阅读说明：本技术 用于植入于心脏的左心耳中的装置 (Device for implantation in the left atrial appendage of the heart ) 是由 T·奥哈洛伦 J·汤普森 于 2019-10-11 设计创作，主要内容包括：本发明涉及一种用于植入心脏的左心耳中的装置,装置包括对接站和闭合件；对接站包括径向可扩展元件,径向可扩展元件在收缩取向和部署取向之间为可调整的,收缩取向适合于腔内递送,部署取向配置成锚定于左心耳内并且使左心耳与左心房流体地隔离,对接站还包括凹陷插口,凹陷插口为通过开口从左心房可进入的；闭合件覆盖开口。模块化有源元件配置用于可拆卸地接合于对接站的凹陷插口内。模块化有源元件包括治疗元件或感测元件；治疗元件配置成电气地刺激心脏组织,热刺激心脏组织,电穿孔心脏组织,或将物质递送至心脏组织或心脏的腔室；感测元件配置成检测选自温度、压力、电信号、心率或呼吸速率的参数。(The invention relates to a device for implantation in the left atrial appendage of the heart, the device comprising a docking station and a closure member; the docking station includes a radially expandable element adjustable between a collapsed orientation suitable for endoluminal delivery and a deployed orientation configured to anchor within and fluidly isolate the left atrial appendage from the left atrium, the docking station further including a recessed receptacle accessible from the left atrium through the opening; the closure member covers the opening. The modular active element is configured to removably engage within the recessed receptacle of the docking station. The modular active element comprises a therapeutic element or a sensing element; the treatment element is configured to electrically stimulate cardiac tissue, thermally stimulate cardiac tissue, electroporate cardiac tissue, or deliver a substance to cardiac tissue or a chamber of the heart; the sensing element is configured to detect a parameter selected from temperature, pressure, electrical signal, heart rate, or respiration rate.)

1. A device (1) for implantation in the left atrial appendage of a heart, the device (1) comprising:

a docking station (2), said docking station (2) comprising a radially expandable element (3), a recessed receptacle (5) and a closure (8), said radially expandable element (3) being adjustable between a collapsed orientation suitable for endoluminal delivery and a deployed orientation configured to be anchored within and fluidly isolate the left atrial appendage from the left atrium, said recessed receptacle (5) being accessible from the left atrium through an opening, said closure (8) covering said opening; and

a modular active element (12), the modular active element (12) configured to be removably engaged within a recessed receptacle of the docking station;

the device (1) is characterized in that the recessed socket (5) extends completely through the docking station, thereby providing access to an occluded LAA when the docking station has been deployed.

2. The device of claim 1, wherein the modular active element (12) is sized to fit entirely within the LAA.

3. The device according to claim 1 or 2, wherein the modular active element (12) comprises a therapy device (31, 32, 41, 51) or a sensing device.

4. The device of claim 3, wherein the therapeutic device or sensing device is configured for adjustment between a collapsed delivery configuration and a deployed active configuration.

5. The device of any one of claims 3 or 4, wherein the treatment device or sensing device is radially expandable.

6. The device of any one of claims 3 to 5, wherein the therapeutic device or sensing device is disposed toward a distal end of the modular active element and is configured for deployment distal to the recessed receptacle.

7. The device of any one of claims 3 to 6, wherein the modular active element is a sensing element configured to detect a parameter selected from temperature, pressure, pH, electrical signal, heart rate, or respiration rate.

8. The device of any one of claims 3 to 7, wherein the modular active element is a therapeutic device configured to electrically stimulate a heart, ablate cardiac tissue, or deliver a substance into the heart, a heart wall, or a blood stream.

9. The device of claim 7, wherein the therapeutic device comprises an electrode or an electrode array.

10. A device according to any of the preceding claims, wherein at least one of the modular active element (12) and the docking station (2) comprises a magnet or magnetisable member (22, 24, 26, 27) to guide the modular active element into the recessed socket.

11. The device according to any of the preceding claims, wherein the docking station (2) and the modular active element (12) are configured for electrical connection when the modular active element is operatively engaged within the recessed socket (5).

12. The device according to any of the preceding claims, wherein the docking station (2) is configured to provide an electrical connection between the modular active element (12) and surrounding tissue through the radially expandable element (3).

13. The device according to any of the preceding claims, wherein the modular active element (12) is dimensioned to engage within the recessed socket (5) to close the recessed socket.

14. The device according to any of the preceding claims, wherein the modular active element (12) is configured to engage within the recessed receptacle, wherein a proximal portion of the modular active element is disposed proximal to the recessed receptacle and/or a distal portion of the modular active element is disposed distal to the recessed receptacle.

15. The device of any of the preceding claims, wherein the modular active element is configured to engage within the recessed receptacle having a proximal portion extending into the left atrium, and wherein the proximal portion extending into the left atrium optionally comprises a treatment or sensing device.

16. The device of any of the preceding claims, wherein the recessed receptacle is configured for radial expansion upon receipt of a modular active element, wherein the modular active element optionally has a diameter that is greater than a diameter of the recessed conduit, whereby insertion of the modular active element into the recessed receptacle subjects the recessed receptacle to tensile forces urging it to radially expand.

17. The device of claim 16, wherein the recessed receptacle is formed of a resiliently deformable material, or it is tubular with adjacent but unconnected longitudinal sections that longitudinally abut when the receptacle is unexpanded, but separate when the receptacle is expanded.

18. The device of any of the preceding claims, wherein the closure of the recessed receptacle comprises a mesh cap (7) to fluidly isolate the left atrium from the LAA when the device is deployed in the LAA.

19. The device according to claim 18, wherein the mesh cover (7) comprises a self closing aperture (8).

20. The device of any one of the preceding claims, wherein the closure comprises a pierceable membrane cap or an inflatable valve.

21. The device of any one of the preceding claims, wherein the occlusive member is configured to promote epithelial cell proliferation.

22. The device according to any of the preceding claims, wherein the radially expandable element is a radially expandable cage (3).

23. The device according to any one of the preceding claims, wherein said radially expandable element comprises a proximal portion (4), said proximal portion (4) having a substantially annular shape and comprising an opening of said recessed socket, a cap (7) of said recessed socket and a substantially cylindrical distal portion (6).

24. The apparatus of any of the preceding claims, wherein the modular active component and the recessed receptacle are configured to engage each other when the modular active component is fully received in the recessed receptacle.

25. The apparatus of any of the preceding claims, wherein the modular active element and the recessed receptacle are configured for a screw-fit removable engagement or an interference-fit removable engagement.

26. The apparatus of any of the preceding claims, wherein the modular active element comprises a radially expandable anchor configured to anchor the modular active element in the recessed receptacle when engaged.

27. The device of claim 26, wherein the radially-expandable anchor is configured to be deployed distal or proximal of the conduit or the radially-expandable element when the modular active element engages the recessed receptacle.

28. The apparatus of any of the preceding claims, wherein the modular active element comprises an inductor.

29. The device of claim 28, wherein the inductor comprises an inductor coil that is optionally adjustable between a contracted orientation suitable for endoluminal delivery and a radially deployed expanded orientation.

30. The device of claim 28 or 29, wherein the inductor coil is disposed on a distal end of the modular active element and is configured for deployment distal to the recessed conduit.

31. The apparatus of any preceding claim, wherein the modular active element comprises a resonant power circuit configured with a plurality of coils adapted to provide a desired Q factor greater than or equal to 0.5.

32. The apparatus of any of the preceding claims, wherein the modular active element comprises a capacitor paired with an inductor to provide a first LC circuit.

33. The apparatus of any preceding claim, wherein the modular active element comprises an RC circuit operatively connected to a DC regulator and adapted to provide a steady state current to the circuit.

34. The apparatus of claim 32 and optionally claim 33, wherein the modular active element comprises a second LC circuit external to the modular active element, the modular active element adapted to provide magnetic flux to energize the LC circuit.

35. A system comprising a device according to any one of claims 1 to 34, and a delivery catheter (10) to deliver a modular active element (12) endoluminally to the recessed conduit (5) of the docking station (2).

36. The system of claim 35, wherein the delivery catheter is configured to receive the modular active element (typically received within a distal end of the catheter), deliver the modular active element endoluminally to the docking station, and partially or completely deliver the modular active element from the distal end of the delivery catheter into a recessed receptacle of the docking station.

37. The system of claim 36, wherein the delivery catheter comprises an inner element configured for detachable attachment with a proximal end of the modular active element and axial movement relative to the catheter.

38. The system of claim 37, wherein the internal element is configured to rotate the modular active element about a longitudinal axis of the catheter.

39. A kit of parts comprising the apparatus of any one of claims 1 to 34 and at least one replacement modular active element.

40. The kit of parts of claim 39, wherein the modular active element is a tissue ablation device and the replacement modular active element is selected from a treatment device or a sensing device.

41. The kit of parts of claim 39 or 40, comprising a catheter having an outer portion configured to abut a proximal surface of the radially expandable element, the proximal surface surrounding an opening of the recessed receptacle, and an inner portion configured for engaging a proximal end of the modular active element, and optionally configured for axial movement into the recessed receptacle.

42. The kit component of claim 41, wherein an interior portion of the catheter has a piercing tip configured to pierce the cap covering an opening of the recessed receptacle.

Technical Field

The present invention relates to a device for implantation in the left atrial appendage of the heart. The invention also contemplates methods of treatment or diagnosis using the device, particularly diagnosis of cardiac function.

Background

Heart disease is a significant problem in humans, and during the last 20 years devices have been developed that aim at in situ treatment and monitoring of the heart. The space within the beating heart is extremely limited and this presents a significant challenge to the development of safe and effective in situ cardiac implants.

Medical implant devices for the Left Atrial Appendage (LAA) of the heart are known from the literature and generally comprise a catheter and a radially expandable member disposed at the distal end of the catheter, the catheter being configured for deployment in the ostium of the LAA and fluidly isolating the LAA from the heart. These devices are typically operatively connected to an external controller through a catheter; operable to treat tissue of the LAA to alter an electrical characteristic of the LAA; and ultimately electrically isolates the LAA from the heart tissue as a means of suppressing or preventing atrial fibrillation. Some of these devices also include a sensor that can sense a parameter of the tissue of the LAA. An exemplary device is described in WO 2016/202708.

It is an object of the present invention to overcome at least one of the above-described and problems.

Disclosure of Invention

Applicants have appreciated that the LAA may provide additional space to accommodate the cardiac therapy/sensing device, and by using LAA implants to safely and specifically isolate the LAA, it is possible to create additional space within but isolated from the heart. The space may then be used as a container for therapeutic or monitoring equipment or as a portal to access the exterior surface of the heart from within the heart or to access the interior of the heart from outside the heart.

The present invention addresses the need for a cardiac monitoring/therapy device that can be safely implanted in the heart without adversely affecting cardiac function and that is configured for modular adjustment. The device comprises two main components: a docking station and a modular active element; the docking station is designed for implantation within a Left Atrial Appendage (LAA) of a heart, wherein the docking station is anchored to a wall of the LAA; the modular active component is designed to be removably engaged in a recessed conduit (socket) formed in the docking station. The modular active element may be a therapeutic device or a sensing device, and may be removed from the docking station while it is in situ in the heart and replaced with a different modular active element (e.g., replacement of a tissue ablation module with a cardiac parameter sensor), or replaced with a new type of the same modular active element or replaced with the same modular active element with a new battery. The treatment or sensing device may be configured for treatment or sensing procedures applied to the LAA, the heart, a chamber of the heart (e.g., the left atrium), or blood passing through the heart. The modular active element and the recessed receptacle are configured for removable engagement to allow detachment and retraction of the modular active element, and reattachment of the same or a different modular active element, while the docking station remains in place in the LAA of the heart. The present invention thus provides a safe and convenient appliance for treating or monitoring the condition of the heart. The recessed receptacle may extend through the docking station, allowing a portion of the modular active element (e.g., a therapeutic or sensing device) to enter the occluded LAA.

In a first aspect, the present invention provides an apparatus for implantation in a body lumen (e.g., the left atrial appendage of a heart), the apparatus comprising a docking station including a radially expandable element adjustable between a collapsed orientation (orientation) suitable for endoluminal delivery and a deployed orientation (deployment) configured to reside within the left atrial appendage (and preferably fluidly isolate the left atrial appendage from the left atrium). In one embodiment, the docking station includes a recessed receptacle that is accessible from the left atrium. The device generally includes a modular active element configured to removably engage within the recessed receptacle of the docking station.

In one embodiment, the proximal surface of the recessed receptacle includes a closure configured to prevent fluid from entering the recessed receptacle. Various forms of closures are described herein, including self-closing closures and pierceable closures.

In one embodiment, at least one of the modular active element and the docking station includes a magnet (or is magnetized) configured to guide the modular active element into the recessed receptacle.

The modular active elements generally include therapeutic elements or sensing elements. The therapeutic or sensing element may be radially expandable. The sensing element may be configured to detect any parameter, examples including a parameter selected from temperature, pressure, pH, electrical signal, heart rate, or respiration rate.

In one embodiment, the modular active element is a therapeutic element configured to electrically stimulate the heart, ablate cardiac tissue (by any means including thermal, electrical, radiation, physical or chemical ablation), or deliver a substance to the heart, the heart wall, or the bloodstream.

In one embodiment, the treatment elements include thermal and non-thermal energy delivery elements (such as RF), reversible and irreversible electroporation cryo-elements or capacitive coupling. The element may be an electrode or an array of electrodes. The cryogenic element may be a radially expandable balloon.

In one embodiment, the treatment element or sensing element is configured for adjustment between a collapsed delivery configuration and a deployed active configuration. Generally, in these embodiments, the therapeutic or sensing element is disposed toward the distal end of the modular active element and is configured for deployment distal to the recessed receptacle.

In one embodiment, the docking station and the modular active element are configured for electrical connection when the modular active element is operatively engaged within the recessed receptacle. In one embodiment, the docking station is configured to provide an electrical connection between the modular active element and surrounding tissue through the radially expandable element.

In one embodiment, the recessed receptacle extends completely through the docking station, thereby providing access to the occluded LAA when the docking station is deployed.

In one embodiment, the modular active component is sized to fully engage within the recessed receptacle. In one embodiment, the modular active component is sized to engage within the recessed receptacle to close the recessed receptacle. This prevents the flow of fluid from the heart to the LAA through the sunken jack when the hole has been opened, for example when the sunken jack closure comprises a pierceable membrane or cap.

In one embodiment, the modular active component is configured to engage within the recessed receptacle, wherein a proximal portion of the modular active component is disposed proximal to the recessed receptacle and/or a distal portion of the modular active component is disposed distal to the recessed receptacle. In one embodiment, the modular active component is configured to sit within a recessed receptacle having a proximal portion extending into the left atrium. In one embodiment, the proximal portion that extends into the left atrium includes a treatment or sensing element.

In one embodiment, the modular active element is sized to fit within the heart. In one embodiment, the modular active element is sized to fit within the left atrium (including the left atrial appendage). In one embodiment, the modular active element is sized to fit within the left atrial appendage.

In one embodiment, the recessed conduit is configured for radial expansion upon receipt of the modular active element. In this embodiment, the modular active element may have a diameter that is larger than the diameter of the recessed conduit. Insertion of the modular active component into the recessed receptacle subjects the recessed receptacle to tensile forces, forcing it to expand radially. The receptacles may be formed of a resiliently deformable material, such as a suitable resilient polymer or expandable mesh, that is configured to assume its original dimensions when the modular active component is removed. Alternatively, the socket may be tubular, with adjacent but unconnected longitudinal sections; these longitudinal sections longitudinally abut when the socket is unexpanded, but separate when the socket is expanded. The modular active component may have a distal end that tapers inwardly (i.e., a funnel shape) which allows the distal end of the modular active component to be inserted into the recessed socket prior to radial expansion, whereby further insertion of the component into the socket affects radial expansion of the socket.

In one embodiment, the closure of the sunken jack comprises a mesh cap; the mesh cover generally fluidly isolates the left atrium from the LAA when the device is deployed in the LAA. In one embodiment, the mesh includes self-closing pores.

In one embodiment, the closure comprises a pierceable membrane cap.

In one embodiment, the self-closing closure comprises an expandable valve (valve).

In one embodiment, the occlusive member is configured to promote epithelial cell proliferation.

In one embodiment, the self-closing closure includes an openable flap and associated biasing means for biasing the flap to a closed position. In one embodiment, the biasing means comprises a spring element attached to the flap, for example a hinged spring as disclosed herein.

In one embodiment, the radially expandable element is a radially expandable cage. In one embodiment, the recessed receptacle is a pipe; the conduit extends at least partially (and in one embodiment, completely) axially through and into the radially expandable cage or member. In one embodiment, the radially expandable element comprises a proximal portion, a cap of a recessed receptacle, and a generally cylindrical distal portion; the proximal portion has a generally annular shape and includes an opening of a recessed receptacle.

In one embodiment, the modular active component and the recessed receptacle are configured for engagement with each other when the modular active component is fully received in the recessed receptacle.

In one embodiment, the modular active component and the recessed receptacle are configured for screw-fit removable engagement.

In one embodiment, the modular active component and the recessed socket are configured for interference fit removable engagement.

In one embodiment, the modular active element includes a radially expandable anchor configured to anchor the modular active element in the recessed receptacle (or as an engagement instrument) when engaged. In one embodiment, the radially expandable anchor is inflatable.

In one embodiment, the modular active element comprises a distal radially expandable anchor configured to be deployed distal to the pipe or radially expandable element when the modular active element engages the recessed receptacle and/or a proximal radially expandable anchor configured to be deployed proximal to the pipe or radially expandable element when the modular active element engages the recessed receptacle.

In one embodiment, the modular active component includes an inductor.

In one embodiment, the inductor comprises an inductor coil that is optionally adjustable between a contracted orientation suitable for endoluminal delivery and a radially deployed expanded orientation.

In one embodiment, the inductor coil is disposed on a distal end of the modular active element and is configured for deployment distal to the recessed conduit.

In one embodiment, the modular active component includes a resonant power circuit configured with a plurality of coils adapted to provide a desired Q factor of greater than or equal to 0.5.

In one embodiment, the modular active component includes a capacitor that is paired with an inductor to provide the first LC circuit.

In one embodiment, the modular active component includes an RC circuit operatively connected to the DC regulator and adapted to provide a steady state current to the circuit.

In one embodiment, the modular active component includes a second LC circuit external to the modular active component adapted to provide magnetic flux to energize the LC circuit.

In one embodiment, the proximal end of the modular active element comprises an anchoring formation configured to engage the collapsed snare.

In one embodiment, the modular active element is configured to remain attached to its delivery catheter during use. The delivery catheter may include modular active element control elements including a power source appliance and a data relay appliance. The catheter and modular active element may be configured for detachment from the docking station and withdrawal from the cavity. The modular active element may be configured for detachment from the delivery catheter, and the catheter is configured for attachment of a replacement modular active element. The catheter and replacement modular active element may be delivered intraluminally to the docking station, and the modular active element operatively engaged within the recessed receptacle.

In one embodiment, the cover at the distal end of the docking station includes a network of electrode receiving conduits extending radially from a center of the cover to a periphery of the cover. Electrodes disposed at the distal end of the delivery catheter are threaded through conduits that guide the distal end of the electrodes to the periphery of a cap that, in use, will be adjacent to the wall of the LAA. In one embodiment, the circumference of the tissue-engaging portion of the cover includes a plurality of apertures configured to expose the distal end of the electrode to the wall of the LAA. The catheter and electrodes are configured for detachment and extraction from the docking station, leaving the docking station in place.

In one embodiment, the radially expandable element includes one or more brush members configured to engage tissue upon deployment of the radially expandable element. The brush helps to attach the element to the tissue when deployed and also forms a fluid tight seal against the tissue. For example, the radially expandable element may be a cage formed from wires, and at least one of the wires may include a brush member. As used herein, the term "brush member" generally means a spine and a plurality of bristles coupled to the spine, the bristles extending outwardly (generally radially outwardly) from the spine. The bristles may have an axial, circumferential or helical arrangement. Brush members and methods of making the same are described in the following documents: US8528147, EP0800781 and DE 10328445. The bristles may be porous, which aids in tissue integration. The voids may be formed during extrusion or after cutting or laser forming.

The present invention also provides a system comprising the device of the present invention and a delivery catheter that endoluminally delivers the modular active element to the recessed tubing of the docking station. In one embodiment, the delivery catheter is configured to receive a modular active element (typically received within the distal end of the catheter), deliver the modular active element endoluminally to the docking station, and dispense the modular active element partially or completely from the distal end of the delivery catheter into the recessed receptacle of the docking station. In one embodiment, the delivery catheter includes an inner element configured for detachable attachment to the proximal end of the modular active element and axial movement relative to the catheter. In one embodiment, the internal element is configured to rotate the modular active element about a longitudinal axis of the catheter.

In one embodiment, the present invention provides an apparatus for occluding a body lumen, the apparatus comprising an implantable occlusion device operatively attached to an elongate catheter member configured for endoluminal delivery and deployment of the occlusion device in the body lumen, the occlusion device comprising a radially expandable element; the radially expandable element is removably attached to the elongate catheter member and is adjustable between a collapsed orientation suitable for endoluminal delivery and a deployed orientation configured to occlude a body lumen; wherein the radially expandable element includes one or more brush members configured to engage tissue upon deployment of the radially expandable element. In one embodiment, an apparatus includes an energy delivery element configured to deliver energy to surrounding tissue to heat the tissue. In one embodiment, an apparatus includes a sensor configured to detect a parameter of a wall of a body lumen. In one embodiment, the energy delivery element and the sensor are optionally configured for axial movement independently of the radially expandable element, whereby the energy delivery element and the sensor are endoluminally contractible in use, thereby leaving the radially expandable element in place, thereby occluding the body lumen.

The invention also relates to a method comprising the steps of:

delivering the device of the invention endoluminally to the left atrial appendage of the heart of the subject;

deploying a device to anchor the device in the left atrial appendage;

actuating the modular active element to perform a first operation in situ in the heart;

after a period of time, disengaging the modular active element from the docking station and extracting the modular active element from within the subject cavity;

endoluminally delivering the replacement modular active element to a heart of the subject;

inserting a replacement modular active component into the recessed tube of the docking station and into engagement with the recessed tube; and

the modular active element is actuated to perform a second operation in situ in the heart.

In one embodiment, the first and second operations are each independently a therapeutic operation (i.e., LAA tissue ablation, drug or gene therapy delivery) or a sensing operation (i.e., detection of electrical signals, pressure or temperature in the LAA). The first and second operations may be different or the same. The modular active element and the replacement modular active element may be different or the same. For example, one may include a therapeutic element and one may include a sensing element, or they may both include a therapeutic or sensing element.

In one embodiment, the step of disengaging the modular active element from the docking station and extracting the modular active element from within the subject cavity employs a catheter having an outer portion configured to abut a proximal surface of the radially expandable element surrounding the opening of the recessed socket and an inner portion configured for axial movement into the recessed socket and engagement with the proximal end of the modular active element. Typically, the inner portion of the catheter has a piercing tip configured to pierce a cap covering the opening of the recessed receptacle. Suitably, the outer portion of the catheter comprises a magnet to facilitate correct positioning of the outer portion against the proximal surface of the radially expandable element.

In one embodiment, the replacement modular active element comprises a radially expandable anchor configured to anchor the replacement modular active element in the recessed receptacle when engaged, wherein the method comprises the step of deploying the anchor after the replacement modular active element has been inserted into the recessed conduit. In one embodiment, the radially expandable anchor is inflatable.

The methods of the present invention may be methods of occluding, revascularizing, or electrically isolating a LAA, wherein the modular active element comprises a tissue ablation element for direct (wherein a portion of the element is configured to engage LAA tissue) or indirect (wherein the tissue ablation element is configured to deliver ablation energy to the tissue through the radially expandable element) ablation of the tissue.

The invention also provides a kit of parts comprising a device according to the invention and at least one (i.e. 1,2,3,4,5) replacement modular active element.

In one embodiment, the modular active element is a tissue ablation device and the replacement modular active element is selected from a treatment device or a sensing device.

In one embodiment, a kit includes a catheter having an outer portion and an inner portion; the outer portion is configured to abut a proximal surface of a radially expandable element surrounding an opening of the recessed socket, the inner portion is configured for engagement with a proximal end of the modular active element, and optionally configured for axial movement into the recessed socket.

In one embodiment, the inner portion of the catheter has a piercing tip configured to pierce a cap covering an opening of the recessed receptacle.

In another aspect, the invention provides a device for implantation in the left atrial appendage of a heart, the device comprising:

a docking station comprising a radially expandable element adjustable between a collapsed orientation suitable for endoluminal delivery and a deployed orientation configured to anchor within and fluidly isolate the left atrial appendage from the left atrium, a recessed receptacle accessible from the left atrium through an opening, and a closure covering the opening; and

a modular active component configured to be removably engaged within the recessed receptacle of the docking station, wherein the modular active component includes an inductor.

In one embodiment, the inductor comprises an inductor coil that is optionally adjustable between a contracted orientation suitable for endoluminal delivery and a radially deployed expanded orientation. In one embodiment, the inductor coil is disposed on a distal end of the modular active element and is configured for deployment distal to the recessed conduit.

In another aspect, the invention provides a device for implantation in the left atrial appendage of a heart, the device comprising:

a docking station comprising a radially expandable element adjustable between a collapsed orientation suitable for endoluminal delivery and a deployed orientation configured to anchor within and fluidly isolate the left atrial appendage from the left atrium, a recessed receptacle accessible from the left atrium through an opening, and a closure covering the opening; and

a modular active component configured for removable engagement within the recessed receptacle of the docking station, wherein the modular active component comprises a resonant power circuit configured with a plurality of coils adapted to provide a desired Q factor of greater than or equal to 0.5.

In another aspect, the invention provides a device for implantation in the left atrial appendage of a heart, the device comprising:

a docking station comprising a radially expandable element adjustable between a collapsed orientation suitable for endoluminal delivery and a deployed orientation configured to anchor within and fluidly isolate the left atrial appendage from the left atrium, a recessed receptacle accessible from the left atrium through an opening, and a closure covering the opening; and

a modular active component configured to be removably coupled within the recessed receptacle of the docking station, wherein the modular active component includes a capacitor that is paired with the inductor to provide the first LC circuit.

In one embodiment, the modular active component includes an RC circuit operatively connected to the DC regulator and adapted to provide a steady state current to the circuit.

In one embodiment, the modular active component includes a second LC circuit external to the modular active component adapted to provide magnetic flux to energize the LC circuit.

Other aspects and preferred embodiments of the invention are defined and described in the other claims, which are explained below.

Drawings

Fig. 1A to 1F: the docking station of the present invention is shown in a deployed configuration having a radially expandable cage with a proximal end being a generally annular shape and a recessed conduit and a distal end having a cylindrical shape; and showing the aperture recloseable to facilitate removal and insertion of the modular active component. Fig. 1A shows the docking station with a mesh cover covering the proximal end of the cage, and fig. 1B shows the docking station with the cover removed for clarity. Fig. 1B also shows the distal end of the catheter attached to the docking station. Fig. 1C and 1D are side views of the docking station showing the reclosable aperture in the open (fig. 1C) and closed (fig. 1D) configurations. Fig. 1E and 1F are end views of the docking station.

Fig. 2A and 2B show a cover for the proximal end of a docking station having a reclosable aperture in the form of a polymeric valve in a closed (fig. 2A) and open (fig. 2B) configuration.

Fig. 2C-2F are side cross-sectional views of the docking station, showing the valve in a closed configuration (fig. 2C) and an open configuration (fig. 2D) in which the catheter protrudes through the valve, the modular active elements delivered into the recessed receptacle (fig. 2E), and the removed catheter (fig. 2F) and the closed valve.

Fig. 3 shows four different ways in which the modular active element and tubing interact, namely, threaded engagement (fig. 3A), interference fit (fig. 3B), anchor deployment (fig. 3C), balloon deployment (fig. 3D), and spring engagement (fig. 3E and 3F).

Fig. 4 shows how the modular active elements can electrically connect the tissues of the LAA through the radially expandable member.

Fig. 5 illustrates how the proximal end of the radially expandable element can have a sealing skirt configured to engage an irregularly shaped LAA.

Fig. 6A, 6B, and 6C illustrate a delivery catheter of a modular active element that incorporates magnets to help direct the delivery catheter toward the opening of the duct.

Fig. 7 shows a modular tissue ablation active element: fig. 7A shows the modular active element in a deployed active configuration, and fig. 7B shows the modular active element in a collapsed delivery configuration. Fig. 7C shows the deployed modular active element engaged within a conduit.

Fig. 8A shows a modular active element including an inflatable balloon, fig. 8B is a cross-sectional view taken along line 1-1 of fig. 8A, and fig. 8C shows a modular active element including an inflatable balloon having different compartments configured to deliver different cryogenic ablation treatments.

Fig. 9 shows a modular active element with two inflatable balloons engaged within the duct.

Fig. 10 shows a modular active element incorporating a hook configured to engage a delivery/removal device.

Fig. 11A and 11B illustrate a device for left atrial monitoring incorporating an inductive coil for remote powering or charging of the device.

Fig. 12A to 12G show a method of using the device of the present invention.

FIG. 13 is an illustration of a docking station forming part of the apparatus of the present invention, the docking station having a radially expandable cage and a recessed conduit (the mouth of which is shown); and shows the sunken tube in a resting configuration (left) and in an expanded configuration (right). These figures also show how the conduit may comprise longitudinal sections or sections that are contiguous but unconnected and allow radial expansion of the conduit.

Fig. 14 shows a docking station forming part of a device according to the invention, the docking station having a cover comprising a network of radial ducts configured to receive electrodes or wires and direct the wires radially outwards to the periphery of the cover. The cover includes circumferentially arranged holes configured to expose the distal end of the electrode to tissue when the docking station is used with a body lumen.

Fig. 15A and 15B illustrate an embodiment of the device of the present invention wherein the radially expandable element is a cage comprising circumferential brush members.

Detailed Description

All publications, patents and patent applications and other references mentioned herein are hereby incorporated by reference in their entirety for all purposes to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference and was set forth in its entirety herein.

Definitions and general preferences

As used herein and unless otherwise expressly indicated, these terms are intended to have the following meanings, in addition to any broader (or narrower) meanings the following terms may have in the art.

As used herein, the singular is to be understood to include the plural and vice versa, unless the context requires otherwise. The terms "a" or "an" used with respect to an entity should be taken to refer to one or more of that entity. Thus, the terms "a" (or "an"), "one or more" and "at least one" are used interchangeably herein.

As used herein, the terms "comprises," "comprising," or variations thereof, such as "comprises" or "comprising," should be taken to imply the inclusion of any stated and formal (e.g., feature, element, characteristic, property, method/process step or limitation) or group of integers (e.g., features, elements, characteristics, property, method/process step or limitation) but not the exclusion of any other integer or group of integers. Thus, as used herein, the term "comprising" is inclusive or open-ended and does not exclude additional, unrecited integers or method/process steps.

As used herein, the term "disease" is used to define any abnormal condition that impairs physiological function and is associated with a particular symptom. The term is used broadly to encompass any disorder, condition, abnormality, pathology, affliction, condition, or symptom in which physiological function is impaired regardless of the nature of the etiology (or, indeed, regardless of whether the etiologic basis of the disease is established). Thus, the term encompasses conditions resulting from infection, trauma, injury, surgery, radiation ablation, poisoning, or malnutrition.

As used herein, the term "treatment" or "treating" refers to an intervention (e.g., administration of an agent to a subject) that cures, ameliorates or reduces a symptom of a disease, or eliminates (or reduces) the effects of its etiology (e.g., reduces the accumulation of pathological levels of lysosomal enzymes). In this case, the term is used synonymously with the term "therapy".

Furthermore, the terms "treatment" or "treating" refer to an intervention (e.g., administration of an agent to a subject) that prevents or delays the onset or progression of a disease, or reduces (or eliminates) its incidence in a treated population. In this case, the term treatment is used synonymously with the term "prophylactic measure".

As used herein, an effective or therapeutically effective amount of an agent defines an amount that can be administered to a subject without excessive toxicity, irritation, allergic response, or other problem or complication; this amount is commensurate with a reasonable removal/risk ratio, but is sufficient to provide the desired effect, e.g., treatment or prevention, manifested as a permanent or temporary improvement in the condition of the subject. This amount will vary for each subject, depending on the age and general condition of the individual, the mode of administration, and other factors. Thus, although it is not possible to specify an exact effective amount, one skilled in the art will be able to determine an appropriate "effective" amount in any case using routine experimentation and background knowledge. In this context, treatment results include elimination or alleviation of symptoms, reduction of pain or discomfort, prolongation of survival, improvement of mobility, and other signs of clinical improvement. The therapeutic outcome need not be a complete cure.

In the context of treatment and effective amounts as defined above, the term subject (which shall be taken to include "individual", "animal", "patient" or "mammal" where the context permits) defines any subject, in particular a mammalian subject, for which treatment is performed. Mammalian subjects include, but are not limited to, humans, domestic animals, farm animals, zoo animals, sport animals, pet animals (such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cows, beef cattle), primates (such as apes, monkeys, orangutans, and chimpanzees), canines (such as dogs and wolves), felines (such as cats, lions, and tigers), equines (such as horses, donkeys, and zebras), food animals (such as beef cattle, pigs, and sheep), ungulates (such as deer and giraffes), and rodents (such as mice, rats, hamsters, and guinea pigs). In a preferred embodiment, the subject is a human.

By "intraluminal delivery" is meant delivery of a device through a body lumen to a target site (e.g., the heart), such as through an artery or vein. In one embodiment, the device of the present invention is advanced through an artery or vein into the left atrium of the heart and at least partially into the LAA.

"docking station" refers to a portion of the device of the present invention that is anchored inside the individual's heart, inside the Left Atrial Appendage (LAA), and remains in the LAA, allowing for periodic replacement of modular active elements. For example, the modular active element may be a battery powered sensor that requires periodic replacement of the battery. The docking station generally includes a radially expandable element deployed to store the device in the LAA; and generally includes a recessed conduit (socket) that is accessible from the left atrium and configured for removable engagement with the modular active element. In one embodiment, the radially expandable element comprises an expandable cage having a conduit (typically an axial conduit). The conduit typically has an opening disposed on the proximal side of the docking station to allow access to the conduit from the left atrium. The duct is generally covered by a cover, which typically has a reclosable aperture configured to allow the modular active component to enter the duct and close after the component has been placed in the duct (i.e., a self-closing aperture). Various types of reclosable apertures are disclosed herein, including flap valves and pierceable membranes. In one embodiment, the reclosable aperture includes a flap and an associated biasing means configured to bias the flap to a closed position.

By "radially expandable element" is meant a body that is expandable from a collapsed delivery configuration to an expanded deployed configuration. The body may take a variety of forms, such as a wire frame structure formed from a woven or mesh material. Examples of expandable wire frame structures suitable for endoluminal delivery are known in the literature and described in, for example, WO01/87168, US6652548, US2004/219028, US6454775, US4909789, US5573530, WO 2013/109756. Other body forms suitable for use with the invention include a plate or dish shaped scaffold or an inflatable balloon or stent. In one embodiment, the body is formed of a metal, for example a shape memory metal such as nitinol. The body may have any shape suitable for the purpose of the invention, for example disc-like or spherical. In one embodiment, the body comprises a tissue ablation device. In one embodiment, the ablation device includes an array of electrical components. In one embodiment, the array of electrical components is configured to deliver ablation energy in a specific pattern while mapping temperature. In one embodiment, the array of electrical components is configured to pace cardiac tissue for confirmation of ablation and destruction of chaotic signals of the LAA. In one embodiment, the distal surface of the radially expandable element comprises a covering configured to promote epithelial cell proliferation. In one embodiment, the body comprises a stepped radial force stiffness profile from the distal to the proximal device. In one embodiment, the body comprises a metal mesh cage stand. In one embodiment, the coupling between the body and the catheter member is distal to the left atrium facing the side of the body. In one embodiment, the body of the deployed configuration has a radial diameter at the deployment point that is at least 10% larger than the radial diameter of the left atrial appendage. In one embodiment, the distal-most body is configured to be atraumatic to the cardiac tissue. In one embodiment, the body cover is configured to self-close the contraction of the delivery component (i.e., the catheter member). In one embodiment, the body includes a woven mesh scaffolding that, in one embodiment, facilitates collagen infiltration upon thermal energy transfer to promote increased resistance to migration. In one embodiment, the electrode array generates an electrical map or profile of the ablation zone and surrounding tissue electrical impedance measurements to characterize the electrical properties of the tissue, wherein the characterization is optionally used as a measure and confirmation of ablation efficiency.

By "modular active element" is meant a device designed to be removably engaged in a recessed conduit formed in a docking station. The modular active element may be a therapeutic element or a sensing element, and is generally configured for removal from the docking station while the modular active element is in situ in the heart and replaced with a different modular active element (e.g., replacement of a tissue ablation module with a cardiac parameter sensor), or replaced with a new type of the same modular active element, or replaced with the same modular active element with a new battery. The treatment or sensing element may be configured for treatment or sensing operations applied to the LAA, the heart, a chamber of the heart (e.g., the left atrium), or blood passing through the heart. The modular active element and the recessed conduit (socket) are generally configured for removable engagement to allow detachment and retraction of the modular active element and reattachment of the same or a different modular active element while the docking station remains in place in the LAA of the heart. In one embodiment, the modular active element is sized to fit within the heart. In one embodiment, the modular active element is sized to fit within the left atrium (including the left atrial appendage). In one embodiment, the modular active element is sized to fit within the left atrial appendage.

By "closure" or "cap" is generally meant a layer disposed on the proximal side of the radially expandable element that covers the opening to the recessed receptacle. Which is intended to prevent blood flow through the occluding device into the LAA. It may be formed of a woven mesh material and may comprise a reclosable closure, such as an overlapping material flap or a polymeric valve, or it may comprise a pierceable cap. In some embodiments, the connection hub is disposed in a recess between the cap and the concave proximal surface of the radially expandable body.

By "cover configured to promote epithelial cell proliferation" is meant a material for promoting epithelial proliferation of the distal or proximal body. In one embodiment, the covering is a membrane comprising an agent that promotes epithelial cell proliferation. Examples include growth factors such as fibroblast growth factor, transforming growth factor, epidermal growth factor, and platelet-derived growth factor, cells (such as endothelial cells or endothelial progenitor cells), and biological materials (such as tissues or tissue components). Examples of tissue components include endothelial tissue, extracellular matrix, submucosa, dura mater, pericardium, endocardium, serosa, peritoneum, and basement membrane tissue. In one embodiment, the cover is porous. In one embodiment, the covering is a biocompatible scaffold formed from a biomaterial. In one embodiment, the covering is a porous scaffold formed from a biomaterial, such as collagen. In one embodiment, the cover is a freeze dried scaffold.

"radially expandable" means expandable from a collapsed configuration suitable for delivery to a deployed, expanded position. Typically, the body is radially expandable about a longitudinal axis of the device. One or both of the bodies may be self-expandable. In another embodiment, the ontology is non-self-expandable, but configured for manual deployment. An extensible ontology configured for manual extension is described in PCT/IE 2014/000005.

By "removably engaged" is meant that the modular active element and the conduit are configured to allow the modular active element to be attached to and subsequently detached from the conduit, thereby allowing the modular active element to be detached from the conduit and withdrawn from the body, and replaced with the same or a different modular active element. Various means of detachable attachment are described herein, including snap fit, friction fit, threaded screws, and magnetic arrangements.

"intraluminal delivery" as applied to the device of the present invention or portions thereof (docking station or modular active elements) means delivery through a body lumen to a target site (e.g., the heart), such as through an artery or vein. In one embodiment, the apparatus of the present invention is advanced through an artery or vein to deliver an occlusion device to the left atrium of the heart and at least partially within the LAA.

An "anchor" applied to the docking station means a protrusion, typically on the periphery of the body, configured to protrude into the wall of the LAA. Examples of suitable anchors include hooks or barbs. Generally, the anchor comprises a plurality of individual anchors, for example disposed around the periphery of the radially expandable element.

By "sensor" or "sensing element" is meant an electrical sensor configured to detect environmental parameters within or proximal to the LAA, such as blood flow, electrical signal activity, pressure, impedance, humidity, temperature, radiation, and the like. The sensor may comprise an emission sensor and a detection sensor, suitably spaced apart. In one embodiment, the sensors are electrodes. In one embodiment, the sensor is configured to detect fluid flow. In one embodiment, the sensor is configured to detect conductivity. In one embodiment, the sensor is configured to detect electrical impedance. In one embodiment, the sensor is configured to detect acoustic (i.e., photoacoustic and acousto-optic) signals. In one embodiment, the sensor is configured to detect a light signal that is generally indicative of a change in blood flow in the surrounding tissue. In one embodiment, the sensor is configured to detect stretching. In one embodiment, the sensor is configured to detect humidity. In one embodiment, the sensor is configured for wireless transmission of the detected signal to the processor. The sensors may be used in real time during the methods of the present invention to allow the surgeon to determine when the LAA is sufficiently occluded, for example to determine blood flow or electrical activity within the LAA. Examples of suitable sensors include optical sensors, radio frequency sensors, microwave sensors, sensors based on lower frequency electromagnetic waves (i.e., from DC to RF), radio frequency waves (from RF to MW), and microwave sensors (GHz). In one embodiment, the device of the present invention is configured for axial movement of the sensor relative to the radially expandable body. In one embodiment, the device of the present invention is configured for rotational movement of the sensor generally about the longitudinal axis of the device. This helps in the positioning of the sensor and helps in achieving full circumferential sensing. In one embodiment, the sensor is configured to detect a parameter of the left atrium. In one embodiment, the sensor is configured to perform in vivo dosimetry to detect radiation dose, ideally in real time.

By "optical sensor" is meant a sensor suitable for detecting changes in blood flow in tissue, and the sensor generally involves directing light at the tissue and measuring the reflected/transmitted light. These sensors are particularly sensitive to detecting changes in blood flow in adjacent tissue and are therefore suitable for detecting blood flow blockage in tissue, such as LAA. Examples include optical probes using pulse oximetry, optical plasma imaging, near infrared spectroscopy, contrast enhanced ultrasound imaging, dispersion related spectroscopy (DCS), transmission or reflection sensors, LED RGB, laser doppler flow meters, diffuse reflection, fluorescence/autofluorescence, Near Infrared (NIR) imaging, dispersion related spectroscopy, and optical coherence tomography. An example of a spectral sensor is a device that transmits light of two wavelengths through tissue to a photodetector that measures the absorbance change at each of the wavelengths, allowing it to determine absorbance as a result of pulsing only arterial blood (excluding venous blood, muscle, fat, etc.). The photo graph measures changes in tissue volume caused by the heartbeat detected by illuminating the tissue with light from a single LED and then measuring the light reflected to a photodiode.

"treatment element" refers to a device configured to deliver therapy to the heart or blood. Examples include energy delivery elements and drug dispensing devices (e.g., devices configured to release a chemical or biologically active agent, such as drugs, gene therapy, etc.). An "energy transfer element" refers to a device configured to receive energy and direct the energy to tissue, and ideally convert the energy into heat to heat the tissue (thereby causing collagen denaturation (tissue ablation)). Tissue ablation devices are known to the skilled artisan and operate based on emitting thermal energy (hot or cold), microwave energy, radiofrequency energy, radiation, other types of energy suitable for tissue ablation, or chemicals configured to ablate tissue. Tissue ablation devices are sold by ANGIODYNAMICS, including the STARBURST radio frequency ablation system and the ACCULIS microwave ablation system. Examples of tissue ablation chemicals include alcohols, heated saline, heated water. Typically, the liquid is heated to at least 45 ℃, i.e. 45 ℃ to 70 ℃. In one embodiment, the tissue ablation device includes an electrode array or electrical component that is generally configured to deliver heat to adjacent tissue (alcohol, heated saline, heated water). In one embodiment, one or more of the electrodes includes at least one or two thermocouples in electrical communication with the electrode. In one embodiment, one or more of the electrodes is configured to deliver RF or microwave energy. In one embodiment, one or more of the electrodes are configured to deliver both reversible and irreversible electroporation. In one embodiment, one or more of the electrodes is configured to be delivered by capacitive coupling. In one embodiment, the device of the present invention is configured for axial movement of the energy delivery element relative to the radially expandable body. In one embodiment, the energy delivery element comprises a radially expandable body. In one embodiment, the device of the present invention is configured for rotational movement of the energy delivery element generally about the longitudinal axis of the device. This facilitates positioning of the energy delivery element and facilitates achieving full circumferential tissue ablation. In one embodiment, the energy delivery element comprises a radioactive material suitable for radiotherapy. In one embodiment, the energy delivery element is configured to apply a radioactive material to tissue, for example, a radioactive substance, such as a pill or gel. The radioactive material may include radioactive iodine, cesium or palladium isotopes. In one embodiment, the substance takes the form of "seeds" that are small (typically about 0.8 x 4.5mm) cylinders containing the radioactive element in a stainless steel housing. A plurality of seeds (typically between 80 and 120 seeds) are placed in contact with the cardiac tissue by attaching them to a gantry or to a radially expandable element. The seed may remain permanently in place while the emitted radiation decays over time. Common radioisotopes used in seeds are iodine-125, palladium-103 and cesium-131. Over a period of weeks or months, the level of radiation emitted by the source will drop to almost zero. However, null seeds remained at the treatment site with no lasting effect. The goal of the seed is to ensure that the total dose received by the heart cells is sufficient to kill them, thereby permanently electrically isolating the tissue in contact with the seed.

"atrial fibrillation" or "AF" is a common heart rhythm disorder whose impact is predicted only in the united states for six million patients. AF is the second leading cause of stroke in the united states and can account for nearly one third of the strokes in older adults. In cases where blood clots (thrombi) are found in more than 90% of patients with AF, the clots develop in the Left Atrial Appendage (LAA) of the heart. The irregular heartbeat of AF causes blood to pool in the left atrial appendage because clotting occurs when blood is retained, clots and thrombi can form in the LAA. These blood clots may detach from the left atrial appendage and may enter the cranial circulation causing stroke, the coronary circulation causing myocardial infarction, the peripheral circulation causing limb ischemia, and other vascular beds. The term includes all forms of atrial fibrillation, including paroxysmal (intermittent) AF and persistent and long-lasting AF (plpaf).

An "ischemic event" refers to a restricted blood supply to a body organ or tissue, resulting in a shortage of oxygen and glucose supply to the affected organ or tissue. The term includes stroke, obstruction of blood supply to a part of the brain (caused by a blood clot that obstructs blood supply to the brain), and resulting damage to the affected part of the brain, and transient ischemic events (TIA) (also known as "small strokes"); this transient ischemic event is similar to a stroke, but transient in nature and generally does not cause lasting damage to the brain. When a coronary artery is given a restricted blood supply, the ischemic event is known as a Myocardial Infarction (MI) or a heart attack.

An "inductor" generally refers to a two-terminal electrical component that stores energy in a magnetic field when a current flows through it. The inductor typically takes the form of a coil of wire, with or without a magnetic core.

"resonant power circuit" generally refers to an LC circuit connected to a voltage or current source. Resonant power circuits typically generate a strong magnetic field that can be used to wirelessly transfer power to a receiving circuit.

The "desired Q factor" generally refers to the ratio between the center frequency and the bandwidth of the resonant LC circuit.

An "RC circuit" generally refers to an electronic circuit consisting of a resistor and a capacitor.

"DC regulator" generally refers to an electronic component that converts non-direct current (usually alternating current) to direct current.

An "LC circuit" generally refers to an electronic circuit consisting of an inductor and a capacitor.

Illustration of

The invention will now be described with reference to specific examples. These examples are exemplary only and for illustrative purposes only: they are not intended to limit the scope of the monopoly claimed or the invention described in any way. These examples constitute the best modes presently contemplated for practicing the invention.

With reference to the drawings, and initially to fig. 1A to 1F, there is shown a docking station 2, the docking station 2 forming part of the device 1 of the present invention, shown in its deployed configuration, and comprising a radially expandable element (in this case, a cage 3); the radially expandable element has a toroidal proximal end 4 with a recessed socket 5 (fig. 1D) and a cylindrical distal end 6. As shown in fig. 1A-1C, the proximal end of the cage includes a mesh cover 7; the mesh cover 7 is impermeable to blood and fluidly isolates the LAA from the left atrium in use when the device is anchored to the LAA. A re-closable aperture is provided over the recessed receptacle 5 in the form of a flap 8 and an associated hinged spring clamp 9, the associated hinged spring clamp 9 being configured to bias the flap to a closed position. The purpose of the re-closable aperture is to allow access to the recessed receptacle from the left atrium when the modular active element is removed and replaced, and to fluidly isolate the recessed receptacle from the left atrium at other times. In fig. 1B, the modular active element 12 is shown engaged within the recessed socket 5, and the delivery catheter 10 is shown abutting the mouth of the recessed socket 5.

Fig. 2A and 2B illustrate one embodiment of a reclosable flap 8 formed on a mesh cover 7, the mesh cover 7 including a plurality of valve leaflets 11, the valve leaflets 11 being biased to the closed orientation shown in fig. 2A and being urged inwardly to the open configuration shown in fig. 2B upon application of a force. The valve material used for the leaflets can be the same material used for replacement heart valves, such as TAV1, e.g., porcine epicardial tissue.

Fig. 2C-2F illustrate the operation of the valve. In fig. 2C, the valve is shown in a closed configuration, fluidly isolating the left atrium from the LAA and the recessed receptacle 5. In fig. 2D, the delivery catheter 10 is shown including modular active elements 12, the delivery catheter 10 protruding through the valve with the valve leaflets conforming closely to the catheter sidewalls. In fig. 2E, the modular active component 12 has been delivered to and engaged with the recessed socket 5; and in fig. 2F, the catheter 10 has been withdrawn, allowing the valve to close.

Fig. 3A shows a number of different ways in which the modular active component 12 and the recessed socket 5 are removably engaged, namely: a threaded engagement (fig. 3A) in which the modular active component 12 and the inner wall of the recessed socket 5 have cooperating threads configured to allow the modular active component 12 to be screwed into the recessed socket; an interference fit (fig. 3B), wherein the element 12 has a distal end 12A, the distal end 12A configured for radial expansion to frictionally fit in the conduit; an anchoring deployment (fig. 3C) in which the distal end 12A and the proximal end 12B of the element 12 have anchoring elements 14, the anchoring elements 14 being configured to deploy radially outwardly at each end of the conduit 5 to provide engagement; balloon deployment (fig. 3D) wherein the distal end 12A of element 12 has an inflatable balloon 16; and a spring engagement (fig. 3E and 3F), wherein the distal end 5A of the recessed tube 5 tapers inwardly and the distal end of the modular active element has a circumferential slot 17, the circumferential slot 17 being sized to engage the inwardly tapered end 5A of the recessed tube.

Fig. 4A, 4B and 4C illustrate one embodiment of the device of the present invention in which the radially expandable element 3 comprises a series of radially conductive elements 30, thereby providing electrical communication between the modular active element 12 (when it is engaged in the recessed socket 5) and the wall of the LAA. In this embodiment, the conductive element is attached to the inside of the mesh cover and can be used as an energy delivery element to deliver ablative energy from the modular active element 12 to the wall of the LAA to electrically isolate the LAA. In another embodiment, the conductive element 30 may be a sensor configured to detect a parameter of the wall of the LAA.

FIG. 5 illustrates one embodiment of a radially expandable member; wherein the circumferential periphery of the cage 3 has a double layer of mesh 29, the mesh 29 being configured to more readily circumferentially engage the wall of the LAA and may include bristles, or may wear, or may incorporate unidirectional anchors.

Fig. 6A shows one embodiment of the device of the present invention in which the distal end of the modular active component 12 incorporates magnets of a first polarity 22 and the perimeter of the recessed socket 5 incorporates magnets of a second polarity 24 to facilitate insertion of the component 12 into the recessed socket 5. Fig. 6B shows another embodiment of the device of the present invention in which the delivery catheter 10 has a magnetized head of a first polarity 26 and the perimeter of the recessed socket 5 incorporates magnets of a second polarity 27 to interface the catheter and recessed socket during delivery of the modular active element 12. Fig. 6C shows another embodiment of the device of the present invention in which the delivery catheter 10 has a magnetized head of a first polarity 26 and the perimeter of the recessed socket 5 incorporates magnets of a second polarity 27 to interface the catheter and recessed socket during delivery of the modular active element 12. In this embodiment, the modular active element 12 disposed within the catheter 10 has a piercing tip configured to pierce the mesh cap 7.

Fig. 7 shows a tissue ablation modular active element forming part of the device of the invention and having an inflatable balloon 31, and a radially expandable RF electrode coil 32, the radially expandable RF electrode coil 32 being disposed distally of the RF electrode. In this embodiment, the device of the present invention comprises a catheter 10, the catheter 10 remaining attached to the modular active element 12 during use of the device. The catheter and the modular active element are configured to be withdrawn from the docking station and withdrawn from within the patient cavity. The modular active element may be detached from the catheter, replaced with another modular active element before intraluminal delivery to the left atrium, and re-engaged with the docking station and deployed through the recessed receptacle. Fig. 7A shows the modular active element in a partially deployed active configuration, and fig. 7B shows the modular active element in a collapsed delivery configuration. Fig. 7C shows the deployed modular active element deployed and anchored in the LAA with the RF coil 32 deployed within the cage 12 and in contact with the LAA tissue for tissue ablation.

Fig. 8A shows a modular active element 40 comprising coaxially mounted inflatable balloons 41; FIG. 8B is a cross-sectional view taken along line 1-1 of FIG. 8A, showing a plurality of separate lumens in element 40 for inflation and deflation of the balloon for providing light and for optical imaging. Fig. 8C illustrates a modular active element including an inflatable balloon having different compartments configured to deliver different cryogenic ablation therapies. The ablation therapy may be zone controlled or activated depending on the ablation application (i.e., the distal zone and the proximally-facing zone).

Fig. 9 shows a modular active element 50 with two inflatable balloons 51,52, the inflatable balloons 51,52 being engaged within the LAA. In this embodiment, the first balloon 51 may be configured to deliver cryotherapy to adjacent LAA tissue to ablate tissue at the treatment region 53; and the second balloon 52 may be configured to receive a warm fluid to heat tissue near the phrenic nerve to protect the nerve from ablation by cryotherapy of the adjacent treatment region 53.

Fig. 10 shows one embodiment of a modular active element forming part of the inventive device, wherein the proximal end of the element 12 comprises an extension 54, which extension 54 can be grasped by a snare 55 to allow removal of the modular active element 12 with the recessed socket 5.

Fig. 11 shows one embodiment of a modular active element forming part of the inventive device inside a delivery catheter 10 in a delivery configuration (fig. 11A) and engaged in a recessed receptacle 5 of a docking station 2 in a deployed configuration (fig. 11B). The modular active element includes a charging coil 55, the charging coil 55 operatively connected to a battery 56 and having distal and proximal anchoring arms 57, the distal and proximal anchoring arms 57 biased to deploy outward and anchor the element within the recessed receptacle upon ejection of the element from the delivery catheter. The coil 55 is configured to receive power from an external source and relay data to a remote receiver.

Fig. 12A-12H illustrate one embodiment of a method of using the device of the present invention. Fig. 1 shows the device of the present invention attached to a delivery catheter 10A of the LAA in proximity to the left atrium of a human heart. Fig. 12B shows the device in a deployed configuration with the docking station 2 anchored in the mouth of the LAA and the modular active element 62 engaged within the recessed socket 5 of the docking station. Fig. 12C shows the catheter 10A with the catheter 10A detached from the docking station prior to retraction from the heart's cavity. Fig. 12D shows the extraction catheter 10B with the magnetized head 26 near the proximal surface of the docking station; and fig. 12E shows the catheter engaging the docking station and protruding through the reclosable valve in the cover, and the modular active element 62 retracted from the recessed receptacle of the docking station into the extraction catheter. Fig. 12F shows the extraction catheter 10B with modular active elements in situ, the extraction catheter 10B being extracted endoluminally from the heart. Fig. 12G shows a replacement catheter 10C including a replacement modular active element 63, the replacement modular active element 63 being proximal to the docking station and protruding through the reclosable valve before delivering the element 63 into the empty-recessed receptacle 5, as shown in fig. 12H.

FIG. 13 is an illustration of the alignment forming part of the apparatus of the present invention, the docking station having a radially expandable cage and a recessed socket (the mouth of the socket is shown); and shows the recessed sockets in a resting configuration (left) and in an expanded configuration (right). These figures also show how the socket may comprise longitudinal sections or segments; these sections or segments are contiguous but unconnected and allow radial expansion of the socket when, for example, an oversized modular active element is advanced into the socket.

Fig. 14 shows a docking station forming part of a device according to the invention, the docking station having a cover comprising a network of radial conduits disposed on an inside surface of the cover and configured to receive electrodes or wires disposed at the distal end of an associated catheter and direct the wires radially outwardly to the periphery of the cover. The cover includes circumferentially arranged apertures configured to expose the distal end of the electrode to tissue when the docking station is deployed in a body lumen.

Fig. 15A and 15B illustrate an embodiment of the device of the present invention wherein the radially expandable element is a cage comprising circumferential brushes. The cage may be formed from wires (e.g., stainless steel or nitinol wires), and some of the wires may include a brush member having a central spine and an arrangement of bristles extending radially outward from the spine.

Equivalents of

The foregoing description details the presently preferred embodiments of the invention. Many modifications and variations in their practice are expected to occur to those skilled in the art upon consideration of this description. Such modifications and variations are intended to be included herein in the appended claims.