1178.

The catheter system 1169 also includes an electrode holder 11690, the electrode holder 11690 having two or more ribs 1171 extending radially away from a peripheral surface 1176 of the elongate catheter body 1102 toward the inflatable balloon 1178. As shown, each rib 1171 of the electrode holder 11690 has a first end 11692 that extends away from the elongate catheter body 1101 toward the inflatable balloon 1178. Each of the first ends 11692 of the ribs 1171 of the electrode holder 11690 are distal from each other relative to each other first end of the ribs 1171. In addition, the rib portion 1171 of the electrode holder 1169 is bent into the first half 1116 of the first plane 1110. Each rib 1171 of electrode holder 1169 also includes one or more electrodes 1125. One or more electrodes 1125 on each rib 1171 form an array of electrodes on the first half 1116 of the first plane 1110. The catheter system 1169 also includes a conductive element 1120 extending through the ribs 1171 of the electrode holder 1169 and the elongate catheter body 1101 and/or along the ribs 1171 of the electrode holder 1169 and the elongate catheter body 1101, wherein the conductive element 1120 conducts electrical current to a combination of one or more electrodes 1125 in the electrode array.

The catheter system 1169 also includes an anchor cage 1173, the anchor cage 1173 having two or more ribs 1171 extending radially away from a peripheral surface 1176 of the elongate catheter body 1101 toward the inflatable balloon 1178. As illustrated, two or more ribs 1171 of the anchor cage 1173 are bent into the second half 1134 of the first plane 1110. In the example shown, the two or more ribs 1171 of the anchor cage 1173 do not include any electrodes. In some examples, two or more ribs 1171 of anchor cage 1173 comprise one or more electrodes.

The catheter system 1169 may also include a second inflatable balloon on a peripheral surface 1176 of the elongate catheter body 1101. For example, the elongate catheter body 1101 can further include a third end and a second inner surface defining a second inflation lumen extending at least partially between the first end and the third end of the elongate catheter body 1101. The second inflatable balloon may be located on the peripheral surface 1176 of the elongate catheter body 1101 adjacent the third end of the elongate catheter body 1101. As with the first inflatable balloon 1178, the second inflatable balloon may include a balloon wall having an inner surface that defines a fluid-tight volume along with a portion of the outer peripheral surface of the elongate catheter body. The second inflation lumen may include a first opening into the fluid-tight volume of the second inflatable balloon and a second opening proximate the first opening to allow fluid to move into and out of the volume to inflate and deflate the second balloon.

Fig. 11 also shows the elongate delivery sheath 1151 having a lumen 1153 extending over the peripheral surface of the elongate catheter body 1101 and the ribs 1171 of both the electrode holder 1169 and the anchor holder 1173. The elongate delivery sheath 1151, in the first position, can have ribs 1171 that anchor both the electrode holder 1169 and the anchor holder 1173 within the lumen 1153 of the elongate delivery sheath 1151. As the elongate delivery sheath 1151 moves relative to the peripheral surface 1107 of the elongate body 1101, the ribs 1171 of the electrode holder 1169 extend from the elongate body 1101 to curve into the first half 1116 of the first plane 1110 and the ribs 1171 of the anchor holder 1173 extend from the elongate body 1101 to curve into the second half 1134 of the first plane 1110.

Referring now to fig. 12A, a perspective view of an example of a catheter 1200 is shown. The catheter 1200 includes an elongated body 1202 having a first end 1204 and a second end 1206 distal to the first end 1204. As shown, the elongate body 1202 includes a longitudinal central axis 1208 extending between the first end 1204 and the second end 1206 of the elongate body 1202. The elongate body 1202 also includes a portion 1210 having three or more surfaces 1212 defining a convex polygonal cross-sectional shape taken perpendicular to the longitudinal central axis 1208.

As used herein, the convex polygonal cross-sectional shape of the elongated body 1202 includes those shapes whose each interior angle is less than 180 degrees and in which each section between two vertices of the shape remains inside or on the boundary of the shape. Examples of such shapes include, but are not limited to, triangular, rectangular (as shown in fig. 12A), square, pentagonal, and hexagonal, among others.

As shown, the catheter 1200 includes one or more (e.g., two or more) electrodes 1214 on one of three or more surfaces 1212 of the elongate body 1202. The electrically conductive element 1216 extends through the elongate body 1202 and/or along the elongate body 1202, wherein the electrically conductive element 1216 can be used, for example, as described herein, to conduct electrical current to a combination of one or more electrodes 1214. Each of the one or more electrodes 1214 is coupled to a corresponding conductive element 1216. In some examples, the conductive elements 1216 are electrically isolated from each other and extend from each respective electrode 1214 through the elongated body 1202 through the first end 1204 of the elongated body 1202 and/or along the elongated body 1202. The conductive elements 1216 may terminate at connector ports, wherein each conductive element 1216 is releasably coupleable to a stimulation system, e.g., a stimulation system as described herein. In some examples, the conductive element 1216 is permanently coupled to the stimulation system (e.g., non-releasably coupled). The stimulation system may be used to provide stimulation electrical energy that is conducted through the electrically conductive elements 1216 and delivered over a combination of one or more arrays 1214. The one or more electrodes 1214 can be electrically isolated from one another, and the elongate body 1202 can be formed of an electrically insulating material as described herein. As shown, according to one example, the one or more electrodes 1214 are located on only one of the three or more surfaces 1212 of the elongate body 1202.

There may be various numbers and configurations of one or more electrodes 1214 on one of the three or more surfaces 1212 of the elongate body 1202. For example, one or more electrodes 1214 may be configured as an electrode array, where the number of electrodes and their relative positions with respect to each other may vary depending on the desired implant (e.g., deployment or target) location. As described herein, the one or more electrodes 1214 may be configured to allow electrical current to be transferred from and/or between different combinations of the one or more electrodes 1214. Thus, for example, the electrodes in an electrode array may have a repeating pattern in which the electrodes are equally spaced from each other. For example, the electrodes in the electrode array may have a column and row configuration (as shown in fig. 12). Alternatively, the electrodes in the electrode array may be in a concentric radial pattern, with the electrodes positioned to form concentric rings of electrodes. Other patterns are also possible, wherein such patterns may be repeating patterns or random patterns.

As shown, one or more electrodes 1214 have an exposed surface 1218. Unlike the volume of blood facing an artery or other vessel, lumen, or organ, exposed face 1218 of electrode 1214 provides an opportunity for electrode 1214 to be placed in proximity to and/or in contact with vascular tissue of the patient (e.g., of the right or left pulmonary artery) when implanted (temporarily or for an extended duration of time) in the patient. When one or more electrodes 1214 are located on one of the three or more surfaces 1212 of the elongate body 1202, the electrodes 1214 may be placed in direct proximity to and/or in contact with tissue of any combination of the main, left, and/or right pulmonary arteries.

By having one or more electrodes 1214 on one of the three or more surfaces 1212, an exposed surface 1218 of the electrode can be positioned inside the patient's vasculature to face and/or contact tissue of the main, left, and/or right pulmonary arteries. When the one or more electrodes 1214 are in contact with the luminal surface of the patient's vasculature, the one or more electrodes 1214 direct the volume of blood away from the region of the pulmonary artery, allowing electrical pulses from the one or more electrodes 1214 to be directed into tissue adjacent the implant location rather than into the volume of blood.

The exposed surface 1218 of the one or more electrodes 1214 can have a variety of different shapes. For example, the exposed surface 1218 may have a flat planar shape. In this example, an exposed surface 1218 of the electrode 1214 can be coplanar with one of the three or more surfaces 1212 of the elongate body 1202. In an alternative example, the exposed surface 1218 of the electrode 1214 can have a semi-hemispherical shape. Other shapes for the exposed face 1218 of the electrode 1214 can include a semi-cylindrical shape, an undulating shape, or a zig-zag shape. The exposed surface 1218 of the electrode 1214 can also include one or more anchor structures. Examples of such anchor structures include hooks that may optionally include barbs. Similarly, the electrodes 1214 may be shaped to act as anchor structures.

In one example, one of the three or more surfaces 1112 of the elongate body 1102 that includes the exposed surface 1218 of the one or more electrodes 1214 can also include an anchor structure 1220 extending over one of the three or more surfaces 1212. As shown, the anchor structure 1220 can include portions that can contact the vascular tissue in a manner such that movement of the one or more electrodes 1214 at their locations of contact with the vascular tissue is reduced (e.g., minimized). The anchor structure 1220 can have a variety of different shapes that can help achieve this goal. For example, the anchor structure 1220 can have a conical shape, wherein the apex of the conical shape can contact vascular tissue. In one example, the anchor structure 1220 has a hook configuration (with or without barbs). In additional examples, one or more of the anchor structures 1220 can be configured as electrodes.

As shown, the elongate body 1202 of the catheter 1200 can also include a portion 1222 having a circular cross-sectional shape taken perpendicular to the longitudinal central axis 1208. The elongate body 1202 of the catheter 1200 also includes a surface 1224 defining a guidewire lumen 1226 extending through the elongate body 1202. The guidewire lumen 1226 can have a diameter sufficiently large to allow a guidewire to freely pass through the guidewire lumen 1226. The guidewire lumen 1226 can be concentrically positioned relative to the longitudinal central axis 1208 of the elongate body 1202.

Alternatively, and as shown in fig. 12A, the guidewire lumen 126 may be positioned eccentrically relative to the longitudinal central axis 1208 of the elongate body 1202. When the guidewire lumen 1226 is positioned concentrically with respect to the longitudinal central axis 1208, the guidewire lumen 1226 has a wall thickness 1228 that is greater than a wall thickness 1230 of the remainder of the catheter taken perpendicular to the longitudinal central axis. For this configuration, the difference in wall thicknesses 1228 and 1230 helps to provide a preferential direction for the elongate body 1202 to flex. For example, according to several examples, the wall thickness 1228 of the elongate body 1202 that is greater than the wall thickness 1230 causes the side of the elongate body 1202 having the greater wall thickness to preferentially have a greater radius of curvature as the elongate body 1102 flexes. By positioning the exposed face 1218 of the one or more electrodes 1214 on the side of the elongate body 1202 having the greater wall thickness (e.g., the wall thickness 1228), the one or more electrodes 1214 can be more easily and predictably brought into contact with the luminal surface of the vasculature in or around at least one of the main and right and left pulmonary arteries.

The catheter 1200 shown in fig. 12A may be positioned in one or both of the patient's main pulmonary artery and/or left and right pulmonary arteries, e.g., as described herein. To do this, a pulmonary artery catheter guide catheter is introduced into the vasculature through a percutaneous incision and navigated to the right ventricle using known techniques. For example, a pulmonary artery catheter guide catheter may be inserted into the vasculature via a peripheral vein of the arm (e.g., like a peripherally inserted central catheter), via a peripheral vein of the neck or chest (e.g., like the swan-ganz catheter approach), or via a leg vein (e.g., the femoral vein). Other methods include, but are not limited to, the internal jugular vein method. Changes in the patient's electrocardiogram and/or pressure signals from the vasculature may be used to guide and position the pulmonary artery guide catheter within the patient's heart. Once in place, a guidewire may be introduced into the patient via a pulmonary artery guide catheter, wherein the guidewire is advanced into one of the main and/or pulmonary arteries (e.g., left and right pulmonary arteries). Using the guidewire lumen 1226, the catheter 1200 can be advanced over the guidewire to position the catheter 1200 in one or both of the main pulmonary artery and/or the left and right pulmonary arteries of the patient, e.g., as described herein. Various imaging medical devices may be used to position the guidewire of the present disclosure in one of the main and/or left and right pulmonary arteries of a patient. Such imaging modalities include, but are not limited to, fluoroscopy, ultrasound, electromagnetic and potentiometric modalities.

Stimulation electrical energy (e.g., current or pulses) may be transmitted over a combination of one or more of the electrodes 1214 using a stimulation system (e.g., the stimulation system described herein). According to several examples described herein, the cardiac response of a patient to stimulation electrical energy may be monitored and recorded for comparison with other subsequent tests. It will be appreciated that for any of the catheters described herein, any combination of electrodes, including reference electrodes positioned within or on a patient's body (as described herein), may be used to provide stimulation to a subject (e.g., a patient) and sense cardiac signals from the subject.

Fig. 12B shows another example of a catheter 1200. The catheter 1200 includes the features and components discussed above, and the discussion thereof is not repeated, but rather the element numbers are included in fig. 12B, with the understanding that the discussion of these elements is implicit. Further, the elongate body 1202 of the catheter 1200 includes a serpentine portion 1232 proximate to the one or more electrodes 1214. When implanted (e.g., deployed) in the vasculature of a patient, the serpentine portion 1232 of the elongate body 1202 can act as a "spring" to absorb and isolate movement of the one or more electrodes 1214 from the rest of the elongate body 1202 of the catheter 1200. In addition to having a serpentine shape, serpentine portion 1232 may have a coil-like configuration. Other shapes that achieve the purpose of absorbing once implanted and isolating movement of the one or more electrodes 1214 from the rest of the elongate body 1202 of the catheter 1200 can also be used as needed and/or desired. The presence of the guidewire within the guidewire lumen 1226 during delivery of the catheter 1200 may help temporarily straighten the serpentine portion 1232 of the elongate body 1202.

Referring now to fig. 12C, an additional example of a catheter 1200 provided herein is shown. The catheter 1200 may include the features and components discussed above with respect to the catheter described in fig. 12A and 12B, the discussion of which is not repeated, but the inclusion of element numbers in fig. 12C, it being understood that the discussion of these elements is implicit. In addition, the catheter 1200 of the present example includes an inflatable balloon 1234. As shown, the elongate body 1202 includes an outer peripheral surface 1236, wherein the inflatable balloon 1234 is located on the outer peripheral surface 1236 of the elongate body 1202. The inflatable balloon 1234 includes a balloon wall 1238 having an inner surface 1240, the inner surface 1240 defining, along with a portion 1242 of the outer peripheral surface 1236 of the elongate body 1202, a fluid-tight volume 1244.

The elongate body 1202 also includes a surface 1245 that defines an inflation lumen 1246 that extends through the elongate body 1202. The inflation lumen 1246 includes a first opening 1248 into the fluid sealed volume 1244 of the inflatable balloon 1234 and a second opening 1250 proximate the first opening 1248 to allow fluid to move into and out of the fluid sealed volume 1244 to inflate and deflate the balloon 1234. A syringe or other known device containing a fluid (e.g., saline or a gas (e.g., oxygen)) may be used to inflate and deflate balloon 334.

The catheter 1200 shown in fig. 12C may be positioned in one or both of the patient's main pulmonary artery and/or left and right pulmonary arteries, e.g., as described herein. As described herein, a pulmonary artery catheter guide catheter is introduced into the vasculature through a percutaneous incision and directed to the right ventricle. Once in place, the balloon 1234 may be inflated in accordance with the described manner to allow the catheter 1200 to be carried from the right ventricle to the main pulmonary artery and/or one of the pulmonary arteries by the flow of blood. Additionally, various imaging medical devices may be used to position the catheter of the present disclosure in one of the patient's main and/or pulmonary arteries. Such imaging modalities include, but are not limited to, fluoroscopy, ultrasound, electromagnetic and potentiometric modalities.

The catheter 1200 may be advanced along the main pulmonary artery until the second end 1206 of the catheter 1200 contacts the top of the main pulmonary artery (e.g., at a location distal to the pulmonary valve and adjacent to both pulmonary arteries). Once the second end 1206 of the catheter 1200 reaches the top of the main pulmonary artery, the pulmonary artery guide catheter can be moved relative to the catheter 1200 to deploy the catheter 1200 from the pulmonary artery guide catheter.

There may be indicia on the outer peripheral surface of the catheter body 1202, where the indicia starts at the second end 1202 and extends from the second end 1202 towards the second end 1206 of the catheter body 1202. The distance between the markers may have units (e.g., millimeters, inches, etc.), which may allow the length between the second end 1206 of the catheter 1200 and the top of the main pulmonary artery to be determined.

The ability to measure this distance from the top of the main pulmonary artery may facilitate placement of one or more electrodes 1214 in a desired location (e.g., at a location within the main pulmonary artery). In addition to measuring the distance from the top of the main pulmonary artery from the second end 1206 from which the elongate body 1202 is placed, the elongate body 1202 may also be used to identify or map an optimal location of one or more electrodes 1214 within the vasculature. For example, using indicia on the peripheral surface of the catheter body 1202, the second end 1206 of the elongate body 1202 can be positioned at a desired distance from the top of the main pulmonary artery.

Stimulation electrical energy (e.g., electrical current or electrical pulses) may be transmitted over the combination of one or more electrodes 1214 using a stimulation system (e.g., the stimulation system described herein). The patient's cardiac response to the stimulation electrical energy may be monitored and recorded for comparison with other subsequent tests. It will be appreciated that for any of the catheters described herein, any combination of electrodes, including reference electrodes positioned within or on the body of a patient (as described herein), may be used to provide stimulation to the patient and sense cardiac signals from the patient.

Referring now to fig. 12D, an additional example of a catheter 1200 is shown. The catheter 1200 may include features and components like those discussed above with respect to fig. 12A-12BC, the discussion of which is not repeated, but the inclusion of element numbers in fig. 12D, it being understood that the discussion of these elements is implicit. Further, the catheter 1200 of the present example includes a surface 1252 that defines a deflection lumen 1254. The deflection lumen 1254 includes a first opening 1256 and a second opening 1258 in the elongated body 1202. In one example, the second opening 1258 is opposite one or more electrodes 1214 on one of the three or more surfaces 1212 of the elongate body 1202.

The catheter 1200 also includes an elongate deflecting member 1260. The elongated deflection member 1260 includes an elongated body 1261 having a first end 1263 and a second end 1265. An elongated deflection member 1260 extends through the first opening 1256 to a second opening 1258 of the deflection lumen 1254. The deflection lumen 1254 has a size (e.g., diameter) sufficient to allow the deflection member 1260 to pass through the deflection lumen 1254, wherein the first end 1263 of the deflection member 1260 is proximate the first end 1204 of the elongate body 1202 and the second end 1265 of the deflection member 1260 may extend from the second opening 1258 of the deflection lumen 1254. Pressure applied from the first end 1263 of the deflection member 1260 may cause the deflection member 1260 to move within the deflection lumen 1254. For example, when pressure is applied to the deflection member 1260 to move the first end 1263 of the deflection member 1260 toward the first opening 1256 of the deflection lumen 1254, the pressure extends the second end 1265 of the deflection member 1260 from the second opening 1258.

As generally illustrated, the elongate deflection member 1260 may be advanced through the deflection lumen 1254 such that the elongate deflection member 1260 extends laterally away from one or more electrodes 1214 on one of the three or more surfaces 1212 of the elongate body 1202. The elongate deflection member 1260 may have a length and shape that allows the elongate deflection member 1260 to be extended a distance sufficient to bring the one or more electrodes 1214 into contact with a blood luminal surface (e.g., the posterior surface of one or both of the main pulmonary artery and/or pulmonary artery) with various pressures. Optionally, the elongate deflecting member 1260 may be configured to include one or more electrodes 1214, e.g., as described herein.

For various examples, the elongate body 1261 of the deflecting member 1260 is formed from a flexible polymeric material. Examples of such flexible polymeric materials include, but are not limited to: medical grade polyurethanes, in particular, for example, polyester-based polyurethanes, polyether-based polyurethanes and carbonate-based polyurethanes; polyamides, polyamide block copolymers, polyolefins (e.g., polyethylene (e.g., high density polyethylene)); and a polyimide.

In one example, the elongate body 1261 of the elongate deflecting member 1260 further comprises one or more strut wires. The strut wires may be encased in a flexible polymer material of the elongate body 1261, wherein the strut wires may help provide column strength and a predetermined shape to the elongate deflecting member 1260. For example, the strut wires may have a coil shape that extends longitudinally along the length of the elongate body 1261. According to several examples, the coil shape advantageously allows longitudinal forces applied at or near the first end 1263 of the deflection member 1260 to be transmitted through the elongated body 1261 to laterally extend the second end 1265 of the deflection member 1260 from the second opening 1258 of the deflection lumen 1254.

The strut wire may also provide a predetermined shape to the deflection member 1260 after extending laterally from the second opening 1258 of the deflection lumen 1254. The predetermined shape may be determined to engage the lumen wall of the pulmonary artery in order to bring the electrodes 1214 into contact with the vascular tissue. The predetermined shape and strut wires can also help impart a stiffness to the deflection member 1260 sufficient to maintain the electrodes 1214 on the luminal wall of the pulmonary artery in a condition within the vasculature of a subject (e.g., patient). The strut wires 566 may be formed from a variety of different metals or metal alloys. Examples of such metals or metal alloys include surgical grade stainless steel, such as austenitic 316 stainless steel and nickel titanium alloys known as Nitinol (Nitinol), among others. Other metals and/or metal alloys may be used as needed and/or desired.

The catheter 1200 shown in fig. 12D may be positioned in one or both of the patient's main pulmonary artery and/or left and right pulmonary arteries, e.g., as described herein. According to several methods, a pulmonary artery catheter guide catheter is introduced into the vasculature through a percutaneous incision and directed to the right ventricle (e.g., using the swan-ganz catheterization method). Once in place, the balloon 1234 may be inflated in accordance with the described manner to allow the catheter 1200 to be carried from the right ventricle to the main pulmonary artery and/or one of the right and left pulmonary arteries by the flow of blood. Additionally, various imaging modalities may be used to position the catheter in one of the main and/or right and left pulmonary arteries of the patient. Such imaging modalities include, but are not limited to, fluoroscopy, ultrasound, electromagnetic and potentiometric modalities.

The catheter 1200 may be advanced along the main pulmonary artery until the second end 1206 of the catheter 1200 contacts the top of the main pulmonary artery (e.g., at a location distal to the pulmonary valve and adjacent to both pulmonary arteries). Once the second end 1206 of the catheter 1200 reaches the top of the main pulmonary artery, the pulmonary artery guide catheter can be moved relative to the catheter 1200 to deploy the catheter 1200 from the pulmonary artery guide catheter.

There may be markings on the peripheral surface of the elongate body 1202 as described herein that may help position the catheter 1200 within the main pulmonary artery. The ability to measure this distance from the top of the main pulmonary artery may facilitate placement of one or more electrodes 1214 in a desired location (e.g., a location within the main pulmonary artery). In addition to measuring the distance from the top of the main pulmonary artery from the second end 1206 from which the elongate body 1202 is placed, the elongate body 1202 may also be used to identify or map an optimal location of one or more electrodes 1214 within the vasculature. For example, using indicia on the peripheral surface of the catheter body 1202, the second end 1206 of the elongate body 1202 can be positioned at a desired distance from the top of the main pulmonary artery.

When desired, the elongate deflecting member 1260 can be laterally extended from the elongate body 1202 to a length sufficient to cause one of the three or more surfaces 1212 of the elongate body 1202 having one or more electrodes 1202 to contact a surface of a main pulmonary artery (e.g., an anterior surface of the main pulmonary artery), thereby bringing the one or more electrodes 1214 into contact with the main pulmonary artery or one of the pulmonary arteries (left or right pulmonary artery). It will be appreciated that the elongate deflection member 1260 biases and facilitates placement of the one or more electrodes 1214 along a blood vessel surface, e.g., along a main pulmonary artery or one of the pulmonary arteries (left or right).

Due to its adjustable nature (e.g., how much pressure is applied to the elongate deflection member 1260), the elongate deflection member 1260 can be used to bring the one or more electrodes 1214 into contact with the luminal surface of one of the main or pulmonary arteries with a variety of different pressures. Thus, for example, the elongate deflecting member 1260 can bring the one or more electrodes 1214 into contact with the luminal surface of the main pulmonary artery or one of the pulmonary arteries with the first pressure. Stimulation electrical energy (e.g., an electrical current or an electrical pulse) may be transmitted over the combination of one or more electrodes 1214 in the electrode array using a stimulation system (e.g., the stimulation system described herein). The patient's cardiac response to the stimulation electrical energy may be monitored and recorded for comparison with other subsequent tests.

It will be appreciated that for any of the catheters described herein, any combination of electrodes, including reference electrodes positioned within or on the body of a patient (as described herein), may be used to provide stimulation to the patient and sense cardiac signals from the patient.

If desired, the distance that the elongate deflecting member 1260 extends laterally from the elongate body 1202 can be varied (e.g., made shorter) to allow the elongate body 1202 to rotate in a clockwise or counterclockwise direction to reposition the one or more electrodes 1214 in contact with the luminal surface of the main or one of the pulmonary arteries. The stimulation system may again be used to transmit stimulation electrical energy over a combination of one or more of the electrodes 1214 in the electrode array. The patient's cardiac response to this subsequent test can then be monitored and recorded for comparison with the previous and subsequent tests. In this manner, a preferred location for positioning one or more electrodes 1214 along the luminal surface of one of the main pulmonary artery or the left or right pulmonary artery can be identified. Once identified, the elongate deflection member 1260 may be used to increase the lateral pressure applied to one or more electrodes, thereby helping to better anchor the catheter 1200 in the patient.

Fig. 13 provides a perspective view of a catheter 1330 positioned in a heart 200 of a subject (e.g., a patient) with one or more of the electrodes 1344 contacting the posterior surface 221 and/or the superior surface 223 of, for example, the right pulmonary artery 206. Fig. 13 also shows one or more electrodes 1344 contacting the posterior surface 221 and/or the upper surface 223 of the right pulmonary artery 208 at a location above the branching point 207. Fig. 13 also shows positioning at least a portion of catheter 1330 in contact with a portion of the surface defining branch point 207.

As shown, the pulmonary trunk has a diameter 1356 taken on a plane 1358, the plane 1358 being perpendicular to the left and right lateral planes 220, 216. In one example, the electrode array of catheter 1330 is positioned in region 1360, region 1360 extending distally no more than about three times the diameter of pulmonary trunk 202 to the right of branching point 207. This region 1360 is shown in cross-sectional hatching in fig. 13.

The right pulmonary artery 206 can also include a branch point 1362, the branch point 1362 dividing the right pulmonary artery 206 into at least two additional arteries 1364, the additional arteries 1364 distal to the branch point 207 defining the left and right pulmonary arteries 208 and 206. As shown, the electrode array may be positioned between a branch point 207 defining the left and right pulmonary arteries 208, 206 and a branch point 1362 that divides the right pulmonary artery 206 into at least two additional arteries 1364.

Once in place, current may be provided to or from one or more of the electrodes 1344. Using the first sensor 1352, values of a non-cardiac parameter of the patient may be measured in response to current flow from or to one or more of the electrodes 1344. Depending on the value of the non-cardiac parameter, changes may be made to which one or more electrodes are used to provide current in response to the value of the cardiac parameter. The nature of the current provided in response to the value of the non-cardiac parameter may also be varied. Such changes include, but are not limited to, changes in voltage, amperage, waveform, frequency, and pulse width, for example. It is also possible to vary the combination of electrodes used and the nature of the current provided by the electrodes. Further, an electrode of the one or more electrodes on the posterior surface of the right pulmonary artery 206 may be moved in response to one or more values of the non-cardiac parameter. Examples of such cardiac parameters include, but are not limited to, measuring pressure parameters, acoustic parameters, acceleration parameters, and/or electrical parameters (e.g., ECG) of the patient's heart as cardiac parameters. Examples of such pressure parameters may include, but are not limited to, measuring the maximum systolic pressure of the patient's heart as the pressure parameter. Other suitable cardiac parameters are discussed herein.

Moving an electrode of the one or more electrodes on the posterior surface and/or the superior surface of the right pulmonary artery 206 in response to one or more values of the cardiac parameter may be accomplished by: physically moving one or more electrodes of catheter 1330 to different locations on the posterior and/or superior surface of right pulmonary artery 206, electronically moving which of the one or more electrodes are to be used to provide current from or to the electrode array (without physically moving one or more electrodes of catheter 1330), or a combination of both.

As described herein, neuromodulation according to the present disclosure may be achieved by applying an electrical current to the right pulmonary artery 206. Preferably, neuromodulation of the present disclosure includes applying current to the posterior and/or superior wall of the right pulmonary artery 206. More preferably, neuromodulation of the present disclosure includes applying an electrical current to the anterior and/or superior wall of the right pulmonary artery 206. Thus, an electric current is applied to the autonomic cardiopulmonary nerves around the right pulmonary artery 206. These autonomic cardiopulmonary nerves may include the right and left autonomic cardiopulmonary nerves. The right autonomic cardiopulmonary nerve comprises the right dorsal medial and dorsal lateral cardiopulmonary nerves. The left autonomic cardiopulmonary nerves include the left ventral, left dorsal medial, left dorsal lateral, and left stellate cardiorespiratory nerves.

As depicted in fig. 13 and discussed with reference to fig. 13, one or more electrodes of the catheter contact the posterior surface of the right pulmonary artery 206. From this location, the electrical current transmitted through the one or more electrodes may be better able to treat and/or provide treatment (including adjuvant treatment) to a patient experiencing various cardiovascular medical conditions (e.g., acute heart failure). The current may elicit a response from the autonomic nervous system, which may help regulate the patient's cardiac contractility and/or relaxation. The intention of the current is to affect the contractility and/or relaxation of the heart beyond the heart rate, thereby helping to improve hemodynamic control while minimizing unwanted systemic effects.

Referring now to fig. 14A, an additional example of a catheter 1462 is shown. The conduit 1462 includes an elongated body 1402 having a peripheral surface 1436 and a central longitudinal axis 1408 extending between the first end 1404 and the second end 1406. The catheter 1462 may include the features and components discussed above with respect to the catheters 100, 200, 300, and/or 400, the discussion of which is not repeated, but the inclusion of element numbers in fig. 14A, it being understood that the discussion of these elements is implicit.

The catheter 1462 of the present example includes an inflatable balloon 1434. As shown, the elongate body 1402 includes a peripheral surface 1436, wherein the inflatable balloon 1434 is located on the peripheral surface 1436 of the elongate body 1402. Inflatable balloon 1434 includes a balloon wall 1438 having an inner surface 1440, the inner surface 1440 defining, along with a portion 1442 of a peripheral surface 1436 of elongate body 1402, a fluid-tight volume 1444.

The elongate body 1402 also includes a surface 1445 that defines an expansion lumen 1446 extending through the elongate body 1402. The inflation lumen 1446 includes a first opening 1448 into the fluid tight volume 1444 of the inflatable balloon 1434 and a second opening 1450 proximate the first opening 1448 to allow fluid to move into the fluid tight volume 1444 to inflate and deflate the balloon 1434. A syringe or other known device containing a fluid (e.g., saline or a gas (e.g., oxygen)) may be used to inflate and deflate balloon 1434.

The elongate body 1402 also includes an offset region 1464 defined by a series of predetermined bends along the longitudinal central axis 1408. As used herein, a "predetermined bend" is a bend formed in the elongate body 1462 during production of the catheter 1462, wherein a spring-like force is provided to return to its pre-deformed shape (e.g., its original shape) when such a bend is deformed. As shown, the series of predetermined bends includes a first portion 1466, the first portion 1466 having a first bend 1468 on the central longitudinal axis 1408, the first bend 1468 being followed by a second bend 1470 on the central longitudinal axis 1408 of the elongate body 1402. The length and curvature of each of first and second bends 1468, 1470, along with the distance between such bends, define the height of offset region 1464. as described herein, the height of offset region 1464 may be determined by the inner diameter of one or more locations along the main pulmonary artery and/or one of the right and left pulmonary arteries.

The first portion 1466 of the elongated body 1402 is followed by the second portion 1472 of the elongated body 1402. The longitudinal central axis 1408 along the second portion 1472 may have zero curvature (e.g., a straight line), as shown in fig. 14A. The second portion 1472 of the elongated body 1402 is followed by a third portion 1474 of the elongated body 1402. The longitudinal central axis 1408 transitions from the second portion 1472 along a third bend 1476, and the third spline 1476 then transitions to a fourth spline 1478. As shown, after the fourth spline 1478, the central longitudinal axis 1408 is approximately collinear with the central longitudinal axis 1408 leading all the way to the first bend 1468. It is noted that the curvature of first portion 1466 and second portion 1474 may also be approximately in the same plane. However, it is also possible that the curvature of first portion 1466 and second portion 1474 are not in the same plane. For example, when the bending of the first and second portions 1466, 1474 are not in the same plane, the longitudinal central axis 1408 may include a helical bend through these portions of the elongate body 1402. Other shapes are also possible.

The elongated body 1402 may also include one or more electrodes 1414 along the second portion 1472 of the offset region 1464 of the elongated body 1402, e.g., as described herein. As shown, one or more electrodes 1414 may be on the surface of the elongated body 1402 in the second portion 1472 of the offset region 1464. The conductive element 1416 extends through the elongate body 1402 and/or along the elongate body 1402, wherein the conductive element 1416 can be used to conduct electrical current to a combination of one or more electrodes 1414 as described herein. Each of the one or more electrodes 1414 is coupled to a corresponding conductive element 1416. The conductive elements 1416 are electrically isolated from each other and extend from each respective electrode 1414 through the elongate body 1402 through the first end 1404 of the elongate body 1402 and/or along the elongate body 1402. The conductive elements 1416 terminate at connector ports, wherein each conductive element 1416 is releasably coupleable to a stimulation system, e.g., as described herein. It is also possible that the conductive element 1416 is permanently coupled to the stimulation system (e.g., non-releasably coupled). The stimulation system may be used to provide stimulation electrical energy (e.g., an electrical current or electrical pulse) that is conducted through the electrically conductive element 1416 and delivered over a combination of one or more of the electrodes 1414. In some examples, the one or more electrodes 1414 are electrically isolated from each other, wherein the elongate body 1402 is formed of an electrically insulating material.

There may be a variety of different numbers and configurations of one or more electrodes 1414 on one surface of the second portion 1472 of the elongated body 1402. For example, one or more of the electrodes 1414 may be configured as an electrode array, wherein the number of electrodes and their relative positions with respect to each other may vary depending on the desired implant location. As described herein, the one or more electrodes 1414 may be configured to allow electrical current to be transferred from and/or between different combinations of the one or more electrodes 1414. The electrodes in the electrode array may have a repeating pattern in which the electrodes are equally spaced from each other. Thus, for example, the electrodes in an electrode array may have a column and row configuration. Alternatively, the electrodes in the electrode array may be in a concentric radial pattern, with the electrodes positioned to form concentric rings of electrodes. Other patterns are also possible, wherein such patterns may be repeating patterns or random patterns. The catheter 1462 also includes a conductive element 1416 extending through and/or along the elongate body, as described herein, wherein the conductive element 1416 conducts electrical current to the combination of one or more electrodes 1414.

As described herein, the length and curvature of each bend of first portion 1466 and third portion 1474, along with the distance between such bends, that help define longitudinal central axis 1408, help define the relative height of offset region 1464. For various examples, the height of the offset region 1464 may be determined by the inner diameter of one or more locations along the main pulmonary artery and/or one of the right and left pulmonary arteries. In this manner, the first and third portions 1466, 1474 may contact the second portion 1472 and one or more electrodes 1414 on the surface of the elongate body 1402 with a blood vessel wall in the main pulmonary artery and/or one of the left and right pulmonary arteries of the patient. In other words, the transition of the first and third portions 1466, 1474 of the elongate body 1402 in the offset region 1464 can be used to bias the second portion 1472 and the one or more electrodes 1414 against a blood vessel wall of the patient in the main pulmonary artery and/or one of the left and right pulmonary arteries.

The elongate body 1402 also includes a surface 1424 defining a guidewire lumen 1426 extending through the elongate body 1402 and/or along the elongate body 1402. As provided herein, the guidewire lumen 1426 may be concentric with respect to the longitudinal central axis 1408 of the elongate body 1402 (as shown in fig. 14). Alternatively, the guidewire lumen 1426 may be eccentric relative to the longitudinal central axis 1408 of the elongate body 1402. As described herein, the guidewire lumen 1426 may have a wall thickness 1428 that is greater than a wall thickness 1430 of the remainder of the catheter 1462 taken perpendicular to the longitudinal central axis 1408. In additional examples, a portion of the elongated body 1402 includes a serpentine portion proximate to one or more electrodes 1414, as described and illustrated herein.

For the present example, a guidewire used with the catheter 1462 can be used to temporarily "straighten" the offset region 1464 when the guidewire is present in the guidewire lumen 1426 passing along the offset region 1464. Alternatively, a guidewire may be used to impart the shape of the offset region 1464 to the catheter 1462. In such an example, the elongate body 1402 of the catheter 1462 can have a straight shape (e.g., without a predetermined lateral shape). To impart the offset region 1464, the guidewire is "shaped" (e.g., flexed) into a desired configuration of the offset region at a point corresponding to a desired longitudinal position of the offset region on the elongate body 1402. The offset region 1464 of the catheter 1462 may be provided by inserting a guidewire having a predetermined lateral shape.

In fig. 14A, the catheter 1462 of the present example further includes a surface 1452 defining a deflection lumen 1454, as described herein. The catheter 1462 also includes an elongate deflecting member 1460, as also described herein. As generally shown, the elongate deflection member 1460 can be advanced through the deflection lumen 1454 such that the elongate deflection member 1460 extends laterally away from the one or more electrodes 1414 on the second portion 1472 of the elongate body 1402. The elongate deflection member 1460 may have a length and shape that allows the elongate deflection member 1460 to be extended a distance sufficient to bring the one or more electrodes 1414 into contact with a blood luminal surface (e.g., a posterior surface of one or both of the main pulmonary artery and/or pulmonary artery) with various pressures.

In one example, the elongate body 1461 of the elongate deflecting member 1460 can also include one or more strut wires 1481. The strut wires 1481 can be encased within the flexible polymer material of the elongate body 1461, wherein the strut wires 1481 can help provide column strength and a predetermined shape to the elongate deflecting member 1460. For example, the strut wires 1481 may have a coil shape that extends longitudinally along the length of the elongate body 1461. According to several examples, the coil shape advantageously allows a longitudinal force applied at or near the first end 1463 of the deflection member 1460 to be transmitted through the elongated body 1461 to laterally extend the second end 1465 of the deflection member 1460 from the second opening 1458 of the deflection lumen 1454.

The strut wires 1481 may also provide a predetermined shape to the deflecting member 1460 after extending laterally from the second opening 1458 of the deflecting lumen 1454. The predetermined shape may be determined to engage the luminal wall of the pulmonary artery so as to bring the electrodes 1414 on the second portion 1472 of the offset region 1464 into contact with the vascular tissue. The predetermined shape and strut wires 1481 may also help impart stiffness to the deflecting member 1460 sufficient to retain the electrodes 1414 against the luminal wall of the pulmonary artery in a condition located within the patient's vasculature.

The strut wires 1481 may be formed from a variety of different metals or metal alloys. Examples of such metals or metal alloys include surgical grade stainless steel, such as austenitic 316 stainless steel and nickel titanium alloys known as Nitinol (Nitinol), among others. Other metals and/or metal alloys may be used as needed and/or desired.

Referring now to fig. 14B, an additional example of a catheter 1462 is shown. The catheter 1462 may include features and components like those described above with respect to fig. 12A-12D and/or 14A, the discussion of which is not repeated, but rather the inclusion of element numbers in fig. 14B, it being understood that discussion of these elements is implicit.

The catheter 1462 shown in fig. 14B is similar to the catheter 1462 of fig. 14A, in that the elongate body 1402 of the catheter 1462 further includes three or more surfaces 1412 that define a convex polygonal cross-sectional shape taken perpendicular to the longitudinal central axis 1408, as described herein with respect to the catheter 1200. As shown, one or more electrodes 1414 are located on one of the three or more surfaces 1412 of the elongate body 1402. In this example, three or more surfaces 1412 of the elongated body 1402 help form the second portion 1472 of the elongated body 1402. If desired, the elongated body 1402 may include a serpentine portion proximate to one or more of the electrodes 1414.

Referring now to fig. 15A, an additional example of a catheter 1582 in accordance with the present disclosure is shown. The conduit 1582 may include features and components like those described above with respect to fig. 12A-12D, 14A, and/or 14B, the discussion of which is not repeated, but rather the inclusion of element numbers in fig. 15A, it being understood that discussion of these elements is implicit.

The catheter 1582 includes an elongate body 1502 having a peripheral surface 1536 and a central longitudinal axis 1508 extending between a first end 1504 and a second end 1506. The elongate body 1502 includes a surface 1552 that defines a deflection lumen 1554, wherein the deflection lumen 1554 includes a first opening 1554 and a second opening 1556 in the elongate body 1502. The catheter 1582 also includes an inflatable balloon 1534 on a peripheral surface 1536 of the elongate body 1502, the inflatable balloon 1534 having a balloon wall 1538, the balloon wall 1538 having an inner surface 1540, the inner surface 1540 defining a fluid-tight volume 1544 along with a portion 1542 of the peripheral surface 1536 of the elongate body 1502, e.g., as previously discussed herein. An inflation lumen 1546 extends through the elongate body 1502, wherein the inflation lumen 1546 has a first opening 1548 into a fluid-tight volume 1544 of the inflatable balloon 1534 and a second opening 1550 proximate the first opening 1548 to allow a fluid (e.g., a liquid or a gas) to move into and out of the fluid-tight volume 1544 to inflate and deflate the balloon 1534.

One or more electrodes 1514 are positioned on the elongate body 1502, with a second opening 1558 of the deflection lumen 1554 opposing the one or more electrodes 1514 on the elongate body 1502. The catheter 1582 also includes an elongate deflection member 1560, as described herein, wherein the elongate deflection member 1560 extends through a second opening 1558 of the deflection lumen 1554 in a direction opposite the one or more electrodes 1514 on the one surface of the elongate body 1502. The catheter 1582 also includes a conductive element 1516 extending through the elongate body 1502 and/or along the elongate body 1502, wherein the conductive element 1516 conducts electrical current to the combination of one or more electrodes 1514.

The catheter 1582 also includes a surface 1524 that defines a guidewire lumen 1526 that extends through the elongate body 1502 and/or along the elongate body 1502. As shown, the guidewire lumen 1526 is concentric with respect to the central longitudinal axis 1508. The guidewire lumen 1526 can also be eccentric relative to the longitudinal central axis 1508 of the elongate body 1508, as described herein. Examples are discussed herein in which the guidewire lumen 1526 may have a wall thickness taken perpendicular to the longitudinal central axis 1508 that is greater than a wall thickness taken perpendicular to the longitudinal central axis 1508 of the remainder of the catheter 1582. The catheter 1582 may also include a serpentine portion of the elongate body 1502 proximate to the one or more electrodes 1514.

Referring now to fig. 15B, an additional example of a conduit 1582 is shown. The conduit 1582 may include features and components like those described above with respect to fig. 12A-12D, 14A, 14B, and/or 15A, the discussion of which is not repeated, but rather the inclusion of element numbers in fig. 15B, it being understood that the discussion of these elements is implicit.

The catheter 1582 includes an elongate body 1502 having a peripheral surface 1536 and a central longitudinal axis 1508 extending between a first end 1504 and a second end 1506. The elongate body 1502 includes a surface 1552 that defines a deflection lumen 1554, wherein the deflection lumen 1554 includes a first opening 1554 and a second opening 1556 in the elongate body 1502. The catheter 1582 also includes an inflatable balloon 1534 on a peripheral surface 1536 of the elongate body 1502, the inflatable balloon 1534 having a balloon wall 1538, the balloon wall 1538 having an inner surface 1540, the inner surface 1540 defining a fluid-tight volume 1544 along with a portion 1542 of the peripheral surface 1536 of the elongate body 1502, as discussed herein. An inflation lumen 1546 extends through the elongate body 1502, wherein the inflation lumen 1546 has a first opening 1548 into a fluid-tight volume 1544 of the inflatable balloon 1534 and a second opening 1550 proximate the first opening 1548 to allow a fluid (e.g., a liquid or a gas) to move into and out of the fluid-tight volume 1544 to inflate and deflate the balloon 1534.

One or more electrodes 1514 are positioned on the elongate body 1502, with a second opening 1558 of the deflection lumen 1554 opposing the one or more electrodes 1514 on the elongate body 1502. As illustrated, the elongate body 1502 has three or more surfaces 1512 defining a convex polygonal cross-sectional shape taken perpendicular to the longitudinal central axis 1508. One or more electrodes 1514 are located on one of the three or more surfaces 1512 of the elongate body 1502, e.g., as previously described herein.

The catheter 1582 also includes an elongate deflection member 1560, wherein the elongate deflection member 1560 extends through a second opening 1558 of the deflection lumen 1554 in a direction opposite the one or more electrodes 1514 on the one surface of the elongate body 1502. The catheter 1582 also includes a conductive element 1516 extending through the elongate body 1502 and/or along the elongate body 1502, wherein the conductive element 1516 conducts electrical current to the combination of one or more electrodes 1514.

The catheter 1582 also includes a surface 1524 that defines a guidewire lumen 1526 that extends through the elongate body 1502 and/or along the elongate body 1502. As shown, the guidewire lumen 1526 is concentric with respect to the central longitudinal axis 1508. The guidewire lumen 1526 can also be eccentric relative to the longitudinal central axis 1502 of the elongate body 1508, as described herein. Examples are discussed herein in which the guidewire lumen 1526 may have a wall thickness taken perpendicular to the longitudinal central axis 1508 that is greater than a wall thickness taken perpendicular to the longitudinal central axis 1508 of the remainder of the catheter 1582. The catheter 1582 may also include a serpentine portion of the elongate body 1502 proximate to the one or more electrodes 1514.

Referring now to fig. 16, an additional example of a conduit 1684 is shown. The conduit 1684 can include features and components like those of the conduits described above with respect to fig. 12A-12D, 14A, 14B, 15A, and/or 15B, the discussion of which is not repeated, but rather the inclusion of element numbers in fig. 16, it being understood that discussion of such elements is implicit.

The conduit 1684 includes an elongated body 1602 having a peripheral surface 1636 and a central longitudinal axis 1608 extending between a first end 1604 and a second end 1606. The catheter 1684 also includes an inflatable balloon 1634 on the peripheral surface 1636 of the elongate body 1602, the inflatable balloon 1634 having a balloon wall 1638, the balloon wall 1638 having an inner surface 1640, the inner surface 1640, along with a portion 1642 of the peripheral surface 1636 of the elongate body 1602, defines a fluid-tight volume 1644, as discussed herein. An inflation lumen 1646 extends through the elongate body 1602, wherein the inflation lumen 1646 has a first opening 1648 into a fluid-tight volume 1644 of the inflatable balloon 1634 and a second opening 1650 proximate the first opening 1648 to allow fluid (e.g., liquid or gas) to move into and out of the fluid-tight volume 1644 to inflate and deflate the balloon 1634.

The catheter 1682 includes a surface 1624 that defines a guidewire lumen 1626 that extends through the elongate body 1602 and/or along the elongate body 1602. As shown, the guidewire lumen 1626 is concentric with respect to the central longitudinal axis 1608. The guidewire lumen 1626 may also be eccentric with respect to the longitudinal central axis 1608 of the elongate body 1608, as described herein. Examples are discussed herein in which the guidewire lumen 1626 may have a wall thickness taken perpendicular to the longitudinal central axis 1608 that is greater than a wall thickness taken perpendicular to the longitudinal central axis 1608 of the remainder of the catheter 1682. The conduit 1682 can also include a serpentine portion of the elongated body 1602 proximate to the one or more electrodes 1614.

The elongated body 1602 of the conduit 1684 also includes a surface 1686 that defines an electrode lumen 1688. The electrode cavity 1688 includes a first opening 1690 and a second opening 1692 in the elongated body 1602. The catheter 1684 also includes an elongated electrode member 1694, wherein the elongated electrode member 1694 retractably extends through the first opening 1690 of the electrode lumen 1688 of the elongated body 1602. The electrode cavity 1688 has a size (e.g., diameter) sufficient to allow the elongated electrode member 1694 to pass through the electrode cavity 1688 such that the elongated electrode member 1694 can retractably extend through the first opening 1690 of the electrode cavity 1688 of the elongated body 1602. The elongated electrode member 1694 can retractably extend through the first opening 1690 of the electrode lumen 1688 of the elongated body 1602 due to pressure (e.g., compressive force or tension) applied by a user (e.g., a clinician or professional) through the elongated electrode member 1694 proximate the second opening 1692 in the elongated body 1608. For various examples, the elongated electrode members 1694 are formed of a flexible polymer material. Examples of such flexible polymeric materials include, but are not limited to, those flexible materials described herein.

The elongated electrode member 1694 includes one or more electrodes 1696 and a conductive element 1698 extending through an electrode cavity 1688. As shown, one or more electrodes 1696 are located on one surface 1601 of the elongated electrode member 1694. The conductive element 1698 extends through the elongated electrode member 1694, where the conductive element 1698 can be used, for example, as described herein, to conduct electrical current to a combination of one or more electrodes 1696. Each of the one or more electrodes 1696 is coupled to a corresponding conductive element 1698.

The conductive elements 1698 may be electrically isolated from each other and extend from each respective electrode 1696 through the second end 1692 of the electrode cavity 1688 through the elongated electrode member 1694. The conductive elements 1698 terminate at connector ports, wherein each conductive element 1698 is releasably coupleable to a stimulation system, as described herein. It is also possible that the conductive element 1698 is permanently coupled (e.g., non-releasably coupled) to the stimulation system. The stimulation system may be used to conduct electrical currents or electrical pulses to the combination of one or more electrodes 1694 via the electrically conductive element 1698. The one or more electrodes 1696 are electrically isolated from each other, with the elongated electrode members 1694 being formed of an electrically insulating material.

The number and configuration of the one or more electrodes 1696 on the elongated electrode member 1694 can vary in different examples. For example, one or more electrodes 1696 may be configured as an electrode array, wherein the number of electrodes and their relative positions with respect to each other may vary depending on the desired implant location. As described herein, the one or more electrodes 1696 may be configured to allow current to be transferred from and/or between different combinations of the one or more electrodes 1696. Thus, for example, the electrodes in an electrode array may have a repeating pattern in which the electrodes are equally spaced from each other. Other patterns are also possible, wherein such patterns may be repeating patterns or random patterns.

As shown, one or more electrodes 1696 have an exposed surface 1603. Unlike facing the volume of blood in the artery, the exposed face 1603 of electrode 1696 provides electrode 1696 with an opportunity to be placed in proximity to and/or in contact with the patient's vascular tissue when implanted (temporarily or for an extended duration) in the patient. To do so, one or more electrodes 1696 may be located on only one side of the elongated electrode member 1694 (as shown in fig. 16). This allows one or more electrodes 1696 to be brought into contact with the blood luminal surface (e.g., the posterior surface of one or both of the main and/or pulmonary arteries). When one or more electrodes 1696 are located on only one side of the elongated electrode member 1694, the electrodes 1696 may be placed in direct proximity to and/or in contact with the tissue of any combination of the main, left and/or right pulmonary arteries.

The exposed surface 1603 of the one or more electrodes 1696 can have a variety of different shapes, as described herein (e.g., a partial loop configuration in which each of the one or more electrodes 1696 is positioned facing away from the elongate body 1602) the exposed surface 1603 of the electrode 1696 can also include one or more anchor structures. Examples of such anchor structures include hooks that may optionally include barbs.

As generally shown, the elongate electrode member 1694 can be advanced through the electrode cavity 1688 such that the elongate electrode member 1694 extends laterally away from the elongate body 1608. The elongate electrode member 1694 can have a length and shape that allows the elongate electrode member 1694 to be extended from the elongate body 1608 a distance sufficient to bring the one or more electrodes 1696 into contact with a blood luminal surface (e.g., a posterior surface of one or both of the main pulmonary artery and/or pulmonary artery).

As shown in fig. 16, the elongated electrode member 1694 forms a loop 1605 extending away from the peripheral surface 1636 of the elongated body 1602. The ring 1605 can have a variety of different configurations relative to the longitudinal axis 1608 of the elongate body 1602. For example, as shown in fig. 16, the elongate electrode member 1692 forming the loop 1605 lies in a plane 1602 that is collinear with the longitudinal central axis 1608 of the elongate body 1602.

The conduit 1684 also includes an elongated deflection member 1660, as previously described. Pressure is applied to the deflection member 1660 to move the first end 1663 of the deflection member 1660 toward the first opening 1656 of the deflection lumen 1654, as described herein. In addition to moving first end 1663 of deflecting member 1660 toward first opening 1656, pressure also extends second end 1665 of deflecting member 1660 from second opening 1658. As generally shown, the elongate deflection member 1660 can be advanced through the deflection lumen 1654 such that the elongate deflection member 1660 extends laterally away from the one or more electrodes 1696 on the elongate electrode member 1694. The elongate deflection member 1660 can have a length and shape that allows the elongate deflection member 1660 to be extended a distance sufficient to help contact the one or more electrodes 1696 with the blood luminal surface (e.g., the posterior surface of one or both of the main and/or pulmonary arteries) with various pressures. Optionally, the elongated deflection member 1660 may be configured to include one or more electrodes.

The conduit 1684 shown in fig. 16 can be positioned in one or both of the patient's main pulmonary artery and/or left and right pulmonary arteries, e.g., as described herein. To do so, a pulmonary artery catheter guide catheter is introduced into the vasculature through a percutaneous incision and directed into the right ventricle (e.g., using the swan-ganz catheterization method). For example, a pulmonary artery guide catheter may be inserted into the vasculature via a peripheral vein of the arm, neck, or chest (e.g., like a peripherally inserted central catheter). Changes in the patient's electrocardiogram and/or pressure signals from the vasculature may be used to guide and position the pulmonary artery guide catheter within the patient's heart. Once in place, a guidewire may be introduced into the patient via a pulmonary artery guide catheter, wherein the guidewire is advanced into one of the main pulmonary artery and/or pulmonary artery. Using the guidewire lumen 1626, the catheter 1684 can be advanced over the guidewire to position the catheter 1684 in one or both of the patient's main pulmonary artery and/or the left and right pulmonary arteries. Various imaging medical devices may be used to position the guidewire of the present disclosure in one of the main and/or left and right pulmonary arteries of a patient. Such imaging modalities include, but are not limited to, fluoroscopy, ultrasound, electromagnetic and potentiometric modalities.

Stimulation electrical energy (e.g., electrical current or electrical pulses) may be transmitted over a combination of one or more of the electrodes 1696 using a stimulation system (e.g., the stimulation system described herein). The patient's cardiac response to the stimulation electrical energy may be monitored and recorded for comparison with other subsequent tests. It will be appreciated that for any of the catheters described herein, any combination of electrodes, including reference electrodes positioned within or on the body of a patient (as described herein), may be used to provide stimulation to the patient and sense cardiac signals from the patient.

Referring now to fig. 17, an additional example of a conduit 1784 is shown. The catheter 1784 can include features and components like the catheter described above with respect to fig. 12A-12D, 14A, 14B, 15A, 15B, and/or 16, the discussion of which is not repeated, but rather the inclusion of element numbers in fig. 17, it being understood that discussion of such elements is implicit. The catheter 1784 shows an example in which the elongate electrode member 1794 forms a loop 1705 in a plane 1707 perpendicular to the longitudinal central axis of the elongate body. According to several examples, more than one elongate electrode member may be used with the catheter.

Referring now to fig. 18A-18C, perspective views of an exemplary catheter 1830 suitable for performing certain methods of the present disclosure are shown. The catheter 1830 includes an elongate catheter body 1832 having a proximal or first end 1834 and a distal or second end 1836. The elongate catheter body 1832 also includes an outer or peripheral surface 1838 and an inner surface 1840 defining a lumen 1842 (shown in phantom) extending between the first end 1834 and the second end 1836 of the elongate catheter body 1832.

The catheter 1830 also includes a plurality of electrodes 1844 positioned along the peripheral surface 1838 of the elongate catheter body 1832. In some examples, the electrode 1844 is proximate to the distal end 1836 of the catheter 1830. A conductive element 1846 extends through the elongate body 1832 and/or along the elongate body 1832, wherein the conductive element 1846 may be used to conduct electrical current to a combination of a plurality of electrodes 1844 as described herein. Each of the plurality of electrodes 1844 is coupled (e.g., electrically coupled) to a corresponding conductive element 1846. The conductive elements 1846 are electrically isolated from one another and extend from each respective electrode 1844 through the elongate body 1832 through the first end 1834 of the elongate body 1832. The conductive elements 1846 terminate at connector ports, wherein each conductive element 1846 is releasably coupleable to a stimulation system. It is also possible that the conductive element 1846 is permanently coupled (e.g., non-releasably coupled) to the stimulation system. As discussed more fully herein, the stimulation system may be used to provide stimulation electrical pulses that are conducted through the conductive element 1846 and delivered over a combination of the plurality of electrodes 1844. Other positions and configurations of the electrodes are also possible. PCT patent application nos. PCT/US2015/031960, PCT/US2015/047770, and PCT/US2015/047780 are incorporated herein by reference in their entirety, and more particularly, the electrodes (e.g., electrodes on a deployable wire) and electrode matrices disclosed therein are incorporated herein by reference.

The elongate body 1832 may comprise (e.g., be formed at least partially of) an electrically insulating material. Examples of such insulating materials may include, but are not limited to: medical grade polyurethanes, in particular, for example, polyester-based polyurethanes, polyether-based polyurethanes and carbonate-based polyurethanes; polyamides, polyamide block copolymers, polyolefins (e.g., polyethylene (e.g., high density polyethylene)); and a polyimide.

The catheter 1830 optionally includes an anchor 1848. The anchor 1848 includes a strut 1850 forming an open framework, wherein the strut 1850 extends laterally or radially outward from the elongate body 1832 (e.g., from a peripheral surface 1838 of the elongate body 1832) to at least partially define a peripheral surface 1852 configured to engage vascular tissue (e.g., configured to be positioned adjacent to an inner lumen forming a right and/or left pulmonary artery). Fig. 18A-18C illustrate an anchor 1848 positioned between the second end 1836 of the elongate catheter body 1832 and a plurality of electrodes 1844. It is also possible that the anchor 1848 may be positioned between the plurality of electrodes 1844 and the second end 1836 of the elongate catheter body 1832. In some examples, the anchor 1848 may inhibit or prevent at least a portion of the catheter 1830 (e.g., the portion 1854, including a portion of the electrode 1844) from extending into the vasculature less than the expanded strut 1850. For example, referring to fig. 19, a plurality of electrodes 1944 may be proximal to the branching point 1976 such that the portion of the catheter 1930 proximal to the anchor 1948 does not extend into the two additional arteries 1978. If sensor 1966 is distal to anchor 1948, the interaction of anchor 1948 and branch point 1976 may ensure that sensor 1966 is in pulmonary artery branch vessel 1978.

The struts 1850 can have a cross-sectional shape and size that allows the struts 1850 to provide a radial force sufficient to hold the catheter 1830 in an implanted position in a pulmonary artery under various conditions, as discussed herein. The struts 1850 can be formed from a variety of materials, for example, metals, metal alloys, polymers, and the like. Examples of such metals or metal alloys include medical grade stainless steels, such as, in particular, austenitic (austenitic)316 stainless steel, and the like; and nickel and titanium alloys known as Nitinol (Nitinol). Other materials and/or metal alloys may be used that are known or that may be developed.

The portion 1854 of the elongate catheter body 1832 (e.g., which may include one, some, none, or all of the plurality of electrodes 1844) may bend in a predetermined radial direction (e.g., anterior, posterior, inferior, superior, and combinations thereof), such as when under longitudinal compression. To provide bending in the portion 1854, the elongate catheter body 1832 may be pre-stressed and/or the wall may have a thickness that allows the elongate catheter body 1832 to bend in a predetermined radial direction, e.g., when under longitudinal compression. Additionally or alternatively, structures such as coils or helical wires having different numbers of turns per unit length, hypotubes with varying slot spacing (hypotubes), etc. may be located in, around, and/or along the elongate catheter body 1832 in the portion 1854. One or more of these structures may be used to allow longitudinal compression to produce a bend in the portion 1854 in a predetermined radial direction. To achieve longitudinal compression, the anchor 1848 may be deployed in the vasculature of a patient (e.g., in a pulmonary artery), wherein the anchor 1848 provides a location or point of resistance against longitudinal movement of the elongate body 1832. Thus, this allows for a compressive force to be generated in the elongate catheter body 1832 that is sufficient to bend a portion 1854 of the elongate catheter body 1832 (e.g., there are multiple electrodes 1844 along the portion 1854) in a predetermined radial direction.

Fig. 18D provides a view of a portion 1854 of the elongate catheter body 1832 that is bent in a predetermined radial direction when under longitudinal compression. The catheter 1830 shown in fig. 18D is similar to the catheter 1830 shown in fig. 18A and described herein, although other catheters having similar features may also be used. In the catheter 1830 shown in FIG. 18D, the sensor 1866 is proximal to the electrode 1844. When electrode 1844 is in right pulmonary artery 206, sensor 1866 may be, for example, in pulmonary artery trunk 202. If the sensor 1866 is more proximal, the sensor 1866 may be in the right ventricle, superior vena cava, etc. Positioning sensor 1866 proximally along catheter 1830 may allow sensor 1866 to be in a different location than the location of electrode 1844 without positioning sensor 1866 separately from positioning electrode 1844. As shown in fig. 18D, the catheter 1830 is positioned at least partially in the main pulmonary artery 202 of the patient's heart 200 with the anchor 1848 located in the lumen of the right pulmonary artery 206. From this position, the longitudinal compressive force applied to the elongate catheter body 1832 may cause the portion 1854 of the elongate catheter body 1832, along with at least some of the plurality of electrodes 1844 in this example, to bend in a predetermined radial direction, in this example upward. The curvature allows (e.g., causes) the plurality of electrodes 1844 to extend toward and/or contact the luminal surface of the main pulmonary artery 202 and/or the right pulmonary artery 206. Preferably, the plurality of electrodes 1844 are brought into position in and/or contact with the luminal surface of the main pulmonary artery 202 and/or the right pulmonary artery 206.

In some examples, the elongate catheter body 1832 of the catheter 1830 may use a lumen 1842 extending from the first end 1834 toward the second end 1836 to provide bending in a predetermined radial direction. For example, the catheter 1830 may include a forming wire 1857 having a first end 1859 and a second end 1861, as shown in fig. 18A. The shaping wire 1857 may flex and retain a desired shape that may at least partially provide the catheter 1830 with a bend once inserted into the lumen 1842. The lumen 1842 is sufficiently sized (e.g., diameter) to allow the forming wire 1857 to pass through the lumen 1842, wherein the second end 1861 of the forming wire 1857 is proximate to the second end 1836 of the elongate catheter body 1832, such that the buckling portion 1863 of the forming wire 1857 imparts a bend to the portion 1854 of the elongate catheter body 1832, allowing the plurality of electrodes 1844 to extend toward and/or contact a luminal surface of the main pulmonary artery. In some examples, forming wire 1857 may complement portion 1854. In some examples, the forming wire 1857 may be used in place of the portion 1854 (e.g., if the catheter 1830 does not include the portion 1854 or because no longitudinal compressive force is imparted). In some examples, the forming wire 1857 may be used to impart a bend that opposes the bend caused by the portion 1854 with the application of a compressive force. In some examples, the shaping wire 1857 may be inserted into the lumen 1842 in any rotational orientation so that a bend may be imparted in any desired radial direction, e.g., depending on the location of the anchor 1848. The shaping wire 1857 may allow the formation of a bend even if the catheter 1830 does not include the anchor 1848, for example, because the catheter body 1832 conforms to the shape of the shaping wire regardless of whether the catheter 1830 is anchored to the vasculature. In some examples, insertion of the shaping wire 1857 into the lumen 1842 imparts a bend to the portion 1854 such that at least one of the electrodes 1844 is positioned adjacent to the superior/posterior sidewall of the pulmonary artery.

In some examples, the neuromodulation system includes a catheter 1830 and a shaping wire 1857. The catheter 1830 includes a catheter body 1832, electrodes 1844, and sensors 1866. The catheter body 1832 includes a proximal end 1834, a distal end 1836, a lumen 1842 extending from the proximal end 1834 toward the distal end 1836 (e.g., at least at the distal end of the electrode 1844), and an outer surface 1838. Electrode 1844 is on outer surface 1838. The electrodes 1844 are configured to deliver electrical signals to a pulmonary artery of a patient (e.g., to provide calibration and/or therapeutic stimulation to nerves proximate the pulmonary artery).

The shaping wire 1857 comprises a material configured to flex the catheter body 1832. For example, the radial force of the shaping wire 1857 may be greater than the force that maintains the catheter body 1832 in a substantially straight configuration. In some examples, the shaping wire 1857 comprises a shape memory material (e.g., nitinol, chromium cobalt alloy, copper nickel tin alloy, etc.) or an elastic material (e.g., stainless steel, etc.). For example, the shaping wire 1857 may be stressed into a straight wire at the proximal portion of the catheter 1830, but in the portion of the catheter 1830 to be flexed, which may be weaker than the proximal portion of the catheter 1830, for example, the shaping wire 1857 may return to an unstressed, curved shape in the catheter 1830. In some examples where forming wire 1857 includes a shape memory material, forming wire 1857 may utilize thermal shape memory. For example, the forming wire 1857 may be in a generally straight shape until a cold or warm fluid (e.g., saline) causes the return to a curved shape. In some such examples, the entire catheter 1830 may be flexed by the shaping wire 1857, but once the shaping wire 1857 is at a desired longitudinal and/or radial position, a temperature change is incurred. In some examples, the entire catheter 1830 may be bent by the shaping wire 1857. For example, the bend may propagate along the length of the catheter 1830 until the bend is at a desired location.

The shaping wire 1857 has a diameter or cross-sectional dimension that is less than the diameter or cross-sectional dimension of the lumen 1842. For example, if the catheter body 1832 is 20 french (Fr) (about 6.67 millimeters (mm)), the lumen 1842 may be 18Fr (about 6mm) and the forming wire 1857 may be 16Fr (about 5.33 mm). The shaping wire 1857 may, for example, be less than 1Fr than the lumen 1842 (e.g., more radial force than with a small 2 Fr) or less than 2Fr than the lumen 1842 (e.g., less frictional force during navigation than with a small 1 Fr). The shaping wire 1857 may, for example, be 2Fr smaller than the catheter body 1832 (e.g., 1Fr if the lumen 1842 is smaller than the catheter body 1832) or 4Fr smaller than the catheter body 1832 (e.g., providing the size of the lumen 1842 with less flexibility than the catheter body 1 or 2 Fr). Forming wire sizes other than French catheter scale are also possible (e.g., having diameters less than the diameter of the lumen 1842 by about 0.05mm, 0.1mm, about 0.2mm, about 0.25mm, about 0.5mm, ranges between such values, etc.).

Sensor 1866 is on outer surface 1838. The sensors 1866 are configured to sense thermal activity characteristics (e.g., non-electrical cardiac activity characteristics, such as pressure characteristics, acceleration characteristics, acoustic characteristics, temperature, and blood chemistry characteristics) from locations in the patient's vasculature. This location may be different from the pulmonary artery in which the electrode 1844 is positioned. For example, if the electrode 1844 is in the right pulmonary artery, the location of the sensor 1866 may be in the pulmonary artery trunk, pulmonary artery branch vessels, right ventricle, ventricular septum wall, right atrium, right atrial septum wall, superior vena cava, inferior vena cava, left pulmonary artery, coronary sinus, or the like. The shaping wire 1857 is configured to be positioned within the lumen 1842 of the catheter body 1832. The forming wire includes a bight portion 1863. For example, from the proximal end 1859 to the distal end 1861, the forming wire 1857 may be substantially straight in a substantially straight portion and then have a buckled portion 1863 extending away from the longitudinal axis of the straight portion. The flexures 1863 may include one flexure or multiple flexures (e.g., two flexures (as shown in fig. 18A), three flexures, or more flexures). The shaping wire 1857 may optionally include another substantially straight portion after the bight portion, which may have a longitudinal axis substantially aligned with the longitudinal axis of the proximal straight portion. When the forming wire 1857 is inserted within the lumen 1842 of the catheter body 1832, the catheter body 1832 includes a curved portion 1854 that corresponds to the buckling portion 1863 of the forming wire 1857. For example, the catheter body 1832 or portion 1854 may comprise a material that is capable of buckling due to pressure or stress applied to the lumen 1842 or inner surface 1840 of the catheter body 1832. In some examples, insertion of the shaping wire 1857 into the lumen 1842 imparts a bend to the portion 1854 such that at least one of the electrodes 1844 is positioned adjacent to the superior/posterior sidewall of the pulmonary artery.

Fig. 18A-18C further illustrate an exemplary delivery catheter 1856 that may be used with the catheter 1830. The delivery catheter 1856 may be a swan-ganz pulmonary artery catheter, which, as is known, includes a surface 1858 defining an interior cavity 1860 sized sufficiently to receive, store and deploy the catheter 1830. As shown, the delivery catheter 1856 includes a reversibly inflatable balloon 1862 in fluid communication with a balloon inflation lumen that extends from a proximal or first end 1864 of the delivery catheter 1856 (e.g., where the inflation lumen may be to an inflation fluid source) to an interior volume of the reversibly inflatable balloon 1862.

The catheter 1830 also includes a first sensor 1866. As shown in fig. 18A-18C, the first sensor 1866 may be positioned at a plurality of different locations along the conduit 1830. In fig. 18A, a first sensor 1866 is positioned on the elongate catheter body 1832 distal to the anchor 1848. The sensor 1866 proximate the distal end 1836 of the catheter 1830 may also or alternatively be useful for guidance of the catheter 1830, for example, to determine anatomical position during floating of the balloon using, for example, a swan-ganz catheter. In fig. 18B, a first sensor 1866 is positioned on or between the struts 250 of the anchor. In fig. 18C, a first sensor 1866 is positioned proximal to anchor 1848 and plurality of electrodes 1844. In fig. 18D, first sensor 1866 is positioned proximally sufficiently to enable first sensor 1866 to be in a location other than the vasculature of electrode 1844. In some examples, the catheter 1830 includes a plurality of sensors 1866 at one location and/or other locations than that shown in fig. 18A-18C.

The catheter 1830 also includes a sensor conductor 1868. First sensor 1866 is coupled to sensor conductor 1868 and isolated from conductive element 1846 and electrode 1844. The coupling may be electrical, optical, pressure, etc. A sensor conductor 1868 extends from the first sensor 1866 through the elongated body 1832 through the first end 1834 of the elongated body 1832. Sensor conductors 1868 terminate at connector ports, which may be used, for example, to releasably couple first sensor 1866 to a stimulation system, as discussed herein.

The first sensor 1866 may be used to sense one or more activity characteristics (e.g., electrical and/or non-electrical cardiac activity characteristics). In some examples, the characteristic may be measured in response to one or more electrical pulses delivered using the plurality of electrodes 1844. Examples of non-electrical heart activity characteristics include, but are not limited to, one or more of pressure characteristics, acceleration characteristics, acoustic characteristics, temperature, and blood chemistry characteristics measured from within the vasculature of the heart. As understood, two or more of the non-electrical cardiac activity characteristics may be measured by using more than one sensor on the catheter 1830.

For use in detecting pressure characteristics, the first sensor 1866 may be a pressure sensing transducer, such as the pressure sensing transducer disclosed in U.S. patent No.5,564,434 (e.g., configured to detect blood pressure, atmospheric pressure, and/or blood temperature changes, and provide a regulated pressure and/or temperature related signal), which is incorporated by reference herein in its entirety. For use in detecting acceleration characteristics, the first sensor 1866 may be an acceleration sensor, such as the acceleration sensor disclosed in U.S. patent publication No.2004/0172079 to Chinchoy (e.g., configured to generate a signal proportional to acceleration of the myocardium or wall (e.g., coronary sinus wall, septal wall, or ventricular wall)), or the acceleration sensor disclosed in U.S. patent 7,092,759 to Nehls et al (e.g., configured to generate a signal proportional to acceleration, velocity, and/or displacement of the myocardium or wall (e.g., coronary sinus wall, septal wall, or ventricular wall)), each of which is incorporated herein by reference in its entirety. For use in detecting acoustic properties, the first sensor 1866 may be a piezoelectric transducer (e.g., a microphone) or a blood flow sensor, such as the sensor disclosed in U.S. patent No.6,754,532 (e.g., configured to measure the velocity of blood to estimate blood flow), which is incorporated by reference herein in its entirety. For use in detecting temperature, the first sensor 1866 may be a temperature sensor, such as the temperature sensor disclosed in U.S. patent No.5,336,244 (e.g., configured to detect changes in blood temperature and/or oxygen concentration indicative of mechanical pumping action of the heart) and/or the temperature sensor disclosed in U.S. patent publication No.2011/0160790 (e.g., configured to sense temperature and generate a temperature signal), each of which is incorporated herein by reference in its entirety. For use in detecting blood chemistry, the first sensor 1866 may be an oxygen sensor or a blood glucose sensor, such as the sensor disclosed in U.S. patent No.5,213,098 (e.g., configured to sense a blood oxygen saturation level that changes with myocardial oxygen intake) and/or the sensor disclosed in U.S. patent publication No.2011/0160790 (e.g., configured to measure oxygen and/or blood glucose concentrations in blood and/or generate oxygen and/or blood glucose signals), each of which is incorporated herein by reference in its entirety. Other types of sensors may also be used for the first sensor 1866, other sensors described herein, and so on.

The catheter 1830 shown in fig. 18A-18C may be positioned in the right, left, or pulmonary trunk of a patient, for example, as described herein. To do so, the delivery catheter 1856 with the catheter 1830 contained therein may be introduced into the vasculature through a percutaneous incision and directed to the right ventricle. For example, the delivery catheter 1856 can be inserted into the vasculature via a peripheral vein of the neck or chest (e.g., as with a swan-ganz catheter). Changes in the patient's electrocardiogram and/or pressure signals from the vasculature may be used to guide and position the pulmonary artery catheter in the patient's heart. Once in place, a guidewire may be introduced into the patient via a pulmonary artery guide catheter, wherein the guidewire is advanced into a desired pulmonary artery (e.g., the right pulmonary artery). The delivery catheter 1856 with the catheter 1830 received therein may be advanced over a guidewire to position the catheter 1830 in a desired pulmonary artery (e.g., the right or left pulmonary artery) of a patient, e.g., as described herein. Various imaging medical devices may be used to position the guidewire of the present disclosure in a pulmonary artery of a patient. Such imaging modalities include, but are not limited to, fluoroscopy, ultrasound, electromagnetic and potentiometric modalities.

When catheter 1830 is positioned in the right or left pulmonary artery and sensor 1866 is configured proximal to electrode 1844, the distance between electrode 1844 (e.g., from the most proximal electrode 1844) and sensor 1866 may be between about 1cm and about 5cm (e.g., about 1cm, about 2cm, about 3cm, about 4cm, about 5cm, ranges between these values, etc.), in which case sensor 1866 resides in the pulmonary artery stem, between about 8cm and about 2cm (e.g., about 8cm, about 9cm, about 10cm, about 11cm, about 12cm, about 13cm, about 14cm, about 16cm, about 18cm, about 20cm, ranges between these values, etc.), in which case sensor 1866 may reside in the right ventricle, between about 16cm and about 27cm (e.g., about 16cm, about 17cm, about, About 18cm, about 19cm, about 20cm, about 21cm, about 22cm, about 23cm, about 25cm, about 27cm, ranges between these values, etc.), in which case the sensor 1866 resides in the right atrium, or between about 21cm and about 33cm (e.g., about 21cm, about 23cm, about 25cm, about 26cm, about 27cm, about 28cm, about 29cm, about 30cm, about 31cm, about 32cm, about 33cm, ranges between these values, etc.), in which case the sensor 1866 may reside in the superior vena cava.

When the catheter 1830 is positioned in the pulmonary artery trunk and the sensor 1866 is configured distal to the electrode 1844, the distance between the electrode 1844 (e.g., from the most distal electrode 1844) and the sensor 1866 can be between about 1cm and about 5cm (e.g., about 1cm, about 2cm, about 3cm, about 4cm, about 5cm, ranges between these values, etc.), in which case the sensor 1866 can reside in the right or left pulmonary artery. When catheter 1830 is positioned in the pulmonary artery trunk and sensor 1866 is configured proximal to electrode 1844, the distance between electrode 1844 (e.g., electrode 1844 from the most proximal end) and sensor 1866 may be between about 3cm and about 19cm (e.g., about 3cm, about 5cm, about 6cm, about 7cm, about 8cm, about 9cm, about 10cm, about 12cm, about 15cm, about 19cm, ranges between these values, etc.), in which case sensor 1866 may reside in the right ventricle, between about 11cm and about 26cm (e.g., about 11cm, about 13cm, about 15cm, about 16cm, about 17cm, about 18cm, about 19cm, about 20cm, about 22cm, about 24cm, about 26cm, ranges between these values, etc.), in which case sensor 1866 may reside in the right atrium, or between about 16cm and about 32cm (e.g., about 16cm, about 18cm, about 20cm, about 22cm, about 24cm, about 25cm, about 26cm, about 27cm, about 28cm, about 30cm, about 32cm, ranges between these values, etc.), in which case the sensor 1866 may reside in the superior vena cava.

Fig. 19 provides a perspective view of a catheter 1930 positioned in a heart 200 of a subject (e.g., patient), where one or more of the plurality of electrodes 1944 contact the posterior 221 and/or upper surface 223 of the right pulmonary artery 206 (e.g., at a location above the branching point 207). Fig. 19 also shows an example where the first sensor 1966 is positioned at the distal end of the anchor 1948. As shown, the pulmonary trunk 202 has a diameter 1970 taken on a plane 1972, the plane 1972 being substantially perpendicular to the left lateral plane 220 and the right lateral plane 216. In a preferred example, the plurality of electrodes 1944 of the catheter 1930 are positioned in a region 1974, which region 1974 extends distally no more than about three times the diameter 1970 of the pulmonary trunk 202 to the right of the branching point 207. This region 1974 is shown in fig. 19 with cross-sectional hatching.

The right pulmonary artery 206 may also include a branch point 1976, the branch point 1976 dividing the right pulmonary artery 206 into at least two additional arteries 1978, the additional arteries 1978 being distal to the branch point 207 defining the left and right pulmonary arteries 208, 206. As shown in fig. 19, a plurality of electrodes 1944 may be positioned between the branch point 207 defining the left and right pulmonary arteries 208, 206 and a branch point 1976 that divides the right pulmonary artery 206 into at least two additional arteries 1978. In other words, the plurality of electrodes 1944 of the catheter 1930 may be positioned to contact the posterior 221 and/or the superior surface 223 of the right pulmonary artery 206 until a branch point 1976 is included.

Once positioned in the pulmonary arteries of the patient's heart (e.g., the right pulmonary artery 206, the left pulmonary artery 208, and/or the pulmonary trunk 202 as shown in fig. 19), one or more therapeutic and/or calibration electrical pulses can be delivered through the plurality of electrodes 1944 of the catheter 1930. One or more heart activity characteristics responsive to one or more electrical pulses are sensed from at least a first sensor 1966 positioned at a first location in the vasculature of the heart 200.

The catheter 1830,1930 may be capable of being permanently or reversibly implanted into the vasculature. For example, the catheter 1830,1930 can be retracted from the vasculature after a duration (e.g., after removal of the anchor 1848,1948). The duration may be determined based at least in part on a set duration, e.g., a certain number of hours or days (e.g., 12 hours, 18 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, 6 days, etc.). The duration may be determined based at least in part on the patient's response (e.g., to retract when the patient has increased in some way by some amount or is deemed ready to have catheter 1830,1930 removed).

Fig. 20 shows an exemplary catheter 2030 and a separate first sensor 2066 useful in the methods of the present disclosure. Similar to the catheter 1830, the catheter 2030 includes an elongate catheter body 2032, the elongate catheter body 2032 having a proximal or first end 2034 and a distal or second end 2036, an outer peripheral surface 2038 and an inner surface 2040 defining an inner cavity 2042 (shown in phantom), the inner cavity 2042 extending between the first end 2034 and the second end 2036 of the elongate catheter body 2032. The catheter 2030 further includes a plurality of electrodes 2044 positioned along the peripheral surface 2038 of the elongate catheter body 2032, and a conductive element 2046 extending through the elongate body 2032 between the plurality of electrodes 2044 and the first end 2034, as discussed herein. The catheter 2030 further includes an anchor 2048, the anchor 2048 including struts 2050, the struts 2050 providing a peripheral surface 2052 configured to engage vascular tissue (e.g., the right pulmonary artery or the lumen of a pulmonary artery).

The catheter 2030 further includes a portion 2054, such as an elongate catheter body 2032 including a plurality of electrodes 2044, wherein the portion 2054 is capable of bending in a predetermined radial direction when under longitudinal compression, as discussed herein. The elongate catheter body 2032 of the catheter 2030 may also or alternatively include an inner lumen 2042 that may receive a shaping wire, as discussed herein.

However, in contrast to the catheters shown in fig. 18A to 18D, the catheter 2030 does not include the first sensor. Rather, the second conduit 2080 includes a first sensor 2066. As shown in fig. 20, the second conduit 2080 includes an elongate conduit body 2082, the elongate conduit body 2082 having a first end 2084 and a second end 2086, a peripheral surface 2088, and an inner surface 2090 defining a lumen 2092 (shown in phantom) extending between the first end 2084 and the second end 2086 of the elongate conduit body 2082, wherein the lumen 2092 can receive a guidewire to assist in positioning the second conduit 2080 in the vasculature of the heart. The second catheter 2080 also includes a first sensor 2066 (as discussed herein) on the elongate catheter body 2082 and a sensor conductor 2068 that extends through the elongate catheter body 2082 to terminate at a connector port that may be used, for example, to releasably couple the first sensor 2066 to a stimulation system, as discussed herein.

Because the first sensor 2066 is included on the second catheter 2080, the first sensor 2066 can be positioned in a different location in the patient's vasculature than the first location where the catheter 2030 is positioned. For example, the catheter 2030 may be positioned with the plurality of electrodes 2044 positioned in the right pulmonary artery, as discussed herein, and the first sensor 2066 positioned in the left pulmonary artery. In this way, one or more electrical pulses may be delivered through the catheter 2030 positioned in the right artery of the heart without the first sensor 2066. In some examples, the first sensor 2066 may be positioned in the right pulmonary artery when the catheter 2030 is positioned with the plurality of electrodes 2044 positioned in the left pulmonary artery. In this way, one or more electrical pulses may be delivered through the catheter 2030 positioned in the left pulmonary artery of the heart without the first sensor 2066.

In some examples, the catheter 2030 may be positioned with the plurality of electrodes 2044 positioned in either the left or right pulmonary artery, and the first sensor 2066 on the second catheter 2080 may be positioned in the right ventricle of the heart. The first sensor 2066 on the second catheter 2080 may also be positioned in the right atrium of the heart.

In some examples, the first sensor 2066 on the second catheter 2080 may also be positioned on the septal wall of the right atrium or the ventricular septal wall of the heart. The elongate catheter body 2082 of the second catheter 2080 can include active fixation structures (e.g., helical screws) that help secure the elongate catheter body 2082 and the first sensor 2066 to the septal wall of the right atrium of the heart.

In some examples, the first sensor 2066 on the second catheter 2080 may be positioned in the superior vena cava of the heart. In some examples, the first sensor 2066 on the second catheter 2080 may be positioned in the inferior vena cava of the heart. In some examples, the first sensor 2066 on the second catheter 2080 may be positioned in the coronary sinus of the heart. In a preferred example, the first sensor 2066 is used to sense at least one of temperature and blood oxygen level when the first sensor 2066 is positioned in the coronary sinus of the heart.

One or more cardiac properties may also or alternatively be sensed from a skin surface of the patient. Examples of such cardiac properties include electrocardiogram properties, in which the electrical activity of the heart can be sensed using known electrodes attached to the surface of the patient's skin. Another example of such cardiac characteristics may include a doppler echocardiogram, which may be used to determine the velocity and direction of blood flow. Acoustic signals sensed from the surface of the patient's skin may also be used as cardiac characteristics. As discussed herein, the characteristics of one or more electrical pulses delivered through a catheter positioned in a pulmonary artery of the heart may then be adjusted in response to one or more characteristics of heart activity measured intravascularly and/or one or more characteristics of the heart from a surface of the patient's skin.

In some examples, one or more heart activity characteristics may be sensed using a second sensor located at a second location in the vasculature of the heart, e.g., in response to one or more electrical pulses, in addition to the first sensor. The second position is different from the first position. For example, the first location may be the left pulmonary artery and the second location may be the right pulmonary artery; the first location may be the left pulmonary artery and the second location may be the pulmonary trunk; the first location may be the left pulmonary artery and the second location may be the right ventricle; the first location may be the left pulmonary artery and the second location may be the right atrium; the first location may be the left pulmonary artery and the second location may be the septal wall of the right atrium; the first location may be the left pulmonary artery and the second location may be a ventricular septum wall; the first location may be the left pulmonary artery and the second location may be the superior vena cava; the first location may be the left pulmonary artery and the second location may be the inferior vena cava; the first location may be the left pulmonary artery and the second location may be the coronary sinus; and other permutations of these positions.

In some examples, the second sensor is the sensor 2066 of the second conduit 2080 and the first sensor is the sensor 266 of the conduit 230. In some examples, the first sensor and the second sensor may be located on the same conduit (e.g., conduit 230, conduit 2080). For example, both the first sensor and the second sensor may be located on the second conduit 2080 for sensing at least two different cardiac activity characteristics. For another example, both the first sensor and the second sensor may be located on catheter 230 for sensing at least two different cardiac activity characteristics. As discussed herein, characteristics of one or more electrical pulses delivered through a catheter positioned in a pulmonary artery of a heart may be adjusted in response to one or more heart activity characteristics received from a first sensor and a second sensor.

Neuromodulation of a heart according to the present disclosure may be achieved by applying electrical pulses in and/or around a region of a pulmonary artery. For example, neuromodulation of the present disclosure may apply electrical pulses to the posterior, superior, and/or inferior walls of the right pulmonary artery. Preferably, neuromodulation of the present disclosure includes applying electrical pulses to the posterior and/or superior wall of the right pulmonary artery, but other locations in the right, left and pulmonary trunk are possible. Thus, an electrical pulse is applied to the autonomic cardiopulmonary nerves around the right pulmonary artery. These autonomic cardiopulmonary nerves may include the right and left autonomic cardiopulmonary nerves. The right autonomic cardiopulmonary nerve comprises the right dorsal medial and dorsal lateral cardiopulmonary nerves. The left autonomic cardiopulmonary nerves include the left ventral, left dorsal medial, left dorsal lateral, and left stellate cardiorespiratory nerves. Stimulation of other nerves close to the right pulmonary artery is also possible.

Referring to fig. 19, one or more of the plurality of electrodes 1944 of the catheter 1930 may contact the posterior surface 221 of the right pulmonary artery 206. From this location, the electrical pulses delivered by one or more of the plurality of electrodes 1944 may be better able to treat and/or provide treatment (including adjuvant treatment) to a patient experiencing various cardiovascular medical conditions (e.g., acute heart failure). The electrical impulses may elicit responses from the autonomic nervous system, which may help regulate the patient's cardiac contractility and/or relaxation. The electrical impulses applied by the methods described herein preferably affect cardiac contractility and/or relaxation beyond heart rate, which may improve hemodynamic control and/or reduce or minimize unwanted systemic effects when possible.

According to several examples, the stimulation system is electrically coupled (e.g., via a conductive element extending through the catheter) to a plurality of electrodes of the catheter described herein. The stimulation system may be used to deliver stimulation energy (e.g., electrical current or electrical pulses) to the autonomous cardiopulmonary fibers surrounding the pulmonary arteries (e.g., the right or left pulmonary artery, or the main pulmonary artery or trunk). The stimulation system is used to operate and provide stimulation energy (e.g., electrical current or electrical pulses) to a plurality of electrodes of the catheter. The stimulation system controls various characteristics of the stimulation energy (e.g., electrical current or electrical pulses) delivered on the plurality of electrodes. Such characteristics include polarity (e.g., functioning as a cathode or anode), pulse pattern (e.g., unipolar, bipolar, biphasic, and/or multipolar), pulse width, amplitude, frequency, phase, voltage, current, duration, inter-pulse spacing, dwell time, sequence, wavelength, and/or waveform control associated with the stimulation energy (e.g., current or electrical pulse). The stimulation system may operate and provide stimulation energy (e.g., electrical current or electrical pulses) to different combinations and numbers of one or more electrodes, including one or more reference electrodes. The stimulation system may be external to the patient's body or internal to the patient's body. When located outside the body, a professional can program the stimulation system and monitor its performance. When located within the patient, the housing of the stimulation system or electrodes included in the housing may serve as reference electrodes for sensing and monopolar pulse patterns.

Examples of non-electrical cardiac activity characteristics include, but are not limited to, pressure characteristics, acceleration characteristics, acoustic characteristics, temperature, or blood chemistry characteristics. The non-electrical heart activity characteristic may be sensed by at least a first sensor positioned at a first location in a vasculature of the heart. In response to the one or more non-electrical heart activity characteristics, characteristics of one or more electrical pulses delivered through a catheter positioned in a pulmonary artery of the heart may be adjusted. Examples of such adjustments include, but are not limited to, changing which electrode or electrodes of the plurality of electrodes on the catheter are used to deliver the one or more electrical pulses adjustments may also be made to the characteristics of the electrical pulses, such as by changing at least one of the electrode polarity, pulse pattern, pulse width, amplitude, frequency, phase, voltage, current, duration, inter-pulse interval, duty cycle, dwell time, sequence, wavelength, waveform, and/or electrode combination of the one or more electrical pulses. It is also possible to adjust the combination of electrodes used and the characteristics of the electrical pulses provided by the electrodes. Adjusting the characteristics of the one or more electrical pulses may include moving the catheter to reposition the electrodes of the catheter in the pulmonary artery of the heart. Combinations of these adjustments are also possible.

By way of example, the stimulation energy (e.g., current or electrical pulse) can have a voltage between about 0.1 millivolts (mV) and about 75 volts (V) (e.g., about 0.1mV, about 0.5mV, about 1mV, about 10mV, about 100mV, or about 0.1V, about 1V, about 10V, about 20V, about 30V, about 40V, about 50V, about 60V, about 75V, between 1V and 50V, between 0.1V and 10V, ranges between these values, etc.). The stimulation energy (e.g., electrical current or electrical pulse) can also have an amplitude between about 1 milliamp (mA) to about 40mA (e.g., about 1mA, about 2mA, about 3mA, about 4mA, about 5mA, about 10mA, about 15mA, about 20mA, about 25mA, about 30mA, about 35mA, about 40mA, ranges between these values, etc.). Stimulation energy (e.g., electrical current or pulses) may be delivered at a frequency between 1 hertz (Hz) and about 100000Hz or 100 kilohertz (kHz) (e.g., between 1Hz and 10kHz, between 2Hz and 200Hz, about 1Hz, about 2Hz, about 10Hz, about 25Hz, about 50Hz, about 75Hz, about 100Hz, about 150Hz, about 200Hz, about 250Hz, about 500Hz, about 1000Hz or 1kHz, about 10kHz, ranges between these values, etc.). The electrical pulses may have a pulse width between about 100 microseconds (μ s) and about 100 milliseconds (ms) (e.g., about 100 μ s, about 200 μ s, about 500 μ s, about 1000 μ s or 1ms, about 10ms, about 50ms, about 100ms, ranges between these values, etc.). For variations in duty cycle or duration of delivery of the electrical pulse relative to duration of non-delivery of the electrical pulse, the electrical pulse may be delivered for a time between about 250ms and about 1 second (e.g., about 250ms, about 300ms, about 350ms, about 400ms, about 450ms, about 500ms, about 550ms, about 600ms, about 650ms, about 700ms, about 750ms, about 800ms, about 850ms, about 900ms, about 950ms, ranges between these values, etc.) and not delivered thereafter for a time between about 1 second and about 10 minutes (e.g., about 1 second, about 5 seconds, about 10 seconds, about 15 seconds, about 30 seconds, about 45 seconds, about 1 minute, about 2 minutes, about 3 minutes, about 5 minutes, about 10 minutes, ranges between these values, etc.). The optimized duty cycle may, for example, reduce response time, increase battery life, patient comfort (reduce pain, cough, etc.), and the like. Stimulation energy (e.g., electrical current or electrical pulses) may also have various waveforms, such as: square waves, biphasic square waves, sinusoidal waves, electrically safe, effective, feasible, arbitrarily defined waveforms, and combinations thereof. Stimulation energy (e.g., electrical current or electrical pulses) may be applied to the plurality of target sites via the plurality of electrodes at least partially simultaneously and/or sequentially.

In some examples, the waveform of the stimulation signal is a charge balanced constant current cathode first biphasic waveform with a low impedance closed switch second phase electrode discharge. The burst characteristics may include, for example, a pulse amplitude between about 8mA and about 20mA, a pulse width between about 2ms and about 8ms, and a pulse frequency of about 20 Hz. The pulse amplitude and/or pulse width may be lower according to certain electrode designs.

The method of the present disclosure may include assigning a hierarchy of electrode configurations from which to transmit one or more electrical pulses. The hierarchy may include two or more predetermined patterns (patterns) and/or combinations of a plurality of electrodes for delivering one or more electrical pulses. For example, one or more electrical pulses may be transmitted using a hierarchy of electrode configurations. The characteristics of cardiac activity sensed in response to one or more electrical pulses delivered using the hierarchy of electrode configurations may be analyzed. Such analysis may include, for example, determining which level of the electrode configuration provides the most contractility or relative contractility of the patient's heart. Based on the analysis, an electrode configuration may be selected for delivering one or more electrical pulses through a catheter positioned in a pulmonary artery of a heart of the patient.

In some examples, a method may include assigning a tier level to one or more characteristics of one or more electrical pulses delivered through a catheter positioned in a pulmonary artery of a heart. The hierarchy may include the order and how much to change which characteristics (e.g., electrode polarity, pulse pattern, pulse width, amplitude, frequency, phase, voltage, current, duration, inter-pulse intervals, duty cycle, dwell time, order, wavelength, or waveform of one or more electrical pulses) are provided, as well as a predetermined number of electrical pulses for delivery to the patient's heart. The predetermined number of electrical pulses may be, for example, 10 to 100 electrical pulses at a given characteristic of the hierarchy. For a given characteristic of one or more electrical pulses, one or more cardiac activity characteristics may be recorded for a predetermined number of the one or more electrical pulses delivered to the patient's heart. The sensed cardiac activity characteristics in response to the one or more electrical pulses may then be analyzed. For example, the characteristics recorded for each group for a predetermined number of pulses may be analyzed against the characteristics recorded for other groups and/or against predetermined criteria for a given heart activity characteristic and/or heart characteristic (e.g., contractility and/or relaxation). Based on the analysis, an electrode configuration may be selected for delivering one or more electrical pulses through a catheter positioned in a pulmonary artery of a heart of the patient. As a non-limiting example, a current of 1mA may be applied to the electrodes for 50 electrical pulses, followed by a current of 10mA applied to the electrodes for 50 electrical pulses. The responses of 1mA and 10mA can be compared. If 10mA works better, 20mA current can be applied to the electrodes for 50 electrical pulses, and the responses of 10mA and 20mA can be compared. If 10mA works better, 10mA can be selected as the current for the present invention. A wide variety of selection processes may be used, including but not limited to iterative methods (e.g., including making comparisons until a limit is found at which the difference is negligible) and brute force methods (e.g., measuring responses and selecting a magnitude after all responses are completed or until a certain value is obtained). This may be repeated according to hierarchy (e.g., current followed by frequency) for one or more additional characteristics. The selection process may be the same or different for each member of the hierarchy.

In some examples, a first electrical signal of the series of electrical signals is transmitted (e.g., via a stimulation system such as stimulation system 2101) to an electrode in a pulmonary artery (e.g., right pulmonary artery, left pulmonary artery, pulmonary artery trunk). After the first electrical signal is delivered, a second electrical signal of the series of electrical signals is delivered (e.g., via a stimulation system) to the electrodes. The second electrical signal differs from the first electrical signal by a magnitude of a first parameter of the plurality of parameters. For example, if the first parameter is current, the first electrical signal may have a voltage such as 1mA, the second electrical signal may have a different voltage such as 2mA, and each of the other parameters (e.g., polarity, pulse width, amplitude, frequency, voltage, duration, inter-pulse spacing, dwell time, sequence, wavelength, waveform, and/or electrode combination) are the same.

Sensor data indicative of one or more non-electrical cardiac activity characteristics may be determined in response to transmitting a series of electrical signals (e.g., via sensors in the vasculature (e.g., as part of the same catheter including the electrodes, as part of a different catheter), via sensors on the surface of the skin, combinations thereof, etc.). The electrical parameters for therapy adjustment may be selected based at least in part on the sensor data. For example, the selected electrical parameter may comprise a selected magnitude of the first parameter. The therapeutic neuromodulation signal may be delivered to the pulmonary artery using the selected electrical parameter. Treating the neuromodulation signal may increase cardiac contractility and/or relaxation (e.g., beyond heart rate).

In some examples, the first series of electrical signals are transmitted (e.g., via a stimulation system such as stimulation system 501) to electrodes in pulmonary arteries (e.g., right pulmonary artery, left pulmonary artery, pulmonary trunk). The first series includes a plurality of first electrical signals. Each of the plurality of first electrical signals includes a plurality of parameters (e.g., polarity, pulse pattern, pulse width, amplitude, frequency, phase, voltage, current, duration, inter-pulse intervals, duty cycle, dwell time, sequence, wavelength, waveform, electrode combination, subsets thereof, etc.). Each of the first plurality of electrical signals of the first series differs from each other only in a magnitude of a first parameter of the plurality of parameters (e.g., one of a polarity, a pulse pattern, a pulse width, an amplitude, a frequency, a phase, a voltage, a current, a duration, an inter-pulse interval, a duty cycle, a dwell time, a sequence, a wavelength, a waveform variation of each of the first plurality of electrical signals). For example, if the first parameter is current, the first plurality of electrical signals of the first series may differ by having different currents (e.g., 1mA, 2mA, 3mA, 4mA, etc.), while each of the other parameters (e.g., polarity, pulse pattern, pulse width, amplitude, frequency, phase, voltage, duration, inter-pulse spacing, duty cycle, dwell time, sequence, wavelength, waveform) are the same.

After the first series of electrical signals is delivered to the electrodes, a second series of electrical signals may be delivered (e.g., via a stimulation system) to the electrodes. The second series includes a second plurality of electrical signals. Each of the second plurality of electrical signals includes a plurality of parameters. Each of the second plurality of electrical signals of the second series differs from each other only in a magnitude of a second parameter of the plurality of parameters that is different from the first parameter (e.g., a different one of a polarity, a pulse pattern, a pulse width, an amplitude, a frequency, a phase, a voltage, a current, a duration, an inter-pulse interval, a duty cycle, a dwell time, a sequence, a wavelength, a waveform variation for each of the second plurality of electrical signals). For example, if the first parameter is current, the second parameter may relate to timing such as frequency or duty cycle. For example, in the case of frequency, the second plurality of electrical signals of the second series may differ by having different frequencies (e.g., 1Hz, 2Hz, 3Hz, 4Hz, etc.), while each of the other parameters (e.g., current, polarity, pulse pattern, pulse width, amplitude, phase, voltage, duration, inter-pulse interval, duty cycle, dwell time, sequence, wavelength, and waveform) are the same.

Sensor data indicative of one or more non-electrical cardiac activity characteristics may be determined (e.g., via a sensor in the vasculature (e.g., as part of the same catheter including the electrodes, as part of a different catheter), via a sensor on the skin surface, combinations thereof, etc.) in response to transmitting the first series of electrical signals and the second series of electrical signals. The electrical parameters for therapy adjustment may be selected based at least in part on the sensor data. For example, the selected electrical parameter may include a selected magnitude of the first parameter and a selected magnitude of the second parameter. The therapeutic neuromodulation signal may be delivered to the pulmonary artery using the selected electrical parameter. Treating the neuromodulation signal may increase cardiac contractility and/or relaxation (e.g., beyond heart rate).

Other series of electrical signals may be transmitted to the electrodes, for example differing from each other only in the magnitude of a different parameter of the plurality of parameters than the first parameter and the second parameter. As many parameters as may be desired to have a selected value may be calibrated or optimized. The order of the parameters may be based on the hierarchy (e.g., first selecting current, then frequency, etc.).

The calibration or optimization process may be performed once (e.g., when the conduit 1830,1930 is initially positioned) or multiple times. For example, the process may be repeated periodically or after a duration of time (e.g., once every hour, every 2 hours, every 4 hours, every 6 hours, every 8 hours, every 12 hours, every 18 hours, every 24 hours, every 36 hours, every 2 days, every 60 hours, every 3 hours, etc.). In some implementations, the process may repeat when a change is detected (e.g., by the sensor 266,366,466). For example, if the heart activity characteristic changes by more than a certain percentage of a certain duration (e.g., + -10%, + -25%, + -50% in ≦ 1 minute, ≦ 2 minutes, ≦ 5 minutes, etc.), this may indicate that the catheter and/or sensor changed position or that something else in the system or patient may have changed (e.g., patient symptoms, physiological conditions, other treatment regimens, etc.).

For example, fig. 21 shows an example of a stimulation system 2101. U.S. provisional patent application No.62/001,729, filed 5-22/2014, is incorporated herein by reference in its entirety, and more specifically, the stimulation system 11600 disclosed in page 11 and page 41, line 5 to page 42, line 19 is incorporated herein by reference. As shown in fig. 21, stimulation system 1201 includes an input/output connector 2103 that may releasably engage a conductive element of a catheter, a conductive element of a second catheter, and/or a sensor for sensing one or more cardiac characteristics from a skin surface of a patient, as discussed herein. The input from the sensor may also be releasably coupled to the input/output connector 11602 in order to receive the sensor signals discussed herein. The conductive element and/or the sensor may be permanently coupled (e.g., non-releasably coupled) to the stimulation system.

The input/output connector 2103 is connected to an analog-to-digital converter 2105. The output of the analog-to-digital converter 2105 is connected to a microprocessor 2107 through a peripheral bus 2109 comprising, for example, address, data and control lines. The microprocessor 2107 can process the sensor data (when present) in different ways depending on the type of sensor used. The microprocessor 2107 may also control (as discussed herein) a pulse control output generator 2111 that transmits stimulation electrical energy (e.g., electrical pulses) to one or more electrodes via the input/output connector 2103 and/or housing 2123.

Parameters of the stimulation electrical energy (e.g., characteristics of the electrical pulses) may be controlled and adjusted as needed by instructions programmed into the memory 2113 and executed by the programmable pulse generator 2115. Memory 2113 may include a non-transitory computer-readable medium. The memory 2113 may include one or more storage devices, any storage location capable of storing data and allowing direct access by the microprocessor 2107, e.g., Random Access Memory (RAM), flash memory (e.g., non-volatile flash memory), etc. The stimulation system 2101 may include storage devices, such as one or more hard disk drives or a Redundant Array of Independent Disks (RAID), for storing an operating system and other related software, and for storing application software programs, which may be the memory 2113 or a different memory. Instructions for the programmable pulse generator 2115 in memory 2113 may be set and/or modified via the microprocessor 2107 based on input from the sensors and analysis of one or more heart activity characteristics. The instructions in memory 2113 for the programmable pulse generator 2115 may also be set and/or modified by input from a practitioner via input device 2117 connected through peripheral bus 2109. Examples of such input devices include a keyboard and/or mouse (e.g., in conjunction with a display screen), a touch screen, and so forth. A wide variety of different input/output (I/O) devices may be used with the stimulation system 2101. Input devices include, for example, keyboards, mice, touch pads, trackballs, microphones, and tablets. Output devices include, for example, video displays, speakers, and printers. The I/O devices may be controlled by an I/O controller. The I/O devices may be controlled by an I/O controller. An I/O controller may control one or more I/O devices. The I/O device may provide a storage and/or mounting medium for the stimulation system 2101. The stimulation system 2101 may provide a USB connection to receive a handheld USB storage device. The stimulation system 2101 optionally includes a communication port 2119 connected to a peripheral bus 2109 where data and/or programming instructions may be received by the microprocessor 2107 and/or memory 2113.

Input from input devices 2117 (e.g., from a professional), communication port 2119, and/or from one or more heart activity characteristics via microprocessor 2107 may be used to change (e.g., adjust) a parameter of the stimulation electrical energy (e.g., a characteristic of the electrical pulse). Stimulation system 2101 optionally includes a power source 2121. The power supply 2121 may be a battery or a power supply that is powered by an external power source (e.g., an AC/DC power converter coupled to an AC source). Stimulation system 2101 optionally includes housing 2123.

The microprocessor 2107 can execute one or more algorithms to provide the stimulus. The microprocessor 2107 can also be controlled by a practitioner via the input device 2117 to initiate, terminate, and/or alter (e.g., adjust) the characteristics of the electrical pulses. The microprocessor 2107 may execute one or more algorithms to perform analysis of one or more characteristics of cardiac activity sensed in response to the one or more electrical pulses delivered using the hierarchy of electrode configurations and/or the hierarchy of each characteristic of the one or more electrical pulses, for example, to help identify the characteristics of the electrode configurations and/or the one or more electrical pulses delivered to the patient's heart. Such analysis and adjustment may be performed using process control logic (e.g., fuzzy logic, negative feedback, etc.) to maintain control of the pulse control output generator 2111.

In some examples, the stimulation may be operated with closed loop feedback control. In some examples, input is received from a closed loop feedback system via microprocessor 2107. Closed loop feedback control may be used to maintain one or more of the patient's cardiac parameters at or within a threshold or range programmed into memory 2113. For example, under closed-loop feedback control, the measured cardiac parameter value(s) may be compared and it may then be determined whether the measured value(s) is outside of a threshold or predetermined range of values. If the measured cardiac parameter value(s) does not fall outside of the threshold or predetermined range of values, the closed-loop feedback control continues to monitor the cardiac parameter value(s) and periodically repeats the comparison. However, if the cardiac parameter value(s) from the sensor indicate that the one or more cardiac parameters are outside of a threshold or predetermined range of values, then one or more parameters of the stimulation electrical energy are adjusted by the microprocessor 2107.

Stimulation system 2101 may include one or more additional components, such as a display device, a cache (e.g., in communication with microprocessor 2107), logic circuits, signal filters, a secondary or back-end bus, a local interconnect bus, etc. The stimulation system 2101 may support any suitable installation device, for example, a CD-ROM drive, CD-R/RW drive, DVD-ROM drive, tape drives of various formats, USB device, hard drive, communications device connected to a server, or any other device suitable for installing software and programs. The stimulation system 2101 may include a network interface connected to a Local Area Network (LAN), Wide Area Network (WAN), or the internet through various connections including, but not limited to, standard telephone lines, LAN or WAN links, broadband connections, wireless connections (e.g., bluetooth, WiFi), combinations thereof, and the like. The network interface may include a built-in network adapter, network interface card, wireless network adapter, USB network adapter, modem, or any other device suitable for connecting the stimulation system 2101 to any type of network capable of communicating and performing the operations described herein. In some examples, stimulation system 2101 may include or be connected to multiple display devices, which may be of the same or different types and/or forms. Thus, any of the I/O devices and/or I/O controllers can include any type and/or form of suitable hardware, software, or combination of hardware and software to support, enable, or provide for the use of multiple display devices by the connection and stimulation system 2101. The stimulation system may be in communication with any workstation, desktop, laptop or notebook computer, server, handheld computer, mobile phone, any other computer, or other form of computing or communication device capable of communicating and having sufficient processor power and memory capacity to perform the operations described herein and/or communicate with the stimulation system 2101. The arrows shown in fig. 21 generally depict the direction of flow of current and/or information, but current and/or information may also flow in the opposite direction depending on the hardware.

The analysis, determination, adjustment, etc. described herein may be closed loop control or open loop control. For example, in closed-loop control, the stimulation system may analyze cardiac activity characteristics and adjust electrical signal characteristics without input from the user. For another example, in open loop control, the stimulation system may analyze the heart activity characteristics and prompt an action by the user to adjust the electrical signal characteristics, e.g., provide a suggested adjustment or multiple adjustment options.

In some examples, a non-therapeutic calibration method includes positioning an electrode in a pulmonary artery of a heart and positioning a sensor in a right ventricle of the heart. The system also includes transmitting the first series of electrical signals to the electrode via the stimulation system. The first series includes a plurality of first electrical signals. Each of the first plurality of electrical signals includes a plurality of parameters. Each of the first plurality of electrical signals of the first series differs from each other only in a magnitude of a first parameter of the plurality of parameters. The method also includes, after delivering the first series of electrical signals to the electrodes, delivering a second series of electrical signals to the electrodes via the stimulation system. The second series includes a second plurality of electrical signals. Each of the second plurality of electrical signals includes a plurality of parameters. Each of the second plurality of electrical signals of the second series differs from each other only in a magnitude of a second parameter of the plurality of parameters. The second parameter is different from the first parameter. The method also includes determining, via the sensor, sensor data indicative of one or more non-electrical cardiac activity characteristics responsive to transmitting the first series of electrical signals and the second series of electrical signals. The method also includes determining a therapeutic neuromodulation signal to be delivered to the pulmonary artery using the selected electrical parameter. The selected electrical parameter includes a selected magnitude of the first parameter and a selected magnitude of the second parameter. The selected magnitudes of the first and second parameters are based at least in part on the sensor data.

In some examples, a non-therapeutic calibration method includes communicating a first electrical signal of a series of electrical signals to an electrode in a first anatomical location, and after communicating the first electrical signal, communicating a second electrical signal of the series of electrical signals to the electrode. The second electrical signal differs from the first electrical signal by a magnitude of a first parameter of the plurality of parameters. The method also includes sensing, via a sensor in a second anatomical location different from the first anatomical location, sensor data indicative of one or more non-electrical cardiac activity characteristics in response to the delivery of the series of electrical signals, and determining, using the selected electrical parameter, a therapeutic neuromodulation signal to be delivered to the first anatomical location. The selected electrical parameter comprises a selected magnitude of the first parameter. The selected magnitude of the first parameter is based at least in part on the sensor data.

In some examples, the stimulation system may be used to help identify preferred locations for positioning one or more electrodes along the posterior, superior, and/or inferior surfaces of the main, left, and/or right pulmonary arteries. To this end, one or more electrodes of a catheter or catheter system are introduced into a patient, and various locations are tested along the posterior, superior, and/or inferior surfaces of the vasculature using a stimulation system to identify preferred locations for the electrodes. During such testing, the stimulation system may be used to initialize and adjust parameters of the stimulation electrical energy (e.g., current or electrical pulses). Such parameters include, but are not limited to, terminating, increasing, decreasing, or changing the flow rate or pattern of the stimulation electrical energy (e.g., current or electrical pulses). The stimulation system may also transmit occasional, continuous, periodic, clustered, intermittent stimulation electrical energy (e.g., electrical current or electrical pulses) as needed by the patient or medical personnel or programmed to respond to signals or portions of signals sensed from the patient.

Open-loop or closed-loop feedback mechanisms may be used in conjunction with the present disclosure. For an open loop feedback mechanism, a practitioner can monitor cardiac parameters and change the patient's cardiac parameters. Based on the heart parameters, the practitioner can adjust the parameters of the current applied to the autonomous cardiopulmonary fibers. Non-limiting examples of cardiac parameters that are monitored include arterial blood pressure, central venous pressure, capillary pressure, systolic pressure changes, blood gases, cardiac output, systemic vascular resistance, pulmonary artery wedge pressure, gas composition of exhaled breath from the patient, and/or mixed venous oxygen saturation. Cardiac parameters may be monitored by electrocardiography, invasive hemodynamic monitoring, echocardiogram or blood pressure measurement or other means of measuring cardiac function known in the art for medical use. Other parameters such as body temperature and respiration rate may also be monitored and processed as part of the feedback mechanism.

In a closed-loop feedback mechanism, a cardiac parameter of the patient is received and processed by the stimulation system, wherein a parameter of the electrical current is adjusted based at least in part on the cardiac parameter. As described herein, a sensor is used to detect a cardiac parameter and generate a sensor signal. The sensor signal is processed by a sensor signal processor which provides a control signal to a signal generator. The signal generator may then generate a response to the control signal by activating or adjusting one or more of the parameters of the electrical current applied by the catheter to the patient. The control signal may initialize, terminate, increase, decrease, or change a parameter of the current. One or more electrodes of the catheter may be caused to be used as both sensor and recording electrodes. When desired, these sensing or recording electrodes may transmit stimulation electrical energy (e.g., electrical current or electrical pulses) as described herein.

The stimulation system may also monitor to determine whether one or more electrodes have been displaced from their position within the right pulmonary artery. For example, the impedance value may be used to determine whether one or more electrodes have been displaced from their position within the right pulmonary artery. If the change in the impedance value indicates that one or more electrodes have been displaced from their position within the right pulmonary artery, a warning signal is generated by the stimulation system and the current is stopped.

In several examples, catheters provided herein include a plurality of electrodes, including two or more electrodes. It is to be understood that the phrase "plurality of electrodes" may be substituted herein with two or more electrodes, if desired. For the various examples of catheters and systems disclosed herein, the electrodes may have a variety of different configurations and sizes. For example, the electrodes discussed herein may be ring electrodes that completely surround the body on which they are located. The electrodes discussed herein may also be part-annular, wherein the electrodes only partially surround the body on which they are located. For example, the electrodes may be partial ring electrodes that preferably contact only the major pulmonary artery and/or the luminal surface of the pulmonary artery, as described herein. This configuration may help to localize the stimulation electrical energy into the blood vessels and adjacent tissue structures (e.g., autonomic fibers) and away from the blood in the manner discussed herein. The electrodes and conductive elements provided herein may be formed from a conductive biocompatible metal or metal alloy. Examples of such electrically conductive biocompatible metals or metal alloys include, but are not limited to, titanium, platinum, or alloys thereof. Other biocompatible metals or metal alloys are known.

For various examples, the elongate body of the catheter provided herein can be formed from a flexible polymeric material. Examples of such flexible polymeric materials include, but are not limited to: medical grade polyurethanes, in particular, for example, polyester-based polyurethanes, polyether-based polyurethanes and carbonate-based polyurethanes; polyamides, polyamide block copolymers, polyolefins (e.g., polyethylene (e.g., high density polyethylene)); and a polyimide.

Each of the catheters and/or catheter systems discussed herein may also include one or more reference electrodes positioned proximate to one or more electrodes present in the elongate body. These one or more reference electrodes may each include an isolated conductive lead extending from the catheter and/or catheter system so as to allow the one or more reference electrodes to be used as a common or return electrode for current transmitted through one or more of the one or more electrodes on the elongate body of the catheter and/or catheter system.

With respect to treating cardiovascular medical conditions, such medical conditions may include medical conditions related to components of the cardiovascular system (e.g., such as the heart and aorta). Non-limiting examples of cardiovascular symptoms include post-infarction recovery, shock (hypovolemic, septic, neurogenic), valvular disease, heart failure including acute heart failure, angina, microvascular ischemia, myocardial contractility disorders, cardiomyopathy, hypertension including pulmonary hypertension and systemic hypertension, orthopnea, dyspnea, orthostatic hypotension, familial autonomic abnormalities, syncope, vasovagal reflex, carotid sinus hypersensitivity, pericardial effusion, and cardiac structural abnormalities, such as septal defects and mural aneurysms.

In some examples, a catheter, e.g., as described herein, may be used in conjunction with a pulmonary artery catheter (e.g., a swan-ganz pulmonary artery catheter) to deliver transvascular neuromodulation to an autonomous target site via a pulmonary artery to treat a cardiovascular condition. In some such examples, the catheter (or catheters) may be housed within one of the plurality of lumens of the pulmonary artery catheter.

In addition to the catheters and catheter systems of the present disclosure, one or more sensing electrodes may be located on or within the patient. Among other uses, sensing electrodes may be used to detect signals indicative of changes in various cardiac parameters, where the changes may be the result of delivering pulses of stimulation electrical energy to stimulate nerve fibers (e.g., autonomic nerve fibers) surrounding one or both of the main and/or pulmonary arteries. Such parameters include, but are not limited to, inter alia, the heart rate (e.g., pulse) of the patient. The sensing electrodes may also provide signals indicative of changes in one or more electrical parameters of the vasculature (electrical activity of the cardiac cycle). Such signals may be collected and displayed, as is known, using known devices (e.g., Electrocardiogram (ECG) monitors) or the stimulation systems discussed herein, which receive the detected signals and provide information about the patient.

Other sensors may also be used with the patient to detect and measure a variety of different other signals indicative of changes in various cardiac parameters. Such parameters may include, but are not limited to, blood pressure, blood oxygen levels, and/or other components of the patient's exhaled breath. For example, the catheters and catheter systems of the present disclosure may also include a pressure sensor positioned within or in line with the inflation lumen of the inflatable balloon. The signal from the pressure sensor may be used to detect and measure the blood pressure of the patient. Alternatively, the catheters and catheter systems of the present disclosure may include integrated circuits for sensing and measuring blood pressure and/or blood oxygen levels. Such an integrated circuit may be implemented using 0.18 μm CMOS technology. Oxygen sensors may be measured using known optical or electrochemical techniques. Examples of such oxygen sensors include reflective or transmissive pulse oximeters, which use changes in absorbance in the measurement wavelength optical sensor to help determine the blood oxygen level. For these different examples, the elongate body of the catheter may include a sensor (e.g., an oximetry sensor and/or a pressure sensor) and one or more conductive elements extending through each elongate body, where the conductive elements conduct electrical signals from the oximetry sensor and/or the pressure sensor.

The detected signal may also be used by a stimulation system to provide stimulation electrical energy in response to the detected signal. For example, one or more of these signals may be used by the stimulation system to deliver stimulation electrical energy to one or more electrodes of the catheter or catheter system. Thus, for example, a detected signal (e.g., an ECG wave, a band, a wave interval, or a composite of ECG waves) from a patient's cardiac cycle can be sensed using timing parameters of the sensing electrodes and/or the subject's blood pressure. The stimulation system may receive these detection signals and generate and transmit stimulation electrical energy to one or more electrodes of the catheter or catheter system based on the characteristics of the signal(s). As described herein, the stimulation electrical energy has sufficient current and potential and sufficient duration to stimulate one or more nerve fibers surrounding the main pulmonary artery and/or one or more of the pulmonary arteries to provide neuromodulation to the patient.

Fig. 22A is a perspective view of an example of a portion 2200 of a catheter. Fig. 22B is a side elevation view of portion 2200 of fig. 22A. Fig. 22C is a distal end view of portion 2200 of fig. 22A. Fig. 22C is a proximal end view of portion 2200 of fig. 22A. Portion 2200 may be coupled to or form part of a catheter (all-in-one catheter or telescoping catheter), for example, as described herein.

Portion 2200 includes first cut hypotube 2202 and second cut hypotube 2204 coupled at point 2206. As may be appropriate for any of the cut hypotubes described herein, the sheet may be cut and rolled into a hypotube having an intermediate shape set into a tube or directly into a final shape. The first cut hypotube 2202 includes a cylindrical (e.g., uncut) portion 2208 and a plurality of splines 2210. The second cut hypotube 2204 includes a cylindrical (e.g., uncut) portion 2212 and a plurality of splines 2214. As best seen in fig. 22B, spline 2210 is convex and spline 2214 is concave.

In the example shown in fig. 22A and 22B, the distal end of spline 2210 is coupled radially inward from the distal end of spline 2214, but close to the distal end of spline 2214, at point 2206. In some examples, the distal end of spline 2210 may be coupled even further radially inward to spline 2214. In some examples, the distal ends of splines 2214 may be coupled radially inward from the distal ends of splines 2210. The point 2206 may be proximate to a distal end of the spline 2210 and a distal end of the spline 2214 (e.g., as described in fig. 22A and 22B), between the distal end of the spline 2214 and a point along the spline 2210 (e.g., approximating a longitudinal midpoint, about 75% of the length closer to the distal end, etc.), or between the spline 2210 and a point along the spline 2214 (e.g., including examples where the spline 2214 is configured to be convex at the distal end of the point 2206).

As shown in fig. 22C and 22D, the cylindrical portion 2212 telescopes radially inward from the cylindrical portion 2208. The cylindrical portion 2212 has a smaller diameter than the cylindrical portion 2208. As the cylindrical portion 2208 and the cylindrical portion 2212 move away from each other relative to each other (e.g., by distal advancement of the second cutting hypotube 2204 and/or proximal retraction of the first cutting hypotube 2202), the splines 2204 push the splines 2210 radially outward.

Fig. 22A-22D show six splines 2210 and six splines 2214. Other numbers of splines may be possible (e.g., between 2 and 12 (e.g., a range of about 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, etc. between such values)). The splines 2210,2214 may be evenly circumferentially spaced, or some splines 2210,2214 may be axially closer together. Splines 2210,2214 may provide circumferential coverage of about 60 ° to 360 ° (e.g., about 60 °, about 90 °, about 120 °, about 180 °, about 210 °, about 240 °, about 270 °, about 300 °, about 360 °, a range between such values, etc.). Circumferential coverage may optionally be at the lower end of the range if the portion 2200 is rotatable to find the target nerve. As described with respect to fig. 22E, at least some of the splines 2210 may include electrodes. Other splines 2210 may have no electrodes or include electrodes that are not used, but may act as a proximate arm (e.g., where splines 2210 are not pushed to one side of a vessel due to the rigidity of the navigation path and natural route), which may help push the electrodes against or near tissue.

Fig. 22E-22G are side partial cross-sectional views of an example of a catheter 2220 including the portion 2200 of fig. 22A. Splines 2210 include electrodes 2222, e.g., on the outer surface, annularly around, in a U-shaped channel (e.g., as described herein), as part of a grid overlay (e.g., as described with respect to fig. 4C), and so forth. In some examples, the length of each portion of spline 2210 including the electrodes is between about 20mm to about 40mm (e.g., about 20mm, about 25mm, about 30mm, about 35mm, about 40mm, ranges between such values, etc.). The first cutting hypotube 2202 is coupled to a sleeve or sheath 2226. The first cutting hypotube 2202 may be coupled within the lumen of the sleeve 2226 (e.g., as shown in fig. 22E and 22G), on the outside of the sleeve 2226, end-to-end, coupled by a tether, etc. The cannula 2226 may have a diameter of between about 7Fr to about 11Fr (e.g., about 7Fr, about 8Fr, about 9Fr, about 10Fr, about 11Fr, ranges between such values, etc.). The second cut hypotube 2204 is coupled to the inner member 2224. The second cut hypotube 2204 can be coupled within a lumen of the inner member 2224 (e.g., as shown in fig. 22G), on the outside of the inner member 2224, end-to-end, coupled by a tether, etc. Fig. 22G shows first cut hypotube 2202 in cross-section to illustrate the coupling between second cut hypotube 2204 and inner member 2224. Relative movement between the inner member 2224 (and thus the second cutting hypotube 2204) and the cannula 2226 (and thus the first cutting hypotube 2202) may cause splines 2210 to fold radially outward (e.g., proximal retraction of the cannula 2226 and/or distal advancement of the inner member 2224 may cause splines 2210 to fold radially outward, proximal retraction of the inner member 2224 and/or distal advancement of the cannula 2226 may cause splines 2210 to fold radially inward), as shown in fig. 22F. Since the splines 2214 may push the splines 2210 radially outward, the splines 2210 may be formed without taper, which may reduce the profile and length and throw distance (throw distance) of the catheter 2220. In some examples, spline 2210 has a diameter 2225 in the expanded state of between about 15mm and about 35mm (e.g., about 15mm, about 20mm, about 25mm, about 30mm, about 35mm, ranges between such values, etc.).

One potential advantage of the catheter 2220 with the splines 2210 in the collapsed position (fig. 22F) is that in the event of a failure (e.g., proximal fracture), the splines 2210 collapse inwardly rather than expand. That is, the collapsed state is a default state that may be safer than the expanded state as a default state, e.g., when the catheter 2220 passes through a valve, chordae, etc. One potential advantage of not using shape memory materials is reduced cost when expansion is possible due to longitudinal movement.

In some examples, splines 2210 may be self-expanding, e.g., capable of expanding upon removal of force from inner member 2224. The reduced length may be useful when the target vessel is short (e.g., pulmonary artery). The relative movement may be manual or, for example, spring assisted as described herein.

In some examples, catheter 2220 may include a fixation system separate from portion 2200. For example, the fixation system can extend through the lumen of the second cutting hypotube 2204. The fixation system may be capable of axial and rotational movement relative to portion 2200, which may be useful for providing appropriate fixation and neural targeting. Once the user is satisfied with the position of portion 2200 and the fixation system, portion 2200 and the fixation system can be coupled (e.g., at a handle external to the subject). Even once coupled, the portion 2200 and the fixation system can be capable of rotating (e.g., ± 20 °) and/or moving longitudinally (e.g., ± 1cm, ± 2cm) relative to each other. Portion 2200 may be moved even when the fixation mechanism is not moving to improve nerve targeting, which may reduce tissue interference. In some examples, the distal end of the spline 2214 may provide alternative or additional fixation.

In some examples, the splines 2210, splines 2204, or portions 2200, or other portions of the catheter 2200, include sensors (e.g., pressure sensors, contractility sensors, etc.).

In some examples, rotation of the proximal handle imparts a longitudinal movement and/or rotational movement other than 1:1 at the distal end of the catheter 2220, e.g., due to catheter shape, flexion, or other factors.

Fig. 22H-22L are side elevation and partial cross-sectional views of an example of a catheter deployment system 2230, 2240. In fig. 22H to 22J, the proximal end or handle of the catheter deployment system is shown. In fig. 22K and 22L, the proximal end or handle of the catheter deployment system is shown. The catheter deployment system 2230,2240 may be used, for example, with the catheter 2220.

System 2230 includes spring 2232. The spring abuts the holder 2234, the holder 2234 being coupled to the inner member 2224. Spring 2232 has a negative spring constant (restoring force inward), but it is also possible to have a positive spring constant (restoring force outward) by arranging springs with other characteristics. To expand splines 2210, a handle element 2236, such as a grip, is pushed distally relative to sleeve 2226 against the force of spring 2232. System 2230 can include a locking mechanism 2238, the locking mechanism 2238 configured to hold handle element 2236 in a distal position. In the system 2230, in the event of a break in the system 2230 (e.g., a failure of the locking mechanism 2238), the spring 2232 retracts the inner element 2224, collapsing the splines 2210, which may allow the catheter 2230 to be easily retrieved. Spring 2232 provides a range of deployment options compared to a manual-only configuration, e.g., due to the force provided by spring 2232.

Fig. 22I illustrates an example of a locking mechanism 2238 that includes a plurality of arms that can resiliently hold the handle element 2236 in a distal position. The arms can be opened at the distal end and the handle element 2236 (e.g., the entire handle element 2236) can be captured in the arms. When the line is to be collapsed, the arms can be opened, allowing spring 2232 to force handle element 2236 distally, retracting internal element 2224 and collapsing splines 2210.

Fig. 22J illustrates another example of a locking mechanism 2238 that includes a plurality of arms that can resiliently hold the handle element 2236 in a distal position. The arms may be closed at the proximal end. The arms may be biased radially outward to facilitate radial expansion. The arm may act as an auxiliary leaf spring. In some examples, the closed proximal ends of handle element 2236 and locking mechanism 2238 includeA magnet, threads, or other features to hold the handle element 2236 in a distal position. When the line is to be collapsed, it can be disengaged from handle element 2236, allowing spring 2232 (and arms) to force handle element 2236 distally, retracting internal element 2224 and collapsing splines 2210. In some examples, compressing the arm may disengage the handle element 2236.

System 2240 includes a spring 2242. The spring abuts the holder 2244, the holder 2244 being coupled to the inner member 2224. Spring 2242 has a positive spring constant (return force inward), but it is also possible to have a positive spring constant (return force outward) by arranging springs with other features.

In fig. 22K, to expand the splines 2210, the handle element coupled to the inner member 2224 is pulled distally relative to the sleeve 2226 against the force of the springs 2242. The pulling element 2246 is coupled to the inner member 2224. The pull elements 2246 are coupled to splines 2247 (e.g., similar to splines 2214 but opposite in orientation such that the splines 2247 extend distally in the collapsed state). As the pulling element 2246 is pulled proximally, the splines 2247 expand radially outward, pushing the splines 2210 radially outward to the expanded state.

In fig. 22L, the splines 2210 have a slightly tapered shape so that the pulling elements 2246 may rest between the splines 2210 in the collapsed state and interact with the splines 2210 during retraction. To expand the splines 2210, a handle element coupled to the inner member 2224 is pulled distally relative to the sleeve 2226 against the force of the spring 2242. The pulling element 2246 is coupled to the inner member 2224. As the pulling elements 2246 are pulled proximally, the proximal ends of the pulling elements 2246 bear against the inside surfaces of the splines 2210, pushing the splines 2210 radially outward into an expanded state.

In the system 2240 of fig. 22K and 22L, in the event of a break in the system 2230, the spring 2242 advances the inner element 2224, collapsing the splines 2210, which may allow the catheter 2230 to be easily retrieved. The spring 2242 provides a range of deployment options compared to a single manual configuration, for example due to the force provided by the spring 2242.

Fig. 22M illustrates an exemplary component 2250 of the portion 2200 of fig. 22A. Rather than a first cutting hypotube 2202, the component 2250 includes a hypotube 2252 coupled to a plurality of wires 2254 shaped as splines 2210. Orange threads 2254o show the shape of the spline 2210 in an open or expanded state, while gray threads 2254g show the shape of the spline 2210 in a closed or collapsed state. Like splines 2210 of the first cutting hypotube 2202, the wire 2254 may comprise a shape memory material (e.g., nitinol) and/or may be moved to an expanded position by a second cutting hypotube 2204 or similar device. Referring to fig. 22E and 4C, the component 2250 may include electrodes on the wire 2254, on a grid attached to the wire 2254, or a group thereof, or the like.

Fig. 23A is a perspective view of an exemplary section 2300 of a strut. Section 2300 has a generally U-shape. Section 2300 includes a wall 2302 that at least partially defines a channel or trough 2304. The walls 2302 and the trough 2304 can be formed in a variety of different ways. In some examples, the wire may be extruded in a U-shape. In some examples, the hypotube can be cut to form a generally rectangular strut, and material can be removed from the strut (e.g., by milling) to form the slots 204. In some examples, the sides of the flat wire may be curved upward. In some examples, the U-shape may comprise plastic (e.g., extruded, molded, etc.). The slots 2304 may be in-line with the insulating material. In some examples, the insulating material includes an epoxy. In some examples, the slots 2304 in line with the insulating material may help in electrode orientation, which may help target energy at the vessel wall and at the nerves. A plurality of wires or leads or conductors 2306 may be located in the slots 2304. Positioning the wire 2306 in the groove 2304 may aid in manufacturing (positioning of the wire 2306), may reduce the risk of possible cross-talk of conductors, and/or may prevent the wire 2306 from breaking. The wire 2306 is electrically connected to electrodes, transducers, etc., which may be used to provide neuromodulation. Fig. 23B-23F show examples of configurations that may be used to position the wire 2306, insulator and electrode 2308 at least partially in the U-shaped section of the strut. In some examples, the U-shaped section may be coupled to the strut (e.g., adhered, welded, brazed, interference fit, etc.).

The groove 2304 can have a depth 2370 of between about 0.003 inches to about 0.02 inches (e.g., about 0.003 inches, about 0.005 inches, about 0.01 inches, about 0.015 inches, about 0.02 inches, ranges between such values, etc.). The slots 2304 may have a width 2372 of between about 0.15 inches and about 0.1 inches (e.g., about 0.015 inches, about 0.02 inches, about 0.025 inches, about 0.05 inches, about 0.06 inches, about 0.08 inches, about 0.1 inches, ranges between such values, etc.).

Fig. 23B is a transverse cross-sectional view of an example of a post 2320. The post 2320 includes a wall 2302 that at least partially defines a slot. In some examples, the walls 2302 form a depth 2370 configured to at least partially laterally cover the electrodes 2308. A plurality of wires 2306 are positioned in the slots. The wire 2306 is covered by a release sheet or insert 2310. Each of the wires 2306 may be coated with an isolation material and/or an isolation sheet 2310 may provide isolation for the wires 2306. Isolation at the weld or junction between the wire 2306 and the electrode 2308 may inhibit or prevent damage and erosion from bodily fluids. The electrodes 2308 are electrically connected to one of the wires 2306 through a separator sheet 2310. The electrode 2308 shown in fig. 23B has a rectangular cross section. Fig. 23C shows a lateral cross-sectional view of an example of a post 2325 in which the electrode 2308 has a circular cross-section (e.g., shaped as a dome), which may help reduce edge effects and hot spots due to sharp edges. In examples where the electrodes 2308 include sharp edges, the isolation material may at least partially cover the sharp edges, which may help reduce edge effects. The electrodes 2308 may be sunk into the holes of the isolation material such that only the top surface is exposed, which may aid in electrode 2308 orientation. The electrodes 2308, as well as all electrodes described herein, can be free of sharp edges and/or free of sharp edges not covered by the isolation material.

Fig. 23D is a cross-sectional view of another example of a pillar 2330. The post 2330 includes a wall 2302 that at least partially defines a slot. A plurality of wires 2306 are positioned in the slots. The wire 2306 is covered by an isolation layer 2312. The isolation layer 2312 may comprise, for example, silicone or any suitable isolating flexible material. Each of the wires 2306 may be coated with an isolation material and/or an isolation layer 2312 may provide isolation for the wires 2306. The electrodes 2308 are electrically connected to one of the wires 2306 through an isolation layer 2312. The electrode 2308 may have the same height as the isolation layer 2312. The release layer 2312 may include a dome shape.

Fig. 23E is a transverse cross-sectional view of yet another example of a post 2340. Post 2340 includes walls 2302 that at least partially define a slot. A plurality of wires 2306 are positioned in the slots. The wire 2306 is covered by an isolation layer 2314. The isolation layer 2314 may comprise, for example, silicone or any suitable isolating flexible material. Each of the wires 2306 may be coated with an isolation material and/or an isolation layer 2314 may provide isolation for the wires 2306. The electrodes 2308 are electrically connected to one of the wires 2306 through an isolation layer 2314. The electrode 2308 may have the same height as the isolation layer 2314. The isolation layer 2312 may include a generally planar or planar upper surface.

Fig. 23F is a transverse cross-sectional view of yet another example of a support post 2350. The post 2350 includes a wall 2302 that at least partially defines a slot. A plurality of wires 2306 are positioned in the slots. The wire 2306 is covered by an isolation layer 2316. The isolation layer 2316 may comprise, for example, silicone or any suitable isolating flexible material. Each of the wires 2306 may be coated with an isolation material and/or an isolation layer 2316 may provide isolation for the wires 2306. The electrodes 2308 are electrically connected to one of the wires 2306 through an isolation layer 2316. The release layer 2316 may include a generally convex surface. The electrode 2308 may be buried in the isolation layer 2316, which may help reduce edge effects. Reducing edge effects can improve the uniformity of the electric field emitted from the electrode 2308. The electrodes 2308 below the upper surface of the isolation layer 2316 may be spaced from tissue, which may allow blood flow across the electrodes 2308.

The isolation layer 2312,2314,2316 may maintain the position of the filaments 2306 in the U-shaped channels, e.g., to inhibit entanglement and/or maintain spatial separation. The isolation layer 2312,2314,2316 may protect the wire 2306 from bodily fluids and external forces.

Isolation layer 2312,2314,2316 may be deposited in the trench over wire 2306. Isolation layer 2312,2314,2316 can be cured and then ablated (e.g., laser ablated, milled) to allow electrodes 2308 and connectors to be positioned thereon. In some examples, a plug (e.g., a material comprising a material that does not stick to isolation layer 2312,2314,2316, such as PTFE) may be positioned in isolation layer 2312,2314,2316 and then removed after curing to allow electrode 2308 to be positioned thereto.

Fig. 23G is a top partial cross-sectional view of an exemplary section 2360 of a strut. As shown, the wires 2306 are spatially separated. In examples where the wires 2306 are not individually isolated, the isolation material may inhibit or prevent electrical communication between the wires 2306. The first wire 2306a is connected to the first electrode 2308 a. The second wire 2306b is connected to the second electrode 2308 b. The third wire 2306c is connected to a third electrode (not shown).

Fig. 23H illustrates an example of a strut system 2380 that includes a plurality of struts or splines 2382, where the plurality of struts or splines 2382 each have a generally U-shaped groove. The U-shaped slots can help align or maintain the spacing or separation between the struts 2382. Fig. 23I shows an example in which the distance between the first support 2382a and the second support 2382b is smaller than the distance b between the third support 2382c and the second support 2382 b. Fig. 23J shows an example in which the distance between the first support 2382a and the second support 2382b is substantially the same as the distance b between the third support 2382c and the second support 2382 b. In some examples, the distance between struts b or the strut-to-strut spacing 2374 may be between about 10mm to about 15mm (e.g., about 10mm, about 11mm, about 12mm, about 13mm, about 14mm, about 15mm, ranges between such values, etc.). In the case of the U-shape, splines 2382 may be less tortuous in a radial configuration than a circular wire spline system, which may help to keep the spacing between splines more consistent, whether the spacing is intended to be consistent or varying. The U-shape may reduce the likelihood that splines 2382 slide relative to each other and electrodes 2308 in each spline 2382 slide relative to each other, which may maintain the spacing of the electrodes.

Fig. 23K shows an example of electrodes on a wire system 2390. System 2390 includes a wire 2392 and electrodes 2394 on the wire 2392 (e.g., radially outward from the wire 2392, annularly or arcuately around the wire 2392). The wire 2392 may include a shape memory material (e.g., nitinol). Electrode 2394 may include, for example, a platinum-iridium electrode. Other materials for the wire 2392 and the electrodes 2394 are also possible. System 2390 can include an insulator 2396 between wire 2392 and electrode 2394. The electrode 2394 may be electrically coupled to the conductor wire 2398. In some examples, a single wire 2392 can include multiple electrodes 2394, e.g., forming an array.

Fig. 23L is a cross-sectional view of electrode 2308 spaced from a vessel wall 2397. The blood vessels are spaced from the nerves 2399. The electrodes 2308 may be positioned as close as possible to the vessel wall 2397 so that the electrodes 2308 are as close as possible to the nerve 2399. In some examples, the electrodes 2308 can be intentionally spaced a distance d from the vessel wall 2397, which can allow blood to flow above and below the electrodes, e.g., as shown by the thin arrows. In some examples, the distance d is between about 0.1mm to about 1mm (e.g., about 0.1mm, about 0.2mm, about 0.3mm, about 0.5mm, about 0.7mm, about 0.9mm, about 1mm, ranges between such values, etc.). Referring again to fig. 23F, the isolation material 2316 may, for example, act as a spacer. Allowing blood to flow over the electrodes 2308 may inhibit erosion of the electrodes 2308. Allowing blood to flow over the electrodes 2308 may allow blood to contact the vessel wall 2397 in the area of the electrodes 2308 so that the cells may be replenished. In some examples, the electrodes may include longitudinal channels, concave-convex surfaces, etc. to allow blood to flow radially outward from the electrodes 2308 but still closer to the nerve 2399. In some such examples, it may be advantageous to increase the surface area of the electrodes 2308.

Fig. 23Ni to 23Nix illustrate an exemplary method of fabricating a component on a substrate 2301. The substrate 2301 may, for example, comprise a shape memory alloy, such as nitinol forming a spline of an electrode system. Flex circuit processing can be used to pattern electrodes, conductors, insulators, and other components (e.g., resistors) on the splines. In fig. 23Ni, an insulating layer 2303 comprising an insulating material (e.g., oxide, polyimide) is deposited over substrate 2301. Layer 2303 may be omitted if substrate 2301 is insulating. When used with respect to fig. 23Ni-23Nix, the term "over" may refer to being on … … or directly on … … when viewed from a certain orientation and is not intended to limit intervening layers, and the term "layer" may refer to multiple layers (e.g., including adhesion layers). In fig. 23Nii, a conductive layer 2303 comprising a conductive material (e.g., aluminum, copper, and doped silicon) is deposited over insulating layer 2303. In fig. 23Niii, conductive layer 2305 is patterned into conductor wire 2306 (e.g., using photolithography, lift-off etching, etc.). In some examples, the conductor wires 2306 can be formed directly (e.g., using screen printing, ink jet printing, etc.). In fig. 23Niv, an insulating layer 2307 comprising an insulating material (e.g., oxide, polyimide) is deposited over conductor wire 2306 and insulating layer 2303. The insulating material of insulating layer 2303,2307 may be the same or different. At 23Nv, vias 2311 are formed (e.g., by etching, milling) in the insulating layer 2307, thereby exposing portions of the intermediate to body wire 2306. In fig. 23Nvi, a conductive layer 2309 comprising a conductive material (e.g., aluminum, copper, and doped silicon) is formed over insulating layer 2307 and fills vias 2311. The conductive material of conductive layer 2305,2309 may be the same or different. In fig. 23Nvii, a conductive layer 2309 is patterned into electrodes 2308. The wet etch may, for example, help form a dome shape for the electrode 2308. Although not shown, vias 2311 may be formed to connect each conductor wire 2306 to a different electrode 2308. In fig. 23Nviii, an insulating layer 2313 (e.g., comprising oxide, polyimide) is formed over the electrodes 2308 and the insulating layer 2307. The insulating material of insulating layer 2303,2307,2313 may be the same or different. In fig. 23Nix, insulating layer 2313 has been patterned to expose electrodes 2308 and form insulating layer 2316 comprising a generally convex surface. The electrode 2308 embedded in the insulating layer 2316 may help reduce edge effects, which may improve uniformity of an electric field emitted from the electrode 2308. The electrodes 2308 may also be spaced from tissue by an upper surface of the insulating layer 2316, which may allow blood to flow across the electrodes 2308. In some examples, the insulating layer 2316 may be omitted. In some examples, a dual damascene structure may be formed in insulating layer 2307, and electrode 2308 may be formed in insulating layer 2307, which may be shaped to have a convex surface. A wide variety of different layers, patterns, and processes may be used to form the described components and other components. For example, a resistor layer may be patterned proximate to the substrate 2301, which may provide localized heating that may cause the shape memory substrate to locally deform into an austenitic state.

Although not intended to be limiting, the following electrode dimensions may be sufficient to generate a hemodynamic response due to neural stimulation. It may be assumed that about half of the electrodes contact the blood vessel and that about half of the electrodes are exposed to low impedance blood flow. Referring again to the front view of fig. 23G as an example, the length of the electrode 2806 can be between about 1mm to 3mm (e.g., about 1mm, about 1.5mm, about 2mm, about 2.5mm, about 2mm, ranges between such values, etc.); the width of the electrode 2806 can be between about 1mm to about 4mm (e.g., about 1mm, about 2mm, about 3mm, about 4mm, ranges between such values, etc.); and the spacing between the electrodes 2806 can be between about 2mm to about 8mm (e.g., about 2mm,about 3mm, about 4mm, about 5mm, about 6mm, about 7mm, about 8mm, ranges between such values, etc.). The spacing between the electrodes may refer to the distance between the distal end of the proximal electrode and the proximal end of the distal electrode, the distance between the center of one electrode and the center of the other electrode, and/or the distance between circumferentially or laterally spaced electrodes. Electrode 2308 can be configured to maintain charge density at a value for Pt/Ir^1,2,3Less than about 400 μ C/cm²The electrochemical stability level of (a). Referring again to fig. 23G as an example of a ring electrode, electrodes 2394 may have a diameter of about 7Fr (about 2.3mm), have a length of about 1.5mm and be spaced about 8mm apart. In some examples, the electrodes 2394 may have a length between about 1mm and about 3mm (e.g., about 1mm, about 1.5mm, about 2mm, about 2.5mm, about 2mm, ranges between such values, etc.), a diameter between about 0.5mm and about 1.5mm (e.g., about 0.5mm, about 0.75mm, about 1mm, about 1.25mm, about 1.5mm, ranges between such values, etc.), and a spacing between about 1mm and about 3mm (e.g., about 1mm, about 1.5mm, about 2mm, about 2.5mm, about 2mm, ranges between such values, etc.).

The target nerve may be a very small target to be captured via nerve stimulation. The electrode (most likely the cathode) may need to be very close to the nerve if there is a different pass depth than by lateral positioning. One option to provide close lateral positioning is to have an effectively infinite number of electrodes or at least one electrode matrix that can cover all possible areas of the nerve with respect to the target vessel. Another option to provide close lateral positioning is to provide repositionable electrodes, for example electrodes in a matrix that can be extended, retracted and/or rotated.

Fig. 23M illustrates an exemplary electrode matrix. The electrode edges were spaced approximately 2mm proximally-distally and above-below edge to edge. The initial target area may be estimated to be as large as 15mm proximal-distal and 19mm lateral. In some examples, such as shown in fig. 23M, the electrode matrix has these dimensions, which can function as virtually an infinite number of electrodes in view of the size of the target area. In some examples, the electrode matrix may be of a smaller size and may be rotated and/or moved longitudinally. Although illustrated in two dimensions in fig. 23N, in some examples, the electrode matrix Having a shape that assumes three dimensions (e.g., conforms to the inside wall of a blood vessel). In some such examples, the electrode matrix may cover between about 15 ° and about 360 ° of the circumference of the vessel wall (e.g., about 15 °, about 30 °, about 45 °, about 60 °, about 75 °, about 90 °, about 105 °, about 120 °, about 180 °, about 210 °, about 270 °, about 300 °, about 360 °, a range between such values, etc.). The e-value indicates the percentage above the baseline hemodynamic response. E between electrodes C5 and C4₁The value of (D) was 3.0%. E between electrodes C4 and C3₂The value of (A) was 12.1%. E between electrodes D6 and D5₃The value of (A) was 18.5%. E between electrodes D5 and D4₄The value of (A) was 40.2%. E between electrodes D4 and D3₅The value of (A) was 23.7%. E between electrodes E5 and E4₆The value of (A) is 0%. E between electrodes E5 and E3₇The value of (A) was 0.3%. E between electrodes C4 and D4₈The value of (A) was 28.9%. E between electrodes C3 and D3₉The value of (A) was 21.3%. E between electrodes C2 and D2₁₀The value of (A) was 7.1%.

The hemodynamic response is reduced by about half when the excitation moves from one segment of the electrode to an adjacent spatial pair. When the centre-to-centre spacing is 3.5mm, this means that once the optimal target has been determined, movement of the electrode matrix on the order of 3.5mm will significantly reduce the hemodynamic response. Certain fixation systems described herein may limit electrode movement to an order of magnitude less than this change over the treatment administration period (e.g., a total electrode migration of about 0.035 mm). In some examples, the fixation system may inhibit electrode migration to less than about 1mm, less than about 0.5mm, less than about 0.25mm, less than about 0.1mm, less than about 0.075mm, less than about 0.05mm, less than about 0.035mm, less than about 0.025mm, or less than about 0.015mm, where the lower limit of such "less than" range is 0 mm.

In some examples, the electrode matrix (e.g., including a portion of the electrodes used for calibration stimulation and/or therapy stimulation) may have about 10mm²To about 15mm²Area in between (e.g., about 10 mm)²About 11mm²About 12mm²About 13mm²About 14mm²About 15mm²A range between such values, etc.). In some examples, the electrode matrix may have about 10mm²To about 300mm²Area in between (e.g., about 10 mm)²About 50mm²About 100mm²About 150mm²About 200mm²About 250mm²About 300mm²A range between such values, etc.).

Fig. 24A shows an example of a fixation system 2400. Fixation system 2400 includes a fixation mechanism 2402 and a fixation mechanism 2404. The fixed structure 2402 may, for example, comprise a hypotube that has been cut and shaped into a plurality of arms, a wire that has been shaped into a plurality of arms, or the like. The arms may be the same or different (e.g., one arm may be meandered upward as shown in fig. 24A). The securing mechanism 2404 may, for example, include points or barbs directed radially outward from the securing mechanism 2402. Securing mechanism 2404 may be integral with securing structure 2402 or coupled to securing structure 2402.

Fig. 24B and 24C show the fixation system 2400 of fig. 24A interacting with a catheter 2406. As the fixed structure 2402 and the catheter 2406 move longitudinally relative to each other (e.g., retract the fixed structure 2402 and/or advance the catheter 2406), the arms of the fixed structure 2402 move radially inward. Fixation mechanism 2402 may damage tissue during this interaction. The securing mechanism 2402 may catch on the catheter 2406 (e.g., starting at the end of the catheter 2406) and may dig into the catheter 2406 to form a groove, which may release catheter remnants, use more longitudinal interaction force, etc. In some examples, the catheter 2406 may include a groove or channel configured to receive the fixation mechanism, but the radially outward force provided by the fixation structure 2402 may still cause tissue damage and/or grooves 2408.

Fig. 25A is a perspective view of another example of a fixation system 2500. Fig. 25B is a side elevation view of the fixation system 2500 of fig. 25A. Fig. 25C is an end view of the fixation system 2500 of fig. 25A. Fixation system 2500 includes a fixation structure 2502 and a fixation mechanism 2504. The fixation structure 2502 may, for example, comprise a hypotube that has been cut and shaped, a ribbon that has been shaped, and the like. The fixation mechanism 2504 may, for example, comprise points or barbs directed radially outward in the deployed position or state and radially inward in the constrained position or state due to the fixation structure 2502 comprising the rotation or twist 2510. Rotation 2510 can be between about 60 ° and about 300 ° (e.g., about 60 °, about 90 °, about 120 °, about 150 °, about 180 ° (e.g., as shown in fig. 25A-25C), about 210 °, about 240 °, about 270 °, about 300 °, a range between such values, etc.). In some examples, the fixed structure 2502 comprises a shape memory material and the rotation 2510 is imparted as at least a portion of a shape setting. Securing mechanism 2504 may be integral with securing structure 2502 or coupled to securing structure 2502.

Fig. 25D and 25E illustrate the fixation system 2500 of fig. 25A interacting with a catheter 2506. As the fixation system 2500 moves longitudinally relative to the catheter 2506, the fixation structure 2502 rotates relative to the longitudinal axis. Fixation mechanism 2502 (which faces radially inward in catheter 2506) rotates to face radially outward when extended from catheter 2506. Conversely, retaining mechanism 2502 (which faces radially inward and outward beyond catheter 2506) rotates to face radially inward when retracted into catheter 2506. The fixation structure 2502 can be biased radially outward to push against the lumen of the catheter 2506.

Fig. 25F shows an example of a catheter 2506 that includes a lumen 2512 having a shape configured to receive a fixation structure 2502 and a fixation mechanism 2504. Lumen 2512 may comprise, for example, a pentagon configured to interact with three sides of a rectangular fixation structure 2502 and a directional fixation mechanism 2504 extending from the other side of fixation mechanism 2502. Other shapes for the internal cavity 2512 are possible. For example, referring again to fig. 25C, the inner lumen 2512 can comprise a generally arcuate shape configured to interact with both sides of a rectangular fixation structure 2502.

Fig. 25G-25J illustrate an example of deployment of fixation structure 2502 and fixation mechanism 2504 from catheter 2506 of fig. 25F. As shown in fig. 25G, when fixation structure 2502 and fixation mechanism 2504 are initially deployed from lumen 2512 of catheter 2510, fixation mechanism 2504 faces radially inward with torque 2510 still in lumen 2512. As shown in fig. 25H, when torque 2510 is outside of lumen 2512, securing mechanisms 2504 may begin to rotate radially outward. Fig. 25I shows that fixation mechanisms 2504 continue to rotate radially outward as torque 2510 is further away from lumen 2512, which allows the shape of fixation structures 2502 to rotate. Fig. 25J illustrates a securing mechanism 2504 that is radially outward or upstanding. In some examples, fixation structure 2502 and fixation mechanism 2504 can be deployed out of the end of catheter 2506. In some examples, securing mechanism 2502 and securing mechanism 2504 may be deployed out of the side of the catheter.

Fig. 26A is a side elevation view of an example of a catheter system 2600. The catheter system 2600 includes a fixation system 2602 and an electrode system 2604. Fixation system 2602 may include radially outwardly extending features, e.g., as described herein. The electrode system 2604 may include a stent and an electrode, e.g., as described herein. In the example shown in fig. 26A, the electrode system 2604 includes a tether 2605, which may help to be positioned in and out of the sheath 2606. Fixation system 2602 is distal to electrode system 2604.

Fig. 26B-26H illustrate an exemplary method of deploying the catheter system 2600 of fig. 26A. This is an example of a over-the-wire or step-wise placement method, where a balloon is used to place a guidewire, which provides a track to guide the component to the target location.

In fig. 26A, swan-ganz catheter 2612, including distal balloon 2614, floats to the target area. For example, the swan-ganz catheter 2612 may be inserted into an access point of the internal jugular vein (left or right) in an unexpanded state, then inflated, after which it may be carried through the blood flow to a target site, such as a pulmonary artery (left, right pulmonary artery, or pulmonary trunk). In some examples, swan-ganz catheter 2616 is a catheter having a length of 1.5cm ³Balloon 8Fr swan-ganz catheter, available from edward life sciences, for example. In fig. 26C, the wire 2616 is conveyed through the lumen of the swan-ganz catheter 2612 until the distal end of the wire 2614 extends from the distal end of the swan-ganz catheter 2612. In fig. 26D, the swan-ganz catheter 2616 is withdrawn, leaving the wire 2616 behind.

In fig. 26E, the fixation catheter 2620 including the fixation system 2602 at the distal end of the tether 2622 is advanced over the guidewire 2616 and the fixation system 2602 is deployed. In some examples, the fixed tubing 2620 is 8Fr or 9 Fr. In fig. 26F, the guidewire 2616 and fixation catheter 2620 are withdrawn, leaving the fixation system 2602 and tether 2622 in place. In fig. 26G, the sheath 2606 including the electrode system 2604 is advanced via a tether 2622. In some examples, the distance between the fixation system 2602 and the distal end of the sheath 2606 may be known, for example, according to proximal markers. In fig. 26H, the sheath 2606 is proximally retracted to deploy the electrode system 2604. In some examples, the electrode system 2604 has a diameter of about 25mm in the expanded state. The fixation system 2602 and the electrode system 2604 may be coupled at, for example, a proximal end. In some examples, the electrode system 2604 is movable relative to the fixation system 2602. Deploying the catheter (target site, then fixation system, then electrode system) in a serial fashion may allow for smaller catheter diameters and flexibility (e.g., compared to integrated or combined systems).

To revoke the system, the steps may be reversed, with some of the access steps omitted. For example, the sheath 2606 may be advanced distally to capture the electrode system 2604, e.g., due to a tether 2605, to help drag the electrode system 2604 into the sheath 2606. The sheath 2606 including the electrode system 2604 may then be withdrawn. The fixation catheter 2620 may be advanced by a tether 2622 to capture the fixation system 2602, and the fixation catheter 2620 including the fixation system 2602 may be withdrawn. Dimensions in this example method are not intended to be limited to any particular example (e.g., see other dimensions provided herein for these types of elements).

In some examples, a single catheter may include fixation system 2602 and electrode system 2604 (e.g., allowing integration of fig. 26E-26H). In some examples, the fixation system 2602 may be proximal to the electrode system.

In some examples, the fixation system 2602 may be anchored in the distal right pulmonary artery (e.g., to deliver the fixation catheter 2620 as far as possible between deploying the fixation systems 2602), and the electrode system 2604 may be deployed at a more proximal location. The fixation in the distal right pulmonary artery is more stable and/or repeatable. The electrode system 2604 can be repositionable (e.g., can slide, rotate) to map without modifying the position of the fixation system 2602. The proximal hub may include a locking mechanism to hold the electrode system 2604 in the set position and/or the proximity device may secure the electrode system 2604.

Fig. 27A is a perspective view of another example of a fixation system 2700. Fig. 27B is an elevation view of a portion of the fixation system 2700 of fig. 27A. Fixation system 2700 includes fixation structure 2702 and fixation mechanism 2504. The fixation structure 2702 may, for example, comprise a hypotube that has been cut and shape set, a ribbon that has been shape set, or the like. The retaining structure 2702 can be shaped to flare radially outward, for example, when unconstrained by the catheter 2706. The securing mechanism 2704 is shown as including a conical structure, but may include other shapes, such as dots or barbs. Fixation system 2704 is coupled to fixation structure 2702 by fixation arm 2703. In some examples, the fixation arm 2703 may be integral or unitary with the fixation structure 2702, e.g., milled from the fixation structure 2702. In some examples, securing arm 2703 has the same thickness as securing structure 2702. In some examples, securing arm 2703 has a different thickness than securing structure 2702, e.g., to provide different collapse characteristics. In some examples, the fixation arm 2703 may be separately formed and then coupled to the fixation structure 2702, such as by being coupled to the fixation structure 2702 by welding, brazing, or the like, in a hole or bore that has been milled in the fixation structure 2702. In some examples, securing arm 2703 may be integral or monolithic with securing mechanism 2704, e.g., both milled from the same piece of material (e.g., securing structure 2702). In some examples, securing arm 2703 may be formed separately and then coupled to securing mechanism 2704, such as by welding, brazing, or the like. Securing arms 2703 are configured to flare radially outward from securing structure 2702 when unconstrained. Securing arm 2703 includes a curved shape such that when securing arm 2703 is constrained, for example, by catheter 2706, securing mechanism 2704 is radially inward from securing structure 2702 or below an outer surface of securing structure 2702.

Fig. 27C-27F illustrate the fixation system 2700 of fig. 27A retracted after engagement with the tissue 2708. Prior to the state shown in fig. 27C, the system is advanced to the fixation site. System 2700 is advanced out of catheter 2706, e.g., into and out of the side or end of catheter 2706. When unconstrained by catheter 2706, retaining structure 2702 can splay radially outward. When unconstrained by catheter 2706, retaining arms 2703 can splay radially outward from retaining structure 2702 and engage tissue 2708. For example, securing arm 2703 may pivot or rotate at the point where securing arm 2703 contacts securing structure 2702. In fig. 27D-27F, catheter 2706, which is advanced through securement arm 2703, causes securement arm 2703 to flex radially inward until securement mechanism 2704 is radially inward from securement structure 2702 or below the outer surface of securement structure 2702, as shown in fig. 27F. In fig. 27D, fixation structure 2704 is pulled out of tissue 2708 in the same direction as the initial interaction with tissue 2708, which can be gentle to tissue 2708 (e.g., reduce or prevent endothelial damage, such as lacerations, tears, abrasions, etc.).

Fig. 27G is a front view of yet another example of a fixation system 2750. Fixing system 2750 is similar to fixing system 2700 in that it includes a fixing structure 2752, a fixing mechanism 2754, and a fixing arm 2753, but fixing arm 2753 is not configured to move relative to fixing structure 2752. Fig. 27G also shows a securing arm 2753 having an end shape configured to correspond to the shape of the base of securing mechanism 2754 (e.g., annular for conical securing mechanism 2754). Fig. 27H is a side view of securing system 2750 of fig. 27G. Fixed arm 2753 is spaced radially inward from an outer surface of fixed structure 2752 by a first cavity 2755. Fixed arm 2753 is spaced radially outward from an inner surface of fixed structure 2752 by a second cavity 2757. When fixation system 2750 is pressed against tissue, some tissue may enter cavity 2755 and interact with fixation mechanism 2754. Second cavity 2757 may allow securing arms 2753 to flex or flex radially inward. When fixation system 2750 is pried away from the tissue (e.g., by retracting fixation structure 2752 into the catheter), the tissue may exit cavity 2755 and cease interacting with the tissue.

Fig. 27I is a side view of yet another example of a securing system 2760. Fixing system 2760 is similar to fixing system 2750, including fixing structure 2762, fixing mechanism 2764, and fixing arm 2763, but fixing arm 2763 is not configured to meander. Fixed arm 2763 is spaced radially inward from an outer surface of fixed structure 2762 by first cavity 2755, but is not spaced radially outward from an inner surface of fixed structure 2752 by a second cavity. When fixation system 2760 is pressed against tissue, some tissue may enter cavity 2765 and interact with fixation mechanism 2764. The absence of a second cavity may allow the fixation arm to remain solid, which may increase the likelihood of tissue engagement. When fixation system 2760 is pried away from the tissue (e.g., by retracting fixation structure 2762 into the catheter), the tissue may exit cavity 2765 and cease interacting with the tissue.

Fig. 28A is a side view of an example of a fixation system 2800. The fixation system 2800 includes a fixation structure 2802, a distal fixation mechanism 2804a, and a proximal fixation mechanism 2804 b. The distal fixation mechanism 2804a extends distally from a distal end of the fixation structure 2802 (e.g., a distal end of a cell formed by the struts of the fixation structure 2802). The distal fixation mechanisms 2804a are splayed radially outward in the expanded position. Upon retraction of the fixation structure 2802 (e.g., into a catheter), the distal fixation mechanism 2804a flexes radially inward from the proximal end to the distal end. The proximal fixation mechanism 2804b extends proximally from a middle portion of the fixation structure 2802 (e.g., the proximal end of a cell formed by the struts of the fixation structure 2802). The proximal fixation mechanisms 2804b are radially outwardly flared in the expanded position. Upon retraction of the fixation structure 2802 (e.g., into a catheter), the proximal fixation mechanism 2804a flexes radially inward, as described in further detail herein. Fig. 28B is an enlarged view of the circle in fig. 24A to better illustrate the radially outward flexing of the proximal fixation mechanism 2804B (e.g., for other contours of the fixation system 2800). The securing mechanism 2804 is shaped to extend beyond the walls of the securing mechanism 2802.

Fig. 28C is a partial front view of the fixation system 2800 of fig. 28A. The proximal fixation mechanism 2804b is coupled to the fixation structure 2802 at attachment point 2812. The proximal fixation mechanism 2804b may be integral or monolithic with the fixation structure 2802 (e.g., cut from the same hypotube, e.g., as described with respect to fig. 28F). The strand proximate to attachment point 2812 is tether 2808 which includes twists or buckles 2810. When cutting the hypotube to form the attachment point 2812, the proximal fixation mechanism 2804b, the tether 2808, the cell strut, etc., the attachment point 2812 naturally becomes radially offset (e.g., naturally wants to remain straight due to the large mass) such that the proximal fixation mechanism 2804b is slightly radially inward from the cell strut and tether 2808. A similar phenomenon occurs at the connecting strut 2817 (fig. 28A) between the cells. The cut hypotube may be a shape set including, but not limited to: spreading the fixation structure 2802 radially outward from a proximal end to a distal end, spreading the fixation mechanisms 2804a,2804b radially outward from the fixation structure 2802 (e.g., so that the fixation mechanisms 2804a,2804b stand upright compared to the fixation structure 2802), and twisting the tether 2808.

Fig. 28D shows an example of a radiopaque marker 2814 coupled to the proximal fixation mechanism 2804 b. The radiopaque marker 2814 can include a band, identifiable shape (e.g., rectangular, circular, etc.). In some examples, radiopaque member 2814 protrudes outward from proximal fixation mechanism 2804 b. In some examples, radiopaque member 2814 is flush with proximal fixation mechanism 2804 b. Other portions of fixation system 2800 may include radiopaque markers (e.g., other proximal fixation mechanisms 2804b, distal fixation structures 2804a, fixation structures 2802, tethers 2810, etc.).

Fig. 28E shows an example of a hole or opening or bore 2816 in the proximal fixation mechanism 2804 b. In some examples, the holes 2816 can be used to attach other components (e.g., radiopaque markers, fixation elements, such as conical members, barbs, fixation arms, etc.), for example, by crimping, welding, etc. Attaching certain structures may provide better control over certain properties (e.g., shape settings). In some examples, hole 2816 can help capture tissue, e.g., an edge of hole 2816 proximate to the tissue penetrates hole 2816.

Fig. 28F is an expanded view of an example of a hypotube cutting pattern 2820. The cutting pattern 2820 includes a tether 2808, an attachment point 2812, a proximal fixation mechanism 2804b including a hole 2816, a fixation mechanism 2802, and a distal fixation mechanism 2804 a. The cutting pattern also shows a sloped or tapered region 2822. The tapered region 2822 may engage the distal end of the catheter during retraction and may help rotate the proximal fixation mechanism 2804 b. In some examples, the sheet may be cut and rolled into a tube (e.g., an initial shape set as a cylinder and then a shape set or a direct shape set). The cut hypotube can be shaped, for example, as shown in fig. 28A.

Fig. 28G is an enlarged view of the dashed box 28G in fig. 28F. The struts adjacent the proximal fixation mechanism 2804b may flex at an angle, among other ways of shape setting described herein. Fig. 28H is a side view of the post 2824 of fig. 28G. The proximal end 2826 of the proximal fixation mechanism 2804b and the distal end 2828 of the proximal fixation mechanism 2804b are shown in phantom behind the post 2824. Fig. 28I is a side view of the proximal fixation mechanism 2804b flexed radially outward. Fig. 28J is a side view of the proximal fixation mechanism 2804b flexed radially outward and the strut 2824 flexed at the flexion point 2830. Referring again to fig. 28H, the length x of the proximal fixation mechanism 2804b is shown. In some examples, flexion point 2830 is about 50% ± 20% of x (e.g., about 20% of x, about 30% of x, about 40% of x, about 50% of x, about 60% of x, about 70% of x, ranges between such values, etc., as measured from proximal 2826 or distal 2826). The more proximal the flexion point 2830, the more radially outward the proximal fixation mechanism 2804b protrudes. The more distal the flexion point 2830, the less the proximal fixation mechanism 2804b protrudes radially outward. The angle of the portion of the post 2824 proximal to the flex point 2830 relative to the portion of the post 2824 distal to the flex point 2830 is between about 20 ° and about 50 ° (e.g., about 20 °, about 30 °, about 40 °, about 50 °, a range between such values, etc.). In some examples, the distance y between the distal end of the proximal fixation mechanism 2804b and the portion of the strut 2824 distal of the flexion point (or, in fig. 28I, the un-flexed strut 2824) in the unconstrained state is between about 0.02 inches and about 0.06 inches (e.g., about 0.02 inches, about 0.03 inches, about 0.04 inches, about 0.05 inches, about 0.06 inches, ranges between such values, etc.), although factors such as vessel diameter, length x, etc. may affect the distance y.

Fig. 28K is a side view of the strut 2824 flexed at the flex point 2830. In contrast to fig. 28J, the proximal fixation mechanism 2804b is not flexed, but other parameters (e.g., flex angle, location of flex point 2830, distance y, etc.) may remain the same.

Fig. 28L-28O illustrate the proximal fixation mechanism 2804b rotated inward during retrieval into the catheter 2806. In fig. 28L, the stationary system 2800 is fully deployed. The proximal fixation mechanism 2804b stands upright. The distal fixation mechanism 2804a is also upright, providing bi-directional fixation. In fig. 28M, the fixation system 2800 is beginning to be withdrawn into the catheter 2806. The proximal fixation mechanism 2804b is still upright. In fig. 28N, the fixation system 2800 is further withdrawn into the catheter 2806. As the distal end of the catheter 2806 interacts with the tapered portion 2822, the proximal fixation mechanism 2804b is still rotated inward. In fig. 28O, the fixation system 2800 is further withdrawn into the catheter 2806. The proximal fixation mechanism 2804b is positioned within the catheter 2806 except at the distal end. No snags, scrapes, etc. occur during retraction. Further retraction of the fixation system 2800 places the fixation structure 2802 and distal fixation mechanism 2804a in the catheter 2806.

Pointing the proximal fixation mechanism 2804b distally may allow for improved performance during retrieval of the fixation system 2800 (e.g., reducing the probability of the proximal fixation mechanism 2804b, or any other portion of the fixation system 2800, being snagged by the distal end of the conduit 2806). Because the proximal fixation mechanism 2804b articulates radially inward upon retrieval, the proximal fixation mechanism 2804b may have little concern for scratching and/or engaging the inner surface of the catheter 2806 during deployment or retrieval. The degree to which the proximal fixation mechanism 2804b flexes inward during retrieval may be controlled by, for example, the location of the flexion point 2830, attachment point 2812, and/or flexion of the proximal fixation mechanism 2804 b. The distal end may include a distal fixation mechanism 2804a, which may provide resistance to distal movement.

In some examples, the securing mechanisms described herein may take the form of a textured surface. For example, material may be added to and/or removed from the securing arms or securing structures to form stippled, striped, roughened, etc. surfaces. Texturing may increase the surface area, which may increase the amount of tissue being joined.

Fig. 29A shows an example of a catheter system 2900. Catheter system 2900 includes a sheath 2906, a first loop 2902 extending from a distal end of sheath 2906, and a second loop 2904 extending from a distal end of sheath 2906. At least one of the first ring 2902 and the second ring 2904 includes a plurality of electrodes 2908. In some examples, catheter system 2900 includes securement feature 2910 (e.g., including an atraumatic hard ring).

Fig. 29B-29F illustrate an exemplary method of deploying the catheter system 2900 of fig. 29A. In fig. 29B, the sheath 2906 has been advanced past the pulmonary valve 2928 into the pulmonary trunk 2922. The pulmonary valve 2928 is a tricuspid valve. In some examples, the sheath 2906 may have a shape configured to interact with the tricuspid of the pulmonary valve 2928. The sheath 2906 may include a pressure sensor proximate the distal end to assist the user in determining when the distal end of the sheath 2906 is distal of the pulmonary valve 2928. Fig. 29A also shows a right pulmonary artery 2924, a left pulmonary artery 2926, a bifurcation 2925 between the right and left pulmonary arteries 2924, 2926, and a target nerve 2920 (e.g., a right star-shaped CPN).

In fig. 29C, the loop 2902,2904 is deployed from the distal end of the sheath 2906. In some examples, rings 2902,2904 are deployed substantially simultaneously, which may reduce delivery complexity, e.g., using a single actuation mechanism with a short delivery throw. In some examples, loops 2902,2904 may be deployed sequentially, serially, or interleaved with either loop being deployed first, which may reduce the profile of catheter system 2900. Ring 2902,2904 may be in any rotational orientation.

In fig. 29D, sheath 2906 is advanced toward bifurcation 2925 with ring 2902,2904 deployed. Regardless of the initial rotational orientation of ring 2902,2904, ring 2902,2904 self-orients into right pulmonary artery 2904 and left pulmonary artery 2906. For example, catheter system 2900 may rotate during distal advancement in response to ring 2902,2904 interacting with the anatomical structure.

In fig. 29E, the sheath 2906 is advanced further distally toward the bifurcation 2925. The ring 2902,2904 may be advanced further into the right and left pulmonary arteries 2924 and 2926, respectively, but the advancement is limited by the bifurcation 2925. In fig. 29F, the securement feature 2910 may optionally be deployed from the sheath 2906, such as proximate to the pulmonary valve 2928. The securing feature 2910 may bias the sheath 2906 distally toward the bifurcation 2925, which may limit distal advancement. In some examples, the fixation feature 2910 includes a shape memory material such as nitinol. Blood flow is in the distal direction, which may help maintain the position of the ring 2906. In some examples, the sheath 2906 may include features (e.g., fins, balloons, etc.) for interacting with blood flow.

The electrode 2908 of the first loop 2902 and the electrode 2908 of the second loop 2904 may be activated according to a predetermined or logical sequence used to determine which loop 2902,2904 may modulate the target nerve 2910. Selected rings of electrodes 2908 may be used for neuromodulation while other rings of electrodes 2908 may be deactivated.

In some examples, only the first ring 2902 includes an electrode 2908. Second ring 2904 may still provide self-orientation and interaction with bifurcation 2925. The electrodes 2908 of the first loop 2902 may be activated according to a predetermined or logical sequence used to determine whether the first loop 2902 may modulate the target nerve 2910. If the first loop 2902 is determined to be unable to accommodate the target nerve 2910, the catheter system 2900 may be repositioned (e.g., including, for example, rotated 180 °) so that the first loop 2902 is located in the other of the right and left pulmonary arteries 2924 and 2926.

In some examples, rather than ring 2902,2904, the catheter system includes two fingers with a pull end. The tap end may provide the same benefits as ring 2902,2904, such as bifurcation interaction, and reduce potential problems, such as poking the vasculature, buckling, etc.

In some examples, none of rings 2902,2904 include an electrode 2938. In some such examples, the electrode 2938 can be disposed on the sheath 2906. Fig. 29G shows an example of a catheter system 2930. The catheter system 2930 includes a sheath 2906, a first loop 2902 extending from a distal end of the sheath 2906, and a second loop 2904 extending from a distal end of the sheath 2906. The sheath 2906 includes a plurality of electrodes 2938. In some examples, the catheter system 2930 includes a fixation feature 2910 (e.g., including an atraumatic hard ring). Ring 2902,2904 may inhibit or prevent distal migration and/or fixation feature 2910 may inhibit or prevent proximal migration. Catheter system 2930 may be positioned as described with respect to catheter system 2900, e.g., delivered distal to a pulmonary valve, ring 2902,2904 deployed, and advanced toward a bifurcation where one ring 2902 extends into one branch vessel and the other ring 2904 extends into the other branch vessel.

The electrode 2938 may be annular, partially annular, point, etc. In some examples, such as where the electrode 2938 is located on a side of the sheath 2906, the electrode 2938 may be activated according to a predetermined or logical sequence to determine whether to capture a target nerve. If the target nerve is not captured, the catheter system 2930 can be repositioned (e.g., including rotating, e.g., 180 °) so that the first loop 2902 is located in the other of the right and left pulmonary arteries 2924 and 2926. In some examples where one or both of rings 2902,2904 includes an electrode 2908, sheath 2908 may include an electrode 2938.

In some examples, an electrode separate from ring 2902,2904 may be deployed from catheter 2906. For example, the catheter systems described herein provide a matrix of electrodes that can be deployed from one side of the catheter and/or one end of the catheter. In some such examples, loop 2902,2904 may be used to orient and position catheter 2906 at a target site, where the electrode matrix may then be deployed from catheter 2906.

In some examples, at least one of loops 2902,2904 may be modified instead of a plain loop, e.g., as described herein with respect to other catheter systems. In some examples, each of rings 2902,2904 may be modified differently.

Fig. 29H shows an example of a catheter system 2940. The catheter system 2940 includes a sheath 2906, a first loop 2942 extending from a distal end of the sheath 2906, and a second loop 2904 extending from a distal end of the sheath 2906. The first ring 2942 includes a first wire 2943a and a second wire 2943 b. Each of the wires 2943a, 2943b includes an electrode 2948, forming an electrode matrix. Distal to the distal end of the sheath 2906, the first and second wires 2943a and 2943b are spaced to form a gap 2943c that spaces the electrodes 2948 on the wires 2943a from the electrodes 2948 on the wires 2943 b. More wires and electrodes are possible. For example, a third wire may extend between the first wire 2943a and the second wire 2943 b. The electrode 2948 is shown as a button electrode, but other types of electrodes are possible (e.g., a tube, within a U-shaped channel, etc.).

In some examples, the catheter system 2940 includes a securement feature 2910 (e.g., including an atraumatic hard ring). Catheter system 2940 may be positioned as described with respect to catheter system 2900, e.g., delivered distal to a pulmonary valve, deployed ring 2942,2904, and advanced toward a bifurcation where one ring 2942 extends into one branch vessel and the other ring 2904 extends into the other branch vessel.

Fig. 29I shows an example of a catheter system 2950. The catheter system 2950 includes a sheath 2906, a first loop 2952 extending from a distal end of the sheath 2906, and a second loop 2904 extending from a distal end of the sheath 2906. The first ring 2952 comprises a wire having an undulating or saw-tooth shape or a sinusoidal or wave shape. The first ring 2952 includes electrodes 2958 at the peaks and valleys, forming an electrode matrix. The electrode 2958 may also or alternatively be located between the peaks and valleys. The first ring 2952 may include additional wires and/or electrodes. For example, a second wire, which may be straight, sinusoidal, or otherwise shaped, may extend along the first wire. The electrode 2958 is shown as a button electrode, but other electrode types are possible (e.g., a tube, within a U-shaped channel, etc.). In some examples, the sinusoidal shape may be in a plane configured to be laterally proximate to the vessel wall. In some such examples, the electrodes are at sinusoidal peaks, which may provide increased or optimal vessel wall contact. In some examples, the sinusoidal shape may increase stiffness, which may improve wall proximity, e.g., as compared to a straight shape.

In some examples, the catheter system 2950 includes a fixation feature 2910 (e.g., including an atraumatic hard ring). Catheter system 2950 may be positioned as described with respect to catheter system 2900, e.g., delivered distal to a pulmonary valve, ring 2952,2904 deployed, and advanced toward the bifurcation where one ring 2952 extends into one branch vessel and the other ring 2904 extends into the other branch vessel.

Several processes described herein are provided for the following: into the pulmonary trunk and then into the right and/or left pulmonary arteries, or more generally into a main or afferent vessel and into one or more efferent or branch vessels. In some examples, the catheter system may be accessed from a branch vessel and advanced toward the main vessel and/or another branch vessel. For example, the catheter system may be inserted into the right internal jugular vein and advanced toward the superior vena cava. As another example, the catheter system may be inserted into the left internal jugular vein and advanced toward the left brachiocephalic vein.

Fig. 29J shows another example of a catheter system 2960. The catheter system 2960 includes a sheath 2906 and a ring 2962. The ring 2962 is configured to extend from the distal end of the sheath 2906 and flex back proximally toward the sheath. In some examples, ring 2962 may include an electrode, e.g., as described with respect to catheter system 2900. In some examples, the catheter system 2960 includes a fixation feature 2910 (e.g., including an atraumatic hard ring). For example, as described with respect to the catheter system 2930, the sheath 2906 includes an electrode 2968. In some examples, the catheter system 2960 includes a sheath electrode 2968 and an electrode on the ring 2962.

Fig. 29K shows another example of a catheter system 2965. The catheter system 2965 is similar to the catheter system 2960, except that the ring 2963 is configured to extend from one side of the sheath 2906 through the aperture 2907 and flex proximally. In some examples, the aperture 2907 may include a turning feature, such as a ramp.

29L-29N illustrate an exemplary method of deploying the catheter system 2965 of FIG. 29K. The exemplary method may also or alternatively be used to deploy the catheter system 2960 of fig. 29J or other catheter systems. The vasculature shown in fig. 29L-29N includes a left innominate or left brachiocephalic vein 2955, a left subclavian vein 2961, and a left internal jugular vein 2964, described in further detail herein with reference to fig. 2I, but other methods may be applicable to other vessel or other luminal bifurcations. Depending on the relative size of the vessel, etc., the catheter system may be adapted to better interact with Y-bifurcations, T-bifurcations from afferent vessels, efferent vessels. In some examples, such a catheter system may advantageously position the catheter at the anatomical connection with certainty. Some such anatomical connections may have a known transit nerve, which may allow a user to position the electrode at a precise location with reduced or minimal or no visualization (e.g., fluoroscopy) and/or guidance (e.g., using a guidewire and/or guiding catheter). In some examples, the Y or T anatomy may help ensure that the catheter and electrodes remain fixed in place.

In fig. 29L, the catheter system 2965 is located in the left internal jugular vein 2964, which may be the point at which the introducer enters the vasculature. The catheter system 2965 is advanced toward the left brachiocephalic vein 2955. The ring 2963 is deployed from the sheath 2906 at least during advancement through the connection of the left subclavian vein 2961 and the left internal jugular vein 2964. As the sheath 2906 is advanced within the left internal jugular vein 2964, the ring 2963 compressively slides inward along the wall of the left internal jugular vein 2964.

In FIG. 29M, the catheter system 2965 is advanced far enough so that the ring 2963 is unconstrained and able to expand outward to a set shape. In FIG 29N, the catheter system 2965 is retracted until the ring 2963 contacts the left subclavian vein 2961. The catheter system 2965 may be repeatably placed at the junction between the left subclavian vein 2961 and the left internal jugular vein 2964. In some examples, placement may be performed without fluoroscopy, e.g., using distance and/or tactile changes to determine that the catheter system 2965 is properly positioned. The fixation feature 2910 may optionally be deployed from the sheath 2906, e.g., proximate to a connection in the left internal jugular vein 2964. The electrode 2968 may be positioned along the sheath 2906 to capture the target nerve 2921. The target nerve 2921 may include, for example, a thoracic cardiac branch nerve. In some examples, the target nerve 2921 is a cervical cardiac nerve. The cervical cardiac nerve may also or alternatively be targeted from the left internal jugular vein 2964. In some examples, the catheter system 2965 includes features that may help capture the target nerve. For example, the sheath 2906 may include a curvature that flexes toward the location 2921, the catheter system 2965 may include a second loop that includes an electrode and is configured to be deployed out of a distal end or side of the sheath 2906 in a direction opposite the loop 2963, and/or the electrode 2968 may be longitudinally aligned with the aperture 2907 and/or distally aligned with the aperture 2907.

Fig. 30A is a perspective view of an example of the electrode system 3000. System 3000 includes a catheter 3006, a frame 3002, and a plurality of electrodes 3008. Fig. 30B is a top plan view of a portion of the electrode system 3000 of fig. 30A. The catheter 3006 includes a proximal section 3010 having a generally circular cross-section and a distal section 3012 having a generally elliptical cross-section. The circular shape of the proximal end section 3010 may be useful, for example, for coupling to a circular proximal component, e.g., a luer fitting, other circular catheter, etc. The elliptical shape of the distal section 3012 may be useful, for example, to preferentially align near a target region, which may reduce or minimize the distance from the sheath 3006 to the target region. The elliptical shape of the distal section 3012 may be useful, for example, to resist torque and rotation. The frame 3002 may include two shape memory (e.g., nitinol) wires, for example, formed in a zigzag or undulating or sinusoidal pattern or serpentine to create an undulating frame or folded shape. The frame 3002 may be substantially horizontal or planar, or may include a bend, for example, to bias or conform to a vessel wall. Leads or wires coupling the electrodes 3008 to the conditioning system may extend along the frame 3002 and/or through the frame 3002.

The electrode 3008 includes buttons coupled to the frame 3002. In some examples, the diameter of the electrode 3008 is between about 1mm and about 3mm (e.g., about 1mm, about 1.5mm, about 2mm, about 2.5mm, about 3mm, ranges between such values, etc.). As shown in phantom in fig. 30B, the electrodes 3008 are longitudinally offset to sequentially nest in the catheter 3006 prior to deployment and/or upon retraction, which can reduce the profile of the catheter. In some examples, at least some of the electrodes 3008 may be side-by-side. In some examples, one side of electrode 3008 is insulated, which can provide a directional electrode 3008. The electrode 3008 can be coupled to the frame 3002 to inhibit rotation of the electrode 3008, e.g., to maintain a surface of the electrode 3008 substantially horizontal or planar. Interaction with tissue (e.g., a vessel wall) can induce frame 3002 to buckle before inducing electrode 3008 to rotate.

Fig. 30C is a perspective view of another example of electrode system 3020. Similar to system 3000, system 3020 includes a catheter 3006, a frame 3002, and a plurality of electrodes 3028. Fig. 30D is a distal end view of electrode system 3020 of fig. 30C in a collapsed state. Fig. 30E is a distal end view of electrode system 3020 of fig. 30C in an expanded state. The expanded state shown in fig. 30C and 30E is partially expanded because some of the electrodes 3028 are still in the catheter 3006. As determined by the user, a selected number of electrodes 3028 may be deployed (e.g., based on the anatomy of the subject, instructions, etc.).

Electrode 3028 includes a tube shape coupled to frame 3002. Frame 3002 may include longitudinal sections rather than peaks to accommodate the length of electrode 3008, and flexures in frame 3002 may maintain the longitudinal positioning of electrode 3028. In some examples, the diameter of electrode 3028 is between about 0.01 inches and about 0.1 inches (e.g., about 0.01 inches, about 0.02 inches, about 0.03 inches, about 0.04 inches, about 0.05 inches, about 0.06 inches, about 0.08 inches, about 0.1 inches, ranges between such values, etc.). In some examples, the length of electrode 3028 is between about 0.02 inches and about 0.2 inches (e.g., about 0.02 inches, about 0.03 inches, about 0.04 inches, about 0.05 inches, about 0.06 inches, about 0.07 inches, about 0.08 inches, about 0.09 inches, about 0.1 inches, about 0.12 inches, about 0.15 inches, 0.2 inches, ranges between such values, etc.). Edge electrodes 3028 are laterally side-by-side, which may provide certain electrode combination patterns (e.g., as discussed with respect to fig. 32A-32D). In some examples, the central electrode 3028 may be a cathode and the four closest lateral electrodes 3028 may be anodes. In some examples, electrode 3028 may be laterally offset (e.g., similar to electrode 3008). In some examples, the circumferential arc of electrode 3028 is insulated, which may provide a directional electrode 3028. Electrode 3028 may be coupled to frame 3002 to inhibit rotation of electrode 3028, e.g., to keep the non-insulated surface of electrode 3028 facing in a certain direction. Other shapes of electrode 3028 are possible (e.g., cylindrical, spherical).

System 3020 includes an optional core component 3024. The core element may, for example, help carry the wires and/or maintain the shape of the frame 3002. In some examples, core element 3024 comprises a round tube (e.g., a hypotube). In some examples, core element 3024 is flat or ribbon-like, rectangular, oval, or other shape. In some examples, the core element 3024 is laterally offset from the center of the frame 3002.

Fig. 30F is a plan view of yet another example of an electrode system 3030. Similar to system 3000, system 3030 includes a frame 3002 and a plurality of electrodes 3038. The system 3030 includes a sheet or film or mesh 3032. Unlike systems 3000, 3020, the electrodes 3038 of system 3030 are located on a sheet 3032 comprising a flexible material (e.g., polyimide, silicone). The sheet 3032 may include, for example, a flexible circuit including patterned conductive lines. The sheet 3032 may include a mesh, for example, as described with respect to fig. 4C. The sheet 3032 holding the electrodes 3038 may provide control over the relative position and spacing of the electrodes 3038.

The system 3030 optionally includes a core component 3034. The frame 3032 may be coupled to the core element 3034, for example, as a separate V-shaped section. The sheet 3032 is coupled to the frame 3002 and, optionally, to the core element 3034. In some examples, the frame 3002 and the sheet 3034 wrap around the core element 3034 in a collapsed state. The system 3030 may be delivered in a collapsed state without a catheter (e.g., tracking the core member 3034 via a guide wire or tether), for example, if the sheet 3032 at least partially thermally insulates the frame 3002 such that thermal shape memory is slow to effect. Fig. 30G is a distal end view of the electrode system 3030 of fig. 30F. In the deployed state, as best shown in fig. 30G, the sheet 3032 has a curved shape, which can help hold the electrodes 3038 against the vessel wall.

Fig. 31A and 31B show example electrode combinations of nine electrodes in a 3 × 3 matrix. Other numbers of electrodes and matrix patterns may be used and a 3 x 3 matrix is shown for discussion purposes only. In examples where the power source is off-subject, the energy budget may not be as interesting as accurate tissue neural targeting. A series of combinations in which the first electrode is a cathode and the second electrode is an anode can be tested to see which combinations provide a particular effect (e.g., affecting contractility and/or relaxation and/or not affecting heart rate). The subject may provide input regarding pain, coughing, general discomfort, tingling and/or other sensations during the procedure to give the system feedback as to which electrode combinations cause these effects. Contractility and/or relaxation responses may be measured, for example, by pressure sensors, accelerometers, or other contractility and/relaxation measurements, including external tools such as echoultrasound.

Fig. 31A shows an example sequence of twelve combinations in which one electrode is an anode and one electrode is a cathode. Each combination may operate, for example, for 4ms and then substantially immediately follow the next combination in the sequence. If the initial run is successful, the sequence may be repeated, for example, after about 50ms (20 Hz). After running the sequence of tests 1-12, electrode combinations with effects above or below a particular threshold may be identified for use and/or non-use in calibration stimulation and/or therapeutic stimulation. This can automate the mapping of nerve locations and increase or optimize the stimulation response for efficacy and tolerance. Fig. 32A shows that other combinations of these same electrodes are possible, e.g., electrodes in the middle, diagonal, etc. The same sequence or shorter sequences (e.g., including tests 1,2,7, and 8) may be used to verify localization on a macroscopic level (e.g., certain electrode combinations in the matrix location provide stimulation), e.g., at initial localization, at repositioning, and/or periodically, to check for matrix migration.

In some examples, a unipolar mode may be used to find nerves faster before a bipolar combination of electrodes, where one electrode in the matrix becomes the cathode and the anode body patch (or vice versa) is on the chest, back, or arm of the subject, and then the bipolar or guard bipolar or bullseye (e.g., as discussed herein) combination may be used to more selectively capture nerves.

In some examples, multiple sequences may be available (e.g., with at least one different electrical parameter or electrode combination sequence). For example, if a first sequence results in more than a threshold number of undesired responses, a second sequence may begin, and so on. The system may return to the initial sequence based on the results of the other sequences.

Sequences of the following combinations are also possible: wherein the plurality of electrodes are cathodic and one electrode is cathodic, wherein one electrode is anodic and the plurality of electrodes are cathodic, and wherein the plurality of electrodes are anodic and the plurality of electrodes are cathodic.

Electrical stimulation may produce noise on the ECG. Some parameters that can be used to reduce or minimize the noise caused by stimulation include stimulation vector, amplitude, pulse width, and/or frequency. Fig. 31Ci to 31Cxi show an example method of setting a stimulation vector. Prior to fig. 31Ci, electrode 3102 has been established to be able to capture a nerve when used as a cathode, for example, using the systems and/or techniques described herein. The stimulation vector can be set by a line between the cathode 3102 and the electrode acting as an anode. In some examples, the electrodes around the cathode 3102 are tested for a stimulation vector that is orthogonal to the primary ECG vector, which is the physical vector between the two ECG leads. The master ECG vector can be the ECG vector that is being displayed on the hospital monitor and/or the ECG vector that is being used by the hospital monitoring system to detect abnormalities in the ECG, such as arrhythmias or other undesirable changes. In some examples, the master ECG vector can be an ECG vector being monitored by another device that records cardiac electrical activity, such as an implantable cardiac defibrillator. Finding and setting a stimulation vector orthogonal to the primary ECG vector can, for example, reduce the amount of stimulation noise interference seen on the ECG signal. Without being bound by any particular theory, it is believed that the stimulation creates an electric field in the body that creates a voltage that is recorded on the ECG vector, and thus, if the stimulation is parallel to the ECG vector, the stimulation field adds to the field created by the cardiac electrical signal and creates detectable (e.g., visible) noise on the main ECG signal.

If the stimulation vector is orthogonal to the ECG vector, and an isotropic homogeneous medium is assumed in which the conductivity is the same in all directions, no voltage is applied to the ECG vector and has no effect, no noise is generated, and/or is not displayed on the ECG signal. In fact, the human body includes various tissue types and is not isotropic or homogeneous. Positioning the stimulation vector as orthogonal as possible to the primary ECG vector can result in reduced noise on the ECG. If the primary ECG vector is known a priori, the test can be reduced to include or only include stimulation vectors that are approximately orthogonal to the primary ECG vector. In some examples, a trial-and-error process may be used to adjust the stimulation vector to reduce or minimize noise on the ECG.

In fig. 31Ci, the first electrode 3104 serves as an anode. In fig. 31Cii, the second electrode 3106 serves as an anode. In fig. 31Ciii, the third electrode 3108 serves as an anode. In fig. 31Civ, the fourth electrode 3110 functions as an anode. In fig. 31Cv, the fifth electrode 3112 serves as an anode. In fig. 31Cvi, the sixth electrode 3114 serves as an anode. In fig. 31Cvii, the seventh electrode 3116 serves as an anode. In fig. 31Cviii, the eighth electrode 3118 serves as an anode. The electrodes 3104, 3106, 3108, 3110, 3112, 3114, 3116, 3118 provide eight different stimulation vectors approximately 360 ° around the electrode 3102. More or fewer electrodes can be used as anodes. Using more electrodes can provide additional stimulation vectors that can improve accuracy and help reduce ECG signal interference. Using fewer electrodes may provide fewer stimulation vectors, but may reduce the stimulation build-up duration and may still be sufficient to identify noise-reducing stimulation vectors. Fig. 31Ci to 31Cviii show the anode traveling around the cathode 3102 (marking). For the sake of this example, the configuration of fig. 31Civ in which electrode 3110 is anodic produces a stimulation vector 3120, which stimulation vector 3120 produces a minimal amount of ECG signal interference. This configuration may be used for therapeutic stimulation. In some examples, this configuration may be used as one of a number of factors in determining an electrode configuration for therapeutic stimulation.

In some examples, additional anodic tests may be performed depending on the electrode array. In fig. 31Cix, the ninth electrode 3122 serves as an anode. In fig. 31Cx, the tenth electrode 3124 functions as an anode. In fig. 31Cxi, the eleventh electrode 3126 functions as an anode. For example, fig. 31 Cix-31 Cxi can be a portion of the original anode travel (e.g., all electrodes in an array can be tested). In some examples, fig. 31 Cix-31 Cxi may be tested based on the test results in fig. 31 Ci-31 Cviii, which find that stimulation vector 3120 reduces ECG signal noise. For example, if the minimal ECG signal noise in fig. 31Ci to 31Cviii is produced by the stimulation vector produced using electrode 3104 as the anode, the tests shown in fig. 31Cix to 31Cxi may be omitted. For the purposes of this example, the configuration of figure 31Cx in which electrode 3124 is anodic produces a stimulation vector 3128, which stimulation vector 3128 produces a minimal amount of ECG signal interference, even less than stimulation vector 3120. This configuration can be used for therapeutic stimulation. In some examples, this configuration may be used as one of a number of factors in determining an electrode configuration for therapeutic stimulation. In some examples, fig. 31 Cix-31 Cxi can be part of the original anode travel (e.g., all electrodes in an array can be tested). In general, the smaller the distance between the anode and cathode on the stimulation vector, the less noise is generated on the ECG due to the more limited field around the active stimulation electrodes. Monopolar stimulation with the anode relatively far from the cathode can cause the most noise on the main ECG signal, while a more compact bipolar configuration with the anode in close proximity to the cathode may produce less stimulation noise on the ECG.

Other stimulation settings that can affect ECG noise include amplitude, pulse width, and/or frequency. When relatively low stimulation amplitudes and/or stimulation pulse widths are utilized, stimulation noise on the ECG may be reduced. Reducing the stimulation amplitude and/or stimulation pulse width can help reduce noise on the ECG if the therapeutic effect is maintained at a desired level. In addition to using approximately orthogonal ECG vectors, the use of reduced stimulation amplitude and/or pulse width may further reduce or minimize noise on the ECG. For example, matching the stimulation frequency to the notch filter frequency of the ECG monitor in combination with reducing the stimulation amplitude and/or stimulation pulse width and/or with orthogonal ECG vectors, as described herein, can further reduce, minimize or eliminate stimulation noise on the ECG.

Treatment efficacy may be a major consideration for electrode selection. Cathode selection may be a primary driver of treatment efficacy, such that selecting anodes for stimulation vectorization to reduce ECG noise and/or side effects may be a compatible secondary consideration. In some examples, ECG noise due to stimulation can also (e.g., in addition to stimulation vectorization orthogonal to ECG vectors) or alternatively be reduced using other systems and methods described herein.

In some examples, the system may utilize a method that: in this approach, different anodes are tested in a non-progression order, for example by focusing on a particular anode based on the results of testing other anodes. For example, if the stimulation vector produced by using electrode 3112 as the anode is found to produce greater interference than the stimulation vector produced by using electrode 3110 as the anode, the tests of fig. 31vi to 31viii may be skipped. The system may then test additional electrodes, such as electrodes 3122, 3124, with similar stimulation vectors as shown in fig. 31Cix and 31Cx (e.g., omitting electrode 3126 of fig. 31 Cxi).

In some examples, the user may use a combination of images of the electrode matrix in the subject (e.g., fluoroscopy images) that can provide some information about the orientation of the various electrodes relative to the anatomy or to each other, and knowing the location of the ECG results in skipping the testing of certain anodes. For example, cathode-anode combinations that appear substantially parallel to the ECG vector may be skipped, and/or cathode-anode combinations that appear substantially perpendicular to the ECG vector may be included or tested. The user can understand the limitations of certain image types (e.g., providing a two-dimensional image for a three-dimensional space) and thus suppress the reduction of testing.

If the apparatus for setting stimulation parameters and/or generating stimulation output has feedback on the primary ECG vector, the apparatus can use the feedback to automatically identify stimulation parameters that reduce or minimize noise on the ECG. For example, the leads of the device may be attached to the same electrodes as are used to generate the primary ECG vector. Stimulation parameters (including stimulation vector, amplitude, pulse width, and/or frequency) may be adjusted to reduce or minimize noise on the ECG and increase or maximize signal-to-noise ratio. The parameter set being tested may be limited using limits set by the user, such as cathode selection or upper and lower amplitude limits.

Fig. 32A-32D show example electrode combinations of 12 electrodes in a 3 x 4 matrix. A 3 x 4 matrix is an example, and other matrices are possible (e.g., without limitation, 2 x 2,2 x 3,2 x 4,2 x 5,3 x 3,3 x 5,4 x 4,5 x 5, transpose (e.g., 3 x 2 is a transpose of 2 x 3), etc.). In some examples, the matrix may be irregularly shaped, e.g., 2 x 2 followed by 3 x 3. In fig. 32C and 32D, the middle column is offset with respect to the left and right columns. The electrode combination of fig. 32A-32D may be referred to as a "guard bipolar" combination because the cathode is completely surrounded by the anode, or at least not adjacent to a non-anode cathode. In fig. 32A, the cathode electrode in row 2, column 2 is surrounded by the anode electrodes in row 1, row 3, and column 2, and columns 1 and 3. In fig. 32B, the cathode electrode in row 4, column 2 is surrounded by the anode electrodes in row 3 and row 4, column 1 and column 3. In fig. 32C, the cathode electrodes of column 2 from the top are surrounded by the anode electrodes in the first two of column 1 from the top, the first two of column 3 from the top, and the 1 st and 3 rd of column 2 from the top. In fig. 32C, the 1 st cathode from the bottom of the 3 rd column is surrounded by the anode electrodes in the 1 st from the bottom of the 1 st column, the 1 st from the bottom of the 2 nd column, and the 2 nd from the bottom of the 3 rd column. The guard cathode (using two or more anodes) may allow for control of the spread of the electric field, which may provide more efficient stimulation of the target nerve, and/or may reduce spillage of the electric field to non-target nerves, which spillage may lead to unexpected side effects.

In some examples, an electrode matrix may be used to electronically reposition the electrodes. For example, referring to FIG. 32A, if all anodes and cathodes are moved down one row, this would cause the cathode electrodes in row 3, column 2 to be surrounded by the anode electrodes in row 2, row 4, and column 3, columns 1 and 3. Referring again to fig. 31A, a change from test 3 to test 9, from test 1 to test 11, etc. may be considered an electronic relocation. The electrodes may thereby be electronically repositioned in multiple directions. The electrode matrix itself does not move or migrate when the electrons are repositioned. Electron repositioning may be used to counter accidental movement or migration of the electrode matrix.

In some examples, the stimulus comprises an active biphasic waveform, where the area under the curve is actively managed to zero by measuring the charge over a longer duration by pulses forcing opposite charges. In some examples, the stimulus comprises a passive biphasic waveform with the area under the curve being zero by allowing charge to dissipate from the tissue.

In some examples, the stimulus includes an amplitude between about 1mA and about 20mA (e.g., about 1mA, about 2mA, about 3mA, about 4mA, about 5mA, about 6mA, about 7mA, about 8mA, about 9mA, about 10mA, about 15mA, about 20mA, ranges between such values, etc.). Lower amplitudes may advantageously have a smaller penetration depth, which may inhibit or avoid stimulating non-targeted nerves or other tissue. Higher amplitudes may advantageously be more likely to have a therapeutic effect. In some examples, the stimulus includes a pulse width between about 0.5ms and about 4ms (e.g., about 0.5ms, about 0.75ms, about 1ms, about 1.25ms, about 1.5ms, about 1.75ms, about 2ms, about 2.25ms, about 3ms, about 4ms, ranges between these values, etc.). In some examples, a lower amplitude (e.g., less than about 10mA) may be used in conjunction with the pulse width to provide the desired effect according to the intensity-duration curve. Lower amplitudes may be advantageous with smaller penetration depths that may inhibit or avoid stimulating non-targeted nerves or other tissue. Higher amplitudes may advantageously be more likely to have a therapeutic effect. In some examples, a lower amplitude (e.g., less than about 10mA) may be used in conjunction with the pulse width to provide the desired effect according to the intensity-duration curve.

In some examples, the stimulus includes a frequency between about 2Hz and about 40Hz (e.g., about 2Hz, about 5Hz, about 10Hz, about 15Hz, about 20Hz, about 25Hz, about 30Hz, about 40Hz, ranges between these values, etc.). Low frequencies (e.g., less than about 10Hz) can advantageously have negligible effect on pain receptors, which generally respond to higher frequencies, making the subject more resistant to treatment.

In some examples, the stimulation is ramped at the beginning and/or end of the stimulation duration. For example, if the stimulation duration is 10 seconds, the initial stimulation burst may be about 50% based ON at least one parameter (e.g., ON duration, amplitude, pulse width, frequency, etc.), then increased or ramped to 60%, 70%, etc. over the course of 2 seconds until 100% is reached. After 6 seconds of 100%, the stimulation may be reduced or ramped down to 95%, 90%, etc. over the course of 2 seconds until 50% is reached, after which the stimulation may be turned off. Ramping up and/or down may reduce side effects, increase subject tolerance, and/or avoid shock to the system that may occur from an initial full burst. The duration of the ramp may be based on a percentage of the stimulation duration (e.g., 20% ramp up, 20% ramp down), an absolute duration (e.g., 2 second ramp regardless of stimulation duration), or other factors. The ramp may be linear or take some other function (e.g., decreasing steps of ramp up, increasing steps of ramp down). In examples using ramp up and ramp down, the ramp up may be different than the ramp down (e.g., the start percentage may be different than the end percentage, the ramp up duration may be different than the ramp down duration, the ramp up function may be different than the ramp down duration, etc.).

Fig. 33A is a plot of contractility versus stimulation. Starting from baseline contractility, stimulation was on for time 1. There is some time delay for the stimulation to cause a change in contractility (e.g., about 10 to 20 seconds), and then the contractility steadily rises until a fairly steady state is reached. When the contractility is turned off in time 2, there is some time delay before the contractility starts to decay. The decay delay when the stimulus is off is longer than the delay when the stimulus is on. The time during the decay ramp up to the baseline level is also less than the time from baseline. The attenuation may also decrease over time. Thus, stimulus turn-on and turn-off are not completely related to the duration of time when contractility changes.

In some examples, the stimulation is turned on for 5 seconds and then off for 10 seconds. In some examples, the stimulus is turned on for 2 seconds and then turned off for 5 seconds. In some examples, the stimulation is turned on for 10 seconds and then off for 30 seconds. In some examples, the stimulus is turned on until a substantially steady state is reached, then turned off until some contractility is reached, at which time the stimulus is turned on until a substantially steady state is again reached, and so on. This approach may reduce or minimize effective dosages. The duty cycle approach in view of this discovery may reduce the amount of time stimulation is on, which may reduce energy usage, maintain therapeutic effect, and/or reduce side effects, which may increase patient comfort and tolerability.

In some examples, a ramp feature may be used to ramp the intensity of the stimulus on and off slowly, or to turn the stimulus off quickly. The sloping features may allow the patient to adapt to the stimulus and reduce abrupt transitions. For example, at least one parameter (e.g., on-time, amplitude, pulse width, frequency, etc.) may be slowly increased and/or decreased over time until a final value is established.

In some examples, for short-term treatment, for example, the duty cycle may include alternating on for 5 seconds and off for 5 seconds for 1 hour. In some examples, for short-term treatment, for example, the duty cycle may include alternating on for 5 seconds and off for 10 seconds for 1 hour. In some examples, for short-term treatment, for example, the duty cycle may include alternating on 10 minutes and off 50 minutes for 1 hour. In some examples, for long-term treatment, for example, the duty cycle may include alternating on 1 hour and off 1 hour for 1 day. In some examples, for long-term treatment, for example, the duty cycle may include alternating on for 1 hour and on for 1 hour for 1 day. In some examples, for long-term treatment, for example, the duty cycle may include alternating on 1 hour and off 23 hours for 1 day. The on-duration in the long-term treatment may include a cycle of the short-term treatment. For example, if alternating on 1 hour and off 1 hour for 1 day, the stimulus on a duration of 1 hour may include alternating on 5 seconds and off 5 seconds for the 1 hour. In some examples, multiple different on/off cycles may be used during the long on duration, e.g., 10 second on and 10 second off for 1 minute, then 1 minute on and 5 minutes off for 10 minutes, then 10 minute on and 50 minutes off for 4 hours, for long on durations of 4 hours and 11 minutes. The short-term and/or long-term on/off cycles may be based at least in part on the patient state (e.g., awake or sleeping, lying down or upright, time since initial stimulation, etc.).

Fig. 33B is a plot of contractility versus stimulation using a threshold-based approach and optimized duty cycle. The stimulus is switched on and off for a period of time. As described above, the decay of the contractility decreases after the duration, such that the contractility remains above the threshold for a certain duration. The particular duration may be known or determined, for example, by sensing contractility. The dashed line in fig. 33B represents the time at which another duration of the stimulation cycle is determined to resume. This process may be repeated for the time the subject is treated, until recalibration, and so on.

Fig. 34 is an exemplary process flow that may be used to implement a duty cycle method, e.g., a space ratio method such as the methods described with respect to fig. 33A and 33B. Stimulation was turned on for 5 seconds, then off for 5 seconds, then repeated for 10 minutes, then off for 1 hour. The process flow of fig. 34 then begins. The physiological signal is monitored beginning with the cardiac stimulus being turned off. The baseline trend is stored. The current signal is checked for deviation from the trend by a threshold set by the physician (e.g., less than or greater than a certain amount, percentage, etc.). If the current signal does not deviate, the cardiac stimulation remains off and the physiological signal continues to be monitored and baseline trends stored until the current deviation. On the current deviation trend, the cardiac stimulation is switched on. The patient monitor report is sent to the physician. At regular intervals, the physiological signal is rechecked to see if the trend returns to baseline. If the trend does not return to baseline, the cardiac stimulation remains on. If the trend returns to baseline, the cardiac stimulation is turned off and the process begins all over again.

In some examples, the system includes one or more of: means for adjustment (e.g., electrodes or other types of stimulation catheters or delivery devices), means for fixation (e.g., barbs, prongs, anchors, tapered structures, or other types of fixation mechanisms), means for sensing (e.g., sensors integral with the catheter, sensors on a separate catheter, sensors external to the subject), and means for calibration (e.g., determining a predetermined or logical sequence of stimulation parameters).

Several examples of the invention are particularly advantageous in that they include one, several or all of the following benefits: (i) increasing contractility and/or relaxation (e.g., left ventricle), (ii) not affecting heart rate or affecting heart rate less than contractility and/or relaxation, (iii) providing an anchoring or fixation system that resists movement, (iv) and/or (x)

Fig. 35A schematically illustrates a mechanically repositionable electrode catheter system 3500. The system 3500 includes a proximal end portion handle or hub 3502. The handle 3502 includes a mechanical repositioning system 3504 that includes a track or channel or groove 3510 and a grip 3512 slidable within the groove 3510. System 3500 also includes a sheath 3506 and an electrode system 3508. The electrode system 3508 can be moved into and out of the sheath 3506. Fig. 35A shows electrode system 3508 having been expanded out of sheath 3506. The grip 3512 is coupled to the electrode system 3508 such that longitudinal and/or rotational movement of the grip 3512 results in corresponding longitudinal and/or rotational movement of the electrode system 3508. The sheath 3506 may be separately anchored in the vasculature, e.g., as described herein, such that only the electrode system 3508 moves as the grip 3512 moves.

In some examples, longitudinal movement of the grip 3512 results in the same or 1: 1 in the longitudinal direction. In some examples, gears or other mechanical devices may be used to make the ratio of movement greater than or less than 1: 1. pulleys and other mechanical devices may be used to reverse the movement of the grip 3512. Fig. 35A shows a detent groove (detent) 3522 in the sheath 3506, which can interact with a detent and/or grip 3512 coupled to the electrode system 3508, e.g., as described with respect to fig. 35B. In fig. 35A, the grip 3512 has been advanced longitudinally from a proximal position sufficient for the electrode system 3508 to deploy out of the sheath 3506.

In some examples, the electrodes of the electrode system 3508 may be stimulated to test the effect of certain electrode pairs. If none of the electrode pairs has an effect, the electrode system 3508 can be moved using the repositioning system 3504 and the test re-run. In some examples, the most distal electrode pair may have the greatest effect, but not as great an effect as might be expected. The electrode system 3508 may be advanced distally to better test the effect of the electrodes distal to the original site.

Fig. 35B shows the catheter system 3500 of fig. 35A after longitudinal advancement. In comparison to fig. 35A, grip 3512 has been advanced longitudinally a distance 3514. Movement of the grip 3512 may be manual, electronic, mechanical, a combination thereof, and the like. Electrode system 3508 has also advanced longitudinally a distance 3514. Electrode system 3508 is coupled to pawl 3520. For example, pawl 3520 can be coupled to a hypotube, a wire, or the like. When the pawl 3520 reaches a certain longitudinal position, the pawl 3520 may extend into a pawl groove 3522 in the shield 3506. The extension may produce an audible click or other recognizable sound. In some examples, multiple audible clicks (e.g., 1,2,3, or more) may notify the user that the electrode system 3508 is fully deployed. In some examples, the detent interaction may indicate that an event has occurred to provide a deterministic position, e.g., a longitudinal advancement of a particular distance (e.g., one centimeter, one inch, etc.), a longitudinal advancement sufficient to fully deploy the electrode system 3508, a longitudinal advancement to a rotational movement track, etc. System 3500 can include a plurality of pawls 3520 and/or a plurality of pawl grooves 3522. In some examples, the detent system can inhibit undesired or accidental movement of the electrode system 3508.

In some examples, rotational movement of the grip 3512 or movement of the grip 3512 transverse to the longitudinal movement may result in rotational movement of the electrode system 3508 in the same rotational or transverse direction. Twisting and turning of the sheath 3506 may result in a ratio of movement that is not 1: 1. The catheter system 3500 may include a rotational hard stop to limit rotational movement of the electrode system 3508, such as described with reference to fig. 35C and 35D.

Fig. 35C shows the catheter system 3500 of fig. 35A after longitudinal advancement and rotation. FIG. 35D is a cross-sectional view taken along line 35D-35D of FIG. 35C. In contrast to fig. 35A, grip 3512 has been advanced longitudinally and rotated. The electrode system 3508 has also advanced longitudinally and rotated. The rotation of the grip 3512 may be greater than the rotation of the electrode system 3508. In some examples, system 3500 includes a rotational hardstop 3524, such as in sheath 3506. Even if the grip 3512 is able to rotate further in the track groove 3510, the hard stop 3524 inhibits or prevents further rotation of the electrode system 3508. Such a system may provide a predictable amount of rotational repositioning. The system 3500 can include a stop 3516 (e.g., including a physical barrier) or other means for inhibiting or preventing accidental or undesired movement of the grip 3512 and/or movement of the electrode system 3508.

Fig. 36A is a perspective view of an example of a catheter system 3600. The system 3600 includes a proximal portion 3602 configured to remain outside of a subject and a distal portion 3604 configured to be inserted into the vasculature of the subject. The distal portion 3604 includes an expandable structure 3620. The proximal portion includes a handle 3610 and an actuation mechanism 3612. The proximal portion 3602 is coupled to the distal portion 3604 by a catheter shaft 3606. In some examples, the system 3600 includes a strain relief 3626 between the catheter shaft 3606 and the expandable structure 3620. Proximal end portion 3602 may include an adapter including a plurality of ports, e.g., a Y-adapter includes a first Y-adapter port 3616 and a second Y-adapter port 3618. The first Y-adapter port 3616 may be in communication with a lumen configured to allow insertion of a guidewire 3615 through the system 3600. The second Y-adapter port 3618 may include an electronic connector 3619 that may be used to couple the electrode matrix of the system 3600 to a stimulator system.

Fig. 36B is a perspective view of a portion of the catheter system 3600 of fig. 36A in a collapsed state. The illustrated portions include a portion of a catheter shaft 3606, a strain relief 3626, and an expandable structure 3620. The strain relief 3626 may be at least partially within the lumen of the catheter shaft 3606. Expandable structure 3620 includes a plurality of splines 3622. Four of the splines 3622 include an electrode array 3624, and the electrode array 3624 includes four electrodes to form a 4 x 4 electrode matrix. The number of electrodes in the electrode matrix, electrode size, electrode spacing, etc. may be consistent with other systems described herein. For example, in some examples, expandable structure 3620 includes a mesh or membrane containing electrodes that extend across two or more splines 3622. The illustrated portion also includes an actuator wire 3628, the actuator wire 3628 may be coupled to an actuator mechanism 3612 to cause expansion or retraction of the expandable structure 3620. An actuator wire 3628 may be located in the lumen of the catheter shaft 3606. A guidewire 3615 is also shown in the lumen of the actuator wire 3628. In some examples, the actuator wire 3628 includes a lumen configured to receive an 0.018 inch guidewire 3615.

Fig. 36C is a side view of a portion of the catheter system 3600 of fig. 36A in an expanded state. Operation of actuation mechanism 3612 can cause expandable structure 3620 to expand and contract. For example, rotating and/or longitudinally moving actuation mechanism 3612 can cause actuator wires 3628 to retract proximally, which can push splines 3622 radially outward. In some examples, the distal ends of the splines 3622 are coupled to a distal hub that is coupled to the actuator wire 3628, and the proximal ends of the splines 3622 are coupled to a proximal hub that is coupled to the catheter shaft 3606. In the expanded state, the expandable structure 3620 includes splines 3622, the splines 3622 being spaced apart from one another generally parallel to the longitudinal axis at a location radially outward of the splines. The parallel orientation of the splines 3622 may provide circumferential spacing of the splines 3622, e.g., as opposed to individual splines or wires that may be bundled in the circumferential direction. In some examples, splines 3622 comprise wires having diameters between about 0.006 inches (about 0.15mm) to about 0.015 inches (about 0.38mm) (e.g., about 0.006 inches (about 0.15mm), about 0.008 inches (about 0.2mm), about 0.01 inches (about 0.25mm), about 0.012 inches (about 0.3mm), about 0.015 inches (about 0.38mm), ranges between such values, etc.). A frame including openings between arms or splines may help secure expandable structure 3620. For example, the vascular tissue may deform such that some vascular tissue enters the opening, which may provide good fixation.

In some examples, the diameter 3621 of the expandable structure 3620 in the expanded state is between about 15mm and about 30mm (e.g., about 15mm, about 20mm, about 22mm, about 24mm, about 26mm, about 28mm, about 30mm, ranges between these values, etc.). In some examples, splines 3622 may be self-expanding such that actuation mechanism 3612 or another mechanism (e.g., retraction of a sheath over splines 3622) allows the splines to self-expand from a compressed state for guidance to a target site to an expanded state for treatment at the target site. In some such examples, the diameter of expandable structure 3620 in the expanded state may be sized to exceed the expected vasculature of most subjects to ensure vessel wall proximity. In some examples, splines 3622 may be non-self-expanding such that the splines only expand when actuation mechanism 3612 is operated. In some examples, splines 3622 may be self-expanding and actuation mechanism 3612 may further expand splines 3622, which may provide for an adjustable diameter of expandable structure 3620, available for a range of vessel sizes, wall proximity forces, and the like. Examples where expandable structure 3620 is not proximate to a wall in the event of an error are advantageous for safety, for example as described with respect to system 2200. In some examples, the wires are not distally fixed (e.g., to a distal hub), which may allow each wire to move independently, which may accommodate curvature at the deployment site. Upon expansion of the expansion structure 3620, the electrodes in the electrode matrix may be selectively activated to test nerve capture, calibration, and/or therapy, e.g., as described herein.

FIG. 36D schematically illustrates a side view of an example of expandable structure 3620. Expandable structure 3620 includes eight splines 3622 that extend from proximal hub 3607 to distal hub 3608. The splines 3622 are grouped in pairs, the spline pairs extending generally parallel to each other. Pairs of splines 3622 may be different wires or the same wire (e.g., curved at the proximal or distal ends), e.g., as described herein. Splines 3622 extend laterally and only extend outward from proximal hub 3607 at a first angle to longitudinal axis 3671, or parallel to longitudinal axis 3671, and then flex to form the first angle after a short length. The splines 3622 continue the first length 3675 at this angle. In some examples, the angle between longitudinal axis 3671 and first length 3675 is between about 10 ° and about 60 ° (e.g., about 10 °, about 20 °, about 30 °, about 40 °, about 50 °, about 60 °, a range between such values, etc.).

After the first length 3675, the splines 3622 of each pair of parallel splines diverge circumferentially along the first length 3675 at a second angle from an axis aligned with the splines, away from a plane having a longitudinal axis 3671. The second angles may be the same or different. After a short length, the splines 3622 are again flexed at a third angle relative to the axis of the first length 3675 to return the splines 3622 to being parallel to each other. The third angles may be the same or different. In some examples, the difference between the second angle and the difference between the third angle are complementary. The splines 3622 are parallel to the longitudinal axis 3671 by a second length 3676 at a fourth angle, the fourth angle being about 0 °. In some examples, the angle between first length 3675 and second length 3676 is between about 120 ° and about 170 ° (e.g., about 120 °, about 130 °, about 140 °, about 150 °, about 160 °, about 170 °, a range between such values, etc.).

After the second length 3676, the splines 3622 are flexed a small distance at a fifth angle out of the plane of the longitudinal axis 3671 until the splines 3622 converge. The fifth angles may be the same or different. In some examples, one or both of the fifth angles are the same as one or both of the third angles. After the splines 3622 converge, the splines 3622 buckle at a seventh angle, returning the splines 3622 to being parallel to each other and into a plane having the longitudinal axis 3671 for a third length, still at a fifth angle to the longitudinal axis 3671. In some examples, the angle between longitudinal axis 3671 and third length 3677 is between about 10 ° and about 60 ° (e.g., about 10 °, about 20 °, about 30 °, about 40 °, about 50 °, about 60 °, a range between such values, etc.). In some examples, the angle between third length 3677 and second length 3676 is between about 120 ° and about 170 ° (e.g., about 120 °, about 130 °, about 140 °, about 150 °, about 160 °, about 170 °, a range between these values, etc.). First length 3665 may be the same as or different from third length 3667. After the third length 3677, the splines 3622 flex at a fifth angle into the distal hub 3608 or flex to extend parallel to the longitudinal axis 3671 into the distal hub 3608.

The angles described herein may refer to the shape of expandable structure 3620 in the absence of force. The force exerted by the sheath and/or actuator wires 3628 can increase or decrease the angle. For example, the constraining of expandable structure 3620 in the sheath may reduce the angle of first length 3675 and third length 3677 relative to longitudinal axis 3671. For another example, the longitudinal extension of the distal hub 3608 relative to the proximal hub 3607 (e.g., by distally advancing the actuator wire 3628) may reduce the angle of the first and third lengths 3675, 3677 relative to the longitudinal axis 3671. For yet another example, longitudinal retraction of the distal hub 3608 relative to the proximal hub 3607 (e.g., by proximally retracting the actuator wire 3628) may increase the angle of the first and third lengths 3675, 3677 relative to the longitudinal axis 3671.

The area created by the diverging, parallel, then converging pairs of splines 3622 may be a honeycomb. The splines 3622 may include electrodes along at least a second length 3672. The pattern may be generated using any number of splines. Other buckling patterns are also possible. For example, splines 3622 may buckle to become parallel to longitudinal axis 3671 and/or remain parallel to longitudinal axis 3671 before diverging until converging and/or may converge and/or diverge at an angle that is not parallel to first length 3675 and second length 3677. As another example, splines 3622 may diverge along first length 3675 and/or converge along third length 3677. For yet another example, a single wire may be bent back and forth to form a spline. As another example, the flexion may be more gradual than the angle. The elongate contact between splines 3622 along second lengths 3676 and the vessel wall may inhibit or prevent oscillation of the longitudinal axis 3671 of the expandable structure 3620. In some examples, expandable structure 3620 includes parallel portions for splines 3622 that include electrodes but do not include splines 3622 for electrode vessel wall approximation, e.g., splines 3622 for vessel wall approximation, may include parallel wires, non-parallel wires, wires having other shapes, wires having different diameters, different numbers of wires (e.g., more or less), etc. In some such examples, expandable structure 3620 may be radially and/or circumferentially asymmetric.

FIG. 36E schematically illustrates a side view of another example of an expandable structure 3630. The portions of the expandable structure 3630 that include splines 3632 of the electrodes (e.g., as shown in fig. 36C) are radially inward from the outer diameter in the expanded state. The intersection of the recessed portion and the outer diameter may form an anchor point 3634 that may help secure the position of the expandable structure 3630. In some examples, expandable structure 3620 may take the shape of expandable structure 3630.

FIG. 36F schematically illustrates a side view of yet another example of an expandable structure 3640. Portions of the expandable structure 3640 that include splines 3642 of an electrode (e.g., as shown in fig. 36C) protrude or are bulged radially outward in the expanded state. In some examples, the expandable structure 3640 may take the shape of the expandable structure 3620, for example because a substantially straight vessel wall may straighten portions of the splines 3642. The protruding expandable structure 3640 can counteract forces on the expandable structure 3620 that can cause the shape of the expandable structure 3630 in the blood vessel, which can increase the proximity area and/or reduce longitudinal oscillation.

FIG. 36G schematically illustrates a perspective view of yet another example of an expandable structure 3650. Expandable structure 3620,3630,3640 is shown with splines 3622,3632,3642 that are parallel until diverging to form parallel portions. The expandable structure 3650 includes twisted wires 3652 rather than parallel wires, which can make the expandable structure 3650 stiffer while still providing a certain amount of movement as the wires can slide slightly along and around each other. The stiffer expandable structure 3650 may facilitate circumferential spacing of the parallel portions and electrodes of the electrode matrix. In some examples, the wires of expandable structure 3650 or expandable structure 3620,3630,3640 may be coupled (e.g., using a coupling structure), crimped, soldered, welded, adhered, combinations thereof, or the like, which may also or alternatively increase stiffness.

Fig. 36H schematically illustrates an example of an expandable structure pattern. The pattern is also shown in the expandable structure 3620,3630,3640 and includes parallel portions having proximal and distal starting points that are generally circumferentially aligned. Circumferential alignment can reduce manufacturing complexity, for example because expandable structure 3620 is symmetrical, the same tools and settings can be used to form each wire. Circumferential alignment may provide flexibility of the electrode matrix, for example, if each spline includes the same electrode array such that any rotational position is acceptable.

Figure 36I schematically illustrates another example of an expandable structure pattern. The middle parallel portion has a proximal start point and a distal end point that are distally displaced from the proximal start point and the distal end point of the top and bottom parallel portions, respectively. Staggering the starting and/or ending points may allow splines to nest in the collapsed state, which may reduce the system diameter. Staggering the starting and/or ending points may reduce the likelihood that the electrodes may snag during expansion and/or collapse of the expandable structure.

Fig. 36J schematically illustrates another example of an expandable structure pattern. The middle parallel portion has a proximal start point and a distal end point displaced proximally and distally from the proximal start point and the distal end point of the top and bottom parallel portions, respectively. Staggering the starting and/or ending points may allow splines to nest in the collapsed state, which may reduce the system diameter. Staggering the starting and/or ending points may reduce the likelihood that the electrodes may snag during expansion/collapse of the expandable structure.

Figure 36K schematically illustrates another example of an expandable structure pattern. The wires include parallel portions as in the expandable structure 3620,3630,3640, and the proximal and distal portions of the parallel portions of the wires do not circumferentially converge for each set of parallel portions. Non-converging filaments or less or partially converging filaments (e.g., at one end of each set of parallel portions) may reduce forces (e.g., rotational or torsional forces) that may result in uneven spacing of the parallel portions in the expanded state.

Figure 36L schematically illustrates another example of an expandable structure pattern. The parallel portions include a third non-diverging spline between the diverging parallel portions. In examples where each spline includes an electrode, the third spline may increase the number of rows in the electrode matrix and/or provide greater flexibility in electrode positioning. More or fewer wires or splines are also possible. Some or all of the wires or splines may include electrodes and/or may be coupled to a membrane or mesh that includes electrodes.

Figure 36M schematically illustrates another example of an expandable structure pattern. The splines comprise flat surfaces that cut hypotubes, as opposed to comprising a plurality of wires. In some examples, the plurality of electrodes are located on an outer side of the one or more splines. There may be a variety of cutting patterns. For example, splines comprising electrodes may be shaped to correspond to electrode shapes and/or patterns. In some examples, the splines may comprise flat wires (e.g., having a rectangular cross-section). In some examples, the splines may comprise U-shaped wires (e.g., as described herein).

Fig. 36N schematically illustrates an example of an expandable structure. The expandable structure includes a mesh 3660 coupled to the splines. The grid 3660 may include an electrode matrix according to the disclosure herein. In some examples, a first circumferential edge of the mesh 3660 may be coupled to a first spline and a second circumferential edge of the mesh 3660 may be coupled to a second spline such that the remainder of the mesh may slide relative to the other splines.

Fig. 36O schematically illustrates an example of an expandable structure pattern. Splines comprise sinusoidal or wavy or undulating or saw tooth shapes. A wavy filament may provide greater flexibility in electrode positioning. For example, the electrodes may be placed at peaks, valleys and/or at ascending or descending portions. The undulating wire may provide better wall approximation than the parallel portion due to more surface area in contact with the vessel wall.

Fig. 36P schematically illustrates a side view of an example of an expandable structure 3660. FIG. 36Q is a proximal end view of the expandable structure 3660 of FIG. 36P. Expandable structure 3660 includes ten splines 3662 extending from a proximal hub 3663 to a distal hub 3664. The splines 3662 are grouped in pairs that extend generally parallel to each other. Pairs of splines 3662 may be different wires or the same wire (e.g., bent at the proximal or distal end), e.g., as described herein. These splines 3622 may each have a proximal start point and a distal end point that are not circumferentially aligned. Splines 3662 extend from the proximal hub 3663 at a first angle to the longitudinal axis 3661, or are straight and then buckle to the first angle after a short length. The splines simultaneously extend in the circumferential direction at a second angle relative to the circumferential origin. The splines 3662 continue the first length 3665 at these angles. After the first length 3665, half of the splines 3662, one of each pair of parallel splines 3662, are curved in the circumferential direction at a third angle greater than the second angle, and the other half of the splines 3662, the other of each pair of parallel splines 3662 is curved at a fourth angle opposite the second angle. These flexures cause spline pairs 3662 to circumferentially diverge.

After a short length, the splines 3622 are again bent at a fifth angle and a sixth angle such that pairs of splines 3662 are parallel to each other at a seventh angle 3668 relative to the longitudinal axis 3661 for a second length 3666. Second length 3666 may be the same as or different from (e.g., greater than) first length 3665. The seventh angle 3668 may be the same as or different from the first angle. The seventh angle 3668 can be between about 5 ° and about 60 ° (e.g., about 5 °, about 10 °, about 15 °, about 20 °, about 25 °, about 30 °, about 35 °, about 40 °, about 45 °, about 50 °, about 55 °, about 60 °, a range between such values, etc.). After the second length 3666, the splines 3662 again flex in the opposite circumferential direction, flexing at eight and ninth angles opposite the seventh angle, converging circumferentially at a tenth angle relative to the longitudinal axis 3661. The region created by the diverging, parallel, then converging pairs of splines 3662 may be a honeycomb. The splines 3662 may include electrodes along at least a second length 3666. The tenth angle may be the same as or different from the first angle. After a short length, the splines 3662 are again flexed at the eleventh and twelfth angles such that the spline pairs 3662 are again parallel to each other, at a tenth angle relative to the longitudinal axis 3661 and at a thirteenth angle relative to the circumferential origin for a third length 3667. Third length 3667 may be the same as or different from first length 3665. Second length 3666 may be the same as or different from (e.g., less than) second length 3666. In the example shown in fig. 36P, first length 3665 is about the same as third length 3667, and second length 3666 is greater than each of first length 3665 and third length 3667. The thirteenth angle may be the same as or different from the seventh angle. The thirteenth angle may be the same as or different from the second angle. Splines 3662 extend into distal hub 3664 at a tenth angle relative to longitudinal axis 3661 and at a thirteenth angle relative to the circumferential origin, or are curved to extend straight into distal hub 3664.

The starting proximal and distal endpoints of each spline 3622 may be circumferentially offset, depending on the flexion angle and length, for example. This pattern can be created using any number of splines 3662. Splines 3662 at an angle to the longitudinal axis 3661 may provide better wall approximation than splines extending parallel to the longitudinal axis, for example due to increased surface area contact with the vessel wall. Although expandable structure 3660 may be considered angled, 5 pairs of versions of expandable structure 3620, for example, any of the expandable structures described herein may be suitably angled. In some examples, splines 3662 may be shaped to be angled. In some examples, splines 3662 may be angled during use, for example, by rotating distal hub 3664 relative to proximal hub 3663.

Combinations of the expandable structure patterns described herein and other expandable structure patterns are also possible. For example, the expandable structure may include a longitudinal offset and three wires. As another example, the expandable structure may include longitudinally offset and undulating wires. In some examples, the anchors (e.g., barbs) may be integrated with splines of the expandable structure.

Fig. 37A is a perspective view of an example of a catheter system 3700. The catheter system 3700 may share at least some similar features with the catheter system 3600 and/or other catheter systems described herein. The system 3700 includes a proximal portion 3702 configured to remain outside of a subject's body, and a distal portion 3704 configured to be inserted into the subject's vasculature. Distal portion 3704 includes expandable structure 3720. The proximal portion includes a handle 3710. Catheter shaft assembly 3706 extends from handle 3710 to the distal end of expandable structure 3720. Extending from the actuation tube 3728 from the handle 3710 through the catheter shaft assembly 3706 to the distal end of the expandable structure 3720. The proximal end 3702 also includes an electrical receptacle 3799 that can be configured as an electrical plug that connects to a nerve stimulator (e.g., a radio frequency generator or other suitable source, depending on the stimulation or ablation modality).

Fig. 37B schematically illustrates a side view of the expandable structure 3720, and fig. 37C illustrates a proximal view of the expandable structure 3720. Expandable structure 3720 includes a plurality of splines 3722 extending from proximal hub 3740 to distal hub 3750. Some splines 3722 of the expandable structure 3720 may include electrodes 3724 configured to stimulate a target nerve. Some splines 3722 may be absent, or include no electrodes 3724. In some examples, the expandable structure 3720 includes ten splines 3722, wherein four circumferentially adjacent splines 3722 each include five electrodes 3724. The splines 3722 may comprise a proximal section, an intermediate section, and a distal section. The intermediate section can be configured to extend radially outward when the expandable structure 3720 is in a self-expanded state. The proximal segments of the splines 3722 may form a first angle with the intermediate segments and the distal segments may form a second angle with the intermediate segments. In some examples, the proximal and distal segments may be straight and the intermediate segment may be convex, curving radially outward. In some examples, the proximal and distal segments may be straight and the intermediate segment may be concave, curving radially inward. In some examples, the proximal, intermediate and distal segments may all be straight. Splines 3722, which include electrodes 3724, may include proximal and distal segments without electrodes 3724. The spline 3722 may further include: a proximal transition section connecting the proximal section and the intermediate section, and a distal transition section connecting the intermediate section and the distal section.

Splines 3722, including electrodes 3724, may be configured to extend outward on one side of a plane that passes across the longitudinal axis of expandable structure 3720. Splines 3722, which do not include electrodes 3724, may be configured to extend outward on the second side. For example, splines 3722 shown in fig. 37C, which do not include electrodes 3724, may be spaced less apart circumferentially to lie on the same side of a plane passing through the longitudinal axis at the center of expandable structure 3720. Splines 3722, including electrodes 3724, may occupy less than 180 ° circumferentially on one side. For example, splines 3722 comprising electrodes 3724 may circumferentially occupy between about 30 ° and about 170 ° (e.g., about 30 °, about 45 °, about 60 °, about 90 °, about 100 °, about 110 °, about 120 °, about 150 °, about 170 °, a range between these values, etc.). The four splines 3722 comprising electrodes 3724 shown in figure 37C circumferentially occupy approximately 110 °.

Other numbers of splines 3722, including electrodes 3724, are also possible. For example, all splines 3722 or a subset of splines 3722 (e.g., 1,2,3,4,5,6,7,8,9, or 10 splines 3722) may include electrode 3724. In examples including more than 10 splines, more than 10 splines may include electrodes. All of the splines 3722 or a percentage of the splines 3722 (e.g., 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% or 100% of the splines 3722) may include the electrode 3724. The splines 3722 comprising the electrodes 3724 may be circumferentially adjacent or have one or more non-electrode splines 3722 therebetween.

Splines 3722 may include between one electrode 3724 and twenty electrodes 3724 (e.g., 1 electrode, 2 electrodes, 3 electrodes, 4 electrodes, 5 electrodes, 6 electrodes, 7 electrodes, 8 electrodes, 9 electrodes, 10 electrodes, 15 electrodes, 20 electrodes, ranges between these values, etc.). More electrodes 3724 may provide more stimulation options and/or more targeted nerve capture. Fewer electrodes 3724 may reduce the number of electrical connectors, which may reduce the device profile and/or reduce the volume of the device that the electrical connectors occupy for high value.

Fig. 37D is a perspective view of the wire bent to form spline pairs 3727. The single wire may be bent at the flex 3725 to form a spline pair 3727, which includes a first spline 3722A from a first portion of the wire and a second spline 3722B from a second portion of the wire. The flexures 3725 may be positioned at the proximal ends of the spline pairs 3727 such that the proximally facing ends of the spline pairs 3727 are atraumatic flexures, rather than the potentially traumatic linear ends. The flexures 3725 may be located at the distal ends of the spline pairs 3727. Spline pairs 3727 may be formed from two or more separate wires positioned in the same configuration, e.g., coupled by brazing, welding, etc. The splines 3722A,3722B may each comprise a different wire. The wires may be coupled, such as at the proximal end, or uncoupled. One or both ends of the wire may be bent to be atraumatic. Spline pairs 3727 may be formed from two generally parallel splines 3722 that extend side-by-side at their proximal and distal ends (e.g., along the proximal and distal segments) but are separated by a substantial distance along a central portion (e.g., the middle segment). As best shown in fig. 37C, the splines 3722 diverge circumferentially at the beginning and at the end of the central portion of the splines 3722 (e.g., along the proximal and distal transition sections) while they continue to extend radially outward. The convergence and divergence of splines 3722 creates two short lengths during which splines 3722 in spline pairs 3727 are not parallel. Splines 3722 in spline pairs 3727 extend parallel within their central portions to form a generally hexagonal shape. Splines 3722 may share features with any pattern or configuration of expandable structures disclosed herein or variations thereof. In non-limiting examples, the central portions of splines 3722 can be substantially parallel to the longitudinal axis of expandable structure 3720, as shown in figure 36H, curved radially inward, e.g., as shown in figure 36E, radially outward, e.g., as shown in figure 36F, and/or have other configurations.

Some splines 3722 of expandable structure 3720 may not include or lack or be absent of electrodes 3724. After inserting the splines 3722 without the electrodes 3724 through the proximal hub 3740, the splines 3722 may be wrapped with a heat shrink tubing 3721, e.g., along their parallel and adjacent proximal and distal portions. Then, the heat-shrinkable tube 3721 is shrunk by heating. The heat shrink tubing 3721 may comprise, for example, polyethylene terephthalate (PET) or other suitable material. The piece of tube 3721 can help inhibit rotation of the wrapped portions of the splines 3722 of spline pairs 3727 relative to each other. If the expandable structure 3720 is retracted through the pulmonary valve in the expanded state, heat shrinking the tube 3721 along the proximal portions of the splines 3722 may provide a more favorable proximal-facing surface than the splines 3722 for interacting with valve tissue.

The wires forming splines 3722 may be formed from a shape memory alloy, such as nitinol. In this case, the wire is heated and programmed to the desired memory shape, such as the configuration shown in fig. 37D, and then rapidly cooled. The wires are then deformed as needed and inserted through the spline lumen 3745 and return to their predetermined memory shape when heated above the transition temperature. Once the guide wire passes through two adjacent spline lumens 3745 and returns to its programmed compliance, including spline flexures 3725 in the wire, the spline pairs 3727 can be pulled distally until the spline flexures snap into place within recesses 3747 behind proximal hub step 3748 (fig. 37G).

Fig. 37E is a perspective view of spline pair 3727. Spline pair 3727 includes five electrodes 3724 positioned across the center portion of each spline 3722A, 3722B. The two splines 3722A, 3722B of a single spline pair 3727 may each include an electrode 3724, may each lack an electrode 3724, or one of the splines 3722A, 3722B may include an electrode 3724 while the other spline 3722A, 3722B does not.

Fig. 37F is an enlarged view of the distal end of the spline pair 3727 of fig. 37E. Splines 3722, including electrodes 3724, may be at least partially covered by liner 3729, e.g., not at the proximal and/or distal ends. Liner 3729 may comprise PTFE. In examples where the inner surface of the electrode 3724 is not insulated, the liner 3729 can electrically insulate the splines 3722 from the electrode 3724, which can inhibit cross talk, undesired activation of the electrode, inefficient operation due to electrical leakage, and the like. In examples where the inner surface of the electrode 3724 is insulating or otherwise, the liner 3729 may be omitted. Splines 3722, which do not include electrodes 3724, may be devoid of liner 3729, e.g., to provide better vessel wall approximation that does not slip easily. After insertion of the splines 3722 through the proximal hub 3740 (which may be before or after the liner), the lined spline wires may be wrapped by a spline tube 3723, which connects the two splines 3722A, 3722B of the spline pair 3727 at its proximal and distal ends. The spline tube 3723 may include two adjacent but distinct lumens for each spline 3722, or it may include a single (e.g., rectangular) lumen at its proximal and distal ends for receiving two splines. The spline tube 3723 can be split at the proximal and distal points, where the splines 3722A, 3722B diverge and individually cover each spline 3722A, 3722B along its central portion, such that the spline tube 3723 has two Y ends. Spacing at the central portion of the spline pairs 3727 can reduce the risk of thrombosis and/or provide better wall proximity by allowing the splines 3722 to abut the wall at circumferential points. The spline tubes 3723 may span the width between the center portions of the splines 3722, which may provide a greater variety of electrode 3724 configurations (e.g., as described with respect to figure 4C) and/or provide better wall proximity by providing more proximate surface area. Multiple spline tubes 3723 can be used, for example, one spline tube 3723 per spline 3722. The spline tubes 3723 may optionally be coupled, for example, at the proximal and distal portions of the spline pairs 3727. The spline tubes 3723 may be sized to contact but not couple. The spline tube 3723 may inhibit rotation of the splines 3722A, 3722B of the spline pairs 3727 relative to each other.

The individual electrodes 3724 may be generally cylindrical around the circumference of the central portions of the splines 3722. Other types and configurations of electrodes 3724 are also possible. For example, the electrodes 3724 can extend only partially around the circumference of the splines 3722 such that they face the outer diameter of the expandable structure 3720 (e.g., as described with respect to electrode 4403).

Expandable structure 3720 can include five spline pairs 3727 spaced around the circumference of the expandable structure. Spline pairs 3727 may be evenly circumferentially spaced (e.g., as shown in figure 37C). Some spline pairs 3727 may be circumferentially clustered. For example, spline pairs 3727 including electrodes 3724 may be on a first side of a plane passing through the longitudinal axis, while spline pairs without electrodes 3724 may be on a second side of the plane opposite the first side. Two circumferentially adjacent spline pairs 3727 may each include a set of electrodes 3724, e.g., five electrodes 3724 of each spline 3722, to form a 4 x 5 array of twenty electrodes 3724.

FIG. 371Fi-37Fiii shows an example of electrical movement of an electrode. Expandable structure 3720 or other expandable members described herein are expanded in the blood vessel. The electrodes may be selectively activated, for example as described herein, to determine a combination of spiked nerves. In fig. 37Fi, it has been found that two electrodes in the first column capture the target nerve when activated. After a treatment duration, the stimulation of the target nerve may not be as effective as during the original selection. One option is to contract, reposition, and re-expand the expandable structure 3720, and then repeat the selective activation process. Another non-mutually exclusive option is to electrically move the expandable structure 3720 to better capture the target nerve. In fig. 37Fii, two electrodes in the fourth column have been found to capture the target nerve when activated. Changing the stimulation from the electrodes in the first column to the electrodes in the fourth column effectively moves or longitudinally moves the expandable structure 3720 the distance 3701. In fig. 37Fiii, it has been found that the two electrodes in the first column, but in the second and third rows, when activated, capture the target nerve. Stimulation changes to these electrodes are effective to rotate the expandable structure 3720 circumferentially a distance 3703. A combination of effective longitudinal movement and circumferential rotation is also possible. Although shown as bipolar operation, where the two electrodes have opposite charges, monopolar operation (stimulating one or more electrodes with the same charge) is also possible in conjunction with a return electrode that is not an electrode of the electrode array (e.g., a chest pad, on a proximal portion of the catheter system 3700, on a separate catheter, etc.). Although shown as a simple bipolar operation for ease of illustration, guard bipolar operation and other techniques may also be compatible with electro-mobility. Factors that may affect the accuracy with which the electrode array may capture the target nerve may include the total number of electrodes 3724, the span and shape of the electrode array, the proportion of electrodes 3724 on each spline 3722, the spacing of electrodes 3724 across the length of the splines 3722, the circumferential spacing of the splines 3722, and so forth. An electrode array configured to allow motorized movement may advantageously reduce or eliminate physical or mechanical repositioning of the expandable structure 3720, which may include contracting, moving, and re-expanding the expandable structure 3720. Physical movement can cause adverse events such as ischemic stroke (e.g., by floating debris or promoting thrombosis), vessel wall damage (e.g., causing stenosis), and the like. Physical movement can be time consuming, during which the subject may not be treated.

Referring again to fig. 37B, expandable structure 3720 includes proximal hub 3740 and distal hub 3750 with splines 3722 extending therefrom. The proximal hub 3740 may comprise stainless steel or other suitable material. The distal hub 3750 may comprise stainless steel or other suitable material. The proximal hub 3740 and the distal hub 3750 can comprise the same material or different materials.

Fig. 37G is a perspective view of an example of the proximal hub 3740 of an expandable structure (e.g., expandable structure 3720). Fig. 37H schematically illustrates a side cross-sectional view of the proximal hub 3740 of fig. 37G. The proximal hub 3740 can comprise a biocompatible material, such as stainless steel, nitinol, plastic, or the like. The proximal hub 3740 can include a proximal portion 3741 and a distal portion 3742. The distal portion 3742 is larger in diameter than the proximal portion 3742 and may be tapered at its distal end to form a partially circular surface 3749. A central lumen 3743 extends through the proximal portion 3741 and the distal portion 3742 providing a passage from the proximal end of the proximal hub 3740 to the distal end of the proximal hub 3740 through which the actuation tube 3728 slidably extends. Although shown as having a circular cross-section, the central lumen 3743 can have other cross-sectional shapes (e.g., oval, arc, polygonal, etc.). The central lumen 3743 may include a lubricious coating or liner (e.g., including PTFE).

The proximal portion 3741 can be radially inward from the distal portion 3742. In some examples, the difference in the diameter or outer dimension of the proximal and distal portions 3741 and 3742 may approximate the thickness of the hinge 3726, which may allow the proximal hub 3740 to couple to the hinge 3726 while maintaining a uniform outer sheath 3711 (fig. 37O) diameter if the outer sheath 3711 overlaps the distal portion 3742. In some examples, the difference in the diameter or outer dimension of the proximal and distal portions 3741 and 3742 may be approximately the thickness of the hinge 3726 plus the thickness of the outer sheath 3711, which may allow the proximal hub 3740 to couple to the hinge 3726 while maintaining a uniform diameter if the outer sheath 3711 abuts the distal portion 3742. Other differences may be applicable to other types of catheter shafts, e.g., not including hinge 3711.

A plurality of peripheral lumens 3744 extend through the proximal portion 3741 and the distal portion 3742 providing a plurality of peripheral channels from the proximal end of the proximal hub 3740 to the distal end of the proximal hub 3740 through which electrical connectors may extend and/or through which fluid may flow. The peripheral lumen 3744 can be radially outward of the central lumen 3743. The peripheral lumen 3744 can have a smaller diameter than the central lumen 3743. The peripheral lumen lumens 3744 may each have the same diameter or at least one peripheral lumen 3744 may have a different diameter. Although shown as having a circular cross-section, the peripheral lumen 3744 can have other cross-sectional shapes (e.g., oval, arc, polygonal, etc.). The peripheral lumens 3744 may each have a circular cross-sectional shape. Have the same shape or at least one peripheral lumen 374 may have a different shape. For example, the peripheral lumen 3744 configured for the electrical connector to extend therethrough may have one diameter or shape and the peripheral lumen 3744 configured to convey fluid may have another diameter or shape. Although the proximal hub 3740 is shown with five peripheral lumens 3744, other numbers of peripheral lumens 3744 are possible. For example, the proximal hub 3740 can include at least one peripheral lumen 3744 of each spline pair 3727, at least one peripheral lumen 3744 of each spline 3722 including the electrode, at least one peripheral lumen 3744 of each electrode connector, and the like. Although the proximal hub 3740 is shown with five peripheral lumens 3744 equally spaced around the circumference of the proximal hub 3740, other arrangements of peripheral lumens 3744 are possible. Some of the peripheral lumens 3744 may be circumferentially bundled or grouped or clustered. For example, the peripheral lumens 3744 configured to have electrical connectors extending therethrough can be circumferentially clustered, and the peripheral lumens 3744 configured to deliver fluid can be substantially equally circumferentially spaced about the remainder of the proximal hub 3740. The proximal hub 3740 includes peripheral lumens 3744, each peripheral lumen 3744 having the same size, shape, and spacing may provide manufacturing flexibility and/or adaptability for various designs. The proximal hub 3740 includes peripheral lumens 3744, each peripheral lumen 3744 having the same size, shape, and spacing may provide enhanced performance for one type of design.

The distal portion 3742 of the proximal hub 3740 may include spline lumens 3745. One or more splines 3722 may be positioned in each spline cavity 3745. In an exemplary method of manufacture, the wire may be bent, for example, as shown in fig. 37D. The free end of the wire may be inserted into the proximal end of the spline lumen 3745 and then advanced distally until the flex 3725 contacts or is proximate to the proximal end of the distal portion 3742 of the proximal hub 3740. Each spline pair 3727 flexure 3725 can inhibit or prevent the spline pair 3727 from sliding distally as it contacts the proximal end of the distal portion 3742 of the proximal hub 3740.

The proximal portion 3741 can include recesses 3747, the recesses 3747 being configured to receive or receive portions of the splines 3722 extending near the proximal end of the distal portion 3742 of the proximal hub 3740. This portion of spline 3722 may include flexures 3725. This portion of splines 3722 may include the free ends of splines 3722, which may optionally be flexed, e.g., into an atraumatic shape. If recess 3747 is a flat portion of the otherwise arcuate proximal portion 3741, the section between recess 3747 and the radially outward surface forms a step. The proximal portion 3740 may include one recess 3747 and one step 3748 per spline pair 3727. The proximal portion 3740 may include one recess 3747 and one step 3748 for every two splines 3722, regardless of whether the two splines 3722 are spline pairs 3727. The proximal portion 3740 may include one recess 3747 and one step 3748 per spline 3722. Proximal portion 3740 can include an arcuate recess 3747 about or substantially about the circumference of proximal portion 3740. Proximal portion 3740 can include one or more arcuate recesses 3747 for splines 3722 including electrodes 3724 and one or more recesses 3747 for splines 3722 without electrodes 3724.

Step 3748 may limit proximal movement of the proximal ends of splines 3722. In examples including the flexures 3725, if the splines 3722 come out of the recesses 3747, the surfaces that may interact with the vessel wall during retraction of the expandable structure 3720 including the splines 3722 and the proximal hub 3740 will be atraumatic and, thus, may not be readily punctured or otherwise adversely affect the vessel. If the distal ends of the splines 3722 are straight wires and exit the distal hub 3750, the surfaces that may interact with the vessel wall during proximal retraction will face distally, which is the opposite direction from retraction, and thus may not easily puncture or otherwise adversely affect the vessel. If splines 3722 of expandable structure 3720 have portions that flex radially outward, the proximal and distal ends of splines 3722 may be biased radially inward from the outward facing surface and, therefore, may not readily puncture or otherwise adversely affect the blood vessel.

Splines 3722 may be slidingly engaged with spline cavities 3745. Upon proximal retraction of the actuation tube 3728, the steps 3748 can provide a reaction force against the proximal ends of the splines 3722, forcing the splines 3722 to flex radially outward. For example, the radially outward configuration may be different than the expanded configuration provided by shape memory. The splines 3722 may be fixably coupled to the spline cavities 3745. In some such implementations, the interaction between the splines 3722 and the spline lumens 3745, independent of the recesses 3747, the steps 3748, and/or the proximal end of the distal portion 3742 of the proximal hub 3740, can inhibit proximal and distal movement of the splines 3722 relative to the hub 3740. In some examples, friction between splines 3722 and spline cavities 3745 may provide additional or alternative reaction forces. The flexures 3725 in the spline pairs 3727 form an atraumatic proximal end that poses less risk to the vasculature in the event of a device failure that results in the proximal ends of the splines 3722 being free or misaligned so that they inadvertently contact the vessel wall. Spline pair 3727 may be formed from a single wire or a wire that includes a flexure at its distal end. In some such examples, the splines 3722 may include a proximal buckle or ring, the splines 3722 may be fixedly coupled to the spline lumen 3745, and/or the spline lumen 3755 may include a channel closed at its proximal end. The distal end of the distal portion 3742 of the proximal hub 3740 can be tapered such that the distal ends of the spline lumens 3745 open at an angle to the rounded surface 3749. The angled open ends of the spline lumens 3745 at their distal ends may allow the splines 3722 to flex radially outward more easily, which may reduce stress on the wire when an expanded configuration is employed.

Fig. 37I is a perspective view of the distal end of the proximal hub 3740 of fig. 37G. Wires or leads or conductors 3712 connecting electrodes 3724 to electrical receptacle 3799 may extend through peripheral lumen 3744 of proximal hub 3740. As shown in fig. 37I, the conductors 3712 may be distributed between the peripheral lumens 3744 such that the conductors 3712 of all electrodes of one or more splines 3722 extend through the same peripheral lumen 3744. For example, if the expandable structure 3720 includes two adjacent pairs of splines 3727, each including five electrodes 3724, five conductors 3712A connected to an electrode 3724 of a first spline 3722 may extend through a first peripheral lumen 3744A, five conductors 3712B connected to an electrode 3724 of a second spline 3722 of a spline pair 3727 having the first spline 3722 may extend through a second peripheral lumen 3744B, five conductors 3712C connected to an electrode 3724 of a third spline 3722 may extend through a second peripheral lumen 3744B, and five conductors 3712D connected to an electrode 3724 of a fourth spline 3722 of a spline pair 3727 having the third spline 3722 may extend through a third peripheral lumen 3744C. The fourth peripheral lumen 347D and the fifth peripheral lumen 3744E may be devoid of conductors 3712. Other distributions of conductors 3712 in the peripheral lumen 3744 are also possible. For another example, all of the conductors 3712 may extend through one peripheral lumen 3744. For yet another example, all of the conductors 3712 of each spline 3722 may extend through one peripheral lumen 3744, which is different for each spline 3722. For yet another example, all conductors 3712 of two splines 3722 (e.g., in spline pairs 3727) may extend through one peripheral lumen 3744. The peripheral lumen 3744 without the conductors 3712 may be located circumferentially between two peripheral lumens 3744 through which the conductors 3712 extend. The fluid flowing through the peripheral lumen 334 may be inversely proportional to the number of conductors 3712 occupying the peripheral lumen 3744, such that more fluid flows through the peripheral lumen 3744 with fewer conductors 3712. The fluid flow through the device 3700 is described in further detail herein.

Fig. 37J schematically illustrates a side cross-sectional view of an example of the distal hub 3750 of an expandable structure (e.g., expandable structure 3720). The distal hub 3750 may comprise a biocompatible material, such as stainless steel, nitinol, plastic, and the like. The distal ends of the splines 3722 extend into the distal hub 3750. The distal hub 3750 can be generally cylindrical and can include an atraumatic (e.g., circular) distal end 3754 and/or a tapered proximal end 3756. The tapered end 3756 may form an angled open face on the proximal end of the channel 3755, which allows the inserted splines 3722 to more easily flex to achieve an expanded configuration. The distal hub 3750 can include a central lumen 3753 configured to receive an actuator tube. The actuator tube 3728 may be inserted into or through the central lumen 3753 and fixably coupled to the distal lumen 3753 by any suitable means, such as by adhesives (e.g., cyanoacrylate), welding, brazing, combinations thereof, and the like. The distal hub 3750 includes a plurality of recesses 3755, the recesses 3755 configured to receive the distal ends of the splines 3722. The recesses 3755 may have the same shape as the distal ends of the splines 3722, e.g., elongated and cylindrical. The distal hub 3750 can include a plurality of recesses 3755, each recess 3755 configured to receive the distal end of one spline 3722. After the distal ends of the splines 3722 are inserted into the recesses 3755, the splines 3722 may be rigidly attached to the distal hub 3750 by welding the distal hub 3750. Welding may include applying a heat source around the outer circumference of the distal hub 3750 (e.g., around 360 °). Welding may include the use of a laser and/or other suitable heat source. Splines 3722 may be welded to distal hub 3750. With or without welded splines, welding the outer circumference of the distal hub 3750 may heat stake the splines 3722 in the recesses 3755 by deformably reducing the inner diameter of the recesses 3755.

The actuation tube 3728 slidably extends through the central lumen 3743 of the proximal hub 3740, then through a radially inner portion (e.g., center) of the expandable structure 3720, and then may be fixedly coupled to the distal central lumen 3753. The distal end of the actuation tube 3728 may be coupled to the distal hub 3750 by any suitable means, such as by adhesive (e.g., cyanoacrylate), welding, brazing, combinations thereof, and the like. When the actuation tube 3728 is retracted proximally, the actuation tube 3728 pulls the distal hub 3750 proximally towards the proximal hub 3740, the proximal hub 3740 being held in place by the catheter shaft assembly 3706. As the proximal hub 3740 and the distal hub 3750 are brought closer together, the compressive force on the expandable structure 3720 forces the splines 3722 to expand radially outward, increasing the diameter and/or decreasing the length of the expandable structure 3720. The diameter of the expandable structure may be larger than the expanded shape in which the shape of expandable structure 3720 is disposed. When tube 3728 is actuated. As advanced distally, the actuation tube 3728 pushes the distal hub 3750 distally away from the proximal hub 3740, the proximal hub 3740 being held in place by the catheter shaft assembly 3706. As the proximal hub 3740 and the distal hub 3750 are further separated, the expansion forces on the expandable structure 3720 force the splines 3722 to retract radially inward, decreasing the diameter and/or increasing the length of the expandable structure 3720.

Figure 37K illustrates a side view of an example of the proximal end 3702 of the catheter system 3700 of figure 37A. Proximal end 3702 includes handle 3710 and a portion of catheter shaft assembly 3706 extending therefrom. Handle 3710 is configured to remain outside the body. Handle 3710 includes a proximal portion 3761 and a distal portion 3762 movable relative to proximal portion 3761. Distal portion 3762 may include handle base 3763 and outer handle 3770. Outer handle 3770 can include a gripping portion (e.g., including a textured surface) that can enhance friction to provide better user grip. The proximal portion 3761 can include an actuator 3780 and a hemostasis valve 3784. Proximal portion 3761 and distal portion 3762 can be movably connected by an actuation tube assembly 3790 and a fixation member 3774 that includes a locking member 3776. Electrical conductors 3712 configured to supply signals to electrodes 3724 can enter handle 3710 via connector tubing 3798, connector tubing 3798 connecting handle 3710 to electrical receptacle 3799. The outer handle 3770 can include a protrusion 3771 having a guide port through which the connector tubing 3798 can pass such that the connector tubing 3798 is secured along one side of the distal portion 3762 of the handle 3710. Handle 3710 may be asymmetric relative to the longitudinal axis of catheter shaft assembly 3706, which may help a user assess the amount of twist or rotation in the attached catheter shaft assembly 3706.

Fig. 37L is a side cross-sectional view of the proximal end 3702 of fig. 37K. The outer handle 3770 includes a recess extending distally from its distal end configured to receive the grip base 3763. A proximal end portion of the handle base 3763 can be partially inserted into the recess and can be fixedly coupled to the handle base 3763.

Outer handle 3770 includes a first lumen 3772, first lumen 3772 configured to slidably receive a portion of actuator tube assembly 3790. Outer handle 3770 may include a second inner lumen 3773, second inner lumen 3773 configured to receive a fixation member 3774, such as a pin, screw, piston, or the like. Fixation member 3774 may comprise, for example, a socket head cap screw including a threaded elongated portion and a cap 3775. If fixation member 3774 is fixably coupled to actuator 3780, inner cavity 3773 may be unthreaded such that fixation member 3774 may slide longitudinally through inner cavity 3773. The threaded elongated portion may interact with complementary threads in locking member 3776. If locking member 3776 is rotationally coupled to actuator 3780, inner cavity 3773 may include complementary threads, and fixation member 3774 may slide longitudinally through inner cavity 3773 while rotating. The outer handle 3770 may include a shoulder extending into the second lumen 3773 configured to interact with an enlarged portion of the fixation member 377. For example, the shoulder may inhibit or prevent proximal retraction of the cap 3775, thereby preventing the proximal retraction of the fixation member 3774 beyond a certain length. Limiting longitudinal translation of fixation member 3774, wherein fixation member 3774 can be fixedly coupled to actuator 3780, and actuator 3780 can be fixedly coupled to actuation tube 3728, can limit radial expansion of expandable member 3720. Limiting radial expansion of expandable member 3720 may enhance safety by reducing the likelihood that expandable member 3720 will expand enough to puncture or tear a blood vessel. The distal end of inner lumen 3773 may be blocked, for example, to prevent debris from interfering with the movement of fixation member 3774. Cap 3775 may include a tool interface, such as a hexagonal recess, a protruding nut, or the like. The tool interface may be used during assembly (e.g., to couple fixation member 3774 to actuator 3780) and/or during surgery.

Actuator 3780 can include a first lumen 3781 aligned with first lumen 3772 of outer handle 3770. The first lumen 3781 can be configured to couple to a valve 3784 (e.g., a hemostasis valve 3784 (e.g., luer lock)), such as by including complementary threads, configured to be threaded, configured to receive a press fit, and the like. Actuator 3780 may include a valve in communication with first lumen 3781, first lumen 3781 being integral with actuator 3780. A portion of the actuator tube assembly 3790 can be fixedly coupled to at least one of the first lumen 3781 and the valve 3784. The lumen of the actuator tube assembly 3790 may be in fluid communication with the lumen of the valve 3784.

Actuator 3780 can include a second inner lumen 3782, second inner lumen 3782 configured to fixably couple actuator 3780 to fixation member 3774. Depending on the shape and configuration of fixation member 3774, second lumen 3782 may be aligned with second lumen 3773 of the outer handle. Second inner cavity 3782 can include threads configured to receive and secure an elongated threaded portion of fixation member 3774. Securing member 3774 may be integrally formed with and extend from a distal surface of actuator 3780.

Locking member 3776 can optionally be positioned along fixation member 3774 between actuator 3780 and external handle 3770. Locking member 3776 can include, for example, a locking slot (e.g., as shown in figure 36K), a nut, a wing nut, and the like. Locking member 3776 includes a threaded lumen configured to interact with an elongated threaded portion of fixation member 3774. Locking member 3776 may include a textured outer surface configured to enhance gripping by a user. The threads transmit rotational force on locking member 3776 to move longitudinally along fixation member 3774. When locking member 3776 abuts the proximal end of outer handle 3770, which can be considered a locked position, locking member 3776 inhibits or prevents actuator 3780 (and thus actuation tube assembly 3790 fixably coupled thereto) from moving distally. Locking the actuators 3780 may inhibit or prevent radial compression and loss of wall proximity of the splines 3722 of the expandable structure 3720.

Locking member 3776 may include any suitable structure for preventing or inhibiting longitudinal movement of fixation member 3774 relative to external handle 3770. In some examples, locking member 3776 may be a non-threaded structure. For example, locking member 3776 may comprise a clamp that is secured to fixation member 3774 by pressure and/or friction. The grip of the clamp of the locking member may be selectively released and/or grasped by a user. In some examples, clamp locking member 3776 can be biased in a gripping position on fixation member 3774 by, for example, a spring. Clamp locking member 3776 may include a channel around the circumference of fixation member 3774, and the diameter of the channel may be expanded or reduced by: the circumference around fixation member 3774 is closed by turning the screws connecting the two ends of clamp locking member 3776. Clip locking member 3776 can include a biased protrusion configured to frictionally engage securing member 3774 and can be temporarily released by a user. Clip locking member 3776 may slide or otherwise be movable along fixation member 3774 when in the released position, and may not slide or otherwise be movable when in the grasping position. In some examples, clamp locking member 3776 can be removed from fixation member 3774 and selectively reattached at a desired location along the length of fixation member 3774. When a surface of clip locking member 3776 abuts the proximal end of outer handle 3770, clip locking member 3776 can inhibit or prevent distal displacement of fixation member 3774 relative to outer handle 3770, thereby placing handle 3710 in the locked position.

Fig. 37Li-37Liii illustrate an exemplary method of manipulating handle 3710 to radially expand expandable member 3720. Fig. 37Li shows handle 3710 in a compressed state, with actuator 3780 abutting or proximate to locking member 3776, with locking member 3776 abutting or proximate to outer handle 370. Expandable member 3720 can be in a self-expanded state, as shown in the left figure. The actuator tube assembly 3790 can be retracted proximally as the expandable structure 3720 self-expands radially outward.

As shown in fig. 37Lii, when actuator 3780 is retracted proximally, securing member 3774 (which may be fixedly coupled to actuator 3780) slides proximally through second lumen 3773 of outer handle 3770, locking member 3776 rests in place on securing member 3774 and is thus retracted proximally, and actuator tube assembly 3790 slides proximally through catheter shaft assembly 3706, lumen 3764 of handle base 3763, and first lumen 3772 of outer handle 3770. When the actuator tube assembly 3790 is proximally retracted, the distal hub 3750, to which the actuator tube 3728 may be fixedly attached, is proximally retracted, exerting a longitudinal compression and radial expansion force on the splines 3722 that is further radially expanded than in the self-expanded state. When the splines 3722 are proximate to the vessel wall, the user may typically feel the reaction force in the actuator 3780, which is beneficial for the manual procedure shown in fig. 37Li-37 Liii. When the wall is felt proximate, the user may adjust the expansion by further proximally retracting the actuator 3780 and/or by distally advancing the actuator 3780. Once the user is satisfied with the close proximity of the walls provided by splines 3722 of expandable member 3720, the user may engage locking member 3776.

As shown in fig. 37Liii, the user rotates locking member 3776. The threads of the threaded elongated portion of fixation member 3774 and locking member 3776 convert the rotational force to a longitudinal force, and locking member 3776 is advanced distally along the fixation member until locking member 3776 abuts the proximal surface of outer handle 3770. If a distal force is applied to actuator 3780, actuator 3780 generally cannot move distally because locking member 3776 presses against the proximal surface of outer handle 3770.

Fig. 37Li and 37Liv illustrate another exemplary method of manipulating the handle 3610 to radially expand the expandable member 3720. Referring again to fig. 37Li, handle 3710 is in a compressed state.

As shown in fig. 37Liv, as locking member 3776 is rotated, the threads of the threaded elongated portion of fixation member 3774 and locking member 3776 convert the rotational force to a longitudinal force. Locking member 3776 forces fixation member 3774 proximally to retract against the surface of proximal outer handle 3770.

As fixation member 3774 is retracted proximally, fixation member 3774 slides proximally through second lumen 3773 of outer handle 3770, actuator 3780, which may be fixedly coupled to fixation member 3774, retracts proximally, and actuator tube assembly 3790 slides proximally through catheter shaft assembly 3706, lumen 3764 of handle base 3763 and first lumen 3772 of outer handle 3770. As the actuator tube assembly 3790 is proximally retracted, the distal hub 3750 may be fixedly coupled together to the actuator moving tube 3728, proximally retracted, exerting a longitudinal compression and radial expansion force on the splines 3722 that radially expands further than in the self-expanding state. Throughout the rotation of locking member 3776, locking member 3776 abuts a surface of proximal outer handle 3770 such that if a distal force is applied to actuator 3780, actuator 3780 will generally not be able to move distally because locking member 3776 is pressed against the proximal surface of outer handle 3770.

The force used to rotate locking member 3776 may provide a fine adjustment when locking member 3776 abuts the proximal surface of outer handle 3770. Depending on the pitch, the rotation of the locking member may be rotated proximally by a certain amount of rotation. Retracting the actuator tube assembly 3790 by an amount and/or radially expanding the expandable member 3720 by an amount. For example, a 90 ° rotation of locking member 3776 may radially expand the expandable member 1mm in diameter in the absence. Finer and coarser spacings are also possible. Finer pitches allow finer adjustments. The coarser spacing reduces the amount of rotation for the longitudinally moving parts, which can reduce the procedure time. Locking member 3776 may include indicia around its perimeter to assist the user in identifying the amount of rotation.

Combinations of the methods of fig. 37Li-37Liv are also possible. For example, a user may first manually retract actuator 3780, e.g., feel the wall attached, rotating locking member 3776 to abut the proximal end of the lateral side. Handle 3770 and then the amount of expansion is fine tuned by rotating locking member 3776. For example, if the user desires to expand expandable member 3720 beyond a diameter of the wall proximate 2mm (e.g., a diameter measurement of a blood vessel at maximum systole), which may provide secure anchoring, the user may rotate locking member 3776 180 ° after abutting outer handle 3770.

Fig. 37M is a side cross-sectional view of exemplary components of the handle base 3763. To provide an example context, fig. 37M also includes portions of the actuation shaft assembly 3790, a portion of the catheter shaft assembly 3706, and the connector tube 3798. Handle base 3763 includes a lumen 3764, lumen 3764 configured to receive sealing element 3766, actuation tube assembly 3790 and/or catheter shaft assembly 3706. When the handle base 3763 is inserted into the recess of the outer handle 3770, the inner cavity 373764 aligns with the first inner cavity 3772 of the outer handle 3770.

The catheter shaft assembly 3706 may be fixedly attached to the handle base 3763 by inserting the proximal end of the catheter shaft assembly 3706 into the inner lumen 3764 and then securing the catheter shaft assembly 3706 to the handle base 3763, such as by an adhesive (e.g., cyanoacrylate). Handle base 3763 may include shoulder 3768 extending into lumen 3764 configured to interact with the proximal end of catheter shaft assembly 3706. For example, shoulder 3768 may provide a stop. For insertion of the catheter shaft assembly 3706 into the inner lumen 3764, which may facilitate manufacturing. The actuator tube assembly 3790 can include a number of components, including, for example, a number of types of tubes. Fewer components may generally reduce the manufacturing complexity of the actuator tube assembly. Multiple components may provide specialization of different portions of the actuator tube assembly 3790. Multiple components can reduce the manufacturing complexity of the actuator tube assembly 3790 if the coupling components are easier together than fewer components are modified for a particular function. The actuation tube assembly 3790 shown in fig. 37M includes a first hypotube 3791, a second hypotube 3792, and an actuation tube 3728. The actuation tube assembly 3790 can include an actuation tube assembly lumen 3793 extending from a proximal end of the actuation tube assembly 3790 to a distal end of the actuation tube assembly 3790. The actuation tube assembly lumen 3793 may include sections in each component (e.g., the first hypotube 3791, the second hypotube 3792, and the actuation tube 3728 of the actuation tube assembly 3790 may be aligned along a longitudinal axis of the actuation tube assembly 3790, the lumens of the components may be connected and/or aligned, for example, the surface of the actuation tube 3728 and/or any other components comprising the actuation tube assembly lumen 3793 that position components having a smaller outer diameter within the lumen of the components having a larger diameter inner diameter may comprise a liner (e.g., a fluoropolymer (e.g., PTFE, PVDF, FEP, Viton, etc.)) to reduce friction therewith the guidewire inserted through the lumen 3793 the outer surface of the actuation tube 3728 and/or any other components comprising the actuation tube assembly 3790 may comprise a liner (e.g., a fluoropolymer (e.g., PTFE, PVDF, FEP, Viton, etc.)) to reduce friction between the actuation tube assembly 3790 and the catheter shaft assembly 3706 or the lumen 3674 of the handle base 3763.

Referring again to fig. 37L, the proximal end of the actuation tube assembly 3790, and more particularly the proximal end of the first hypotube 3791, may be fixedly connected to at least one of the actuator 3780 and the valve 3784. A first hypotube 3791 extends from actuator 3780 through sealing element 3766 to a proximal portion of lumen 3764 of handle base 3763. Sealing element 3766 provides a fluid seal between actuation tube assembly 3790 and handle base 3763. The first hypotube 3791 may be machined to include a first portion 3791A and a second portion 3791B, the first portion 3791A and the second portion 3791B having a diameter smaller than the diameter of the first portion 3791A. The first hypotube 3791 can include one or more apertures 3794, which can provide fluid communication between the actuation tube assembly lumen 3793. As described in further detail herein, fluid (e.g., saline, heparinized saline, contrast media, etc.) injected into the lumen 3793 through the valve 3784 can flow through the fluid. The cavity 3793 reaches the aperture 3794 and can then continue to flow through the cavity 3793 or out the aperture 3794 and then through the cavity 3764. In some examples, the first hypotube 3791 may lack the aperture 3794 and be configured such that fluid injected into the lumen 3793 flows only through the lumen 3793.

The first portion 3791A of the first hypotube 3791 may have an outer diameter that is slightly smaller than the inner diameter of the inner lumen 3764. Such a difference in diameters can reduce (e.g., minimize) the outer surface of the first portion 3791A and the inner surface of the handle base 3763 reduce (e.g., minimize) proximal flow of fluid out of the aperture 3794 and/or can reduce friction between the first portion 3791A and the inner surface of the handle base 3763. Second portion 3791B the first hypotube 3791 of the first hypotube 3791 can provide an arcuate or annular gap or lumen between the outer surface of the second portion 3791B of the first hypotube 3791 and the inner surface of the handle base 3763. Such a difference in diameter may encourage fluid to flow out of the bore. The first hypotube 3791 may comprise a biocompatible material, such as stainless steel, nitinol, plastic, or the like. Although depicted as o, flow distally through the lumen 3764. The first hypotube 3791 may be fabricated from a flat plate, solid rod, or the like.

The proximal end of the lumen 3764 of the handle base 3763 can include an expanded diameter portion configured to receive a sealing element 3766 (e.g., including an O-ring, gasket, washer, etc.). Sealing element 3766 may be positioned between first hypotube 3791 and handle base 3763. Sealing element 3766 may seal the proximal end of inner cavity 3764 to prevent or inhibit fluid flowing through aperture 3794 from flowing out of handle base 3763.

The second hypotube 3792 can include an outer diameter that is slightly smaller than the inner diameter of the first hypotube 3791, such that the proximal end of the second hypotube can be inserted into the distal end of the first hypotube 3791. The second hypotube 3792 can be fixedly coupled to the first hypotube 3791, such as by adhesive (e.g., cyanoacrylate), welding, brazing, combinations thereof, and the like. The second hypotube 3792 may extend to the proximal end of the catheter shaft assembly 3706. The inner diameter of the outer diameter second hypotube 3792 is smaller than the inner diameter of the inner lumen 3764, forming an arcuate or annular gap or lumen that can provide an open section to flow fluid and extend the conductor. The second hypotube 3792 can include a biocompatible material, e.g., stainless steel, nitinol, plastic, etc. Although described as a hypotube, the second hypotube 3792 may be machined from a flat plate, a solid rod, or the like.

The actuation tube 3728 extends from a proximal portion 3704 of the catheter system 3700 to a distal portion 3704 of the catheter system 3700. The actuation tube 3728 may be fixedly coupled to the second hypotube 3792, such as by an adhesive (e.g., cyanoacrylate). The second hypotube 3792 can include a lumen that is slightly larger than the outer diameter of the actuation tube 3728 such that the proximal end of the actuation tube 3728 can extend into the lumen. The distal end of the second hypotube 3792 can include a lumen having an inner diameter slightly larger than the outer diameter of the actuation tube 3728, and the distal end of the second hypotube 3793 can extend to the proximal end of the second hypotube 3792. The actuation tube 3728 may comprise multiple layers. For example, actuation tube 3728 may include a flexible polymer (e.g., polyimide, polyamide, PVA, PEEK, Pebax, polyolefin, PET, silicone, etc.), a reinforcement layer (e.g., including braid, coil, etc.), and a liner (e.g., a fluoropolymer (e.g., PTFE, PVDF, FEP, Viton, etc.)).

The second hypotube 3792 may optionally be omitted, for example, by extending the first hypotube 3791 distally and/or extending the flexible polymer of the actuation tube 3728 proximally. The second hypotube 3792 can include a biocompatible material, such as stainless steel, nitinol, plastic, or the like.

The actuation tube assembly 3790 and catheter shaft assembly 3706 combine to form two concentric lumens between the handle 3710 and the expandable structure 3720. The actuator tube assembly lumen 3793 of the actuator tube 3728 forms an internal lumen. The internal lumen 3793 may be in fluid communication with the hemostasis valve 3784. The distal end of the internal lumen 3793 may be the distal end of the actuator tube assembly 3790, which is coupled to the proximal hub 3740. The hemostasis valve 3784 can allow for insertion of a guidewire, which can extend through the actuation tube 3728 and distally beyond the distal hub 3750 of the expandable structure 3720. Outer lumen 3707 is arcuate or annular between the outer surface of actuation tube assembly 3790 and the inner surface of catheter shaft assembly 3706. The distal end of outer lumen 3707 is the distal end of catheter shaft assembly 3706, which is coupled to proximal hub 3740.

The hemostasis valve 3784 can be used to inject fluid (e.g., saline, heparinized saline, contrast media, etc.). Fluid may be injected into the hemostasis valve 3784 (e.g., via an IV bag, syringe, etc.). Fluid may flow through the first hypotube 3791 to the aperture 3794. Fluid may continue to flow through the inner lumen 3793 of the actuation tube assembly 3790 out of the distal hub 3750 and/or may flow through the aperture 3794 and then through the outer lumen 3707 out of the proximal hub 3740. Referring again to fig. 37G-37I, the proximal hub 3740 includes a peripheral lumen 3743. Fluid exits the outer lumen 3707 through at least one of the peripheral lumens 3743. Fluid flowing through the peripheral lumen 3743 can be inversely proportional to the level of occlusion of the peripheral lumen 3743 (e.g., due to occupation by the conductor 3712). In some examples, the first hypotube 3791 may not include the aperture 3794, and fluid may flow only through the inner lumen 3793 of the actuation tube assembly 37990 to the distal hub 3750.

The irrigation fluid may provide a slight positive pressure within the lumen, which may inhibit blood flow into the catheter system 3700. The irrigation fluid may wash the expandable structure 3720 and/or other portions of the catheter system 3700, which may inhibit thrombus formation during surgery. If the fluid includes contrast media, the flushing fluid may direct the contrast media to aid in fluoroscopy and visualization of the expandable structure 3720 relative to the blood vessel.

The handle base 3763 can include an aperture 3765, the aperture 3765 extending through the sidewall into the lumen 3764, e.g., in communication with an arcuate or annular gap or lumen between the second hypotube 3792 and the handle base 3763. The conductor 3712 can pass from the electrical connector 3799, through the connector tube 3798, through the aperture 3765, into the outer lumen 3707, through the proximal hub 3740 (e.g., as shown in figure 37I), and to the electrode 3724.

Fig. 37N is a perspective view of an example proximal end of the catheter shaft assembly 3706 and the second hypotube 3792. Catheter shaft assembly 3706 surrounds actuation tube 3728 from handle 3710 to proximal hub 3740. The actuation tube 3828 may be proximally retracted and/or distally advanced relative to the catheter shaft assembly 3706.

Catheter shaft assembly 3706 may include multiple layers. For example, the catheter shaft assembly 3706 may include a flexible polymer (e.g., polyimide, polyamide, PVA, PEEK, Pebax, polyolefin, PET, silicone, etc.), a reinforcement layer (e.g., including braid, coil, etc.), and a liner (e.g., a fluoropolymer (e.g., PTFE, PVDF, FEP, Viton, etc.)). There may be different layers along different longitudinal portions.

The flexible polymer may include, for example, polyimide, polyamide, PVA, PEEK, Pebax, polyolefin, PET, silicone, and the like. Different longitudinal portions of the tube may have different stiffness along the length of the catheter shaft assembly 3706. For example, the catheter shaft assembly 3706 may transition from a higher durometer (indicating a harder material) to a lower durometer, indicating a softer material, from the proximal end to the distal end. The length and stiffness of the variable stiffness portions may be set (clock) to suit the different anatomical structures in which these portions will reside during surgery. For example, catheter shaft assembly 3706 may include at least five portions of different hardness: a first portion having a durometer of about 72D, having a length configured to extend from the handle 3710 into the body through the carotid artery near the heart; a second portion having a stiffness of about 63D and a third portion having a stiffness of about 55D, together having a length configured to pass through the right atrium and right ventricle; and a fourth portion having a stiffness of about 40D and a fifth portion having a stiffness of about 25D, which together have a length configured to extend through the pulmonary artery and into the right pulmonary artery. The flexibility of the fourth and/or fifth portions may allow the catheter shaft assembly 3706 to flex and secure the catheter shaft assembly, for example, against the left side of the pulmonary artery trunk, which may help properly position the expandable member 3720 in the pulmonary artery. At least one of the fourth and fifth portions may include hinges 3726, e.g., as described herein, the hinges 3726 may resist kinking if the catheter shaft assembly 3706 makes an acute (e.g., 90 °) rotation, e.g., from the pulmonary trunk to the right pulmonary artery. The length of the five portions may be between about 50-90% of the first portion and between about 1-20% of each remaining portion, as a percentage of the total length of catheter shaft assembly 3706. For example, the lengths may be about 73%, 7.5%, 5.5%, and 8.5%, respectively. Depending on the overall length of catheter shaft assembly 3706, the first portion may be longer or shorter, which may depend on access to the pulmonary artery, the amount located outside the body, etc.

The catheter shaft assembly 3706 may have a length of between about 50 and 200cm (e.g., about 50cm, about 75cm, about 100cm, about 125cm, about 150cm, about 200cm, ranges between these values, etc.). The catheter shaft assembly 3706 may have a length suitable for positioning the expandable structure 3720 in a pulmonary artery from a peripheral vein (e.g., a jugular vein, a femoral vein, a radial vein, or other suitable access location).

The flexibility of the catheter shaft assembly 3706 may additionally or alternatively be adjusted by other means, such as stiffening and adjusting various portions of the catheter shaft assembly 3706. For example, if catheter shaft assembly 3706 includes a reinforcing coil, the pitch of the coil may be varied. As another example, if catheter shaft assembly 3706 includes a reinforcing braid, the parameters of the braid wires (e.g., number, thickness, braid angle, etc.) may be varied. For another example, if catheter shaft assembly 3706 includes a reinforcing braid, the parameters of the braid wires (e.g., number, thickness, braid angle, etc.) may be varied. As another example, the thickness may vary. For yet another example, the composition may be varied (e.g., different portions include at least one different material). Combinations of two or all of the variations are also possible. In addition to being discrete portions, flexibility may transition from one portion to the next.

Fig. 37N shows the proximal end of a catheter shaft assembly 3706, the catheter shaft assembly 3706 including a first portion 3708 and a second portion 3709 that is thicker than the first portion 3708. The thickness variation at the proximal end (e.g., first portion 3708) of the actuation shaft assembly 3706 can provide a strain relief mechanism. The second portion 3709 can have an outer diameter configured to fit within the inner cavity 3764 of the handle base 3763 to fixably couple to the handle base 3763.

Fig. 37O is a side cross-sectional view of an exemplary connection between the distal end of the catheter shaft assembly 3706 and the proximal hub 3740 of the expandable structure 3720. The distal end of catheter shaft assembly 3706 may include a hinge 3726 configured to fixably couple to proximal hub 3740.

The hinge 3726 may comprise, for example, a coil or series of spaced coils that extend slightly beyond the distal end of the other portions of the catheter shaft assembly 3760, such as PTFE liners, wire braids, and flexible tubing. Hinge 3726 may include one or more wires (e.g., one wire, two wires, three wires, or more wires) arranged in a helical pattern. The wire comprises helically wound coils having a uniform pitch. Each coil may occupy space between helical rotations of the other coils. Fig. 37P is a perspective view of an end of an example of a hinge 3726 including three wires. Hinge 3726 may comprise a hypotube, e.g., cut to include a coil pattern and/or opposing circumferential slots.

Hinge 3726 may be positioned about an outer surface of proximal portion 3741 of proximal hub 3740. The hinge 3726 may be fixedly coupled to the proximal hub 3740 by an adhesive (e.g., cyanoacrylate), brazing, welding, combinations thereof, or the like. The distal end of catheter shaft assembly 3706 may include a layer that is spaced proximally from the distal end of hinge 3726 by about 0.01 inches to about 0.1 inches (e.g., about 0.01 inches, 0.025 inches, 0.05 inches, 0.075 inches, 0.01 inches, ranges between these values, etc.), which may provide sufficient space for hinge 3726 to secure (e.g., directly secure) hinge 3726 to proximal hub 3740 without interference from these layers. The distal end of the flexible tube, wire braid, liner, and/or other layers of the catheter shaft assembly 3706 may be longitudinally spaced from the proximal end of the proximal hub 3740, which may reduce force transmission on the catheter shaft assembly 3706, such as by absorption by the articulation 3726, without being transmitted to the expandable structure 3720.

Articulation 3726 may be covered by an articulation tube 3711, which may comprise polyurethane or other suitable material, and which extends from the distal end of articulation 3726 past the proximal end of articulation 3726, e.g., to prevent articulation 3726 from pinching tissue. The hinge tube 3711 may be heat cured to the outer circumference of the hinge 3726 and other components of the catheter shaft assembly 3706. The hinge tube 3711 may be substantially aligned with, flush with, or overlap the proximal distal portion 3742. The hinge tube 3711 may form a fluid seal with the proximal hub 3742, e.g., to allow fluid flowing in the inner lumen 3707 to exit the peripheral inner lumen 3744.

Fig. 37Q is a perspective view of an exemplary handle 3701 of a catheter system (e.g., catheter system 3700) in an unlocked configuration. FIG. 37R schematically illustrates a perspective cross-sectional view of the handle 3701 of FIG. 37Q, taken along line 37R-37R. In addition to the handle 3701, fig. 37Q and 37R illustrate a portion of a catheter shaft assembly 3706 extending therefrom. The handle 3701 is configured to remain outside the body. Handle 3701 includes an outer handle 3713 that a user can grasp. Outer handle 3713 includes a lumen 3714 extending from a proximal end of outer handle 3713 to a distal end of outer handle 3713. The inner cavity 3714 can be configured to receive the tubular base 3715, and the tubular base 3715 can be partially inserted into the inner cavity 3714 and can be fixedly coupled to the external handle 3713. The tubular base 3715 may be generally cylindrical and may include a tapered distal end. Other geometries (e.g., polygonal) are also possible. The tubular base 3715 may extend beyond the distal end of the inner lumen 3714 (as shown in figures 37Q and 37R) or may be received entirely within the inner lumen 3714. The tubular base 3715 includes a channel 3716 extending from the proximal end of the tubular base 3715 to the distal end of the tubular base 3715. Tubular base 3715 may include shoulder 3717 extending into channel 3716, which shoulder 3717 is configured to interact with the proximal end of catheter shaft assembly 3706. The catheter shaft assembly 3706 may be fixedly coupled to the tubular base 3715 by inserting the proximal end of the catheter shaft assembly 3706 into the channel 3716 and then fixing the catheter shaft assembly 3706 to the tubular base 3715, such as by adhesive (e.g., cyanoacrylate), brazing, welding, combinations thereof, and the like. The actuator tube assembly 3790 may be slidably received in the channel 3716, and portions of the actuator tube assembly 3790 may extend through the catheter shaft assembly 3706, e.g., as described herein. The tubular base 3715 may include an annular recess 3718 in a sidewall of the channel 3716 near the proximal end of the channel 3716 that is configured to receive a sealing element (e.g., including an O-ring, gasket, washer, etc.). A sealing element may be positioned between the first hypotube 3791 and the tubular base 3715, and may inhibit or prevent fluid flowing through the aperture 3794 of the first hypotube 3791 from flowing out of the tubular base 3715. In some examples, the annular recess 3718 may extend to the proximal end of the tubular base 3715.

A proximal end of actuation shaft assembly 3790 may be coupled to actuation pin 3730. Actuation pin 3730 includes an actuation channel 3731, actuation channel 3731 extending from a proximal end of actuation pin 3730 to a distal end of actuation pin 3730. Actuation channel 3731 is configured to receive a proximal end of actuation tube assembly 3790 (e.g., first hypotube 3791), which may be partially inserted into actuation channel 3731 and may be fixedly coupled to actuation channel 3731, such as by an adhesive (e.g., cyanoacrylate), welding, combinations thereof, and the like. Actuation pin 3730 may include an expanded diameter grip 3732 to facilitate gripping by a user. The expanded diameter grip 3732 may include a textured surface. Actuation channel 3731 can include a flared diameter portion at a proximal end thereof that is configured to receive tube connector 3797. The tube connector 3797 can be Y-shaped, including two intersecting channels. The channel of the tube connector 3797 can be used to insert a guidewire, electrical conductors, and/or to inject fluids into the actuation tube assembly lumen 3793, as described elsewhere herein. Connector tubing 3797 may include a luer fitting that includes a single lumen.

Outer handle 3713 can include a void 3719 extending between the upper and lower surfaces and intersecting inner lumen 3714 of outer handle 3713. In some examples, the void 3719 may extend to a side surface of the handle 3713 such that it opens to the upper, lower, and side surfaces of the outer handle 3713. Void 3719 may be configured to receive locking member 3777. Fig. 37S is a perspective view of an example of locking member 3777. Locking member 3777 may include a generally cylindrical body and a channel 3778, channel 3778 extending through the generally cylindrical body from a proximal side of locking member 3777 to a distal side of locking member 3777. Locking member 3777 may include at least one protrusion 3789 extending radially inward from a sidewall of channel 3778. If the locking member includes two protrusions 3789, the two protrusions 3789 can be located on opposite sides of the channel 3778. If the channel 3778 is oval, the protrusion 3789 can be positioned along the length of the longer dimension of the channel 3778 (e.g., at a central location along the length of the longer dimension). Locking member 3777 may include a tab 3779 extending away from channel 3778, e.g., in a direction perpendicular to the longitudinal axis of channel 3778. Tab 3779 and the generally cylindrical body can form a b-shape, d-shape, p-shape, or q-shape. Actuation pin 3730 may extend through channel 3778. The handle 3701 can include a bushing 3796, the bushing 3796 configured to be received in the proximal end of the outer handle 3713, where the bushing 3796 can be secured. Bushing 3796 may include a channel through which actuation pin 3730 extends. Locking member 3777 may be rotatable about the longitudinal axis of actuation pin 3730. The locking member 3777 may be configured to place the handle 3701 and the actuation tube assembly 3790 in a locked or unlocked configuration. In some examples, the degree of rotation of locking member 3777 may be limited. As shown in the example of fig. 37Q, the tab 3779 may only allow the locking member 3777 to rotate approximately a quarter turn before the tab 3779 abuts a portion of the housing 3713.

Fig. 37T schematically illustrates an enlarged perspective cut-away view of the handle 3701 of fig. 37Q in an unlocked configuration in the region of the circle 37T of fig. 37R. Actuation pin 3730 may include a series of ridges 3733 and intermediate notches spaced along its outer circumference. Ridge 3733 may be perpendicular to the longitudinal axis of actuation pin 3730. Ridges 3733 may extend away from the circumference of actuation pin 3730 along two opposing sides of actuation pin 3730. For example, the circumference of actuation pin 3730 may be divided into approximately quadrants, and ridge 3733 may extend from two non-adjacent quadrants of the circumference. Several quarters of the circumference where ridge 3733 does not extend may include flat surfaces extending along the length of actuation pin 3730, as shown in figure 37Q (one of which is visible). The protrusion 3789 along the channel 3778 of the locking member 3777 can be configured to be received in the notch between the two ridges 3733. Protrusion 3789 can be configured to mate with an outer circumference of actuation pin 3730 when positioned in the recess. When in the unlocked configuration, the rotational orientation of locking member 3777 positions protrusion 3789 adjacent to the flat surface of actuation pin 3730. As shown in fig. 37T, in the unlocked configuration, the protrusions 3789 are not positioned between the ridges 3733. When in the unlocked configuration, tab 3779 can be positioned in a first position (e.g., an upward position, extending away from a surface of outer handle 3713). In the unlocked configuration, actuation pin 3730 may be translated in a proximal or distal direction by a user, which results in translation of actuation tube assembly 3790, which actuation tube assembly 3790 is rigidly secured to actuation pin 3730. The user may expand the expandable structure 3720 by pulling the actuation pin 3730 in a proximal direction. The user can compress the expandable structure 3720 by pushing the actuation pin 3730 in a distal direction. When in the unlocked configuration, the expandable structure 3720 may assume a self-expanded state without the user pushing or pulling the actuation pin 3730. Locking member 3777 may be devoid of tabs 3777, e.g., including a textured surface such as a thumb wheel.

Fig. 37U is a perspective view of the handle 3701 of fig. 37Q in a locked configuration. A user may place handle 3701 in the locked configuration by moving tab 3779 of locking member 3777 to the second position to rotate locking member 3777 approximately a quarter turn about actuation pin 3730. The outer handle 3713 can include a shoulder 3795 (fig. 37Q) to limit rotation of the tab 3779. In the locked configuration, the tabs 3779 may no longer extend away from the surface of the handle 3701, but may be flush with the surface of the handle 3701. As shown in fig. 37Q and 37U, the different positioning of tabs 3779 in the unlocked and locked configurations can provide a visually discernable indicator of the configuration of handle 3701.

Fig. 37V schematically illustrates a perspective cross-sectional view of the handle 3701 of fig. 37U along line 37V-37V. When in the locked configuration, the protrusions 3789 (two protrusions 3789 in the illustrated example) have rotated into two notches between the ridges 3733 of the actuation pin 3730, thereby inhibiting or preventing the actuation pin 3730 and the actuation tube assembly 3730 coupled thereto from moving in the proximal direction and in the distal direction. Locking of handle 3730 can inhibit or prevent further radial expansion and radial compression of expandable structure 3720. The user can partially rotate tab 3779 to about the desired locked position and can then push or pull actuator pin 3779 until protrusion 3789 falls into position between the ridges. In some examples, the width of protrusion 3789 may form a tight interference fit with the notch such that a "snap" is felt when locking or unlocking locking member 3777. To unlock locking member 3777, the user may place tab 3779 back in the upright position, rotating approximately one-quarter turn in the opposite direction for locking member 3777. Locking member 3777 may be configured to be rotated more or less than a quarter turn to switch between the locked and unlocked configurations.

Handle 3701 can allow a user to quickly and/or easily adjust the expansion of expandable structure 3720 by pushing or pulling actuation pin 3730 a desired amount. Actuation pin 3730 and actuation tube assembly 3790 can be locked in place along the longitudinal axis according to discrete increments determined by the pitch of the series of ridges 3733 and intermediate notches. The pitch and tabs 3789 can be modified to allow narrower or wider adjustment of the expansion and compression of the expandable structure 3720 (e.g., the width can be less than that shown in figures 37Q-37U to provide more locking positions). In some examples, locking member 3777 may include only one protrusion 3789 and/or actuation pin 3730 may include only one flat surface. In some examples, actuation pin 3730 can include a textured surface (e.g., including grooves, protrusions, flanges, etc.) configured to frictionally engage locking member 3777. The notch between the protrusion 3789 and the ridge 3733 may be correspondingly serrated. In such an example, locking member 3777 may be configured to allow actuation pin 3730 to translate in the locked configuration (e.g., back to the self-expanded state of expandable member 3720 in the event of a failure) if sufficient force is applied to force ridge 3733 over serration 3789.

Fig 38A is a perspective view of an example of a catheter system 3800. The system 3800 may include a proximal portion configured to remain outside of the subject and a distal portion configured to be inserted into the vasculature of the subject, such as described with respect to the catheter system 3800. System 3800 includes an expandable structure 3820. The expansible portion 3820 is coupled to the catheter shaft 3806. In some examples, the system 3800 includes a catheter shaft 3806 and a strain relief 3826 between the expansible portion. The strain relief 3826 may be at least partially located within the lumen of the catheter shaft 3806.

Expandable structure 3820 includes a plurality of splines 3822. The splines 3822 comprise a sinusoidal or wavy or undulating or saw-tooth shape. The sinusoidal shape may provide greater flexibility in electrode positioning. For example, the electrodes may be placed at peaks, valleys and/or at ascending or descending portions. In some examples, the electrodes are positioned to emerge from the peaks, which may allow the electrodes to be in intimate contact with the vessel wall. The sinusoidal shape may provide better wall proximity, such as forming anchor points at the peaks. At least one of the splines 3822 includes an electrode array including a plurality of electrodes to form an electrode matrix. The number of electrodes in the electrode matrix, electrode size, electrode spacing, etc. may be consistent with other systems described herein. In some examples, the splines 3822 comprise wires having diameters between about 0.006 inches (about 0.15mm) and about 0.015 inches (about 0.38mm) (e.g., about 0.006 inches (about 0.15mm), about 0.008 inches (about 0.2 mm), about 0.01 inches (about 0.25 mm), about 0.012 inches (about 0.3 mm), about 0.015 inches (about 0.38mm), and so forth. In some examples, splines 3822 may be cut from a hypotube and then shaped into a sinusoidal shape.

Fig 38B is a perspective view of a portion of the catheter system 3800 of fig 38A in a collapsed state. The illustrated portions include the catheter shaft 3806, the strain relief device 3826, and a portion of the expandable structure 3820. The illustrated portion also includes an actuation member 3828, which may be coupled to an actuator mechanism to cause expansion or retraction of the expandable structure 3820. An actuation member 3828 may be in the lumen of the catheter shaft 3806. A guidewire 3815 is also shown in the lumen of the actuation member 3825. In some examples, the actuation member 3828 includes a lumen configured to receive a 0.018 inch guidewire 3815. The actuation member 3828 may include a tubular structure, such as described with respect to the actuation tube assembly 3790. Actuation member 3828 may include a wire with or without a lumen.

Fig 38C is a side view of a portion of the catheter system 3800 of fig 38A in an expanded state. Operation of actuation mechanism 3612 can cause expandable structure 3620 to expand and contract. For example, rotation and/or longitudinal movement of the actuation mechanism 3612 can cause the actuator wires 3628 to retract proximally, the catheter shaft 3606 to advance distally, or a combination thereof, each of which can push the splines 3622 radially outward. In some examples, the distal ends 3622 of the splines are coupled to a distal hub that is coupled to the actuator wire 3628, and the proximal ends of the splines 3622 are coupled to a proximal hub that is coupled to the catheter shaft 3606. In the expanded state, the expandable structure 3620 includes splines 3622 spaced apart from each other substantially parallel to the longitudinal axis at a location radially outward of the splines 3622. The parallel orientation of the splines 3622 may provide a circumferential spacing of the splines 3622, e.g., as opposed to individual splines or wires that may be bundled circumferentially. In some examples, splines 3622 comprise wires having diameters between about 0.006 inches (about 0.15 millimeters) and about 0.015 inches (about 0.38 millimeters) (e.g., about 0.006 inches (about 0.15 millimeters), about 0.008 inches (about 0.2 millimeters), about 0.01 inches (about 0.25 millimeters), about 0.012 inches (about 0.3 millimeters), about 0.015 inches (about 0.38 millimeters), between these values, and so forth).

In some examples, the diameter of the expandable structure 3820 in the expanded state is between about 15mm and about 30mm (e.g., about 15mm, about 20mm, about 22mm, about 24mm, about 26mm, about 28mm, about 30mm, ranges between these values, etc.). In some examples, the splines 3822 may be self-expanding such that the actuation mechanism allows the splines to self-expand from a compressed state for guidance to a target site to an expanded state for treatment at the target site. In some such examples, the diameter of the expandable structure 3820 in the expanded state may exceed the size of the intended vasculature of most subjects to ensure vessel wall proximity. In some examples, splines 3822 may be non-self-expanding, such that the splines expand only upon operation of the actuation mechanism. In some examples, the splines 3822 may be self-expanding, and the actuation mechanism may further expand the splines 3822, which may provide that the diameter of the expandable structure 3820 may be adjustable for a range of vessel sizes, wall proximity forces, and the like. Examples of expandable structure 3820 not being proximate to a wall in the event of an error may be advantageous for safety, such as described with respect to system 2200.

Fig. 38D is a partial side cross-sectional view of expandable structure 3820. The expandable structure includes a distal hub 3830, the distal hub 3830 including a plurality of channels 3832, with distal segments of the splines 3822 positioned in the channels 3832. In some examples, the distal segments of the splines 3822 are not fixed such that they may slide in the channels 3832, which may allow each spline 3822 to move independently, which may accommodate curvature at the deployment site. In some such examples, the distal ends of the splines 3822 include stop members (e.g., expanded diameter ball welds) that inhibit or prevent the distal segments from exiting the channels 3832 and the distal hub 3830. Such a system may also be used with other catheter systems and expandable structures described herein (e.g., expandable structure 3620,3630,3640,3650).

Fig. 38E is a partial side cross-sectional view of the expandable structure 3840. The expandable structure 3840 includes a plurality of splines 3842 having a sinusoidal shape. The expandable structure 3840 includes a plurality of electrodes 3844 at the peaks of a plurality of three splines 3842 to form a 3 x 4 electrode matrix. In some examples where the three splines comprise electrodes, the middle or center spline may be different from the circumferentially adjacent splines. For example, the intermediate splines may include more or fewer peaks, peaks that are longitudinally offset, and the like. Upon expansion of the expandable structure 3820, the electrodes of the electrode matrix may be selectively activated to test nerve capture, calibration, and/or treatment, e.g., as described herein.

FIG. 39A is a side view of an example of an expandable structure 3900. Expandable structure 3900 can be incorporated into a catheter system, such as the catheter systems described herein. Expandable structure 3900 comprises a plurality of splines 3902. Splines 3902 may be flexed to form radially offset parallel portions 3904. Parallel portion 3904 can include electrodes, electrode structures, and the like. In some examples, the flex portions of the splines act as hinges to push the offset parallel portion 3904 against the vessel wall. Expandable structure 3900 can be self-expanding, can be expanded using an actuating mechanism, and combinations thereof, e.g., as described herein. Fig. 39A shows four splines 3902 circumferentially offset by about 90 °, but other numbers of splines and offsets are possible.

Fig. 39B is an end view of an example of another expandable structure 3910. Expandable structure 3910 includes six splines 3912, three of which are grouped on one side of plane 3914 and three of which are grouped on the other side of plane 3914. In some examples, one set of splines 3912 may include electrodes, while another set of splines 3912 may be devoid of electrodes and used for wall approximation, anchoring, etc. In some examples, fig. 39B represents a portion of fig. 36H. For example, the expandable structure 3900,3910 may include a portion (e.g., one half) of a spline as described with respect to fig. 36A-36O.

Fig. 39C is an end view of an example of yet another expandable structure 3920. Expandable structure 3920 includes six splines 3922 and six splines 3924. Similar to spline 3902, spline 3922 includes radially offset parallel portions. Splines 3924 are each substantially parallel to adjacent splines until buckling and continue to extend radially outward.

Fig. 39D is an end view of an example of yet another expandable structure 3930. Expandable structure 3930 includes first splines 3932, second splines 3934, and six splines 3936. Similar to spline 3902, spline 3922 includes radially offset parallel portions. Similar to spline 3902, spline 3924 also includes radially offset parallel portions that are radially offset in a different direction than spline 3922. Splines 3936 extend radially outward, with one spline 3936 circumferentially between splines 3932,3934. Splines 3932,3934 and splines 3936 circumferentially between splines 3932,3934 may include electrodes forming an electrode matrix. In some examples, fig. 39D represents a portion of fig. 36L. For example, the expandable structure 3900,3910,3920,3930 may include a portion (e.g., one half) of a spline as described with respect to fig. 36A-36O.

The parallel portions of the expandable structure 3900,3910,3920,3930 may be straight, concave, convex, sinusoidal, longitudinally offset, load bearing grids, etc., e.g., as described herein.

Fig. 40A is a perspective view of an example of a strain relief device 4026 for a catheter system. The strain relief 4026 may be used like a flexible hinge to decouple catheter forces from an expandable structure, such as in the catheter systems described herein. The strain relief 4026 comprises a spring. The spring may comprise a variable coil which may vary the flexibility longitudinally. In some examples, the spring may be embedded in the polymer. In some examples, the polymer may have a stiffness that varies longitudinally in line with the helical variability and/or is offset longitudinally from the helical variability. In some examples, the strain relief device does not include a spring, but rather a polymer having a longitudinally varying durometer. In some examples, multiple helices of opposite chirality may be braided to form the strain relief device.

Fig. 40B is a perspective view of another example of a strain relief device 4027 for a catheter system. The strain relief 4027 may be used like a flexible hinge to decouple catheter forces from an expandable structure, such as in the catheter systems described herein. The strain relief 4027 comprises a cut hypotube. In the example shown in fig. 40B, the cut includes a first helix 4002 having a first chirality (e.g., clockwise winding) and a second helix 4004 having the same first chirality. The first spiral 4002 is longitudinally offset from the second spiral 4004. In some examples, the cutting pattern may include a variable helix, which may longitudinally vary flexibility. In some examples, the hypotube may be embedded in a polymer. In some examples, the polymer may have a stiffness that varies longitudinally in line with the helical variability and/or is offset longitudinally from the helical variability. Other cutting patterns are also possible. For example, the cutting pattern may comprise a single spiral. For another example, the cutting pattern may include a plurality of transverse slots or cuts connected by one or more struts. In some examples, cutting the hypotube may provide tensile strength.

Fig. 41A is a perspective view of an example of a catheter system 4100. The system 4100 includes a proximal portion 4102 configured to remain outside of the subject and a distal portion 4104 configured to be inserted into the vasculature of the subject. The distal portion 4104 includes a first expandable structure 4120 and a second expandable structure 4122. The proximal portion includes an actuation mechanism 4112. The proximal portion 4102 is coupled to the distal portion 4104 by a catheter shaft 4106. In some examples, the catheter shaft is slightly rigid such that the catheter shaft 4106 can conform to the sidewall and help anchor the system 4100 at the target location. Proximal portion 4102 may include an adapter comprising a plurality of ports, such as a Y adapter including a first Y adapter port 4116 and a second Y adapter port 4118. First Y-adapter port 4116 may be in communication with a lumen in fluid communication with the second expandable member. A second Y adapter port 4118 may be used to couple the electrode matrix of the system 4100 to the stimulator system 4119. In some examples, the proximal portion 4102 includes a stimulator system 4119. For example, the proximal portion 4102 can include electronics configured to provide stimulation to the electrode matrix, sensors (e.g., in communication with the fluid-filled lumen of the catheter shaft 4106), electronics for receiving data from the sensors, electronics for closed-loop control, electronics for providing feedback to a user (e.g., physician, nurse, subject), input mechanisms of the user (e.g., physician, nurse, subject), and the like.

Fig. 41B is a perspective view of the portion 4104 of the catheter system 4100 of fig. 41A in a collapsed and compacted state. Fig. 41C is a transverse cross-sectional side view of the portion 4104 of fig. 41B. The illustrated distal portion 4104 includes a catheter shaft 4106, a first expandable structure 4120, a second expandable structure 4122, and a portion of a tubular member 4128. The first expandable structure 4120 includes a plurality of splines coupled to the catheter shaft 4106. The tubular member 4128 may be within the lumen of the catheter shaft 4106. In some examples, the distal ends of the splines are coupled to a distal hub, which is coupled to the tubular member 4128, and the proximal ends of the splines are coupled to the catheter shaft 4106. The distal segments of the splines may be slidable in the distal hub, e.g., as described herein. The tubular member 4128 includes an inner cavity 4129. The lumen 4129 is in fluid communication with the second expandable member 4122.

The second expandable member 4122 may be adjacent (e.g., a distance of 0 cm) to the first expandable member 4120 or longitudinally (proximally or distally) spaced from the first expandable member 4120 by up to about 5cm (e.g., about 0.25 cm, about 0.5 cm, about 1 cm, about 1.5 cm, about 2 cm, about 2.5 cm, about 3 cm, about 4 cm, about 5cm, ranges therebetween, etc.). The amount of spacing, if any, may depend at least in part on the location of the target site, the hardness of the catheter shaft 4106, the number of splines of the first expandable member 4120, the expanded diameter of the first expandable member 4120, and the like.

Figure 41D is a side view of the portion 4104 of figure 41B in an expanded state. Specifically, the second expandable member 4122 is inflated. In some examples, an injectable fluid (e.g., saline, contrast agent, etc.) enters the lumen 4129 until the second expandable member 4122 radially expands. In some examples, the second expandable member 4122 may expand longitudinally. The inflated second expandable member 4122 may be a swan-ganz balloon that may be used to float the distal portion 4104 to a target site, such as a pulmonary artery. Rather than tracking a guidewire through the catheter system 4100, the catheter system 4100 can include an integrated system in which the second expandable member includes an electrode matrix. In some examples, the catheter system 4100 may be devoid of the second expandable member 4122 and/or may be configured to be tracked over a guidewire that may be positioned in the vasculature (e.g., in the right pulmonary artery 4143) prior to introduction of the catheter system 4100, e.g., using swan-ganz techniques, fluoroscopic guided steering, etc., as described herein.

Figure 41E is a perspective view of the portion of 4104 of figure 41B in an expanded state. Specifically, the first expandable member 4120 is expanded. In some examples, operation of the actuation mechanism 4112 can expand and contract the first expandable structure 4120. For example, rotation and/or longitudinal movement of the actuation mechanism 4112 can cause the tubular member 4128 to retract proximally, the catheter shaft 4106 to advance distally, or a combination thereof, each of which pushes the first expandable member 4120 radially outward. In certain such examples, the tubular member 4128 may expand the second expandable member by flowing fluid through the lumen 4129 and may expand the first expandable member 4120 by retracting proximally. The dual function tubular member 4128 may reduce the mass and/or complexity of the catheter system 4100. In some examples, different structures may be used to implement one or more of these functions. For example, in some examples, the splines may self-expand such that actuation mechanism 4112 or another mechanism (e.g., retraction of a sheath over the splines) allows the splines to self-expand from a compressed state to navigate to a target location to an expanded state for treatment at a target site. In certain such examples, the diameter of the first expandable structure 4120 in the expanded state may exceed the size of the majority of the intended vasculature in most subjects to ensure vessel wall proximity. In some examples, the splines may be non-self-expanding such that the splines expand only upon operation of actuation mechanism 4112. In some examples, the splines may be self-expanding and the actuation mechanism 4112 may further expand the splines, which may provide an adjustable diameter of the first expandable structure 4120 that may be used for a range of vessel sizes, wall approximation, etc. The example of the first expandable structure 4120 not being proximate to the wall in the event of an error is advantageous for safety, such as described with respect to system 2200. In some examples, the wires are not fixed distally (e.g., to a distal hub), which may allow each wire to move independently, which may accommodate curvature at the deployment site.

In the expanded state, the first expandable structure 4120 comprises splines circumferentially spaced apart from one another on one side of a plane including the longitudinal axis of the distal end portion 4104. In some examples, the splines comprise wire diameters between about 0.006 inches (about 0.15mm) and about 0.015 inches (about 0.38mm) (e.g., about 0.006 inches (about 0.15mm), about 0.008 inches (about 0.2mm), about 0.01 inches (about 0.25mm), about 0.012 inches (about 0.3mm), about 0.015 inches (about 0.38mm), ranges therebetween, etc.). In some examples, the diameter of the expandable structure 4120 in the expanded state is between about 15mm and about 30mm (e.g., about 15mm, about 20mm, about 22mm, about 24mm, about 26mm, about 28mm, about 30mm, ranges between these values, etc.).

The splines of the first expandable member 4120 may comprise an electrode array comprising a plurality of electrodes to form an electrode matrix. The number of electrodes in the electrode matrix, electrode size, electrode spacing, etc. may be consistent with other systems described herein. For example, in some examples, expandable structure 4120 includes a mesh or membrane containing electrodes that extend across two or more splines. Upon expansion of the first expandable structure 4120, the electrodes of the electrode matrix may be selectively activated to test nerve capture, calibration, and/or treatment, e.g., as described herein.

Figure 41F schematically illustrates the first expandable structure 4120 expanded within the vasculature. The vasculature may include, for example, a pulmonary trunk 4132, a right pulmonary artery 4134, and a left pulmonary artery 4136. In some examples, the catheter 4106 is asymmetric such that the catheter shaft 4106 can flex during float to naturally align the first expandable structure 4120 with the right pulmonary artery 4134. After expansion of the first expandable structure 4120, the catheter system 4100 can be retracted proximally until the first expandable structure 4120 snaps into place. After positioning the first expandable member 4120, electrodes on splines of the first expandable structure 4120 may be used to stimulate the target nerve 4138.

Figure 41G schematically illustrates another example of the first expandable structure 4120 expanded in the vasculature. The vasculature may include, for example, a pulmonary trunk 4132, a right pulmonary artery 4134, and a left pulmonary artery 4136. Flexing and positioning the tubular member 4128 against the left side of the pulmonary trunk 4132 positions and anchors the first expandable structure 4120 in the right pulmonary artery 4134 in a position to stimulate the target nerve 4138.

In some examples, expansion of the first expandable structure 4120 causes the distal portion 4104 to flex relative to the catheter shaft 4106. Such flexion may advantageously assist in anchoring the distal portion 4104 at the target site. For example, the tubular member 4128 may be proximate a first side of a blood vessel and the catheter shaft 4106 may be proximate an opposite side of the blood vessel.

Fig. 42A is a side view of an example of an electrode structure 4224. The electrode structure 4224 may be used with expandable structures as described herein. In fig. 42A, the electrode structure 4224 is shown on splines 4222 of an expandable structure. The electrode structure 4224 includes a plurality of electrodes 4202 and an insulating portion 4204 surrounding the electrodes 4202. Electrode 4202 extends around the circumference of electrode structure 4224. The electrode structures 4224 may be formed separately and then slid over the splines 4222.

Fig. 42B is a side view of another example of an electrode structure 4225. The electrode structure 4225 may be used with expandable structures as described herein. In fig. 42B, the electrode structure 4225 is shown on splines 4222 of the expandable structure. The electrode structure 4225 includes a plurality of electrodes 4203 and an insulating portion 4204 surrounding the electrodes 4203. Electrode 4203 extends partially around the circumference of electrode structure 4225. Electrode structure 4225 also includes insulation 4205 on the inside, which may insulate electrode 4203 and direct energy radially outward. Electrode structures 4225 may be formed separately and then slid over splines 4222.

Fig. 43A is a side view of an example of an electrode 4302. The electrode 4302 is a button electrode that may be coupled to a spline or grid. The electrode 4302 does not include insulation so that energy can be emitted in all directions.

Fig. 43B is a side view of another example of an electrode 4303. The electrode 4303 is a button electrode that may be coupled to a spline or grid. The electrode 4303 includes an insulating portion 4305 so that energy is emitted from the non-insulated region, which may provide directional control.

Fig. 44A is a side view of an example of the electrode 4402. The electrode 4402 is a tube electrode, which may be coupled to a spline or grid. The electrode 4303 does not include insulation so that energy can be emitted in all directions.

Fig. 44B is a side view of another example of the electrode 4403. The electrode 4403 is a tube electrode that can be coupled to a spline or grid. The electrode 4403 includes an insulating portion 4405 so that energy is emitted from the non-insulating region, which can provide directional control. In some examples, the electrode 4403 is fixed in rotational position around the spline, e.g., directing energy radially outward.

FIG. 45 is a schematic illustration of nerve stimulation of a nerve near a vessel wall. Electrode 4508 is positioned in a vessel lumen 4506, and a vessel wall 4504 is near or adjacent to nerve 4502. Electrode 4508 is partially insulated (e.g., as in electrode 4303) so that energy radiates primarily from one side. Electrode 4508 can have a thickness of between about 1mm²And about 3mm²The area in between. In some examples, electrode 4508 includes platinum iridium. In some examples, the non-insulating surface of electrode 4508 is treated, e.g., to increase the surface area. Energy radiates from the surface of the electrode 4508 and dissipates in the vessel wall 4504. A portion of the energy radiates from the vessel wall 4504 and captures a portion of the nerve 4502. The nerve 4502 also dissipates energy that does not extend far beyond the nerve 4502, which can reduce the likelihood of capturing other unwanted or unintended nerves, which can reduce side effects such as pain, coughing, and the like. The diameter 4503 of the nerve may be between about 1mm and about 2 mm. Even with insulation, some energy may be emitted into the vessel cavity 4506 from the opposite surface, where blood or other materials may dissipate the energy.

Table 1 shows the correlation between right ventricular contractility and left ventricular contractility changes after three different changes. The correlation is a beat-to-beat analysis. Pressure measurements were made by a Millar catheter, which includes a MEMS pressure sensor, in units of max (dP/dt) (max (dP/dt)), used as a surrogate indicator of contractility.

The first change, dobutamine infusion, provided a very high increase in contractility of over 500%. The average correlation between right ventricular contractility and left ventricular contractility was very good, 0.91, with 1.00 being a perfect correlation. Thus, measuring changes in right ventricular contractility can provide accurate information about changes in left ventricular contractility if a subject is given dopamine infusion. The first change was repeated three times.

The second variation, a 5mL calcium infusion, provided about a 20% increase in contractility. Fig. 46A shows left ventricular pressure, in blue, measured by a miller Mikro-cath (mems) pressure sensor catheter, right ventricular pressure, in yellow, measured by a pressure sensor in communication with a fluid-filled lumen, and right ventricular pressure, in purple, measured by a miller Mikro-cath (mems) pressure sensor catheter and arterial pressure, in green, measured in the aorta by a miller Mikro-cath (mems) pressure sensor catheter. The average correlation between right ventricular contractility and left ventricular contractility using a miller (MEMS) sensor on a catheter is very good, 0.91. The average correlation between right and left ventricular contractility using the fluid-filled lumen of the swan-ganz catheter in communication with the external pressure sensor was also very good, 0.87. Thus, in certain cases, such as a measuring animal (normal, non-HF sheep model) model, if a subject is given calcium infusion, measuring changes in right ventricular contractility with a MEMS sensor or a fluid-filled lumen can provide accurate information about changes in left ventricular contractility.

A fourth variation, neural stimulation as described herein, provides an increase in contractility of about 28%. The correlation between right ventricular contractility and left ventricular contractility was very good, 0.90. Thus, measuring changes in right ventricular contractility can provide accurate information about changes in left ventricular contractility if the subject is administered neural stimulation. Fig. 46B shows left ventricular contractility in cyan and right ventricular contractility in gold for neural stimulation changes, with neural stimulation applied after about 35 seconds and then turned off after about two minutes of application. In the first few beats following calcium infusion, the left ventricular contractility increased dramatically, but only slightly. Thereafter, left ventricular contractility decreases logarithmically or exponentially, but right ventricular contractility decreases slowly. These differences help explain why the correlation between left and right ventricular contractility is poor for calcium infusion. The fourth variation is not repeated.

TABLE 1

In some examples, the MEMS pressure sensor may be integrated into the catheter system described herein, e.g., configured to reside in the right ventricle to measure right ventricular contractility, which may be accurately correlated with left ventricular contractility for neural stimulation. In some examples, an alternative pressure measurement system, such as a fluid-filled (e.g., saline-filled) lumen having a first end in communication with an external pressure sensor (e.g., via a luer connection) and a second end in communication with a bore, is configured to reside in the right ventricle to measure right ventricular contractility, which may be accurately correlated with left ventricular contractility for neurostimulation. MEMS pressure sensors can provide higher fidelity (more direct feedback) than pressure sensing lumens. MEMS pressure sensors may occupy less catheter volume because they do not include a lumen, which may reduce the size of the catheter and/or provide additional space for other devices. MEMS pressure sensors may be easier to set, for example, than filling a lumen with fluid and properly coupling the fluid-filled lumen to the sensor. MEMS pressure sensors can be more easily placed anatomically. Easier setup and/or placement may result in more accurate results. MEMS pressure sensors may reduce or eliminate the whip effect (whip effect), where the curvature of the fluid-filled lumen may kink when flexed around a bend, which may provide inaccurate readings. The pressure sensing lumens may be advantageously suitable for long dwell times because they are less likely to be affected by blood than MEMS sensors. In some examples, multiple pressure sensors of the same type or different types may be used, for example, to provide a more accurate measurement (e.g., by taking an average or weighted average of the measurements).

The accuracy of measuring left ventricular contractility by measuring right ventricular contractility during neural stimulation can be used to monitor treatment efficacy. The accuracy of measuring left ventricular contractility by measuring right ventricular contractility during neural stimulation can be used to monitor treatment efficacy. In some examples, left ventricular contractility may be used for closed loop control (e.g., neural stimulation parameter adjustment, turning neural stimulation on and/or off, etc.) after correlation from the measurement of right ventricular contractility.

In some examples, a pressure such as right ventricular pressure may be monitored for safety purposes. For example, right ventricular pressure, associated left ventricular pressure, and optionally other measurements such as right atrial pressure may be used as surrogate ECG signals for determining heart rate and/or arrhythmia. As described below, such variables may not be measurable in general during stimulation.

For another example, pressure may be used to determine whether the catheter has moved, for example, from the right ventricle to the right atrium or superior vena cava, or from the pulmonary artery to the right ventricle. The system may be configured to trigger (e.g., automatically) certain events upon determining movement, such as stopping stimulation, collapsing the electrode basket, releasing the anchors, etc.

Monitoring the efficacy of the treatment in an integrated manner with the stimulation device already in use (e.g. using a sensor on a portion of the catheter proximal to the stimulation element) can provide certain advantages. For example, not having a separate program for placing the sensors can reduce operating time. The sensor preferably responds quickly to the stimulus. The sensor preferably provides useful feedback as to when the target nerve is engaged. The sensor is preferably non-invasive or incorporated into the stimulation catheter.

Can be associated with a contractility and/or a relaxation property andexample signals associated with neural binding to monitor therapeutic binding (therapy engagement) include: systolic interval such as pre-ejection period (time from QRS onset to LV maximum dP/dt on ECG); LV ejection time (time from aortic valve opening to aortic valve closing); and/or systolic pressure and/or mean arterial pressure (e.g., driven by an increase in systolic pressure). With certain stimulation therapies described herein, the systolic time interval can be decreased and/or the systolic pressure can be increased. There are a number of ways to measure each of these signals. LV ejection times can be estimated, for example, by assessing the duration of the S1 to S2 intervals, measuring the time from aortic valve opening to valve closing using arterial pressure and using the dicrotic notch as a landmark, using LV pressure waveforms from the time LV maximum dP/dt to the time LV minimum dP/dt, and/or using heart sounds. Systolic pressure can be measured non-invasively, including intermittently using a blood pressure tourniquet or continuously using a finger tourniquet or tonometer to monitor changes in estimated peripheral arterial pressure (e.g., systolic pressure, mean pressure, pulse pressure). In some examples, changes in systolic time intervals and/or pressure changes on the right side (e.g., using RV pressure signals) may be used to assess the status of neural binding, for example, if left side pressure or other measurements are not available and/or not combined with left side assessment. Another measurement that may be useful for monitoring nerve binding may include the maximum rate of change of pressure of the right ventricle (maximum dP/dt), which is similar to the LV maximum dP/dt, but using the Right Ventricular (RV) pressure. Another example of a nerve binding signal is the rate of change of the dP/dt signal (d) ²P/dt²The second time derivative of the pressure signal) that can be calculated during the start of the stimulation (e.g., from the time of the start of the stimulation to the time of the maximum dP/dt plateau, which can be in the range of 20 to 30 seconds, but can be analyzed in view of other time ranges). In some such examples, an increase in stimulation amplitude may increase the rate of change measurement to indicate that dP/dt increases at a faster rate. If the rate of change measurement fails to vary above a certain threshold with changes in stimulation amplitude, it may be that the nerve is not being incorporated by stimulation therapy. Of neural engagementAnother measurement may include estimating stroke volume and/or cardiac output from a pulse profile of a right or left side pressure signal (e.g., RV pressure). The stroke volume can be estimated by estimating the area under the pressure curve between valve opening and valve closing (minus the pressure at which the valve opens). Multiplying the estimated stroke volume by the heart rate can provide an estimate of cardiac output. With certain stimulation therapies described herein, an increase in stroke volume or cardiac output may be expected, and an increase in stroke volume or cardiac output may be indicative of neural binding. Changes in blood flow velocity in the pulmonary artery can be monitored using ultrasound (e.g., doppler echocardiography), such as by monitoring flow through a site non-invasively and/or via a catheter sensor (e.g., using velocity time integration and multiplying by the cross-sectional area of the site (e.g., pulmonary artery)). One or more feedback signals may be used to determine whether a nerve is engaged during therapy delivery (therapy delivery).

Several parameters useful for monitoring nerve incorporation may vary over time and with different factors such as cardiac loading conditions, subject autonomic status (e.g., white gown syndrome), other physiological conditions (e.g., pressure changes in the right arm as opposed to the left arm), and the like. For example, as described herein, periodic or intermittent monitoring may account for such changes.

For a given set of stimulation parameters and electrode configurations, the increase in LV maximum dP/dt can occur within a few seconds of the start of stimulation, reaching a plateau within 20 to 30 seconds on average. After stimulation is turned off, the LV maximum dP/dt slowly returns to the pre-stimulation baseline or non-stimulation baseline (which may be higher than the pre-stimulation baseline after the duration of treatment), for example, within 3 to 5 minutes after stimulation is turned off.

Several methods can be used to test for neural binding. In one example, the stimulation may be turned off or reduced intermittently to a sub-threshold level when the subject is in a steady state (e.g., once a day in the evening or in sleep, intermittently at regular time intervals each day, etc.). After several minutes, a decay to baseline may be made to detect whether the stimulus is engaging the nerve, and/or a threshold may be used to determine engagement when the signal reaches a threshold level. Reopening the stimulus and seeing the signal change in the favorable direction will further confirm whether the stimulus is engaged with the nerve. Combinations of stimulation parameter variations may be used to test for neural engagement and/or stimulation may be turned off for a given duration of time tested for each parameter (e.g., above the stimulation level, below the therapeutic stimulation level, and/or below a threshold level). The stimulation parameter may be stimulation amplitude, but may also include stimulation pulse width, frequency, duty cycle, and the like. The nerve junction signal can be calibrated in a catheter laboratory (e.g., during catheter delivery) to assess how changes in the stimulation parameters can affect the nerve junction signal, for example, by assessing changes in the signal with changes in LV maximum dP/dt. This calibration phase may be used to determine a threshold for nerve binding detection input to the algorithm, which may be used to assess whether nerves are bound in the hospital room. The signal may be used to intermittently monitor catheter movement. This signal can be used to assess whether the treatment is likely to be titrated (e.g., if the nerve is still in a bound state) or if the movement is large (e.g., enough that the nerve is not in a bound state) so that the catheter position can be assessed using imaging or some other technique to help determine the action (e.g., selecting a different electrode to be activated), or the catheter is moving too much to reprogram (e.g., if the catheter is not moved, the nerve cannot be engaged).

In another example, stimulation parameters (e.g., amplitude, pulse width, etc.) may be turned to a lower setting and/or a higher setting to identify changes in the feedback signal. Thus, stimulation therapy is not interrupted, but is only reduced or increased relative to the therapeutic level of the subject. For example, changing the parameters may advantageously avoid a latency of several minutes, as opposed to turning off the stimulus, which may be related to monitoring the decay from baseline. Changes in the appropriate direction of the feedback signal in relation to changes in parameter changes in a short-time steady-state type of setting may be used as an indicator of neural engagement, particularly since this type of change may be non-physiological. Such testing may be repeated for confirmation and may be triggered manually by the clinician, or may be automatically programmed to occur at specific time intervals. The action may be performed and/or programmed using a stimulator or through a programming interface. The stimulator user interface and/or stimulator panel may indicate whether a nerve is engaged by displaying a nerve engagement status (e.g., engaged or not engaged) and/or displaying a nerve signal.

Fig. 47A schematically shows an exemplary electrocardiogram (ECG or EKG). The ECG includes P-waves, Q-waves, R-waves, S-waves and T-waves, which represent different events during a single heartbeat of a healthy patient. The P-wave represents atrial depolarization that causes the left atrium and the right atrium to push blood into the left ventricle and the right ventricle, respectively. Until the plateau of the Q-wave, the "PR segment" and the P-wave start to the start of the Q-wave are the "PR intervals". The Q, R, and S waves, together the "QRS complex," represent ventricular depolarization that causes the right ventricle to push blood into the pulmonary arteries and toward the lungs, and causes the left ventricle to push blood into the atria for distribution to the body. The T wave represents the repolarization of the left and right ventricles. The plateau up to the T wave is the "ST segment", during which the ventricles depolarize, and collectively the QRS complex, ST segment and T wave are the "QT interval". Some electrocardiograms also have a U wave after the T wave. The timing, amplitude, relative amplitude, etc. of the various waves, segments, intervals, and complexes can be used to diagnose various conditions of the heart. Electrical stimulation from the systems described herein may interfere with a normal ECG. In some examples, the ECG signal may be modified to account for such interference.

In some examples, the ECG may be monitored by the system such that stimulation is applied only during, for example, the period between T-waves and P-waves, the period between S-waves and Q-waves, and so forth. The ECG can artificially become a flat line during stimulation, but is not affected during non-stimulation. Some users may prefer to see flat lines or "blank" periods rather than noise, artificial signals, etc. In some examples, the ECG may be a flat line that is artificially high or low, or displays an irregular pattern during stimulation, such that a user of the ECG recognizes signal inaccuracies during these periods. Fig. 47B is an example of a modified electrocardiogram. During stimulation that occurs in the period between the S-wave and the T-wave, the ECG is artificially low.

Fig. 47C is an example of a monitored electrocardiogram. As described above, the stimulation is timed to the heartbeat. Rather than relying on heartbeats, including intra-beat durations, which remain regular, the stimulation is applied for a portion of the time between beats, and the ECG is then monitored for the next beat. For example, the stimulus is applied for a short period of time after the S-wave (denoted by "S" in fig. 47C), followed by a monitoring period (denoted by "M" in fig. 47C) in which the P-wave should start or finish. If a P-wave is detected, the stimulation and monitoring is repeated. Stimulation may be stopped if no P-waves are detected during the monitoring period, which may indicate that a problem has occurred. After determining that the conditions are suitable for stimulation, the user may resume stimulation. After a certain number of normal heartbeats following the aberration, the system may automatically resume stimulation.

In some examples, e.g., examples where the stimulation system has a low duty cycle (such as 1 second on and 5 second off, 5 second on and 10 second off, etc.), the ECG may be stopped during the stimulation period and replaced with an alternate reading.

Fig. 47D is an example of a modified electrocardiogram. During stimulation, the entire electrocardiogram becomes a flat line. In some examples, the ECG may be a flat line that is artificially high or low, such that a user of the ECG recognizes that the signal during these periods is inaccurate.

Fig. 47E is another example of a modified electrocardiogram. During stimulation, the duration of which is known in advance, the electrocardiogram from the period before stimulation is reproduced and presented again as an ECG during stimulation. Fig. 47F is another example of a modified electrocardiogram. During stimulation, an artificial ECG, for example based on other patient data such as pressure, perfect ECG, etc., is presented as the ECG during stimulation. In some examples, based on the pressure data, the artificial portion of the ECG may include or consist essentially of R-waves indicative of left ventricular contraction. The modified ECG of fig. 47E and 47F may allow integration with other machines that may, for example, sound an alarm or malfunction if the ECG is different from a normal ECG.

Fig. 47G is another example of a modified electrocardiogram. During stimulation, artificial ECGs are known which are artificial by visualization. For example, instead of a wave having peaks, the wave may be represented as a square wave. The modified ECG of fig. 47G may allow integration with other machines, for example, if the ECG is different from a normal ECG, the other machines may sound an alarm or malfunction, and/or may be visualized and may clearly know that actual ECG data is not represented.

In some examples, the effect of the stimulation on the ECG may be filtered out to present a true ECG during stimulation.

Certain safety systems for catheter systems are described herein, such as collapsed to a retracted state. In some examples, a parameter may be monitored, and certain events may be raised in response to the monitored parameter exceeding a threshold.

In some examples, the monitored parameter includes pressure from a pressure sensor configured in a pulmonary artery. Pressure deviating from pulmonary artery pressure may indicate that the catheter has slid backwards such that the electrode may be in the right ventricle. Which may be triggered include stopping the stimulation, collapsing the expandable member, and/or sounding an alarm. In some examples, right ventricular pressure may be monitored to confirm that the offset pressure shows right ventricular pressure. Other combinations of sensor position and vessel pressure, for example, between a downstream lumen and an upstream lumen, are also possible. For example, right pulmonary artery to pulmonary artery, left pulmonary artery to pulmonary artery, pulmonary artery to right ventricle, right ventricle to right atrium, right atrium to superior vena cava, right atrium to inferior vena cava, superior vena cava to left brachiocephalic vein, superior vena cava to right brachiocephalic vein, left brachiocephalic vein to left internal jugular vein, right brachiocephalic vein to right internal jugular vein, combinations thereof, and the like.

In some examples, the monitored parameter includes movement from a movement sensor. The pressure sensor may include, for example, a capacitive sensor, a magnetic sensor, a touch switch, combinations thereof, and the like. In some examples, the movement sensor is positioned at an entry point (e.g., the left internal jugular vein). Movement greater than a certain distance (e.g., greater than about 0.5cm, greater than about 1cm, or greater than about 2cm) may trigger a triggering event, including stopping stimulation, collapsing the expandable member, and/or sounding an alarm. In some examples, multiple movement sensors spaced longitudinally along the system may be used to verify detected movement.

In some examples, the monitored parameter includes heart rate. As described herein, the pressure waveform may be used to monitor heart rate during stimulation. Other methods of monitoring heart rate during stimulation are also possible. If the heart rate changes by a certain amount or percentage, events that may be triggered include stopping stimulation, collapsing the expandable member, and/or sounding an alarm.

In some examples, the monitored parameter includes an electrode impedance. This configuration results in impedance if the electrodes are configured to be pressed against the vessel wall, or spaced a distance from the vessel wall. If the impedance changes by an amount or percentage, events that may be triggered include stopping stimulation, collapsing the expandable member, using unused electrodes, and/or sounding an alarm.

Fig. 47Hi schematically illustrates an example system for blanking nerve stimulation from an ECG. As discussed herein, applying neural stimulation to subject 4702 can affect an ECG reading of subject 4702. One solution is to blank the ECG readings during neural stimulation, for example, using the system of fig. 47 Hi. The subject 4702 is connected to an ECG system 4704 as usual to measure the rate and rhythm of the heartbeat. At times, the signal from the ECG system 4704 may be amplified using the ECG amplifier 4708 before the sensed information is provided on the ECG display 4710. The system shown in fig. 47Hi includes an ECG blanking unit 4706 between the ECG system and the ECG amplifier. The ECG blanker 4706 is configured to capture and manipulate data from the ECG system 4704 before sending the data to the ECG amplifier 4708. The subject 4702 is also connected to a neurostimulation system 4712, such as a neurostimulation system including electrode structures and the like as described herein. Other neurostimulation systems including for other indications are also possible. In some examples, the neurostimulation system 4712 may include an ECG blanking machine 4706. The ECG blanking unit 4706 can inhibit or prevent the corruption of the ECG signal by the neurostimulation waveform and/or the effects of the neurostimulation on the ECG signal.

In some examples, the ECG blanker (blanker)4706 can receive signals from the neurostimulation system 4712 when the neurostimulation system 4712 is applying neurostimulation. This signal can also disconnect the circuitry of the ECG blanker 4706 to interrupt the signal between the ECG system 4704 and the ECG amplifier 4708. The ECG display 4710 may be blank when the ECG amplifier 4708 is not receiving a signal during neural stimulation. Ceasing to send signals when no neural stimulation is applied can reclose the circuit between the ECG system 4704 and the ECG amplifier 4708. In some examples, the neurostimulation system 4712 can send a separate signal to the ECG blanking machine 4706 to produce a similar effect. The ECG blanking device 4706 can include, for example, blanking circuitry, comparators, relays, combinations thereof, and the like.

In some examples, the ECG blanker 4706 uses deterministic timing to predict when a heartbeat will occur and instructs the neuromodulation system 4712 to not apply neural stimulation during those time windows, e.g., so the ECG signal is not blanked when the user desires to see a heartbeat. During neural stimulation, the signal to the ECG amplifier 4708 is blanked (e.g., at least during the biphasic waveform), which inhibits or prevents high energy stimulation noise from saturating the ECG amplifier 4708. The ECG signal may be held at a constant voltage during the stimulation pulse. For complex heartbeats (e.g., Premature Ventricular Contractions (PVCs), bigeminy, etc.), additional blanking and/or other ECG signal manipulation may be used.

FIG. 47Hii schematically illustrates an example method of modifying an ECG waveform. During the first duration, an R-wave of the ECG is detected or monitored. The R to R interval 4720 of the detected ECG is measured (fig. 47 Hii). A weighted sum-total average of the R to R intervals is calculated. In some examples, heartbeats that are not entirely within the weighted sum range may be excluded, e.g., because they may represent PVCs, missed beats, etc.

The weighted sum-sum average may be used to estimate the time window for the next heartbeat. The neural stimulation duty cycle may be reduced (e.g., to 20%) in the startup mode or if a stable R-R interval cannot be established. The prediction window timing can be dynamic based on heart rate. For example, a faster rate may be used for smaller windows and/or a slower rate may be used for wider windows.

When a heartbeat is expected, the neural stimulation is blanked during the estimated window. In some examples, neural stimulation is applied between the expected T wave and the expected P wave (e.g., as shown in fig. 47 Hiii). In some examples, the neural stimulation is applied between an expected T wave and an expected Q wave. In some examples, neural stimulation is applied between the expected S-wave and the expected Q-wave. In some examples, neural stimulation is applied between the expected S-wave and the expected P-wave. Blanking neural stimulation can inhibit or prevent blanking of the ECG amplifier input at times when a heartbeat is expected. The rate of neurostimulation may be slightly modulated to move the stimulation pulses outside of the expected heartbeat window. Multiple stimulation pulses may be skipped to avoid the expected heartbeat window.

In some examples, the ECG amplifier 4708 has an input blanking circuit that is controlled by the neural stimulation signal (e.g., from the ECG blanker 4706 or directly from the neural stimulation system 4712). During active neural stimulation (e.g., with a biphasic waveform), the ECG amplifier 4708 input is blanked. The input potential may be sampled and held during blanking. Thus, the ECG amplifier 4708 is not disturbed by the neural stimulation signal.

Fig. 47Hiii schematically shows an example ECG waveform that is not corrupted by the application of neural stimulation. Waveforms corrupted by application of neural stimulation (e.g., without blanking the neural stimulation) may not be suitable for use by devices and/or personnel to diagnose problems with the subject, falsely trigger an alarm, or cause other problems. As described above, fig. 47Hiii shows an example measured R-to-R interval 4720. Using the methods and systems described herein, neural stimulation is applied, for example, between the T wave 4722 and the P wave 4724. Rather, during the duration between the T wave 4722 and the P wave 4724, the neural stimulation is not blanked and allowed to occur. Two example biphasic neural stimulation signals are shown in dashed circles 4726, 4728. For example, if the duration between the T-wave 4722 and the P-wave 4724 is 1 second, the dashed circle 4726 comprising two cycles would be approximately 120Hz, and the dashed circle 4728 comprising four cycles would be approximately 240 Hz. These are schematic illustrations and it should be understood that the stimulus waves (shape, pulse width, frequency, amplitude, etc.) can vary.

In some examples, the blanking period may be set using time (e.g., in milliseconds) or a percentage of the R-R interval because the time to the next R-wave is known. For example, if the R-R interval is one second, it may allow 300 milliseconds of stimulation after the R-wave, and then after 700 milliseconds after the R-wave, the stimulation is blanked after about 300 milliseconds before the next expected R-wave. As another example, stimulation of 30% of the R-R interval after an R-wave may be allowed to occur, and then stimulation is blanked after 70% of the R-R interval after the R-wave, after about 30% of the R-R interval before the next expected R-wave. These times and percentages are for exemplary purposes only, and the actual times and percentages used can be based on statistical analysis, experience, tolerance to stimulation during T waves, tolerance to stimulation during P waves, duty cycle, effects on contractility and/or relaxation, combinations thereof, and/or other factors.

As described herein (e.g., T-Q, S-Q, S-P, etc.), neural stimulation may be allowed to occur or not be blanked during other portions of the R-R interval. In some examples, the neural stimulation is blanked between the expected P-wave and the expected T-wave, between the expected P-wave and the expected S-wave, between the expected Q-wave and the expected T-wave, and/or between the expected Q-wave and the expected S-wave. In some examples, neural stimulation may be allowed that at least partially overlaps P-waves or T-waves.

Fig. 47I schematically illustrates an example system for filtering noise from an ECG signal. The system includes a filter component 4732 between the ECG leads 4730 and the ECG system 4704. In some examples, the neurostimulation system 4712 includes a filter component 4732.

Fig. 47J schematically illustrates an example filter assembly 4732. The filter component 4732 includes an ECG lead input 4733, an optional analog-to-digital converter 4734, a filter 4735, an optional digital-to-analog converter 4736, and an output to ECG 4737. The ECG lead inputs 4733 are configured to accept inputs from ECG leads (e.g., 3 lead ECG, 5 lead ECG, 12 lead ECG, or other lead ECG). Rather than inserting ECG leads into the ECG system, the ECG leads 4730 are inserted into the filter component 4732. The analog signals from the ECG leads are received by analog-to-digital converters 4734. Analog-to-digital converter 4734 converts analog signals from the ECG leads to digital signals. The digital signal from analog-to-digital converter 4734 is received by digital filter 4735. The filter 4735 may include a digital filter, such as a notch filter, a low pass filter, a band stop filter, a finite impulse response (FIR filter, digital signal processor, etc. the filter 4735 may be configured to filter a digital signal at a particular frequency the filter 4735 may be tuned to different frequencies in some examples, the filter component 4732 is in communication with the neuromodulation system 4712 and the neuromodulation system 4712 sets the filter frequency in some examples, the filter component 4732 includes an input for manually or electronically setting the filter frequency the filtered digital signal from the filter 4735 is received by a digital-to-analog converter 4736, the digital-to-analog converter 4736 converts the filtered digital signal from the digital filter 4735 to an analog signal, the analog signal from the digital-to-analog converter 4736 is received to an output 4737 of an ECG, the output 4737 to the ECG may include a wire that mimics an ECG lead, the analog ECG output 4737 from the ECG is received by the ECG system 4704 Analog signals that do not distinguish between analog signals directly from the ECG leads and analog signals from the output 4737 to the ECG. In certain examples, analog-to-digital converter 4734 and digital-to-analog converter 4736 may be omitted, and filter 4735 may include an analog filter. In some examples, a piece of hardware may include both analog-to-digital converter 4734 and digital-to-analog converter 4736. In some examples, additional hardware may be used to modify the signal to make it more suitable for the ECG system 4704.

Fig. 47Ki to 47Kvii schematically show example effects of filtering noise from an ECG signal. The filter 4735 is a single digital low pass filter, and fig. 47Ki through 47Kvii illustrate the effect of setting the filter 4735 at different frequencies before and during neural stimulation. For example, according to the examples described herein, stimulation at a frequency of 20Hz begins at line 4740.

Fig. 47Ki shows the effect on the ECG signal using a low pass digital filter 4735 with a cut-off frequency set to 100 Hz. The ECG signal is not affected prior to stimulation. After the stimulation begins, the ECG signal shows significant noise and the effect of the digital filter 4735 is small. The 100Hz filter does clean (clean up) the noise on the S-T section of the ECG signal. Fig. 47Kii plots the effect of filter 4735 spectrally disposed at 100 Hz. A stimulation frequency of 20Hz will produce a larger peak at 20Hz and a smaller peak at 40 Hz. The peak values from the ECG leads are also maintained (e.g., between about 1Hz to about 10 Hz). In some examples, stimulation at greater than 100Hz may have little effect on the ECG signal, for example, because the ECG system may include a high pass filter set to a frequency less than 100 Hz.

Fig. 47Kiii shows the effect on the ECG signal using a low-pass digital filter 4735 with a cutoff frequency set at 30 Hz. The ECG signal is not affected prior to stimulation. After the stimulation begins, the ECG signal shows some noise, and the digital filter 4735 significantly attenuates the noise caused by the stimulation. For example, the R-wave peak can be detected while the S-T section is clean (substantially free of noise).

Fig. 47Kiv shows the effect on the ECG signal using a low pass digital filter 4735 with a cutoff frequency set at 20 Hz. The ECG signal is not affected prior to stimulation. After the stimulation begins, the ECG signal shows some noise, and the digital filter 4735 significantly attenuates the noise caused by the stimulation beyond that at 30Hz shown in fig. 47 Kiii. As shown below, matching the filter frequency to the stimulation frequency does not necessarily produce the best ECG signal noise reduction.

Fig. 47Kv shows the effect on the ECG signal using a low-pass digital filter 4735 with a cutoff frequency set at 15 Hz. The ECG signal is not affected prior to stimulation. After the stimulation begins, the ECG signal shows some noise, and the digital filter 4735 significantly attenuates the noise caused by the stimulation beyond that at 20Hz shown in fig. 47 Kiv.

Fig. 47Kvi shows the effect on the ECG signal using a low-pass digital filter 4735 with a cutoff frequency set at 10 Hz. The ECG signal is not affected prior to stimulation. After the stimulation begins, the ECG signal shows little noise, and the digital filter 4735 significantly attenuates the noise caused by the stimulation more than the noise at 15Hz shown in fig. 47 Kv. In fact, the ECG signals before and after stimulation appear the same. Fig. 47kvi plots the effect of filter 4735 spectrally disposed at 10 Hz. There is no peak even at a stimulation frequency of 20 Hz. The peaks from the ECG leads (e.g., between about 1Hz to about 10Hz, but including some frequencies up to about 40 Hz) are reduced but remain unchanged. Without being bound by any particular theory, it is believed that the filter knee or-3 dB point for a 10Hz filter is at the point where the interference decays at the 20Hz stimulation frequency. If the filter is set at a frequency below 10Hz (e.g., 5Hz), the filter can remove data for the ECG (e.g., between 1Hz and 10 Hz) with little or no benefit compared to 10 Hz. In some examples, a series of low pass filters with frequencies above 10Hz may achieve a similar effect, for example, by increasing the slope of the knee point, the-3 dB point, and decreasing the cutoff frequency.

Filtering noise from the ECG signal can provide one or more advantages, as shown, for example, in fig. 47 Kvi. The ECG display can be clean, substantially free of noise caused by the stimulus, for reading by the user. Arrhythmia detection can operate completely normally without false alarms or missed detections. Pacing artifact detection can operate without false detection. For ECG systems that include filter settings, the settings are not changed, but the filters used are changed.

In some examples, filter 4735 may include a notch filter, e.g., set or adjusted to match the stimulation frequency. The notch filter may provide similar advantages as the low pass filter and does not affect the ECG signal at higher frequencies. If it is known or expected that some other frequency will be affected by the neural stimulation (e.g., a multiple of the stimulation frequency), then multiple notch filters at the expected problem frequency may be used.

Fig. 47L schematically illustrates an example system for matching a neural stimulation frequency to an ECG monitoring frequency. The ECG system 4704 typically operates at a single frequency (e.g., 50Hz or 60Hz depending on make, model, etc.). In some neurostimulation systems described herein, the frequency range may be between about 2Hz to about 40Hz (e.g., about 20Hz) to obtain a desired effect on left ventricular contractility and/or relaxivity. The neurostimulation frequency can interfere with the ECG system 4704 (e.g., produce a corrupted ECG signal). The frequency matched neural stimulation system 4740 is configured to apply neural stimulation at the same frequency as the ECG system 4704 operates. In some examples, the neural stimulation frequency 4740 is coupled to the ECG system 4704 and is capable of detecting an operating frequency. In some examples, the neural stimulation frequency 4740 includes a frequency input that can be controlled by a user (e.g., can be selected between a predetermined number of frequencies at which the ECG system 4704 operates). The input may include the frequency itself, the brand, the model, combinations thereof, and the like. As discussed, the frequency of the frequency matching may be less than the ideal frequency with the desired therapeutic effect. Other stimulation parameters may be modified in view of frequency. For example, the pulse width may be decreased, the amplitude may be decreased, the duty cycle may be increased, combinations thereof, and/or the like. In some examples, the frequency may be predetermined rather than optimized, and then the systems and methods described herein may be used to optimize other stimulation parameters. In some examples, the stimulation waveforms may be modified to provide the same average energy.

The catheter systems disclosed herein may be delivered, deployed, operated, and removed from the body according to any suitable method. Fig. 48A-48H illustrate an example method for delivering and deploying a catheter system 4800, the catheter system 4800 including an expandable structure 4820 including an electrode 4824. The catheter system 4800 can be the same as or similar to the catheter system 3700 or other catheter systems disclosed herein. The catheter system 4800 can be delivered through the jugular vein to the superior vena cava, right atrium, right ventricle, through the pulmonary valve, and into the right pulmonary artery.

As shown in fig. 48A, a syringe 4813 can be used to insert a needle 4814 to initially access the jugular vein 4815. Guidewire 4816 may then be inserted through needle 4814In the jugular vein 4815. As shown in fig. 48B, the needle 4814 may be removed and an introducer 4830 may be inserted into the jugular vein 4815 over the guidewire 4816 such that the introducer 4830 spans and remains in the opening into the jugular vein 4815. The introducer may comprise, for example, 11French from Teleflex corporation of Westmeath, IrelandAn introducer, but other introducers may be used. The introducer may include a flexible shaft 4831 and a hemostatic valve 4832.

After insertion of the introducer 4830 into the jugular vein 4815, the swan-ganz catheter 4840 can be floated into the right pulmonary artery 4842, as shown in fig. 48C. Swan-ganz catheter 4840 includes an inflatable balloon 4841 at its distal end. A swan-ganz catheter 4842 can be inserted into the introducer 4830 over a guidewire 4816, and once the balloon 4841 is distal to the introducer 4830, the balloon 4841 can be inflated. The inflated balloon 4841 is carried by the natural blood flow, pulling the distal tip of the swan-ganz catheter 4840 into the right pulmonary artery 4842. The guidewire 4816 can be advanced distally through the guidewire lumen of the swan-ganz catheter 4840 until the distal end of the guidewire 4816 is positioned in the right pulmonary artery 4842. Once the guidewire 4816 is in place, the balloon 4841 can be deflated and the swan-ganz catheter 4840 can be retracted proximally out of the vasculature. The catheter assembly 4800 may include a balloon at its distal end such that the swan-ganz catheter 4840 and guidewire 4816 may be omitted.

Introducer sheath 4833 and dilator 4834 can be tracked over guidewire 4816 to the pulmonary trunk or right pulmonary artery 4842. When the introducer sheath 4833 is in place, the dilator 4834 can be withdrawn. The catheter system 4800 can be inserted through an introducer 4830, through an introducer sheath 4833, and tracked to the distal end of the introducer sheath 4833 over a guidewire 4816. If the expandable structure 4820 is self-expanding, the expandable structure may be in a radially compressed state within the introducer sheath 4833 and in a radially expanded state out of the introducer sheath 4833. The expandable structure 4820 can be withdrawn from the distal end of the introducer sheath 4833 by advancing the expandable structure distally, retracting the introducer sheath 4833 proximally, and/or combinations thereof. For example, if the distal end of the introducer sheath 4833 is in the pulmonary trunk, the expandable structure 4820 can be advanced distally and follow the guidewire 4816 into the right pulmonary artery 4842. Fig. 48D shows the expandable structure 4820 in a radially expanded configuration after exiting the distal end of the introducer sheath 4833.

The introducer sheath 4833 can be retracted to a position proximal or distal to the pulmonary valve 4847. If the catheter system 4800 includes a pressure sensor located in the right ventricle 4849, the distal end of the introducer sheath 4833 can be retracted to a position proximal to the pressure sensor, and thus proximal to the pulmonary valve 4847, to expose the pressure sensor to the right ventricle. The introducer sheath 4833 can be retracted to a position distal to the pulmonary artery 4847 such that proximal retraction of the expandable member 4820 causes the expandable member 4820 to be radially compressed by the introducer sheath 4833 and the expanded expandable member 4820 cannot pass over the pulmonary valve 4847. If the introducer sheath 4833 is severable, the introducer 4830 can be fully retracted from the body and removed from the catheter shaft assembly 4806 by being divided along its circumference.

FIGS. 48D-48E illustrate an expandable structure 4820 positioned within the right pulmonary artery 4842. In fig. 48D, after exiting the distal end of the introducer sheath 4833, it is in a self-expanding state. In fig. 48E, expandable structure 4820 is in a further expanded state, e.g., due to retraction of an actuation tube. As shown in fig. 48D-48E, the stiffness of the articulation of the flexible tube and/or catheter shaft assembly 4806 may allow for tight flexion (about 90 degrees) as the catheter system 3800 transitions from the pulmonary artery trunk into the right pulmonary artery 4842. The catheter shaft assembly 4806 can be securely positioned against the left side of the pulmonary trunk. Upon further expansion, e.g., 2 mm larger than the diameter of the right pulmonary artery 4842 in its most contracted state, the expandable structure 4820 is anchored. The neuromodulation procedure may be performed over several days, and thus maintaining the position of the expandable structure 4820 in the right pulmonary artery 4842 by anchoring may provide consistency over the duration of the procedure.

The catheter 4830 may optionally be fixed relative to the patient during surgery to inhibit or prevent inadvertent repositioning of the catheter system 4800. Fig. 48F shows an example of a handle 4810 of a catheter assembly 4800 with an introducer 1830 inserted. A silicone sleeve may be placed over the introducer 4830 and sutured to a surface outside the patient's body and/or directly to the patient. In some examples, the introducer 4830 is about 65cm long and the catheter shaft assembly 4806 is about 100cm long, leaving a neck 4835 of about 35 cm. After partial retraction of the introducer sheath 4833, such as proximal to the pulmonary valve 4847, the neck 4835 can be reduced to about 15 to 20 cm. The introducer valve 4832 can form a secure connection between the introducer 4830 and the catheter shaft assembly 4806 of the catheter system 4800 such that the catheter system 4800 does not easily move relative to the introducer 4830. A silicone sleeve may optionally be placed over the actuation shaft assembly 4806 along the neck portion 4835 to maintain a desired spacing. If the electrodes 4824 are moved out of the proper stimulation location, inadvertent dislocation of the expandable structure 4820 can be detected by measuring changes in the contractility and/or relaxation of the heart.

The electrode array 4829 of the expandable structure 4820 may be positioned toward the superior and posterior portions of the right pulmonary artery 4842 for stimulation of one or more cardiopulmonary nerves. Fluoroscopy may be used to visualize the positioning of the catheter system 4800 (including the expandable structure 4820) to ensure that the correct orientation is achieved, particularly in relation to the circumferential orientation of the electrode array 4829. Fluoroscopy may be performed with or without a contrast agent. Fig. 48G shows a fluoroscopic image of the catheter system 4800 inserted into the right pulmonary artery 4842. The array 4829 of expandable structures 4820 can be seen without the use of contrast media. Navigational guidance systems incorporating position sensors on catheters (e.g., NavX from st. jude Medical Inc^TM) And/or a cardiac mapping system that maps electrophysiology of the surface of the heart may be used in conjunction with or as an alternative to fluoroscopy. The mapping performed in addition to the fluoroscopy may be performed prior to or concurrently with the fluoroscopy. Pressure sensors or other devices may be used to track the position of components of the catheter system, which may reduce or eliminate the use of fluoroscopy.

Fig. 48H schematically depicts the activation of all electrodes 4824 on a single spline for stimulating the target nerve 4843, but an actual stimulation protocol may include as few as two electrodes 4824, including electrodes 4824 on different splines, etc. The target nerve 4843 may be the cardiopulmonary nerve. In some examples, two electrodes 4824 positioned on either side of the target nerve 4843 may be activated. In some examples, the target nerve 4843 may be identified after positioning the expandable structure 4820 by "electro-mobile" catheter system 4800, where the catheter system 4800 and expandable structure 4820 are not physically repositioned, but the selection of "active" electrodes 4824 within electrode array 4829 is moved or otherwise altered on array 4829 to better capture the target nerve 4843. The electrode array 4829 can be positioned such that the nerve is located between two or more electrodes (e.g., between two electrodes, between three electrodes, between four electrodes, etc.).

In some examples, a voltage pre-pulse may be applied to the tissue surrounding the target nerve 4843 immediately prior to the stimulation pulse. The pre-pulse may pre-polarize nearby tissue and make it easier to stimulate target nerve 4843 while avoiding stimulating nearby pain nerves. For example, the stimulation protocol may include a smaller amplitude pulse having a first polarity (e.g., positive or anodal polarity) configured to pre-polarize tissue, followed immediately or nearly immediately by a larger amplitude pulse of a second polarity, e.g., negative or cathodal, configured to stimulate target nerve 4843. The second polarity may be the same as or opposite to the first polarity. The pre-pulses may be applied by the same or different electrodes 4824 of the electrode array 4829.

In some use examples, the active electrodes used during stimulation are first identified by a quick titration. During a rapid titration, the patient may be sedated to avoid pain so that the electrodes 4824 can be selectively activated at full power to determine which electrode or electrodes 4824 best captures the target nerve 4843. After a fast titration, the selected active electrode 4824 may be activated with lower power and the power increased to determine the optimal power setting for stimulating the target nerve 4843, during which the patient does not need sedation.

The effects of stimulation parameter titration (including effects such as variations in stimulation amplitude, pulse width, and/or frequency) may be useful to achieve a desired response. After a short duration of stimulation (e.g., 1 to 2 minutes), LV max + dP/dt may decay from the peak plateau to baseline after approximately 5 minutes. Since the programming stimulation may be based on a trial-and-error process, which may be quite time consuming, it would be advantageous to automate the process based on feedback signals, e.g. heart rate and/or contractility and/or relaxation measures. In some examples, an automatic stimulation parameter titration is established once an electrode or combination of electrodes producing an increase in contractility and/or relaxation has been identified. In some examples, the responsive electrode may not have been identified. For example, as described herein, cycling through an automated system as an anode, cathode, or uncharged electrode can be used to identify a responsive electrode or combination based on, for example, contractility and/or relaxation and cardiac signals. Once the electrode combination (cathode/anode) is selected, a stimulation titration can be set up.

As a first example, stimulation is started with predetermined settings such as an amplitude of 20mA, a pulse width of 4ms, and a frequency of 20Hz, and a single stimulation parameter is used to titrate the effect. Titratable stimulation parameters may include, but are not limited to, amplitude, pulse width, or frequency. The heart rate or the heart rate and/or thresholds for contractility and/or laxity (or alternative measures of contractility and/or laxity, such as pressure) are set by the user to titrate the effect. Absolute or relative changes from baseline levels can be used for titration effects. If an increase in contractility and/or relaxation is observed with minimal or no increase in heart rate, the stimulation parameters (e.g., amplitude) are increased until side effects or an undesirable increase in heart rate is observed. The stimulation parameters (e.g., amplitude) are then decreased until the undesirable heart rate is no longer observed.

As a second example, stimulation is started with predetermined settings such as an amplitude of 20mA, a pulse width of 4ms, and a frequency of 20Hz, and a plurality of stimulation parameters are used to titrate the effect. Titratable stimulation parameters may include, but are not limited to, amplitude, pulse width, or frequency. The heart rate or the heart rate and/or thresholds for contractility and/or laxity (or alternative measures of contractility and/or laxity, such as pressure) are set by the user to titrate the effect. Absolute or relative changes from baseline levels can be used for titration effects. If an increase in contractility and/or relaxation is observed with minimal or no increase in heart rate, each of the multiple stimulation parameters (e.g., amplitude and pulse width) is increased until an adverse effect or an undesirable increase in heart rate is observed. The stimulation parameters (e.g., amplitude and pulse width) are then decreased until the undesirable heart rate is no longer observed.

The frequency of stimulation may be adjusted to increase or maximize the stimulation response and/or to maintain the stimulation response. For example, the frequency may be increased (e.g., from 20Hz to 40Hz) to increase the systolic and/or the flaccidity and/or to more quickly achieve systolic and/or flaccidity plateaus. Stimulation of the sympathetic nerve at a higher frequency may result in additional release of neurotransmitters, as more stimulation pulses are being delivered to the nerve endings to transmit neurotransmitter release in response to increased systolic and/or relaxed signaling. In some examples, increasing the stimulation frequency may allow a more efficient way to search for an appropriate electrode (e.g., cathode) for stimulation by reducing the amount of time it takes to identify a stimulation response. This may involve starting an initial programming session (programming session) at a higher frequency than is used for the rest of the patient treatment. In some cases, the treatment may use a higher frequency (e.g., 20Hz) to identify whether the contractility and/or laxity (or other measures) are changing towards a favorable direction, and/or the treatment may use a lower frequency (e.g., 10Hz) if stimulation is used to maintain the treatment. Reducing the stimulation frequency can be used as a means to maintain a more effective stimulation therapy. In some examples, increasing the stimulation frequency may allow for ways to increase the amplitude of the contractile and/or flaccid response.

A burst mode of stimulation is considered in which bursts of stimulation are delivered at a particular duty cycle. The stimulation frequency (intra-burst frequency) during the burst mode may be between about 100Hz and about 800Hz (e.g., about 100Hz, about 200Hz, about 300Hz, about 400Hz, about 500Hz, about 600Hz, about 700Hz, about 800Hz, ranges between these values, etc.) and/or the burst frequency (intra-burst frequency) may be between about 0.1Hz and about 20Hz (e.g., about 0.1Hz, about 0.5Hz, about 1Hz, about 2Hz, about 5Hz, about 10Hz, about 15Hz, about 20Hz, ranges between these values, etc.). The parameter ranges in the burst mode of stimulation may be used to simulate the physiological activity of cardiac nerves (e.g., cardiac sympathetic nerves).

An automated system may be used to set the duty cycle for stimulation. For example, the initial cycle may be set to a particular setting, such as 5 minutes on and 1 minute off. The duty cycle may be set to, but is not limited to, a range of 5 second to 30 minute increments or up to 1 hour increments. Similar to stimulation parameter titration, the duty cycle may be varied such that stimulation is delivered only when the contractility and/or relaxivity and heart rate are within a desired range specified or observed by the user. From an efficiency standpoint (e.g., battery life, charge interval), it may be advantageous to reduce or stop stimulation during a portion of the decay to baseline. In some examples, the stimulation duty cycle may be pre-specified. For example, stimulation may be stopped for 1 minute and then turned on for another 1 minute to take advantage of the slow decay of maximum + dP/dt to baseline and still maintain therapeutic effect. In some examples, the stimulation duty cycle may be set for a particular patient based on the feedback signal (e.g., LV max + dP/dt) and the decay of the feedback signal to baseline when stimulation is turned off. It may be advantageous to include a duty cycle to the stimulation where the stimulation is turned on and off periodically, for example to allow the user to periodically view the ECG, which can contain stimulation artifacts when the stimulation is on.

Stimulation parameters may be set to increase (e.g., maximize) the desired response and/or decrease (e.g., minimize) the delivered energy and/or undesired response. For example, the frequency may be used to identify locations in the pulmonary artery that are close to cardiac tissue and, if stimulated, may result in an undesirable response (e.g., arrhythmia). Stimulation at 2Hz at a given amplitude and pulse width may bind or activate myocardial tissue and result in atrial activation at 2Hz (120 beats per minute). It may be desirable to avoid electrodes that cause such a response, or the amplitude and/or pulse width may be reduced to avoid activation of the atria. The user or the device itself can recognize this reaction relatively quickly. This atrial capture test can be used prior to testing each stimulation electrode or at the beginning of a programming session to test which electrodes are likely to be in close proximity to the myocardial tissue. Also for example, a sensation or pain fiber that conveys an undesired sensation (e.g., pressure, pain, etc.) may be activated while an autonomic nerve fiber is simultaneously activated. The stimulation vector may be varied to tighten the stimulation vector and decrease the distance between the anode and the cathode, and/or to add an anode around the cathode to tighten the stimulation field. The stimulation amplitude and/or pulse width may be reduced to avoid activating unwanted nerve fibers, either alone or in combination with changing the stimulation vector.

Stimulation may be titrated for an initial period of time or may be used in an acute or chronic setting to monitor and titrate therapy. Upper and lower thresholds for heart rate and contractile and/or relaxivity measures may be set to ensure that stimulation is delivered within the desired limits. The upper and lower limits of the stimulation parameters may be set so that those limits are not exceeded. Stimulation titrations may be performed periodically or continuously to ensure that stimulation continues to provide the desired effect.

Other metrics that may be used to titrate, maintain, or test the contractility and/or relaxivity and/or therapeutic effect of the effect may include LV pressure, derived LV max + dP/dt, right ventricular pressure, derived RV max + dP/dt, arterial blood pressure, derived mean arterial pressure, Muscle Sympathetic Nerve Activity (MSNA), plasma norepinephrine levels, cardiac output (invasive or non-invasive measurement), pulmonary arterial pressure, mixed venous oxygen saturation, central venous oxygen saturation, myocardial oxygen consumption, pulmonary arterial wedge pressure, astraganic nerve activity, or other physiological signals and/or combinations thereof. The measure of heart rate may include an external ECG (e.g., such as an ECG recorded external to the subject using patch electrodes on the skin) and/or an internal ECG (e.g., such as an ECG recorded internal to the subject on a stimulation device (e.g., electrodes on the device) and/or on a remote device).

Preclinical work in a pig model investigating intravascular stimulation of the cardiac sympathetic nerves from the subclavian artery revealed that stimulation of the left sympathetic nerve can increase contractility and/or relaxation of the heart as the stimulation amplitude increases. It has been shown that left ventricular systolic pressure (LVP) generally increases with increasing stimulation amplitude, particularly up to about 30 volts. Conversely, for low stimulation amplitudes, particularly amplitudes less than about 15 volts, the heart rate has been shown to remain relatively constant, but as the stimulation amplitude increases the heart rate increases, and then for higher stimulation amplitudes, particularly stimulation amplitudes greater than about 30 volts, the heart rate remains relatively constant.

Electrode selection may be based on system titration. For a given electrode array, there may be millions of combinations or permutations for electrode selection (e.g., anode or cathode, amplitude, pulse width, frequency, stimulation duration, duty cycle, etc.). The user interface can help guide the user through a subset of the stimulation parameter space.

Fig. 56A shows a screen of an example user interface 5600. For example, the user interface 5600 may be shown on a screen of the computing device 5520 described herein. Fig. 56A shows the screen when in titration mode, which can be enabled by tapping the icon 5602 for titration mode. Icons for other modes include icon 5604 for a new patient mode (e.g., to initiate a new subject or patient session input or import data about the subject), icon 5606 for interrogating the stimulator device, icon 5608 for a monitoring mode (e.g., for monitoring vital data of the subject such as ECG, blood pressure, etc.), icon 5610 for a new impedance mode (e.g., for monitoring and/or calculating impedance data, resistance data, etc.), icon 5612 for a new setting mode (e.g., for adjusting stimulator settings such as polarity, electrode selection of anode and/or cathode, amplitude, pulse width, duty cycle, on (ramp on) and/or off (ramp off) duration, limits of alarm settings, etc.), icon 5614 for a pressure sensor mode (e.g., for monitoring, calibrating, calibration, etc.), Reset isopressure sensors), an icon 5616 for a sync mode (e.g., to synchronize time between a stimulator (e.g., stimulation system 5500) and a computing device (e.g., computing device 5520), an icon 5618 for a data mode (e.g., to record changes, to access stored data, to export and/or view databases, to view and/or export event logs, etc.), an icon 5620 for an annotation mode (e.g., to enter annotations such as regarding medication dosage, subject movement, system issues, etc.), an icon 5622 for a save mode (e.g., to save information to disk and/or external memory), an icon 5624 for a therapy decline mode (therapy ramp down mode), an icon 5626 for a resend mode (e.g., to reset the stimulator), an icon 5628 for an emergency off mode (e.g., for immediate stopping of all stimuli), icon 5630 for program information mode (e.g., for viewing system software form, firmware, hardware, etc.), icon 5638 for laboratory mode (e.g., for viewing stimulator settings, administrator level settings, etc.), and icon 5634 for shutdown mode (e.g., for closing user interface 5600). The screen may include many icons as described herein, but more, fewer, and/or alternative icons, functions, modes, sequences, etc. are possible. Fig. 56A shows optional information such as a connection icon 5636 (e.g., indicating a Universal Serial Bus (USB) connection between the computing device and the stimulation system). In some examples, the user interface is configured to store a picture or series of pictures (e.g., fluoroscopy, cinematograph, x-ray, etc.) of the electrode matrix in the subject. Such data may provide information to the user as to which electrodes initiated the test. A script (script) containing a series of programming steps may be created or modified based at least in part thereon. In some such examples, a user may be able to initiate a titration using a step or test that includes a particular combination of electrodes.

In the titration mode as shown in fig. 56A, the screen may display a representation 5638 of an electrode matrix, for example a 4 x 5 matrix of 20 electrodes. In some examples, the stimulation system can automatically provide the electrode matrix representation 5638. In some examples, electrode matrix representation 5638 may be created manually. In some examples, the electrodes used for the test or step may change color, including as shown by indicia (e.g., "anode," "cathode," "a" (e.g., as shown in fig. 56A), "V" (e.g., as shown in fig. 56A), "+", "-", etc.). The screen may optionally display a graph 5640 (e.g., electrocardiogram, right ventricular pressure, pulmonary artery pressure, left ventricular contractility and/or relaxation (e.g., associated with measurements in the right ventricle), heart rate) and/or real-time parameters 5642 (e.g., right ventricular pulse pressure, left ventricular contractility and/or relaxation (e.g., associated with measurements in the right ventricle), heart rate, active electrode impedance) with respect to the subject. The user interface 5600 may provide controls for selecting and modifying the graph 5640 and/or the parameter 5642. The screen may optionally display parameters 5644 (e.g., pulse amplitude, pulse width, frequency, duration, etc.) of the test or step that is currently running at that time.

Still in the titration mode of fig. 56A, the screen shows a drop-down box 5650, which drop-down box 5650 may contain various programs. In fig. 56A, the procedure "amplitude test" has been selected. Settings icon 5652 may be used to adjust parameters of a program, create a new program, delete a program (e.g., with appropriate authorization), and so forth. Icon 5654 can be used to run the selected program. Icon 5654 can be used to stop running the selected program. Icon 5654 may include, for example, an octagonal red button with or without a "stop" flag. Icon 5658 can be used to bring up screen 5680, which will be described in further detail. Icon 5660 can be used to reset the program (e.g., after the subject moves, once per day, etc.). Icon 5662 shows which step or test of the program will be run if icon 5666 is clicked. Icons 5664, 5668 can be used to select other steps or tests of the selected program (e.g., icon 5664 reverses one step or test, icon 5668 advances one step or test). As described, the icon 5666 can be clicked to run the steps or tests shown in the icon 5662. In some examples, after running a test or step, the user interface 5600 may automatically advance to the next step or test. In some examples, after running a test or step, the user interface 5600 remains on the step or test until the user modifies the step or test using the icons 5664, 5668. In some examples, the user may be forced to decide whether the test can be accepted by using icons 5670, 5672 before being allowed to use different tests.

Fig. 56B shows another screen 5680 of the example user interface 5600 of fig. 56A. If icon 5658 (FIG. 56A) is pressed, screen 5680 can be opened. Screen 5680 includes a table with steps or test rows. Icon 5662 shows that there are 8 steps or tests in the "amplitude test" procedure. If desired, a scroll bar can be provided if more steps can be involved than are seen on screen 5600. The first column provides step or test numbers from 1 to 8. The second column provides the pulse amplitude for this test or step. The third column provides the pulse width for this test or step. The fourth column provides the frequency for this test or step. The fifth column provides the duration for this test or step. The sixth column provides the electrode used as the anode for this test or step. Column seven provides the electrode used as the cathode for this test or step. For example, referring to illustration 5638 in fig. 56A, in row 1, the lower right electrode 20 or E20 serves as the cathode, while the electrode 15 or E15 directly above electrode 20 or E20 serves as the anode.

If a test or step has been run, screen 5680 may provide information regarding the results of the test or step. For example, the eighth column provides heart rate, the ninth column provides impedance, the tenth column provides response, and the eleventh column provides pressure change. More results, fewer results, alternative results, or no results may also be displayed. In some examples, the rows may be changed in color, e.g., to red or green, based on user input, e.g., to indicate whether the electrode combination is likely to cause a side effect and/or result in a therapeutic response, respectively.

Referring again to fig. 56A, icon 5670 may be pressed to indicate that the user dislikes or disagrees the results of the test or procedure. Rather, icon 5672 may be pressed to indicate that the user likes or approves the results of the test or step. The user can enter the reason for approval or disapproval. For example, pulldown box 5674 may automatically add data for some reason (e.g., regarding side effects, therapeutic effect, etc.). For another example, the user can manually enter comments in box 5676. To add comments, the user may click on icon 5678.

Predefined scripts may be used to define stimulation parameters (e.g., anode or cathode, amplitude, pulse width, frequency, stimulation duration, duty cycle, etc.) that may be used to test which electrode is providing a therapeutic effect. The user may start with a first set of parameters and then the next set of parameters until a suitable treatment location is found. In some examples, the user enters an annotation indicating whether the electrode and parameter combination is therapeutic, whether the electrode and parameter combination causes mild side effects, whether the electrode and parameter combination causes severe side effects, and/or whether the electrode and parameter combination should not be tested again (e.g., automatically selected based on an indication of severe side effects, lack of therapeutic response, or other parameters, or by manual selection). The electrodes or cathodes may be labeled with specific colors to identify which electrodes may be therapeutic and which other electrodes may cause unwanted side effects. Once the first set of parameters is evaluated, the user can manually step through the various steps in the script (e.g., the set of stimulation parameters) to continue testing the various electrodes in the array. In this way, the user does not have to set electrodes and parameters to evaluate the entire space covered by the electrode array. Instead, the script will guide the user through the test stimulation process to identify which electrodes are likely to be most beneficial for therapeutic use. The program may automatically cycle through these steps, or the user may indicate whether the tested electrode combination can be accepted and indicate the next step in which the script can be evaluated. The output may, for example, include a log of some or all of the test parameters and/or a color-coded electrode array indicating which electrodes are likely to be useful for treatment and which are preferably avoided. Based on the output, the electrodes and stimulation parameters for the treatment may be indicated.

In the Therapy decline (Therapy Ramp Down) mode 5624, the stimulation may be titrated Down to a predetermined level (e.g., reduced from a high stimulation amplitude to a low stimulation amplitude) so that the stimulation does not abruptly stop. The high stimulation amplitude may be a therapeutic amplitude while the low stimulation amplitude may be set at 0V or 0mA, or a threshold amplitude (e.g., an amplitude at which a desired response is initially observed using the feedback signal). In some examples, the feedback signal may include left ventricular maximum + dP/dt, and the low amplitude may be set at a level at which the signal just begins to increase from its baseline level. A timer may be set to trigger a therapy decline for a particular duration after the start of the therapeutic stimulation, such as 30 minutes, 1 hour, 24 hours, 3 days, etc. in increments of change within a time frame in the range of 30 minutes to 5 days. The timer to begin therapy descent may be set to begin at the beginning of stimulation and/or may be manually initiated at any given time. A countdown triggering therapy decline may be displayed in monitor mode 5608 and/or an alert message may be provided to the user indicating that the therapy decline mode is about to begin or is beginning soon. The target amplitude of therapeutic decline may be set at a threshold amplitude or other desired level. Other target values may be included. For example, a slow decline in stimulation therapy may involve a decrease in amplitude, pulse width, rate, and/or duty cycle. In some examples, the duration of the therapeutic decline may be set to 30 minutes, 1 hour, 24 hours, 3 days, or 7 days, or various durations within this range.

The electrode 4824 may be activated in a monopolar or bipolar (e.g., guard bipolar) manner. Monopolar stimulation may use either negative or positive polarity and includes the use of a return conductor. The return conductor may be at least 5mm from the electrode. For example, the return conductor may be attached to or integral with the catheter system 4800 or configured as part of another catheter in the right ventricle 4849. For another example, the return conductor may be attached to the catheter system 4800 or configured as part of or integral with another catheter in the superior vena cava. For yet another example, the return conductor may be attached to the catheter system 4800 or configured as part of or integral with another catheter in the brachiocephalic or innominate veins. The current vector from the electrode 4824 to the brachiocephalic vein may be away from at least one of the heart and trachea, which may reduce side effects and/or increase patient tolerance. In some such examples, the incoming jugular vein may be the left jugular vein. The return conductor may comprise a patch applied to the skin.

After the procedure is completed, the catheter system 4800 can be removed from the body according to any suitable method. The actuation mechanism of the handle 4810 of the catheter system 4800 can be released such that the expandable structure 4820 can be in a self-expanding, but not further expanded state. The expandable structure 4820 can then be advanced into the introducer sheath 4833 by proximal retraction of the expandable member, distal advancement of the introducer sheath 4833, or a combination thereof. The introducer sheath 4833 can be retracted to be towed with the catheter system 4800 and retracted from the body. The expandable structure 4820 may be retracted from the body through the introducer sheath 4833 and then the introducer sheath 4833 may be retracted.

The effectiveness of the neural stimulation on the contractility and/or relaxation of the heart, in particular the left ventricle, can be monitored, for example, by measuring the pressure within the heart. The pressure may be measured by a pressure sensor, such as a fluid-filled column, a MEMS sensor, or other suitable type of pressure sensor. The pressure sensor may be attached to or integrated with the catheter system 4800, e.g., along the catheter shaft assembly 4806. If the pressure sensor is attached to or integrated with the catheter system 4800, the sensor may be located in the right ventricle. The pressure in the right ventricle may be related to the pressure in the left ventricle so that the left ventricle pressure, and thus the left ventricle contractility and/or relaxivity, may be sufficiently close. The pressure sensor may alternatively be inserted into the heart through another catheter and may be placed in the right ventricle, left ventricle, or other suitable location. During surgery, left ventricular pressure can be used to optimize the effect of neural stimulation on cardiac contractility and/or relaxation. The contractility and/or relaxation of the heart may increase measurably during surgery, e.g. by 5-12%. A single catheter may include multiple sensors. For example, one sensor may be configured as described above, and a second sensor may be configured to reside in the right pulmonary artery. The sensor in the right pulmonary artery may provide wedge pressure, a reading known to the user from swan-ganz catheterization. The sensor in the right pulmonary artery can be used for safety. For example, if the pressure sensor in the right pulmonary artery migrates below the pulmonary valve, the stimulation may be turned off (e.g., immediately turned off when a change in pressure (e.g., a percentage change or an absolute change) and/or an absolute value of the pressure (e.g., above or below a certain pressure) is detected) to inhibit or prevent arrhythmia.

Fig. 49A is a perspective view of an exemplary expandable structure 4900 in an expanded state. Operation of the actuation mechanism can cause the expandable structure 4900 to expand and contract, e.g., as described herein. Expandable structure 4900 includes a proximal portion 4901 and a distal portion 4903. Expandable structure 4900 includes a plurality of splines 4908 and a plurality of expandable elements 4904a, 4904 b. For example, splines 4908 may be similar to splines 3622 of expandable structure 3620 or any variation thereof, as described herein. The coupling of splines 4908 at proximal portion 4901 and/or distal portion 4903 may be similar to the coupling of splines 3622 of expandable structure 3620 or any variation thereof, e.g., as described herein with respect to fig. 37G-37J. The expandable structure 4908 may be absent, or absent of splines 4908 in the circumferential region of the expandable elements 4904a, 4904 b. The expandable structure 4900 may be used in an over-the-wire system or as part of a swan-ganz system.

The expandable elements 4904a, 4904b may include, for example, balloons 4904a1, 4904a2, 4904b1, 4904b2 that are inflatable via a single common inflation lumen (e.g., in fluid communication with each balloon 4904a1, 4904a2, 4904b1, 4904b2, which balloons may advantageously provide uniform inflation), multiple common inflation lumens (e.g., a first inflation lumen in fluid communication with balloons 4904a1, 4904a2 and a second inflation lumen in fluid communication with balloons 4904b1, 4904b2, which inflation lumens may provide uniform inflation of the balloons on one side of the expandable structure), or separate inflation lumens, which may advantageously provide complete control of inflation of the separate balloons. The individual balloons may be compliant and/or non-compliant. The expandable elements 4904a, 4904b can advantageously provide compliance when navigating the expandable structure 4900 through a catheter. For example, the balloon is very flexible when deflated and is capable of navigating in tight bends. When inflated, the balloon will stiffen and will expand to close the sidewall of a large diameter vessel.

The plurality of expandable elements 4904a, 4904b of the expandable structure 4900 includes a first expandable element 4904a and a second expandable element 4904 b. The swellable elements 4904a, 4904b are circumferentially opposite or spaced apart by about 180 °. Other circumferential spacings are also possible (e.g., about 30 °, about 45 °, about 60 °, about 75 °, about 90 °, about 115 °, about 130 °, about 145 °, about 160 °, about 175 °, ranges between these values, etc.). The circumferential spacing may be measured, for example, between midpoints, between similar edges, and as other methods that may be suitable for constructing expandable elements. The expandable element 4904a includes a first balloon 4904a1 and a second balloon 4904a 2. First balloon 4904a1 is generally parallel to second balloon 4904a 2. The expandable element 4904b includes a first balloon 4904b1 and a second balloon 4904b 2. First balloon 4904b1 is generally parallel to second balloon 4904b 2. The expandable elements 4904a, 4904b may include fewer balloons (e.g., one balloon) or more balloons. Additionally and/or alternatively, the balloons can be longitudinally aligned, angled, circumferential, combinations thereof, and the like. Expandable elements 4904a, 4904b may be coupled to the proximal and distal hubs. An inflation lumen may extend through the proximal hub. The expandable elements 4904a, 4904b may be lined or subdivided into smaller chambers to control the shape and/or profile when expanded. For example, the opposing sides may be welded together to form a chamber or balloon. The subdivided chambers may conform better to the vessel wall than the unitary expandable element.

The expandable elements 4904a, 4904b may be filled with saline, contrast media, or other biocompatible fluids. If the expandable elements 4904a, 4904b are filled with a contrast agent, the position and rotational orientation of the expandable structure 4900 can be viewed under fluoroscopy. If the position and/or rotational orientation of the expandable structure 4900 is observed to be undesirable, the expandable structure 4900 can be collapsed (e.g., including deflating the expandable elements 4904a, 4904 b) and repositioned. If a precise rotational orientation is desired, the swellable elements 4904a, 4904b may be asymmetric.

The swellable elements 4904a, 4904b may include an electrode 4906 a. Electrodes 4906a may be printed, for example, on balloons 4904a1, 4904a2, 4904b1, and/or 4904b 2. In fig. 49A, only electrode 4906a on balloon 4904a2 is visible. Some of balloons 4904a1, 4904a2, 4904b1, 4904b2 may include an electrode 4906a, and some of balloons 4904a1, 4904a2, 4904b1, 4904b2 may lack an electrode 4906 a. For example, balloons 4904a1, 4904a2 of expandable element 4904a may include electrodes 4906a, while balloons 4904b1, 4904b2 of expandable element 4904b may not have electrodes 4906 a. Conductors for electrode 4906a may be printed on the swellable elements 4904a, 4904b, embedded in the material of the swellable elements 4904a, 4904b, and/or extend through the swelling lumen. Non-limiting example printing processes are described with respect to fig. 23Ni through 23Nvix, in which substrate 2301 may be the material of swellable elements 4904a, 4904 b. Electrodes 4906a are shown in fig. 49A spaced longitudinally along balloon 4904a2, but other arrangements are possible. Additionally or alternatively to being positioned on the balloons, the electrode 4906a may be positioned between the balloons of the expandable elements 4904a, 4904 b. This arrangement may space the electrode 4906a from the vessel wall and allow blood to flow past the electrode 4906a, e.g., thereby providing the advantages described with respect to fig. 23L.

Spline 4908 may include an electrode 4906b as described herein, for example, but not limited to, as described with respect to spline 3622 of expandable structure 3620. Fig. 49A shows an expandable structure 4900, wherein expandable elements 4904a and/or 4904b include electrodes 4906a and splines 4908 include electrodes 4906 b. Fig. 49Ai is a perspective view of an example expandable structure 4903 in an expanded state. Splines 4908 of expandable structure 4903 do not include any electrodes. All of the electrodes 4906a of the expandable structure 4903 are located on the expandable elements 4904a and/or 4904 b. Fig. 49Aii is a perspective view of an example expandable structure 4905 in an expanded state. The expandable elements 4904a, 4904b of the expandable structure 4903 do not include any electrodes. All of the electrodes 4906b of the expandable structure 4905 are located on splines 4908. All splines 4908 of the expandable structure 4900 of fig. 49A include electrodes 4906 b. Regardless of whether the swellable elements 4904a, 4904b include electrodes, some of the splines 4908 may include electrodes 4906b and some of the splines 4908 may lack electrodes 4906 b. For example, splines 4908 of expandable structure 4905 including electrodes 4906b are circumferentially located between a first edge 4912 of expandable member 4904a and a second edge 4913 of expandable member 4904 b. For example, spline 4908 closest to expandable member 4904a may include electrode 4906b, while spline 4908 closest to expandable member 4904b may lack electrode 4906 b.

The electrodes 4906a and/or 4906b may form an electrode matrix. The number of electrodes in the electrode matrix, electrode size, electrode spacing, etc. may be in accordance with other systems described herein. Upon expansion of the expandable structures 4900, 4903, 4905, electrodes of the electrode matrix may be selectively activated to test nerve capture, calibration, and/or treatment, e.g., as described herein.

Fig. 49B is a perspective view of the example expandable structure 4920 in an expanded state. Expandable structure 4920 includes a proximal portion 4921 and a distal portion 4923. The expandable structure 4920 includes a plurality of expandable elements 4924a, 4924 b. The expandable elements 4924a, 4924b may be proximally coupled to the conduit 4930 (e.g., to a distal portion or end of the conduit 4930). The swellable elements 4924a, 4924b may be coupled at a distal end to a tubular member 4928. The expandable structure 4920 may lack splines or be devoid of splines or splines in the circumferential region of the expandable elements 4924a, 4924 b. Tubular member 4928 may extend at least partially within the lumen of conduit 4930. The distal portion of tubular member 4928 may extend laterally beyond the sides of conduit 4930. The tubular member 4928 optionally includes a lumen, such as a guidewire lumen. The tubular member 4928 optionally includes an atraumatic distal tip or nose, for example as shown in distal portion 4923. The tubular member 4928 may be used to pull the distal tip proximally, which can cause the electrode 4926a to arc against the vessel wall. The catheter shaft 4930 may be used to provide some rigidity to hold the electrode 4926a in place and against the vessel wall. The expandable structure 4920 may be used in a over-the-wire system or as part of a swan-ganz system.

The expandable elements 4924a, 4924b may include, for example, balloons 4924a1, 4924a2, 4924b1, 4924b2 that are expandable via a single common expansion lumen (e.g., in fluid communication with each balloon 4924a1, 4924a2, 4924b1, 4924b2, which may advantageously provide uniform expansion), multiple common expansion lumens (e.g., a first expansion lumen in fluid communication with balloons 4924a1, 4924a2 and a second expansion lumen in fluid communication with balloons 4924b1, 4924b2, which may advantageously provide uniform expansion of the balloons in one circumferential region of the expandable structure) or a separate expansion lumen (which may advantageously provide complete control over expansion of the separate balloons). The expandable elements 4924a, 4924b can advantageously provide compliance when navigating the expandable structure 4920 through the catheter.

The plurality of expandable elements 4924a, 4924b of the expandable structure 4920 includes a first expandable element 4924a and a second expandable element 4924 b. The swellable elements 4924a, 4924b are circumferentially adjacent or spaced less than about 30 °. Other circumferential spacings are also possible (e.g., less than about 90 °, about 60 °, about 45 °, about 15 °, about 10 °, about 5 °, ranges between these values, etc.). The circumferential spacing may be measured, for example, between midpoints, between similar edges, and as other methods that may be suitable for constructing expandable elements. The expandable element 4924a includes a first balloon 4924a1 and a second balloon 4924a 2. First balloon 4924a1 is generally parallel to second balloon 4924a 2. The expandable element 4924b includes a first balloon 4924b1 and a second balloon 4904b 2. First balloon 4924b1 is generally parallel to second balloon 4924b 2. The expandable elements 4924a, 4924b may include fewer balloons (e.g., one balloon) or more balloons. Additionally and/or alternatively, the balloons can be longitudinally aligned, angled, circumferential, combinations thereof, and the like. In some examples, a single inflatable element may include each balloon of the device (e.g., each balloon 4924a1, 4924a2, 4924b1, 4924b 2). Multiple expandable elements can provide better wall proximity, compliance, blood flow to the vessel wall, and/or other advantages.

The expandable elements 4924a, 4924b may be filled with saline, contrast media, or other biocompatible fluids. If the expandable elements 4924a, 4924b are filled with a contrast agent, the position and rotational orientation of the expandable structure 4920 can be viewed under fluoroscopy. If the position and/or rotational orientation of the expandable structure 4920 is observed to be undesirable, the expandable structure 4920 may be collapsed (e.g., including deflating the expandable elements 4924a, 4924 b) and repositioned.

The swellable elements 4924a, 4944b may include an electrode 4926 a. Electrodes 4926a may be printed, for example, on balloons 4924a1, 4924a2, 4924b1, and/or 4924b 2. Some of balloons 4924a1, 4924a2, 4924b1, 4924b2 may include an electrode 4926a, and some of balloons 4924a1, 4924a2, 4924b1, 4924b2 may lack an electrode 4926 a. For example, the balloons 4924a1, 4924a2 of the expandable element 4924a may include electrodes 4926a, and the balloons 4924b1, 4924b2 of the expandable element 4924b may not have electrodes 4926 a. For another example, one of the balloons 4924a1, 4924a2 of the expandable element 4924a may include an electrode 4926a, and one of the balloons 4924b1, 4924b2 of the expandable element 4924b may include an electrode 4926 a. Conductors for the electrode 4926a may be printed on the swellable elements 4924a, 4924b, embedded in the material of the swellable elements 4924a, 4924b, and/or extend through the swelling lumen. A non-limiting example printing process is described with respect to fig. 23Ni through 23Nvix, where substrate 2301 may be the material of inflatable elements 4924a, 4924 b. Electrodes 4926a are shown in fig. 49B spaced longitudinally along balloon 4924a2, but other arrangements are possible. Additionally or alternatively to being positioned on the balloons, the electrode 4926a may be positioned between the balloons of the expandable elements 4924a, 4924 b. This arrangement may space the electrode 4926a from the vessel wall and allow blood to flow past the electrode 4926a, e.g., thereby providing the advantages described with respect to fig. 23L and 53B.

Tubular member 4928 may include an electrode 4926b, e.g., similar to a spline as described herein. Fig. 49B illustrates an expandable structure 4920 in which the expandable elements 4924a and/or 4924B include electrodes 4926a and the tubular member 4928 includes electrodes 4926B, but in some examples only expandable elements 4924a, 4924B include electrodes 4926a or only tubular member 4928 includes electrodes 4926B.

The electrodes 4926a and/or 4926b can form an electrode matrix. The number of electrodes in the electrode matrix, electrode size, electrode spacing, etc. may be in accordance with other systems described herein. Upon inflation of the expandable structure 4920, electrodes of the electrode matrix may be selectively activated to test nerve capture, calibration, and/or treatment, e.g., as described herein.

The expandable structure 4920 may be expanded in the vasculature in orientations similar to those described with respect to expandable structure 4120. For example, the vasculature may include the pulmonary trunk, the right pulmonary artery (e.g., as shown in fig. 41G), and the left pulmonary artery. In some examples, the conduit 4930 is asymmetric such that the catheter shaft can be bent (e.g., during floating in the swan-ganz system) to naturally align the expandable structure 4920 with the right pulmonary artery.

Fig. 49C is a perspective view of the example expandable structure 4940 in an expanded state. The expandable structure 4940 includes a proximal portion 4941 and a distal portion 4943. The expandable structure 4940 includes a plurality of expandable elements 4944a, 4944b, 4944C, 4944d (not visible in the view of fig. 49C). The swellable elements 4944a, 4944b, 4944c, 4944d may be coupled proximally to the catheter 4950. The swellable elements 4944a, 4944b, 4944c, 4944d may be coupled at a distal end to a catheter 4950. The swellable elements 4944a, 4944b, 4944c, 4944d can be coupled (e.g., continuously or discontinuously) to the catheter 4950 between the proximal and distal ends. The catheter 4950 optionally includes a lumen, such as a guidewire lumen. The expandable structure 4940 may be used in a over-the-wire system or as part of a swan-ganz system.

The expandable elements 4944a, 4944b, 4944c, 4944d may each include, for example, one or more balloons that are expandable via a single common inflation lumen (e.g., in fluid communication with each balloon, which may advantageously provide uniform inflation), multiple common inflation lumens (e.g., a first inflation lumen in fluid communication with the balloon of the expandable element 4944a, 4944c and a second inflation lumen in fluid communication with the balloon of the expandable element 4944b, 4944d, which may advantageously provide uniform inflation of the balloon in selected relative circumferential regions of the expandable structure), or separate inflation lumens (which may advantageously provide complete control over inflation of the separate balloons). One or more of the expandable elements 4944a, 4944B, 4944c, 4944d may include multiple balloons, e.g., as described herein with respect to fig. 49A-49B. The expandable elements 4944a, 4944b, 4944c, 4944d may advantageously provide compliance when navigating the expandable structure 4940 through the catheter.

The plurality of expandable elements 4944a, 4944b, 4944c, 4944d of the expandable structure 4940 includes a first expandable element 4944a, a second expandable element 4944b, a third expandable element 4944c, and a fourth expandable element 4944 d. Other numbers of expandable elements are possible (e.g., 2, 3, 5, 6, 7, 8, 9, 10, etc.). Fig. 49Ci is a perspective view of an example expandable structure 4943 in an expanded state. The expandable structure 4943 includes six expandable elements 4944a, 4944b, 4944c, 4944d (not visible), 4944e (not visible), 4944 f. The swellable elements 4944a, 4944b, 4944c, 4944d may be evenly spaced circumferentially. For example, the circumferential spacing may be about 30 °, about 36 ° (e.g., for 10 expansion elements), about 40 ° (e.g., for 9 expansion elements), about 45 ° (e.g., for 8 expansion elements), about 51 ° (e.g., for 7 expansion elements), about 60 ° (e.g., for 6 expansion elements), about 72 ° (e.g., for 5 expansion elements), about 75 °, about 90 ° (e.g., for 4 expansion elements), 115 °, about 120 ° (e.g., for 3 expansion elements), about 130 °, about 145 °, about 160 °, about 180 ° (e.g., for 2 expansion elements), a range between these values, and so forth. The swellable elements 4944a, 4944b, 4944c, 4944d may be unevenly circumferentially spaced. The swellable elements 4944a, 4944b, 4944c, 4944d may be circumferentially tufted (e.g., swellable elements 4944a, 4944b, 4944c on one side of the longitudinal axis and swellable elements 4944c on the opposite side of the longitudinal axis). In some examples, the clustered swellable elements may include an electrode 4946a, and the opposing swellable element may lack an electrode. The circumferential spacing may be measured, for example, between midpoints, between similar edges, and other methods as may be suitable for constructing the expandable elements.

The swellable elements 4944a, 4944b, 4944c, 4944d may be filled with saline, contrast media, or other biocompatible fluid. If the expandable elements 4944a, 4944b, 4944c, 4944d are filled with a contrast agent, the position and rotational orientation of the expandable structure 4940 can be viewed under fluoroscopy. If the position and/or rotational orientation of the expandable structure 4940 is observed to be undesirable, the expandable structure 4940 can be collapsed (e.g., including deflating the expandable elements 4944a, 4944b, 4944c, 4944 d) and repositioned. If precise rotational orientation is desired, the swellable elements 4944a, 4944b, 4944c, 4944d may be asymmetric.

The swellable elements 4944a, 4944b, 4944c, 4944d may include an electrode 4946 a. The electrodes 4946a may be printed, for example, on one or more of the balloons of the expandable elements 4944a, 4944b, 4944c, 4944 d. Some balloons may include electrode 4946a, while some balloons may lack electrode 4946 a. For example, the balloon of expandable elements 4944a, 4944b may include electrode 4946a, and the balloon of expandable elements 4944c, 4944d may not have electrode 4946 a. Conductors for the electrode 4946a may be printed on the swellable elements 4944a, 4944b, 4944c, 4944d, embedded in the material of the swellable elements 4944a, 4944b, 4944c, 4944d, and/or extend through the swelling lumen. A non-limiting example printing process is described with respect to fig. 23Ni-23Nvix, where substrate 2301 may be the material of swellable elements 4944a, 4944b, 4944c, 4944 d. The electrodes 4946a of the expandable structure 4940 are longitudinally spaced along the balloon 4944a2, but other arrangements are possible. For example, fig. 49Cii is a perspective view of an example expandable structure 4945 in an expanded state, where the expandable structure 4945 includes two rows of electrodes 4946a, 4946b on each balloon of expandable elements 4944a, 4944 b.

The electrodes 4946a and/or 4946b may form an electrode matrix. The number of electrodes in the electrode matrix, electrode size, electrode spacing, etc. may be in accordance with other systems described herein. Upon inflation of the expandable structures 4940, 4943, 4945, the electrodes of the electrode matrix may be selectively activated for testing nerve capture, calibration, and/or treatment, e.g., as described herein.

Referring again to fig. 49Ci, each of the expandable elements 4944a through 4944f includes a lumen 4952. For example, the lumen 4952 can provide a larger cross-sectional area for blood flow than an enclosed expandable element. The lumen 4952 may also allow the expandable structure 4943 to be more compact, e.g., as compared to an enclosed expandable element. In some examples, the swellable elements 4944a-4944f may include an elastic or self-expanding material. In some such examples, the inflation media, lumens, etc. may be omitted. For simplicity, the electrodes 4946a, 4946b are not shown in fig. 49 Ci. Lumen 4952 may be, for example, a thin balloon member that can reduce (e.g., minimize) occlusion of the vessel, but provide sufficient radial expansion to contact the vessel wall.

Fig. 49D is a perspective view of an exemplary expandable structure 4960 in an expanded state. The expandable structure 4960 includes a proximal portion 4961 and a distal portion 4962. Expandable structure 4960 includes a first spine (spine)4968a, a second spine 4968b, and a plurality of splines 4964 extending between first spine 4968a and second spine 4968 b. In the collapsed state, the first spine 4968a may contract proximally as compared to the expanded state. In some example collapsed states, the first spine 4968a and the second spine 4968b may be longitudinally aligned. In some example collapsed states, a distal portion of the first spine 4968a and a proximal portion of the second spine 4968b may overlap longitudinally. The expandable structure 4960 may include a shape memory material, such as nitinol, that transitions from a collapsed state to an expanded state upon release of a force (e.g., constrained in a catheter) and/or change in temperature. The expandable structure may be expanded by advancing the first spine 4968a distally relative to the second spine 4968b and/or by retracting the second spine 4968n proximally relative to the first spine 4968 a. In some examples, the expandable structure 4960 can include a shape memory material to expand to a first expanded state, and can be further expanded to a second expanded state by advancing the first spine 4968a distally relative to the second spine 4968b and/or by retracting the second spine 4968n proximally relative to the first spine 4968 a. Such further expansion can help anchor the expandable structure in the vessel, e.g., as described herein with respect to fig. 37 Li-37 Liv. In some examples, spines 4968a, 4968b and splines 4964 may be cut from a single hypotube to form a monolithic support structure. In some examples, some or all of the spines 4968a, 4968b and splines 4964 may be formed separately and then coupled.

Splines 4964 of expandable structure 4960 are arranged in pairs that are longitudinally spaced along each spine 4968a, 4968 b. Other configurations are also possible. For example, a single spline 4964 may be longitudinally spaced along each ridge 4968a, 4968 b. For another example, the individual splines 4964 may overlap longitudinally (e.g., but not circumferentially). As another example, more than two splines 4964 may extend between the spines 4968a, 4968 b.

The splines 4964 may include electrodes 4966 as described herein, for example, but not limited to, as described with respect to splines 3622 of expandable structure 3620. In the expandable structure 4960 of fig. 49D, one spline 4964 of each of the pairs of splines 4964 includes an electrode 4966, and the other spline 4964 of the pair does not include an electrode 4966. Splines 4964 that include electrodes 4966 are on one side of a first plane that includes the longitudinal axis of the expandable structure 4960, and splines 4964 that do not include electrodes 4966 are on the opposite side of the first plane. The electrode 4966 is located on a portion of the spline 4964 on one side of a second plane that includes the longitudinal axis, and portions of the spline 4964 on an opposite side of the second plane do not include the electrode 4966. Such an arrangement can help target a portion of a vessel or nerve site and/or reduce profile in the collapsed state. The spines 4968a, 4869b can be pulled into the catheter (e.g., deployed and/or retracted). The splines 4964 can increase (e.g., optimize) placement of the electrodes on the vessel wall. One or both of the spines 4968a, 4869b can increase (e.g., optimize) contact of the spline 4964 and electrode 4966 against the vessel wall.

Fig. 50A is a perspective view of an exemplary expandable structure 5000 in an expanded state. The expandable structure 5000 includes a proximal portion 5001 and a distal portion 5002. The expandable structure 5000 includes a plurality of splines 5004 between the proximal and distal ends. The splines 5004 radially converge in the proximal portion 5001. The proximal portion 5001 can be considered closed. The closed proximal end enables the expandable structure 5000, which has an open proximal end, to be more reliably retracted into the catheter. Splines 5004 are radially outward in the distal portion 5002. Some or all of the splines 5004 may include electrodes as described herein, for example, but not limited to, electrodes as described with respect to splines 3622 of expandable structure 3620. For example, three circumferentially adjacent splines 5004 may include electrodes, and the remaining splines 5004 may have no electrodes. In some examples, splines 5004 including electrodes are located on one side of a plane including the longitudinal axis of the expandable structure 5000, and splines 5004 not including electrodes may be located on an opposite side of the plane. The expandable structure 5000 can include additional splines 5008, for example additional splines at the distal ends of the splines 5004 (e.g., as shown in fig. 50A). Additional splines 5008 can help anchor the expandable structure 5000 in the vessel.

Fig. 50B is a perspective view of the example expandable structure 5020 in an expanded state. The expandable structure 5020 includes a proximal portion 5021 and a distal portion 5022. The expandable structure 5020 includes a plurality of splines 5024 between the proximal and distal ends. Splines 5024 are radially outward in the proximal portion 5021. The proximal portion 5021 can be considered open. The proximal portion 5021 of the expandable structure 5020 can include a proximal tether, such as described herein, that can allow the expandable structure 5020 to be retracted into the catheter. Splines 5024 are radially outward in the distal portion 5022. The distal portion 5022 may be considered open. One or both open ends can reduce occlusion and/or enhance blood flow through the vessel in which the expandable structure 5020 is located. Some or all of the splines 5024 may comprise electrodes as described herein, for example and without limitation as described with respect to splines 3622 of expandable structure 3620. For example, three circumferentially adjacent splines 5024 may include electrodes, and the remaining splines 5024 may not have electrodes. In some examples, splines 5024 comprising electrodes may be located on one side of a plane comprising the longitudinal axis of the expandable structure 5020, and splines 5024 not comprising electrodes are located on an opposite side of the plane. The expandable structure 5020 may include additional splines 5028, such as additional splines at the proximal and distal ends of the splines 5024 (e.g., as shown in fig. 50B). Additional splines 5028 can help anchor the expandable structure 5020 in the vessel.

Figure 50C is a perspective view of an example expandable structure 5040 in an expanded state. The expandable structure 5040 includes a proximal portion 5041 and a distal portion 5042. The expandable structure 5040 includes a plurality of splines 5044, 5045 between the proximal and distal ends. Splines 5044 are radially outward of the proximal portion 5041. The proximal portion 5041 may be considered open. The proximal portion 5041 of the expandable structure 5040 may include a proximal tether, such as described herein, that is configured to allow retraction of the expandable structure 5040 into a catheter. In the expandable structure 5040, the splines 5044 converge to two circumferential points 5046. If the tether is attached to the point 5046 such that the point 5046 can be retracted into the catheter, the entire expandable structure 5046 can be collapsed into the catheter. Splines 5045 are radially outward of the distal portion 5042. The distal portion 5042 may be considered open. One or both open ends can reduce occlusion and/or enhance blood flow through the vessel in which the expandable structure 5040 is located. Some or all of the splines 5044, 5045 may include electrodes as described herein, for example, but not limited to, as described with respect to splines 3622 of expandable structure 3620. For example, three circumferentially adjacent splines 5044, 5045 may include electrodes, and the remaining splines 5044, 5045 may be devoid of electrodes. In some examples, splines 5044, 5045 that include electrodes may be located on one side of a plane that includes the longitudinal axis of the expandable structure 5040, and splines 5044, 5045 that do not include electrodes are located on an opposite side of the plane.

The expandable structure 5000, 5020, 5040 may comprise a shape memory material, such as nitinol, that transitions from a collapsed state to an expanded state upon release of a force (e.g., constrained in a catheter) and/or a change in temperature. In some examples, splines 5004, 5024, 5044, 5045 and optionally additional splines 5008, 5028 may be cut from a single hypotube to form a monolithic support structure. In some examples, some or all of the splines 5004, 5024, 5044, 5045 and optionally additional splines 5008, 5028 may be formed separately and then coupled.

Fig. 51A is a perspective view of an example expandable structure 5100 in an expanded state. Expandable structure 5100 includes a proximal portion 5101 and a distal portion 5102. Expandable structure 5100 includes a plurality of splines 5104 between the proximal and distal ends. Splines 5104 are radially outward in proximal portion 5101. Proximal portion 5101 may be considered open. In the expandable structure 5100, splines 5104 converge to two circumferential points 5105. The tether 5110 is attached to a point 5105, which can allow for retraction of the expandable structure 5100 into the catheter, as described herein with respect to fig. 51 Ei-51 Ev. The tether 5110 may include, for example, a structural wire, a polyurethane tube, or the like. In some examples, the electrical connectors for electrodes 5106 can be bundled to form tethers 5110. Splines 5104 are radially outward in distal portion 5102. The distal portion 5102 may be considered open. One or both open ends can reduce occlusion and/or enhance blood flow through the vessel in which the expandable structure 5100 is located. The tether 5110 can reduce (e.g., minimize) cardiac motion. The tether 5110 is capable of strain relief of the catheter. If the tether 5110 is considered a cord, movement of the catheter cannot push the expandable structure 5100. If the slack is left in place, the tether 5110 cannot be pulled, which may allow the catheter body to migrate (e.g., from the pulmonary artery to the right ventricle), or even be completely removed. If the catheter body is in place, for example in the right ventricle, the heart movement should not push or pull the expandable structure 5100, which can decouple the heart movement.

Some or all of the splines 5104 may include electrodes 5106 as described herein, for example, but not limited to, as described with respect to splines 3622 of expandable structure 3620. For example, in the expandable structure 5100 shown in fig. 51A, four circumferentially adjacent splines 5104 include electrodes 5106, and the remaining splines 5104 lack electrodes 5106. In some examples, such as in the expandable structure 5100, splines 5104 that include the electrode 5106 are located on one side of a plane that includes the longitudinal axis of the expandable structure 5100, and splines 5104 that do not include the electrode 5106 are located on an opposite side of the plane. Expandable structure 5100 may include additional splines 5108, such as additional splines at the distal ends of splines 5104 (e.g., as shown in fig. 51A). Additional splines 5108 can help anchor the expandable structure 5100 in the blood vessel.

The electrodes 5106 can form an electrode matrix. The number of electrodes in the electrode matrix, electrode size, electrode spacing, etc. may be in accordance with other systems described herein. Upon expansion of the expandable structure 5100, the electrodes 5106 of the electrode matrix may be selectively activated to test nerve capture, calibration, and/or treatment, e.g., as described herein. The electrode 5106 of the expandable structure 5100 can be positioned at a pulmonary artery incision or branch between the left and right pulmonary arteries. Additional splines 5108 can anchor expandable structure 5100 in a blood vessel (e.g., the right pulmonary artery). For example, additional splines 5108, which are the distal-most portions of the expandable structure 5100, can extend into the right pulmonary artery, e.g., distal to the pulmonary artery branches. The electrode 5106 can cantilever back toward the pulmonary artery branch.

Fig. 51B is a perspective view of an exemplary expandable structure 5120 in a collapsed state. Fig. 51C is a perspective view of an exemplary expandable structure 5120 in an expanded state. The expandable structure 5120 may include similar features (e.g., splines 5124, additional splines 5128, cut patterns, material, etc.) as the expandable structure 5100, with some differences. For example, the expandable structure 5120 may include a tether 5110, but for simplicity any such tether 5110 is omitted from fig. 51B and 51C. For another example, the electrodes 5106 of the expandable structure are located on the tubular element for each spline 5104, but the electrodes 5126 are individually coupled to the struts 5124. As shown in fig. 51B, in the collapsed state, the electrodes 5126 are able to nest. Nested electrodes 5126 can provide a reduced delivery profile. Electrodes of other expandable structures described herein may also be configured to nest in a collapsed state.

Fig. 51D is a cross-sectional view of an example catheter 5140, the catheter 5140 configured to receive an expandable structure in a collapsed state. Catheter 5140 schematically shows how a 9Fr outer diameter catheter can accommodate a 1mm electrode on four splines 5144 (e.g., electrode 5106 on splines 5104, electrode 5126 on splines 5124) and a guidewire lumen 5142 configured to allow passage of a 0.025 inch guidewire. The portion of the expandable structure that does not include electrodes tends to be more easily received and is not shown.

Fig. 51Ei through 51Ev illustrate an example method of retrieving an expandable structure 5160. For simplicity, the expandable structure 5160 includes only two struts 5164 with electrodes, but the expandable structure 5160 may include features similar to, for example, the expandable structures 5100, 5120. The expandable structure 5160 includes a tether 5162 coupled to the proximal end point. Fig. 51Ei through 51Ev also illustrate a sheath 5170 that may be used to capture a catheter of an expandable structure 5160. The catheter optionally includes a tubular member 5172. The tubular member 5172 can include a guidewire lumen. In some examples, the tether 5172 is coupled to the tubular member 5172 (e.g., as shown in fig. 51 Ei). In some such examples, the tubular member 5172 can be longitudinally movable relative to the sheath 5170 for expanding and/or capturing the expandable structure 5170. In some examples, the tether 5172 is coupled to different tubular members. In some examples, the tether 5172 is not coupled to a tubular member, such as a tubular member that extends proximally of the sheath 5170 for direct manipulation by a user. The tubular member 5172 optionally includes a tip 5174. The tip 5174 may include an atraumatic distal end. The tip 5174 may be configured to occlude the sheath 5170, for example as shown in fig. 51 Ev.

Fig. 51Ei shows the expandable structure 5160 in an expanded state after release from the sheath 5170. In a blood vessel, the struts 5164 will be proximate to the vessel wall and the electrodes 5166 will form an electrode matrix configured to stimulate the target nerve. Fig. 51Eii shows the expandable structure 5160 after the tubular member 5172 is proximally retracted and/or the sheath 5170 is distally advanced. The proximal end of the tether 5162 is proximal to the distal end of the sheath 5170 and the expandable structure is still in the expanded state. Fig. 51 eji illustrates the expandable structure 5160 after the tubular member 5172 is further proximally retracted and/or the sheath 5170 is further distally advanced. The tether 5162 is positioned within the sheath 5170 and a proximal portion of the expandable structure 5160 is positioned within the sheath 5170. The tether 5162 directs the proximal portion of the expandable structure 5160 radially inward and into the distal end of the sheath 5170. A proximal portion of the expandable structure 5160 is radially compressed by the sheath 5170, thereby radially compressing the remainder of the expandable structure 5160 toward a compressed state. Fig. 51Eiv shows the expandable structure 5160 after the tubular member 5172 has been further proximally retracted and/or the sheath 5170 has been further distally advanced. The majority of the expandable structure 5160 is located within the sheath 5170. Fig. 51Ev does not show the expandable structure 5160 because the expandable structure 5160 is in the collapsed state within the sheath 5170 after further proximal retraction of the tubular member 5172 and/or further distal advancement of the sheath 5170. The tip 5174 engages the distal end of the sheath 5170. For example, as described herein, the expandable structure 5170 can be configured to collapse into the sheath 5170 upon failure and/or movement.

Fig. 51Fi is a perspective view of an exemplary expandable structure 5180 in an expanded state. Fig. 51Fii is a side view of the example expandable structure 5180 of fig. 51 Fi. An expandable structure 5180 is coupled to the guidewire sheath 5182. The expandable structure 5180 can be tracked over the guidewire 5183 by positioning the proximal end of the guidewire 5183 within the lumen of the guidewire sheath 5182. The expandable structure 5180 includes a plurality of first splines 5184 located between the proximal end and the distal end. A plurality of first splines 5184 extend longitudinally and circumferentially from one side of the hub 5186 toward the distal end from the proximal end to the distal end. Such a configuration can, for example, reduce the amount of spline material in a lumen, such as a blood vessel. Extension from the hub 5186 can allow retraction of the expandable structure 5180 into the catheter 5181 (e.g., by proximally retracting the guidewire sheath 5182 and/or distally advancing the catheter 5181). The expandable structure may include a plurality of second splines 5188. As best seen in fig. 51Fi, the plurality of second splines 5188 can form an annular cage configured to anchor the expandable structure 5180 in a blood vessel (e.g., the right pulmonary artery). For example, splines 5188, which are the distal-most portions of expandable structure 5180, can extend into the right pulmonary artery, e.g., in the right pulmonary artery distal to the pulmonary artery branches. In the expanded state, the guidewire sheath 5182 is proximal to the circumference of the expandable structure 5180, e.g., as opposed to in a central portion of the expandable structure 5180. The close proximity of the circumferential guidewire sheath 5182 can reduce the amount of material in the central portion of the lumen (such as a blood vessel). This can reduce the interaction of the guidewire sheath 5182 with blood, thereby reducing the risk of emboli. If the guidewire sheath 5182 is adjacent to the vessel wall for an extended period of time, the guidewire sheath 5182 can include a coating to inhibit endothelialization.

Some or all of the splines 5184 may include electrodes 5186 as described herein. In some examples, an electrode structure (e.g., as described with respect to fig. 53A) may be coupled to splines 5184 prior to coupling splines 5184 to hub 5186. In the expandable structure 5180 shown in fig. 51Fi, four circumferentially adjacent splines 5184 can include electrodes, and two remaining splines 5184 can lack electrodes 5186. As best seen in fig. 51Fii, splines 5184 that include electrodes may be located on one side of the plane of the segmented expandable structure 5180, and splines 5184 that do not include electrodes may be located on the opposite side of the plane. The electrodes can form an electrode matrix. The number of electrodes in the electrode matrix, electrode size, electrode spacing, etc. may be in accordance with other systems described herein. Upon expansion of the expandable structure 5180, the electrodes of the electrode matrix may be selectively activated to test nerve capture, calibration, and/or treatment, e.g., as described herein. The electrodes of the expandable structure 5180 can be positioned, for example, in the right pulmonary artery.

Fig. 52Ai is a perspective view of an exemplary expandable structure 5200 in an expanded state. Fig. 52Aii is a side view of the expandable structure 5200 of fig. 52Ai in an expanded state. Fig. 52Aiii is an end view of the expandable structure 5200 of fig. 52Ai in an expanded state. The expandable structure 5200 includes a proximal portion 5201 and a distal portion 5202. The expandable structure 5200 includes a plurality of splines 5204 between the proximal end and the distal end. In the fully expanded state, the splines 5204 project radially outward in the proximal portion 5201 to form an almost spherical shape. In the expandable structure 5200, the splines 5204 converge toward a circumferential point, optionally coupled to a proximal hub 5205, which can allow the expandable structure 5200 to be retracted into a catheter 5209 as described herein with respect to fig. 22F, 22M, 36B, 37B, and 50A. The splines 5204 are flexible, which can help the splines 5204 conform to the shape of the vessel in which they are located (e.g., the right pulmonary artery). The expandable structure 5200 may include additional splines 5208, such as additional splines at the distal end of the splines 5204 (e.g., as shown in fig. 52A). Additional splines 5208 can help anchor the expandable structure 5200 in the vessel. For example, some expandable structures may include only highly compliant splines, which may be acceptable for short term use, but the anchoring splines 5208 can help maintain the position of the compliant splines for long treatment durations (e.g., 0.5 to 6 days). Additional splines 5208 in the distal portion 5202 may be positioned substantially circumferentially about and/or parallel to a longitudinal axis of the expandable structure 5200. The distal portion 5202 may be considered to be open. One or both open ends can reduce occlusion and/or enhance blood flow through the vessel in which the expandable structure 5200 is located.

In some examples, the proximal portion 5201 includes a first set of splines 5204 and the distal portion 5202 includes a second set of splines 5208. The first set of splines 5204 may have a higher compliance (e.g., a lower coefficient of elasticity) than the second set of splines. In some examples, in a fully expanded state, the proximal portion 5201 has a first shape (e.g., spherical) and the distal portion 5202 has a second shape (e.g., cylindrical). In some examples, in the fully expanded state, the proximal portion 5201 has a first diameter and the distal portion 5202 has a second diameter smaller than the first diameter. For example, referring to fig. 52Aiii, the difference Δ r in radius between splines 5204 of proximal portion 5201 and splines 5208 of distal portion 5202 may be about 1mm to about 4mm (e.g., about 1mm, about 2mm, about 3mm, about 4mm, ranges between these values, etc.). In a partially expanded state (e.g., constrained by a vessel wall), the first diameter and the second diameter may be the same.

In some examples, the proximal and distal portions 5201 and 5202 can be integrally cut from a single tube or sheet, which can reduce the need to couple the proximal and distal portions 5201 and 5202. The coupling point can be a weak point that is easily broken. In some examples, the proximal portion 5201 may be cut from a first tube or sheet, while the distal portion 5202 may be cut from a second tube or sheet different from the first tube or sheet, and the proximal portion 5201 may be coupled with the distal portion 5202. Cutting from different tubes or sheets can more effectively separate certain properties, such as radial stiffness. In some examples, the cutting of the monolithic structure can attempt to mimic the effects of individual cutting, such as by varying thickness and/or geometry, twisting, and the like.

Some or all of the splines 5204 may include electrodes 5206 as described herein, for example, but not limited to, as described with respect to splines 3622 of expandable structure 3620. For example, in the expandable structure 5200 shown in fig. 52Aii, two circumferentially adjacent splines 5204 include electrodes 5206 and the remaining splines 5204 lack electrodes 5206. In some examples, such as in the expandable structure 5200, the splines 5204 including the electrodes 5206 may be located on one side of a plane including the longitudinal axis of the expandable structure 5200. Splines 5204 that do not include electrodes 5206 may be located on opposite sides of the plane. The electrode 5206 may be overmolded in an insulating material, for example, as described with respect to fig. 53A-53 Eii. After coupling the overmolded electrode structure, splines 5204 may be coupled to a hub 5205.

The electrodes 5206 can form an electrode matrix. The number of electrodes in the electrode matrix, electrode size, electrode spacing, etc. may be in accordance with other systems described herein. Fig. 52Ai and 52Aii show two splines 5204, each spline 5204 having three electrodes 5206, thereby forming a 2 x 3 matrix of six electrodes 5206. Upon expansion of the expandable structure 5200, the electrodes 5206 of the electrode matrix may be selectively activated to test nerve capture, calibration, and/or treatment (e.g., nerve stimulation to increase left ventricular contractility and/or relaxivity), e.g., as described herein. In some examples, each spline 5204 may include an electrode 5206, thereby forming a full circumferential electrode array. A full circumferential electrode array can advantageously avoid rotational repositioning. Partial circumferential electrode arrays (e.g., as shown in fig. 52Ai and 52 Aii) can reduce cost, device size, and/or manufacturing complexity. The portion circumferential electrode array can be rotationally repositioned as desired. For example, the electrode structure 5200 can be deployed, tested (e.g., by activating a combination of electrodes), and then retrieved, torqued, redeployed, and retested as needed, which can be repeated as needed.

The electrodes 5206 of the expandable structure 5200 can be positioned at a pulmonary artery incision or bifurcation between the left and right pulmonary arteries. Additional splines 5208 can anchor the expandable structure 5200 in a blood vessel (e.g., right pulmonary artery, left pulmonary artery). For example, an additional spline 5208 as the distal-most portion of the expandable structure 5200 can extend into the right or left pulmonary artery, e.g., in the right or left pulmonary artery distal to the pulmonary artery branch.

Fig. 52Aiv illustrates the expandable structure 5200 of fig. 52Ai positioned in the right pulmonary artery 5214. Splines 5208 anchor expandable structure 5200 in the right pulmonary artery. Referring to fig. 2B, in some examples, spline 5208 is located to the right of right flat surface 216. The splines 5204 conform to the shape of the pulmonary artery 5214, and may conform to the shape of the pulmonary trunk 5212 and/or the left pulmonary artery 5216 based on the desired location of the expandable structure 5200.

Fig. 52Bi is a perspective view of an exemplary expandable structure 5220 in an expanded state. Fig. 52Bii is an end view of the expandable structure 5220 of fig. 52Bi in an expanded state. The expandable structure 5220 can have similar features (e.g., proximal portion 5221, distal portion 5222, etc.) as the expandable structure 5200. In the expandable structure 5220, the proximal portion 5221 comprises two types of splines 5224a, 5224 b. The splines 5224a can be similar to splines 5204 of the expandable structure 5200. Splines 5224b are branched between the proximal end of proximal portion 5221 and the distal end of proximal portion 5221. Splines 5224b become circumferentially farther from the proximal end of proximal portion 5221 toward the distal end of proximal portion 5221, and become circumferentially farther from the distal end of proximal portion 5221 toward the proximal end of proximal portion 5221, thus being furthest apart in the middle portion of the proximal portion. The branches of the splines 5224b can help stabilize the distance between adjacent splines. In some examples, each spline 5224b can comprise an electrode. In some examples, each spline 5224a can comprise an electrode. In some examples, some of the splines 5224b can comprise electrodes. In some examples, some of the splines 5224a can comprise electrodes. In some examples, some of the splines 5224b can comprise electrodes, and some of the splines 5224a can comprise electrodes. As described herein, more splines 5224a and/or 5224b comprising electrodes can reduce repositioning, while fewer splines 5224a and/or 5224b comprising electrodes can reduce device size, cost, and/or manufacturing complexity.

As best shown in fig. 52Bii, the splines 5224a, 5224b alternate circumferentially around the expandable structure 5220. In some examples, the branched splines 5224b may be circumferentially adjacent. In some examples, the expandable structure 5220 can comprise more branched splines 5224b than splines 5224 a. In some examples, the expandable structure 5220 can comprise only branched splines 5224b and no splines 5224 a. In some examples, the expandable structure 5220 can comprise fewer branching splines 5224b than splines 5224 a. The difference Δ r in radius between the splines 5224a, 5224b of the proximal portion 5221 and the splines 5228 of the distal portion 5222 may be about 1mm to about 4mm (e.g., about 1mm, about 2mm, about 3mm, about 4mm, ranges between these values, etc.). The distal portion 5222 shown in fig. 52Bi comprises six cells, each cell tapering proximally and then being a tail. Three of the tails are branched splines 5224b and three of the tails are splines 5224 a. In some examples, only one of the tails is a branched spline 5224 b.

Fig. 52Ci is a perspective view of an exemplary expandable structure 5230 in an expanded state. Fig. 52Cii is a side view of the expandable structure 5230 of fig. 52Ci in an expanded state. The expandable structure 5230 can share similar features (e.g., proximal portion 5231, distal portion 5232, etc.) as the expandable structure 5200. In the expandable structure 5230, the proximal ends of the splines 5234 comprise an S-shaped feature, best seen in FIG. 52Cii, which then converge to a point. The splines 5234 have an S-shaped feature at the proximal end before converging to the circumferential point 5235. The S-shaped feature can, for example, reduce the length of the expandable structure 5230 in the main pulmonary artery. For example, the expandable structure 5230 can be several millimeters shorter than the expandable structure 5200 because the splines 5234 curve distally and then proximally rather than continuously distally. The S-shaped structure can provide a radial spring that can dampen movement. Attenuating movement can help maintain the position of the electrode 5206 during movement, for example, due to blood flow and/or respiration. The spring characteristics of the S-shaped features can be adjusted or customized based on, for example, the thickness of the splines 5234, the geometry of the splines 5234, sliding the hub 5235 along the guidewire sheath 5237, combinations thereof, and the like. The electrodes 5236 can be positioned on and/or near the vertices of the splines 5234.

FIG. 52Ciii shows the expandable structure of FIG. 52Ci in the right pulmonary artery. The splines 5238 anchor the expandable structure 5230 in the right pulmonary artery. Referring to fig. 2B, in some examples, spline 5238 is to the right of right plane 216. The splines 5234 conform to the shape of the pulmonary artery 5214, and can conform to the shape of the pulmonary trunk 5212 and/or the left pulmonary artery 5216 based on the desired location of the expandable structure 5230.

Fig. 52Di is a perspective view of an example expandable structure 5240 in an expanded state. Fig. 52Dii is a side view of the expandable structure 5240 of fig. 52Di in an expanded state. Fig. 52Diii is an end view of the expandable structure 5240 of fig. 52Di in an expanded state. The expandable structure 5240 can share similar features as the expandable structure 5230 (e.g., a proximal portion 5231, a distal portion 5232, etc., including S-shaped features). In the expandable structure 5240, the proximal portion 5241 comprises splines 5244, which splines 5244 branch between the proximal end of the proximal portion 5241 and the distal end of the proximal portion 5241. The splines 5244 are circumferentially further from the proximal end of the proximal portion 5241 toward the distal end of the proximal portion 5241 and are circumferentially further from the junction between the cells of the distal portion 5242 toward the proximal end of the proximal portion 5241, thus being furthest apart in the middle portion of the proximal portion 5241. As best seen in fig. 52Diii, pairs of splines 5244 are side-by-side at least for the S-shaped feature. The branches of the splines 5244 can help stabilize the distance between adjacent splines.

Fig. 52E is a perspective view of the example expandable structure 5250 in an expanded and advanced state. The expandable structure 5250 comprises a proximal portion 5251 and a distal portion 5252. For example, like the expandable structures 5200, 5220, 5230, 5240, the distal portion includes a plurality of struts 5258 configured to anchor the expandable structure 5250 in a blood vessel. The proximal portion 5251 comprises a plurality of splines 5255 that couple the distal portion 5252 to the elongate member. The proximal portion 5251 further comprises a guidewire sheath 5254 containing an electrode 5256. The distal end of the guidewire sheath 5254 is fixedly coupled to the distal portion 5252. The proximal end of the guidewire sheath 5254 can be moved relative to the expandable structure 5250. As the guidewire sheath 5254 is advanced distally, the guidewire sheath 5254 flexes radially outward (bow). In some examples, the distal portion 5252 is configured to anchor in the left pulmonary artery and the guidewire sheath 5254 is configured to bend into the right pulmonary artery bend. In some examples, the guidewire sheath 5254 is not configured to bend, but the splines 5255 comprise electrodes 5256 and are configured to bend. In some examples, the guidewire sheath 5254 comprises an electrode 5256 and is configured to bend, and the at least one spline 5255 comprises an electrode 5256 and is configured to bend. In some examples, at least two of the splines 5255 comprise an electrode 5256 and are configured to be curved. Deflecting the guidewire sheath 5254 including the electrode 5256 can reduce the number of components of the expandable structure 5250. A plurality of splines 5255 and/or a guide wire sheath 5254 comprising electrodes 5256 can form nested arcs, thereby forming an electrode matrix. The plurality of splines 5255 and/or the guidewire sheath 5254 comprising the electrode 5256 can be independently or non-independently operable.

Fig. 52Fi and 52Fii illustrate an example method of using the expandable structure 5250 of fig. 52E. The anatomical model shown includes a pulmonary trunk 5212, a right pulmonary artery 5214, and a left pulmonary artery 5216. The distal portion 5252 is anchored in the left pulmonary artery 5216. In fig. 52Fi, the proximal end of the guidewire sheath 5254 is advanced distally, as indicated by arrow 5257, which causes the guidewire sheath 5254 to begin to curve into the right pulmonary artery 5214, as indicated by arrow 5258. In fig. 52Fii, the proximal end of the guidewire sheath 5254 is advanced further distally, as indicated by arrow 5257, which causes the guidewire sheath 5254 to bend further into the right pulmonary artery 5214, as indicated by arrow 5258. The position of the guidewire sheath 5254 can be fixed (e.g., by fixing the position of the proximal end of the guidewire sheath 5254), and a nerve stimulation signal can be applied to the electrode 5256.

Fig. 52Gi is a perspective view of an exemplary expandable structure 5260 in a collapsed state. The expandable structure 5260 can provide a significantly less collapsed state than an expandable structure including stent-like features. Fig. 52Gii is a perspective view of the example expandable structure 5260 of fig. 52Fii in an expanded state. The device 5260 comprises a first guidewire 5262, a guidewire sheath 5264, and a second guidewire 5268 extending distally from a catheter 5265. The guidewire sheath 5264 comprises an electrode 5266 and is configured to bend, e.g., similar to the guidewire sheath 5254 of the expandable structure 5450. The expandable structure 5260 can provide a versatile device in comparison to expandable structures that include stent-like features. For example, depending on radial strength, a stent-like structure may need to have an expanded diameter that is within a certain percentage of the diameter of the vessel in which it is deployed; if the stent-like structure is too large, the vessel may be damaged or the expandable structure may only expand to a state that is undesirable for the procedure (e.g., bringing the electrodes too close together); if the stent-like structure is too small, the expandable structure may not be anchored in the vessel, thereby allowing the electrodes to move during the procedure. In contrast, the expandable structure 5260 need not be subjected to such potential adverse effects, as the preloaded opposing guide wires can accommodate any diameter.

Fig. 52Giii through 52Gv illustrate an example method of using the expandable structure 5260 of fig. 52 Gi. In fig. 52Giii, the expandable structure 5260 has been advanced in the left pulmonary artery 5216. The expandable structure is expanded such that the first wire 5262 is preloaded against a first wall of the left pulmonary artery 5216 and the lung stem 5212, and the second wire 5268 is preloaded against an opposing wall of the left pulmonary artery 5216. The expandable structure 5260 is preferably curved with the anatomy of the left pulmonary artery 5216. In fig. 52Giv, the expandable structure 5260 is proximally retracted in the expanded state, as shown by arrow 5272. The second wire 5268 is snapped into the ostium of the right pulmonary artery 5214, thereby providing a self-aligning method of accurately deploying the expandable structure 5260 into a particular anatomical location. The first and second wires 5262, 5268 anchor the expandable structure 5260 in place. In fig. 52Gv, the guidewire sheath 5276 is advanced distally, thereby bending the guidewire sheath 5264 into the right pulmonary artery 5214, as indicated by arrow 5278. The electrode 5266 on the guidewire sheath 5264 can be used to target a nerve, as described in detail herein. The wire sheath 5264 moves independently of the first and second wires 5262, 5268, which advantageously separates the anchoring structure and the electrode structure. As shown in fig. 52Gv, the guidewire sheath 5264 can optionally extend radially outward of the second wire 5268. As described with respect to the expandable structure 5250, the guidewire sheath 5264 and/or one or more splines can comprise an electrode 5266, and positioning the electrode 5266 on the guidewire sheath 5264 can reduce the number of components.

Fig. 52Gvi illustrates an example method of using a version of the expandable structure 5260 that includes electrode splines 5265. The electrode splines 5265 can operate independently of the guidewire sheath 5264 or in conjunction with the guidewire sheath 5264. When the electrode splines 5265 are in the advanced position, as shown in fig. 52Gvi, the electrode splines 5265 are nested with the guidewire sheath 5264, forming a two-dimensional or three-dimensional matrix of electrodes 5266. The electrodes 5266 can be positioned on the guidewire sheath 5264 and/or electrode splines 5265 such that in the advanced position, the electrodes 5266 are in a position targeted to a particular anatomical structure (e.g., a nerve that increases left ventricular contractility and/or relaxation when stimulated).

Fig. 53A is a perspective view of an example electrode assembly 5300. The electrode assembly 5300 can be used in the expandable structures described herein. Electrode assembly 5300 includes electrodes 5306 interspersed between electrically insulating material 5304. Each electrode 5306 is electrically coupled to an electrical connector 5307. In examples where the electrode 5306 is located on the tubular device, the electrical connector 5307 can extend through the lumen 5310 of the tubular device.

Fig. 53B is a scanning electron microscope image at 3,560 times magnification of the area of electrode 5306 in circle 53B of fig. 53A. The surface of electrode 5306 is surface modified by laser ablation. Laser ablation produces valleys 5322 and hills 5324. In some examples, the depth of the valleys 5322 is between about 0.1mm and about 1mm (e.g., about 0.1mm, about 0.2mm, about 0.3mm, about 0.5mm, about 0.7mm, about 0.9mm, about 1mm, ranges between these values, etc.) as compared to the mountains 5324. Laser ablation may be in one direction, two directions (e.g., a first direction and a second direction transverse (e.g., perpendicular) to the first direction), or multiple directions. In some examples, the effective surface area of electrode 5306 can be increased by a factor of about 300 to about 500 times by laser ablation. Electrode 5306 is a cylindrical electrode, but laser ablation can be used on any of the electrodes described herein.

Laser ablation can space portions of the electrode 5306 from the vessel wall, which can allow blood to flow through the electrode 5306. Referring again to fig. 23F, an insulating material 2316 may be used as a spacer, for example. Allowing blood to flow through the electrodes 2308 may inhibit corrosion of the electrodes 2308. Allowing blood to flow past the electrodes 2308 may allow blood to contact the vessel wall 2397 in the area of the electrodes 2308, which may replenish the cells. In some examples, the electrodes may include longitudinal channels, concave-convex surfaces, etc. to allow blood to flow radially outward from the electrodes 2308 but still closer to the nerve 2399. In some such examples, it may be advantageous to increase the surface area of the electrode 2308

Fig. 53 Ci-53 Ciii-2 schematically illustrate an example method of manufacturing an electrode assembly 5300a, 5300b, such as the electrode assembly 5300 of fig. 53A. Fig. 53Ci illustrates the placement of electrode 5306 in mold 5340. When forming the cylindrical electrode assembly 5300, the mold 5340 may have a cylindrical or annular shape. Electrode 5306 is coupled to electrical connector 5307. Fig. 53Cii-1 shows that electrode 5306 in mold 5340 is overmolded with a biocompatible electrically insulating material 5342, such as polyurethane, silicone, combinations thereof, and the like. The electrical connector 5307 is in substantially the same position as in fig. 53 Ci. Some portions of electrical connector 5307 are encapsulated in insulating material 5342, while other portions of electrical connector 5307 are not encapsulated in insulating material 5342, e.g., in cavity 5310 between inner surfaces of insulating material 5342. Fig. 53Cii-2 also shows that electrode 5306 in mold 5340 is overmolded with a biocompatible electrically insulating material 5342, such as polyurethane, silicone, combinations thereof, or the like. The electrical connectors 5307 are moved, such as by stretching and/or by a radially outward force of the overmolding process, such that substantially all of the electrical connectors 5307 are encapsulated in the insulating material 5342. Encapsulating the electrical connector 5307 in the insulating material 5342 can help protect the wires, reduce the risk of electrical leakage, and/or reduce the risk of corrosion of the wires (e.g., through pinholes in the insulation of the electrical connector 5307). In some examples, encapsulating the electrical connectors 5307 in the insulating material 5342 can reduce or eliminate electrical insulation from the individual electrical connectors. Fig. 53Ciii-1 and 53Ciii-2 illustrate removal of electrode assemblies 5300a, 5300b, respectively, from mold 5340. The resulting electrical components 5300a, 5300b are shown in cross-section along lines 53C-53C in fig. 53A. The overmolding process can also be applied to non-ring electrodes.

Fig. 53Di and 53Dii schematically illustrate another example method of manufacturing an example electrode assembly 5300c (such as the electrode assembly 5300 of fig. 53A). Fig. 53Di shows the placement of electrode 5306 in mold 5350. When forming the cylindrical electrode assembly 5300, the mold 5350 may have a cylindrical or annular shape. The mold 5350 includes features 5352, such as annular grooves, as opposed to overlapping features 5354, such as annular ridges formed during the molding process. Electrode 5306 is coupled to electrical connector 5307. Referring to fig. 53Cii-1, electrode 5306 is overmolded in mold 5350 with a biocompatible electrically insulating material 5342, such as polyurethane, silicone, combinations thereof, or the like. The electrical connectors 5307 are in substantially the same position as in fig. 53Cii-2, e.g., moved by stretching and/or by the radially outward force of the overmolding process, such that all or substantially all of the electrical connectors 5307 are encapsulated in the insulating material 5342. Encapsulating the electrical connector 5307 in the insulating material 5342 can help protect the wire, reduce the risk of electrical leakage, and/or reduce the risk of corrosion of the wire (e.g., through pinholes in the insulation of the electrical connector 5307). In some examples, encapsulating the electrical connectors 5307 in the insulating material 5342 can reduce or eliminate electrical insulation from the individual electrical connectors. Fig. 53Dii shows the electrode assembly 5300c after being removed from the mold 5350. The resulting electrical component 5300C is shown in cross-section along line 53C-53C in fig. 53A. Overlapping feature 5354 seals the end of electrode 5306. The overlapping features 5354 at least partially define the size (e.g., longitudinal width) of the electroactive area of the electrode 5306, which can provide more predictable and/or uniform stimulation. The overlap features 5354 can space the electrode 5306 from the vessel wall and allow blood to flow through the electrode 5306, e.g., to provide the advantages described with respect to fig. 23L. The overmolding process may also be applied to non-ring electrodes.

Fig. 53Ei schematically illustrates another example electrode assembly 5300d, such as the electrode assembly 5300 of fig. 53A. In contrast to electrode assembly 5300c of fig. 53Dii, where overlapping feature 5354 returns to the outer radius of electrode 5306 at the longitudinally outer side of electrode 5306, overlapping feature 5356 of electrode assembly 5300d extends over the same or substantially the same radial width at the longitudinally outer side of electrode 5306. As shown in fig. 53Dii, returning to the outer radius of electrode 5306 can reduce material usage. Extending over the same or substantially the same radial width can reduce mold complexity, increase wall proximity, and/or provide higher manufacturing tolerances.

Fig. 53Eii schematically illustrates another example electrode assembly 5300e, such as electrode assembly 5300 of fig. 53A. In contrast to the electrode assembly 5300D of fig. 53Ei in which the overlapping features 5356 are smooth or substantially smooth longitudinally outside of the electrodes 5306, the electrode assembly 53058 of the electrode assembly 5300e includes a textured surface that is capable of forming anchoring structures, e.g., to provide the advantages described with respect to fig. 12A-12D and/or 27I (e.g., to contact vascular tissue in a manner such that movement of the electrodes 5306 at their locations that contact the vascular tissue is reduced (e.g., minimized) and/or some tissue may enter the space between the anchoring structures to increase the likelihood of tissue engagement). The anchoring structure can have a variety of shapes including conical, barb-free hooks, ridges and valleys, combinations thereof, and the like. Electrode assembly 5300e, which includes overlapping features 5358 with textured surfaces, can reduce material usage compared to electrode assembly 5300d in fig. 53 Ei.

FIG. 53F is an external perspective view of an example electrode 5366. FIG. 53G is an interior perspective view of the example electrode 5366 of FIG. 53F. For example, struts 5362 can be cut (e.g., laser cut) from a tube or sheet (e.g., comprising a shape memory material such as nitinol) as described with respect to several expandable structures herein. The post 5362 also includes an aperture sized and shaped to receive the electrode 5366.

Electrically insulating material 5364 is coupled to laser cut struts 5362. As best seen in fig. 53F, an electrically insulating material 5364 may cover the outside of the posts 5362. In some examples, the outer side of the strut 5362 includes only electrically insulating material 5364 surrounding the electrode 5366. As best seen in fig. 53G, an electrically insulating material 5364 can cover the inside of the posts 5362. In some examples, the inner side of the struts 5362 only includes the electrically insulating material 5364 surrounding the electrodes 5366. In some examples, the inner side of the strut 5362 includes an electrically insulating material 5364 surrounding the electrode 5366 and proximate to the electrode 5366 (e.g., below the conductor 5368). The electrode 5366 is coupled to a conductor 5368. The conductor 5368 may be insulated.

The conductor 5368 can be electrically coupled to the electrode 5366 without the use of soldering, welding, or the like. For example, the electrode 5366 can be passed through a hole of the post 5362 and then deformed (e.g., swaged, crimped) on the inside to hold the electrode 5366 to the post 5362, e.g., as shown in fig. 53G. In some examples, the posts 5362 can include channels or slots into which the conductors 5368 can be inserted. In some examples, an electrically insulating material can be applied to the deformed electrodes 5366 and conductors 5368 on the inside of the posts 5362, after which the electrodes 5366 are exposed only to the outside, as shown in fig. 53F. In some examples, the strut 5362 can include a plurality of electrodes 5366 coupled thereto in the same manner. In some examples, the expandable structure can include a plurality of struts 5362. Each of the plurality of struts 5362 can include a plurality of electrodes 5366 coupled thereto in the same manner.

Fig. 54A is a schematic illustration of a heart with an example catheter system 5402 including an expandable structure 5408 deployed in a right pulmonary artery 5409. The catheter system 5402 includes a first pressure sensor 5404 in a pulmonary artery 5410 and a second pressure sensor 5406 in a right ventricle 5412. Fig. 54B is a perspective view of an example pressure sensor 5420, which example pressure sensor 5420 can be used with a first pressure sensor 5404 and/or a second pressure sensor 5406. The pressure sensor 5420 shown in fig. 54B comprises a Fr MEMS-based pressure sensor, such as available from milliar, that includes a proximally extending filament 5422. The pulmonary valve 5411 is located between the pulmonary artery 5410 and the right ventricle 5412. The first pressure sensor 5404 and the second pressure sensor 5406 can be used to detect catheter movement, for example, as described with respect to fig. 54C.

FIG. 54C is a graph illustrating an example use of a pressure sensor for monitoring catheter movement. Data from the first pressure sensor 5404 is shown in the top graph 5442. Data from the second pressure sensor 5406 is shown in the bottom graph 5444. In some examples, data from the first pressure sensor 5404 and the second pressure sensor 5406 may be displayed on the same graph. In some examples, data from the first and second pressure sensors 5404, 5406 may not be displayed to the user and/or may be displayed upon request by the user, but the system may be configured to issue an alert when movement is sensed. The data may be performed beat-to-beat, per second, or at other intervals as appropriate. During the first duration 5446, data from the pulmonary artery is within a range and data from the right ventricle is within a range. During the second duration 5447, data from the pulmonary artery is in a different range while data from the right ventricle is still in a certain range. Data from the pulmonary artery is within a certain range of the right ventricle, which may indicate to the user that the first pressure sensor 5404 has migrated from the pulmonary artery 5410 into the right ventricle 5412 through the pulmonary valve 5411. This migration may be indicative of migration of the catheter system 5402, the catheter system 5402 including an expandable structure 5408 that provides stimulation. Upon such detection, an alarm may sound, the stimulus may automatically turn off, the expandable structure may collapse, and/or other events may occur. During the duration 5448, the catheter system 5402 has been moved such that the first pressure sensor 5404 and the second pressure sensor 5406 are in the pulmonary artery 5410 and the right ventricle, respectively. Monitoring the movement of the catheter can alert the user to migration, which may cause adverse events such as myocardial stimulation, arrhythmias, damage to cardiac structures (e.g., due to accidental removal of the catheter), and the like.

The catheter system 5302 can additionally or alternatively include first and second pressure sensors configured to detect catheter movement at other locations. For example, a first pressure sensor may be configured to detect pressure in the right ventricle, while a second pressure sensor may be configured to detect pressure in the right atrium. For another example, a first pressure sensor may be configured to detect pressure in the right atrium and a second pressure sensor may be used to detect pressure in the right inferior vena cava. In some examples, the first pressure sensor and the second pressure sensor are configured to detect pressure in adjacent chambers (e.g., separated by a valve). In some examples, the first and second pressure sensors may be further apart (e.g., separated by a plurality of valves).

Fig. 54Di and 54Dii illustrate example methods and systems for detecting movement of the catheter 5452. In fig. 54Di, the catheter 5452 is in a delivery configuration. For example, as shown in fig. 54A but with respect to any expandable structure described herein or otherwise, the expandable structure shown by dashed line X is anchored in the right pulmonary artery 5409. Alternatively, anchoring or positioning may be performed in the left pulmonary artery and/or the pulmonary trunk 5410. The catheter 5452 includes an elongate element that extends from the expandable structure, through the pulmonary trunk 5410, pulmonary valve 5411, right ventricle 5412, tricuspid valve 5413, right atrium 5414, vena cava, and out of the subject (e.g., through the jugular vein or femoral vein). The catheter 5452 includes a first pressure sensor 5454 located in the right ventricle 5412. The catheter 5452 optionally includes a second pressure sensor 5456 located in the lung shaft 5410. Single sensor configurations are described in further detail herein. For example, as described with respect to fig. 54A and 54B, pressure sensors 5454, 5456 may include milliar sensors or other types of pressure sensors.

In fig. 54Dii, the catheter 5452 has been pulled proximally as shown by arrow 5458. As the slack in the elongate member of the catheter 5452 is initially reduced, the expandable structure remains anchored in place. This causes the catheter 5452 to be pulled alongside the annulus of the tricuspid valve 5413, as shown in figure 54 Dii. The first sensor 5454 remains in the right ventricle 5412, but is in contact with the leaflets and chordae tendineae of the tricuspid valve 5413, which causes a change in the sensor signal even before reaching the right atrium 5414. If the catheter 5452 is further retracted proximally, the first sensor 5454 is pulled into the right atrium 5414, further altering the sensor signal. If the catheter 5452 is further retracted proximally, slack will be absorbed and the force may begin to act to dislodge the expandable structure. The methods and systems described with respect to the first sensor 5454 of fig. 54Di and 54Dii can provide an early warning or precaution of movement of the catheter 5452 even before the expandable structure moves and stimulation may be compromised.

An optional second sensor 5456 remains in the pulmonary trunk 5410. For example, as described with respect to fig. 54A-54C, the second sensor 5456 may be used to confirm movement of the catheter 5452 (e.g., such that the second sensor 5456 moves through the pulmonary valve 5411 as the expandable structure becomes un-anchored to move).

Fig. 54E illustrates in a single figure an example method and system for detecting movement of a catheter 5462. The catheter 5462 is shown in solid lines in a delivery configuration in the vena cava and pulmonary trunk 5410 and in dashed lines in the right ventricle 5412 and right atrium 5414, and is shown in solid lines throughout in a pull configuration. In contrast to the catheter 5452 of fig. 54Di and 54Dii, the catheter 5462 includes one sensor 5464, which is shown in the delivery position 5464a and the pull position 5464 b. In comparison to fig. 54Dii, catheter 5462 has been pulled out such that pulled position 5464b is located in right atrium 5414. Sensor 5464, when passing through tricuspid valve 5413, provides a right atrial pressure signal that is different from the right ventricular pressure signal and the signals indicative of contact with the leaflets and chordae tendinae of tricuspid valve 5413. The methods and systems described with respect to sensor 5464 of fig. 54E can provide an early warning or precaution of movement of catheter 5462 even before the expandable structure moves and stimulation may be compromised.

Fig. 55 is a front view of an example stimulation system 5500. Stimulation system 5500 includes a housing 5502, a catheter connector 5504 that includes an electrical connector 5506, a display 5508, and an input 5510. The housing 5502 can contain stimulation electronics including a switch matrix for electrode stimulation. In some examples, the minimum output of the stimulation matrix is 25mA, up to 8ms, and 100 Hz. Other minimum, maximum, and specified parameters (e.g., number of poles, pulse pattern, amplitude, phase, voltage, duration, inter-pulse interval, duty cycle, dwell time, sequence, waveform, etc.) are also possible. Computing device 5520 (e.g., a networked computer terminal, desktop, laptop, tablet, smartphone, smartwatch, etc.) can be communicatively coupled to stimulation system 5500 via a wired or wireless system. In some examples, the tablet may be connected to the stimulation system 5500 via a USB connection 5522 (e.g., as shown in fig. 55). Computing device 5520 can include a display that provides a graphical user interface configured to set stimulation parameters, present sensor data, view waveforms, store data, and the like. The computing device 5520 can be networked to other computing devices, networks, the internet (e.g., via a secure HIPAA compliant protocol), and so forth. Referring again to fig. 54A, electrical connector 5506 may be configured to interface with electrical connectors from pressure sensors (e.g., two pressure sensors). Electrical connector 5506 may be configured to interface with electrical connectors from ECG leads (e.g., three leads from a skin ECG patch). The electrical connector 5506 may be configured to interface with an electrical connector from a sensor configured to provide data that may be used for contractility measurements. The stimulation system 5500, the computing device 5520, and/or another computing device may be configured to use this data to provide contractility measurements. The stimulation system 5500 may include additional electrical connectors that are not used to connect to current catheters, but can provide the ability to retrofit systems for future development. The stimulation system 5500, the computing device 5520, and/or another computing device may include embedded programs for stimulation and/or sensing. The stimulation system 5500, the computing device 5520, and/or another computing device may include a security alarm configured to alert a user of an alarm event at the stimulation system 5500, the computing device 5520, and/or another computing device. In some examples, the third pressure sensor can provide confirmation (e.g., detect that the second pressure sensor 5306 moved from the right ventricle 5312 into the right atrium).

Fig. 57A is a perspective view of an example of a catheter system 5700. The system 5700 includes a proximal portion 5702 configured to remain outside of a subject and a distal portion 5704 configured to be inserted into the vasculature of the subject. The distal portion 5704 includes an expandable structure 5720. The system 5700 includes an outer sheath 5706, an elongate inner member 5708 radially inward of the outer sheath 5706. The system 5700 can include a shaft 5703 radially inward of the inner member 5708. The inner member 5708 can include a guidewire lumen, for example, for allowing tracking of the system 5700 over a guidewire. The shaft 5703 can include a guidewire lumen, for example, for allowing tracking of the system 5700 over a guidewire. The outer sheath 5706 and the inner member 5708 can be coupled at a proximal end 5702.

The proximal portion 5702 can include a handle and an actuation mechanism, for example, to move the outer sheath 5706 relative to the inner member 5708. To deploy the expandable structure, the outer sheath 5706 can be retracted while keeping the inner member 5708 stationary, the inner member 5708 can be advanced while the outer sheath 5706 remains stationary, and/or the outer sheath 5706 can be retracted while the inner member 5708 is advanced. To collapse the expandable structure 5720, the outer sheath 5706 can be advanced while the inner member 5708 remains stationary, the inner member 5708 can be retracted while the outer sheath 5706 remains stationary, and/or the outer sheath 5706 can be advanced while the inner member 5708 is retracted. The proximal portion 5702 can include a handle and an actuation mechanism, for example, to move the outer sheath 5706 relative to the shaft 5703. The proximal portion 5702 can include a handle and an actuation mechanism, for example, to move the inner member 5708 relative to the shaft 5703. The handle may include a locking mechanism, for example as described herein.

The jacket 5706 can include a reinforcing layer such as a braid, coil, spiral, combinations thereof, and the like. The reinforcement layer may provide column strength to capture the expandable structure 5720. The distal end of the sheath 5706 can be atraumatic. For example, the distal end of the atraumatic sheath 5706 can reduce or prevent injury from interaction between the sheath 5706 and the vasculature after deployment of the expandable structure 5720. In some examples, the distal end of the sheath 5706 can be selectively positioned or rest in a portion of the vasculature during treatment. For example, the distal end of the sheath 5706 can be located in the right pulmonary artery, the left pulmonary artery, the pulmonary trunk, the right ventricle, the right atrium, the superior vena cava, or other location as appropriate. For example, if the sheath includes a pressure sensor, the location of the distal end of the sheath 5706 can be such that the pressure sensor is positioned in a desired body cavity (e.g., right pulmonary artery, left pulmonary artery, pulmonary torso, right ventricle, right atrium, superior vena cava, or other suitable location). Instead, saline, heparin, and/or other fluids may be injected through the sheath 5706, for example, proximal to the expandable structure 5720. Blood may be drawn through the sheath 5706, for example, to sample blood characteristics (e.g., SpO2) at a location distal to the sheath 5706. Preferably, movement of the sheath 5706 does not impart the expandable structure 5720.

The sheath 5706 can include radiopaque markers 5707. The radiopaque markers 5707 can include, for example, arcuate bands.

Proximal portion 5702 may include an adapter that includes a plurality of ports, such as a first Y adapter port and a second Y adapter port. The first Y-adapter port can be in communication with a lumen configured to allow a guidewire to be inserted through the system 5700. The second Y-adapter port can include an electronics connector that can be used to couple the electrode matrix of system 5700 to a stimulation system.

Fig. 57B is a side view of an exemplary expanded structure 5720 of the catheter system 5700 in an expanded state. The expandable structure 5720 includes a proximal portion 5722 and a distal portion 5724. The expandable structure 5720 includes a plurality of wires 5726 and a plurality of electrode assemblies 5730.

Fig. 57C is a side view of the expandable structure 5720 in an expanded state and without the electrode assembly 5730. Each of the plurality of wires 5726 is bent at a medial portion to form a flexure 5728 at the distal portion 5724 of the expandable structure 5720. In some examples, the expandable structure includes a loop at the distal portion 5724, for example, as described in U.S. patent No. 7,018,401, which is incorporated herein by reference in its entirety. In some examples, the distal end 5724 of the expandable structure 5720 does not include any coupling structures. Flexures 5728 at the ends of the expandable structure 5720 can, for example, provide atraumatic ends. The flexures 5728 at the end of the expandable structure 5720 can, for example, inhibit or prevent breakage at that end (e.g., because a continuous wire is less likely to break than a cut strut intersection or a wire that has been coupled together). The expandable structure 5720 may be devoid of struts that are cut from hypotubes. The expandable structure 5720 can be comprised of a plurality of wires 5726 or can be comprised substantially of a plurality of wires 5726 (e.g., also including a tube 5758, etc.).

A plurality of filaments 5724 may be braided (e.g., braided, and/or knitted) from the flexures 5728 toward the proximal portion 5702. The weave may be, for example, one-one type, one-two type, two-two type, etc. The tangled structure may be referred to as a basket, a stent, an anchor, and/or other suitable terminology. The plurality of wires 5726 may include, for example, a number of wires 5726 such that 2 times the number of wire ends are tangled toward the proximal portion 5722. In some examples, the number is included between 4 filaments and 24 filaments (e.g., 4 filaments, 6 filaments, 8 filaments, 10 filaments, 12 filaments, 14 filaments, 16 filaments, 20 filaments, 24 filaments, a range between these values, etc.). After being twisted a certain longitudinal distance, the pairs of wires 5726t, 5726c are positioned side-by-side to couple to the electrode assembly 5730. One wire 5726t from each side-by-side pair 5726t, 5726c terminates in an electrode assembly 5730. The other wire 5726c from each side-by-side pair 5726t, 5726c continues to extend proximally of the electrode assembly 5730. The wires 5726c form spokes 5728 that extend from the periphery of the expandable structure 5720 toward the longitudinal axis 5709. The braided structure may provide a greater radial force than, for example, a laser cut structure. The spokes 5728 at the approximate end of the expandable structure 5720 can, for example, provide an atraumatic end. The spokes 5728 at the end of the expandable structure 5720 can, for example, inhibit or prevent breakage at that end (e.g., because continuous wires are less likely to break than wires where cut struts intersect or have been coupled together). The coupling of the wires 5726 may each be within a sheath or other structure so as to contain any breaks that may occur.

The expandable structure 5720 can optionally include radiopaque markers 5725, for example, at or near the distal end of the expandable structure 5720. When the radiopaque marker 5725 is located at the distal end of the expandable structure 5720, the user can partially deploy the expandable structure 5720 to verify alignment (e.g., lowermost, uppermost) prior to fully deploying the expandable structure 5720. Although one radiopaque marker 5725 is shown in fig. 57B-57 Dii, and a single radiopaque marker can provide certain alignment advantages (e.g., as discussed herein), multiple radiopaque markers 5725 are also possible. When the expandable structure includes a plurality of radiopaque markers 5725, at least one of the radiopaque markers 5725 can include different characteristics (e.g., shape, thickness, material, etc.) than at least one other of the radiopaque markers 5725. For example, the different characteristics can allow the at least one radiopaque marker 5725 to be distinguished and used for alignment.

FIG. 57Di is an end view of expandable structure 5720. Fig. 57Di shows spokes 5728 extending toward the central longitudinal axis 5709. Fig. 57Di also shows the electrode assembly 5730 extending over only a portion of the circumference of the expandable structure 5720. For example, the electrode assembly 5730 can be located on one side of a plane 5711 that includes the longitudinal axis 5709. In some examples, the electrode assemblies 5730 are coupled to circumferentially adjacent spokes 5728. The radiopaque markers 5725 may be located on the opposite side of the plane 5711 from the electrode assembly 5730 (e.g., as shown in fig. 57 Di). The radiopaque marker 5725 may be circumferentially opposite a circumferential midpoint of the electrode assembly 5730 (e.g., as shown in fig. 57 Di). Radiopaque markers 5725 may aid in rotational positioning of electrode assembly 5730. For example, radiopaque marker 5725 may be positioned at about 6:00 if the electrode assembly preferably extends circumferentially between about 11:00 and about 3:00 relative to the clock. Electrode 5736 may act as a radiopaque marker.

Fig. 57Dii is an end view of another example expandable structure similar to expandable structure 5720, but with radiopaque markers 5725 positioned differently relative to electrode assembly 5730 and plane 5711. In the example shown in fig. 57Dii, the radiopaque marker 5725 is about 180 ° from the uppermost electrode assembly 5730-1. Knowing the location of the radiopaque marker 5725 and its orientation about 180 ° from the uppermost electrode assembly 5730 can provide the user with the following information: when the radiopaque marker is in the lower position, the other electrode assemblies 5730 are in front of the uppermost electrode assembly 5730, which can provide information that all of the electrode assemblies 5730 are in the target area (e.g., the upper front). In another example, the radiopaque marker 5725 is about 0 ° from the uppermost electrode assembly 5730. Knowing the location of the radiopaque marker 5725 and its orientation at about 0 ° to the uppermost electrode assembly 5730 can provide the user with the following information: when the radiopaque marker is in the upper position, the other electrode assemblies 5730 are in front of the uppermost electrode assembly 5730, which can provide information that all of the electrode assemblies 5730 are in the target area (e.g., front upper). The radiopaque markers 5725 can be positioned in other orientations relative to the electrode assembly 5730 to target specific anatomical structures with the electrode array. For example, an example of a target region in the right pulmonary artery is provided throughout the present disclosure (e.g., with reference to quadrants in fig. 2D, it should be understood that fig. 57Di and 57Dii are proximal views as opposed to the distal views of fig. 2D).

The wire 5726 may include a filament, wire, ribbon, or the like having a circular cross-section, an arcuate non-circular cross-section (e.g., oval, elliptical, etc.), a rectangular cross-section (e.g., square), a trapezoidal cross-section, combinations thereof, or the like. In some examples, some wires 5726 may have a cross-section configured to interact with the shape of the electrode assembly 5730, the hub system 5750, and/or other components. The wire 5726 may have a diameter or lateral cross-section of between about 0.002 inches (approximately 0.051mm) to about 0.02 inches (approximately 0.51mm) (e.g., about 0.002 inches (approximately 0.051mm), about 0.004 inches (approximately 0.1mm), about 0.006 inches (approximately 0.15mm), about 0.008 inches (approximately 0.2mm), about 0.01 inches (approximately 0.25mm), about 0.012 inches (approximately 0.3mm), about 0.015 inches (approximately 0.38mm), about 0.02 inches (approximately 0.51mm), ranges between these values, etc.). In some examples, some wires 5726 may have different diameters, e.g., configured to interact with the dimensions of the electrode assembly 5730, the system 5750, and/or other components. In some examples, the end of the wire that continues with the spoke 5728 may have a relatively small diameter, for example, to reduce the amount of material at the proximal portion 5722.

The wires 5726 may comprise, for example, nickel, titanium, chromium, cobalt and alloys thereof, including nickel titanium (e.g., nickel titanium alloys), chromium cobalt, and the like. The wires 5726 can be heat treated to impart shape memory or superelasticity to the expandable structure 5720. For example, the plurality of wires 5726 can be heat treated such that the expandable structure 5720 assumes an expanded shape in the absence of an external force (e.g., as shown in fig. 57B) and can collapse to a compressed or delivery state (e.g., due to a force applied by the outer sheath 5706). At least one of the wires 5726 can include a radiopaque material, such as a drawn filled tube having a radiopaque core and a shape memory cladding, a radiopaque marker coupled to the shape memory material, combinations thereof, and the like.

In some examples, the diameter 5721 of the expandable structure 5720 in the expanded state is between about 15mm to about 45mm (e.g., about 15mm, about 20mm, about 22mm, about 24mm, about 26mm, about 28mm, about 35mm, about 39mm, about 43mm, about 45mm, ranges between these values, etc.). In some examples, the plurality of wires 5726 are heat treated to self-expand them such that the expandable structure 5720 is capable of self-expanding from a compressed state for navigation to a target site to or toward an expanded state for treatment at the target site (e.g., pulmonary arteries (e.g., right pulmonary artery, left pulmonary artery, pulmonary trunk), inferior vena cava, superior vena cava, innominate veins, etc.). In some such examples, the diameter of the expandable structure 5720 in the expanded state may be enlarged to most of the intended vasculature of most subjects to ensure that the vessel walls are proximate. The expanded state in the vessel may be less than the fully expanded state (e.g., without any radially inward force due to the vessel wall). In some examples, the wire 5726 may be non-self-expanding (e.g., balloon-expandable, expandable like an umbrella with wires, etc.). The expandable structure 5720 can be used with vessels of various sizes (e.g., different sizes of the right pulmonary artery), and the braided structure can accommodate the size of the vessel without compromising system performance. For example, the expandable structure 5720 can be adjacent to a vessel wall and push an electrode assembly against the vessel wall to and including a fully expanded state.

In some examples, the expandable structure 5720 can be self-expanding and can be further expanded (e.g., with a wire, such as described herein), which can provide a diameter 5721 of the adjustable expandable structure 5720 that can be used for a range of vessels, vessel sizes, wall proximity forces, and the like. Examples in which the expandable structure 5720 is not proximate to a wall in the event of an error may be advantageous for safety, for example, as described herein. After expansion of the expandable structure 5720, the electrodes 5736 of the electrode assembly 5730 can be selectively activated for testing nerve capture, calibration, and/or treatment, e.g., as described herein.

When weaving multiple wires 5726, the weave pattern may be uniform along at least a portion of the expandable structure 5720. In some examples, the weave pattern may be uniform (e.g., around the formed locations of the spokes 5728) from the distal end of the expandable structure 5720 to the proximal end of the weave structure. Referring again to fig. 57B, in some examples, the weave pattern between the first section 5740 and the second section 5742 is different. For example, first segment 5740 may include a first braid angle 5741 and second segment 5742 may include a second braid angle that is different than first braid angle 5741. Second braid angle 5743 may be greater than first braid angle 5741 (e.g., as shown in fig. 57B), which can provide a more outward radial force in the region including at least some of electrodes 5736. Second braid angle 5743 may be smaller than first braid angle 5743, which can provide a more outward radial force for more wall proximity in the area lacking electrode 5736. The expandable structure 5720 may include more than two sections with varying properties. Other knitting parameters may alternatively or additionally vary between sections (e.g., knitting pattern, weft density per inch, porosity, density, etc.).

In some examples, deploying the expandable structure 5720 includes advancing the expandable structure 5720 in a collapsed state to a distal end of an intended target location. The expandable structure 5720 may be expanded toward an expanded position. The combination and parameters of electrodes 5736 can be tested. If it is determined that the expandable structure is too far, the expandable structure 5720 may be retracted proximally without collapsing. This retraction can use a little force, but is less damaging to the vasculature and/or easier for the user than, for example, advancing the expandable structure 5720 in an expanded state distally and/or recoating the expandable structure 5720, repositioning the expandable structure 5720, and redeploying the expandable structure 5720.

FIG. 57E is a proximal and side perspective view of the example hub system 5750 of the example expandable structure 5720 of FIG. 57B. Fig. 57F is a distal end view of the example hub system 5750 of fig. 57E. Hub system 5750 includes an outer band 5752, an inner band 5754, and an adapter 5756. In fig. 57E, outer band 5752 is shown as transparent to enhance clarity. In fig. 57E, the inner member 5708 is omitted to enhance clarity. Inner member 5708 is coupled to outer band 5752. Outer band 5752 may comprise, for example, a radiopaque band. The radiopaque band can help the user identify the proximal portion 5722 of the expandable structure 5720. Outer band 5752 may comprise, for example, a fully arcuate ring or a partially arcuate ring. The adaptor 5756 may comprise a polymer (e.g., Pebax). Inner strip 5754 may comprise, for example, a metal strip. Metal strips can be suitable for certain coupling methods (e.g. fusion welding). The inner band 5754 may comprise, for example, a radiopaque band. Inner band 5754 may comprise, for example, a fully arcuate ring or a partially arcuate ring.

The continuous wire 5726c adjacent to electrode assembly 5730 is located radially inward of outer band 5752. The spokes 5728 rotate such that the wires 5726c extend approximately parallel to the hub system 5750. The adapter 5756 can include a plurality of radial projections 5755, the radial projections 5755 at least partially defining a plurality of lumens or channels 5757, the lumens or channels 5757 being for insertion of the wires 5726c therein. The wires 5726c are each located in a lumen or channel 5757 defined at least in part by openings between the radial projections 5755 of the adapter 5756. Outer band 5752 may at least partially define an inner cavity 5757. The wire 5726c is also located radially inward of the inner band 5754. The wire 5726c may be coupled to the inner band 5754 (e.g., by welding, brazing, adhesion, friction fit, combinations thereof, etc.). The inner band 5754 may be proximate to the radial projections 5755 of the adapter 5756. The adapter 5756 can include a central lumen 5751 radially inward of the lumen 5753, e.g., to accommodate a guidewire, a shaft 5703 (fig. 57I), etc.

FIG. 57G is a proximal and side perspective view of a portion of an expandable structure 5720 and a portion of an example hub system 5750. For clarity, outer straps 5752 and inner straps 5754 are not shown. Fig. 57F shows adhesive 5760 adjacent to adapter 5756. Adhesive 5760 is also adjacent inner band 5754. In some examples, adhesive 5760 may at least partially longitudinally overlap with adapter 5756 and/or inner band 5754. Adhesive couples the wire 5726c to the shaft 5703. The adhesive can also inhibit or prevent fluid from entering the inner member 5708. The wire 5726c is coupled to a hub system 5750 that is coupled to the inner member 5708. These couplings together couple the expandable structure 5720 to the inner member 5708 and the shaft 5703. In some examples (e.g., adhesive 5760 omitted), the expandable structure 5720 can be coupled to the inner member 5708 and movable relative to the shaft 5703. Adhesive 5760 may provide a fluid tight seal between the expandable structure 5720 and portions of the catheter system 5700 adjacent the expandable structure.

FIG. 57H is a side view of a portion of an expandable structure 5720 and a portion of an example hub system 5750. Fig. 57G and 57H show a polymer tube 5758 surrounding a portion of each filament 5726 c. The polymer tube 5758 may comprise, for example, heat shrink tubing (e.g., comprising PET). The polymer tube 5758 at least partially encloses a pair of wires 5726t, 5726c, including the proximal ends of the wires 5726 t. The polymer tube 5758 can reduce or eliminate exposure of the vasculature to the sharp ends of the wire 5726 t. The polymer tubes 5758 can help couple pairs of wires 5726t, 5726c to maintain the shape of the expandable structure 5720. The polymer tube 5728 may extend to the adapter 5756, for example, such that the spoke 5728 comprises the polymer tube 5728. The polymeric tube may, for example, enhance anti-thrombosis, improve deployment and/or recoating forces (e.g., increase lubricity against the outer sheath 5706). In some examples, the wire 5726 may be shaped prior to attaching the polymer tube 5758. In some examples, the wire 5726 may be shaped prior to terminating the wire 5726 t.

Fig. 57G and 57H further illustrate polymer tubes 5759 surrounding wires 5726c extending from electrode assemblies 5730 (four polymer tubes 5759 surrounding four wires 5726c extending from four electrode assemblies, as shown). Conductor wire 5737 (fig. 57L and 57M) extends radially inward of polymer tube 5759. The polymer tube 5759 may comprise PTFE, for example. Portions of the wire 5726c proximate the polymer tube 5759 and the proximal tube 5758 may be exposed, such as for welding or brazing, to the inner band 5754.

Fig. 57I is a cross-sectional view of the example hub system of fig. 57E taken laterally of the inner band 5754 of the hub system 5750. Fig. 57I shows that the wire 5726 can be sandwiched between the inner band 5754 and the proximal portion of the adapter 5756 without the radial projections 5755. In some examples, the wire 5726 is welded to the inner band 5754. In some examples, the inner band 5754, the wire 5726, and the adapter 5756 form a friction fit.

Fig. 57J is an exploded proximal and side perspective view of the example hub system of fig. 57E. The proximal end of the wire 5726 is also shown for reference. The inner diameter of the outer band 5752 is greater than the outer diameter of the adapter 5756 (e.g., including the radial projections 5755). The outer diameter of the inner band 5754 is greater than the combination of the outer diameter of the portion of the adapter 5756 that does not have the radial projections 5755 and the diameter of the two wires 5726. The diameter of the radial protrusion 5755 can be greater than the combination of the outer diameter of the portion of the adapter 5756 without the radial protrusion 5755 and the diameter of the two wires 5726 (e.g., allowing the radial protrusion 5755 to extend radially outward of the wires 5726). The length of the outer band 5752 may be greater than the length of the adapter 5756. The length of the inner band 5754 may be less than the length of the portion of the adapter 5756 without the radial projections 5755. Other hubs are possible (e.g., without one or more of the outer band 5752, inner band 5754, and/or adapter 5756, or with a different structure altogether), or the hub may be omitted altogether (e.g., adhering the wire directly to the shaft 5703).

Fig. 57K is a top plan view of an example electrode assembly 5730 of the example expandable structure 5720. Fig. 57L is a partially transparent distal end and top perspective view of an example electrode assembly 5730. The expandable structure 5720 includes four electrode assemblies 5730, each including four electrodes 5736. Other numbers of electrode assemblies 5730 and other numbers of electrodes 5736 are possible. Some electrode assemblies 5730 may include fewer electrodes 5736 than other electrode assemblies 5730. Some of the electrode assemblies may be different from electrode assembly 5730.

The electrode assembly 5730 includes a wave-like shape or a dog-bone shape or a landscape shape. Referring again to fig. 57B, the electrode assemblies 5730 are longitudinally offset such that when the expandable structure 5720 is in a collapsed state, electrode portions of one electrode assembly 5730 can nest in laterally inward recessed or valley regions of another electrode assembly 5730 (e.g., a circumferentially adjacent electrode assembly 5730), which can provide a smaller transmission profile for the catheter system 5700. The wider portion may have a width of between about 1mm to about 5mm (e.g., about 1mm, about 2mm, 2.5mm, about 3mm, about 4mm, about 5mm, ranges between these values, etc.). The narrower portion may have a width of between about 0.25mm to about 1.5mm (e.g., about 0.25mm, about 0.5mm, about 0.75mm, about 1mm, about 1.25mm, about 1.5mm, ranges between these values, etc.). In some examples, the ratio of the wider portion to the narrower portion is between about 3: 1 to about 7: 1 (e.g., about 3: 1, about 4: 1, about 5: 1, about 6: 1, ranges between these values, etc.).

Referring again to fig. 57L, the electrode assembly 5730 includes a first insulating layer 5731, a second insulating layer 5733, a plurality of electrodes 5736, and a plurality of conductors 5737. Each conductor 5737 is electrically connected to one electrode 5736. Fig. 57M is a cross-sectional view of the example electrode assembly 5730 taken along line 57M-57M of fig. 57L. Fig. 57M shows conductor 5737 rotated radially outward to connect to electrode 5736. Other attachment mechanisms are also possible. For example, the conductor 5737 may not rotate in the connection portion. The first and/or second insulating layers 5731, 5733 can comprise, for example, polyurethane, epoxy, acrylic adhesive, parylene, combinations thereof, and the like.

The relative thicknesses of the first and second insulating layers 5731 and 5733 can be complementary to provide the thickness of the electrode assembly 5730. In some examples where the second insulating layer 5733 is relatively thin, the first insulating layer 5731 can be relatively thick. In some such examples, second insulating layer 5733 can provide a hole for electrode 5736, while first insulating layer 5731 provides features for mounting electrode 5736, a channel for conductor 5737, features for coupling to a wire 5726 or strut, and the like (e.g., as described with respect to electrode assembly 5730).

In some examples, where the second insulating layer 5733 is relatively thick, the first insulating layer 5731 can be relatively thin. In some such examples, the second insulating layer 5733 can provide holes for the electrodes 5736 and features for mounting the electrodes 5736, while the first insulating layer 5731 provides channels for conductors 5737, features for coupling to wires 5726 or struts, and the like.

Second insulating layer 5733 can be different in stiffness from first insulating layer 5731, which can change flexibility to help keep electrode 5736 aligned with the longitudinal axis. The use of a softer durometer for second insulating layer 5733 is less traumatic to tissue in contact with second insulating layer 5733 and/or electrode 5736. Using a harder durometer for the first insulating layer 5731 may provide more consistent manufacturing, such as laser ablation to form the channels 5734. The use of a harder durometer for first insulating layer 5731 may provide stiffness to evenly distribute radial forces across electrode 5736 along electrode assembly 5730.

FIG. 57N is a partially cut-away proximal end and top perspective view of an example electrode assembly 5730. In fig. 57N, the second insulating layer 5733 and the three electrodes 5736 have been removed, leaving the most distal electrode 5736 for illustration purposes. The electrodes 5736 in fig. 57K and 57N are substantially planar, while the electrodes 5736 in fig. 57L and 57M are dome-shaped, as described in additional detail herein, e.g., with respect to fig. 58A-58 Hiii.

Referring additionally to fig. 57M, the first insulating layer 5731 includes channels 5734. The bottom and sidewalls of the first insulating layer 5731 form a U-shaped channel 5734. The channels 5734 may extend along a length of the first insulating layer 5731 (e.g., as shown in fig. 57N). Channels 5734 may terminate proximate to the distal end of the most distal electrode 5736 (e.g., the distal end of electrode 5736, the distal end of the connection point of electrode 5736 and conductor 5737, etc.). Conductor 5737 is located in channel 5734. The depth of channel 5734 may be between about 0.1mm to about 1mm (e.g., about 0.1mm, about 0.2mm, about 0.3mm, about 0.4mm, about 0.5mm, about 0.751 mm, about 1mm, ranges between these values, etc.). The width of channel 5734 may be between about 0.25mm to about 1.5mm (e.g., about 0.25mm, about 0.5mm, about 0.75mm, about 1mm, about 1.25mm, about 1.5mm, ranges between these values, etc.).

Fig. 57O is a bottom perspective view of an exemplary electrode assembly 5730. A pair of wires 5726t, 5726c are also located in the channel 5734. Wires 5726t, 5726c extend from the radially inner side of bottom or first insulating layer 5731 into channel 5734 via holes 5739. In some examples, the wires 5726t, 5726c can extend into the channel 5734 via holes in the sides of the first insulating layer 5731. As described herein, the wires 5726t terminate in the electrode assembly 5730, and the wires 5726t continue to become spokes 5728. The ends of the wire 5726t and a portion of the wire 5726c are covered with a polymer tube 5758. Conductors 5737 and wires 5726c extend into polymer tube 5759 (e.g., near channels 5734). The electrode assembly 5730 is coupled to a straight portion of the wire 5726. Electrode assembly 5730 may include an adhesive or other material at the proximal and distal ends of channel 5734 to seal channel 5734. Conductors 5737 are preferably individually insulated. In some examples, conductor 5737 may be a bare wire.

Referring again to fig. 57M and 57N, the first insulating layer 5731 further includes a plurality of recesses 5735 configured to receive the electrodes 5736. Recess 5735 allows electrode assembly 5730 to have a low profile. The electrodes 5736 can also help retain the conductors 5737 and the wires 5726t, 5726c in the channels 5734. The depth of recess 5735 can be between about 0.1mm to about 1mm (e.g., about 0.1mm, about 0.2mm, about 0.3mm, about 0.4mm, about 0.5mm, about 0.75mm, about 1mm, ranges between these values, etc.). The thickness of first insulating layer 5731 around recess 5735 can be between about 0.5mm to about 1.5mm (e.g., about 0.5mm, about 0.75mm, about 1mm, about 1.25mm, about 1.5mm, ranges between these values, etc.).

Second insulating layer 5733 is located above or radially outward of electrode 5736. Second insulating layer 5733 may optionally laterally overlap a portion of electrode 5736 such that a portion of the outer surface of electrode 5736 is covered. The overlap may inhibit or reduce damage to the edges of electrode 5736. A damaged electrode 5736 may produce a higher current density, so overlap can inhibit or reduce the higher current density. The exposed portions of the surface of electrodes 5736 provide stimulation as described herein, and covering the surface of electrodes 5736 with second insulating layer 5733 (which has easier manufacturing tolerances) can reduce the expense associated with tight manufacturing tolerances of electrodes 5736. The overlap can help seal the electrode assembly 5730.

57K, 57N, and 57O illustrate electrode assembly 5730, with electrode assembly 5730 including an optional distal tab 5738d and an optional proximal tab 5738 p. Tabs 5738d, 5738p can provide additional interaction between the electrode assembly 5730 and the wire 5726 with little additional material or volume, which can be important in a transmission state. In some examples, tabs 5738d, 5738p are as thick as the bottom of first insulating layer 5731 (e.g., between about 0.025mm to about 0.15mm (e.g., about 0.025mm, about 0.05mm, about 0.075mm, about 0.1mm, about 0.125mm, about 0.15mm, ranges between these values, etc.)). Referring again to fig. 57B, the distal section of the electrode assembly 5730 (e.g., the distal tab and one or both electrodes 5736 distal to the aperture 5739) is radially outward of the litz wire 5726. In some examples, the distal segments are cantilevered as compared to the proximal segments proximate the holes 5739 (which proximal segments include more rigid portions of the wires 5726t, 5726 c). The radial expansion force of the wires 5726 is configured to hold the electrode 5736 against the vessel wall. In some examples, the radial force may be between about 10 grams to about 200 grams (e.g., about 10 grams, about 15 grams, about 20 grams, about 50 grams, about 100 grams, about 150 grams, about 200 grams, ranges between these values, etc.) when tested against the entire structure. The radial force at certain points along the structure may vary (e.g., a strut including an electrode may have a higher flexural modulus than a strut without an electrode).

In some examples, at least a portion of the electrode assembly 5730 (e.g., the distal tabs 5738d) can be under the crossing strands. Positioning at least a portion of electrode assembly 5730 (e.g., distal tabs 5738d) under the crossing strands can aid in alignment with electrode assembly 5730. Positioning at least a portion of electrode assembly 5730 (e.g., distal tabs 5738d) under the crossing strands can reduce movement of cantilevered portions of electrode assembly 5730.

Fig. 58A is a top and side perspective view of an example electrode 5736 of an example electrode assembly 5730. Fig. 58B is a top plan view of an example electrode 5736. Fig. 58C is a side view of an example electrode 5736. Fig. 58D is a cross-sectional view of the example electrode 5736 taken along line 58D-58D of fig. 58B. The upper surface 5802 of electrode 5736 is substantially flat or planar. The electrodes 5736 include a first tab 5804 and a second tab 5806. The second tab 5806 includes an aperture 5807. First tab 5804 may be configured to couple conductor 5737 to electrode 5736, for example. The second tab 5806 can be configured, for example, to help interlock the electrode 5736 with the first and/or second insulating layers 5731, 5733. In some examples, one or both of the tabs may be thinner and/or may be offset than other portions of the electrode 5736. Fig. 58Ci shows an example of an electrode 5736o in which electrode 5736o a first tab 5804o is thinned and offset towards a bottom side of electrode 5736o where electrode 5736o is configured to interact with a conductor 5737, and in which a second tab 5806o is thinned and offset towards an upper side of electrode 5736o where electrode 5736o is configured to interact with a second insulating layer 5733.

Fig. 58E is a cross-sectional view of another example electrode 5810 of the example electrode assembly of fig. 57K. Electrode 5810 includes the same features as electrode 5736 of fig. 58A, except that upper surface 5802 is rounded or domed.

Fig. 58Fi through 58Fiv are side views of other example electrodes 5812, 5814, 5816, 5818, respectively, of the example electrode assembly 5730. The electrodes 5812, 5814, 5816, 5818 increasingly dome-shaped. For example, the electrode can have a dome that protrudes about 0.025mm to about 0.5mm above the main portion (e.g., about 0.025mm, about 0.05mm, about 0.075mm, about 0.1mm, about 0.15mm, about 0.2mm, about 0.25mm, about 0.3mm, about 0.4mm, about 0.5mm, ranges between these values, etc.).

The dome-shaped electrode may give a slight tent or push it into the vessel wall, which can increase the likelihood of good vessel wall contact. Contact with the vessel wall can reduce the distance to the target nerve. During fluoroscopy, the dome may be seen protruding, which can be used to verify tissue contact. Impedance measurements may also or alternatively be used. The dome-shaped electrode may reduce the likelihood of blood flowing around the electrode (e.g., by sticking to the vessel wall), which may result in current loss. The absence of current loss may reduce potential losses due to corrosion (e.g., electrode materials such as Pt/Ir). In some examples, a dome electrode that is at least partially free from contact with the vessel wall may create a larger effective surface area by exposing the circumference to the surrounding electrolyte (blood), thereby creating a virtual electrode around the physical electrode. Dome-shaped electrodes can provide increased surface area compared to flat electrodes while still having the same footprint. The dome-shaped electrode may have reduced edge effects compared to a flat electrode.

A flat electrode may be easier and/or less expensive to manufacture than a dome-shaped electrode. The flat electrodes are less likely to be damaged during deployment and/or recapture of the electrode assembly. A flat electrode is less likely to erase or remove the outer sheath layer, which may damage the outer sheath and/or adversely affect electrode performance (e.g., because the electrode may contain some insulating and/or conductive material from the erased outer sheath layer).

Fig. 58G is a top and side perspective view of an example electrode subassembly 5830 of an example electrode assembly 5730. The electrode subassembly 5830 includes electrodes 5812 and insulators 5820. Fig. 58Hi through 58Hiii are lateral cross-sectional views of other example electrode subassemblies 5830, 5832, 5834, respectively, of the example electrode assembly 5730. The cross-section of electrode subassembly 5830 is taken along line 58Hi-58Hi of fig. 58G. The upper surface 5802 of electrode 5812 protrudes or rises above the upper surface of insulator 5820. In fig. 58Hii, the upper surface 5802 of electrode 5814 is the same height as the upper surface of insulator 5822. The electrode 5814 is more dome-shaped compared to the electrode 5812 of fig. 58Hi, but the insulator 5822 is thicker than the electrode 5820 of fig. 58 Hi. In fig. 58Hiii, the upper surface 5802 of electrode 5816 protrudes or protrudes above the upper surface of insulator 5824. Electrode 5816 is more dome-shaped than electrode 5814 of fig. 58Hii, but insulator 5822 is as thick as insulator 5822 of fig. 58 Hii. Recessed electrodes can produce more uniform charge injection across the electrode surface. In some examples, a recessed electrode can produce a virtually ideal, uniform field across the electrode surface. The recessed electrode can reduce edge effects. For example, areas of high current density at the edges of the holes may not be as extreme as in non-recessed electrodes. Recessed electrodes may produce safer stimulation than non-recessed electrodes.

Electrodes that stand out above the surface of the insulating material (e.g., as in electrode subassembly 5830) can provide at least some of the advantages discussed herein with respect to dome-shaped electrodes and/or other advantages. Electrodes recessed into the insulating layer (e.g., electrodes as in electrode subassembly 5832) can be more directional, provide more uniform current density, undergo more consistent corrosion, and/or help reduce wear (e.g., wear of outer jacket 5706, which may negatively impact electrode performance). Electrodes recessed into and raised above the conductive material (e.g., as in electrode subassembly 5834) can provide some of the advantages associated with electrodes raised above the surface of the insulating layer as well as some of the advantages associated with electrodes recessed into the insulating layer.

The cross-section of the electrode 5810 of fig. 58E shows that the electrode 5810 is hollow. In contrast, the cross-sections of the electrodes 5812, 5814, 5816 of the electrode subassemblies 5830, 5832, 5834, respectively, are solid. The hollow electrode 5810 may be more easily manufactured, for example, by stamping a flat metal sheet. The dome-shaped electrode may provide a larger surface area and may more evenly distribute the current applied to the electrode. In some examples, the conductor wire may be coupled inside the dome portion, which may simplify manufacturing. In some examples, the electrodes may include vertically offset tabs to weld the conductor wires (e.g., similar to tabs 2804, 5806o shown in fig. 58 Ci). Coupling the conductor wire at the tab can help move the connection point away from the active portion of the electrode, which may contain a different material that is susceptible to corrosion.

Fig. 59A is a side view of a portion of an example inner member 5708 of an example catheter system 5700. The distal end of inner member 5708 is coupled to outer band 5752 of hub system 5750. In other examples, the distal end of the inner member 5708 can also or additionally be coupled to one or more other portions of the hub system 5750, directly to the expandable structure 5720, or can be movable relative to the expandable structure 5720.

Fig. 59B is a perspective view of a portion of an example inner member 5708. Fig. 59C is a perspective view of another portion of the example inner member 5708. The inner member 5708 includes a first port 5910 and a second port 5912. A pressure sensor, such as the example pressure sensor 5420 of fig. 45B, may be in fluid communication with one or both of the ports 5910, 5912.

As shown in FIG. 59C, the first port 5910 is circumferentially spaced apart from the second port 5912 by a distance 5916. If the inner member 5708 is pressed against the vessel wall of one of the occlusion ports 5910, 5912, the other of the ports 5910, 5912 is likely not to be occluded. In some examples, the first and second ports 5910, 5912 may at least partially circumferentially overlap. In some examples, the first and second ports 5910, 5912 may be generally circumferentially aligned. For example, the inner member 5708 may twist and/or rotate such that if the inner member 5708 is pressed against the wall of a blood vessel occluding one of the ports 5910, 5912, the other port 5910, 5912 is likely not to be occluded.

In some examples, a pressure sensor in fluid communication with one or both of the ports 5910, 5912 is configured to sense movement of the catheter system 5700, e.g., as described herein with respect to fig. 54A and 54C, 54Di and 54Dii and/or 54E. The ports 5910, 5912 may be covered by the outer sheath 5706, e.g., during navigation, and uncovered when deploying the expandable structure 5720.

The inner member 5708 may include a radiopaque marker 5902 proximate the first port 5910. The inner member 5708 may include a radiopaque marker 5904 proximate the second port 5912. Radiopaque markers 5902, 5904 may provide the user with an approximate longitudinal position of ports 5910, 5912, respectively. The radiopaque markers 5902, 5904 may include arcuate bands. In some examples, the radiopaque markers 5902, 5904 may include rotational markers (e.g., gaps in an arcuate band circumferentially associated with the ports 5910, 5912).

Fig. 60A is a perspective view of a portion of a distal portion of an example catheter system 6700. The distal portion includes a shaft 5703 and a nose cone 6002. The nose cone 6002 can include a lumen 6004, e.g., a guidewire lumen, which allows the system 6700 to be tracked over a guidewire, e.g., as described with respect to fig. 26E. The nose cone 6002 may be atraumatic. The nose cone 6002 may substantially seal the system 6700 during advancement. In some examples in which the shaft 5703 is movable relative to the expandable structure 6720, the nose cone 6002 can be retracted proximally after the expandable structure 6720 is deployed.

As generally shown in fig. 60A, when the expandable structure 5720 is in an expanded state, the nose cone 6002 can move distally of the expandable structure 5720. For example, the nose cone 6002, which may have a diameter of about 5mm, may occlude the right pulmonary artery, gradually decreasing to less than 5mm as the nose cone 6002 travels downstream in the right pulmonary artery.

Fig. 60Bi is a distal and side perspective view of another example of nose 6052. Fig. 60Bii is a distal end view of nose 6052. Like nose cone 6002, nose 6052 is coupled to the distal end of shaft 5703 or other internal element and includes a lumen 6054 (e.g., for tracking over a guidewire). The nose 6052 may be coupled to the shaft 5703, for example, by overmolding, adhesive, and/or other suitable methods. Nose 6052 includes a proximal segment 6062 and a distal segment 6064. Nose 6052 may include radiopaque markers. In some implementations, nose 6052 includes a polymer with a radiopaque antireflective agent (radiopacifier).

The distal segment 6064 includes a plurality of projections 6066 that at least partially define a plurality of channels 6067. The thickness of the protrusion 6066 is sufficient to form a channel 6067 even when the nose 6052 is proximate to a vessel wall. For example, if the widest diameter of nose 6052 is 5mm, protrusion 6066 may be at least about 0.5mm, at least about 1mm, or at least about 1.5 mm. For another example, the protrusion 6066 may be at least about 10% mm, at least about 15%, at least about 20%, or at least about 25% of the widest diameter of the nose 6052. Even when nose 6052 can circumferentially abut a blood vessel, passage 6067 provides blood flow through nose 6052. That is, even if nose 6052 fits tightly in a small blood vessel, fluid may flow through passage 6067 and thus through the small blood vessel to provide downstream perfusion. Nose 6052 includes four protrusions 6066 and four channels 6067, but other numbers of protrusions 6066 and/or channels 6067 are possible. For example, nose 6052 can include between one protrusion and eight protrusions (e.g., 1 protrusion, 2 protrusions, 3 protrusions, 4 protrusions, 5 protrusions, 6 protrusions, 7 protrusions, 8 protrusions, a range between these values, etc.). More than eight projections may be used. There may also be a single protrusion 6066 if at least one channel 6067 is formed thereby.

The projections 6066 may be evenly spaced in the circumferential direction (e.g., as shown in fig. 60Bi and 60 Bii). The uniform spacing can, for example, accommodate a variety of blood vessels. The projections 6066 may be unevenly spaced circumferentially (e.g., grouped on one side of the nose 6052). For example, non-uniform spacing can be configured for a particular anatomical structure. The channel 6067 may be wider than the protrusion 6066 (e.g., as shown in fig. 60Bi and 60 Bii). The wide channel 6067 can, for example, provide a larger area for fluid flow. Protrusion 6066 may be wider than channel 6067. Wider protrusions 6066 can, for example, help define channels 6067. The wider the protrusion 6066 relative to the channel 6067, the thinner the protrusion 6066 can be to still provide the channel 6067. The protrusion 6066 may include a wall that is parallel to a radius of the nose 6052 (e.g., as shown in fig. 60 Bii). The wall parallel to the radius may provide the maximum offset and possible creation of the channel 6067 for a given thickness of the protrusion 6066. Protrusion 6066 may comprise a wall that is angled with respect to a radius of nose 6052. The angled wall may, for example, facilitate the formation of a channel 6067 on the radially inner side of the wall.

Fig. 60Biii is a perspective view of an example distal end of a system that includes a nose 6052. Fig. 60Biv is a distal and side perspective view of an example distal end of a system including a nose 6052. The proximal end segment 6062 of the nose 6052 is intended to capture the distal end of the expandable structure 5720, thereby making the overall system better responsive to torque inputs on the outer sheath 5706. Otherwise, if the outer sheath 6706 rotates, the inner component (e.g., the expandable structure 5720) may slip and/or lag in response. The shaft 5703, inner element, etc. to which the nose 6052 is coupled is in a retracted state, e.g., for navigation to a target site. During navigation, the protrusions 6066 continue to protect the distal tip of the outer sheath 5706 from penetrating the myocardium as the system traverses, for example, the atrium and ventricle. Nose 6052 may also be of other designs, including, for example, lumens, holes, spirals, and other elements that provide for fluid flow through nose 6052.

Fig. 61A is a bottom and proximal perspective view of another example electrode assembly 6100 of the example expandable structure 5720. Figure 61B is a bottom and distal perspective view of an example electrode assembly 6100. In contrast to electrode assembly 5730, in which two wires 5726c, 5726t enter channel 5734 through holes 5739 in the sides and/or bottom of first insulating layer 5731, two wires 5726c, 5726t are coupled to clips 6102, 6104. In some examples, the wires 5726c, 5726t may be welded or otherwise coupled to the clips 6102, 6104 in a manner that inhibits or prevents longitudinal movement. The clips 6102, 6104 may be the same or different. For example, as best shown in fig. 61B, the clip 6102 may be configured to accommodate one wire 5726c, and the clip 6104 may be configured to accommodate two wires 5726c, 526 t. The clips 6102, 6104 may extend at least partially into the channel 5734 (e.g., as shown in fig. 61A), or may be inside and/or to the side of the channel 5734.

The electrode assembly 6100 can reduce the depth of the channel 5734, for example, because the wires 5726c, 5726t do not extend through the channel 5734. Electrode assembly 6100 can increase the overall thickness of expandable structure 5720, for example, by the difference between the thickness of wires 5726c, 5726t and the thickness of conductor 5737. Electrode assembly 6100 is easier to assemble than electrode assembly 5730, for example, because wires 5726c, 5726t can be snapped into place rather than threaded into channel 5734.

To measure the ECG, a nurse, caregiver or other practitioner may place a plurality of adhesive electrode pads on the subject. In some examples, four, six, ten, or twelve electrode pads are used. Other numbers of leads or pads are also possible. For example, in a 12-lead system, one electrode pad can be placed on each limb (right arm anywhere between the right shoulder and right elbow, right leg anywhere between the right torso and right ankle, left arm anywhere between the left shoulder and left elbow, and left leg anywhere between the left torso and left ankle), the first electrode pad is placed on the fourth intercostal space of the right sternum, the second electrode pad is placed on the fourth intercostal space of the left sternum, the third electrode pad is placed at the fifth intercostal space of the mid-clavicular line, the fourth electrode pad is placed in the middle between the second and third electrode pads, the fifth electrode pad is placed on the same horizontal line as the third electrode pad on the anterior axillary line, and the sixth electrode pad is placed on the same horizontal line as the third and fifth electrode pads on the medial axillary line. Each electrode pad may function as a positive electrode, a negative electrode, and/or a ground electrode to be used in combination with other electrodes of other electrode pads. The lead may be snapped onto or otherwise coupled to the electrode pad. In some examples, the leads may be integrated with the electrode pads. The ECG electrode pads and ECG leads can be color coded, labeled, and/or include other indicia configured to reduce errors in placement and connection. For example, the first electrode pad may be red and include the designation "V1" to be connected to the red lead designated "V1", the second electrode pad may be yellow and include the designation "V2" to be connected to the yellow lead designated "V2", and so on. The other end of the ECG lead may be connected to an ECG system.

Referring again to fig. 47I, the ends of the ECG leads 4730 can be coupled to electrode pads on the subject, and the other ends of the ECG leads 4730 can be directly connected to the ECG system 4704 for normal ECG operation (e.g., without interacting with the filter assembly 4732). To include the filter assembly 4732, an end of the ECG lead 4730 can be coupled to an electrode pad on the subject, and another end of the ECG lead 4730 can be connected to the filter assembly 4732, which filter assembly 4732 can be connected to the ECG system 4704. The filter component 4732 may be confusing to some users, and thus the use of the same or similar color coding and/or other markings may facilitate accurate use of the filter component 4732.

Fig. 61Ci is a top, lateral, and proximal perspective view of another example electrode assembly 6110. Fig. 61Cii is a rear, lateral, and proximal perspective view of an example electrode assembly 6110. Electrode assembly 6110 may have the same features as other electrode assemblies described herein (e.g., electrode assemblies 5730, 6100), and may have some different, additional, and/or fewer features. For example, the electrode assembly 6110 includes a lower insulator 6111, an upper insulator 6113, and an electrode 6116.

Like the lower insulator 5731, the lower insulator 6111 includes a channel. The upper insulator 6113 also includes a channel. The passageways of the lower insulator 6111 and the upper insulator 6113 together form an inner cavity 6114. The electrical conductors can be coupled to the respective electrodes 6116 and positioned in the lumen 6114. Lumen 6114 may have an open proximal end (e.g., as shown in fig. 61Ci and 61 Cii) and a closed distal end. Such a configuration may simplify manufacturing, for example, by sealing one end only after coupling of the conductive wires, attachment to the expandable structure, and the like. Lumen 6114 may have an open proximal end (e.g., as shown in fig. 61Ci and 61 Cii) and an open distal end. Such a configuration can simplify manufacturing, for example, by allowing the lower insulator 6111 and the upper insulator to be used in either longitudinal direction.

In some implementations, the electrode assembly 6110 includes a distal tab (e.g., the same as distal tab 5738 d). The distal tabs can help inhibit or prevent the distal end of the electrode assembly 6110 from protruding through the open cell area of the expandable structure. In some implementations, the length of the distal tab is at least about 10% greater, at least about 25% greater, at least about 50% greater, at least about 75% greater, at least about 100% greater, or even greater than the longitudinal length of the cell in the fully expanded position. The distal tab should not protrude distally beyond the expandable structure. The distal tab may protrude less than about five, less than about four, less than about three, less than about two, etc., unit lengths, and greater than one unit length. The electrode assembly 6110 and/or one or more portions of the electrode assembly 6110 can be annealed in an upward or outward bend. Such annealing can bias the distal tabs away from the expandable structure, thereby reducing the risk of the electrode assembly 6110 protruding through the expandable structure.

Fig. 61Ciii is a bottom plan view of the example upper insulator 6113 and the example electrode 6116 of the example electrode assembly 6110. In some implementations, the upper insulator 6113 can omit the channel 6115 and/or recess 6117, e.g., along the line discussed with respect to the upper insulator 5733, leaving a hole for the upper surface of the electrode 6116. In certain such implementations, the lower insulator 6111 can include the inner cavity 6114 and/or the recess 6117. If the upper insulator 6113 is too thin, manufacturing can become difficult, for example, because tearing can occur at thin points (e.g., near the electrode aperture). In some embodiments, the upper insulator has a thickness of between about 0.006 inches (receiving 0.15mm) and about 0.012 inches (about 0.3mm) (e.g., about 0.006 inches (approximately 0.15mm), about 0.007 inches (approximately 0.18mm), about 0.008 inches (about 0.2mm), about 0.009 inches (approximately 0.23mm), about 0.01 inches (approximately 0.25mm), about 0.011 inches (approximately 0.28mm), about 0.012 inches (approximately 0.3mm), ranges between these values, etc.). Different materials may have different manufacturable thickness ranges. As discussed above, the upper insulator 6113 includes a channel 6115 that at least partially defines the inner lumen 6114. The upper insulator 6113 includes a recess 6117 configured to receive the electrode 6116. The upper insulator 6113 including some features and the lower insulator 6111 including some features can increase the thickness of the upper insulator 6113, thereby reducing the risk of tearing or other defects during manufacturing.

Fig. 61Civ is a side view of a plurality of example electrode assemblies 6100 coupled to an expandable structure 5720. Fig. 61Cii shows that the lower insulator 6111 includes a first hole 6112p and a second hole 6112 d. The second aperture 6112d is distal to the first aperture 6112 p. When the electrode assembly 6110 is coupled to an expandable structure (e.g., expandable structure 5720), a filament of the expandable structure (e.g., wires 5726c, 5726t) can enter the lumen 6114 through one of the apertures 6112p, 6112 d. The filament can extend proximally and exit the lumen 6114 with the conductor.

Fig. 61Cv is a bottom plan view of a plurality of example electrode assemblies 6110 in an example alignment for coupling to an expandable structure. The first apertures 6112p of the electrode assemblies 6110a and 6110c are longitudinally aligned with the second apertures 6112d of the electrode assemblies 6110b and 6110 d. The apertures 6112p, 6112d are configured (e.g., sized, positioned) such that the electrode assemblies 6110a-6110d can nest when the expandable structure is in the collapsed state. Nesting or staggering or offsetting electrode assemblies 6110 can provide for more tightly packed electrode assemblies 6110 in a smaller space. The nested or staggered or offset electrode assembly 6110 can reduce the delivery diameter to navigate through small vessels and/or around tortuous bends. FIG. 61Civ shows the electrode assembly 6110 remaining in a staggered longitudinal position when the expandable structure is in an expanded state.

Fig. 61Di is a top view of an example electrode 6116. The electrode 6116 has an oblong shape comprising two semicircles 6120, the two semicircles 6120 connected by a parallel line tangent to the end points of the semicircles 6120, forming a rectangular cross-section 6122. The oblong shape may be referred to as a rectangular disc (discordant rectangular) or a sausage shape. The oblong shape can provide a greater surface area than the circular shape when an electrode that is not wide is desired (e.g., to reduce circumferential thickness, such as for compression in a catheter). The oblong shape can provide the same or similar current density as a circular electrode. In some implementations, the length of the rectangular portion 6122 is the same as the diameter of the semi-circular portion 6120, making the rectangular portion 6122 square. In some implementations, the length of the rectangular portion 6122 is less than the diameter of the semi-circular portion 6120, such that the rectangular portion 6122 is rectangular with a length less than a width. In some implementations, the length of the rectangular portion 6122 is greater than the diameter of the semi-circular portion 6120, such that the rectangular portion 6122 is rectangular with a length greater than a width. The ratio of the length of the rectangular portion 6122 to the diameter of the semi-circular portion 6120 can be between about 1: 3 to about 3: 1 (e.g., about 1: 3, about 1: 2, about 1: 1.5, about 1: 1.25, about 1: 1, about 1.25: 1, about 1.5: 1, about 2: 1, about 3: 1, ranges between these values, etc.). Factors that affect this ratio can include, for example, a desired surface area, a desired electrode width, spacing between electrodes, spacing between electrode assemblies, and the like. In some implementations, the surface area of the electrode 6116 is the same as a circular electrode having a diameter between about 0.5mm to about 3mm (e.g., about 0.5mm, about 1mm, about 1.5mm, about 2mm, about 2.5mm, about 3mm, ranges between these values, etc.). The electrode 6116 also includes proximal and distal tabs 6124. Other shapes that can provide the same or similar thinner electrodes and current densities as circular electrodes are also possible. For example, fig. 61Dii is a top plan view of another example electrode 6126 having an oval or elliptical shape 6128. The electrode 6126 also includes proximal and distal tabs 6124.

As shown and described with respect to fig. 58Ci, the tab 6124 can be integral with but thinner than the body of the electrodes 6116, 6126. For example, the thickness of the tab 6124 can be between about 1/4 and about 3/4 (e.g., about 1/4, about 1/3, about 1/2, about 2/3, about 3/4, ranges between these values, etc.) of the thickness of the body of the electrode 6116, 6126. Although fig. 58Ci shows the first tab 5804o and the second tab 5806o extending from opposing upper and lower surfaces, the tabs 6124 can each extend from the lower surface. Offsetting the tab 6124 toward the lower surface of the electrodes 6116, 6126 can reduce the electrical effect that the engagement region can have on the electrodes 6116, 6126 during operation. In some implementations, the conductor wire is coupled (e.g., welded, soldered, etc.) to the distal tab 6124 (e.g., the bottom surface of the distal tab 6124) and the conductor extends along the length of the electrode near the connection point. Such connectors are less prone to damage during manufacture. Coupling the conductor to the bottom surface of the tab 6124 can also or additionally reduce the electrical effect that the engagement region can have on the electrodes 6116, 6126 during operation. Tabs 6124 that are not used for coupling to conductors can help sandwich the electrodes 6116, 6126 between the upper and lower insulators. The features of the oblong electrode 6116 and/or the oval electrode 6126 can also be the same as the other electrodes described herein, or vice versa, including but not limited to having a hole in the tab, being domed, being part of an electrode subassembly, etc.

Fig. 61Ei is a top, lateral, and proximal perspective view of another example electrode assembly 6130. Fig. 61Eii is a rear, lateral, and distal perspective view of an example electrode assembly 6130. Fig. 61 ehi is a top, lateral, distal perspective exploded view of an example electrode assembly 6130. Fig. 61Eiv is a top and side longitudinal cross-sectional view of an example upper insulator 6133 of an electrode assembly 6130. Fig. 61Ev is an enlarged plan view and a lateral longitudinal sectional view of the example upper insulator 6133. Fig. 61Evi is a top and side longitudinal sectional view of an example lower insulator 6131 of an electrode assembly 6130. Fig. 61eviii is a top and distal longitudinal sectional view of the electrode assembly 6130. Fig. 61Eviii is an expanded top and bottom longitudinal sectional view of the electrode assembly 6130. Electrode assembly 6130 may share features with other electrode assemblies described herein (e.g., electrode assemblies 5730, 6100, 6110) and may have some different, additional, and/or fewer features.

The lower insulator 6131 includes a tube 6134. The tube 6134 may have a circular cross-section (e.g., as shown in fig. 61Ei, 61Eii, 61Eviii, and 61 Eviii). Other shapes are also possible. For example, the tube may be oval or oblong. The tube 6134 can be integral with the lower insulator 6131 (e.g., in a single molding). The integral tube 6134 may provide easier single-piece manufacture, may provide better bonding between components, and the like. The tube 6134 can be formed separate from the lower insulator 6131 and then coupled to the lower insulator 6131 (e.g., by bonding, by a two-shot mold, etc.). The separate tubes 6134 may provide for easier use of different materials, materials with different hardnesses, easier modification of one of the components, etc. Although shown as being relatively short, the tube 6134 may extend to or proximal of a spoke of the expandable structure. The lower insulator can include a tab (e.g., as shown in fig. 61 Ei) extending distally from the tube 6134, e.g., to provide a better transition from the proximal end to the distal end to the wider portion of the electrode assembly 6130.

Similar to the lower insulator 5731, the lower insulator 6131 includes a channel 6139, best seen in fig. 61 efi, 61Evi, 61Eviii, and 61 Eviii. The upper insulator 6133 does not include a channel, but may include a channel if desired. Electrical conductors can be coupled to the respective electrodes 6136 and positioned in the channels 6139. The upper insulator 6133 includes a recess 6141 for an electrode tab. The upper insulator 6133 includes a hole 6143 for exposing the upper surface of the electrode 6136. Thus, the upper insulator 6133 has more features than the upper insulator 5733, but less features than the upper insulator 6113.

The channel 6139 may have a closed distal end (e.g., as shown in fig. 61 eji, 61Evi, and 61 eviii). The channel 6139 may have a closed proximal end in fluid communication with the lumen 6135 of the tube 6134 via an aperture 6137 (e.g., as shown in fig. 61Evii, 61Eviii, and 61 Eviii). The conductor can be connected to the electrode 6136 (e.g., to the bottom of the distal tab, as described herein), extend through the channel 6139, and extend into the lumen 6135 via the aperture 6137. The conductor can then extend beyond the proximal end of the tube 6134. The channel 6139 can be filled, for example, with an adhesive to inhibit or prevent fluid from entering and/or bonding the upper insulator 6133 and the lower insulator 6131. The upper insulator 6133 and the lower insulator 6131 can be reflowed together using, for example, a heated tool, which can enhance and/or further enhance bonding to inhibit or prevent fluid from entering the channel 6139. Fig. 61Eviii shows a conductor 6138 coupled to the proximal electrode 6136, the conductor 6138 extending through the channel 6136, through the aperture 6137 into the lumen 6135, and out the proximal end of the tube 6134. In some implementations, the channel 6139 can have an open proximal end (e.g., like the lumen 6114), and the tube 6134 can include an aperture near the proximal end of the channel 6139 so that the conductor can exit the proximal end of the channel 6139, extend through the aperture in the tube 6134 into the tube 6134, and then extend out of the proximal end of the tube. Such an implementation may be easier to manufacture, particularly for the two-piece lower insulator 6133, but with more final components, such as to occlude the proximal end and bore of the channel 6139.

When the electrode assembly 6130 is coupled to an expandable structure (e.g., expandable structure 5720), filaments of the expandable structure (e.g., wires 5726c, 5726t) can enter the lumen 6135 through the distal end of the lumen 6135. It has been found that sliding the electrode assembly 6130 onto the expandable structure in this manner allows for easier manufacturing than, for example, side holes, bottom holes, and the like. When the wires 5726c, 5726t are coupled and the wire 5726t is severed, for example as described herein, the coupled portions of the wires 5726c, 5726t and the proximal end of the wire 5726t can be positioned in the tube 6134. If the coupling fails, the tube 6134 can provide a layer of safety such that the wire 5726t will have difficulty exiting the tube 6134 and damaging the vasculature of the subject.

Fig. 61Eix is a proximal perspective view of a plurality of example electrode assemblies 6130 coupled to an example expandable structure 5720. For example, as described herein, other expandable structures may also be coupled. Sliding the electrode assembly 6130 over the proximal end of the filament or strut can allow the electrode array to have various dimensional shapes (e.g., in orthogonal views) or configurations, such as rectangular, parallelogram (e.g., as shown in fig. 61 Eix), staggered (e.g., as shown in fig. 57B and 61 Cv), while using the same or substantially the same electrode assembly 6130 for each electrode assembly 6130 of the electrode array. In the parallelogram arrangement, the distal end of the lumen 6135 is positioned at a more distal end for each circumferentially adjacent electrode assembly 6130. In some implementations, the filament 5726t can be severed at a location where the proximal end of the filament 5726t is located in the tube 6134 of the respective electrode assembly 6130. In some implementations, the length of the tube 6134 proximal to the upper insulator 6133 can be longer for an electrode assembly 6130 positioned more distally on the expandable structure 5720. A parallelogram may be easier to capture than an electrode array having a different shape. For example, in a rectangular electrode array, the most proximally disposed electrode assembly may cinch when recaptured in the outer sheath. Staggering the electrode assemblies in a parallelogram may allow more movement of each electrode assembly to find a lower energy state during recapture. The shape or arrangement of the parallelogram may be considered based on the precise spacing between similar or identical components (e.g., the proximal end of each electrode assembly (e.g., no proximal end tabs, the most proximal electrode)) is distal to the proximal end of a circumferentially adjacent electrode assembly, and wherein the distal end of each electrode assembly (e.g., no distal end tabs, the most distal electrode) is distal to the distal end of a circumferentially adjacent electrode assembly). The shape or arrangement of the parallelogram may be considered based on the overall shape, e.g. a rough outline may be drawn around the electrode array and/or the plurality of electrodes as a whole. The other electrode arrays and expandable structures described herein may also take any suitable shape.

The right pulmonary artery is typically angled from anterior to posterior, which means toward the posterior as it travels to the right side of the subject. The anterior electrodes of the electrode array in the rectangular configuration are deployed in the right pulmonary artery closer to the right side of the subject, which may be further from the target region. Fig. 61Ex shows the expandable structure of fig. 61Eix and a plurality of example electrode assemblies positioned in a blood vessel 6140 (e.g., right pulmonary artery). When an electrode array having a parallelogram configuration is deployed in a vessel, such as the right pulmonary artery, that rotates near a target site, the parallelogram can function and/or appear more vertical to better fill the target region. The electrode array shaped as a parallelogram may include a plurality of electrode assemblies each having a linear electrode array.

The distal-most electrode 5736-1 in the expanded state is also the distal-most electrode in the compressed or collapsed state and in a partially expanded state. The distal-most electrode 5736-1 can be used to longitudinally and/or rotationally align the expandable structure 5720 and/or the electrode assembly 5730. In some examples, distal-most electrode 5736-1 is positioned above in a blood vessel 6140 (e.g., the right pulmonary artery). Distal-most electrode 5736-1 can be used as a radiopaque marker (e.g., in addition to or in place of radiopaque marker 5725). Knowing the location of the distal-most electrode 5736-1 and its 0 orientation with the uppermost electrode assembly 5730-1 can provide the user with information that other electrode assemblies 5730 are in front of the uppermost electrode assembly 5730-1 when the distal-most electrode 5736-1 is in the upper position, which can provide information that all electrode assemblies 5730 are in the target area (e.g., front upper). In some examples, the expandable structure 5720 may be rotated after initial alignment, causing the electrode assembly to rotate. For example, after superior alignment using the distal-most electrode 5736-1, the expandable structure 5720 may be rotated between about 5 ° to about 85 ° (e.g., about 5 °, about 15 °, about 25 °, about 35 °, about 45 °, about 55 °, about 65 °, about 75 °, about 85 °, and ranges between such angles). The rotation may be clockwise or counter-clockwise. This rotation can help provide an improved or optimal position of the electrode assembly 5730 in the target area. In some examples, the distal-most electrode 5736-1 can be longitudinally aligned with a carina, which is the left and right branches of the main bronchus or the left edge of the trachea (e.g., as discussed with respect to fig. 2F). If repositioning of the expandable structure 5720 and/or electrode assembly 5730 is desired, the user can use the distal-most electrode 5736-1 as a reference (e.g., save a phantom fluoroscopic view) and adjust to a second position.

For example, if the blood vessel is undersized relative to the expandable structure and/or the expandable structure is oversized relative to the blood vessel, the proximal splines curve inwardly from the spokes and then outwardly toward the braided portion, as shown, for example, in fig. 61F. The electrode assembly generally follows this curvature such that one of the electrodes 6136-3 can be radially inward of the electrodes 6136-2 and 6136-4 (and electrode 6136-1, not shown). As shown in fig. 61Fii, increasing the thickness and/or stiffness of the bottom insulator can stiffen the bending region and make better wall contact between the electrode 6136-3 and the vessel wall. FIG. 61Fii shows all four electrodes 6136-1, 6136-2, 6136-3, 6136-4 at about the same radial position. Without being bound by any particular theory, it is believed that the stiffer lower insulator of the electrode assembly is less prone to bending and straightening of the wire 5726 c. In some implementations, the hardness is between about 55D to about 63D (e.g., about 55D, about 57D, about 59D, about 61D, about 63D, ranges between these values, etc.). In some implementations, the thickness is between about 0.004 inches (approximately 0.1mm) to about 0.012 inches (approximately 0.3mm) (e.g., about 0.004 inches (approximately 0.1mm), about 0.006 inches (approximately 0.15mm), about 0.008 inches (approximately 0.2mm), about 0.01 inches (approximately 0.25mm), about 0.012 inches (approximately 0.3mm), ranges between these values, etc.).

Fig. 61Gi to 61Giv show schematic side views or sectional views of the upper insulator 6133 and the lower insulator 6131. In fig. 61Gi, both the upper insulator 6133 and the lower insulator 6131 have little or no bevel, which can create sharp corners and/or reduce the ability to package the electrode assembly into a tube (e.g., the outer sheath of a catheter). Depending on the radius of curvature, rounded or filleted edges can be considered as chamfers. In fig. 61Gii, the lower insulator 6131 is chamfered. In some implementations, the upper insulator 6133 is also or alternatively beveled. In fig. 61Giii, both the lower insulator 6131 and the upper insulator 6133 are chamfered. The oblique angles may be the same or different (e.g., at different angles). In fig. 61Giii, both the lower insulator 6131 and the upper insulator 6133 are partially chamfered. The oblique angles may be the same or different (e.g., at different angles, with different starting and ending points, etc.). Combinations of the illustrated bevels are also possible (e.g., the lower insulator 6131 is beveled as in fig. 61Gii, the upper insulator 6133 is beveled as in fig. 61Giv, or vice versa, etc.). The beveled upper and/or lower insulators can reduce loading, increase the amount of fill in the tube and/or reduce damage that may be caused by sharp edges. In some implementations, beveling the insulator still provides at least about 0.01 inch (approximately 0.25mm) of insulating material around all portions of the electrode 6136.

Fig. 62A illustrates an example housing 6200 for the filter assembly 4732. The housing 6200 includes at least ten electrode pads 6202, 6204, 6206, 6208, 6210, 6212, 6214, 6216, 6218, 6220. The electrode pads 6202, 6204, 6206, 6208, 6210, 6212, 6214, 6216, 6218, 6220 are color coded and marked with letter and/or number marks. Electrode pad 6202 is white and labeled "RA" and is configured to connect to the right arm lead. Electrode pad 6204 is green and labeled "RL" and is configured to connect to the right leg lead. The electrode pad 6206 is black and labeled "LA" and is configured to connect to the left arm lead. Electrode pad 6208 is red and labeled "LL" and is configured to connect to a left leg lead. The electrode pad 6210 is red and labeled "V1" and is configured to be connected to a first chest lead. The electrode pad 6212 is yellow and labeled "V2" and is configured to be connected to a second chest lead. The electrode pad 6214 is green and labeled "V3" and is configured to connect to a third chest lead. The electrode pad 6216 is blue and labeled "V4" and is configured to connect to a fourth chest lead. The electrode pad 6218 is brown or orange and is labeled "V5" and is configured to be connected to the fifth chest lead. The electrode pad 6220 is purple and labeled "V6" and is configured to connect to a sixth chest lead. Electrode pads 6202, 6204, 6206, 6208, 6210, 6212, 6214, 6216, 6218, 6220 are in positions that may match or mimic the positions of the electrode pads on the subject such that the user connects the lead to electrode pads 6202, 6204, 6206, 6208, 6210, 6212, 6214, 6216, 6218, 6220 with a similar experience as placing the lead on the subject. The electrode pads 6202, 6204, 6206, 6208 may be located at positions that mimic the positions of the electrode pads at the periphery of the subject. The electrode pads 6210, 6212, 6214, 6216, 6218, 6220 may be in positions that mimic the positions of the electrode pads on the chest of the subject. The housing can include markings 6222, 6224 to indicate where the electrode pads 6202, 6204, 6206, 6208, 6210, 6212, 6214, 6216, 6218, 6220 are to be positioned on the subject. The housing 6200 can provide a user-friendly interface based on a familiar positioning method.

The filter component 4732 can include an input for coupling to an ECG lead 4730 of a subject. For example, the housing 6200 can include integrated leads 6226 (e.g., leads configured to be coupled to electrode pads on a subject at one end and fed directly into the filter assembly 4732 at the other end). For another example, the housing 6200 may include a female connector 6228 configured to connect to an end of a male connector of the ECG lead 4730. For another example, the housing 6200 can include a connector port 6230 configured to connect to a complementary connector coupled to the ECG lead 4730. In some examples, the housing can include one, two, or all three of the connectors 6226, 6228, 6230. Other connectors for the ECG leads 6730 are also possible.

Other color coding is also possible. For example, fig. 62B illustrates another example housing 6250 for the filter assembly 4732. The housing 6250 includes electrode pads 6252, 6254, 6256, 6258, 6260, 6262, 6264, 6266, 6268, 6270. The electrode pads 6252, 6254, 6256, 6258, 6260, 6262, 6264, 6266, 6268, 6270 are color coded and marked with letter and/or number markings. The electrode pad 6252 is red and labeled "R" and is configured to be connected to the right arm lead. The electrode pad 6254 is black and labeled "N" and is configured to connect to the right leg lead. The electrode pad 6256 is yellow and labeled "L" and is configured to be connected to the left arm lead. The electrode pad 6258 is green and labeled "F" and is configured to be connected to the left leg lead. The electrode pad 6260 is red and labeled "C1" and is configured to be connected to a first chest lead. The electrode pad 6262 is yellow and labeled "C2" and is configured to be connected to a second chest lead. The electrode pad 6264 is green and labeled "C3" and is configured to connect to a third chest lead. The electrode pad 6266 is brown or orange and labeled "C4" and is configured to connect to a fourth chest lead. The electrode pad 6268 is black and labeled "C5" and is configured to connect to a fifth chest lead. The electrode pad 6270 is purple and labeled "C6" and is configured to connect to a sixth chest lead. The electrode pads 6252, 6254, 6256, 6258, 6260, 6262, 6264, 6266, 6268, 6270 are in a position that can match or mimic the position of the electrode pads on the subject so that the user's connection of the lead to the electrode pads 6252, 6254, 6256, 6258, 6260, 6262, 6264, 6266, 6268, 6270 has a similar experience as placing a wire on the subject. The housing may include markings 6272, 6274 to indicate where the electrode pads 6252, 6254, 6256, 6258, 6260, 6262, 6264, 6266, 6268, 6270 will be located if on the subject. The housing 6250 can include one or more connectors 6276, 6278, 6280 corresponding to the connectors 6226, 6228, 6230. The housing 6250 can provide a user-friendly interface based on a familiar positioning method.

Certain procedures described herein may be divided between a user of a catheter laboratory and a room of an intensive care unit or subject. A catheter lab may deploy the device in a subject. The catheter lab may perform a therapy titration (e.g., determine a stimulation parameter for a maximum tolerable increase in contractility and/or relaxation, determine a stimulation parameter for an increase in contractility and/or relaxation greater than a minimum value, determine a stimulation parameter for an increase in contractility and/or relaxation less than a maximum value, determine a stimulation parameter for an increase in heart rate less than a maximum value, etc.). The intensive care unit and/or the room of the subject may be treated according to preset parameters. The intensive care unit and/or the subject's room may monitor therapy (e.g., via ECG, BP/MAP, SvO2, changes in contractility and/or relaxation, changes in pressure, heart rate, etc.). The intensive care unit and/or the subject's room may perform an initial and/or subsequent (e.g., as needed) therapy titration (e.g., determining a stimulation parameter for a maximum tolerable increase in contractility and/or relaxivity, determining that the stimulation parameter for a contractility and/or relaxivity increase is greater than a minimum value, determining that the stimulation parameter for a contractility and/or relaxivity increase is less than a maximum value, determining that the stimulation parameter for a heart rate is less than a maximum value, etc.). Intensive care units and/or the room of the subject may slow down the treatment rate. Certain functions may be performed at any location where appropriate. For example, subsequent titration treatments may be performed by the catheter lab, which may be more empirical in establishing stimulation parameters.

The foregoing description and examples have been set forth merely for the purpose of illustration and are not intended to be limiting. Each of the disclosed aspects and examples of the disclosure may be considered alone or in combination with other aspects, examples, and variations of the disclosure. Moreover, unless specifically stated, any steps of the methods of the present disclosure are not limited to any particular order of execution. Modifications of the disclosed examples, including the spirit and substance of the disclosure, may be suggested to one skilled in the art and are intended to be within the scope of the disclosure. In addition, all references cited herein are incorporated by reference in their entirety.

While the methods and apparatus described herein are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various examples described and the appended claims. Moreover, the disclosure herein of any particular feature, aspect, method, property, trait, attribute, element, etc. in combination with one example may be used in all other examples set forth herein. Any methods disclosed herein need not be performed in the order of presentation. According to an example, one or more acts, events or functions of any of the algorithms, methods or processes described herein can be performed in a different order, may be added, merged, or left out (e.g., not all described acts or events are required for the implementation of an algorithm). In some examples, acts or events may be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or multiple processors or processor cores, or on other parallel architectures, rather than sequentially. Moreover, no element, feature, block, or step is essential or critical to each example. Moreover, all possible combinations, subcombinations, and rearrangements of systems, methods, features, elements, modules, blocks, and the like are within the scope of the present disclosure. The use of sequential or chronological words such as "then," "next," "after," "then," etc. is generally intended to facilitate the flow of text and is not intended to limit the order of operations performed unless otherwise stated or otherwise understood in the context. Thus, some examples may be performed using the order of operations described herein, while other examples may be performed following a different order of operations.

The various illustrative logical blocks, modules, processes, methods, and algorithms described in connection with the examples disclosed herein may be implemented as electronic hardware, computer software, or combinations of both. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, operations, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. The described functionality may be implemented in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present disclosure.

The various illustrative logical blocks and modules described in connection with the examples disclosed herein may be implemented or performed with a machine such as a general purpose processor, a Digital Signal Processor (DSP), an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general purpose processor may be a microprocessor, but in the alternative, the processor may be a controller, microcontroller, state machine, combination thereof, or the like. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

The blocks, operations, steps of a described method, process, or algorithm in connection with the examples disclosed herein may be embodied directly in hardware, in a software module executed by a processor, or in a combination of the two. A software module may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, an optical disk (e.g., a CD-ROM or DVD), or any other form of volatile or non-volatile computer-readable storage medium known in the art. A storage medium may be coupled to the processor such that the processor can read information from, and write information to, the storage medium. In the alternative, the storage medium may be integral to the processor. The processor core storage medium may reside in an ASIC. The ASIC may reside in a user terminal. In the alternative, the processor and the storage medium may reside as discrete components in a user terminal.

Unless specifically stated otherwise, or otherwise understood in the context, conditional language used herein, such as particularly "can," "might," "may," "for example," and the like, is generally intended to convey that some examples include but other examples do not include certain features, elements, and/or states. Thus, such conditional language is not generally intended to imply that features, elements, blocks, and/or states are in any way required for one or more examples or that one or more examples must include logic for deciding, with or without author input or prompting, whether such features, elements, and/or states are included or are to be performed in any particular example.

The methods described herein may include implementing certain actions taken by a person, however, the methods may also include any third party instructions for such actions, either explicitly or implicitly. For example, actions such as "positioning an electrode" include "indicating the positioning of an electrode".

The ranges disclosed herein also include any and all overlaps, sub-ranges, and combinations thereof. Terms such as "up to," at least, "" greater than, "" less than, "" between. Numerals following terms such as "about" or "approximately" include the numbers recited, and should be understood as appropriate (e.g., as reasonably accurate as possible in each case, e.g., ± 5%, ± 10%, ± 15%, etc.). For example, "about 1V" includes "1V". A term subsequent to a term such as "substantially" includes the recited phrase and should be understood as context-dependent (e.g., as much as reasonably possible in each instance). For example, "substantially vertical" includes "vertical". Unless otherwise stated, all measurements are under standard conditions including temperature and pressure. The phrase "at least one" is intended to require at least one item in the subsequent list, rather than a type for each item in the subsequent list. For example, "at least one of A, B and C" may include: A. b, C, respectively; a and B, A and C, B and C; or A, B and C.