阅读说明：本技术 心脏瓣膜对接设备和植入方法 (Heart valve docking device and method of implantation ) 是由 D·迈蒙 H·阿特曼 于 2016-02-11 设计创作，主要内容包括：在各种实施例中,设备被配置为修复天然心脏瓣膜或将假体心脏瓣膜固定在患者心脏的天然瓣膜内。该设备的实施例至少包括一个上部线圈和一个下部线圈,其中该设备被配置为呈现其中整个上部线圈相对于中心轴线定位在下部线圈的第一侧上的轴向膨胀状态和其中上部线圈的至少一部分相对于中心轴线定位在与第一侧相对的下部线圈的至少一部分的第二侧上的轴向压缩状态。(In various embodiments, the device is configured to repair a native heart valve or to secure a prosthetic heart valve within a native valve of a patient's heart. Embodiments of the apparatus include at least one upper coil and one lower coil, wherein the apparatus is configured to assume an axially expanded state in which the entire upper coil is positioned on a first side of the lower coil relative to the central axis and an axially compressed state in which at least a portion of the upper coil is positioned on a second side of at least a portion of the lower coil opposite the first side relative to the central axis.)

1. A device for implantation at a native heart valve of a heart of a patient, the device comprising an upper coil and a lower coil and a central axis extending through the upper coil and the lower coil;

wherein the device is configured to assume an axially expanded state in which the entire upper coil is positioned on a first side of the lower coil relative to the central axis; and

wherein the device is configured to assume an axially compressed state in which at least a portion of the upper coil is positioned on a second side of at least a portion of the lower coil opposite the first side relative to the central axis.

2. The apparatus of claim 1, wherein the apparatus comprises a first set of one or more coils comprising the upper coil and a second set of one or more coils comprising the lower coil, wherein the first set of coils has a first inner diameter and the second set of coils has a second inner diameter different from the first inner diameter.

3. The apparatus of claim 2, wherein the first set of coils comprises at least two coils and the second set of coils comprises at least two coils.

4. The device of claim 2, wherein at least one of the coils in the first set of coils is positioned between two coils in the second set of coils relative to the central axis when the device is in the compressed state.

5. The device of claim 2, wherein the first set of coils is configured to be positioned on a ventricular side of a native mitral valve and the second set of coils is configured to be positioned on an atrial side of the native mitral valve.

6. The apparatus of claim 1, wherein the upper coil and the lower coil each comprise a shape memory material.

7. The apparatus of claim 1, wherein the upper coil and the lower coil each comprise nitinol.

8. The apparatus of claim 1, wherein the upper coil is positioned radially inward relative to the lower coil when the apparatus is in the compressed state.

9. The device of claim 8, wherein the upper coil is configured to apply a radially outward directed force to the lower coil when the device is in the compressed state.

10. The apparatus of claim 1, wherein an axial tension is applied to the apparatus when the apparatus is in the axially expanded state.

Technical Field

The present disclosure relates generally to prosthetic heart valves and associated devices and related methods for implanting such devices. More particularly, the present disclosure relates to repair and replacement of heart valves having malformations and/or dysfunctions, wherein additional abutments or anchors are utilized at the implantation site along with the prosthetic heart valve, and methods of implanting such anchors and/or prosthetic heart valves.

Background

Referring generally to fig. 1A-1B, the native mitral valve controls blood flow from the left atrium to the left ventricle of a human heart. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annulus composed of native valve tissue surrounding the mitral valve orifice, and a pair of cusps or leaflets extending downward from the annulus into the left ventricle. The mitral annulus can form a "D" shape, an oval shape, or a non-circular cross-sectional shape having a major axis and a minor axis. The anterior leaflet may be larger than the posterior leaflet of the valve, forming a generally "C" shaped boundary between the abutting free edges of the leaflets when they are closed together.

When properly operated, the anterior and posterior leaflets of the mitral valve together act as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. After the left atrium receives oxygenated blood from the pulmonary veins, the muscles of the left atrium contract and the muscles of the left ventricle expand (also referred to as "ventricular diastole" or "diastole"), and the oxygenated blood collected within the left atrium flows into the left ventricle. The muscles of the left atrium then relax, and the muscles of the left ventricle contract (also referred to as "ventricular contraction" or "contraction") to move oxygenated blood out of the left ventricle and through the aortic valve to the rest of the body. The increased blood pressure in the left ventricle during ventricular systole drives the two leaflets of the mitral valve together to close the unidirectional mitral valve so that blood cannot flow back into the left atrium. To prevent the two leaflets from prolapsing under pressure during ventricular contraction and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords, known as chordae tendinae, tie the leaflets to papillary muscles in the left ventricle.

One common form of valvular heart disease is mitral valve leakage, also known as mitral regurgitation. Mitral regurgitation occurs when the native mitral valve fails to close properly during the systolic phase of systole, and blood flows back into the left atrium from the left ventricle. Mitral regurgitation has different causes such as leaflet prolapse, dysfunctional papillary muscles and/or stretching of the mitral annulus caused by left ventricular dilation. In addition to mitral regurgitation, mitral stenosis or stenosis is another example of valvular heart disease.

Like the mitral valve, the aortic valve is susceptible to complications such as aortic stenosis. One method for treating such valvular heart disease involves the use of prosthetic valves implanted within the native heart valve. These prosthetic valves can be implanted using various techniques, including various transcatheter techniques. One transcatheter technique commonly used to access native valves is the transvascular technique, in which a catheter enters the left side of the heart via the femoral vein, the inferior vena cava, the right atrium, and then via a puncture in the interatrial septum. The prosthetic valve can then be mounted in a crimped state on an end portion of a second flexible and/or steerable catheter, advanced to the implantation site, and then expanded to its functional size, for example, by inflating a balloon on which the valve is mounted. Alternatively, the self-expanding prosthetic valve can be held within a sheath of a delivery catheter in a radially compressed state, and the prosthetic valve can be deployed from the sheath, which allows the prosthetic valve to expand to its functional state.

Another common transcatheter technique for implanting prosthetic valves is the transcervical approach, in which a small incision is made in the chest wall and ventricular wall of the patient, and then a catheter or introducer sheath is inserted into the left ventricle. A delivery catheter containing or holding the prosthetic valve can then be advanced through the introducer sheath to the implantation site.

Such prosthetic valves are generally better deployed for implantation or use at the aortic valve. However, due to structural differences between the aortic and mitral valves, similar catheter-based prosthetic valves can be more difficult to apply or implant at the native mitral valve. For example, the mitral valve has more complex sub-valvular organs that include chordae tendineae. In addition, the native mitral valve is less rounded in shape and generally does not provide sufficient structure to anchor and resist migration of the prosthetic valve.

Disclosure of Invention

Since many valves have been developed for aortic locations, it is desirable to attempt to utilize these existing valve technologies as well as utilize the same or similar valves for tricuspid, pulmonary artery, and mitral valve replacement. One way of utilizing these pre-existing prosthetic valves is to use the prosthetic valve with anchors or other docking stations (docking stations) that will form a more appropriately shaped implantation site at the native valve annulus, enabling a more secure implantation of the prosthetic valve while reducing or eliminating leakage around the valve after implantation. For example, the mitral anchor or docking station can form a more circular hole at the annulus to more closely match the circular profile of existing aortic valve implants. In this way, an existing valve implant (which may have some modifications) developed for the aortic position can then be implanted with this anchor at the mitral valve position. In addition, such anchors may also potentially be used at other native valves of the heart to more securely anchor the prosthetic valve at those sites as well.

Embodiments of a prosthetic device primarily intended for implantation at one of the native mitral, aortic, tricuspid, or pulmonary valve regions of a human heart, as well as apparatus and methods for implanting the prosthetic device, are described herein. The prosthetic device can be used to repair a native valve annulus, as well as to position and secure a prosthetic heart valve in the native valve region. The disclosed devices can include a spiral anchor having a plurality of turns or a plurality of coils, wherein the spiral anchor can assume an axially collapsed position in which portions of at least two of the coils are aligned or overlapping in a radial direction.

In one embodiment, a spiral device for implantation at a native heart valve of a heart of a patient includes an upper coil and a lower coil and a central axis extending through the upper coil and the lower coil. The device is configured to assume an axially expanded state in which the entire upper coil is positioned on a first side of the lower coil relative to the central axis, and is further configured to assume an axially compressed state in which at least a portion of the upper coil is positioned on a second side of at least a portion of the lower coil opposite the first side relative to the central axis. The apparatus can include: a first set of one or more coils comprising an upper coil having a first inner diameter; and a second set of one or more coils including a lower coil having an inner diameter different from the first inner diameter.

In certain embodiments, the apparatus can include a first set of at least two coils and a second set of at least two coils. At least one coil of the first set of coils is positioned between two coils of the second set of coils relative to the central axis when the device is in a compressed state. The first set of coils can be configured to be positioned on a ventricular side of the native valve and the second set of coils can be configured to be positioned on an atrial side of the native valve. Preferably, the upper and lower coils are made of a shape memory material such as nitinol.

In another embodiment, a method of implanting a helical device comprising an upper coil and a lower coil at a native valve of a heart of a patient includes positioning the lower coil on a ventricular side of the native valve, positioning the upper coil on an atrial side of the native valve such that the entire upper coil is positioned on a first side of the lower coil relative to a central axis of the device, and adjusting the device to a position where at least a portion of the upper coil is positioned on a second side of at least a portion of the lower coil opposite the first side relative to the central axis.

The method may include implanting a prosthetic heart valve within the device. When the prosthetic heart valve is in a radially compressed state, the prosthetic heart valve is positioned in the device, and the prosthetic heart valve radially expands such that radial pressure is applied between the prosthetic heart valve and the device to anchor the prosthetic heart valve within the device.

In another embodiment, a system for securing a prosthetic heart valve at a native heart valve of a heart of a patient comprises: a helical docking device comprising an upper coil and a lower coil, wherein a central axis extends through the upper coil and the lower coil; and a prosthetic heart valve configured to be retained in the docking device. The docking device is configured to assume an axially expanded state in which the entire upper coil is positioned on a first side of the lower coil relative to the central axis, and an axially compressed state in which at least a portion of the upper coil is positioned on a second side of at least a portion of the lower coil opposite the first side relative to the central axis. The system can include a delivery catheter configured to deploy a docking device at a native heart valve.

Drawings

The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings. In the figure:

FIG. 1A shows a schematic cross-sectional view of a human heart;

FIG. 1B shows a schematic top view of the mitral annulus of the heart;

fig. 2A to 2C show a perspective view, a side view and a top view, respectively, of a screw device according to a first embodiment of the present invention;

FIGS. 3A and 3B show perspective and cross-sectional views, respectively, of the screw device of FIGS. 2A-2C in a compressed state;

4A-4M illustrate one embodiment of a delivery apparatus and method for implanting a helical docking device and prosthetic valve at a native mitral valve of a heart using a transcervical technique;

FIGS. 5A-5E illustrate another embodiment of a delivery apparatus and method for implanting a spiral device at the native mitral valve of the heart using a transseptal technique;

FIG. 6A shows a perspective view of a helical docking device according to a second embodiment of the present invention;

6B-6D illustrate various cross-sectional views of the helical docking device of FIG. 6A implanted at the native mitral valve of the heart;

FIG. 7A shows a perspective view of an expanded state of a helical docking device according to a third embodiment of the present invention;

fig. 7B and 7C show cross-sectional views of the helical docking device of fig. 7A at the native mitral valve of the heart;

FIG. 8A shows a perspective view of an expanded state of a helical docking device according to a fourth embodiment of the present invention;

FIGS. 8B and 8C show cross-sectional views of the spiral docking device of FIG. 8A at the native mitral valve of the heart; and

fig. 9A-9C show perspective views of a portion of a delivery catheter for a helical docking device, according to one embodiment

Detailed Description

Embodiments of a prosthetic device primarily intended for implantation in one of the native mitral, aortic, tricuspid, or pulmonary valve regions of a human heart, as well as apparatus and methods for implanting the prosthetic device, are described herein. The prosthetic device can be used to repair a native valve and position and secure a prosthetic heart valve in the native valve area. These prosthetic devices can improve the function of prosthetic heart valves to better repair the function of a replacement or replica defective native heart valve. The present disclosure is directed to all features and aspects of the various disclosed embodiments, both separately and in various combinations and sub-combinations with each other.

In certain embodiments, the prosthetic assembly includes an anchoring or docking device configured to be implanted at or near the native valve and configured to receive and retain the prosthetic valve. The docking device can be delivered and implanted in a minimally invasive manner via the left ventricle and/or left atrium, after which the individual prosthetic valves can be delivered and implanted in a minimally invasive manner within the docking device.

In certain embodiments, the docking device comprises a spiral anchor having a plurality of turns or a plurality of coils, at least one of the coils having a negative pitch relative to an adjacent coil when the spiral anchor is in at least one state (e.g., its undeformed or untensioned state). As used herein, the "pitch" of a helical anchor is the distance from the center of one coil to the center of an adjacent coil. In a typical spiral, the coils extend in the same axial direction, so that each coil can be said to have a positive pitch in this axial direction relative to the previous coil. However, if one of the turns or coils is superimposed on the outside or inside of its preceding coil, that particular coil can be said to extend in a direction opposite to the positive axial direction, making the pitch of that coil "negative" with respect to its preceding coil. Thus, the coil having the "negative pitch" extends along the longitudinal axis of the spiral anchor in a direction opposite to the direction of extension of the other coils in the spiral anchor. In some embodiments, the helical anchor can be preformed such that at least one of the coils has a negative pitch relative to the other coils in the anchor when the anchor is in its undeformed or untensioned state. In these embodiments, when the helical anchor is held in tension, the pitch measured from the first coil to the second coil extends in a first direction and defines a positive pitch, and when the helical anchor is released from tension, the second coil is axially movable back toward and through the first coil such that the second coil extends in an opposite direction and defines a negative pitch. In this way, the first coil can be at least partially disposed within the second coil (i.e., radially inward from the second coil) in this non-tensioned state, or vice versa. The anchor can be adjusted to its final position by self-alignment or guided or mounted by a delivery system.

Fig. 2A to 3B show a screw docking device 34 according to a first embodiment of the present invention. The docking device 34 includes first and second lower or ventricular coils 54a, 54b configured to be positioned on the ventricular side of the native valve and first and second upper or atrial coils 56a, 56b configured to be positioned on the atrial side of the native valve. Although the illustrated docking device 34 has two ventricular coils and two atrial coils, other embodiments of the docking device can have a greater or lesser number of ventricular coils and/or atrial coils.

In the embodiment of fig. 2A-3B, the atrial coils 56a, 56B have an inner diameter that is different than the inner diameter of the ventricular coils 54a, 54B to facilitate nesting or positioning of the atrial coils within the ventricular coils when the docking device 34 is in a compressed state. As shown in fig. 2B-2C, the atrial coils 56a, 56B have an inner diameter 72 that is smaller than an inner diameter 74 of the ventricular coils 54a, 54B. Larger ventricular coils can, for example, make it easier to wrap (loop) the ventricular coils 54a, 54b around the leaflets of the native mitral valve and/or chordae tendinae. Larger ventricular coils can also, for example, allow the docking device and docked prosthetic heart valve to be placed higher up (i.e., toward the atrium) in the native valve, as described further below.

The atrial coils 56a, 56b can have an inner diameter 72 of about 22mm to about 30mm, with about 25mm being a specific example. The ventricular coil can have an inner diameter 74 of about 24mm to about 32mm, with about 27mm being a specific example. The coil wire can have a diameter of about 0.3mm to about 1.2mm, with about 1mm being a specific example. When the dock 34 is in an axially compressed state (e.g., as shown in fig. 3A-3B), the innermost diameter of the dock can be about 25mm, and the outermost diameter of the dock can be about 29 mm. The prosthetic valve 36 can be selected to have a nominal outer diameter that is slightly larger than the innermost diameter of the docking device to create sufficient anchoring force between the prosthetic valve and the docking device in a radial direction to hold the prosthetic valve in place. For example, a docking device having the dimensions described above can be used with a 26mm prosthetic valve.

In an alternative embodiment, the inner diameter of the atrial coil can be larger than the inner diameter of the ventricular coil (e.g., as shown in fig. 6A-6D described in more detail below).

In particular embodiments, the inner diameter of each ventricular coil can be substantially the same, and/or the inner diameter of each atrial coil can be substantially the same. Thus, when the docking device 34 is moved from the axially expanded state to the axially compressed state, the ventricular coils 54a, 54b axially overlap the atrial coils 56a, 56b in a manner similar to a cylinder within a cylinder, as described further below.

In other embodiments, the inner diameter of each of the atrial coil and the ventricular coil can vary. For example, one atrial coil can have a larger or smaller inner diameter than the inner diameter of the other atrial coil, and one ventricular coil can have a larger or smaller inner diameter than the inner diameter of the other ventricular coil. Further, the one or more atrial coils can have the same inner diameter as the one or more ventricular coils.

In one embodiment, the dock 34 may expand axially when tension is applied to one or both ends of the dock 34, and the dock 34 may compress axially when tension is released from the dock 34. In this way, it can be said that the docking device 34 is constituted by or acts like an extension spring. Fig. 2A-2C show the docking device in an axially expanded state such that all coils have a positive pitch relative to adjacent coils. That is, the second atrial coil 54b is located upstream (i.e., above as shown) in the axial direction from the first atrial coil 54a, the first atrial coil 56a is located upstream from the second atrial coil 54b, and the second atrial coil 56b is located upstream from the first atrial coil 56 a. Thus, in this embodiment, the positive pitch direction can be defined as being oriented in the upstream direction or the upward direction.

Meanwhile, fig. 3A-3B illustrate the docking device 34 in an axially compressed state, for example, after releasing tension from the docking device 34. In this state, the first atrial coil 56a is moved or activated by the delivery system axially through the center of the second ventricular coil 54b in the downstream direction (i.e., downward as shown) such that the first atrial coil 54a is located below the second ventricular coil 54b (and in the illustrated embodiment between the first and second ventricular coils 54a, 54 b). Thus, the first atrial coil 56a is positioned at a negative pitch, as it were, relative to the second ventricular coil 54 b. Further, in the compressed state, the atrial coils 56a, 56b are located radially inward of the ventricular coils 54a, 54 b. As shown, the atrial coils 56a, 56b become interleaved and nested within the ventricular coils 54a, 54 b.

As the docking device 34 assumes the axially compressed state shown in fig. 3A-3B, the native valve leaflets can be lodged between the ventricular coils 54a, 54B and the atrial coils 56a, 56B (see, e.g., fig. 4L and 4M), wherein the coils compress or clamp the leaflets between adjacent coils in the radial direction, and in some cases also in the axial direction. Prior to implanting the prosthetic heart valve within the docking device 34, the docking device 34 exerts sufficient force on the native leaflets to hold the docking device 34 in place and resist migration due to blood flow between the left atrium and left ventricle. Because the docking device 34 can be secured to the valve leaflets without being held in place by a delivery device or other device, the delivery device can be removed from the patient's heart prior to deployment of the prosthetic heart valve within the docking device 34, as described further below. This can, for example, advantageously reduce the complexity of the overall procedure for subsequent implantation of the docking device and prosthetic heart valve.

Since at least some of the coils of the docking device 34 axially overlap (similar to a spring within a spring), the docking device can be formed from a relatively thin wire. This is because the axially overlapping coils together provide sufficient radial force to hold the prosthetic heart valve firmly in place during the dynamic diastolic and systolic phases of systole. A docking device formed from a relatively thin wire can, for example, make the docking device 34 easier to transport through a delivery apparatus and can facilitate deployment from the delivery apparatus.

The docking device 34 can be formed or otherwise formed from a length of wire, tubing, or ribbon of flexible, resilient material, such as nitinol, stainless steel, or a polymer, that returns to its original shape when released from a deformed or deflected state. Coil flexibility can also be achieved, for example, by using narrow or thin springs, applying notches to thin tubes, or using woven materials. In some embodiments, the docking device can be loaded into the shaft of the delivery catheter and held within the delivery catheter in a substantially straight configuration for delivery into the patient's heart. When formed of a flexible, resilient material, the docking device 34 can be formed or shaped (e.g., by thermoforming a nitinol wire) into a helical, axially compressed state as shown in fig. 3A. In this manner, the docking device 34 can be transitioned from the substantially straight configuration to its coiled configuration after being released from the delivery catheter.

As shown, the coil wire of the docking device 34 has a generally circular cross-sectional shape. In other embodiments, the coil wire can include various other cross-sectional shapes, such as square, rectangular, oval, and the like. For example, the coil wires of the docking device 300 and the docking device 400 (see fig. 7A to 7C and 8A to 8C) have a substantially rectangular cross-sectional shape.

It should be noted that the docking apparatus can be formed from one or more lengths of helical wire, tubing or strip. For example, in some embodiments, the ventricular coil and the atrial coil can be formed from a length of continuous wire. In other embodiments, the ventricular coil can be formed from a first length of wire or material and the atrial coil can be formed from a separate second length of wire or material. When the docking device is formed from two or more lengths of wire or material, each section of the docking device can be deployed, for example, using the same delivery apparatus or using a separate delivery apparatus.

In the above embodiments, at least a portion of the first set of coils is nested within the second set of coils, wherein at least a portion of one or more coils in the second set is aligned or overlaps with one or more coils in the first set in a radial direction, for example, by releasing tension on the docking device and allowing the device to assume a shape memory state. In other embodiments, the docking device can be configured such that the atrial coil and the ventricular coil do not return to the nested configuration when the tension is released from the docking device. Instead, the docking device can be configured to cause the first set of coils to be manually moved to an axial position where one or more coils of the second set overlap one or more coils of the first set in a radial direction, such as by applying an axially directed force to one or both ends of the docking device. In these embodiments, the docking device can be forced into a nested or radially overlapping state, for example, by manually applying a force (e.g., an axial compressive force) to the docking device with the delivery apparatus.

Fig. 4A-4M illustrate a method of implanting the docking device 34 and prosthetic heart valve 36 at a native mitral valve 42 of a patient's heart 12 using the delivery apparatus 10, according to one embodiment using transcompartmental techniques.

As shown in fig. 4A, the delivery device 10 includes an introducer 14 and a flexible delivery catheter 16 (also referred to as a "guide catheter" in some embodiments). The introducer 14 of the delivery device 10 has an axially extending shaft portion 18 and a hub or housing 20. The housing 20 is fixedly secured or coupled to the proximal end 24 of the shaft portion 18. Introducer 14 also has a lumen 22 extending coaxially through shaft 18 and housing 20. Various other components of the delivery device 10 and/or other devices (prosthetic implants, catheters, etc.) can be introduced into the patient's heart 12 through the lumen 22 of the introducer 14. The housing 20 can also house one or more elastomeric seals to maintain hemostasis as the device is inserted through the lumen 22, as is known in the art.

The guide catheter 16 of the delivery device 10 includes an elongate shaft 25. The shaft 25 has a flexible section 26 extending along a distal portion of the shaft 25, a relatively more rigid section 30 located adjacent to the flexible section 26 and proximal to the flexible section 26, and a lumen 32 extending the length of the shaft 25.

The flexible section 26 of the shaft 25 is positionable in a first delivery configuration and a second activation configuration. In the delivery configuration, the flexible segment 26 is substantially straight, allowing the flexible segment 26 to easily pass through the lumen 22 of the introducer 14 and the mitral valve 42, as shown in fig. 4A. In the activated configuration, the guide catheter 16 forms a first "U" shaped bend 46 and a second helical bend 48, as shown in fig. 4B and 4C. The first curved portion 46 forms a 180 degree bend at the end of the rigid section 30 and extends substantially parallel to the rigid section 30. The second curved portion 48 includes a proximal section 48a that curves radially away from the first curved portion 46 in a plane substantially perpendicular to the first curved portion 46, and the second curved portion 48 includes a distal tip portion 48b that angles downwardly away from the plane of the proximal section 48 a. These curved portions 46, 48 can help properly position the helical docking device 34 during the implantation procedure, as described further below.

In one embodiment, the flexible section 26 of the shaft 25 can be formed from a flexible, resilient material, such as nitinol or a polymer, that returns to its original shape when released from a deformed or deflected state. When formed of a resilient material, the flexible section 26 of the shaft 25 can be formed or shaped (e.g., by thermoforming a nitinol tube) into an activated configuration (as shown in fig. 4B). In this way, the curved activated configuration is an undeformed state of the flexible section, and thus, in the absence of any external force applied to the shaft, the flexible section will assume the activated configuration.

Due to its flexibility, the flexible section 26 of the shaft 25 can be held in the delivery configuration shown in fig. 4A, for example, by inserting a rigid rod (not shown) through the lumen 32 of the shaft 25. Inserting the rigid rod through the lumen 32 of the shaft 25 forces the flexible section 26 of the shaft 25 to axially elongate or straighten, thus reducing the radial profile of the distal end of the guide catheter 16 compared to the radial profile of the distal end of the guide catheter 16 in the activated configuration. The delivery configuration can allow the guide catheter 16 to more easily move through the vasculature of a patient. Once the flexible section 26 of the shaft 25 has been advanced into the left atrium of the heart, the rigid rods can be retracted from within the flexible section 26 of the shaft 25, which allows the flexible section 26 to return to its curved, activated configuration.

In an alternative embodiment, the flexible section 26 of the shaft 25 can be placed in its activated configuration by one or more actuators or steering mechanisms. For example, the flexible section 26 can be converted from the delivery configuration to the activated configuration using at least one pull wire (see, e.g., pull wire 104 in fig. 9A-9C). The pull wire can extend coaxially through the lumen 32 of the shaft 25 and can have a distal end fixedly secured to the inner surface of the distal end 28 of the shaft 25. The flexible section 26 of the shaft 25 can be configured such that pulling the proximal end of the pull wire applies an axial compressive force to the guide catheter 16 while maintaining axial positioning of the guide catheter 16. This axial compressive force causes the flexible section 26 of the shaft 25 of the guide catheter 16 to bend from the delivery configuration to the activation configuration, for example, based on specific cuts or slots formed along the length of the shaft 25 to control the shaping of the flexible section 26.

In another embodiment, the docking device itself can be used to effect the transition of the flexible section 26 of the shaft 25 from the delivery configuration to the activated configuration. Once the guide catheter 16 is advanced to the desired location for placement of the docking device, the docking device can be advanced through the lumen 32 of the shaft 25. In this alternative embodiment, the relatively more rigid section 30 of the shaft 25 can be configured to resist the spring force exerted by the docking device 34 (which attempts to return to its undeformed helical configuration), while the flexible section 26 of the shaft 25 can be configured to yield under the force of the spring applied by the docking device 34. As a result, as the docking device 34 is advanced through the lumen 32 of the shaft 25, the rigid section 30 maintains its shape, while the flexible section 26 is caused to assume its activated configuration under the force of the docking device 34.

In some embodiments, the flexible section 26 and the rigid section 30 can be formed from the same material and/or from a single piece of material (e.g., an alloy tube). When formed from the same material and/or a single piece of material, the shaft can be formed (e.g., laser cut) with a series of slots at selected locations to impart a desired shape and flexibility along particular portions of the flexible section and/or to effect bending of the curved portions 46, 48 when the shaft is in the activated configuration. In other embodiments, the flexible section 26 and the rigid section 30 can be formed of different materials and/or formed of different pieces of the same material, and they are fixedly secured or coupled together by adhesives, welding, fasteners, or the like. Materials having varying flexibility can be selected to form different sections of the shaft to achieve a desired flexibility for each section of the shaft.

Further, although not shown, it should be noted that the guide catheter 16 can have multiple radial layers. For example, the delivery catheter 16 can have an inner tube of nitinol, stainless steel, plastic, or other suitable material surrounded by a polymeric cover (e.g., PTFE). The delivery catheter 16 can also be formed from an alloy or metal mesh or braid (e.g., braided nitinol) with an inner polymer liner and/or an outer polymer liner. The interior of the delivery catheter can be lined with a lubricious material (e.g., PTFE) to allow other devices to more easily pass through the lumen 32 of the shaft 25.

Referring back to fig. 4A-4C, the distal end 38 of the shaft 18 of the introducer 14 can be inserted through the wall of the left ventricle 40, e.g., at or near the apex of the heart, until the distal end 38 is positioned in the left ventricle 40. The positioning of the delivery device 10 and subsequently the docking device 34 and prosthetic valve 36 can be visually confirmed, for example, by using imaging modalities such as fluoroscopy, X-ray, CT, or MR imaging. 2D or 3D echocardiography can also be used to help guide and adjust the positioning of the delivery device 10, the docking apparatus 34, and the prosthetic valve 36.

Although not shown, standard purse string sutures can be used to hold the introducer 14 in place against the heart 12 and prevent blood leakage around the introducer 14, as well as to seal the opening in the heart 12 when the introducer 14 is removed. As described above, the introducer 14 can include an internal sealing mechanism (e.g., a hemostatic seal) to prevent leakage of blood through the lumen 22 of the introducer 14.

When the flexible segment 26 of the shaft 25 is in the delivery configuration (i.e., straight or substantially straight), the delivery catheter 16 can be inserted into the patient's heart 12 by advancing the distal end 28 of the shaft 25 through the lumen 22 of the introducer 14 such that the flexible segment 26 extends through the left ventricle 40 and the mitral valve 42 of the heart 12 into the left atrium 44. The flexible section 26 of the shaft 25 can then be moved or adjusted to the activated configuration, as described above.

As shown in fig. 4B-4C, the delivery catheter 16 can then be rotated in the direction indicated by arrow 58, causing the distal end 28 of the shaft 25 to move laterally over the posterior leaflet 50 toward the coaptation edge of the leaflets 50, 52. The distal end 28 of the shaft 25 can then be positioned under the anterior leaflet 52 (e.g., desirably near the a3 and P3 regions of the leaflet, as determined by Carpentier nomenclature) such that the lumen 32 of the shaft 25 opens to the ventricular side of the anterior leaflet 52, while the helical curved portion 48 and the "U" shaped portion 46 remain on the atrial side of the leaflets 50, 52, as shown in fig. 4D-4E.

When the delivery catheter 16 is in the position shown in fig. 4D-4E, the docking device 34 can be advanced through the lumen 32 of the shaft 25 such that the first ventricular coil 54a extends from the lumen 32 into the left ventricle 40 of the patient's heart. Due to the flexible and resilient nature of the docking device 34, the docking device 34 is able to assume a coiled or helical configuration upon exiting the lumen 32 of the shaft 25. For example, when the first ventricular coil 54a is advanced from the lumen 32 of the shaft 25, as shown in fig. 4F-4G, the first ventricular coil 54a travels under the leaflets 50, 52 and advances around the rigid section 30 of the shaft 25. As the docking device 34 is advanced further through the lumen 32 of the shaft 25, as shown in fig. 4H, the second ventricular coil 54b also travels under the leaflets 50, 52 and around the rigid section 30 of the shaft 25 over the first lower turn 54 a.

When the ventricular coil 54 of the helical docking device 34 is positioned under the leaflets 50, 52, the delivery catheter 16 can then be rotated in the direction of arrow 76 in fig. 4I such that the distal end 28 of the shaft 25 and the lumen 32 rotate back and again open to the atrial side of the leaflets 50, 52 for deployment of the atrial coils 56a, 56b from the distal end 28 of the shaft 25. The delivery catheter 16 can also be advanced upward into the left atrium 44 in the direction of arrow 60 to apply a small amount of tension to the docking device against the native mitral valve when the atrial coils 56a, 56b are deployed. Positioning the delivery catheter 16 in this manner allows the atrial coils 56a, 56b to be deployed on the atrial side of the mitral valve 42 while tension keeps the atrial coils 56a, 56b spaced slightly above the native leaflets.

The atrial coils 56a, 56b can then be fully deployed, such as by continuing to rotate the delivery catheter 16 in the direction of arrow 76, to further release the docking device 34 from the lumen 32 of the shaft 25. Fig. 4J shows a first coil 56a and a second coil 56b, respectively, extending around the delivery catheter 16 on the atrial side of the mitral valve 42. During this deployment, the axial space 62 and positive pitch between the second ventricular coil 54b and the first atrial coil 56a is maintained, as shown in fig. 4J. Fig. 4K is a schematic cross-sectional view showing the docking device 34 while still in a partially axially expanded state.

Full deployment of the docking device 34 from the delivery catheter 16 releases the tension on the docking device 34, allowing the atrial coils 56a, 56b to move axially downward toward the ventricular coils 54a, 54 b. The ventricular coils 54a, 54b may also be moved axially upward toward the atrial coils 56a, 56 b. In this manner, the docking device 34 moves toward its axially compressed state, as shown in FIG. 4L. When the atrial coils 56a, 56b are nested within the ventricular coils 54a, 54b, the native leaflets 50, 52 are captured between the ventricular coil on the ventricular side of the native leaflets and the atrial coil on the atrial side of the native leaflets. Securing the docking device 34 to the native leaflets 50, 52 with the native leaflets being axially and radially compressed or pinched between the coils can assist the docking device in better maintaining its position relative to the native leaflets than a coil that can only apply an axially directed force to a stuck leaflet.

Due to the axially compressed state of the docking device 34 and by deploying the atrial coils 56a, 56b in the manner described, the docking device 34 is also able to achieve a relatively high anchoring location (e.g., the second atrial coil 56b can be positioned near or above the annulus of the mitral valve 42). Positioning the docking device at a relatively high position can, for example, help avoid or reduce Left Ventricular Outflow Tract (LVOT) occlusion, as well as chordae tendineae and/or left ventricular injury or leakage due to inadequate leaflet coaptation.

Once the docking device 34 is secured to the native leaflets 50, 52, the delivery catheter 16 can be removed from the patient's heart 12, for example, by straightening the flexible section 26 of the shaft 25 and retracting the delivery catheter 16 through the lumen 22 of the introducer 14. The flexible section 26 of the shaft 25 can be straightened, for example, by advancing a rigid rod through the lumen 32 of the shaft 25 into the flexible section 26, or by adjusting one or more pull wires.

When the delivery catheter 16 is removed, the prosthetic valve 36 can then be introduced into the patient's heart 12. As shown in fig. 4L, the prosthetic valve 36 can be mounted on an inflatable balloon 66 of a balloon catheter 64. However, the prosthetic valve 36 can be any plastically-expandable prosthetic valve that can be mounted in a radially-compressed state on the expansion mechanism of the valve delivery catheter. Alternatively, the prosthetic valve can be a self-expanding prosthetic valve or a mechanically expandable valve that can be held in a radially compressed state within a sheath of a delivery catheter.

The prosthetic valve 36 can be introduced into the heart via any known delivery technique or method. In the illustrated example, a balloon catheter 64 is inserted transcompartmentally through the introducer 14 and into the heart 12. In other embodiments, the balloon catheter can instead be advanced transfemorally (via the femoral artery and aorta), transseptally (via the superior or inferior vena cava and through the septal wall between the right and left atria), transatrial (via a surgical opening in the left atrium), or by other methods and/or via other access points.

The balloon catheter 64 is advanced distally through the introducer 14 until the prosthetic valve 36 is positioned within the docking device 34. Once the positioning of the prosthetic valve 36 is confirmed, the prosthetic valve 36 is radially expanded to its functional size and secured to the helical docking device 34 by inflating the balloon 66 of the balloon catheter 64. In the case of a self-expanding prosthetic valve, the prosthetic valve is pushed distally out of the distal opening of the sheath of the delivery catheter, or the sheath is retracted, allowing the prosthetic valve to self-expand to its functional size.

The prosthetic valve 36 can be selected to have a nominal outer diameter in its radially expanded state that is slightly larger than the inner diameter of the atrial coils 56a, 56 b. As a result, when the prosthetic valve 36 is radially expanded within the docking device 34 to its functional configuration, the outer surface of the prosthetic valve 36 is forced radially against the inner diameter of the atrial coils 56a, 56b, thereby radially compressively securing the prosthetic valve within the docking device 34.

As shown in fig. 4M, the prosthetic valve 36 can also include a blood-impermeable outer covering or sealing member 70 (also referred to as an "outer skirt" in some embodiments) that extends over the metal frame 68 of the prosthetic valve. Sealing member 70 can comprise or be made of, for example, any of a variety of biocompatible fabrics (e.g., PET) or natural tissue (e.g., pericardial tissue). The sealing member 70 can help create a seal between the prosthetic valve and the docking device to minimize or prevent paravalvular leakage between the prosthetic valve and the docking device. Similarly, the docking device 34 can include an outer sealing layer (not shown) covering the coil wire to further enhance the seal between the prosthetic valve and the docking device.

Once the prosthetic valve 36 is secured within the docking device 34, the balloon catheter 64 can be removed from the patient's heart 12 by deflating the balloon 66 and retracting the catheter 64 from the prosthetic valve 36 and the introducer 14. The introducer 14 can then be removed from the patient's heart 12 and the opening in the patient's heart 12 can be closed.

Fig. 5A-5E illustrate a method of implanting a helical docking device 34 at a native mitral valve 42 of a patient's heart 12 using a delivery apparatus 200 according to another embodiment using transseptal techniques.

The delivery device 200 includes an outer catheter 202 and a flexible delivery catheter 204. The outer catheter 202 can have an axially extending shaft 206 and a lumen 208, the lumen 208 extending coaxially through the shaft 206. Various other components (e.g., delivery catheter 204, device 34, etc.) can be introduced into the patient's heart 12 through the lumen 208 of the outer catheter 202.

The delivery catheter 204 of the delivery device 200 forms or includes an elongate shaft 210. The shaft 210 has a flexible section 212 extending along a distal portion of the shaft 210, a relatively rigid section 214 located adjacent to and proximal to the flexible section 212, and a lumen 216 extending the length of the shaft 210.

The flexible section 212 of the shaft 210 is positionable or adjustable between a first delivery configuration and a second activation configuration. Although not shown, in the delivery configuration, the flexible section 212 is substantially straight, allowing the flexible section 212 to easily pass through the lumen 208 of the outer catheter 202. As best shown in fig. 5A, in the activated configuration, the delivery catheter forms a helical bend 218. The helical curved portion 218 has a proximal section 220 that curves radially away from the shaft 210 in a plane substantially perpendicular to the shaft 210 and a distal tip portion 222 that angles downward from the plane of the proximal section 220. As described further below, the activated configuration can help position the helical docking device 34 during the implantation procedure.

The shaft 210 can be formed of similar materials and can have a structure similar to the shaft 25 described above to effect the transition of the shaft from the delivery configuration to the activated configuration.

In the transseptal technique illustrated in fig. 5A-5E, first, the distal end 224 of the outer catheter 202 is inserted through the femoral and inferior vena cava 90 and into the right atrium 92. The atrial septum 94 is then punctured and an outer catheter 202 is inserted through the left atrium 44, as shown in FIG. 5A. Alternatively, the right atrium 92 can be accessed through the superior vena cava via other access points to the patient's vasculature. The outer catheter can have a steerable or pre-curved distal end portion to facilitate steering the outer catheter 202 into the left atrium.

When the delivery catheter 204 is in the delivery configuration, the delivery catheter 204 is then advanced through the lumen 208 of the outer catheter 202 such that the distal tip 222 of the delivery catheter 204 is positioned in the left atrium 44. The delivery catheter 204 is then advanced further through the mitral valve 42 and into the left ventricle 40. As shown in fig. 5A, the flexible section 212 of the delivery catheter 204 can then be moved into the activated configuration, for example by allowing the flexible section 212 to assume its shaped shape or by actively bending the flexible section 212, for example, by using a method similar to that discussed with respect to the delivery catheters described in fig. 4A-4M.

When the delivery catheter 204 is in this position, the docking device 34 can be advanced through the lumen 216 such that the first ventricular coil 54a extends from the lumen 216 into the left ventricle 40. Due to the flexible and resilient nature of the docking device 34, the docking device 34 is able to assume a coiled or spiral configuration as it exits the internal cavity 216. For example, when the first ventricular coil 54a is advanced from the inner lumen 216, the first ventricular coil 54a travels under the leaflets 50, 52, as best shown in fig. 5B. As the docking device 34 is advanced further through the lumen 216, as shown in fig. 5C, the second ventricular coil 54b also travels under the leaflets 50, 52 and over the first ventricular turn 54 a.

When the ventricular coil 54 of the helical docking device 34 is positioned under the leaflets 50, 52, the delivery catheter 204 can then be retracted upward into the left atrium 44 in the direction of arrow 226 (see, e.g., fig. 5D). Retracting the delivery catheter 204 upward in the direction of arrow 226 allows the atrial coils 56a, 56b to be deployed on the atrial side of the mitral valve 42 and also applies a small amount of tension to the docking device when the atrial coils 56a, 56b are deployed to keep the atrial coils slightly spaced above the native leaflets.

The atrial coils 56a, 56b can then be deployed by further advancing the docking device 34 through the lumen 216, for example, by rotating the delivery catheter 204 in a direction opposite to the direction in which the coils extend. Fig. 5D shows the first atrial coil 56a and the second atrial coil 56b positioned on the atrial side of the mitral valve 42. The upward tension from the delivery catheter 204 causes the atrial coils 56a, 56b to deploy higher than the ventricular coils 54a, 54b and creates an axial space 62 and positive pitch between the second ventricular coil 54b and the first atrial coil 56a, as shown in fig. 5D.

Fully deploying and releasing the docking device 34 from the delivery catheter 204 releases the tension on the docking device 34, allowing the atrial coils 56a, 56b to move axially downward toward the ventricular coils 54a, 54b, wherein the ventricular coils 54a, 54b may also move axially upward toward the atrial coils 56a, 56b to move the docking device to an axially compressed state, as shown in fig. 5E. When the atrial coils 56a, 56b are nested within the ventricular coils 54a, 54b, the native leaflets 50, 52 are captured between the ventricular coil on the ventricular side of the native leaflets and the atrial coil on the atrial side of the native leaflets.

Once the docking device 34 is secured to the native leaflets 50, 52, the delivery catheter 204 can be removed from the patient's heart 12, for example, by straightening the flexible section 212 and retracting the delivery catheter 204 through the lumen 208 of the outer catheter 202.

When the delivery catheter 204 is removed, a prosthetic valve (e.g., prosthetic valve 36) can be introduced into the patient's heart 12 using, for example, known techniques or methods as described above with respect to fig. 4L-4M. The prosthetic valve can then be secured within the docking device 34, also similar to that described above.

Once the prosthetic valve is secured within the docking device 34, the prosthetic valve delivery device and outer catheter 202 can be removed from the patient's body and the opening in the patient's septum 94 and right femoral vein can be closed.

Fig. 6A to 6D show a docking device 80 according to a second embodiment. The docking device 80 includes three ventricular coils 82a, 82b, 82c and three atrial coils 84a, 84b, 84 c. As can be seen, the atrial coils 84a, 84b, 84c have a larger inner diameter than the inner diameter of the ventricular coils 82a, 82b, 82 c.

Similar to the embodiment of fig. 2A-3B, the docking device 80 may be axially expandable, such as when tension is applied to one or both ends of the docking device 80, and the docking device 80 may be axially compressible, such as when tension is released from the docking device. Fig. 6A-6B show the docking device in an axially expanded state, wherein all coils extend in the same axial direction and have a positive pitch relative to adjacent coils in the axial direction.

Fig. 6C-6D show the docking device 80 fully deployed and in an axially compressed state, for example, after tension is released from the docking device 80. In this state, the axial coils and the ventricular coils are moved toward each other until at least some of the ventricular coils are nested within the axial coils. Furthermore, the third ventricular coil 82c is located upstream of the first atrial coil 84a and can therefore be considered to have a negative pitch relative to the first atrial coil 84 a.

As the docking device 80 assumes the axially compressed state shown in fig. 6C-6D, the native mitral valve leaflets 50, 52 are captured and clamped between the atrial coils 84a, 84b, 84C and the ventricular coils 82a, 82b, 82C.

Fig. 6D shows the final configuration in which the prosthetic valve 36 is secured in the docking device 80. In some embodiments, a portion of the native leaflets 50, 52 are clamped or otherwise retained between the inner coil ( ventricular coils 82a, 82b, 82c in the illustrated embodiment) and the sealing member 70 of the prosthetic valve 36 to enhance the seal between the docking device 34 and the prosthetic valve 36.

Fig. 7A to 7C show a docking device 300 according to a third embodiment. In the illustrated embodiment, the docking device 300 has one ventricular coil 302 and one atrial coil 304. Similar to the embodiment of fig. 2A-3B, the inner diameter of the atrial coil 304 is smaller than the inner diameter of the ventricular coil 302, thereby allowing the atrial coil 304 to nest with the ventricular coil 302 in a compressed state, similar to that described above with respect to other embodiments. However, unlike the first and second embodiments, the docking device 300 is made of a flat strip having a rectangular cross section. Having a docking device with only one ventricular coil and one atrial coil can free more native leaflets 50, 52, e.g., in a compressed state (i.e., not caught by the docking device 300), as best shown in fig. 7C, which can, for example, in turn, advantageously improve the ability of the native leaflets to perform their normal functions (i.e., open and close the valve during the diastolic and systolic phases of systole, respectively) during the implantation procedure and after the docking device 300 is deployed. Providing a single ventricular coil and a single atrial coil can also, for example, reduce the complexity of the implantation procedure and allow for a more robust design. As shown in fig. 7C, in a compressed state, when the atrial coil 304 is nested inside the ventricular coil 302, the atrial coil 304 can be disposed substantially coplanar with or at about the same axial position as the ventricular coil 302, such that the coils in this embodiment can be considered to be disposed at zero pitch, rather than exhibiting negative pitch.

Fig. 8A to 8C show a docking device 400 according to a fourth embodiment. In the illustrated embodiment, the docking device 400 includes three ventricular coils 402a, 402b, 402c and three atrial coils 404a, 404b, 404 c. Similar to the embodiment of fig. 7A-7C, the docking device 400 is made of a flat wire with a rectangular cross-section. Further, the ventricular coil 402a has a smaller inner diameter than the ventricular coil 402b, and the ventricular coil 402b has a smaller inner diameter than the ventricular coil 402 c. Atrial coil 404a has a smaller inner diameter than atrial coil 404b, and atrial coil 404b has a smaller inner diameter than atrial coil 404 c. In this manner, the atrial coils 404a, 404b, 404c together have a conical shape that tapers from the uppermost atrial coil 404c to the lowermost atrial coil 404a, and the ventricular coils also together have a conical shape that tapers from the uppermost ventricular coil 402c to the lowermost ventricular coil 402 a.

As best shown in fig. 8B, the ventricular coil 402a and the atrial coil 404a have substantially similar inner diameters, the ventricular coil 402B and the atrial coil 404B have substantially similar inner diameters, and the ventricular coil 402c and the atrial coil 404c have substantially similar inner diameters. As such, when the device 400 is moved from the axially expanded state shown in fig. 8A-8B to the axially compressed state shown in fig. 8C, the respective ventricular coils 402a, 402B, 402C can at least partially radially overlap the atrial coils 404a, 404B, 404C in a manner similar to a cone within a cone.

Due to the conical shape of the coils, the ventricular coils 402a, 402b, 402C and the atrial coils 404a, 404b, 404C can axially interlock in a wedge-like manner with the native leaflets 50, 52 captured between the ventricular coils 402a, 402b, 402C and the atrial coils 404a, 404b, 404C, as shown in fig. 8C. The wedge-shaped interlock can, for example, enhance the retention force applied to the native leaflets 50, 52 by the docking device 400. The conical shape can also, for example, allow the device 400 to better track the natural curved shape of the native leaflets 50, 52. Thus, docking device 400 can be less traumatic to native leaflet tissue. Furthermore, the conical shape enables, for example, better self-alignment of the ventricular coil and the atrial coil when the coils are moved from an axially expanded state to an axially compressed state.

Fig. 9A-9C illustrate an embodiment of a portion of a delivery catheter 100, similar to the guide catheter 16 described above, with a portion of the delivery catheter 100 configured to deliver a docking device. The delivery catheter 100 in the illustrated embodiment includes an elongate shaft 102 and a pull wire 104. The shaft 102 has a centrally disposed and axially extending lumen 106, and the pull wire 104 extends coaxially through the lumen 106 of the shaft 102. The distal end 108 of the pull wire 104 can be fixedly secured or attached (e.g., using an adhesive, welding, etc.) to the distal end 110 of the shaft 102. The shaft 102 of the guide catheter 100 has different axial sections, including a flexible distal section 112 and a relatively more rigid section 114 located adjacent to and proximal to the flexible distal portion 112 (e.g., as shown in fig. 9C).

As shown in fig. 9A-9B, near the distal end 110 of the shaft 102, the flexible section 112 has a first plurality of circumferentially extending, axially spaced apart slots 116 on one side of the shaft and a plurality of oblique or generally helically extending slots 118 on the opposite side of the shaft. The circumferential slots 116 can be axially spaced from one another and angularly offset from one another such that the slots are spaced from one another in a spiral or helical configuration, as best shown in fig. 9A. The oblique slots 118 can extend axially and circumferentially in a helical shape, as best shown in fig. 9B. The circumferential slot 116 is substantially diametrically opposed to the angled slot 118 on the shaft 102.

The flexible section 112 of the shaft 102 also has a second plurality of circumferential slots 120 and a third plurality of circumferential slots 122 positioned proximally relative to the first plurality of circumferential slots 116 and the diagonal slots 118. The second plurality of circumferential grooves 120 are axially spaced from one another and are angularly aligned with one another, as best shown in fig. 9A. A third plurality of circumferential slots 122 are also axially spaced from one another and are angularly aligned with one another, as best shown in fig. 9B. The slots 120 and 122 can also be formed in diametrically opposite sides of the shaft 102 relative to one another.

The shaft 102 can be formed, for example, from a tube. The slots 116, 118, 120, 122 can be formed, for example, by laser cutting the tube. In a particular embodiment, the shaft 102 can be formed from an elastically deformable shape memory material, such as nitinol.

Due to the manner in which the slots 116, 118, 120, 122 are positioned relative to one another and the width of the slots, pulling on the proximal end of the pull wire 104 causes the flexible section 112 of the shaft 102 to deform into the activated configuration, as shown in fig. 9C. Releasing the tension on the pull wire 104 allows the flexible section to return to its undeformed, straight configuration.

Fig. 9C shows an activated configuration in which the flexible section 112 of the shaft 102 forms a first "U" shaped bend section 124 and a second helically bent section 126. The slot 120 is located along an inner radius of the curved section 124 and the slot 122 is located along an outer radius of the curved section 124. Slot 116 is located along an inner radius of curved section 126 and slot 118 is located along an outer radius of curved section 126. In the illustrated embodiment, the first curved section 124 forms a 180 degree bend at the end of the rigid section 114 and has a distal section that extends substantially parallel to the rigid section 114. The second curved section 126 has a proximal section 126a that curves radially away from the first curved section 124 in a plane substantially perpendicular to the first curved section 124, and the second curved section 126 also has a distal tip portion 126b that angles downwardly away from the plane of the proximal section 126 a. The shape of the curved sections 124, 126 can assist in positioning the helical docking device relative to the native leaflets 50, 52 when the docking device is deployed from the lumen 106 of the shaft 102, e.g., similar to that described above relative to the delivery catheter 16.

The slots 118, 122 facilitate bending by reducing strain on the outer radius of the bent sections 124, 126. The slots 116, 118, 120, 122 can also help avoid kinking of the shaft 102, allowing a device (e.g., the docking device 34) to more easily pass through the lumen 106 of the shaft when the flexible section 112 is in the activated configuration.

Although not shown, the guide catheter 100 can have multiple radial layers. For example, the shaft 102 of the guide catheter 100 can have a polymeric outer covering (e.g., PTFE). The guide catheter 16 can also include an alloy or metal mesh or braid (e.g., braided nitinol). In addition, the interior of the guide catheter can be lined with a lubricious material (e.g., PTFE) to allow other devices and components to more easily pass through the lumen 106 of the shaft 102.

It should be noted that the devices and apparatus described herein can be used with other placement techniques (e.g., transatrial, open heart, etc.). It should also be noted that the devices described herein (e.g., helical docking devices and prosthetic valves) can be used in conjunction with other delivery systems and methods. For example, additional information regarding the apparatus, delivery systems, and methods can be found in U.S. provisional patent application No.62/088,449 and international patent application No. pct/IB2013/000593(WIPO publication No.2013/114214), the entire contents of which are incorporated herein by reference.

For the purposes of this specification, certain aspects, advantages and novel features of the embodiments of the disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and subcombinations with one another. The methods, apparatus and systems are not limited to any specific aspect or feature or combination thereof, nor are the disclosed embodiments limited to any specific advantages or problems that may be required to be solved.

Although some operations of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular order is required by specific language. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Moreover, the description sometimes uses terms like "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are readily recognized by one of ordinary skill in the art.

In view of the many possible embodiments to which the principles of this disclosure may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the disclosure. Rather, the scope of the disclosure is defined by the appended claims.