Adjustable and reversible locking mechanism for catheter delivery of implants

Abstract

The present invention relates to an adjustable and reversible locking mechanism for catheter delivery of an implant. An implantable heart valve device has a main body including a first end and a second end. The main body is configured to be implanted around a native leaflet of a heart valve such that the first end is on an atrial side of the leaflet and the second end is on a ventricular side of the leaflet, and such that the main body can be brought into and out of apposition with an opposing native leaflet during operation of the heart valve. One of the first end or the second end includes a coupling assembly, and the other of the first end or the second end includes a coupling member configured to extend through the native leaflet to engage the coupling assembly when the heart valve device is implanted in the heart valve.

Description

[0001] This application is a divisional of Chinese Patent Application No. 2018800038664 (PCT / US2018 / 033802), filed May 22, 2018, entered into the National Stage on April 10, 2019, entitled “ADJUSTABLE AND REVERSIBLE LOCKING MECHANISM FOR CATHETER DELIVERED IMPLANTS.” TECHNICAL FIELD

[0002] The present disclosure relates to prosthetic devices and related methods for assisting in sealing a native heart valve and reducing or preventing regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices. BACKGROUND

[0003] Natural heart valves (i.e., the aortic valve, the pulmonary valve, the tricuspid valve, and the mitral valve) play a critical role in ensuring forward flow of sufficient blood supply through the cardiovascular system. Congenital malformations, inflammatory processes, infectious conditions, or disease can reduce the efficiency of these heart valves. Such damage to the valves can lead to serious cardiovascular impairment or death. For many years, the definitive treatment for such disease has been surgical repair or replacement of the valve during open-heart surgery. However, such surgery is highly invasive and is prone to many complications. As a result, elderly and infirm patients with heart valve defects often go untreated. More recently, transcatheter techniques have been developed for introducing and implanting prosthetic devices in a less invasive manner than open-heart surgery. Such transcatheter techniques are increasingly popular due to their high success rates.

[0004] A healthy heart generally has a conical shape that tapers to a lower apex. The heart is four-chambered and includes a left atrium, a right atrium, a left ventricle, and a right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The natural mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure than the other natural heart valves. The mitral valve includes an annulus portion, which is an annular portion of native valve tissue around the mitral valve orifice, and a pair of cusps or leaflets that extend downward from the annulus into the left ventricle. The mitral valve annulus can form a D-shape, an oval shape, or other non-circular cross-sectional shape having a major axis and a minor axis. The anterior leaflet can be larger than the posterior leaflet, such that when they close together they form a generally C-shaped boundary between the abutting free edges of the leaflets.

[0005] When functioning correctly, the anterior and posterior leaflets together act as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates, the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract, the increased blood pressure in the left ventricle pushes the two leaflets of the mitral valve together, thus closing the one-way mitral valve. This prevents blood from flowing back into the left atrium; instead, it flows out of the left ventricle through the aortic valve. To prevent the two leaflets from detaching under pressure and folding back into the left atrium through the mitral valve ring, multiple fibrous bands called chordae tendineae attach the leaflets to the papillary muscles of the left ventricle.

[0006] Mitral regurgitation occurs when the natural mitral valve fails to close properly and blood flows from the left ventricle to the left atrium during the systolic phase of the cardiac cycle. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation has various causes, such as leaflet prolapse, dysfunctional papillary muscles, and / or stretching of the mitral annulus due to left ventricular dilation. Mitral regurgitation at the central portion of the leaflet can be called central jet mitral regurgitation, while mitral regurgitation closer to a commissure (i.e., where the leaflets meet) can be called eccentric jet mitral regurgitation.

[0007] Some existing techniques for treating mitral regurgitation involve directly binding portions of the natural mitral valve leaflets together. Other existing techniques involve using a device implanted between the natural mitral valve leaflets. Despite these existing techniques, there is still a need for improved devices and methods for treating mitral regurgitation. Summary of the Invention

[0008] Certain embodiments of this disclosure relate to apparatus and methods for adjustably and / or releasably securing a prosthetic implant to the leaflet of a natural heart valve. In a representative example, the implantable heart valve device includes a body comprising a first end and a second end. The body is configured to be implanted around the natural leaflet of the heart valve such that the first end is on the atrial side of the leaflet and the second end is on the ventricular side of the leaflet, and the body is configured to coapt with and move away from the opposing natural leaflet during operation of the heart valve. One of the first or second ends includes a coupling assembly, and the other of the first or second ends includes a coupling member configured to extend through the natural leaflet to engage a coupling mechanism when the heart valve device is implanted into the heart valve.

[0009] In another representative embodiment, an assembly includes an implantable heart valve device including a main body having a first end and a second end. The main body is configured to be implanted around a native leaflet of a heart valve such that the first end is on an atrial side of the leaflet and the second end is on a ventricular side of the leaflet, and such that the main body can coapt with and dis- coapt from an opposing native leaflet during operation of the heart valve. The first end includes a coupling assembly, and the second end includes a coupling member configured to extend through the native leaflet to engage the coupling assembly when the heart valve device is implanted in the heart valve. The assembly also includes a catheter including a shaft having a distal end releasably coupled to the first end of the heart valve device.

[0010] In another representative embodiment, a method includes delivering an implantable heart valve device to a native heart valve of a patient's body via a guide wire formed in a loop and extending through a leaflet of the native heart valve such that first and second ends of the guide wire are located outside the patient's body. The method also includes positioning a first end of the heart valve device on an atrial side of the leaflet. The first end includes a coupling assembly. The method also includes positioning a second end of the heart valve device on a ventricular side of the leaflet such that a main body of the heart valve device can coapt with and dis-coapt from an opposing native leaflet during operation of the heart valve. The second end includes a coupling member. The method also includes coupling the first end of the heart valve device to the second end of the heart valve device by inserting the coupling member through the leaflet such that the coupling assembly engages the coupling member.

[0011] The foregoing and other objects, features and advantages of the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0012] Figure 1 is a cross-sectional view of a heart having a prosthetic device for treating mitral valve regurgitation implanted on a posterior mitral valve leaflet, in accordance with one embodiment.

[0013] Figure 2 is Figure 1 is a perspective view of the prosthetic device of

[0014] Figure 3 is Figure 1 is a perspective view of the prosthetic device of

[0015] Figure 4 is a cross-sectional view of a heart showing a guide wire extending through a native leaflet of a mitral valve to form a loop.

[0016] Figure 5 is a perspective view of a prosthetic device of Figure 1 coupled to a delivery catheter.

[0017] Figure 6 is a perspective view of a prosthetic device of Figure 5 a delivery catheter.

[0018] Figure 7 is a side view of a prosthetic device of Figure 1 and a delivery catheter of Figure 5 wherein the cap member of the prosthetic device and the distal end of the catheter are shown in cross-section, and the first and second actuator members of the delivery catheter are in a proximal position.

[0019] Figure 8 is a side view of a prosthetic device of Figure 1 and a delivery catheter of Figure 5 wherein the cap member of the prosthetic device and the distal end of the catheter are shown in cross-section, and the first and second actuator members of the delivery catheter are in a distal position.

[0020] Figure 9 is a partial cutaway view of a mitral valve showing a prosthetic device of Figure 1 positioned around the posterior leaflet prior to coupling the first and second end portions of the device together.

[0021] Figure 10 is a partial cutaway view of a mitral valve showing a prosthetic device of Figure 1 positioned around the posterior leaflet, wherein the first and second end portions of the device are coupled together by a coupling member. DETAILED DESCRIPTION

[0022] Embodiments of prosthetic devices primarily for implantation in one of the mitral valve, aortic valve, tricuspid valve, or pulmonary valve regions of a human heart, as well as apparatus and methods for implanting the prosthetic devices, are described herein. In certain embodiments, the prosthetic devices can be used to assist in restoring and / or replacing the function of a defective native mitral valve. The disclosed embodiments should not be construed as limiting in any way. Instead, this disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and subcombinations with each other.

[0023] Figure 1A cross-sectional view of a human heart 10 is shown, in which a prosthetic device 100 is secured to a posterior leaflet 12 of a mitral valve 14, according to one embodiment. The device can include a main body 102 including a first end portion 104 and a second end portion 106. In a deployed configuration, the main body 102 can be wrapped or otherwise disposed around the leaflet 12 such that the first end portion 104 is disposed in the left atrium 18 and covers the atrial surface of the leaflet 12, and the second end portion 106 is disposed in the left ventricle 20 and covers the ventricular surface of the leaflet.

[0024] Figure 2 and Figure 3 The device 100 is shown in greater detail. In the illustrated embodiment, the main body 102 can include a tubular braided mesh 108 covered by a non-traumatic covering 110. The braided mesh 108 can be made of nitinol or other elastically deformable and / or shape-settable material that can resume a desired shape upon release from a delivery catheter or sheath tube within the heart. In some embodiments, the braided mesh 108 and covering 110 can allow the main body 102 to expand laterally when it is longitudinally shortened, and to contract laterally when it is longitudinally lengthened, as further described in U.S. Patent Application Publication No. 2015 / 0230919, which is incorporated by reference herein. In some embodiments, the braided mesh 108 can be shaped to have a curved shape when in a non-deflected state.

[0025] Referring to Figure 2 and Figure 3 , the first end portion 104 can include a cap member 112, while the second end portion 106 can include a cap member 114. As shown in Figure 2 , the cap member 112 can be coupled to the main body of the implant 100 (e.g., to the braided mesh 108), and can include a housing portion 118. The housing portion 118 can define a first opening 120, a second opening 122, and a channel 124 extending between the openings 120, 122. In some embodiments, the cap member 112 can open to the interior of the main body 102, such that the housing portion 118 and the main body of the implant are in fluid communication with one another. The cap member 112 can also define an opening extending laterally through the housing portion 118, such as opening 115( Figure 3 ), and a suture can be passed through the opening to couple the implant 100 to a delivery catheter, as further described below. As best shown in Figure 3 , the cap member 114 can define an internal channel 130, and a slot 132 extending along an upper surface of the cap member 114.

[0026] Referring again to Figure 2The device 100 may include a coupling mechanism generally indicated at 134, configured to releasably and / or adjustably couple a first end 104 and a second end 106 together. For example, in the illustrated configuration, coupling mechanism 134 may include a coupling assembly 136 configured to engage a coupling member 138. In some embodiments, coupling assembly 136 may be coupled to the first end 104 of the device, while coupling member 138 may be coupled to the second end 106 and may extend from the second end to engage the coupling assembly.

[0027] For example, in the illustrated configuration, the connecting assembly 136 is located within the internal channel 124 of the cap member 112. The connecting assembly 136 may be included in a first position ( Figure 7 ) and second position ( Figure 8 A pawl member 140 movable between the two components. The pawl member 140 may include a first end 142 configured to engage the connecting member 138, and a second end 144 configured to engage the spring member 146. The pawl member 140 may be configured to pivot about the pivot member 148. The spring member 146 may be configured to bias the pawl member toward a first position. Applying a force to the second portion 144 of the pawl member can compress the spring member 146 and pivot the pawl member toward a second position.

[0028] In the illustrated embodiment, the connecting member 138 is configured as a coil comprising a plurality of turns 150. The connecting member 138 is connectable to the cap member 114 and can extend through the slot 132 when engaged with the connecting assembly 136. In some embodiments, the connecting member 138 can be flexible, allowing it to move relative to the cap member 114 within the slot 132. In some configurations, the end 116 of the connecting member 138 opposite the cap 114 (… Figure 3 It can also be tapered to facilitate the insertion of the connecting member into the tissue that passes through the natural leaflet. For example, in some configurations, one or more turns 150 of the coil can be ground so that the ends 116 of the coil have a tapered profile.

[0029] See you again Figure 2 The pawl member 140 can be configured to engage with the turn 150 of the connecting member 138. Movement of the connecting member 138 in the direction of arrow 151 causes the pawl member 140 to pivot counterclockwise, compressing the spring member 148 and allowing the successive turns 150 of the connecting member to advance past / past the pawl member. In this way, the portion of the connecting member 138 that extends beyond the length of the pawl member 140 can be adjusted.

[0030] The implant 100 can be delivered using a guidewire or suture that advances through the septum into the left ventricle, is inserted through a target leaflet (e.g., the base of a leaflet near the annulus of an adjacent natural valve), and loops back through the patient's body to the entry site, as described in detail above in U.S. Patent Application Publication No. 2015 / 0230919, which is incorporated herein by reference. In this manner, the guidewire forms a loop, with both ends of the guidewire located outside the patient's body. Figure 4 A guidewire 152 is shown that extends through the natural leaflet 12 of the adjacent valve ring 16 to form a circuit.

[0031] Guide wire 152 can extend through implant 100, allowing the implant to advance along the guide wire to the treatment site. For example, see reference... Figure 3 The first portion 154 of the guide wire 152 can extend through the opening 120 to the channel 124 of the cap member 112. Figure 2 The guidewire 152 extends through the cap member 114 and coaxially through the connecting member 138. The guidewire 152 can then extend through the cap member 112 from the opening 122 back to the opening 120, such that a second portion 156 of the guidewire is exposed from the cap member 112 and extends posteriorly through the patient to the entry site.

[0032] refer to Figure 5 In the delivery configuration, the implant 100 may be coupled to the shaft 158 ​​of a first conduit configured as a delivery catheter 160. In some embodiments, the delivery catheter 160 may be coaxially disposed within a delivery sheath (not shown), the delivery sheath being configured to constrain the implant 100 into a relatively straight and radially constricted configuration for insertion through the patient's vascular system to the treatment site. When the implant 100 reaches the treatment site, it may be advanced from the delivery sheath and may exhibit its functional configuration, such as Figure 5 As shown.

[0033] Figure 7 and Figure 8 The distal end 166 of the shaft 158 ​​of the delivery catheter 160 is shown in more detail. The distal end 166 of the shaft 158 ​​may include an end cap or cap member 168. The cap member 168 may include a pair of extensions or arms 170A, 170B that may extend at least partially over the cap member 112 when the shaft 158 ​​is coupled to the implant 100. Figure 6 As best shown, arms 170A and 170B can define corresponding lumens 172A and 172B. In some examples, suture 174 ( Figure 5) or other filaments can extend from the lumen 172A, traverse laterally through the cap member 112 (e.g., through the opening 115), and return through the lumen 172B back to the cap member 168. In this manner, the implant 100 can be coupled (e.g., tethered) to the delivery catheter 160. In certain configurations, the pivot member 148 can be housed in the opening 115 and can define a lumen through which the suture 174 can pass. In some configurations, the implant 100 can be pivoted between the arms 170A, 170B about the pivot member 148 and / or around the suture 174.

[0034] The delivery catheter 160 can be used to constrain movement of the cap member 112 relative to the cap member 114. Thus, applying tension to one or both portions 154, 156 of the guidewire 152 can reduce the length of the guidewire within the main body 102 of the implant, as shown. This, in turn, can cause the implant to crimp such that the cap member 114 is adjacent to the cap member 112. In this manner, the coupling member 138 coaxially disposed on the guidewire 152 can be received within the cap member 112 such that the detent member 140 engages the turn 150 of the coupling member. Continued proximal movement of the coupling member 138 through the cap member 112 can cause the implant to cinch by continuing to pass the turn 150 of the coupling member through the detent member 140 in a ratcheting manner. In some embodiments, the first end 142 of the detent member 140 can be curved such that a downward force on the first end causes it to clamp or “bite” onto the turn of the coupling member with which it is engaged. In this manner, inadvertent distal movement of the coupling member 138 can be avoided. Figure 3

[0035] Returning to Figure 7 and Figure 8 , the delivery catheter 160 can also include a first actuator member 176 and a second actuator member 178. In the illustrated configuration, the first actuator member 176 can extend through an opening 180 in the cap member 168 and can be movable between a proximal position ( Figure 7 ) and a distal position ( Figure 8 ). In the illustrated embodiment, the first portion 154 of the guidewire 152 can extend through a lumen of the actuator member 176 and into the implant 100, although other configurations are possible. In certain configurations, a distal end 184 of the actuator member 176 can have a bulbous shape to help contact the detent member 140, as described further below.

[0036] In the illustrated configuration, the second actuator member 178 can be located below the first actuator member 176 and can also be movable through an opening 182 in the cap member 168 between a proximal position ( Figure 7 ) and a distal position ( Figure 8 ​The guide wire 152 is movable between the connecting member 138 and the actuator member 178. The second portion 156 of the guide wire 152 can extend from the connecting member 138 and enter the cavity of the actuator member 178. In some embodiments, the distal end 186 of the actuator member 178 may have a bulb-like shape similar to the actuator member 176, or any other suitable shape as required.

[0037] Figure 9 An implant 100 is shown positioned around the leaflet 12 prior to the first and second cap components 112, 114 being joined together. Figure 9 In this configuration, cap member 112 is disposed on the atrial surface adjacent to the ring 16 of the leaflet 12 and is connected to cap member 168 of the delivery catheter 160. Body 102 extends over the leaflet 12, and cap member 114 is located in the left ventricle 20, adjacent to the ventricular surface of the leaflet. Cap member 114 can be pulled near the ventricular surface of the leaflet 12 by tensioning one or both of portions 154 and 156 of the guidewire 152, while keeping cap member 112 stationary via the delivery catheter 160. Connecting member 138 can track guidewire 152 such that it extends through the leaflet tissue and protrudes on the atrial side of the leaflet adjacent to cap member 112. Further tensioning of guidewire 152 can pull connecting member 138 into cap member 112, such that connecting assembly 136 engages connecting member, as... Figure 10 As shown.

[0038] See you again Figure 8 The first actuator member 176 can be configured such that, when it advances to the distal position, its distal end 184 can contact the second end 144 of the pawl member 140. This can compress the spring member 148, causing the pawl member 140 to pivot to the second position and disengage from the coupling member 138. When the pawl member 140 disengages from the coupling member 138, the second actuator member 178 can be advanced distally. The distal end 186 of the second actuator member 178 can be configured to contact the end 116 of the coupling member 138. Further distal movement of the actuator member 178 can cause the coupling member 138 to move beyond the pawl member 140 in the direction of arrow 188 (e.g., back to the direction of the left ventricle 20).

[0039] In this manner, the position of the coupling member can be adjusted, and thus the degree of curvature of the implant 100. Tensioning of the guide wire 152 can pull the coupling member 138 proximally beyond the detent member 140, clamping the leaflet between the cap members 112, 114 and conforming the body 102 to the shape of the leaflet 12. The clamping of the leaflet and implant, and / or regurgitation through the valve can then be assessed. If it is desired to adjust the position of the implant, the detent member 140 can be disengaged from the coupling member 138 using the actuator member 176, and the coupling member can be pushed back through the cap member 112 in the direction of the left ventricle 20 using the actuator member 178. This process can be repeated until the desired positioning of the prosthetic device 100 is achieved. In the event that, for example, the implant 100 needs to be removed, the coupling member 138 can also be pushed completely out of the cap member 112.

[0040] When the clinician is satisfied with the placement of the implant 100, the delivery catheter 160 can be disengaged from the cap member 112 by withdrawing the suture 174. The guide wire 152 can also be withdrawn from the body 102, leaving the implant in place on the leaflet 12 as shown. Figure 1

[0041] In other embodiments, the coupling member 138 need not be a coil, but can be a solid flexible member configured, for example, to include a ridge or teeth that can engage the detent member 140. The coupling assembly 136 can also be configured in various different ways. For example, in other embodiments, the detent member 140 can be a tab member integrally formed with the cap member 112, and configured to engage the coupling member as described above.

[0042] General Considerations

[0043] For purposes of this summary, certain aspects, advantages and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, devices and systems should not be construed as limiting in any manner. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both singly and in various combinations and sub-combinations with one another. The methods, devices and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed embodiments require the presence of any one or more of the recited advantages or solutions to the problems.

[0044] ​Although the operations of some 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 ordering is required by specific language set forth below. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures can not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like "provide" or "achieve" 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 discernible by one of ordinary skill in the art.

[0045] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “include” means “comprise.” Further, the terms “coupled” and “associated” generally mean electrically, electromagnetically, and / or physically (e.g., mechanically or chemically) coupled or linked and do not exclude the presence of intermediate elements between coupled or associated items absent specific contrary language.

[0046] It will be appreciated that the disclosed embodiments can be applied to any native valve of the heart (e.g., the pulmonary valve, the mitral valve, and the tricuspid valve) and can be used with any of a variety of approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0047] As used herein, the term “proximal” refers to a location, direction, or portion of a device that is closer to a user and further away from an implant site. As used herein, the term “distal” refers to a location, direction, or portion of a device that is further away from a user and closer to an implant site. Thus, for example, proximal movement of a device is movement of the device toward a user, while distal movement of a device is movement of the device away from a user. The terms “longitudinal” and “axial” refer to an axis that extends in the proximal and distal directions, unless otherwise specifically defined.

[0048] As used herein, the terms “integrally formed” and “unitary structure” refer to a structure that does not include any welds, fasteners, or other devices used to secure separately formed materials to one another.

[0049] In view of the many possible embodiments to which the principles of the disclosed technology can be applied, it should be recognized that the embodiments are only exemplary and should not be considered as limiting the scope of the disclosure. Rather, the scope of the disclosure is broader than the embodiments, and will only be defined by the following claims.

Claims

1. A device implantable at a heart valve of a subject, the device comprising: a body comprising a first end and a second end, the body configured to be implanted around a leaflet of the heart valve such that the first end is on an atrial side of the leaflet and the second end is on a ventricular side of the leaflet such that the body can coapt with and de-coapt from an opposing leaflet during operation of the heart valve, wherein: one of the first end or the second end comprises a coupling mechanism, the other of the first end or the second end comprises a coupling member configured to extend through the leaflet to engage the coupling mechanism when the device is implanted in the heart valve, and the coupling mechanism comprises a pawl member pivotable between a first position and a second position, and the pawl member is configured to engage the coupling member when the pawl member is in the first position; and a spring member configured to bias the pawl member toward the first position, wherein the pawl member comprises a first end configured to engage the coupling member and a second end configured to engage the spring member, and wherein the coupling mechanism is configured such that by application of force to the second end of the pawl member, the spring member is compressed and the pawl member pivots toward the second position to disengage from the coupling member such that the coupling member can be pushed back over the pawl member in a ventricular direction.

2. The device of claim 1, wherein the coupling member comprises a coil having a plurality of turns.

3. The device of claim 2, wherein: the pawl member and the spring member are located in a first cap member, the first cap member coupled to the first end of the device; and the coupling member is coupled to a second cap member, the second cap member coupled to the second end of the device.

4. The device of claim 3, wherein the pawl member is pivotable about a pivot member disposed in the first cap member.

5. The device of any one of claims 3 or 4, wherein the first cap member is in fluid communication with the body such that a guide wire can extend from the first cap member into the body.

6. The device of claim 5, wherein the coupling member defines an internal lumen such that the guide wire can extend through the internal lumen of the coupling member.

7. A system for implanting a device at a heart valve of a subject, the system comprising: a device according to any one of claims 1 to 6; and a catheter comprising a shaft having a distal end releasably coupled to the first end of the device.

8. The system of claim 7, wherein the catheter comprises a first actuator movable between a proximal position and a distal position to selectively engage the coupling mechanism such that when the first actuator is in the distal position, the coupling mechanism is disengaged from the coupling member.

9. The system of claim 8, wherein the first actuator is configured to move the pawl member to the second position when the first actuator engages the pawl member.

10. The system of claim 9, wherein the catheter further comprises a second actuator that is movable between a proximal position and a distal position to selectively engage the coupling member.

11. The system of claim 10, configured such that (i) when the second actuator contacts the coupling member and (ii) the pawl member is in the second position, distal movement of the second actuator member causes corresponding distal movement of the coupling member relative to the coupling mechanism.

12. The system of any of claims 7-11, wherein the distal end of the catheter is releasably coupled to the first end of the device by a suture.

13. The system of claim 12, wherein: the first end of the device comprises a cap member; the distal end of the catheter comprises a first arm portion and a second arm portion; and the suture extends from a lumen defined in the first arm portion, through the cap member, and through a lumen defined in the second arm portion.

14. The system of claim 13, further comprising a guidewire that extends from the catheter, through the main body of the device, through a coupling member, and back into the catheter.

15. An implantable heart valve device comprising: a main body comprising a first end and a second end, the main body configured to be implanted around a native leaflet of a heart valve such that the first end is on an atrial side of the leaflet and the second end is on a ventricular side of the leaflet such that the main body can be brought into and out of apposition with an opposing native leaflet during operation of the heart valve; wherein one of the first end or the second end comprises a coupling mechanism; and wherein the other of the first end or the second end comprises a coupling member configured to extend through the native leaflet to engage the coupling mechanism when the heart valve device is implanted in a heart valve, and wherein the coupling mechanism comprises a pawl member pivotable between a first position and a second position, the pawl member configured to engage the coupling member when the pawl member is in the first position; and a spring member configured to bias the pawl member toward the first position; and wherein: the pawl member and the spring member are located in a first cap member that is coupled to the first end of the implantable heart valve device; and the coupling member is coupled to a second cap member that is coupled to the second end of the implantable heart valve device.

16. The implantable heart valve device of claim 15, wherein the coupling member comprises a coil having a plurality of turns.

17. The implantable heart valve device of claim 15, wherein the pawl member is pivotable about a pivot member disposed in the first cap member.

18. The implantable heart valve device of any one of claims 15-17, wherein the first cap member is in fluid communication with the main body such that a guide wire can extend from the first cap member into the main body.

19. The implantable heart valve device of claim 18, wherein the coupling member defines an internal lumen such that the guide wire can extend through the internal lumen of the coupling member.

20. An assembly for implanting a device at a heart valve of a subject, comprising: an implantable heart valve device of any one of claims 15 to 19, including a main body having a first end and a second end, the main body configured to be implanted about a native leaflet of a heart valve such that the first end is on an atrial side of the leaflet and the second end is on a ventricular side of the leaflet such that the main body can coapt with and de-coapt from an opposing native leaflet during operation of the heart valve, the first end including a coupling assembly and the second end including a coupling member configured to extend through the native leaflet to engage the coupling assembly when the heart valve device is implanted in a heart valve; and a catheter including a shaft having a distal end releasably coupled to the first end of the heart valve device.

21. The assembly of claim 20, wherein the catheter includes a first actuator member movable between a proximal position and a distal position to selectively engage the coupling assembly such that the coupling assembly is disengaged from the coupling member when the first actuator member is in the distal position.

22. The assembly of claim 21, wherein: the coupling assembly includes a pawl member movable between a first position and a second position, the pawl member configured to engage the coupling member when the pawl member is in the first position; and the first actuator member is configured to move the pawl member to the second position when the first actuator member engages the pawl member.

23. The assembly of claim 22, wherein the catheter further includes a second actuator member movable between a proximal position and a distal position to selectively engage the coupling member.

24. The assembly of claim 23, configured such that distal movement of the second actuator member causes corresponding distal movement of the coupling member relative to the coupling mechanism when the second actuator contacts the coupling member and the pawl member is in the second position.

25. The assembly of any one of claims 20 to 24, wherein the distal end of the catheter member is releasably coupled to the first end of the heart valve device by a suture.

26. The assembly of claim 25, wherein: The first end portion of the heart valve device includes a cap member; The distal end portion of the catheter includes a first arm portion and a second arm portion; and The suture extends from a lumen defined in the first arm portion, through the cap member, and through a lumen defined in the second arm portion.

27. The assembly of any of claims 20-24, further comprising a guidewire extending from the catheter, through the body of the heart valve device, through the coupling member, and back into the catheter.

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