HEART VALVE SEALING DEVICE AND DELIVERY DEVICE THEREFOR - Patent application

Abstract

Disclosed herein is a valve repair device configured to reduce or inhibit regurgitant blood flow through a native heart valve. The valve repair device is configured to be positioned within the native heart valve orifice and attached to the native heart valve. The device can be connected to the leaflets of the native valve by a variety of different types of paddles.

Description

[Technical field]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 279,012, filed November 12, 2021, which is incorporated by reference in its entirety herein. [Background technology]

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform important functions in ensuring the forward flow of blood to be properly delivered through the cardiovascular system. These heart valves can be damaged, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc., and therefore can be less effective. Such damage to the valves can lead to severe cardiovascular disability or death. Damaged valves can be repaired or replaced surgically during open-heart surgery. However, open-heart surgery is highly invasive and complications can occur. Transvascular techniques can be used to introduce and implant devices in a much less invasive manner than open-heart surgery. As an example, a transvascular technique that can be used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting the catheter into the right femoral vein, ascending the inferior vena cava, and into the right atrium). The septum is then punctured and the catheter is passed into the left atrium. A similar transvascular technique may be used, beginning as the transseptal technique, but not going as far as puncturing the septum, instead rotating the delivery catheter toward the tricuspid valve in the right atrium to implant the device inside the tricuspid valve.

[0003] A healthy heart has a generally conical shape that tapers toward the apex and base. The heart is a four-chamber structure 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 native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure than other native heart valves. The mitral valve includes an annulus portion, which is a circular portion of native valve tissue that surrounds the mitral valve opening, and a pair of cusps or leaflets that extend downward from the annulus into the left ventricle. The mitral valve annulus may form a "D" shape, an elliptical shape, or other non-circular cross-sectional shape with major and minor axes. The anterior leaflet may be larger than the posterior leaflet, and when closed together, form a generally "C" shaped boundary between the abutting sides of the leaflets.

[0004] When operating properly, the anterior and posterior leaflets function together as a one-way valve that can only allow blood to flow from the left atrium to the left ventricle. The left atrium receives oxygen-rich blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle expands (also called "ventricular diastole" or "diastole"), the oxygen-rich blood that is collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricle muscle contracts (also called "ventricular systole" or "systole"), the rising blood pressure in the left ventricle urges the sides of the two leaflets together, thereby closing the one-way mitral valve, so that blood cannot flow back into the left atrium, but instead is ejected out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, multiple fibrous chordae, called chordae tendineae, anchor the leaflets to papillary muscles in the left ventricle.

[0005] Valve regurgitation involves a valve inappropriately allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the native mitral valve fails to close properly during the systolic phase of heart contraction, allowing blood to flow from the left ventricle to the left atrium. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, papillary muscle insufficiency, stretching of the mitral annulus from dilation of the left ventricle, or a combination of these. Mitral regurgitation in the central portion of the leaflets can be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one of the leaflets' commissures (i.e., where the leaflets meet) can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the leaflet edges do not meet in the middle, so the valve does not close and regurgitation is present. Tricuspid regurgitation is similar but can occur on the right side of the heart. Summary of the Invention [Problem to be solved by the invention]

[0006] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any features included in an example of this summary are not required by the claims unless the claims explicitly recite those features. Also, features, components, steps, concepts, etc. described in the examples of this summary and elsewhere in this disclosure can be combined in various ways. Various features and steps described in relevant parts of this disclosure may be included in the examples summarized herein. [Means for solving the problem]

[0007] In some implementations, the valve repair device is configured to reduce or inhibit regurgitant blood flow through the native heart valve. The valve repair device is configured to be positioned within the native heart valve opening and attached to the native heart valve. The device may be connected to the leaflets of the native valve by a variety of different types of anchors. The anchors may include a variety of different types of paddles.

[0008] In some implementations, a valve repair device for repairing a patient's native valve includes a coaptation element formed from a solid or hollow piece of molded material, a paddle portion having a plurality of paddles movable between an open position and a closed position, and a mounting portion having a collar and two clasp elements, each clasp element having a clasp fixation recess. The paddle portion is configured to attach to the patient's native valve and hold the leaflets of the native valve against the mounting portion. The paddles are independently movable between the open position and the closed position.

[0009] In some implementations, the paddle portion is secured within a paddle securing recess of the interface element.

[0010] In some implementations, the attachment portion is secured within a clasp securing recess of the interface element.

[0011] In some implementations, the mounting portion is formed from a superelastic sheet.

[0012] In some implementations, the valve repair device includes a biasing element that biases one of the paddles into one of the open and closed positions.

[0013] In some implementations, the valve repair device includes a connecting element configured to move one of the paddles between the open and closed positions, and the paddle can include a connecting portion for connecting to the connecting element.

[0014] In some implementations, the paddle portion includes an outer paddle and an inner paddle.

[0015] In some implementations, a valve repair system and / or device for repairing a patient's native valve is formed from a solid or hollow piece of molded material and includes a mating element having a passageway, a paddle portion having a plurality of paddles movable between an open position and a closed position, and an attachment portion having a collar and two clasp elements.

[0016] In some implementations, the paddle portion is configured to be attached to the patient's native valve and to hold the leaflets of the native valve against the attachment portion.

[0017] In some implementations, the paddles can be moved independently between the open and closed positions.

[0018] In some implementations, the interface element further comprises a biasing mechanism or element for engaging the paddle extension shaft of the paddle. The biasing mechanism or element can bias the paddle into the closed position.

[0019] In some implementations, the paddle can be moved to an open position using an actuation element.

[0020] In some implementations, the paddle portion is formed from a single superelastic sheet.

[0021] In some implementations, the interface element further comprises a passageway.

[0022] In some implementations, a valve repair system and / or device for repairing a native valve (e.g., of a patient or a simulation) includes a coaptation element having two actuators and an anchor portion, hi some implementations, the anchor portion includes a paddle portion having a plurality of paddles movable between an open position and a closed position.

[0023] In some implementations, the valve repair system / device includes an attachment portion.

[0024] In some implementations, the anchor portion (eg, the paddle portion) is configured to be attached to the patient's native valve and to hold the leaflets of the native valve against the attachment portion.

[0025] In some implementations, the paddles can be independently moved between the open and closed positions.

[0026] In some implementations, distal movement of one of the actuators moves one of the paddles to an open position, and proximal movement of one of the actuators moves one of the paddles to a closed position.

[0027] In some implementations, each actuator is connected to one of the paddles by a connecting element.

[0028] In some implementations, the movement of each of the paddles is controlled by a biasing element.

[0029] In some implementations, the paddle is distally biased.

[0030] In some implementations, the paddle portion is formed from a single superelastic sheet.

[0031] In some implementations, the attachment portion is distally biased.

[0032] In some implementations, a valve repair system and / or device for repairing a patient's native valve includes a first retention hinge, a second retention hinge, and a paddle. In some implementations, the second retention hinge is disposed proximal to the first retention hinge.

[0033] In some implementations, the paddle includes a paddle arm and a driven arm.

[0034] In some implementations, the paddle arm has a first paddle member having a stop and a paddle fastener rotatably retained within the first retaining hinge.

[0035] In some implementations, the driven arm has a driven fastener rotatably retained in the second retaining hinge and a paddle connector slidable along a portion of the first paddle member.

[0036] In some implementations, the paddle is rotatable from an open position to a first position where the paddle connector abuts a stop, a central position where the paddle arm and the driven arm are substantially aligned, and a closed position, At least one of the first retention hinge, the second retention hinge, and the driven arm biases the paddle arm to the closed position when the paddle rotates past the central position.

[0037] In some implementations, at least one of the first retention hinge and the second retention hinge biases the paddle arm to a closed position when the paddle rotates past a central position.

[0038] In some implementations, one of the first retention hinge and the second retention hinge biases the paddle arm to a closed position when the paddle rotates past a center position.

[0039] In some implementations, a second retaining hinge biases the paddle arm to a closed position when the paddle rotates past a center position.

[0040] In some implementations, the paddle arm further includes a second paddle member disposed opposite the first paddle member.

[0041] In some implementations, the first paddle member is a wire loop and the stop comprises a rod disposed between the legs of the first paddle member.

[0042] In some implementations, at least one of the paddle arm and the driven arm comprises Nitinol.

[0043] In some implementations, the paddle further includes a gripping member having a movable arm movable between a closed position and an open position.

[0044] In some implementations, the gripping member further comprises a collar disposed about the joint element and a joint portion between the collar and the movable arm, the joint portion biasing the movable arm to the closed position.

[0045] In some implementations, the gripping member further includes a fixed arm attached to the first paddle member and a joint portion between the fixed arm and the movable arm, the joint portion biasing the movable arm to the closed position.

[0046] In some implementations, the second paddle member is positioned at an obtuse angle from the first paddle member.

[0047] In some implementations, the follower arm applies a leaf spring biasing force to the paddle as the paddle rotates proximally past the first point.

[0048] In some implementations, the valve repair system / device includes an abutment element attached to the first retention hinge and the second retention hinge.

[0049] In some implementations, the valve repair system / device includes a base and a paddle. The paddle may include a paddle arm and a paddle arm connector.

[0050] In some implementations, the paddle arm has a first leg portion having a first connecting portion and a second leg portion having a second connecting portion.

[0051] In some implementations, the paddle arm connector has a fixed holding portion for receiving the second connecting portion, and a first receiving portion and a second receiving portion for receiving the first connecting portion.

[0052] In some implementations, the paddle arm is rotatable about the paddle arm connector when the first connecting portion is disposed within the first receiving portion and is biased against rotation when the first connecting portion is disposed within the second receiving portion.

[0053] In some implementations, the paddle arm connector includes a channel connecting the first and second receiving portions.

[0054] In some implementations, the first receiving portion and the fixed retaining portion are disposed at a first height and the second receiving portion is disposed at a second height, the second height being greater than the first height.

[0055] In some implementations, the channel is L-shaped.

[0056] In some implementations, the channel includes a first channel portion extending upwardly from the first receiving portion, a second channel portion extending laterally from the first channel portion, and a third channel portion extending downwardly from an end of the second channel portion opposite the first channel portion into the second receiving portion.

[0057] In some implementations, the first channel portion extends to a third height that is greater than the second height.

[0058] In some implementations, the paddle arms comprise Nitinol.

[0059] In some implementations, the force required to rotate the paddle arm when the first receiving portion is disposed within the second receiving portion is proportional to the amount the paddle arm rotates about the paddle arm connector.

[0060] In some implementations, the base includes a joint element.

[0061] In some implementations, any of the devices herein can be part of a valve repair system that includes a delivery system and a device (eg, a valve repair device, etc.).

[0062] In some implementations, the valve repair system and / or device are sterilized.

[0063] Any of the above systems, devices, apparatus, components, etc. may be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on patients, and the above methods may include sterilization of the systems, devices, apparatus, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0064] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like elements bear like reference characters and in which:

[0065] To further clarify various aspects of the implementations of the present disclosure, certain embodiments and implementations will be described in more detail by reference to various aspects of the accompanying drawings. These drawings depict only exemplary implementations of the present disclosure and therefore should not be considered as limiting the scope of the present disclosure. Furthermore, the drawings may be drawn to scale for some embodiments, but not necessarily to scale for all embodiments. The embodiments and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0066] [Figure 1] FIG. 1 shows a cross-section of a human heart in diastole. [Diagram 2] FIG. 2 shows a cross-section of a human heart during systole. [Diagram 3] FIG. 3 shows a cross-section of a human heart during systole, showing valvular regurgitation. [Figure 4] FIG. 4 is a cross-sectional view of FIG. 3, annotated to show the natural shape of the mitral valve leaflets during systole. [Diagram 5] FIG. 5 shows a healthy mitral valve with the leaflets closed as viewed from the atrial side of the mitral valve. [Figure 6]FIG. 6 shows an incompetent mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 7] FIG. 7 shows the tricuspid valve as viewed from the atrial side of the tricuspid valve. [Figure 8] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 9] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 10] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 11] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 12] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 13] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 14] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 15] FIG. 15 shows one embodiment of an implantable device or implant similar to the device shown in FIGS. 8-14, but in which the paddles are independently controllable. [Figure 16] 16-21 show the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 17] 16-21 show the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 18] 16-21 show the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 19]16-21 show the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 20] 16-21 show the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 21] 16-21 show the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 22] FIG. 22 shows a perspective view of an exemplary implantable device or implant in a closed position. [Figure 23] FIG. 23 shows a front view of the implantable device or implant of FIG. [Figure 24] FIG. 24 shows a side view of the implantable device or implant of FIG. [Diagram 25] FIG. 25 shows a front view of the implantable device or implant of FIG. 22 with a cover over the paddle and the coaptation element or spacer. [Figure 26] FIG. 26 shows a top perspective view of the implantable device or implant of FIG. 22 in an open position. [Figure 27] FIG. 27 shows a bottom perspective view of the implantable device or implant of FIG. 22 in an open position. [Figure 28A] FIG. 28A shows a clasp for use in an implantable device or implant. [Figure 28B] FIG. 28B illustrates a perspective view of an exemplary clasp on an exemplary implantable device or implant in a closed position. [Figure 29] FIG. 29 shows a portion of native valve tissue grasped by a clasp. [Diagram 30] FIG. 30 illustrates a side view of an exemplary implantable device or implant in a partially open position with the clasp in a closed position. [Diagram 31] FIG. 31 illustrates a side view of an exemplary implantable device or implant in a partially open position with the clasps in the open position. [Diagram 32] FIG. 32 illustrates a side view of an exemplary implantable device or implant in a half-open position with the clasp in a closed position. [Diagram 33] FIG. 33 illustrates a side view of an exemplary implantable device or implant in a half-open position with the clasp in the open position. [Diagram 34] FIG. 34 illustrates a side view of an exemplary implantable device or implant in a three-quarters open position with the clasp in a closed position. [Diagram 35] FIG. 35 illustrates a side view of an exemplary implantable device or implant in a three-quarters open position with the clasps in the open position. [Diagram 36] FIG. 36 illustrates a side view of an exemplary implantable device in a fully open or fully bailed out position with the clasp in the closed position. [Figure 37] FIG. 37 illustrates a side view of an exemplary implantable device in a fully open or fully bale-out position with the clasp in the open position. [Figure 38] 38-49 show the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within the native valve. [Figure 39] 38-49 show the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within the native valve. [Diagram 40] 38-49 show the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within the native valve. [Diagram 41]38-49 show the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within the native valve. [Diagram 42] 38-49 show the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within the native valve. [Diagram 43] 38-49 show the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within the native valve. [Diagram 44] 38-49 show the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within the native valve. [Diagram 45] 38-49 show the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within the native valve. [Figure 46] 38-49 show the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within the native valve. [Figure 47] 38-49 show the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within the native valve. [Figure 48] 38-49 show the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within the native valve. [Figure 49] 38-49 show the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within the native valve. [Figure 50]FIG. 50 is a schematic diagram illustrating the path of the native valve leaflets along each side of a coaptation element or spacer in an exemplary valve repair device or implant. [Figure 51] FIG. 51 is a schematic diagram from above illustrating the path of the leaflets of a native valve around a coaptation element or spacer in an exemplary valve repair device or implant. [Figure 52] FIG. 52 illustrates a coaptation element or spacer positioned within the gap of the native valve as viewed from the atrial side of the native valve. [Figure 53] FIG. 53 illustrates a valve repair device or implant attached to the leaflets of a native valve with a coaptation element or spacer positioned within the gap of the native valve when viewed from the ventricular side of the native valve. [Figure 54] FIG. 54 is a perspective view of a valve repair device or implant attached to the leaflets of a native valve with a coaptation element or spacer positioned within the gap of the native valve when viewed from the ventricular side of the native valve. [Figure 55] FIG. 55 shows a perspective view of an exemplary implantable device or implant in a closed position. [Figure 56A] FIG. 56A illustrates the valve repair device with the paddles in the open position. [Figure 56B] FIG. 56B illustrates the valve repair device of FIG. 56A with the paddle in an open position and the gripping member actuated to create a wider gap between the gripping member and the paddle. [Figure 56C] FIG. 56C illustrates the valve repair device of FIG. 56A in the position shown in FIG. 56A with the valve tissue disposed between the grasping members and the paddles. [Figure 56D] FIG. 56D illustrates the valve repair device of FIG. 56A where the gripping members have been actuated to reduce the gap between the gripping members and the paddles. [Figure 56E]56E-56F illustrate the paddles in the valve repair device of FIG. 56A moving from an open position to a closed position. [Fig. 56F] 56E-56F illustrate the paddles in the valve repair device of FIG. 56A moving from an open position to a closed position. [Figure 56G] FIG. 56G illustrates the valve repair device of FIG. 56A in a closed position with the gripping members engaged against the valve tissue. [Fig. 56H] FIG. 56H illustrates the valve repair device of FIG. 56A after being detached from the delivery device and attached to valve tissue, where the valve repair device is in an occluded and locked state. [Figure 57] FIG. 57 illustrates an embodiment of an implantable prosthetic device having independently controllable paddles. [Figure 58] FIG. 58 shows a front view of the implantable prosthetic device of FIG. [Figure 59A] 59A-59D show various views of an optional joint element for use with the implantable prosthetic device of FIG. [Figure 59B] 59A-59D show various views of an optional joint element for use with the implantable prosthetic device of FIG. [Figure 59C] 59A-59D show various views of an optional joint element for use with the implantable prosthetic device of FIG. [Fig. 59D] 59A-59D show various views of an optional joint element for use with the implantable prosthetic device of FIG. [Figure 60A] 60A-60D show various views of a paddle portion for use with the implantable prosthetic device of FIG. [Figure 60B] 60A-60D show various views of a paddle portion for use with the implantable prosthetic device of FIG. [Figure 60C] 60A-60D show various views of a paddle portion for use with the implantable prosthetic device of FIG. [Figure 60D]60A-60D show various views of a paddle portion for use with the implantable prosthetic device of FIG. [Figure 61A] 61A-61D show various views of attachment portions for use with the implantable prosthetic device of FIG. [Figure 61B] 61A-61D show various views of attachment portions for use with the implantable prosthetic device of FIG. [Figure 61C] 61A-61D show various views of attachment portions for use with the implantable prosthetic device of FIG. [Figure 61D] 61A-61D show various views of attachment portions for use with the implantable prosthetic device of FIG. [Figure 62A] 62A and 62B show top perspective and front views of the implantable prosthetic device of FIG. 57 with the coaptation elements removed. [Figure 62B] 62A and 62B show top perspective and front views of the implantable prosthetic device of FIG. 57 with the coaptation elements removed. [Figure 63] 63 is a front view of the implantable prosthetic device of FIG. 57. FIG. [Figure 64] 64 is a top perspective view of the implantable prosthetic device of FIG. 57. FIG. [Figure 65] 65-67 show schematic front views of the implantable prosthetic device of FIG. 57 in various stages of deployment. [Figure 66] 65-67 show schematic front views of the implantable prosthetic device of FIG. 57 in various stages of deployment. [Figure 67] 65-67 show schematic front views of the implantable prosthetic device of FIG. 57 in various stages of deployment. [Figure 68] FIG. 68 shows an embodiment of an implantable prosthetic device in which the paddles are independently controllable. [Figure 69] 69 and 70 show front and side views of the implantable prosthetic device of FIG. [Figure 70]69 and 70 show front and side views of the implantable prosthetic device of FIG. [Figure 71A] 71A and 71B show top and bottom views of the implantable prosthetic device of FIG. [Figure 71B] 71A and 71B show top and bottom views of the implantable prosthetic device of FIG. [Figure 72] 72 and 73 show a top perspective view and a front exploded view of the implantable prosthetic device of FIG. [Figure 73] 72 and 73 show a top perspective view and a front exploded view of the implantable prosthetic device of FIG. [Fig. 74A] 74A-74D show various views of an optional joint element for use with the implantable prosthetic device of FIG. [Fig. 74B] 74A-74D show various views of an optional joint element for use with the implantable prosthetic device of FIG. [Fig. 74C] 74A-74D show various views of an optional joint element for use with the implantable prosthetic device of FIG. [Fig. 74D] 74A-74D show various views of an optional joint element for use with the implantable prosthetic device of FIG. [Fig. 75A] 75A-75C show various views of a paddle portion for use in the implantable prosthetic device of FIG. [Fig. 75B] 75A-75C show various views of a paddle portion for use in the implantable prosthetic device of FIG. [Fig. 75C] 75A-75C show various views of a paddle portion for use in the implantable prosthetic device of FIG. [Figure 76A] 76A-76D show various views of attachment portions for use with the implantable prosthetic device of FIG. [Figure 76B] 76A-76D show various views of attachment portions for use with the implantable prosthetic device of FIG. [Figure 76C] 76A-76D show various views of attachment portions for use with the implantable prosthetic device of FIG. [Fig. 76D] 76A-76D show various views of attachment portions for use with the implantable prosthetic device of FIG. [Figure 77] 77-79 show schematic front views of the implantable prosthetic device of FIG. 68 in various stages of deployment. [Figure 78] 77-79 show schematic front views of the implantable prosthetic device of FIG. 68 in various stages of deployment. [Figure 79] 77-79 show schematic front views of the implantable prosthetic device of FIG. 68 in various stages of deployment. [Figure 80A] 80A and 80B show an embodiment of an implantable prosthetic device in which the paddles are independently controllable. [Figure 80B] 80A and 80B show an embodiment of an implantable prosthetic device in which the paddles are independently controllable. [Figure 81] 81 and 82 show front and top perspective exploded views of the implantable prosthetic device of FIGS. 80A and 80B. [Figure 82] 81 and 82 show front and top perspective exploded views of the implantable prosthetic device of FIGS. 80A and 80B. [Figure 83A] 83A-83E show various views of a joint element for use in the implantable prosthetic device of FIGS. 80A and 80B. [Figure 83B] 83A-83E show various views of a joint element for use in the implantable prosthetic device of FIGS. 80A and 80B. [Figure 83C] 83A-83E show various views of a joint element for use in the implantable prosthetic device of FIGS. 80A and 80B. [Fig. 83D] 83A-83E show various views of a joint element for use in the implantable prosthetic device of FIGS. 80A and 80B. [Figure 83E]83A-83E show various views of a joint element for use in the implantable prosthetic device of FIGS. 80A and 80B. [Fig. 84A] 84A and 84B are front views of a paddle portion for use with the implantable prosthetic device of FIGS. 80A and 80B at various stages of deployment. [Fig. 84B] 84A and 84B are front views of a paddle portion for use with the implantable prosthetic device of FIGS. 80A and 80B in various stages of deployment. [Fig. 85A] 85A and 85B are side views of a paddle portion for use with the implantable prosthetic device of FIGS. 80A and 80B in various stages of deployment. [Fig. 85B] 85A and 85B are side views of a paddle portion for use with the implantable prosthetic device of FIGS. 80A and 80B in various stages of deployment. [Figure 86A] 86A and 86B are top views of a paddle portion for use with the implantable prosthetic device of FIGS. 80A and 80B at various stages of deployment. [Figure 86B] 86A and 86B are top views of a paddle portion for use with the implantable prosthetic device of FIGS. 80A and 80B at various stages of deployment. [Fig. 87A] 87A-87D show various views of attachment portions for use with the implantable prosthetic device of FIGS. 80A and 80B. [Fig. 87B] 87A-87D show various views of attachment portions for use with the implantable prosthetic device of FIGS. 80A and 80B. [Fig. 87C] 87A-87D show various views of attachment portions for use with the implantable prosthetic device of FIGS. 80A and 80B. [Fig. 87D] 87A-87D show various views of attachment portions for use with the implantable prosthetic device of FIGS. 80A and 80B. [Figure 88]88-94 show schematic front views of the implantable prosthetic device of FIGS. 80A and 80B in various stages of deployment. [Figure 89] 88-94 show schematic front views of the implantable prosthetic device of FIGS. 80A and 80B in various stages of deployment. [Figure 90] 88-94 show schematic front views of the implantable prosthetic device of FIGS. 80A and 80B in various stages of deployment. [Figure 91] 88-94 show schematic front views of the implantable prosthetic device of FIGS. 80A and 80B in various stages of deployment. [Figure 92] 88-94 show schematic front views of the implantable prosthetic device of FIGS. 80A and 80B in various stages of deployment. [Figure 93] 88-94 show schematic front views of the implantable prosthetic device of FIGS. 80A and 80B in various stages of deployment. [Figure 94] 88-94 show schematic front views of the implantable prosthetic device of FIGS. 80A and 80B in various stages of deployment. [Figure 95] 95-98 show schematic diagrams of example implantable devices or implants at various stages of deployment. [Figure 96] 95-98 show schematic diagrams of example implantable devices or implants at various stages of deployment. [Figure 97] 95-98 show schematic diagrams of example implantable devices or implants at various stages of deployment. [Figure 98] 95-98 show schematic diagrams of example implantable devices or implants at various stages of deployment. [Figure 99] 99-103 illustrate examples of implantable devices or implants similar to the devices illustrated in FIGS. 95-98 in various stages of deployment. [Figure 100] 99-103 illustrate examples of implantable devices or implants similar to the devices illustrated in FIGS. 95-98 in various stages of deployment. [Figure 101] 99-103 illustrate examples of implantable devices or implants similar to the devices illustrated in FIGS. 95-98 in various stages of deployment. [Figure 102] 99-103 illustrate examples of implantable devices or implants similar to the devices illustrated in FIGS. 95-98 in various stages of deployment. [Figure 103] 99-103 illustrate examples of implantable devices or implants similar to the devices illustrated in FIGS. 95-98 in various stages of deployment. [Figure 104] FIG. 104 illustrates an exemplary valve repair device or implant similar to the device or implant of FIGS. 99-103, but having two paddles. [Figure 105] FIG. 105 illustrates the valve repair device or implant of FIG. 104 in which the paddles are independently controllable. [Fig. 106] FIG. 106 illustrates the valve repair device or implant of FIG. 104 in which the paddles are integrally controllable. [Figure 107] FIG. 107 illustrates an exemplary valve repair device or implant similar to the device or implant of FIG. 104, but with an attachment portion or gripping member in a closed position. [Figure 108] FIG. 108 illustrates the valve repair device or implant of FIG. 107 but with the gripping members in an open position. [Fig. 109] FIG. 109 illustrates an exemplary valve repair device or implant similar to that of FIG. 104, but with another embodiment of a gripping member, the gripping member being in a closed position. [Figure 110] FIG. 110 illustrates the valve repair device or implant of FIG. 109 with the gripping elements in an open position. [Figure 111] FIG. 111 shows a schematic diagram of an implantable device or implant in an open position. [Figure 112]FIG. 112 shows a schematic diagram of the implantable device or implant of FIG. 111 in a closed position. [Figure 113] 113-116 illustrate perspective views of an exemplary paddle of the implantable device of FIG. 110 in various positions. [Fig. 114] 113-116 illustrate perspective views of an exemplary paddle of the implantable device of FIG. 110 in various positions. [Figure 115] 113-116 illustrate perspective views of an exemplary paddle of the implantable device of FIG. 110 in various positions. [Fig. 116] 113-116 illustrate perspective views of an exemplary paddle of the implantable device of FIG. 110 in various positions. [Fig. 117A] 117A-117C illustrate the force required to rotate the paddles of the valve repair device of FIG. 110 when the paddles are in the unbiased position. [Fig. 117B] 117A-117C illustrate the force required to rotate the paddles of the valve repair device of FIG. 110 when the paddles are in the unbiased position. [Fig. 117C] 117A-117C illustrate the force required to rotate the paddles of the valve repair device of FIG. 110 when the paddles are in the unbiased position. [Fig. 118A] 118A-118C illustrate the force required to rotate the paddles of the valve repair device of FIG. 110 when the paddles are in the biased position. [Fig. 118B] 118A-118C illustrate the force required to rotate the paddles of the valve repair device of FIG. 110 when the paddles are in the biased position. [Fig. 118C] 118A-118C illustrate the force required to rotate the paddles of the valve repair device of FIG. 110 when the paddles are in the biased position. [Figure 119] 119-124 show the implantable device or implant of FIG. 110 at various stages of deployment in the native heart. [Figure 120]119-124 show the implantable device or implant of FIG. 110 at various stages of deployment in the native heart. [Figure 121] 119-124 show the implantable device or implant of FIG. 110 at various stages of deployment in the native heart. [Figure 122] 119-124 show the implantable device or implant of FIG. 110 at various stages of deployment in the native heart. [Figure 123] 119-124 show the implantable device or implant of FIG. 110 at various stages of deployment in the native heart. [Figure 124] 119-124 show the implantable device or implant of FIG. 110 at various stages of deployment in the native heart. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0067] In the following description, reference is made to the accompanying drawings which illustrate exemplary implementations of the present disclosure. Other implementations having different structure and operation do not depart from the scope of the present disclosure.

[0068] Some implementations of the present disclosure are directed to systems, devices, methods, etc., for repairing defective heart valves. For example, implementations of valve repair devices, implantable devices, implants, and systems (including systems for delivering them) are disclosed herein, and any combination of these options can be performed unless specifically excluded. In other words, the individual components of the disclosed devices and systems can be combined unless they are mutually exclusive or physically impossible. Furthermore, the treatment techniques, methods, processes, etc. described or suggested herein, or references incorporated herein, may be performed on live animals or on non-living simulations, such as cadavers, cadaver hearts, simulators (e.g., simulating body parts, tissues, etc.). As used herein, the term "simulation" encompasses simulations performed on cadavers, computer simulators, virtual people, open spaces, etc.

[0069] Any of the various systems, devices, apparatus, etc. disclosed herein can be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on patients, and the methods herein can include sterilization (e.g., sterilization by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of the associated systems, devices, apparatus, etc.

[0070] As described herein, when one or more components are described as being connected, joined, fastened, coupled, attached, or otherwise interconnected, such interconnection may be direct, such as between the components, or may be indirect, such as through the use of one or more intermediate components. Also, references to a "member," "component," or "portion" described herein are not limited to a single structural member, component, or element, but may include an assembly of components, members, or elements. Also, the terms "substantially" and "about" described herein are defined as at least close to (and including) a given value or condition (preferably within 10%, more preferably within 1%, and most preferably within 0.1%). Although the terms "clasp" and "clasp arm" are often used herein with respect to specific embodiments, the terms "gripping member" and / or "gripper arm" may be substituted and function in the same or similar manner, even if not configured in the same manner as a typical clasp.

[0071] 1 and 2 are cross-sectional views of a human heart H during diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, i.e., atrioventricular valves, respectively. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in Figs. 3-6 and leaflets 30, 32, 34 shown in Fig. 7) that extend inwardly across their respective valve openings, which come together or "coapt" in flow to form a unidirectional fluid occlusion surface. The native valve repair system of the present application is frequently described and / or illustrated with respect to the mitral valve MV. Accordingly, the anatomy of the left atrium LA and the left ventricle LV will be described in more detail. However, the devices described herein may also be used in the repair of other native valves, for example, the devices may be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0072] The left atrium LA receives oxygen-rich blood from the lungs. During the expansion phase, or diastole, as seen in FIG. 1, blood already collected in the left atrium LA (during the contraction phase) moves through the mitral valve MV into the left ventricle LV due to the expansion of the left ventricle LV. During the contraction phase, or systole, as seen in FIG. 2, the left ventricle LV contracts to pump blood through the aortic valve AV and the ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close, preventing blood from flowing back from the left ventricle LV into the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In some implementations, the device described in the present application is used to restore the function of a defective mitral valve MV. That is, the device is configured to assist in the closure of the leaflets of the mitral valve to prevent or inhibit blood from flowing back from the left ventricle LV into the left atrium LA. Many of the devices described in this application are designed to easily grasp and secure the native valve leaflets around a coaptation element or spacer that beneficially acts as a filler within the regurgitant opening to prevent or reduce backflow or reflux during systole, although this is not required.

[0073] Referring now to Figures 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24, which is a variably dense, fibrous ring of tissue surrounding the leaflets 20, 22. Referring to Figures 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., muscles located in the wall of the left ventricle LV at the base of the chordae tendineae CT) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM function to limit the movement of the leaflets 20, 22 of the mitral valve MV and to prevent the mitral valve MV from everting. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Rather, the papillary muscles PM support or brace the leaflets 20, 22 against the high pressures required to circulate blood throughout the body. Together, the papillary muscles PM and chordae tendineae CT are known as the subvalvular tissue, which function to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As can be seen from the left ventricular outflow tract (LVOT) diagram shown in Figure 3, the anatomy of the leaflets 20, 22 is such that the inner surfaces of the leaflets coapt at their free ends and the leaflets 20, 22 begin to retract or spread apart from one another. The leaflets 20, 22 spread apart toward the atrium until each leaflet contacts the mitral valve annulus.

[0074] Various disease processes can impair the proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, elastic fiber deficiency, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or right ventricle RV from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathies, etc.) can distort the shape of the native valve, which can cause the native valve to malfunction. However, the majority of patients who undergo valve surgery, such as mitral valve MV surgery, suffer from a degenerative disease that causes the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV) to malfunction, resulting in prolapse and regurgitation.

[0075] In general, native valves can malfunction in different ways, including (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when a native valve does not open completely, thereby causing impaired blood flow. Typically, valve stenosis is due to the accumulation of calcified material on the leaflets of the valve, which thickens the leaflets and impairs the ability of the valve to open completely to allow forward blood flow. Valve regurgitation occurs when the leaflets of the valve do not close completely, thereby causing blood to leak back into the previous heart chamber (e.g., blood leaks from the left ventricle into the left atrium).

[0076] There are three main mechanisms by which native valves become regurgitant or incompetent, including Carpentier's Type I, II, and III insufficiencies. Carpentier's Type I insufficiency involves dilatation of the valve annulus, so that normally functioning leaflets move apart and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in the insufficiency of the Type I mechanism is leaflet perforation, as occurs in endocarditis. Carpentier's Type II insufficiency involves prolapse of one or more leaflets of the native valve above the plane of coaptation. Carpentier's Type III insufficiency involves restriction of the movement of one or more leaflets of the native valve, so that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease or ventricular dilatation.

[0077] With reference to FIG. 5, when a healthy mitral valve MV is in a closed position, the anterior leaflets 20 and posterior leaflets 22 coapt, thereby preventing blood from leaking from the left ventricle LV into the left atrium LA. With reference to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflets 20 and / or posterior leaflets 22 of the mitral valve MV are displaced into the left atrium LA during systole, such that the edges of the leaflets 20, 22 do not contact one another. This failure to coapt creates a gap 26 between the anterior leaflets 20 and posterior leaflets 22, which allows blood to flow regurgitantly from the left ventricle LV into the left atrium LA during systole, as shown by the mitral regurgitation MR flow path in FIG. 3. With reference to FIG. 6, the gap 26 may have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some circumstances, the gap 26 may have a width W of greater than 15 mm or even greater than 17.5 mm. As discussed above, there are several different ways in which a valve leaflet (e.g., the leaflets 20, 22 of the mitral valve MV) may become incompetent, causing valvular regurgitation.

[0078] In any of the above situations, a valve repair device or implant that can engage the anterior leaflets 20 and posterior leaflets 22 and close the gap 26 to prevent or inhibit backflow of blood through the mitral valve MV is desirable. As can be seen from FIG. 4, an abstract representation of a valve repair device, implantable device, or implant 10 is shown implanted between the leaflets 20, 22 such that no backflow occurs during systole (compare FIG. 3 with FIG. 4). In some implementations, the coaptation elements (e.g., spacers, coaptation elements, gap fillers, membranes, sheets, plugs, wedges, balloons, etc.) of the device 10 have a generally tapered or triangular shape that naturally matches the shape of the native valve and its tendency to expand (towards the annulus). In this application, terms such as spacer, coaptation element, coaptation element and gap filler are used interchangeably and refer to elements that are configured to fill a portion of the space between the leaflets of the native valve and / or to cause the leaflets of the native valve to engage or "coapt" (e.g., such that the native leaflets coapt not only to each other but also to the coaptation element, e.g., spacer, coaptation element, gap filler, etc.).

[0079] Although stenosis or regurgitation can affect any valve, stenosis has been found to primarily affect either the aortic valve AV or the pulmonary valve PV, and regurgitation has been found to primarily affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the burden on the heart H and, if left untreated, can lead to very serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. The left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) is primarily responsible for circulating blood flow throughout the body. Therefore, since pressures are substantially higher in the left side of the heart, insufficiency of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening.

[0080] Dysfunctional native heart valves can be either repaired or replaced. Repair typically involves maintaining and correcting the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Since the stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic valve or pulmonary valve can be removal of the valve and replacing it with a surgically implanted heart valve, or replacing it with a transcatheter heart valve. The mitral valve MV and tricuspid valve TV are more prone to deformation of the leaflets and / or surrounding tissue, which, as described above, prevents the mitral valve MV or tricuspid valve TV from closing properly and allows regurgitation or backflow of blood from the ventricle into the atrium (e.g., deformation of the mitral valve MV can allow regurgitation or backflow from the left ventricle LV into the left atrium LA, as shown in FIG. 3). Regurgitation or backflow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. In addition, regurgitation can occur due to incompetence of the chordae tendineae CT (e.g., the chordae tendineae CT can stretch or rupture), allowing the anterior leaflet 20 and the posterior leaflet 22 to evertate, resulting in blood flowing back into the left atrium LA. Problems caused by incompetent chordae tendineae CT can be repaired by repairing the structure of the chordae tendineae CT or the mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0081] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it is understood that the devices and concepts provided herein can be used to repair any native valve, as well as to repair any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit backflow of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts provided herein can be used between any two of the anterior leaflet 30, the septal leaflet 32, and the posterior leaflet 34 to prevent or inhibit backflow of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein can be used on all three of the leaflets 30, 32, 34 together to prevent or inhibit backflow of blood from the right ventricle into the right atrium. That is, the valve repair device or implant provided herein can be centrally located between the three leaflets 30, 32, 34.

[0082] An exemplary implantable device or implant may optionally have a coaptation element (e.g., a spacer, coaptation element, gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, an implantable device or implant may have any combination or subcombination of the features disclosed herein without a coaptation element. When included, the coaptation element (e.g., a coaptation element, a spacer, etc.) is configured to be positioned within the native heart valve opening to help fill the space between the leaflets and form a more effective seal, thereby reducing, preventing, or inhibiting the above-mentioned backflow. The coaptation element may be impermeable to blood (or resist blood flow therethrough) and may have a structure that allows the native leaflets to close around the coaptation element during ventricular systole, thereby blocking backflow of blood from the left or right ventricle into the left or right atrium, respectively. The device or implant can be configured to seal against two or three native leaflets, i.e., the device can be used with native mitral (bicuspid) and native tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element can fill the space between native leaflets (e.g., mitral valve 20, 22 or tricuspid leaflets 30, 32, 34) that do not close completely or function properly.

[0083] The optional coaptation elements (e.g., spacers, coaptation elements, gap fillers, etc.) can have a variety of shapes. In some implementations, the coaptation elements can have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the coaptation elements can have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some implementations, the coaptation elements can have an atrial portion positioned in or adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a lateral surface extending between the native leaflets. In some implementations configured for use with a tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the lateral surface extends between the native tricuspid leaflets.

[0084] In some implementations, the anchors can be configured to secure the device to one or both of the native leaflets such that the coaptation element is positioned between two native leaflets. In some implementations configured for use with a tricuspid valve, the anchors can be configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between three native leaflets. In some implementations, the anchors can be attached to the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some implementations, the anchors can be attached to an actuating element, such as a shaft, rod, tube, wire, etc., to which the coaptation element is also attached. In some implementations, the anchors and coaptation elements can be independently positioned relative to one another by separately moving each of the anchors and coaptation elements along a longitudinal axis of the actuating element (e.g., actuating shaft, actuating rod, actuating tube, actuating wire, etc.). In some implementations, the anchors and coaptation elements can be simultaneously positioned by moving the anchors and coaptation elements together along a longitudinal axis of the actuating element (e.g., shaft, actuating wire, etc.). The anchors can be configured to be positioned behind the native valve leaflets when implanted such that the leaflets are grasped by the anchors.

[0085] The device or implant may be configured to be implanted via a delivery system or other delivery means. The delivery system may include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, and the like. The coaptation elements and anchors may be compressible to a radially compressed state and may be self-expandable to a radially expanded state when the compressive pressure is released. The device may be configured such that the anchors are expanded radially away from the initially still compressed coaptation elements to create a gap between the coaptation elements and the anchors. The native leaflets may then be positioned within the gap. The coaptation elements may be expanded radially to close the gap between the coaptation elements and the anchors, capturing the leaflets between the coaptation elements and the anchors. In some implementations, the anchors and coaptation elements are optionally configured to be self-expanding. The implantation methods for various implementations may vary and are described more fully below for each implementation. Additional information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599, U.S. Patent Application Publication No. 2014 / 0222136, U.S. Patent Application Publication No. 2014 / 0067052, U.S. Patent Application Publication No. 2016 / 0331523, and PCT Patent Application Publication No. WO2020 / 076898, which are incorporated by reference in their entirety for all purposes. These methods can be performed, mutatis mutandis, on live animals or can be performed on simulations, such as cadavers, cadaver hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0086] The disclosed device or implant may be configured such that anchors are connected to the leaflets and utilize tension from the natural chordae tendineae to resist the large systolic pressures that urge the device toward the left atrium. During diastole, the device may rely on compressive and retaining forces exerted against the leaflets that are gripped by the anchors.

[0087] 8-15, a schematic device or implant 100 (e.g., an implantable prosthetic device, a prosthetic spacer device, a valve repair device, an implantable device, etc.) is shown in various stages of deployment. The device or implant 100, as well as other similar devices / implants, are described in more detail in PCT Patent Application Publication Nos. WO2018 / 195215, WO2020 / 076898, and WO2019 / 139904, which are incorporated by reference in their entireties. The device 100 may include any other features of another device or implant described in this application or the applications cited above, and the device 100 may be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the applications cited above).

[0088] The device or implant 100 is deployed from a delivery system or other delivery means 102. The delivery system 102 may include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a passageway, combinations thereof, etc. The device or implant 100 includes an interface portion / region 104 and an anchor portion / region 106.

[0089] In some implementations, the interface portion 104 of the device or implant 100 is adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and includes an interface element 110 (e.g., a spacer, plug, filler, foam, sheet, membrane, interface element, etc.) slidably attached to an actuation element 112 (e.g., an actuation wire, shaft, tube, hypotube, line, suture, braid, etc.). The anchor portion 106 includes one or more anchors 108 that are actuable between an open state and a closed state and can take a wide variety of forms, such as, for example, a paddle, a gripping element, or the like. Actuation of the actuation element 112 causes the anchor portion 106 of the device 100 to open and close and grip the leaflets of the native valve during implantation. The actuation element 112 (as well as other actuation means and actuation elements disclosed herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, threads, sutures, lines, strips, combinations thereof, etc.), can be made from a variety of different materials, and can have a variety of configurations. As one example, the actuation element can be threaded such that rotational actuation of the actuation element moves the anchor portion 106 relative to the interface portion 104. Alternatively, the actuation element can be unthreaded such that pushing or pulling actuation of the actuation element 112 moves the anchor portion 106 relative to the interface portion 104.

[0090] The anchor portion 106 and / or anchor of the device 100, in some implementations, includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the interface element 110 by portions 124, 126, 128. The portions 124, 126, 128 may be interfaced and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 120, the inner paddle 122, the interface element 110, and the cap 114 by portions 124, 126, 128 may constrain the device to the positions and movements shown herein.

[0091] In some implementations, the delivery system 102 includes a steerable catheter, an implant catheter, and an actuating element 112 (e.g., an actuating wire, an actuating shaft, etc.), which may be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuating means or element 112 extends through the delivery catheter and the interface element 110 to a distal end (e.g., a cap 114 or other attachment at the distal connection of the anchor portion 106). Extending and retracting the actuating element 112 increases and decreases the spacing between the interface element 110 and the distal end of the device (e.g., the cap 114 or other attachment), respectively. In some implementations, a collar or other attachment element (e.g., a clamp, clip, lock, suture, friction fit, buckle, snap fit, lasso, etc.) removably attaches, either directly or indirectly, the interface element 110 to the delivery system 102 such that the actuation element 112 slides through the collar or other attachment element, and in some implementations, through the interface element 110 during actuation, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0092] In some implementations, the anchor portion 106 and / or the anchor 108 may include an attachment portion or gripping member (e.g., a gripping arm, a clasp arm, etc.). The illustrated gripping member may include a clasp 130 including a base or fixed arm 132, a movable arm 134, an optional friction enhancing element or other fastening structure 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and a joint portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 with the joint portion 138 disposed proximate to the mating element 110. The joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the clasp 130. The joint portion 138 may be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the joint portion 138 is a flexible piece of material integrally formed with the fixed arm 132 and the movable arm 134. The fixed arm 132 is attached to the inner paddle 122 and remains stationary or substantially stationary relative to the inner paddle 122 when the movable arm 134 is in an open state, opening the clasp 130 and exposing the optional barb, friction enhancing element, or securing structure 136.

[0093] In some implementations, the clasp 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, bend or pivot on a joint portion 138. The actuation line 116 extends through the delivery system 102 (e.g., through the steerable catheter and / or the implant catheter). Other actuation mechanisms are also possible.

[0094] The actuation line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The clasp 130 can be spring loaded so that the clasp 130 continues to provide a clamping force against the grasped native leaflet in the closed position. Optional barbs, friction enhancing elements, or other fixation structures 136 of the clasp 130 can grasp, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0095] The paddles 120, 122 may be opened and closed during implantation, for example, to grip a native leaflet (such as a leaflet of a native mitral valve) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation element 110 (spacer, plug, membrane, gap filler, etc.). The clasps 130 may be used to grip and / or further secure the native leaflet by engaging the leaflet with optional barbs, friction enhancing elements, or fixation structures 136 and clamping the leaflet between the movable arm 134 and the fixed arm 132. The optional barbs, friction enhancing elements, or other fixation structures 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) of the clasps 130 may increase friction with the leaflet or partially or completely puncture the leaflet. The actuation lines 116 may be actuated separately such that each clasp 130 may be opened and closed separately. Acting separately allows one leaflet to be grasped at a time, or the clasp 130 to be repositioned on a leaflet that was not adequately grasped without changing the good grip on the other leaflets. The clasp 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), allowing the leaflets to be grasped in various positions as the particular situation requires.

[0096] 8, the device 100 is shown in an extended or fully open state for deployment from an implant delivery catheter of a delivery system 102. The device 100 is placed at the end of the catheter of the delivery system 102 in the fully open position. In the extended state, the cap 114 is spaced from the interface element 110 such that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the interior of the outer paddle 120 and the inner paddle 122 is about 180 degrees. The clasp 130 can be maintained in a closed state during deployment through the delivery system 102 so that the optional barb, friction enhancing element, or other securing structure 136 (FIG. 9) does not get caught or damaged by the delivery system 102. The actuation line 116 can be extended and attached to a movable arm 134.

[0097] 9, device 100 is shown in an extended state similar to FIG. 8, but with clasp 130 in a fully open position ranging from about 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or about 180 degrees between fixed portion 132 and movable portion 134 of clasp 130. Full opening of paddles 120, 122 and clasp 130 has been found to improve ease of disentanglement or detachment from patient anatomical structures, such as chordae tendineae CT, during implantation of device 100.

[0098] 10, the device 100 is shown in a contracted or fully closed state. To move the device 100 from the extended state to the contracted state, the actuation means or element 112 is retracted, pulling the cap 114 towards the interface element 110. The connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained from moving, so that the paddle or gripping element moves radially outward due to the compressive force acting on the outer paddle 120 from the cap 114 retracted towards the interface element 110. The outer paddle 120 maintains an acute angle with the actuation means or element 112 during the movement from the open position to the closed position. The outer paddle 120 can optionally be biased towards the closed position. The inner paddle 122 moves over a very large angle and crushes along the side of the closed interface element 110 during the same movement, as it is oriented away from the open interface element 110.

[0099] 11-13, the device 100 is shown in a partially open, ready to grasp state. To move from the fully closed state to the partially open state, an actuation means or element (e.g., actuation wire, actuation shaft, etc.) is extended to push the cap 114 away from the coaptation element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor or anchor portion 106 to partially unfold. The actuation line 116 is also retracted to open the clasp 130, which allows the leaflets to be grasped. In some implementations, the pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation means or single actuation element 112. Also, the position of the clasp 130 depends on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 will close the clasp. In some implementations, the paddles 120, 122 can be independently controllable. For example, in the embodiment shown in FIG. 15, the device 100 can have two actuation elements 111, 113 and two independent caps 115, 117 (or other mounting parts), such that one independent actuation element (e.g., wire, shaft, etc.) and cap (or other mounting part) is used to control one paddle, and the other independent actuation element and cap (or other mounting part) is used to control the other paddle.

[0100] 12, one of the actuation lines 116 can be extended to close one of the clasps 130. Now, referring to FIGURE 13, the other actuation line 116 can be extended to close the other clasp 130. One or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0101] 14, the device 100 is shown in a fully closed and deployed state. The delivery system or delivery means 102 and actuation means or actuation elements 112 are retracted and the paddles 120, 122 and clasp 130 remain in a fully closed position. Once deployed, the device 100 may be maintained in the fully closed position by a mechanical latch or may be biased to remain closed by the use of spring materials such as steel, other metals, plastics, composites, or shape memory alloys such as Nitinol. For example, the connecting portions 124, 126, 128, joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from metals such as steel or from shape memory alloys such as Nitinol, fabricated into wires, sheets, tubes, or laser sintered powders, and biased to hold the outer paddle 120 closed around the coaptation elements 110 and the clasp 130 in a clamped state around the native leaflets. Similarly, the fixed and movable arms 132, 134 of the clasp 130 are biased to clamp the valve leaflets. In some implementations, the attachment or connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be made from metal or any other suitable resilient material, such as a polymeric material, to maintain the device 100 in a closed state after implantation.

[0102] Figure 15 shows an embodiment in which the paddles 120, 122 are independently controllable. The device 101 shown in Figure 15 is similar to the device shown in Figure 11, except that the device 100 of Figure 15 includes actuation elements configured as two independent actuation elements (e.g., actuation shafts, actuation rods, actuation tubes, actuation wires, etc.) 111, 113 coupled to two independent caps 115, 117. The actuation elements 111 are extended to push the caps 115 away from the interface element 110 to transition the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the first anchor 108 to partially expand. The actuation element 113 is extended to push the cap 115 away from the interface element 110 to transition the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchor 108 to partially expand. The independent paddle control shown in Figure 15 can be implemented in any device disclosed in this application. For comparison, in the embodiment shown in Figure 11, the pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation element 112.

[0103] 16-21, the device 100 of FIGS. 8-14 is shown being delivered and deployed within the native mitral valve MV of the heart H. With reference to FIG. 16, a delivery sheath / catheter is inserted through the septum into the left atrium LA and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state as shown in FIG. 16. The actuating element 112 is then retracted, moving the implant / device to a fully closed state as shown in FIG. 17.

[0104] As can be seen from Figure 18, the implant / device is moved into a position within the mitral valve MV and into the ventricle LV in a partially open state so as to grasp the leaflets 20, 22. For example, a steerable catheter may be advanced to steer or bend the steerable catheter to position it as shown in Figure 18. An implant catheter connected to the implant / device may be advanced from within the steerable catheter to position the implant as shown in Figure 18.

[0105] 19, the implant catheter may be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 within the clasps 130. The actuating line 116 is extended to close one of the clasps 130, capturing the leaflet 20. FIG. 20 shows the other actuating line 116 then being extended to close the other clasp 130, capturing the remaining leaflet 22. Finally, as can be seen from FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), actuating means or element 112, and actuating line 116 are then retracted and the device or implant 100 is fully closed and deployed within the native mitral valve MV.

[0106] Any of the features disclosed herein may be used in a wide variety of different valve repair devices. Figures 22-27 and 56A-56H illustrate examples of valve repair devices that may be modified to include any of the features disclosed herein. Any combination or subcombination of the features disclosed herein may be combined with, substituted for, and / or added to any combination or subcombination of the features of the valve repair devices illustrated in Figures 22-27 and 56A-56H.

[0107] 22, an embodiment of an implantable device or implant 200 is shown. The implantable device 200 is one of many different configurations that the device 100, shown generally in FIGS. 8-14, may take. The device 200 may include any of the other features of an implantable device or implant described herein, and the device 200 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system, such as any of the valve repair systems disclosed herein. The device / implant 200 may be a valve repair device, an implantable device, or another type of implant that is attached to the leaflets of a native valve.

[0108] In some implementations, the implantable device or implant 200 includes a coaptation portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some implementations, the coaptation portion 204 of the device optionally includes a coaptation element 210 (e.g., a spacer, coaptation element, plug, membrane, sheet, etc.) for implantation between the leaflets of a native valve. In some implementations, the anchor portion 206 includes multiple anchors 208. The anchors may be configured in a variety of ways. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clasp 230. In some implementations, the attachment portion 209 includes a first or proximal collar 211 (or other attachment element) for engaging a capture mechanism 213 (FIGS. 43-49) of the delivery system 202 (FIGS. 38-42 and 49). The delivery system 202 may be the same as or similar to the delivery system 102 described elsewhere and may comprise one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, etc. The capture mechanism may be configured in a variety of ways and in some implementations may comprise one or more of a clamp, clip, pin, suture, line, lasso, noose, snare, buckle, lock, latch, etc.

[0109] In some implementations, the joint elements 210 and paddles 220, 222 are formed from a flexible material, which may be a metal fabric formed as a mesh, woven fabric, braided fabric, or in any other suitable manner, or a flexible material that is laser cut or otherwise cut. The material may be a fabric, a shape memory alloy wire such as Nitinol to provide shape setting capabilities, or any other flexible material suitable for implantation in the human body.

[0110] An actuating element 212 (e.g., an actuating shaft, actuating rod, actuating tube, actuating wire, actuating line, etc.) extends from the delivery system 202 to engage and enable actuation of the implantable device or implant 200. In some implementations, the actuating element 212 extends through the capture mechanism 213, the proximal collar 211, and the interface element 210 to engage a cap 214 on the distal portion 207. The actuating element 212 may be configured to releasably engage the cap 214, such as with a threaded connection, such that the actuating element 212 may be disengaged and removed from the device 200 after implantation.

[0111] The coaptation element 210 extends from a proximal collar 211 (or other attachment member) to an inner paddle 222. In some implementations, the coaptation element 210 has a generally elongated, circular shape, although other shapes and configurations are possible. In some implementations, the coaptation element 210 has an elliptical shape or cross-section when viewed from above (e.g., FIG. 51), a tapered shape or cross-section when viewed from the front (e.g., FIG. 23), and a circular shape or cross-section when viewed from the side (e.g., FIG. 24). A mixture of these three geometries can result in a three-dimensional shape for the illustrated coaptation element 210 that achieves the advantages described herein. It can be seen that the circular shape of the coaptation element 210 also substantially follows or approximates the shape of the paddle frame 224 when viewed from above.

[0112] The size and / or shape of the coaptation element 210 may be selected to minimize the number of implants required per patient (preferably one) while maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the apex of the coaptation element is about 5 mm, and the medial-lateral distance at the widest point of the coaptation element is about 10 mm. In some implementations, the overall geometry of the device 200 may be based on these two dimensions and the overall shape plan described above. Using other anterior-posterior and medial-lateral distances as a starting point for the device, it will be readily apparent that the device will have different dimensions. Additionally, using other dimensions and the shape plan described above will also result in the device having different dimensions.

[0113] In some implementations, the outer paddle 220 is joinably attached to the cap 214 of the distal portion 207 by connecting portion 221 and to the inner paddle 222 by connecting portion 223. The inner paddle 222 is joinably attached to the joint element by connecting portion 225. In this manner, the anchor 208 is configured similar to a leg in that the inner paddle 222 is like an upper portion of a leg, the outer paddle 220 is like a lower portion of a leg, and the connecting portion 223 is like a knee portion of a leg.

[0114] In some implementations, the inner paddle 222 is rigid, relatively rigid, stiff, has a stiff portion, and / or is stiffened by a stiffening member or fixed portion 232 of the clasp 230. The stiffening of the inner paddle allows the device to be driven into a variety of different positions as shown and described herein. The inner paddle 222, outer paddle 220, and interface elements may all be interconnected as described herein such that the device 200 is constrained to the movements and positions described and illustrated herein.

[0115] In some implementations, the paddle frame 224 is attached to the cap 214 of the distal portion 207 and extends to a connection 223 between the inner paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is made from a material that is stiffer and harder than the material that forms the paddles 222, 220, such that the paddle frame 224 provides support for the paddles 222, 220.

[0116] The paddle frame 224, as can be seen in FIG. 51, provides additional clamping force between the inner paddle 222 and the coaptation element 210 and helps wrap the leaflets around the sides of the coaptation element 210 for better sealing between the coaptation element 210 and the leaflets. That is, the paddle frame 224 may be configured with a rounded three-dimensional shape that extends from the cap 214 to the connecting portion 223 of the anchor 208. The connections between the paddle frame 224, the outer and inner paddles 220 and 222, the cap 214, and the coaptation element 210 may constrain each of these members to the movements and positions described herein. In particular, the connecting portion 223 is constrained by its connections between the outer and inner paddles 220 and 222 and by its connections to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connecting portion 223 (and thus the inner paddle 222 and the outer paddle 220 ) and by its attachment to the cap 214 .

[0117] Configuring the paddle frame 224 in this manner provides an increased surface area compared to the outer paddle 220 alone, which may, for example, allow easier grasping and fixation of the native leaflets. The increased surface area may also distribute the clamping force of the paddles 220 and paddle frame 224 against the native leaflets over a larger surface area of ​​the native leaflets to further protect the native leaflet tissue. Referring again to FIG. 51, the increased surface area of ​​the paddle frame 224 may also clamp the native leaflets to the implantable device or implant 200 such that the native leaflets are generally coapted against the periphery of the coaptation member or element 210. This may, for example, improve sealing of the native leaflets 20, 22, thereby preventing, inhibiting, or further reducing mitral regurgitation.

[0118] In some implementations, the clasp comprises a movable arm coupled to the anchor. In some implementations, the clasp 230 includes a base or fixed arm 232, a movable arm 234 with optional barbs, friction enhancing elements, or fastening structures 236, and a joint portion 238. The fixed arm 232 is attached to the inner paddle 222 with the joint portion 238 disposed proximate to the mating element 210. The joint portion 238 is spring loaded such that the fixed arm 232 and the movable arm 234 are biased toward each other when the clasp 230 is in a closed state. In some implementations, the clasp 230 includes friction enhancing members or fastening means, such as barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.

[0119] In some implementations, the fixed arm 232 is attached to the inner paddle 222 through a hole or slot 231 using a suture (not shown). The fixed arm 232 may be attached to the inner paddle 222 by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, a weld, an adhesive, a clamp, a latch, or the like. The fixed arm 232 remains substantially stationary relative to the inner paddle 222 when the movable arm 234 is opened to open the clasp 230 and expose the optional barb, friction enhancing element, or fixation structure 236. The clasp 230 is opened by applying tension to an actuation line 216 (e.g., as shown in FIGS. 43-48 ) attached to a hole 235 in the movable arm 234, thereby causing the movable arm 234 to articulate, pivot, and / or bend on a joint portion 238.

[0120] 29, there is shown a close-up view of one of the leaflets 20, 22 being gripped by a clasp, such as clasp 230. The leaflets 20, 22 are gripped between a movable arm 232 and a fixed arm 234 of the clasp 230. The tissue of the leaflets 20, 22 is not pierced by the optional barbs, frictional enhancing elements, or fixation structures 236, although in some implementations the optional barbs 236 can partially or fully pierce the leaflets 20, 22. The angle and height of the optional barbs, frictional enhancing elements, or fixation structures 236 relative to the movable arms 234 helps to secure the leaflets 20, 22 within the clasp 230. In particular, the force pulling the implant away from the native leaflets 20, 22 encourages the optional barbs, frictional enhancing elements, or fixation structures 236 to further engage the tissue, thereby ensuring a better hold. Retention of the leaflets 20, 22 within the clasp 230 is further improved by the location of the fixation arms 232 near the optional barbs, frictional enhancement elements, or fixation structures 236 when the clasp 230 is closed. In this arrangement, the tissue is forced into an S-shaped, distorted path by the fixation arms 232 and the movable arms 234 and the optional barbs, frictional enhancement elements, or fixation structures 236. Thus, the force pulling the leaflets 20, 22 away from the clasp 230 encourages the tissue to further engage the optional barbs, frictional enhancement elements, or fixation structures 236 before the leaflets 20, 22 escape. For example, tension on the leaflets during diastole may encourage the optional barbs, frictional enhancement elements, or fixation structures 236 to pull towards the ends of the leaflets 20, 22. Thus, the S-shaped pathway may take advantage of the leaflet tension during diastole to more tightly engage the leaflets 20, 22 with optional barbs, friction enhancing elements, or anchoring structures 236.

[0121] 25, the device or implant 200 may also include a cover 240. In some implementations, the cover 240 may be disposed on the interface elements 210, the outer and inner paddles 220 and 222, and / or the paddle frame 224. The cover 240 may be configured to prevent or reduce blood flow through the device or implant 200 and / or to promote natural tissue ingrowth. In some implementations, the cover 240 may be a cloth or fabric, such as PET, velour, or other suitable fabric. In some implementations, instead of or in addition to a fabric, the cover 240 may include a coating (e.g., a polymer) applied to the implantable device or implant 200.

[0122] During implantation, the paddles 220, 222 of the anchor 208 can be opened and closed to grip the native valve leaflets 20, 22 between the paddles 220, 222 and the coaptation element 210. The anchor 208 is actuated between a closed position (FIGS. 22-25) and various open positions (FIGS. 26-37) by extending and retracting the actuation element 212. The extension and retraction of the actuation element 212 increases and decreases the spacing between the coaptation element 210 and the cap 214, respectively. The proximal collar 211 (or other attachment member) and coaptation element 210 slide along the actuation element 212 during operation, thereby changing the spacing between the coaptation element 210 and the cap 214 to move the paddles 220, 220 between different positions to grip the mitral valve leaflets 20, 22 during implantation.

[0123] To open and close the device 200, the pair of inner and outer paddles 222, 220 are moved together, rather than independently, by a single actuation element 212. Also, the position of the clasp 230 depends on the position of the paddles 222, 220. For example, the clasp 230 is configured such that closure of the anchor 208 simultaneously closures the clasp 230. In some implementations, the device 200 can be configured with the paddles 220, 222 independently controllable in the same manner (e.g., the device 100 illustrated in FIG. 15).

[0124] In some implementations, the clasp 230 further secures the native leaflets 20, 22 by engaging the leaflets 20, 22 with optional barbs, friction enhancing elements, or fixation structures 236 and / or by clamping the leaflets 20, 22 between the movable arm 234 and the fixation arm 232. In some implementations, the clasp 230 is a barbed clasp that includes barbs that can increase friction with the leaflets 20, 22 and / or partially or fully pierce the leaflets 20, 22. The drive lines 216 (FIGS. 43-48) can be individually actuated so that each clasp 230 can be individually opened and closed. Individual actuation allows for gripping one leaflet 20, 22 at a time, or allows for repositioning the clasp 230 on a leaflet 20, 22 that was not adequately gripped without altering the good grip on the other leaflets 20, 22. The clasps 230 can be fully opened and closed when the inner paddle 222 is not occluded, thereby allowing the leaflets 20, 22 to be grasped in a variety of positions as a particular situation requires.

[0125] 22-25, the device 200 is shown in a closed position. When occluded, the inner paddle 222 is disposed between the outer paddle 220 and the coaptation element 210. The clasp 230 is disposed between the inner paddle 222 and the coaptation element 210. Upon successful capture of the native leaflets 20, 22, the device 200 is moved and held in a closed position such that the leaflets 20, 22 are secured within the device 200 by the clasp 230 and pressed against the coaptation element 210 by the paddles 220, 222. The outer paddle 220 can have a wider curved shape that fits around the curved shape of the coaptation element 210 (e.g., as can be seen from FIG. 51) to more securely grip the leaflets 20, 22 when the device 200 is occluded. The curved shape and rounded edges of the outer paddle 220 also prevent or inhibit tearing of the leaflet tissue.

[0126] 30-37, the implantable device or implant 200 described above is shown in various positions and configurations ranging from partially open to fully open. The paddles 220, 222 of the device 200 transition between the positions shown in FIGS. 30-37 from the closed position shown in FIGS. 22-25 to the upward extension of the actuating element 212 from a fully retracted position to a fully extended position.

[0127] 30-31, the device 200 is shown in a partially open position. The device 200 is actuated into the partially open position by extending the actuation element 212. The extension of the actuation element 212 pulls down the bottom of the outer paddle 220 and the paddle frame 224. The outer paddle 220 and the paddle frame 224 pull down the inner paddle 222, which is connected to the outer paddle 220 and the paddle frame 224. As the proximal collar 211 (or other attachment member) and the joint element 210 are held in place by the capture mechanism 213, the inner paddle 222 is caused to articulate, pivot, and / or bend toward the opening. The inner paddle 222, the outer paddle 220, and the paddle frame all bend to the positions shown in FIGS. 30-31. Releasing the paddles 222, 220 and frame 224 creates a gap between the coaptation element 210 and the inner paddle 222 that can receive and grip the native leaflets 20, 22. This movement also exposes the clasp 230, which can move between a closed position (FIG. 30) and an open position (FIG. 31) to create a second gap for gripping the native leaflets 20, 22. The extent of the gap between the fixed arm 232 and the movable arm 234 of the clasp 230 is limited to the extent that the inner paddle 222 extends away from the coaptation element 210.

[0128] 32-33, the device 200 is shown in a laterally extended or laterally open position. The device 200 is driven into the laterally extended or laterally open position by continuing the extension of the actuating element 212 as described above, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207. Continuing the extension of the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 down, thereby spreading the inner paddle 222 further away from the coaptation element 210. In the laterally extended or laterally open position, the inner paddle 222 extends more horizontally than in other positions of the device 200, forming an angle of approximately 90 degrees with the coaptation element 210. Similarly, the paddle frame 224 are in their maximum spread position when the device 200 is in the laterally extended or laterally open position. The increased gap created between the interface element 210 and the inner paddle 222 in the laterally extended or laterally open position allows the clasp 230 to open further (FIG. 33) before engaging the interface element 210, thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0129] 34-35, the exemplary device 200 is shown in a three-quarters extended position. The device 200 is driven to the three-quarters extended position by continuing the extension of the actuating element 212 as described above, thereby increasing the distance between the interface element 210 and the cap 214 of the distal portion 207. Continuing the extension of the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 down, thereby spreading the inner paddle 222 further away from the interface element 210. In the three-quarters extended position, the inner paddle 222 opens to an angle of more than 90 degrees to about 135 degrees with the interface element 210. The paddle frame 224 spreads less than in the laterally extended or laterally open position and begins to move inwardly toward the actuating element 212 as the actuating element 212 extends further. The outer paddle 220 also bends backwards toward the actuating element 212. Similar to the laterally extended or laterally open positions, the increased gap between the interface element 210 and the inner paddle 222 formed in the laterally extended or laterally open positions allows the clasp 230 to open further (FIG. 35), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0130] 36-37, the exemplary device 200 is shown in a fully extended position. The device 200 is driven to the fully extended position by continuing the extension of the actuating element 212 as described above, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207 to the maximum distance allowable by the device 200. Continuing the extension of the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 down, thereby spreading the inner paddle 222 further away from the coaptation element 210. The outer paddle 220 and the paddle frame 224 move to a position where they are closer to the actuating element. In the fully extended position, the inner paddle 222 is opened to an angle of about 180 degrees with the coaptation element 210. In the fully extended position, the inner and outer paddles 222, 220 are linearly extended to form an angle of about 180 degrees between the paddles 222, 220. The fully extended position of the device 200 provides the maximum size of the gap between the coaptation element 210 and the inner paddle 222, and in some implementations, the clasp 230 also allows for the clasp 230 to be fully opened to about 180 degrees between the fixed arm 232 and the movable arm 234 of the clasp 230 ( FIG. 37 ). The position of the device 200 is its longest and narrowest configuration. Thus, the fully extended position of the device 200 may be a desired position for extrication of the device 200 from an attempted implantation, or may be in a desired position for placement of the device into a delivery catheter or the like.

[0131] Configuring the device or implant 200 such that the anchors 208 may extend into a straight or nearly straight configuration (e.g., about 120 degrees to 180 degrees relative to the coaptation element 210) may provide several advantages. For example, this configuration may reduce the radial crimp profile of the device or implant 200. The configuration may make it easier to grasp the native leaflets 20, 22 by providing a larger opening between the coaptation element 210 and the inner paddle 222 for grasping the native leaflets 20, 22. Additionally, the relatively narrow and straight configuration may prevent or reduce the likelihood of the device or implant 200 becoming entangled in natural anatomy (e.g., the chordae tendineae CT shown in FIGS. 3 and 4) when positioning and / or retrieving the device or implant 200 within the delivery system 202.

[0132] 38-49, an exemplary device 200 is shown being delivered and deployed into the native mitral valve MV of the heart H. As discussed above, the device 200 shown in FIGS. 38-49 includes an optional cover 240 (e.g., FIG. 25) over the coaptation element 210, the clasp 230, the inner paddle 222 and / or the outer paddle 220. The device 200 is deployed from a delivery system 202 (which may include, for example, a steerable catheter and / or an implant catheter extendable from a guide sheath) and is held by a capture mechanism 213 (see, for example, FIGS. 43 and 48) and actuated by extending and retracting an actuating element 212. Fingers of the capture mechanism 213 releasably attach the collar 211 to the delivery system 202. In some implementations, the capture mechanism 213 is held in a closed state around the collar 211 by the actuating element 212, such that after the device 200 is successfully implanted, the actuating element 212 can be removed to allow the fingers of the capture mechanism 213 to open the collar 211, thereby releasing the collar 211 and thus detaching the capture mechanism 213 from the device 200.

[0133] 38, a delivery system 202 (e.g., its delivery catheter / sheath) is inserted through the septum into the left atrium LA and the device / implant 200 is deployed from the delivery system 202 in a fully open state for the reasons described above with respect to device 100 (e.g., the implant catheter holding the device / implant can be expanded to deploy the device / implant from the steerable catheter). The device 200 is then driven through a partially occluded state (FIG. 39) to a fully occluded state as shown in FIGS. 40-41 by retracting the actuating element 212. The delivery system or catheter then steers the device / implant 200 towards the mitral valve MV as shown in FIG. 41. 42, when the device 200 is aligned with the mitral valve MV, the actuation element 212 extends to release the paddles 220, 222 to a partially open position and the drive line 216 (FIGS. 43-48) is retracted to open the clasp 230 ready to grasp the leaflets. The partially open device 200 is then inserted (e.g., by advancing an implant catheter from the steerable catheter) through the native valve until the leaflets 20, 22 are properly positioned between the inner paddle 222 and the coaptation element 210 and within the open clasp 230, as shown in FIGS. 43-44.

[0134] FIG. 45 shows the device 200 with both clasps 230 occluded, but with optional barbs, friction enhancing elements, or fixation structures 236 of one clasp 230 disengaging one leaflet 22. As can be seen from FIGS. 45-47, the misaligned clasp 230 is again opened and occluded to properly grasp the escaped leaflet 22. When both leaflets 20, 22 are properly grasped, retracting the actuating element 212 drives the device 200 to a fully closed position shown in FIG. 48. When the device 200 is fully occluded and implanted within the native valve, the actuating element 212 can be disengaged and withdrawn from the cap 214 to release the capture mechanism 213 from the proximal collar 211 (or other attachment member), allowing the capture mechanism 213 to be withdrawn into the delivery system 202 (e.g., into a catheter / sheath) as shown in FIG. 49. Once deployed, the device 200 may be maintained in a fully closed position by mechanical means such as a latch, or may be biased to remain closed through the use of a spring material such as steel, and / or a shape memory alloy such as Nitinol. For example, the paddles 220, 222 may be formed from steel or Nitinol shape memory alloy fabricated into a wire, sheet, tube, or laser sintered powder and biased to hold the outer paddle 220 in a closed position around the inner paddle 222, the coaptation element 210, and / or the clasp 230 in a clamped position around the native leaflets 20, 22.

[0135] 50-54, after the device 200 is implanted in the native valve, the coaptation element 210 functions as a gap filler in a valve regurgitation opening, such as the gap 26 in the mitral valve MV illustrated in FIG. 6 or in another native valve. In some implementations, when the device 200 is deployed between two opposing leaflets 20, 22, the leaflets 20, 22 no longer coapt against each other in the region of the coaptation element 210, but instead coapt against the coaptation element 210. This reduces the distance that the leaflets 20, 22 must approach to close the mitral valve MV during systole, thereby facilitating the repair of functional valve disease that may cause mitral regurgitation. The reduction in leaflet approach distance may provide several other benefits as well. For example, the stresses experienced by the native valve are reduced or minimized by the reduction in the approach distance required for the leaflets 20, 22. A closer approximation of the leaflets 20, 22 may require a reduced approximation force, which may result in less tension on the leaflets 20, 22 and less reduction in the diameter of the valve annulus. Less or no reduction in the valve annulus may result in less reduction in valve opening area compared to a device without a coaptation element or spacer. In this manner, the coaptation element 210 may reduce the transvalvular gradient.

[0136] To adequately fill the gaps 26 between the leaflets 20, 22, the device 200 and its components can have a wide variety of different shapes and sizes. For example, the outer paddle 220 and paddle frame 224 can be configured to fit against the shape or geometry of the coaptation element 210, as shown in FIGS. 50-54. As a result, the outer paddle 220 and paddle frame 224 can mate with both the coaptation element 210 and the native valve leaflets 20, 22. In some implementations, when the leaflets 20, 22 are coapted against the coaptation element 210, the leaflets 20, 22 completely surround or "hugge" the coaptation element 210 with their entirety, and thus small leaks at the outer and inner surfaces 201, 203 of the coaptation element 210 can be prevented or reduced. The interaction of the leaflets 20, 22 with the device 200 is made clear in Figure 51, which shows a schematic atrial or surgeon's eye view showing a paddle frame 224 (which would not actually be visible from a true atrial view, e.g., in Figure 52) conforming to the geometry of the coaptation element 210. The opposing leaflets 20, 22 (whose ends would also not be visible from a true atrial view, e.g., in Figure 52) are driven closer together by the paddle frame 224 to completely surround or "embrace" the coaptation element 210.

[0137] This coaptation of the leaflets 20, 22 against the lateral and medial surfaces 201, 203 of the coaptation element 210 (shown from the atrial side in FIG. 52 and from the ventricular side in FIG. 53) would seem to contradict the statement above that the presence of the coaptation element 210 minimizes the distance the leaflets need to come together. However, the distance the leaflets 20, 22 need to come together is still minimized if the coaptation element 210 is positioned exactly at the regurgitation gap 26, and further if the regurgitation gap 26 is smaller than the width (medial minus lateral) of the coaptation element 210.

[0138] FIG. 50 illustrates the geometry of the coaptation element 210 and paddle frame 224 from the perspective of the LVOT. As can be seen from this figure, the coaptation element 210 has a tapered shape with smaller dimensions in the area close to where the inner surfaces of the leaflets 20, 22 are desired to coapt and larger dimensions as the coaptation element 210 extends toward the atrium. Thus, the challenges of the illustrated native valve geometry are addressed by the tapered coaptation element shape. Still referring to FIG. 50, the tapered coaptation element geometry, in combination with the illustrated expanded paddle frame 224 shape (towards the annulus), can help achieve capture at the bottom of the leaflets, reduce stress, and minimize transvalvular gradients.

[0139] 54, the shapes of the coaptation element 210 and the paddle frame 224 can be defined based on the inner commissure diagram of the native valve and the device 200. The two factors for these shapes are the coaptation of the leaflets to the coaptation element 210 and the reduction of stress on the leaflets due to coaptation. With reference to FIG. 54 and FIG. 24, the coaptation element 210 can have a circular or round shape and the paddle frame 224 can have a full radius that spans almost the entirety of the paddle frame 224 to both coapt the leaflets 20, 22 to the coaptation element 210 and to reduce the stress that the coaptation element 210 and / or paddle frame 224 apply to the leaflets 20, 22. The round shape of the coaptation element 210 and / or the fully round shape of the paddle frame 224 shown distributes the stress on the leaflets 20, 22 over a large curved engagement region 209. For example, in FIG. 54, the force exerted by the paddle frame on the leaflets 20, 22 is spread along the entire rounded length of the paddle frame 224 as the leaflets 20 attempt to open during diastole.

[0140] Additional features of device 200, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) and U.S. Provisional Patent Application No. 63 / 217,622, filed July 1, 2021. Any combination or subcombination of features disclosed by this application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) and / or U.S. Provisional Patent Application No. 63 / 217,622. Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) and U.S. Provisional Patent Application No. 63 / 217,622 are hereby incorporated by reference in their entireties for all purposes.

[0141] 55, an example of an implantable device or implant 300 (e.g., an implantable prosthetic device, a valve repair device, a valve repair device, etc.) is shown. The implantable device 300 is one of many different configurations that the device 100, shown generally in FIGS. 8-14, may take. The device 300 may include any of the other features of an implantable device or implant described herein, and the device 300 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0142] The implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 includes a coaptation portion / region 304 that optionally includes a coaptation element 310 (e.g., a spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 can include one or more paddles, for example, an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchors can also include and / or be coupled to a clasp 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment member) for engaging with a capture mechanism (e.g., a capture mechanism such as capture mechanism 213 shown in Figures 43-49, or another capture mechanism described herein or otherwise known) of a delivery system (e.g., a delivery system such as the systems shown in Figures 38-42 and 49).

[0143] The anchors 308 can be attached to other portions of the device and / or to each other in a variety of different manners (e.g., directly, indirectly, by welding, by stitching, by adhesive, by linking, by latching, by integral formation, by any or all combinations thereof, etc.) In some implementations, the anchors 308 are attached to the interface member or element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0144] The anchor 308 may include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connecting portion 323. The connecting portion 323 may be attached to a paddle frame 324 that is hingedly attached to the cap 314 or to another mounting portion. In this manner, the anchor 308 is configured similar to a leg, in that the inner paddle 322 is like an upper portion of a leg, the outer paddle 320 is like a lower portion of a leg, and the connecting portion 323 is like a knee portion of a leg.

[0145] In some implementations including the interface member or element 310, the interface member or element 310 and the anchor 308 may be coupled together in a variety of ways. For example, as shown in the illustrated embodiment, the interface element 310 and the anchor 308 may be coupled together by integrally forming the interface element 310 and the anchor 308 as a single unitary component. This may be accomplished, for example, by forming the interface element 310 and the anchor 308 from a continuous piece 301 of braided or woven material, such as braided or woven Nitinol wire. In some implementations, as shown, the interface element 310, outer paddle portion 320, inner paddle portion 322, and connecting portions 321, 323, 325 are formed from a continuous piece 301 of fabric.

[0146] Similar to the anchor 208 of the implantable device or implant 200 described above, the anchor 308 may be configured to transition between various configurations by axially moving a distal end of the device (e.g., cap 314, etc.) relative to a proximal end of the device (e.g., proximal collar 311 or other attachment member, etc.). This movement may occur along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device. For example, the anchor 308 may be positioned in a fully extended configuration or a straightened configuration (e.g., similar to the configuration of the device 200 shown in FIG. 36) by moving the distal end (e.g., cap 314, etc.) away from the proximal end of the device.

[0147] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight with respect to the orientation of the longitudinal axis of the device. In some implementations, the connecting portion 323 of the anchor 308 is adjacent with respect to the longitudinal axis of the coaptation element 310 (e.g., similar to the configuration of the device 200 shown in FIG. 36). From the straight configuration, the anchor 308 can be driven into a fully collapsed configuration (e.g., FIG. 55), for example, by driving the proximal and distal ends toward each other and / or toward the midpoint or center of the device. Initially, as the distal end (e.g., cap 314, etc.) moves toward the proximal end and / or toward the midpoint or center of the device, anchor 308 bends at connecting portions 321, 323, 325 and connecting portion 323 moves radially outward relative to the longitudinal axis of device 300 and axially toward the midpoint and / or proximal end of the device (e.g., similar to the configuration of device 200 shown in FIG. 34). As cap 314 continues to move toward the midpoint and / or proximal end of the device, connecting portion 323 moves radially inward relative to the longitudinal axis of device 300 and axially toward the proximal end of the device (e.g., similar to the configuration of device 200 shown in FIG. 30).

[0148] In some implementations, the clasp comprises a movable arm coupled to the anchor. In some implementations, the clasp 330 (shown in detail in FIG. 28B ) includes a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancing element 336, and a joint portion 338. The fixed arm 332 is attached to the inner paddle 322 with the joint portion 338 disposed proximate to the mating element 310. The joint portion 338 is spring loaded such that the fixed arm 332 and the movable arm 334 are biased toward each other when the clasp 330 is in a closed state.

[0149] The fixed arm 332 is attached to the inner paddle 322 by sutures (not shown) through holes or slots 331. The fixed arm 332 may be attached to the inner paddle 322 by any suitable means, such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, or the like. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is opened to open the clasp 330 and expose optional barbs, friction enhancing elements, or fixation structures. The clasp 330 is opened by applying tension to an actuation line (e.g., actuation line 216 shown in FIGS. 43-48 ) attached to a hole 335 in the movable arm 334, thereby allowing the movable arm 334 to articulate, pivot, and / or bend on a joint portion 338.

[0150] In summary, the implantable device or implant 300 is similar in construction and operation to the implantable device or implant 200 described above, except that the joint elements 310, the outer paddle 320, the inner paddle 322, and the connecting portions 321, 323, 325 are formed from a single piece of material 301. In some implementations, the piece of material 301 is attached to the proximal collar 311, the cap 314, and the paddle frame 324 by weaving or inserting through openings in the proximal collar 311, in the cap 314, and in the paddle frame 324 that are configured to receive the continuous piece of material 301. The continuous piece 301 can be a single layer of material or can include two or more layers. In some implementations, portions of the device 300 have a single layer of the strip of material 301, and other portions are formed from multiple overlapping or overlapping layers of the strip of material 301.

[0151] For example, Figure 55 shows a joining element 310 and an inner paddle 322 formed from multiple overlapping layers of a strip of material 301. The single continuous strip of material 301 can begin and end at various locations on the device 300. The ends of the strip of material 301 can be located at the same or different locations on the device 300. For example, in the example illustrated in Figure 55, the strip of material 301 begins and ends at the location of the inner paddle 322.

[0152] As with the implantable device or implant 200 described above, the size of the coaptation element 310 can be selected to minimize the number of implants (preferably one) required per patient while maintaining a low transvalvular gradient. Notably, by forming many of the components of the device 300 from a single piece of material 301, the device 300 can be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance at the widest point of the device 300 (i.e., the width of the paddle frame 324, which is wider than the coaptation element 310) is about 5 mm.

[0153] Additional features of device 300, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) and U.S. Provisional Patent Application No. 63 / 217,622. Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) and / or U.S. Provisional Patent Application No. 63 / 217,622. Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) and U.S. Provisional Patent Application No. 63 / 217,622 are hereby incorporated by reference in their entireties for all purposes.

[0154] The concepts disclosed herein can be used with a wide variety of different valve repair devices. Figures 56A-56H illustrate another example of one of many valve repair systems for repairing a patient's native valve, a valve repair system 40056, to which the concepts of the present application may be applied. The valve repair system 40056 includes a delivery device 40156 and a valve repair device 40256.

[0155] The valve repair device 40256 includes a base assembly 40456 and an anchor portion. In some implementations, the anchor portion includes a pair of paddles 40656 and a pair of gripping members 40856. In some implementations, the paddles 40656 can be integrally formed with the base assembly. For example, the paddles 40656 can be formed as an extension of a link of the base assembly. In some implementations, as shown, the base assembly 40456 of the valve repair device 40256 has a shaft 40356, a coupler 40556 configured to move along the shaft, and a lock 40756 configured to lock the coupler in a stationary position on the shaft. The coupler 40556 is mechanically connected to the paddle 40656 such that moving the coupler 40556 along the shaft 40356 moves the paddle between an open position and a closed position. In this manner, the couplers 40556 function as a means for mechanically coupling the paddles 40656 to the shaft 40356 and for moving the paddles 40656 between their open and closed positions as they move along the shaft 40356.

[0156] In some implementations, the gripping member 40856 can be pivotally connected to the base assembly 40456 (e.g., the gripping member 40856 can be pivotally connected to the shaft 40356, or any other suitable member of the base assembly) such that the gripping member can be moved to adjust the width of the opening 41456 between the paddle 40656 and the gripping member 40856. The gripping member 40856 can include a gripping portion (e.g., barbs, projections, ridges, grooves, textured surfaces, adhesive, etc.) 40956 for attaching the gripping member to valve tissue when the valve repair device 40256 is attached to the valve tissue. The gripping member 40856 forms a means for gripping valve tissue (particularly tissue of the valve leaflets) using an anchoring means or portion such as the barb portion 40956. When the paddle 40656 is in the closed position, the paddle engages the gripping member 40856 such that when the valve tissue is attached to the barbed portion 40956 of the gripping member, the paddle acts as a retention or fixation means to hold the valve tissue at the gripping member and fix the valve repair device 40256 to the valve tissue. In some implementations, the gripping member 40856 is configured to engage the paddle 40656 such that the barbed portion 40956 engages the valve tissue member and the paddle 40656 to fix the valve repair device 40256 to the valve tissue member. For example, in certain circumstances it may be advantageous to have the paddle 40656 maintain an open position and move the gripping member 40856 outwardly toward the paddle 40656 to engage the valve tissue and the paddle 40656.

[0157] Although the example shown in FIGS. 56A-56H illustrates a pair of paddles 40656 and a pair of gripping members 40856, it will be understood that the valve repair device 40256 can include any suitable number of paddles and gripping members.

[0158] In some implementations, the valve repair system 40056 includes a deployment shaft 41356 that is removably attached to the shaft 40356 of the base assembly 40456 of the valve repair device 40256. The deployment shaft 41356 is detached from the shaft 40356 after the valve repair device 40256 is secured to the valve tissue, removing the valve repair device 40256 from the remainder of the valve repair system 40056 such that the valve repair device 40256 can remain attached to the valve tissue and the delivery device 40156 can be removed from the patient's body.

[0159] The valve repair system 40056 can also include a paddle control mechanism 41056, a gripping member control mechanism 41156, and a locking control mechanism 41256. The paddle control mechanism 41056 is mechanically attached to the coupler 40556 to drive the coupler along the shaft, thereby driving the paddle 40656 between the open and closed positions. The paddle control mechanism 41056 can take any suitable form and can include, for example, a shaft, a wire tube, a hypotube, a rod, a suture, a line, etc. For example, the paddle control mechanism can include a hollow shaft and a catheter tube or sleeve that fits over the deployment shaft 41356 and the shaft 40356 and connects to the coupler 40556.

[0160] The gripper control mechanism 41156 is configured to move the gripping member 40856 such that the width of the opening 41456 between the gripping member and the paddle 40656 can be altered. The gripper control mechanism 41156 can take any suitable form, such as, for example, a line, suture, wire, rod, catheter, tube, hypotube, etc.

[0161] The lock control mechanism 41256 is configured to lock and unlock the lock. The lock 40756 functions as a locking means for locking the coupler 40556 in a stationary position relative to the shaft 40356 and can take a wide variety of different forms, and the type of lock control mechanism 41256 can be dictated by the type of lock used. In some implementations, the lock 40756 includes a pivotable plate having a hole, and the shaft 40356 of the valve repair device 40256 is disposed within the hole of the pivotable plate. In this implementation, when the pivotable plate is in a tilted position, the pivotable plate engages the shaft 40356 to maintain its position on the shaft 40356, but when the pivotable plate is in a substantially non-tilted position, the pivotable plate can move along the shaft (thereby allowing the coupler 40556 to move along the shaft 40356). In other words, the coupler 40556 is prevented or inhibited from moving in the direction Y (as shown in FIG. 56E ) along the shaft 40356 when the pivotable plate of the lock 40756 is in the tilted position (or locked position), and the coupler is permitted to move in the direction Y along the shaft 40356 when the pivotable plate is in the substantially non-tilted position (or unlocked position). In some implementations in which the lock 40756 includes a pivotable plate, the lock control mechanism 41256 is configured to engage the pivotable plate to drive the plate between the tilted position and the substantially non-tilted position. The lock control mechanism 41256 can be, for example, a rod, suture, wire, or any other member capable of driving the pivotable plate of the lock 40756 between the tilted position and the substantially non-tilted position. In some implementations, the rotatable plate of the lock 40756 is biased to a tilted position (or locked position) and the lock control mechanism 41256 can be used to drive the plate from the tilted position to a substantially non-tilted position (or unlocked position).In some implementations, the rotatable plate of the lock 40756 is biased to a substantially non-tilted position (or unlocked position), and the lock control mechanism 41256 can be used to drive the plate from the substantially non-tilted position to the tilted position (or locked position).

[0162] 56E-56F illustrate the valve repair device 40256 being actuated from an open position (shown in FIG. 56E) to a closed position (shown in FIG. 56F). The base assembly 40456 includes a first link 102156 extending from point A to point B, a second link 102256 extending from point A to point C, a third link 102356 extending from point B to point D, a fourth link 102456 extending from point C to point E, and a fifth link 102556 extending from point D to point E. The coupler 40556 is movably attached to the shaft 40356, which is fixed relative to the fifth link 102556. The first link 102156 and the second link 102256 are pivotally attached to the coupler 40556 at point A, such that movement of the coupler 40556 along the shaft 40356 drives the position of point A, which in turn drives the first link 102156 and the second link 102256. The first link 102156 and the third link 102356 are pivotally attached to one another at point B, and the second link 102256 and the fourth link 102456 are pivotally attached to one another at point C. One paddle 40656a is attached to the first link 102156 such that movement of the first link 102156 drives the paddle 40656a, and the other paddle 40656b is attached to the second link 102256 such that movement of the second link 102256 drives the paddle 40656b. In some implementations, the paddles 40656a, 40656b may be connected to the links 102356, 102456 or may be extensions of the links 102356, 102456.

[0163] To drive the valve repair device from an open position (shown in FIG. 56E) to a closed position (shown in FIG. 56F), the coupler 40556 is driven along the shaft 40356 in a direction Y, which drives the pivot point A for the first link 102156 and the second link 102256 to a new position. Driving the coupler 40556 (and pivot point A) in direction Y drives a portion of the first link 102156 located near point A in direction H and drives a portion of the first link 102156 located near point B in direction J. The paddle 40656a is attached to the first link 102156 such that driving the coupler 40556 in direction Y drives the paddle 40656a in direction Z. In addition, the third link 102356 is pivotally attached to the first link 102156 at point B such that driving the coupler 40556 in direction Y drives the third link 102356 in direction K. Similarly, driving the coupler 40556 (and pivot point A) in direction Y drives a portion of the second link 102256 located near point A in direction L and drives a portion of the second link 102256 located near point C in direction M. The paddle 40656b is attached to the second link 102256 such that driving the coupler 40556 in direction Y drives the paddle 40656b in direction V. In addition, the fourth link 102456 is pivotally attached to the second link 102256 at point C such that driving the coupler 40556 in direction Y drives the fourth link 102456 in direction N. Figure 56F illustrates the final position of the valve repair device 40256 after the coupler 40556 has been driven as shown in Figure 56E.

[0164] 56B, the valve repair device 40256 is shown in an open position (similar to the position shown in FIG. 56E) with the gripping member control mechanism 41156 actuating the gripping member 40856 to provide a wider gap at the opening 41456 between the gripping member and the paddle 40656. In some implementations, as shown, the gripping member control mechanism 41156 includes a line, such as a suture, wire, etc., attached through an opening in an end of the gripping member 40856. Both ends of the line extend through a delivery opening 51656 of the delivery device 40156. When the line is pulled through the delivery opening 51656 in direction Y, the gripping member 40856 is actuated inward in direction X to provide a wider opening 41456 between the gripping member and the paddle 40656.

[0165] 56C, the valve repair device 40256 is shown with the valve tissue 20, 22 disposed into the opening 41456 between the gripping member 40856 and the paddle 40656. With reference to FIG. 56D, after the valve tissue 20, 22 is disposed between the gripping member 40856 and the paddle 40656, the gripping member control mechanism 41156 is used to narrow the opening 41456 between the gripping member and the paddle. That is, in the illustrated example, the line of the gripping member control mechanism 41156 is released or pushed out of the delivery member opening 51656 in a direction H, allowing the gripping member 40856 to move in a direction D, thereby narrowing the opening 41456. Although the gripping member control mechanism 41156 is shown as actuating the gripping member 40856 to widen the opening 41456 between the gripping member and the paddle 40656 ( FIG. 56C ), it will be understood that actuation of the gripping member may not be necessary to place valve tissue within the opening 41456. However, in certain circumstances, it may be necessary to make the opening 41456 between the paddle 40656 and the gripping member 40856 wider to receive valve tissue.

[0166] 56G, the valve repair device 40256 is in a closed position and secured relative to the valve tissue 20, 22. The valve repair device 40256 is secured relative to the valve tissue 20 by the paddles 40656a, 40656b and the gripping members 40856a, 40856b. In particular, the valve tissue 20, 22 is attached to the valve repair device 40256 by the gripping portions 40956 of the gripping members 40856a, 40856b, and the paddles 40656a, 40656b engage the gripping members 40856 to secure the valve repair device 40256 relative to the valve tissue 20, 22.

[0167] To drive the valve repair device 40256 from an open position to a closed position, the lock 40756 is driven to an unlocked state by the lock control mechanism 41256 (as shown in FIG. 56G). After the lock 40756 is unlocked, the coupler 40556 can be driven along the shaft 40356 by the paddle control mechanism 41056. In some implementations, as shown, the paddle control mechanism 41056 drives the coupler 40556 along the shaft in a direction Y to drive one paddle 40656a in a direction X and the other paddle 40656b in a direction Z. Driving the paddles 40656a, 40656b in a direction X and in a direction Z engages the paddles with the gripping members 40856a, 40856b and secures the valve repair device 40256 to the valve tissue 20, 22.

[0168] 56H, after the valve repair device 40256 is secured to the valve tissue 20, 22 by driving the paddle 40656 to the closed position (as shown in FIG. 56G), the lock 40756 is driven to a locked state by the lock control mechanism 41256 (FIG. 56G) to maintain the valve repair device 40256 in the closed position. After the valve repair device 40256 is maintained in the locked state by the lock 40756, the valve repair device 40256 is removed from the delivery device 40156 by decoupling the shaft 40356 from the deployment shaft 41356 (FIG. 56G). Additionally, the valve repair device 40256 is decoupled from the paddle control mechanism 41056 (FIG. 56G), from the gripping member control mechanism 41156 (FIG. 56G), and from the lock control mechanism 41256. Detachment of the valve repair device 40256 from the delivery device 40156 allows the valve repair device to remain fixed relative to the valve tissue 20, 22 while the delivery device 40156 is removed from the patient.

[0169] Additional features of device 40256, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) and U.S. Provisional Patent Application No. 63 / 217,622. Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) and / or U.S. Provisional Patent Application No. 63 / 217,622. Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) and U.S. Provisional Patent Application No. 63 / 217,622 are hereby incorporated by reference in their entireties for all purposes.

[0170] The clasp or leaflet grasping device disclosed herein can take a wide variety of different forms. An example of a clasp is disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Any combination or subcombination of the features disclosed by this application can be combined with any combination or subcombination of the features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201) is incorporated herein by reference in its entirety.

[0171] When implanting an implantable device or implant into a native heart valve, the actuation of the device to the implantation position may be hindered or impeded by the structure of the native heart. For example, the articulating portion of the implantable device or implant (such as the paddle portion of the anchor used to secure the device to the native heart valve tissue) may rub, be temporarily caught, or be temporarily blocked by the chordae tendineae CT (shown in Figures 3 and 4) extending to the leaflets. An exemplary implantable device or implant may be configured to reduce the likelihood that the device or implant will be temporarily caught or blocked by the CT. For example, the implantable device or implant may have a wide variety of different configurations that are configured to actively or passively constrict to reduce the width of the paddle frame at the anchor portion of the device, thereby reducing the surface area of ​​the device to facilitate movement of the device / implant over and / or through the CT.

[0172] 57-67, an example of a device 400 (e.g., an implantable prosthetic device, a prosthetic spacer device, a valve repair device, etc.) is shown. The valve repair device 400 is one of many different configurations that the device 100, illustrated generally in FIGS. 8-15, may take. The device 400 may include any other features of an implantable prosthetic device described in this application or any application incorporated herein by reference, and the device 400 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or any application incorporated herein by reference). The various components of the valve repair device 400 may be made in any suitable size to accommodate the anatomies of different sized patients.

[0173] The valve repair device 400 extends from a proximal portion 401 to a distal portion 402. The valve repair device may include an optional coaptation portion 404 and an anchor portion. In some implementations, the anchor portion includes a paddle portion 406 and / or a mounting portion 410. The coaptation portion 404 (e.g., a spacer, coaptation element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) includes a coaptation element 420 for implantation between the leaflets 20, 22 of a native valve. The coaptation element 420 has a generally elongated and round shape. In particular, the coaptation element 420 has an elliptical shape or cross section when viewed from above (FIG. 59D) and a tapered shape or cross section when viewed from a front view (e.g., FIG. 59C). A mixture of these three geometries may result in the illustrated three-dimensional shape of the coaptation element 420 achieving the advantages described herein. It can also be seen that the circular shape of interface element 420, when viewed from above, substantially follows or approximates the shape of the collars of mounting portion 410 and paddle portion 406, as described below.

[0174] As shown in FIGS. 59A-59D, the coaptation element 420 (e.g., a spacer, coaptation element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) can include a boss or connecting portion 422 extending upwardly from a proximal portion of the coaptation element 420. The boss or connecting portion 422 can be sized and shaped to be secured and / or manipulated by a user during an implantation operation. The boss or connecting portion 422 can be sized and shaped such that the coaptation element 420 can be retained, deployed, positioned, recaptured, repositioned, and / or repositioned during an implantation operation. For example, the boss or connecting portion 422 can be sized, shaped, or otherwise configured to be engaged or positioned by an actuation element (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) ( FIGS. 66-67 ) and / or removably attached to a delivery system or capture mechanism.

[0175] The interface element 420 may include one or more paddle securement recesses 423 and one or more clasp securement recesses 425 extending inwardly into an outer portion of the interface element 420. The paddle securement recess 423 may be sized and shaped to at least partially receive or secure the paddle portion 406 to the interface element 420. The clasp securement recess 425 may be located distal or below the paddle securement recess 423 and may be sized and shaped to at least partially receive or secure the attachment portion 410 to the interface element 420. However, the connection of the interface element 420, attachment portion 410, and paddle portion 406 may take any configuration. For example, the interface element 420 may include a single paddle securement recess 423 and a single clasp securement recess 425, each extending around the interface element 420, or the interface element 420 may be integral with the attachment portion 410 and / or the paddle portion 406.

[0176] 59A-59D , the coaptation element 420 can include two or more passageways 424 on either side of a boss or connecting portion 422. The passageways 424 extend longitudinally through the coaptation element 420 from a proximal portion to a distal portion. The passageways 424 can be sized and shaped to receive one or more components capable of opening and closing the valve repair device 400.

[0177] As shown in FIGS. 62A-64, the coaptation element 420 can include an actuator 426 disposed at least partially in a proximal portion or upper portion of each passageway 424. Each actuator 426 can be sized and shaped to slidably fit into a respective passageway 424. The actuator 426 can be a cap, button, or other component that can be actuated by an actuation element (e.g., an actuation wire, shaft, rod, line, etc.) extending from a delivery sheath or system (e.g., delivery system 102, 202). For example, the actuator 426 can be configured to be engaged or actuated by an actuation element 491 (e.g., an actuation shaft, actuation wire, etc.; FIGS. 22-24) to at least partially open the valve repair device 400.

[0178] The paddle portion 406 of the valve repair device 400 includes a plurality of paddles 408, each of which includes an outer paddle 430, an inner paddle 432, and a paddle extension shaft 434. The paddles 408 can facilitate engagement of the valve tissues 20, 22 as part of any suitable valve repair system. The paddle extension shaft 434 can be a substantially vertical shaft that can be at least partially received in one of the passageways 424 of the coaptation element 420.

[0179] The outer paddles 430 may be substantially rectangular and may facilitate engagement of the tissues 20, 22 as part of any suitable valve repair system. However, the outer paddles 430 may also be a wire or mesh frame, or any other suitable configuration. Each outer paddle 430 may extend upwardly and outwardly from a distal end of a paddle extension shaft 434. The outer paddles 430 may be flexibly connected to the paddle extension shaft 434 such that the outer paddles 430 may be at least partially rotatable about the end of the paddle extension shaft 434. For example, the outer paddles 430 may be connected to the paddle extension shaft 434 by a hinge, joint, or other rotatable connector, or may be flexibly integrated with the distal end of the paddle extension shaft 434.

[0180] The inner paddle 432 may be generally flat with a spherical or bulb-like cross-section, with a wider distal end and a narrower inner end. The inner paddle 432 may be substantially a wire frame. However, the inner paddle 432 may be of any suitable shape or configuration. For example, the inner paddle 432 may be rectangular or any other shape, and may be a mesh or solid frame or any other suitable configuration. Each inner paddle 432 may extend upwardly and radially outwardly from an inner location to a proximal and radially outer end of one of the outer paddles 430. The wider portion of the inner paddle 432 may be flexibly connected to the upper end of the outer paddle 430 such that the outer paddle 430 and / or the inner paddle 432 may be at least partially pivotable about one another. In some implementations, as shown, the inner paddle 432 is integral with the outer paddle 430 such that the inner paddle 432 and the outer paddle 430 may bend or pivotable about one another. However, the inner paddle 432 and the outer paddle 430 may be connected by any suitable connection. For example, the inner paddle 432 may be connected to the outer paddle by a hinge, joint, or other pivotable connector.

[0181] The paddle portion 406 also includes a rounded or oval paddle collar 436 that can connect or secure the paddle portion 406 to the interface element 420. For example, the paddle collar 436 can be sized and shaped to fit into the paddle securement recess 423 and around an outer portion of the interface element 420. For example, the paddle collar 436 can be sized and shaped to at least partially snap-fit ​​within the paddle securement recess 423 of the interface element 420. The paddle collar 436 and the paddle securement recess 423 can also be sized, shaped, or otherwise configured such that the paddle collar 436 can be at least partially secured within the paddle securement recess 423 by an interference fit. Each inner paddle 432 can be connected to a paddle collar 436, and the outer paddle 430 and the outer paddle 430 can be connected to a paddle extension shaft 434 such that each paddle 408 (e.g., the outer paddle 430, the inner paddle 432, and the paddle extension shaft 434) can be articulated, manipulated, or otherwise articulated independently of the other paddles 408, as described below.

[0182] The outer paddle 430, inner paddle 432, paddle extension shaft 434, and paddle collar 436 may be derived from a single superelastic sheet, ribbon, or wire capable of withstanding plastic deformation. In some implementations, as shown, the paddle collar 436 is semicircular and integral with the inner paddle 432. However, the paddle portions 406 may be configured or connected in any suitable manner. For example, the paddle collar 436 may be circular and separate from the inner paddle 432, which may be connected to opposing sides of the paddle collar 436 by a hinge, joint, or other flexible or pivotable connector.

[0183] 61A-61D, the attachment portion or gripping member (e.g., gripping arm, clasp arm, etc.) 410 may include a rounded or oval collar 442 that connects two clasp arms together. The collar may connect or secure the attachment portion or gripping member 410 to the interface element 420. The collar 442 may be sized and shaped to be secured, positioned, or otherwise disposed on the interface element 420. For example, the collar 442 may be sized and shaped to at least partially snap-fit ​​into the clasp securement recess 425 of the interface element 420. The collar 442 and clasp securement recess 425 may also be sized, shaped, or otherwise configured such that the collar 442 may be at least partially secured within the clasp securement recess 425 by an interference fit.

[0184] The attachment portion or gripping member 410 may include two or more clasp elements (clasps, clasp arms, etc.) 444 that can facilitate engagement of the valve tissue 20, 22 as part of any suitable valve repair system. The gripping member 410 may include a clasp 130 including a base or fixed arm, a movable arm, optional barbs, friction enhancing elements or other fastening means (e.g., projections, ridges, grooves, textured surfaces, adhesives, etc.), and a joint portion 138, as illustrated in FIGS. 8-27, 28A, 28B, and 29-51. Each clasp element 444 may have a narrower radially proximal portion 440 connected to a collar 442 and a wider radially distal portion that may include a clasp engagement portion 446 for engaging the valve tissue 20, 22 as part of any suitable valve repair system. In some implementations, as illustrated, the clasp elements 444 are substantially flat with a spherical or bulb-shaped or teardrop-shaped cross-section. However, the clasp element 444 may have any suitable size, shape, or configuration. For example, the clasp element 444 may be substantially solid, a wire frame, rectangular, and / or may be similar in size, shape, or configuration to the outer paddle 430 or the inner paddle 432.

[0185] The clasp element 444 may extend radially outward and proximally upward from the collar 442. The clasp element 444 may be integrally formed with the collar 442. The attachment portion or gripping member 410 may be formed from a single superelastic sheet, ribbon, or wire such that the attachment portion or gripping member 410 can withstand deformation. For example, the attachment portion or gripping member 410 may be formed from a single sheet or piece of material such that the radially outward portion of the clasp element 444 is biased or urged downward or distally. However, the attachment portion or gripping member 410 may have any suitable shape, size, or configuration, and the collar 442 and the clasp element 444 may have any suitable connection. For example, the clasp element 444 may be connected to the collar 442 by a hinge, joint, or other flexible or pivotable connector.

[0186] Each clasp element 444 may include one or more protrusions or barbs 448 that extend into the clasp engagement portion 446. The optional barbs 448 may engage the leaflets 20, 22 when the device 400 is in a closed position to secure the valve repair device 400 within a native valve, e.g., a native mitral valve, as described below. The tissue of the leaflets 20, 22 is not pierced by the barbs 448, although in some implementations, the barbs 448 may partially or completely pierce the leaflets 20, 22. In some implementations, as shown, the optional barbs 448 extend radially inward along the remainder of the clasp element 444, into the clasp engagement portion 446. However, the barbs 448 may have any suitable size, shape, orientation, or configuration for securing the valve repair device 400 within the native valve. For example, the barbs 448 can be angled or perpendicular to the remainder of the clasp element 444 so that the barbs 448 can engage the tissue of the valve leaflets 20,22.

[0187] 62A-64, the coaptation element 420 may also include a biasing element 428 in each of the passages 424 that may counteract the force output from the paddle portion 406 when the valve repair device 400 is in the closed position, as described in more detail below. Each biasing element 428 (e.g., a spring, an elastic band, a compressible member, a compressible fluid, etc.) is disposed between the actuator 426 and a proximal portion of the paddle extension shaft 434, and is connected or secured between the actuator 426 and a proximal portion of the paddle extension shaft 434. In some implementations, as shown, the biasing element 428 is a coil spring. However, the biasing element 428 may be any device or component capable of providing a biasing force. For example, the biasing element 428 may be a leaf spring, a shape memory alloy such as Nitinol, or any other biasing device.

[0188] 65-67, the valve repair device 400 can be moved between a closed position and an open position. As shown in FIG. 65, the device 400 can be deployed in a closed position with the paddles 408 (e.g., the outer paddle 430, the inner paddle 432, and the paddle extension shaft 434) pulled proximally upward and radially inward. The biasing element 428 can hold the paddle extension shaft 434 pulled proximally into the passage 424 of the coaptation element 420. The clasp element 444 can optionally be pulled proximally upward and radially inward. The clasp element 444 can engage the inner paddle 432 of the paddle 408.

[0189] As shown in FIG. 66, one of the paddles 408 can be moved to an open position using an actuation element 491 (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.). The actuation element 491 can engage one of the actuators 426 to oppose a respective biasing element 428 and move the actuator 426 downward. Moving the actuator 426 and / or the biasing element 428 distally or downwardly within the passageway 424 exerts a downward force on the paddle extension shaft 434, which moves the paddle extension shaft 434 distally or downwardly from the passageway 424. The downward movement of the paddle extension shaft 434 opens the respective paddle 430, 432. The outer paddle 430 is pulled downwardly or distally and the radially outer portion of the outer paddle 432 is pulled radially outward. Movement of the outer paddle 430 pulls the radially outer portion of the inner paddle 432 downward and radially outward, creating a tissue-receiving gap 452 between the outer paddle 430 and the inner paddle 432 and between the inner paddle 432 and the clasp element 444 .

[0190] 67, the other paddle 408 can be moved to the open position using one of the actuation elements 491. The same process can be repeated to move the paddle extension shaft 434, the outer paddle 430, and the inner paddle 432 to create tissue receiving gaps 452 between the outer paddle 430 and the inner paddle 432, and between the inner paddle 432 and the catch element 444.

[0191] While the valve repair device 400 is in a partially open position (e.g., one paddle open in FIG. 66 ) or a fully open position (e.g., both paddles open in FIG. 67 ), the valve repair device 400 can be manipulated, positioned, or otherwise moved to a desired position. The valve repair device 400 can be manipulated or otherwise moved such that the native leaflets 20, 22 are in one of one or both tissue receiving gaps 452 of the valve repair device 400. For example, the position or movement of the valve repair device 400 can be controlled by connection or engagement with a boss or connecting portion 422 of the coaptation element 420. For example, the boss or connecting portion 422 can be sized, shaped, or otherwise configured to be engaged or positioned by the actuation element 491 and / or to be removably attached to a delivery system, collar, or capture mechanism (e.g., one or more of a clamp, clip, pin, suture, line, lasso, noose, snare, buckle, lock, latch, etc.).

[0192] With the native leaflets 20, 22 in the tissue receiving gaps 452 on either side of the device 400, and one of the paddles 408 in place within the native valve, e.g., the native mitral valve, the respective paddles 408 can be closed. For example, the valve repair device 400 can be closed to capture the native leaflets 20, 22, such as between the inner paddle 432 and the catch element 444. The actuation element 491 can be retracted proximally or upwardly to disengage the actuator 426. Disengaging the actuator 426 retracts the biasing element 428 and the paddle extension shaft 434 proximally or upwardly within the passageway 424. The upward movement of the paddle extension shaft 434 allows the outer paddle 430 and the inner paddle 432 to move upward and bend or pivot inward toward the catch element 444. The outer paddle 430 can move the inner paddle 432 upward and inward to press the valve tissue against the clasp element 444. The native leaflets 20, 22 can be secured by the biasing force of the biasing element 428 acting on the paddles 430, 432 and / or by the distal or downward bias of the clasp element 444.

[0193] Once the native leaflets 20, 22 are secured on one side of the valve repair device 400, the valve repair device 400 can be positioned or repositioned such that the native leaflets 20, 22 are disposed in one of the tissue-receiving gaps 452 on the other side of the valve repair device 400. The closing process can be repeated for the other paddle 408 when the native leaflets 20, 22 are disposed in place on the other side of the valve repair device 400, such as in one of the tissue-receiving gaps 452.

[0194] Although the process is described as opening both paddles 408 and closing each paddle 408 in turn, the device 400 can be opened, positioned, and closed in other manners. For example, one paddle 408 can be opened, positioned, and closed in place, and then the other paddle 408 can be opened, positioned, and closed in place, or both paddles 408 can be opened, positioned, and closed in place simultaneously.

[0195] Once the valve repair device 400 is closed in a desired position, the valve repair device 400 can be released from the delivery system or capture mechanism and the actuation element 491 can be withdrawn and removed. The native leaflets 20, 22 can be secured or engaged by a clasp engagement portion 446, such as barbs 448 of the clasp element 444.

[0196] 68-79, an example of a device 500 (e.g., an implantable prosthetic device, a prosthetic spacer device, a valve repair device, etc.) is shown. The valve repair device 500 is one of many different configurations that the device 100, illustrated generally in FIGS. 8-15, can assume. The device 500 may include any other features related to implantable prosthetic devices discussed in this application or any application incorporated herein by reference, and the device 500 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or any application incorporated herein by reference). The various components of the valve repair device 500 may be made in any suitable size to accommodate the anatomies of different sized patients.

[0197] The valve repair device 500 extends from a proximal portion 501 to a distal portion 502 and may include an optional coaptation portion 504 and an anchor portion. In some implementations, the anchor portion may include a paddle portion 506 and / or a mounting portion or gripping member 510. The coaptation portion 504 includes a coaptation element 520 (e.g., a spacer, coaptation element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) for implantation between the leaflets 20, 22 of the native valve. The coaptation element 520 has a generally elongated and round shape. In particular, the coaptation element 520 has an oval shape or cross section when viewed from above (FIG. 74D) and a tapered shape or cross section when viewed from a front view (e.g., FIG. 74C). A mixture of these three geometries may result in the three-dimensional shape of the illustrated coaptation element 520 that achieves the advantages described herein. It can also be seen that the circular shape of the interface element 520, when viewed from above, substantially follows or approximates the shape of the attachment portion or gripping member and collar of the paddle portion, as described below.

[0198] As shown in FIGS. 74A-74D, the coaptation element 520 can include a boss or connecting portion 522 extending upwardly from a proximal portion of the coaptation element 520. The boss or connecting portion 522 can be substantially similar to the boss or connecting portion 422 of FIGS. 57-67. The boss or connecting portion 522 can be sized and shaped to be secured and / or manipulated by a user during the implantation operation. The boss or connecting portion 522 can be sized and shaped such that the coaptation element 520 can be retained, deployed, positioned, recaptured, repositioned, and / or repositioned during the implantation operation. For example, the boss or connecting portion 522 may be sized, shaped, or otherwise configured to be engaged or positioned by an actuation element (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) 591 (FIGS. 78-79) and / or removably attached to a delivery system or capture mechanism (e.g., one or more of a clamp, clip, pin, suture, line, lasso, noose, snare, buckle, lock, latch, etc.).

[0199] The interface element 520 may include one or more paddle securement recesses 523 and one or more clasp securement recesses 525 extending inwardly into an outer portion of the interface element 520. The paddle securement recess 523 may be sized and shaped to at least partially receive or secure the paddle portion 506 to the interface element 520. The clasp securement recess 525 may be located distal to or below the paddle securement recess 523 and may be sized and shaped to at least partially receive or secure the attachment portion or gripping member 510 to the interface element 520. However, the connection of the interface element 520, the attachment portion or gripping member 510, and the paddle portion 506 may take any configuration. For example, the interface element 520 may include a single paddle securement recess 523 and a single clasp securement recess 525, each extending around the interface element 520, or the interface element 520 may be integral with the attachment portion or gripping member 510 and / or the paddle portion 506.

[0200] As shown in FIGS. 74A-74D, the coaptation element 520 may include two or more passageways 524 on either side of the boss or connecting portion 522. The passageways 524 may be angled or partially L-shaped with a passageway inlet 527 on a proximal or top portion of the coaptation element 520 and one or more passageway outlets 529 on an outer or side portion of the spacer or coaptation element 520. The passageway inlet 527 and at least a portion of the passageway 524 may be sized and shaped to receive one or more components capable of opening and closing the valve repair device 500. The passageway outlet 529 may be located proximally above the paddle securement recess 523 and above the clasp securement recess 525.

[0201] The coaptation element 520 can include an actuator 526 disposed at least partially in a proximal or upper portion of each passageway 524. Each actuator 526 can be sized and shaped to fit securely into a respective passageway 524. The actuator 526 can be a cap, button, or other component that can be actuated by an actuation element (e.g., an actuation wire, shaft, rod, line, etc.) extending from the delivery sheath or system. For example, the actuator 526 can be configured to be engaged or actuated by an actuation element 591 (e.g., an actuation shaft, actuation wire, etc.; FIGS. 77-79)) to at least partially open the valve repair device 500.

[0202] The paddle portion 506 of the valve repair device 500 includes a plurality of paddles 508, each of which includes a paddle 530 and a connecting portion 532. The paddles 508 can facilitate engagement of the valve tissues 20, 22 as part of any suitable valve repair system. The paddles 530 can be generally flat with a spherical or bulb-like cross-section having a wider distal end and a narrower inner end. The paddles 530 can be substantially wire-framed. However, the paddles 530 can be of any suitable shape or configuration. For example, the paddles 530 can be rectangular or any other shape, and can be a mesh or solid frame or any other suitable configuration. Each paddle 530 can extend upwardly and radially outwardly from an inner location to a proximal and radially outer end.

[0203] The connecting portion 532 of the paddle 508 can be used to control the movement of the paddle 530. The connecting portion 532 can be moved, controlled, or otherwise manipulated by an actuation element (e.g., an actuation shaft, an actuation wire, etc.). The connecting portion 532 can be located on a narrower inner portion of the paddle 530 and can be formed by pinching or crimping the frame of the paddle 530. However, the connecting portion 532 can be formed in any suitable manner. For example, the connecting portion 532 can be a loop, hook, or other connecting component that can enable connection with the paddle 530.

[0204] The paddle portion 506 also includes a rounded or oval paddle collar 536 that can connect or secure the paddle portion 506 to the interface element 520. For example, the paddle collar 536 can be sized and shaped to fit into the paddle securement recess 523 and around an outer portion of the interface element 520. For example, the paddle collar 536 can be sized and shaped to at least partially snap-fit ​​within the paddle securement recess 523 of the interface element 520. The paddle collar 536 and the paddle securement recess 523 can also be sized, shaped, or otherwise configured such that the paddle collar 536 can be at least partially secured within the paddle securement recess 523 by an interference fit. Each paddle 530 may be connected to a paddle collar 536 such that each paddle 508 (e.g., paddle 530, connecting portion 532) may bend or pivot about paddle collar 536 and may be articulated, manipulated, or otherwise articulated independently of the other paddles 508, as described below.

[0205] The paddle portion 506 can be configured such that the paddle 530 is biased downward and outward (e.g., away from the proximal portion of the valve repair device 500). The paddle 530, the connecting portion 532, and the paddle collar 536 can be derived from a single superelastic sheet, ribbon, or wire capable of withstanding plastic deformation. In some implementations, as shown, the paddle collar 536 is semicircular and integral with the paddle 530. However, the paddle portion 506 can be configured or connected in any suitable manner. For example, the paddle collar 536 can be circular and separate from the paddle 530, which can be connected to opposing sides of the paddle collar 536 by a hinge, joint, or other flexible or pivotable connector.

[0206] The mounting portion or gripping member 510 may be substantially similar to the mounting portion or gripping member 410 shown in FIGS. 57-67. As shown in FIGS. 76A-76D, the mounting portion or gripping member 510 may include a rounded or oval collar 542 that may connect or secure the mounting portion or gripping member 510 to the interface element 520. The collar 542 may be sized and shaped to be secured, positioned, or otherwise disposed on the interface element 520. For example, the collar 542 may be sized and shaped to at least partially snap-fit ​​within the clasp securement recess 525 of the interface element 520. The collar 542 and clasp securement recess 525 may also be sized, shaped, or otherwise configured such that the collar 542 may be at least partially secured within the clasp securement recess 525 by an interference fit.

[0207] The attachment portion or gripping member 510 may include two or more clasp elements 544 that can facilitate engagement of the valve tissue 20, 22 as part of any suitable valve repair system. Each clasp element 544 may have a narrower portion 540 connected to the collar 542 and a wider portion that may include a clasp engagement portion 546 for engagement of the valve tissue 20, 22 as part of any suitable valve repair system. In some implementations, as shown, the clasp elements 544 are spherical with a partial bulb or teardrop shape. However, the clasp elements 544 may have any suitable size, shape, or configuration. For example, the clasp elements 544 may be substantially solid, wire frame, rectangular, and / or similar to the size, shape, or configuration of the paddle 530.

[0208] The clasp element 544 may extend radially outward and proximally upward from the collar 542. The clasp element 544 may be integrally formed with the collar 542. The attachment portion or gripping member 510 may be formed from a single superelastic sheet, ribbon, or wire such that the attachment portion or gripping member 510 can withstand deformation. For example, the attachment portion or gripping member 510 may be formed from a single sheet or piece of material such that the radially outward portion of the clasp element 544 is biased or urged downward or distally. However, the attachment portion or gripping member 510 may have any suitable shape, size, or configuration, and the collar 542 and the clasp element 544 may have any suitable connection. For example, the clasp element 544 may be connected to the collar 542 by a hinge, joint, or other flexible or pivotable connector.

[0209] Each clasp element 544 may include one or more optional protrusions or barbs 548 extending into the clasp engagement portion 546. The barbs 548 may engage the leaflets 20, 22 and secure the valve repair device 500 to a native valve, e.g., a native mitral valve, when the device 500 is in a closed position, as described below. The tissue of the leaflets 20, 22 is not pierced by the barbs 548, although in some implementations, the barbs 548 may partially or completely pierce the leaflets 20, 22. In some implementations, as shown, the barbs 548 extend radially inward into the clasp engagement portion 546 and along the remainder of the clasp element 544. However, the barbs 548 may have any suitable size, shape, orientation, or configuration for securing the valve repair device 500 to a native valve. For example, the barbs 548 can be angled or perpendicular to the remainder of the clasp element 544 so that the barbs 548 can engage the tissue of the valve leaflets 20,22.

[0210] As shown in FIGS. 72 and 73, the coaptation element 520 may also include a connection element (e.g., a wire, rod, tube, shaft, hypotube, etc.) 528 for each of the passages 524 that can facilitate opening and closing of the valve repair device 500, as described in more detail below. Each connection element 528 is disposed between and connected or secured to one of the actuators 526 and one of the paddles 530 (see FIGS. 77-79). FIGS. 72 and 73 are exploded views, and therefore the connection elements 528 are shown as being separated from and spaced apart from the paddles 530. The connection elements 528 may be connected or secured to the paddles 530 in a wide variety of different manners. For example, an end of the connection element 528 may be looped around or connected or secured to the connection portion 532. In some implementations, as shown, the connection element 528 is a suture or wire. However, the connection element 528 may be any device or component capable of providing a connection between the actuators 526 and the paddles 530. For example, the connecting elements 528 can be a shape memory alloy, such as Nitinol. In some implementations, as shown, the device 500 is illustrated as having one connecting element 528 in each passageway 524. However, the device 500 can have any number of connecting elements 528. For example, the device 500 can have two connecting elements 528 in each passageway 524, one connecting element 528 connected to each side of the paddle 530 and / or connecting portion 532.

[0211] 77-79, the valve repair device 500 can be moved between a closed position and an open position. As shown in FIG. 77, the device 500 can be deployed in a closed position with the paddle 508 (e.g., paddle 530, connecting portion 532) pulled proximally upward and radially inward. The connecting element 528 can hold the paddle 530 and connecting portion 532 pulled proximally upward and inward toward the coaptation element 520. For example, the connecting element 528 can provide a tension force that counteracts the downward or distal biasing force of the paddle 508, thereby holding the paddle 508 in the closed or retracted position. For example, a spring or other biasing element (see biasing element 428 in FIG. 64) can bias the actuator 526 toward the proximal end of the spacer. As a result, the actuator 526 pulls the connecting element 528 to bias the paddle toward the closed or retracted position. The clasp element 544 can engage with the paddle 530 .

[0212] As shown in FIG. 78 , one of the paddles 508 can be moved to an open position using an actuating element (e.g., rod, shaft, tube, etc.) 591. The actuating element 591 can engage one of the actuators 526 and move the actuator 526 downward. Moving the actuator 526 distally or downward within the passageway 524 relaxes or reduces tension in the connecting element 528. The increased slack in the connecting element 528 allows the biasing force of the paddle portion 506 to pivot or bend the paddle 530 distally or downward. The downward or distal biasing force of the paddle portion 506 moves the outer portion of the paddle 530 distally and radially outward, creating a tissue receiving gap 452 between the paddle 530 and the clasp element 544.

[0213] 79, the other paddle 508 can be moved to the open position using one of the actuation elements 591. The same process can be repeated to move the other paddle 530 to create another tissue-receiving gap 552 between the other paddle 530 and the other catch element 544.

[0214] While the valve repair device 500 is in a partially open position (e.g., one paddle open in FIG. 78) or a fully open position (e.g., both paddles open in FIG. 79), the valve repair device 500 can be manipulated, positioned, or otherwise moved to a desired position. The valve repair device 500 can be manipulated or otherwise moved such that the native leaflets 20, 22 are in one of one or both tissue receiving gaps 552 of the valve repair device 500. For example, the position or movement of the valve repair device 500 can be controlled by connection or engagement with a boss or connecting portion 522 of the coaptation element 520. For example, the boss or connecting portion 522 may be sized, shaped, or otherwise configured to be engaged or positioned by an actuation element (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) 591 and / or to be removably attached to a delivery system, collar, or capture mechanism (e.g., one or more of a clamp, clip, pin, suture, line, lasso, noose, snare, buckle, lock, latch, etc.).

[0215] With the native leaflets 20, 22 in the tissue receiving gap 552, and one of the paddles 508 in place within the native valve, e.g., the native mitral valve, the respective paddle 508 can be closed. For example, the valve repair device 500 can be closed to capture the native leaflets 20, 22, such as between the paddle 530 and the clasp element 544. The actuation element 591 can be retracted proximally or upwardly to disengage the actuator 526. Disengaging the actuator 526 retracts the actuator 526 and the connecting element 528 proximally or upwardly within the passage 524 and toward the proximal portion 501 of the valve repair device 500. For example, the coaptation element 520 can include a spring or biasing element, such as the biasing element 428 described in FIGS. 57-67, which biases the actuator 526 toward the proximal portion 501 of the valve repair device 500. The upward movement of the actuator 526 and connecting element 528 increases the tension applied to the connecting portion 532, pulling the paddle 530 proximally and radially inward toward the clasp element 544. The paddle 530 can move upward and inward to at least partially engage the clasp element 544. The native leaflets 20, 22 can be secured by the distal or downward bias of the clasp element 544 and the upward tension applied to the paddle 530 by the connecting element 528.

[0216] Once the native leaflets 20, 22 are secured on one side of the valve repair device 500, the valve repair device 500 can be positioned or repositioned such that the native leaflets 20, 22 are disposed within the tissue-receiving gap 552 on the other side of the valve repair device 500. The closure process can be repeated for the other paddle 508 when the native leaflets 20, 22 are disposed in position on the other side of the valve repair device 500, such as within the tissue-receiving gap 552.

[0217] Although the process is described as opening both paddles 508 and closing each paddle 508 in turn, the device 500 can be opened, positioned, and closed in other manners. For example, one paddle 508 can be opened, positioned, and closed in place, and then the other paddle 508 can be opened, positioned, and closed in place, or both paddles 508 can be opened, positioned, and closed in place simultaneously.

[0218] Once the valve repair device 500 is closed in a desired position, the valve repair device 500 can be released from the delivery system or capture mechanism, and the delivery system, capture mechanism, and actuation element 591 can be withdrawn and removed. The native leaflets 20, 22 can be secured or engaged by a clasp engagement portion 546, such as a barb 548 of the clasp element 544.

[0219] 80A-94, an example of a device (e.g., an implantable prosthetic device, a prosthetic spacer device, a valve repair device, etc.) 600 is shown. The valve repair device 600 is one of many different configurations that the device 100, shown generally in FIGS. 8-15, may take. The device 600 may include any other features of an implantable prosthetic device described in this application or any application incorporated herein by reference, and the device 600 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or any application incorporated herein by reference). The various components of the valve repair device 600 may be made in any suitable size to accommodate the anatomies of different sized patients.

[0220] The valve repair device 600 extends from a proximal portion 601 to a distal portion 602 and may include an optional coaptation portion 604 and an anchor portion. In some implementations, the anchor portion includes one or more paddle portions 606 and / or attachment or gripping members 610. The coaptation portion 604 includes a coaptation element 620 (e.g., a spacer, coaptation element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) for implantation between the leaflets 20, 22 of the native valve. The coaptation element 620 has a generally elongated and round shape. In particular, the coaptation element 620 has an oval shape or cross section when viewed from above (FIG. 83D) and a tapered shape or cross section when viewed from a front view (e.g., FIG. 83C). A mixture of these three geometries may result in the illustrated three-dimensional shape of the coaptation element 620 achieving the advantages described herein. It can also be seen that the circular shape of the interface element 620, when viewed from above, substantially follows or approximates the shape of the attachment portion or gripping member and collar of the paddle portion, as described below.

[0221] As shown in FIGS. 83A and 83B, the coaptation element 620 can include a boss or connecting portion 622 extending upwardly from a proximal portion of the coaptation element 620. The boss or connecting portion 622 can be sized and shaped to be secured and / or manipulated by a user during an implantation operation. The boss or connecting portion 622 can be sized and shaped such that the coaptation element 620 can be retained, deployed, positioned, recaptured, repositioned, and / or repositioned during an implantation operation. For example, the boss or connecting portion 622 can be sized, shaped, or otherwise configured to be engaged or positioned by an actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) 691 and / or to be removably attached to a delivery system or capture mechanism. The boss or connecting portion 622 can at least partially comprise one or more actuators, as described in more detail below.

[0222] The interface element 620 can include one or more clasp locking recesses 625 extending inwardly into an outer portion of the interface element 620. The clasp locking recesses 625 can be sized and shaped to at least partially receive or secure the attachment portion or gripping member 610 to the interface element 620. However, the connection of the interface element 620 and the attachment portion or gripping member 610 can take any configuration. For example, the interface element 620 can include a single clasp locking recess 625 extending around the interface element 620, or the interface element 620 can be unitary with the attachment portion or gripping member 610.

[0223] As shown in FIGS. 83A-83E, the interface element 620 may include two or more passages 624 on either side of the boss or connecting portion 622. The passages 624 may be angled or partially L-shaped with a passage inlet 627 at a proximal or top portion of the interface element 620 and two passage outlets 629 at an outer or side portion of the interface element 620. The passage 624 may have a substantially vertical portion extending downward from the passage inlet 627 that branches into two radially extending or angled passages that lead to the two passage outlets 629. The passage inlet 627 and at least a portion of the passage 624 may be sized and shaped to receive one or more components capable of opening and closing one of the paddle portions 606. The passage outlets 629 may be disposed below the clasp locking recess 625.

[0224] With reference to FIG. 82, the coaptation element 620 can include a first actuator 626 disposed over or extending partially into a proximal portion or top of each passageway 624. Each first actuator 626 can be sized and shaped to at least partially fit into a respective passageway 624. The first actuator 626 can be a cap, button, or other component that can be actuated by an actuation element (e.g., an actuation wire, shaft, rod, line, etc.) extending from a delivery sheath or system, such as the delivery system 202 (see FIGS. 38-49). For example, the first actuator 626 can be configured to be engaged or actuated by an actuation element 691 (e.g., an actuation shaft, actuation wire, etc.; FIGS. 89-94) to at least partially open the valve repair device 600.

[0225] The coaptation element 620 may also include two or more passages 631 each disposed radially outward from the passage inlet 627. Each passage 631 may extend longitudinally through the coaptation element 620 from a proximal portion to a distal portion. The passages 631 may be narrower than the passage inlet 627. The passages 631 may be sized and shaped to receive one or more components capable of raising or lowering one of the paddle portions 606, as described in more detail below. The passage outlets 629 may be symmetrically disposed on either side of the passage 631.

[0226] The coaptation element 620 may include a second actuator 633 disposed on or extending partially into a proximal or upper portion of each passageway 631 when the paddle portion 606 is in a raised position, as described in more detail below. Each second actuator 633 may be sized and shaped to fit within a respective passageway 631. The second actuator 633 may be a cap, button, or other component that may be actuated by an actuation element (e.g., an actuation wire, shaft, rod, line, etc.) extending from the delivery sheath or system. For example, the second actuator 633 may be configured to be engaged or actuated by one of the actuation elements 691 (e.g., an actuation wire, actuation shaft, rod, line, etc.) to at least partially open the valve repair device 600.

[0227] Each of the paddle portions 606 of the valve repair device 600 includes a paddle 608 having a paddle 630 and a paddle extension shaft 634. The paddle extension shaft 634 can be a substantially vertical shaft that can be at least partially received in one of the passages 631 of the coaptation element 620. Each of the paddle extension shafts 634 can be partially fixed to one of the passages 631 of the coaptation element 620. The paddle extension shaft 634 can be disposed within the passage 631 such that the remainder of the valve repair device 600 can twist, pivot, or otherwise rotate about the paddle extension shaft 634, such as when the paddle 608 engages the valve tissue 20, 22, as described below. For example, the coaptation element 620, the other paddle portion 606, and / or the mounting portion or gripping member 610 can rotate about a longitudinal axis extending through one of the paddle extension shafts 634 when the paddle 608 associated with the paddle extension shaft 634 engages the valve tissue 20, 22. Such control over the valve repair device 600 may then allow the user to position the valve repair device 600 so that the other paddle portions 606 can engage the valve tissue 20, 22, as described in more detail below.

[0228] The paddles 608 can facilitate engagement of the valve tissues 20, 22 as part of any suitable valve repair system. The paddles 630 can be generally flat with a spherical or bulb-like cross-section with a wider distal end and a narrower inner end. The paddles 630 can be a substantially looped wire frame. However, the paddles 630 can be of any suitable shape or configuration. For example, the paddles 630 can be rectangular or any other shape, and can be a mesh or solid frame or any other suitable configuration. Each paddle 630 can extend upwardly and outwardly from the distal end of one of the paddle extension shafts 634. The paddles 630 can be flexibly connected to the paddle extension shaft 634 such that the paddles 630 can be at least partially pivotable about the end of the paddle extension shaft 634. For example, the paddles 630 can be connected to the paddle extension shaft 634 by a hinge, joint, or other pivotable connector, or can be flexibly integrated with the distal end of the paddle extension shaft 634.

[0229] Paddle 608 may optionally include a connecting portion 632 that may be used to control the movement of paddle 630. Connecting portion 632 may be moved, controlled, or otherwise manipulated by an actuation element (e.g., an actuation shaft, an actuation wire, etc.). Connecting portion 632 may be located on a narrower inner portion of paddle 630 or may be formed by pinching or crimping the frame of paddle 630. However, connecting portion 632 may be formed in any suitable manner. For example, connecting portion 632 may be a loop, hook, or other connecting component that may enable connection with paddle 630.

[0230] The paddle portion 606 can be configured such that the paddle 630 is biased downward and outward (e.g., away from the proximal portion of the valve repair device 600). The paddle 630, the connecting portion 632, and the paddle extension shaft 634 can be obtained from a single superelastic sheet, ribbon, or wire capable of withstanding plastic deformation. However, the paddle portion 606 can be configured or connected in any suitable manner. For example, the paddle extension shaft 634, the paddle 630, and the connecting portion 632 can be separate components connected by pivotable or flexible connectors.

[0231] The attachment portion or gripping member 610 may be substantially similar to the attachment portion or gripping member 410 shown in FIGS. 57-67 or the attachment portion or gripping member 510 shown in FIGS. 68-79. As shown in FIGS. 87A-87D, the attachment portion or gripping member 610 may include a rounded or oval collar 642 that may connect or secure the attachment portion or gripping member 610 to the interface element 620. The collar 642 may be sized and shaped to be secured, positioned, or otherwise disposed on the interface element 620. For example, the collar 642 may be sized and shaped to at least partially snap-fit ​​into the clasp securement recess 625 of the interface element 620. The collar 642 and clasp securement recess 625 may also be sized, shaped, or otherwise configured such that the collar 642 may be secured at least partially within the clasp securement recess 625 by an interference fit.

[0232] The attachment portion or gripping member 610 may include two or more clasp elements 644 that may facilitate engaging the valve tissue 20, 22 as part of any suitable valve repair system. Each clasp element 644 may have a narrower radially proximal portion 640 connected to the collar 642 and a wider radially distal portion that may include a clasp engagement portion 646 for engaging the valve tissue 20, 22 as part of any suitable valve repair system. In some implementations, as shown, the clasp elements 644 are substantially flat with a spherical or bulb-shaped or teardrop-shaped cross-section. However, the clasp elements 644 may have any suitable size, shape, or configuration. For example, the clasp elements 644 may be substantially solid, wire frame, rectangular, and / or similar to the size, shape, or configuration of the paddle 630.

[0233] The clasp element 644 may extend radially outward and proximally upward from the collar 642. The clasp element 644 may be integrally formed with the collar 642. The attachment portion or gripping member 610 may be formed from a single superelastic sheet, ribbon, or wire such that the attachment portion or gripping member 610 can withstand deformation. For example, the attachment portion or gripping member 610 may be formed from a single sheet or piece of material such that the radially outward portion of the clasp element 644 is biased or urged downward or distally. However, the attachment portion or gripping member 610 may have any suitable shape, size, or configuration, and the collar 642 and the clasp element 644 may have any suitable connection. For example, the clasp element 644 may be connected to the collar 642 by a hinge, joint, or other flexible or pivotable connector.

[0234] Each clasp element 644 may include one or more optional protrusions or barbs 648 extending into the clasp engagement portion 646. The optional barbs 648 may engage the leaflets 20, 22 and secure the valve repair device 600 to a native valve, e.g., a native mitral valve, when the device 600 is in a closed position, as described below. The tissue of the leaflets 20, 22 is not pierced by the barbs 648, although in some implementations, the barbs 648 may partially or completely pierce the leaflets 20, 22. In some implementations, as shown, the barbs 648 extend radially inward into the clasp engagement portion 646 along the remainder of the clasp element 644. However, the barbs 648 may have any suitable size, shape, orientation, or configuration for securing the valve repair device 600 to a native valve. For example, the barbs 648 can be angled or perpendicular to the remainder of the clasp element 644 so that the barbs 648 can engage the tissue of the valve leaflets 20,22.

[0235] As shown in FIGS. 81-82 , the interface element 620 may also include one or more connection elements 628 in each of the passages 624 that can facilitate opening and closing of the valve repair device 600, as described in more detail below. Each connection element (e.g., line, shaft, tube, hypotube, wire, etc.) 628 may be disposed between and connected or secured to the first actuator 626 and one of the corresponding paddles 630. When the device 600 is in a closed position, the connection element 628 may provide tension to the paddles 630 that holds the paddles 630 in an upright or closed position, and when the first actuator 626 is engaged or pressed into the passage 624, the connection element 628 may sag or reduce tension that allows the paddles 630 to open or bend radially outward, as described below. The connection element 628 may be connected or secured to the paddles 630. For example, an end of the connection element 628 may be looped around or connected or secured to the connection portion 632. In some implementations, as shown, the connection element 628 is a suture or a wire. However, the connection element 628 may be any device or component capable of providing a connection between the actuator 626 and the paddle 630. For example, the connection element 628 may be a shape memory alloy, such as Nitinol. In some implementations, as shown, the connection element 628 has a single portion at the passage entrance 627 and two ends, each extending from one of the passage exits 629. However, any number and configuration of connection elements 628 may be used. For example, each passage 624 may include two connection elements 628, each extending through one of the passage exits 629.

[0236] As shown in FIGS. 81 and 82 , the interface element 620 may also include a first biasing element (e.g., a spring, a band, a compressible material, a compressible fluid, etc.) 637 in each of the passages 624 that may counteract the force output from the paddle portion 606. For example, the first biasing element 637 may apply a biasing force that holds the first actuator 626 in an upright or undepressed state when the device 600 is in the closed position. Each first biasing element 637 may be disposed between and connected to or secured to the first actuator 626 and a proximal portion of one or more of the connecting elements 628. In some implementations, as shown, the first biasing element 637 is a coil spring. However, the first biasing element 637 may be any device or component capable of providing a biasing force. For example, the first biasing element 637 may be a leaf spring, a shape memory alloy such as Nitinol, or any other biasing device.

[0237] The interface element 620 may also include a second biasing element (e.g., a spring, a band, a compressible material, a compressible fluid, etc.) 638 in each of the passages 631 that may counteract the force output from the paddle portion 606. The second biasing element 638 may hold the paddle extension shaft 634 proximally pulled into the passage 631 of the interface element 620. For example, the second biasing element 638 may apply a biasing force that holds the second actuator 633 in an undepressed state and holds the paddle extension shaft 634 in a proximal or retracted position when the device 600 is in a closed or retracted position. Each biasing element 638 may be disposed between and connected or fixed to the second actuator 633 and a proximal portion of one of the paddle extension shafts 634. In some implementations, as shown, the second biasing element 638 is a coil spring. However, the second biasing element 638 may be any device or component capable of providing a biasing force. For example, the second biasing element 638 may be a leaf spring, a shape memory alloy such as Nitinol, or any other biasing device.

[0238] 88-94, the valve repair device 600 can be moved between a closed position and an open position. As shown in FIG. 88, the device 600 can be deployed in a closed position with the paddle 608 (e.g., paddle 630, connecting portion 632, and paddle extension shaft 634) pulled proximally upward and radially inward. A connecting element (e.g., a wire, rod, tube, hypotube, suture, etc.) 628 can hold the paddle 630 and connecting portion 632 pulled proximally upward and inward toward the coaptation element 620. For example, the connecting element 628 can provide a tension force that counters the downward or distal biasing force of the paddle 608, thereby holding the paddle 630 of the paddle 608 in a closed or retracted position. A second biasing element 638 can provide a biasing force that holds the paddle extension shaft 634 in an upright or retracted position. The clasp element 644 can engage with the paddle 630 .

[0239] 89 , one of the paddles 608 can be moved to an extended position using one of the actuating elements 691. The actuating element 691 can engage one of the second actuators 633 and move the second actuator 633 downward. Moving the second actuator 633 distally or downwardly within the passageway 631 applies a downward force to the paddle extension shaft 634 that counters the biasing force of the second biasing element 638 and moves the paddle extension shaft 634 at least partially distally or downwardly out of the passageway 631.

[0240] As shown in FIG. 90 , one of the paddles 608 can be moved to an open position using one or more actuating elements 691. The actuating elements 691 can engage one of the first actuators 626 and move the first actuator 626 downward or distally. Moving the first actuator 626 downward within the passageway 624 slackens or reduces tension on the connecting element 628. As the slack in the connecting element 628 increases, the biasing force of the paddle portion 606 allows the paddle 630 to pivot or bend distally or downward. The downward or distal biasing force of the paddle portion 606 moves an outer portion of the paddle 630 distally and radially outward, creating a tissue receiving gap 652 between the paddle 630 and the clasp element 644.

[0241] As shown in FIG. 91, the device 600 can be moved to a partially open position with one of the paddles 608 moved to the extended and open positions with one or more actuating elements 691. The one or more actuating elements 691 can engage one of the second actuators 633 (as shown in FIG. 89) and a first actuator 626 (as shown in FIG. 90) on the same side of the joining element 620 as the engaged second actuator 633. Moving the first and second actuators 626, 633 downward and distally moves the paddle extension shaft 634 distally or downwardly from the passageway 631, moving the outer portion of the paddle 630 distally and radially outwardly as described above, creating a tissue receiving gap 652 between the paddle 630 and the catch element 644. Either the first actuator 626 or the second actuator 633 can be engaged and actuated first, or the first and second actuators 626, 633 can be engaged and actuated simultaneously.

[0242] The same process can be repeated to move the other paddle 630 and create another tissue receiving gap 652 between the other paddle 630 and the other catch element 644. As shown in FIG. 92 , the other paddle 608 can be moved to an extended position using one of the actuating elements 691. The actuating element 691 can engage the second actuator 633 and move the second actuator 633 downward. Moving the second actuator 633 distally or downward within the passageway 631 applies a downward force to the paddle extension shaft 634 that counters the biasing force of the second biasing element 638 and moves the paddle extension shaft 634 at least partially distally or downwardly from the passageway 631.

[0243] As shown in FIG. 93 , the other paddle 608 can be moved to an open position using one or more actuating elements 691. The actuating elements 691 can engage the other first actuator 626 and move the first actuator 626 downward or distally. Moving the first actuator 626 downward within the passageway 624 slackens or reduces the tension on the connecting element 628. As the slack in the connecting element 628 increases, the biasing force of the paddle portion 606 allows the paddle 630 to pivot or bend distally or downward. The downward or distal biasing force of the paddle portion 606 moves the outer portion of the paddle 630 distally and radially outward, creating a tissue receiving gap 652 between the paddle 630 and the clasp element 644.

[0244] 89, one of the paddles 608 can be moved to an extended position using one of the actuating elements 691. The actuating element 691 can engage one of the second actuators 633 and move the second actuator 633 downward. Moving the second actuator 633 distally or downwardly within the passageway 631 applies a downward force to the paddle extension shaft 634 that counters the biasing force of the second biasing element 638 and moves the paddle extension shaft 634 distally or downwardly from the passageway.

[0245] One or both of the paddles 608 can be moved to an open position using one or more actuating elements 691. The actuating elements 691 can engage one of the first actuators 626 and move the first actuator 626 downward or distally. Moving the first actuator 626 downward within the passageway 624 slackens or reduces tension on the connecting element 628. As the slack in the connecting element 628 increases, the biasing force of the paddle portion 606 allows the paddle 630 to pivot or bend distally or downward. The downward or distal biasing force of the paddle portion 606 moves the outer portion of the paddle 630 distally and radially outward, creating a tissue receiving gap 652 between the paddle 630 and the clasp element 644.

[0246] As shown in FIG. 94, the device 600 can be moved to a fully open position with both paddles 608 moved to the extended and open positions with one or more actuating elements 691. The one or more actuating elements 691 can engage another second actuator 633 (as shown in FIG. 92) and another first actuator 626 (as shown in FIG. 93) on the same side of the coaptation element 620. Moving the first and second actuators 626, 633 downward and distally moves the paddle extension shaft 634 distally or downwardly from the passageway 631, moving the outer portion of the paddle 630 distally and radially outwardly, as described above, creating a tissue receiving gap 652 between the paddle and the catch element 644. Either the first actuator 626 or the second actuator 633 can be engaged and actuated first, or the first and second actuators 626, 633 can be actuated simultaneously.

[0247] While the valve repair device 600 is in a partially open position (e.g., FIG. 91) or a fully open position (e.g., FIG. 94), the valve repair device 600 can be manipulated, positioned, or otherwise moved to a desired position. The valve repair device 600 can be manipulated or otherwise moved such that the native leaflets 20, 22 are in one of one or both tissue receiving gaps 652 of the valve repair device 600. For example, the position or movement of the valve repair device 600 can be controlled by connection or engagement with a boss or connecting portion 622 of the coaptation element 620. For example, the boss or connecting portion 622 can be sized, shaped, or otherwise configured to be engaged or positioned by an actuating element, such as actuating element 691, and / or to be removably attached to a delivery system, collar, or capture mechanism, such as delivery system 202 (see FIGS. 38-49).

[0248] Once one of the paddles 608 is in place within the native valve, e.g., the native mitral valve, with the native leaflets 20, 22 within the tissue receiving gap 652, the respective paddle 608 can be closed. For example, the valve repair device 600 can be closed to capture the native leaflets 20, 22, such as between the paddle 630 and the clasp element 644. The actuation element 691 can be retracted proximally or upwardly to disengage the first actuator 626 and the second actuator 633. By disengaging the first and second actuators 626, 633, the actuators 626, 633, the connecting element 628, and the paddle extension shaft 634 are retracted proximally or upwardly toward the proximal portion 601 of the valve repair device 600, and the paddle 630 is bent or retracted radially inward toward the coaptation element 620. For example, upon release of the first and second actuators 626, 633, the first and second biasing elements 637, 638 push the first and second actuators 626, 633 toward the proximal portion 601 of the valve repair device 600 and the clasp element 644. The upward movement of the first actuator 626 increases the tension in the connecting element 628 which pulls the connecting portion 632 and the paddle 630 toward the coaptation element 620. The upward movement of the second actuator 633 pulls the paddle extension shaft 634 back proximally or upwardly into the passage 631 of the coaptation element 620. The native leaflets 20, 22 can be secured by the distal or downward bias of the clasp element 644 and the upward tension applied to the paddle 630 by the connecting element 628 and the first and second biasing elements 637, 638. The first and second biasing elements 637, 638 can maintain the device 600 in a closed position (FIG. 88) with the native leaflets 20, 22 secured within the tissue-receiving gap 652.

[0249] Once the native leaflets 20, 22 are secured on one side of the valve repair device 600, the valve repair device 600 can be repositioned so that the native leaflets 20, 22 are disposed within the tissue receiving gap 652 on the other side of the valve repair device 600. The closing process can be repeated for the other paddle 608 when the native leaflets 20, 22 are in place on the other side of the valve repair device 600, such as within the tissue receiving gap 652. Although the process has been described as opening both paddle portions 606 and closing each paddle portion 606 in turn, the device 600 can be opened, positioned, and closed in other manners. For example, one paddle portion 606 can be opened, positioned, and closed in place, and then the other paddle portion 606 can be opened, positioned, and closed in place, or both paddle portions 606 can be opened, positioned, and closed in place, and then closed simultaneously.

[0250] Once the valve repair device 600 is closed in a desired position, the valve repair device 600 can be released from a delivery system or capture mechanism, such as the delivery system 202 (see FIGS. 38-49), and the delivery system, capture mechanism, and actuation element 691 can be withdrawn and removed. The native leaflets 20, 22 can be secured or engaged by a clasp engagement portion 646, such as a barb 648 of the clasp element 644.

[0251] In some implementations, the valve repair device or implant may be configured such that the paddles can transition from a substantially freely rotatable configuration, such as during delivery and deployment, to a substantially safe configuration, such as after the device is secured to the leaflets of the native valve. For example, the device may include a pass-over center mechanism that allows rotation of the paddles during delivery and deployment of the device, and maintains the paddles in a closed position or configuration after the device is deployed or implanted within the native heart.

[0252] 95-98, there is shown generally an example of a device (e.g., an implantable prosthetic device, a prosthetic spacer device, a valve repair device, etc.) 700. In some implementations, device 700 may include a pass-over center mechanism that allows for rotation of the anchor portions (e.g., the paddles and / or the gripping members of the anchor portions) during delivery and deployment of the device, and maintains the anchor portions (e.g., the paddles and / or the gripping members of the anchor portions) in a closed position or configuration after the device is deployed or implanted within the native heart.

[0253] 95-98, a portion of device 700 is shown having paddle portions 706. Device 700 may have any number of paddle portions 706. For example, device 700 may have one, two, or three paddle portions 706, each including a paddle portion configured to engage the leaflets of a native heart valve.

[0254] Device 700 may include any other features of an implantable prosthetic device described in this application or any application incorporated herein by reference, and device 700 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or any application incorporated herein by reference). The various components of device 700 may be made in any suitable size to accommodate the anatomies of different sized patients.

[0255] In some implementations, the device 700 extends from a proximal portion 701 to a distal portion 702 and can include an optional coaptation portion 704 and one or more paddle portions 706. In some implementations, the coaptation portion 704 can include a coaptation element 720 (e.g., a spacer, coaptation element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) for implantation between the leaflets 20, 22 of the native valve. The coaptation element 720 can include any of the features for a spacer or coaptation element discussed in this application or any of the applications incorporated by reference herein.

[0256] In some implementations, the coaptation element 720 includes an outer surface 722 having a first or distal retaining hinge 724 extending outwardly from the outer surface 722 and disposed near the distal portion 702 of the device 700, and a second or proximal retaining hinge 726 extending outwardly from the outer surface 722 and disposed proximally from the first retaining hinge 724 between the proximal and distal portions 701, 702 of the device 700. The second retaining hinge 726 can be disposed upward (proximally) and aligned with the first retaining hinge 724, and the first and second retaining hinges 724, 726 can be configured to pivotally retain a portion of the paddle portion 706 of the device 700, as described below.

[0257] In some implementations, the first and second retention hinges 724, 726 each define a circular passageway that can receive a tube or shaft and allow the tube or shaft to rotate within the passageway. The first and second retention hinges 724, 726 may be flexible to allow the paddle attachment portion 706 to rotate during delivery and deployment, as well as to maintain the paddle portion 706 in a closed position or configuration. Although the illustrated retention hinges 724, 726 are disposed beyond the outer surface 722, the retention hinges 724, 726 may be part of or disposed within the outer surface 722.

[0258] In some implementations, as shown, the optional coaptation element 720 has a substantially cylindrical cross-section. However, the coaptation element 720 may have any suitable size, shape, or configuration. For example, the coaptation element 720 may be any of the spacers or coaptation elements described herein, and / or the coaptation element 720 may be narrower, such as a small shaft size. If included, the coaptation element 720 may have an oval, D-shaped, rounded D-shaped, cross-section that mimics the shape of the native valve, etc. Additionally, the first and second retention hinges 724, 726 may be located on the posts or frame of the device 700, rather than on the coaptation element 720.

[0259] In some implementations, each paddle portion 706 of the device 700 includes a paddle 708 having a paddle arm 730 and a slider or follower arm 740. The paddle arm 730 may include a first paddle member 732 and a second paddle member 734 extending at an angle from the first paddle member 732. The paddle arm 730 may also include a paddle fastener 736 at a junction between the first paddle member 732 and the second paddle member 734 configured to be pivotally coupled and / or otherwise retained within the first retaining hinge 724.

[0260] In some implementations, the paddle arm 730 may be pivotally coupled or otherwise connected to the first retaining hinge 724 via a paddle fastener 736 such that the paddle fastener 736 is retained within the first retaining hinge 724 and the first and second paddle members 732, 734 can rotate or pivot about the first retaining hinge 724 and / or the paddle fastener 736. The paddle fastener 736 can take a wide variety of different forms. For example, the paddle fastener 736 may be a shaft and / or bearing that fits within the first retaining hinge 724. In some implementations, the paddle fastener is integrally formed with one or both of the first and second paddle members 732, 734.

[0261] In some implementations, the paddle arm 730 also includes a stop 738 located along the length of the first paddle member 732, away from the second paddle member 734 and the paddle fastener 736, that can stop, abut, or otherwise prevent an object from sliding further along the first paddle member 732. The stop 738 can take a wide variety of different forms. In some implementations, the stop 738 is a cross bar, a protrusion or projection, a fastener such as a screw or nut, a weld, or the like.

[0262] In some implementations, the first and second paddle members 732, 734 are continuous and formed by bending the paddle arm 730. In some implementations, the first and second paddle members 732, 734 are separate pieces that are connected or bonded together. When the paddle members 732, 734 are fixed together, the angle between the paddle members can be between 90 degrees and 160 degrees. However, the paddle members 732, 734 can be set at any angle or can be movable relative to each other in some implementations.

[0263] In some implementations, the paddle fastener 736 may be vertically connected or fixed between the first paddle member 732 and the second paddle member 734 by integrally forming, welding, fasteners, adhesives, etc., and such that the paddle fastener 736 can extend through the first retaining hinge 724 and such that the first paddle member 732 and the second paddle member 734 can pivot or rotate around the paddle fastener 736 and / or the first retaining hinge 724.

[0264] In some implementations, the driven arm 740 can be substantially linear. In some implementations, the driven arm can have a driven fastener 742 at one end and a paddle connector 744 at an end opposite the driven fastener 742. The driven fastener 742 can take a wide variety of different forms. For example, the driven fastener 742 can be a shaft and / or bearing that fits within the second retaining hinge 726. In some implementations, the driven fastener 742 is integrally formed with the driven arm 740.

[0265] In some implementations, the driven arm 740 may be optionally configured or configured to act as a spring, such as a leaf spring. In some implementations, the driven fastener 742 is configured to be pivotally coupled to or otherwise held by the second retaining hinge 726 such that the driven arm 740 is connected to the second retaining hinge 726 and can rotate or pivot about the second retaining hinge 726 and / or the driven fastener 742. In some implementations, the paddle connector 744 is slidably connected to or otherwise fixed to the paddle arm 730 along the length of the first paddle member 732 between the paddle fastener 736 and the stop 738. In some implementations, the paddle connector 744 of the driven arm 740 is sized, shaped, or otherwise configured to slide along the first paddle member 732 between the paddle fastener 736 and the stop 738. In some implementations, the paddle connector 744 is a loop large enough to slidably fit over a portion of the first paddle member 732, but smaller than the stop 738. However, the paddle connector 744 can have another suitable configuration. For example, the paddle connector 744 can be a tongue that fits and slides within a groove or slot in the first paddle member 732. The follower arm 740 can be optionally sized, shaped, or configured to provide a bias or spring force that can maintain the paddle arm 730 in a closed position, as described below.

[0266] In some implementations, the paddle arm 730 and the driven arm 740 may be configured such that the paddle arm 730 can freely pivot or rotate about the first retaining hinge 724 during delivery and deployment. Additionally, the paddle arm 730, the driven arm 740, and the first and second retaining hinges 724, 726 may be sized, shaped, spaced, and configured such that the driven arm 740 and the second paddle member 734 can exert a biasing force to hold the first paddle member 732 in a closed position, such as around the native valve leaflets 20, 22, when the device 700 is deployed, as described below.

[0267] In some implementations, the actuation element 712 extends through the interface element 720 and is attached or coupled to a second paddle member 734 of the paddle arm 730 opposite the first paddle member 732. The actuation element 712 can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, threads, sutures, lines, strips, combinations thereof, etc.), be made from a variety of different materials, and have a variety of configurations. In some implementations, the actuation element 712 includes a proximal actuation portion 714 pivotally connected to a distal actuation portion 716 at an actuation pivot 715. In some implementations, a distal end of the distal actuation portion 716 can be pivotally connected to a second paddle member 734 and a paddle fastener 736 opposite the first paddle member 732 such that the distal actuation portion 716 and the second paddle member 734 can rotate relative to one another.

[0268] 95, the actuating element 712 extends through the device 700 with the distal actuating portion 716 substantially aligned with the proximal actuating portion 714 and the paddle arm 730 in a home position such that the second paddle member 734 is angled toward the proximal actuating portion 714 of the actuating element 712. For example, the second paddle member 734 can be angled proximally above the first retaining hinge 724 and into the coaptation element 720.

[0269] 96, the actuation element 712 may extend distally through the device 700. As the actuation element 712 extends distally, the length of the second paddle member 734 is substantially fixed or fixed so that the paddle arm 730 can pivot or rotate about the first retaining hinge 724 via the paddle fastener 736 towards the proximal portion 701 of the device and the distal actuation portion 716 can pivot or rotate about the actuation pivot 715. As the paddle arm 730 pivots proximally towards the proximal portion 701 of the device 700, the paddle connector 744 of the follower arm 740 slides along the first paddle member 732 towards the stop 738. The further distal extension of the actuating element 712 causes the pivoting distal actuating portion 716 to rotate the second paddle member 734 about the second retaining hinge 726, thereby rotating the first paddle member 732 proximally toward the proximal portion 701 of the device 700 until the paddle connector 744 abuts the stop 738 of the paddle arm 730, as shown in FIG. 96.

[0270] In some implementations, when the paddle connector 744 of the driven arm 740 abuts the stop 738 of the paddle arm 730, an increased force is required to rotate the first paddle member 732 further about the first retaining hinge 724 toward the proximal portion 701 of the device 700. That is, one or more of the proximal hinge portion 726, the distal hinge portion 724, the proximal hinge portion 726, the paddle arm 730, and the driven arm 740 must flex to allow the rotation of the paddle arm 730 and the driven arm to a further closing rotation. When a sufficient distal force is applied via the actuation element 712, the distal hinge portion 724, the proximal hinge portion 726, the paddle arm 730, and / or the driven arm 740 flex or bend to allow the first paddle member 732 to rotate further toward the proximal portion 701 of the device 700.

[0271] 97 illustrates a central position where an imaginary line passes through the paddle connector 744 / stop 738, the pivot axis of the proximal hinge 726, and the pivot axis of the distal hinge 724. In some implementations where the paddle arm 730 and the driven arm 740 are straight, for example the embodiment illustrated in FIG. 97, the paddle arm 730, the driven arm 740, the pivot axis of the hinge 726, and the pivot axis of the hinge 724 are all aligned in the central position. To reach the central position, the first paddle member 732 rotates proximally past abutment of the stop 738 and the distal hinge portion 724, the proximal hinge portion 726, the paddle arm 730, and / or the driven arm 740 are bent, elastically deformed, or compressed to a maximum amount. In some implementations, the force required to rotate the paddle arm 730 to the central position is maximum or substantially maximum.

[0272] At the midpoint or just beyond the midpoint (i.e., over-center point), the bias of the bent distal hinge portion 724, proximal hinge portion 726, paddle arm 730, and / or follower arm 740 causes the paddle arm 730 and follower arm 740 to flex inward or snap toward any interface element 720. In this manner, the bias of the distal hinge portion 724, proximal hinge portion 726, paddle arm 730, and / or follower arm 740 causes the first paddle member 732 to remain positioned on the closed side of the over-center point, as shown in FIG. 98. In some implementations, the paddle arm 730 remains in the closed position until an amount of force is applied to the paddle arm 730 by the actuation element 712 that is greater than the amount of force required to move the paddle arm 730 and follower arm 740 in the opposite direction beyond the midpoint.

[0273] After the first paddle member 732 and the follower arm 740 rotate or move past the center position, the biasing force further rotates the first paddle member 732 and the follower arm 740 about the first and second retaining hinges 724, 726, respectively, such that the first paddle member 732 and the follower arm 740 are oriented proximally toward the proximal portion 701 of the device 700. After the first paddle member 732 rotates proximally past the over-center position, the distal hinge portion 724, the proximal hinge portion 726, the paddle arm 730, and / or the follower arm 740 bias the first paddle member 732 toward an inner portion of the device 700. In some implementations, the paddle arm 730 is maintained in the closed position without the need for additional locking or application of an external force after the first paddle member 732 moves past the over-center position. The paddle arms 730 can be moved to an over-center and closed position after the natural tissue is properly positioned between the first paddle member 732 and the coaptation element 720 .

[0274] In some implementations, the biasing force provided by the first and second retaining hinges 724, 726, the follower arm 740, and / or the abutment of the paddle connector 744 with the stop 738 can provide a locking effect, such as a snap-lock effect, that maintains the paddle arm 730 in the closed position. Without any additional force being applied to the paddle arm 730, the first paddle member 732 is maintained in the closed position. For example, when the paddle arm 730 is in the closed position, the biasing force of the first and second retaining hinges 724, 726, the follower arm 740, and the abutment of the paddle connector 744 with the stop 738 can maintain or lock the first paddle member 732 in the closed position until a force is applied to the second paddle member 734 by the actuation element 712 sufficient to rotate the paddle arm 730 and the follower arm 740 back past the center position.

[0275] In some implementations, to reopen the paddle arm 730, sufficient force can be applied to retract the actuating element 712 proximally to overcome the bias of the abutment of the driven arm 740, the first and second retaining hinges 724, 726, and / or the stop 738 of the paddle connector 744 and move the paddle arm 730 and the driven arm 740 to the center position. After the paddle arm 730 and the driven arm 740 have moved past the over-center position, the actuating element 712 can be further retracted to rotate the paddle arm 730 further distally such that the first paddle member 732 rotates out of alignment with the driven arm 740 and the paddle connector 744 separates from the stop 738. The paddle arm 730 can be further rotated about the first retaining hinge 724 by further proximal retraction of the actuating element 712 through the device.

[0276] As shown in FIG. 95, the device 700 can be deployed in a fully elongated position with the actuating element 712 within the device 700 and the first paddle member 732 oriented substantially distally from the device 700. The second paddle member 734 can be oriented proximally and the follower arm 740 can position the paddle connector 744 connected to the first paddle member 732 some distance away from the stop 738. In such a position, the cross-sectional profile of the device 700 can be minimized for delivery of the device 700, for example, via the delivery system described above. In some implementations, the first paddle member 732 can be oriented at an angle of 180° distally from the device 700. The follower arm 740 is also oriented distally from the second retaining hinge 726.

[0277] In some implementations, as shown, the first paddle member 732 is oriented substantially distally from the device 700 during delivery. However, the paddle arm 730 can be oriented in other positions and configurations during delivery. For example, the first paddle member 732 can be rotated more than 180° distally from the device 700, can be oriented distally from the device 700 and midway toward the longitudinal axis of the actuation element 712, or the first paddle member 732 can be oriented 180° proximally from the device 700 during deployment.

[0278] As shown in FIG. 96 , the actuation element 712 can be advanced distally through the device 700 to rotate the paddle arm 730. The distal actuation portion 716 rotates from the proximal actuation portion 714 about the actuation pivot 715, causing the second paddle member 734 to rotate about the first retaining hinge 724, thereby causing the first paddle member 732 to rotate about the first retaining hinge 724. In some implementations, the driven arm 740 is connected to the first paddle member 732 and rotates with the first paddle member 732. The paddle arm 730 and the driven arm 740 rotate with the paddle connector 744 sliding along the first paddle member 732 until the paddle connector 744 of the driven arm 740 abuts the stop 738 of the first paddle member 732.

[0279] 97, additional force can be applied to advance the actuating element 712 further distally through the device 700 to further rotate the paddle arm 730 such that the paddle arm 730 and the driven arm 740 are in a centered position. In some implementations, the force applied to the actuating element 712 can compress or bend the distal hinge portion 724, the proximal hinge portion 726, the paddle arm 730, and / or the driven arm 740 as they rotate. In some implementations, the distal hinge portion 724, the proximal hinge portion 726, the paddle arm 730, and / or the driven arm 740 can be bent or compressed a maximum distance when the paddle arm 730 and the driven arm 740 are aligned (i.e., in an over-center position).

[0280] 98, the actuating element 712 may be pulled further distally through the device 700 by the biasing forces of the distal hinge portion 724, the proximal hinge portion 726, the paddle arm 730, and / or the follower arm 740 as the biasing forces rotate the paddle arm 730 further past the over-center point. In some implementations, the first paddle member 732 may be held or locked in the closed position until a sufficient force is applied to the paddle arm 730 by the biasing effect of the follower arm 740 and the first and second retaining hinges 724, 726 to rotate the first paddle member 732 back past the over-center point. When the device is properly secured on the leaflets of the native valve, the actuating element 712 may be removed, leaving the device 700 secured to the leaflets of the native valve.

[0281] 99-103, an embodiment of an implantable device or implant 800 is shown. The implantable device 800 is one of many different configurations that the device 700, shown generally in FIGS. 95-98, may take. The device 800 may include any other features of an implantable device or implant described herein, and the device 800 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system, such as any of the valve repair systems disclosed herein. The device / implant 800 may be a valve repair device, an implantable device, or another type of implant that is attached to the leaflets of a native valve.

[0282] In some implementations, the device 800 extends from a proximal portion 801 to a distal portion 802 and includes an optional interface portion 804 and an anchor portion. In some implementations, the anchor portion comprises one or more paddle portions 806. In some implementations, the anchor portion may optionally include an attachment portion or a gripping member similar to those described elsewhere herein. In some implementations, the interface portion 804 may include an interface element 820 (e.g., a spacer, interface element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) for implantation between the leaflets 20, 22 of the native valve. The interface element 820 may include any of the features of a spacer or interface element discussed in this application or any of the applications incorporated by reference herein.

[0283] In some implementations, the interface element 820 includes an outer surface 822 having a first or distal retaining hinge 824 extending outwardly from the outer surface 822 and disposed near the distal portion 802 of the device 800, and a second or proximal retaining hinge 826 extending outwardly from the outer surface 822 and disposed proximally from the first retaining hinge 824 between the proximal and distal portions 801 and 802 of the device 800. In some implementations, the second retaining hinge 826 can be disposed above (proximal to) the first retaining hinge 824, and the first and second retaining hinges 824, 826 can be configured to pivotally retain a portion of the paddle portion 806 of the device 800, as described below. In some implementations, the first and second retaining hinges 824, 826 each define a circular passageway that can receive a tube or shaft and allow the tube or shaft to rotate within the passageway. In some implementations, the first and second retention hinges 824, 826 may be flexible to allow the paddle portion 806 to rotate after reaching a stop during delivery and deployment, as well as to maintain the paddle portion 806 in a closed position or configuration.

[0284] In some implementations, as shown, the coaptation element 820 is substantially cylindrical. However, the coaptation element 820 may have any suitable size, shape, or configuration. For example, the coaptation element 820 may be any of the spacers or coaptation elements described herein, and / or the coaptation element 820 may be narrower, such as a small shaft size. Additionally, the first and second retaining hinges 824, 826 may be located on a post or frame of the device 800, rather than on the coaptation element 820.

[0285] In some implementations, each paddle portion 806 of the device 800 includes a paddle 808 having a paddle arm 830 and a slide or driven arm 840. In some implementations, the paddle arm 830 includes a first paddle member 832 and a second paddle member 834 extending at an angle from the first paddle member 832. In some implementations, as shown, the paddle arm 830 comprises a wire or tube that is bent into a substantially rectangular loop shape to form the first paddle member 832 and the second paddle member 834 such that the first paddle member 832 and the second paddle member 834 are substantially U-shaped with an end portion and two legs extending from the end. However, the paddle arm 830 may have other suitable sizes, shapes, and configurations. For example, the paddle arm 830 may be elliptical, oval, or hourglass shaped, may include an inwardly or outwardly extending radial flare, may be curved at the proximal end of the first paddle member 832, and may be formed from a mechanical linkage.

[0286] In some implementations, the paddle arm 830 also includes a paddle fastener 836 at a junction between the first paddle member 832 and the second paddle member 834 configured to be fixed or otherwise held within the first retaining hinge 824. In some implementations, the paddle arm 830 can be fixedly or otherwise connected to the first retaining hinge 824 via the paddle fastener 836 such that the paddle fastener 836 is held within the first retaining hinge 824 and the first and second paddle members 832, 834 can rotate or pivot about the first retaining hinge 824 and / or the paddle fastener 836. In some implementations, the paddle fastener 836 can be rotatably connected to the first retaining hinge 824 such that the first and second paddle members 832, 834 can rotate about the first retaining hinge 824. In some implementations, as shown, the paddle fastener 836 is a rod or shaft that extends between the legs of the first and second paddle members 832, 834, and is optionally integral with the first and second paddle members 832, 834. However, the paddle fastener 836 may have another size, shape, or configuration. For example, the paddle fastener 836 may comprise a connector rod that snaps into the end of the first retaining hinge 824, or may comprise a mechanical linkage that pivotally connects the paddle arm 830 with the first retaining hinge 824.

[0287] In some implementations, the paddle arm 830 also includes a stop 838 disposed along the length of the first paddle member 832 away from the second paddle member 834, and a paddle fastener 836 configured to stop, abut, or otherwise prevent an object from sliding further along the first paddle member 832. In some implementations, as shown, the stop 838 is a rod or shaft that extends between the legs of the first paddle member 832. However, the stop 838 may have other sizes, shapes, or configurations. For example, the stop 838 may be a protrusion along the length of the first paddle member 832, or a wall or end of a groove along the length of the first paddle member 832, that prevents an object from sliding further along the length of the first paddle member 832. In some implementations, as shown, the stop 838 is a rod or shaft that extends between the legs of the first paddle member 832 and is secured thereto by welding, a connector, fasteners, adhesives, or the like.

[0288] In some implementations, the driven arm 840 may be optionally configured to act as a biasing element or spring, such as a leaf spring. In some implementations, the driven arm 840 is substantially U-shaped with one end including a driven fastener 842, two legs extending from the driven fastener 842, and a paddle connector 844 at the end of each leg opposite the driven fastener 842. In some implementations, the driven fastener 842 is configured to be secured or otherwise held within the second retaining hinge 826 such that the remainder of the driven arm 840 can rotate or pivot about the second retaining hinge 726 and / or the driven fastener 842. In some implementations, the paddle connector 844 slidably connects to or otherwise secures the paddle arm 830 along the length of the first paddle member 832 between the paddle fastener 836 and the stop 838.

[0289] In some implementations, the paddle connector 844 is a looped portion of the follower arm 840 that is large enough to slidably fit over a portion of the first paddle member 832, but cannot slide past the stop 838. However, the paddle connector 844 can have other suitable configurations. For example, the paddle connector 844 can be a tongue that fits and slides into a groove or slot in the first paddle member 832. In some implementations, the follower arm 840 can be sized, shaped, or configured to optionally provide a bias or spring force that can maintain the paddle arm 830 in a closed position, or can help maintain the paddle arm 830 in a closed position.

[0290] The paddle arm 830 and the driven arm 840 can each comprise steel or a shape memory alloy such as Nitinol fabricated from a wire, sheet, tube, or laser sintered powder, and can be configured such that the paddle arm 830 and the driven arm 840 can freely pivot or rotate about the first retaining hinge 824 during delivery and deployment. Additionally, the paddle arm 830, the driven arm 840, and the first and second retaining hinges 824, 826 can be sized, shaped, spaced, and configured such that when the device 800 is deployed, the paddle arm 830, the driven arm 840, the first retaining hinge 824, and / or the second retaining hinge 826 apply a biasing force to hold the first paddle member 832 in a closed position, such as around the native valve leaflets 20, 22.

[0291] As shown in FIGS. 99-104, device 800 can be moved between an open position and a closed position, similar to device 700. In some implementations, device 800 can be arranged in a configuration in which first paddle member 832 is oriented substantially distally from interface element 820 such that first paddle member 832 is rotated proximally toward interface element 820, and second paddle member 834 is rotated distally away from interface element 820 (FIGS. 99-100). In some implementations, paddle connector 844 can slide along the leg of first paddle member 832 as first paddle member 832 rotates, thereby rotating follower arm 840 proximally. In some implementations, first paddle member 832 can be freely rotated until paddle connector 844 of follower arm 840 abuts stop 838 of first paddle member 832 (FIG. 101).

[0292] In some implementations, by applying additional pressure to the second paddle member 834, the paddle arm 830 and the driven arm 840 can be rotated to a center position where the paddle arm 830 and the first paddle member 832 are substantially aligned. In the center position, the paddle arm 830, the driven arm 840, the first retaining hinge 824, and / or the second retaining hinge 826 are bent, elastically deformed, or compressed to a maximum amount ( FIG. 102 ). In some implementations, a maximum amount of force can be applied to the second paddle member 834 to move the paddle arm 830 and the driven arm 840 across a past position or a center position.

[0293] In some implementations, the biasing force applied by the paddle arm 830, the driven arm 840, the first retaining hinge 824, and / or the second retaining hinge 826 rotates and locks the second paddle member 834 and the first paddle member 832 in the closed position, over or across the center position. For example, the paddle arm 830 can be moved to an over-center position and closed after native heart valve tissue, such as the leaflets of a native heart valve, is properly positioned between the paddle arm 830 and the coaptation element 820 ( FIG. 103 ). In the closed position, the first paddle member 832 can abut and / or be biased against the coaptation element 820.

[0294] 104-106, two or more paddle portions 806 may be included on the device 800. Each paddle 808 has a paddle arm 830 and a driven arm 840. In some implementations, each paddle arm 830 may be pivotally coupled within a first retaining hinge 824, and each driven arm 840 may be secured or otherwise retained within a second retaining hinge 826, as described with respect to FIGS. 96-98 and 99-104. In some implementations, the paddle 808 and the first and second retaining hinges 824, 826 may be evenly spaced and positioned on substantially opposite sides of the device 800 such that the device 800 may be secured to native leaflets on multiple sides of the device 800. In some implementations, as shown, the device 800 has two paddles 808 positioned on opposite sides of the device 800. However, the device 800 may include any number of paddles 808, paddle arms 830, and follower arms 840 that are fixed to or otherwise connected to the first and second retaining hinges 824, 826. For example, the device may include three paddles 808 for use with a tricuspid valve, or four or more paddles 808.

[0295] In some implementations, each paddle 808 can be rotated and moved between an open position and a closed position by an actuation element, as described above with respect to FIGS. 95-98 and 99-104. In some implementations, the device 800 can be delivered and deployed with a first paddle member 832 of each paddle arm 730 disposed substantially distally from the device 800. In some implementations, the paddle arm 730 can then be rotated proximally to an open position, rotated to an over-center position, and rotated past the over-center position to a closed position by an actuation element, as described above. The paddles 808 can be actuated independently or simultaneously.

[0296] As shown in FIG. 105, the device 800 can be configured such that the paddles 808 can be independently actuated and moved between the open, center, and closed positions. Two actuating elements 812, each having a proximal actuating portion 814 pivotally connected to a distal actuating portion 816 at an actuation pivot 815, extend through the interface element 820. In some implementations, the distal actuating portion 816 of each actuating element 812 pivotally connects to one of a first paddle member 832 and a second paddle member 834 opposite a paddle fastener 836. Each actuating element 812 can be independently actuated as described with respect to the actuating element 712 of FIGS. 95-98 to move each paddle 808 between the open and closed positions. For example, a user can extend or retract the proximal actuating portion 814 of any actuating element 812 through the device 800 to move each paddle 808 between an open position, a center position, and a closed position, independent of the other paddles 808.

[0297] As shown in FIG. 106, the device 800 can be configured to allow the paddles 808 to be actuated and moved simultaneously between an open position, an over-center position, and a closed position. In some implementations, an actuating element 812 having a proximal actuating portion 814 and two distal actuating portions 816 pivotally connected to the proximal actuating portion 814 at an actuating pivot 815 extends through a joint element 820. In some implementations, each distal actuating portion 816 is pivotally connected to one of a first paddle member 832 and a second paddle member 834 opposite a paddle fastener 836. In some implementations, the actuating element 812 can be actuated as described with respect to the actuating element 712 of FIGS. 95-98 to move both paddles 808 simultaneously between an open position and a closed position. For example, a user can extend or retract the proximal actuating portion 814 of the actuating element 812 through the device 800 to move both paddles 808 simultaneously between an open position, an over-center position, and a closed position.

[0298] In some implementations, as shown, the proximal actuating portion 814 is T-shaped such that each distal actuating portion 816 pivotally connects to the proximal actuating portion 814 via a separate actuating pivot 815. However, the actuating element 812 may have other configurations. For example, both distal actuating portions 816 may be pivotally connected to the proximal actuating portion 814 at a single actuating pivot 815.

[0299] 107-110, paddle portion 806 and / or paddle 808 may include an attachment portion or gripping member (e.g., gripping arm, clasp arm, etc.) 850 that can move between an open position and a closed position. Device 800 may include a number of gripping members 850 corresponding to the number of paddles 808.

[0300] In some implementations, as shown, the gripping member 850 may include a movable arm 852 and optional frictional enhancing elements or other fixation structures 854 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.). In some implementations, the movable arm 852 may be biased to a normally closed position with the movable arm 852 oriented distally toward the first paddle member 832. In some implementations, the movable arm 852 may be optionally spring loaded such that in the closed position, the gripping member 850 continues to provide a clamping force to the gripped native leaflet. The optional barbs, frictional enhancing elements, or fixation structures 854 of the gripping member 850 may grip, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0301] In some implementations, the gripping member 850 can be released by applying tension to an actuation line 818 attached to the movable arm 852, thereby causing the movable arm 852 to articulate, bend, or pivot away from the first paddle member 832. In some implementations, the actuation line 818 can extend through the delivery system (e.g., through a steerable catheter and / or an implant catheter) and can be connected to the movable arm 852 with a loop 819 disposed through or otherwise connected to an outer portion of the movable arm 852. In some implementations, the actuation line 818 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like.

[0302] In some implementations, the paddles 808 may be opened and closed during implantation, for example to grip a native leaflet (such as a leaflet of a native mitral valve) between the paddles 808 and / or between the paddles 808 and the coaptation element 820. The gripping members 850 may grip and / or further secure the native leaflet by engaging the leaflet with optional barbs, friction enhancing elements, or fixation structures 854 and clamping the leaflet with the movable arms 852. In some implementations, the optional barbs, friction enhancing elements, or other structures 854 of the gripping members 850 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) may increase friction with the leaflet or partially or fully pierce the leaflet.

[0303] In some implementations, the actuation lines 818 may be separately actuated such that each gripping member 850 may be opened and closed separately. Acting separately allows one leaflet to be gripped at a time, or allows the gripping member 850 to be repositioned on a leaflet that was not adequately gripped without changing the good grip on the other leaflets. In some implementations, the gripping member 850 may be opened and closed relative to the position of the first paddle member 832 (as long as the first paddle member 832 is in an open or at least partially open position), thereby allowing the leaflets to be gripped in various positions as the particular situation requires.

[0304] As shown in FIGS. 107-108 , the gripping member 850 can include a collar 856 that can connect or secure the movable arm 852 to the interface element 820. The collar 856 can be sized and shaped to be secured, positioned, or otherwise disposed on the interface element 820. For example, the collar 856 can be rounded or oval and sized and shaped to at least partially snap into a clasp securement recess of the interface element 820 or to be at least partially secured to the clasp securement recess by an interference fit. In some implementations, the collar 856 can provide a spring or biasing force to the movable arm 852 that biases the movable arm 852 toward the closed position with the movable arm 852 biased distally toward the first paddle member 832. In some implementations, the collar 856 can include any suitable joint with the movable arm 852, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the joint between the collar 856 and the movable arm 852 is a flexible piece of material integrally formed with the collar 856 and the movable arm 852 .

[0305] As shown in FIG. 107, when the paddle arm 830 of the device 800 is in the open position and no tension is applied to the actuation line 818, the movable arm 852 is biased toward the first paddle member 832 by the collar 856 and / or the hinge connection between the collar 856 and the movable arm 852. As shown in FIG. 108, tension can be applied to the actuation line 818 connected to the movable arm 852, causing the movable arm 852 to articulate, bend, or pivot at the joint between the movable arm 852 and the collar 856. In some implementations, tension applied to the actuation line 818 moves the gripping member 850 to the open position. For example, the gripping member 850 can be moved to the open position to properly position natural tissue between the movable arm 852 and the first paddle member 832. Releasing tension in the actuation line 818 can move the movable arm 852 back to the closed position. For example, tension in actuation line 818 can be released when the natural tissue is properly positioned between the gripping members 850 and the first paddle member 832 such that the movable arms 852 close and securely hold the natural tissue between the movable arms 852 and the first paddle member 832. While the illustrated gripping members 850 move simultaneously between the open and closed positions, it will be understood that the movable arms 852 of each gripping member 850 can be moved independently between the open and closed positions.

[0306] 109-110 , in some implementations, the gripping members 850 of the device can each include a base or fixed arm 858 and a joint portion 860. In some implementations, the fixed arm 858 is attached to the first paddle member 832 with the joint portion 860 disposed proximate to the mating element 820. In some implementations, the joint portion 860 can provide a spring force between the fixed arm 858 and the movable arm 852 of the gripping member 850. In some implementations, the spring force provided by the joint portion 860 can bias the movable arm 852 distally toward the first paddle member 832 and into a closed position with the movable arm 852 in the closed position.

[0307] In some implementations, the joint portion 860 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, etc. In some implementations, the joint portion 860 is a flexible piece of material integrally formed with the fixed arm 858 and the movable arm 852. In some implementations, the fixed arm 858 is attached to the first paddle member 832 and remains stationary or substantially stationary with respect to the first paddle member 832 when the movable arm 852 opens to open the gripping member 850 and expose optional barbs, friction enhancing elements, or anchoring structures.

[0308] 109, when the paddle arm 830 of the device 800 is in the open position and no tension is applied to the actuation line 818, the movable arm 852 is biased towards the fixed arm 858 by the joint portion 860. As shown in FIG. 110, tension can be applied to the actuation line 818 connected to the movable arm 852, causing the movable arm 852 to articulate, bend, or pivot on the joint portion 860.

[0309] In some implementations, tension applied to the actuation line 818 can move the gripping members 850 to an open position. For example, the gripping members 850 can be moved to an open position to properly position the natural tissue between the movable arm 852 and the fixed arm 858 and / or the first paddle member 832. Releasing tension in the actuation line 818 returns the movable arm 852 to a closed position. For example, tension in the actuation line 818 can be released when the natural tissue is properly positioned between the movable arm 852 and the fixed arm 858 and / or the first paddle member 832, such that the movable arm 852 closes and securely holds the natural tissue between the movable arm 852 and the fixed arm 858 and / or the first paddle member 832. It will be appreciated that while the illustrated gripping members 850 move simultaneously between the open and closed positions, the movable arm 852 of each gripping member 850 can be moved independently between the open and closed positions.

[0310] 111 and 112, an example of a device (e.g., an implantable prosthetic device, a prosthetic spacer device, a valve repair device, etc.) 900 is illustrated generally. Device 900 may include any other features of an implantable prosthetic device described in this application or any application incorporated herein by reference, and device 900 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or any application incorporated herein by reference).

[0311] In some implementations, the device 900 extends from a proximal portion 901 to a distal portion 902 and may include an optional interface portion 904 and an anchor portion. In some implementations, the anchor portion may include one or more paddle portions 906. In some implementations, the anchor portion may optionally include an attachment portion or a gripping member similar to those described elsewhere herein. In some implementations, the interface portion 904 may include an interface element (e.g., a spacer, interface element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) for implantation between the leaflets 20, 22 of the native valve. The interface element 920 may include any feature for a spacer or interface element discussed in this application or any application incorporated herein by reference.

[0312] In some implementations, as shown, the cross section of any interface element 920 is substantially cylindrical. However, the interface element 920 may have any suitable size, shape, or configuration. For example, the interface element 920 may be any of the spacer or interface elements described herein, and / or the interface element 920 may be narrower, such as a small shaft size.

[0313] In some implementations, the paddle portion 906 of the device includes one or more paddles 908 having a paddle arm 930 and a paddle arm connector 950 configured to provide a bias that allows the paddle arm 930 to rotate freely when the paddle arm 930 is disposed in a first, unbiased, or rotatable position or configuration within the paddle arm connector 950 and can prevent the paddle arm 930 from rotating when the paddle arm 930 is disposed in a second, biased, or locked position or configuration within the paddle arm connector 950. In some implementations, as shown, the device 900 includes two paddles 908 disposed substantially on opposite sides of the device 900. However, the device 900 can include any number of paddles 908. For example, the device can include one paddle 908, three paddles 908 for use with a tricuspid valve, or four or more paddles 908.

[0314] In some implementations, the paddle arm 930 can be substantially U-shaped having an end portion 932, a first leg portion 934 extending from one side of the end portion 932, and a second leg portion 938 extending from an opposite side of the end portion 932. In some implementations, the first leg portion 934 can include a first coupling portion 936 at an end of the first leg portion 934 opposite the end portion 932, and the second leg portion 938 can include a second coupling portion 940 at an end of the second leg portion 938 opposite the end portion 932. In some implementations, the first and second coupling portions 936, 940 can be configured to be pivotally connected, arranged, or otherwise attached to the paddle arm connector 950 such that the end portion 932 can rotate about the first and second coupling portions 936, 940.

[0315] In some implementations, the paddle arm 930 comprises a wire, tube, shaft, or the like that is bent into a substantially U-shape to form an end portion 932, first and second leg portions 934, 938, and first and second connecting portions 936, 940. However, the paddle arm 930 may have other suitable sizes, shapes, and configurations. For example, the paddle arm 930, such as the end portion 932 and the first and second leg portions 934, 938, may be elliptical, oval, or hourglass shaped, may include a radial flare extending inwardly or outwardly, may be curved at a proximal end near the end portion 932, or may be formed from a mechanical linkage. Additionally, the paddle arm 930 may comprise a shape memory alloy, such as steel, or a wire, sheet, tube, or Nitinol fabricated from laser sintered powder, and may be configured to provide a biasing force against rotation of the paddle arm 930 about the paddle arm connector 950 when the paddle arm 930 is in a biased or locked position.

[0316] In some implementations, the paddle arm connector 950 may be coupled to or otherwise disposed on the interface 904, such as on the interface element 920. In some implementations, the first and second linking portions 936, 940 may be pivotally connected to or disposed within the paddle arm connector 950 such that when the first and / or second linking portions 936, 940 of the paddle arm 930 are in an unbiased position, the paddle arm 930 can freely rotate about the paddle arm connector 950 and / or the first and second linking portions 936, 940 toward the interface element 920. In some implementations, the position of the first and / or second linking portions 936, 940 in a biased position within the paddle arm connector 950 creates a biasing force, such as a leaf spring biasing force of the paddle arm itself, acting against rotation of the paddle arm 930.

[0317] In some implementations, the paddle arm connector 950 may include a first receiving portion 954 for receiving or holding the first coupling portion 936 when the paddle arm 930 is in an unbiased position, and a second receiving portion 956 for receiving or holding the first coupling portion 936 when the paddle arm 930 is in a biased position. In some implementations, the second coupling portion 940 may be pivotally received in a fixed holding portion of the paddle arm connector 950 that is substantially aligned with the first receiving portion 954 and offset from the second receiving portion 956 (FIGS. 113-116). With reference to FIG. 113, the paddle arm 930 may be free to rotate when the paddle arm 930 is in an unbiased position because the first coupling portion 936 is in the first receiving portion 954 and substantially aligned with the second coupling portion 940.

[0318] 114-116, the first connecting portion 936 can be moved from the first receiving portion 954 to the second receiving portion 956 such that the paddle arm 930 moves to a biased position. In some implementations, when the first connecting portion 936 is disposed within the second receiving portion 956, the first and second connecting portions 936, 940 are offset and the difference in the rotational axes of the first and second leg portions 934, 938 (e.g., the first and second connecting portions 936, 940) provides a biasing force that prevents the paddle arm 930 from rotating. That is, the misalignment between the first connecting portion 936 and the second connecting portion 940 prevents the paddle arm 930 from pivoting without bending or flexing. In some implementations, the force required to flex or flex the paddle arm 930 biases the paddle arm back to the closed position unless the paddle arm is plastically deformed by the bending or flexing.

[0319] 111, the device 900 may be deployed or otherwise moved to a substantially open position with the paddle arms 930 oriented away from the interface elements 920. In some implementations, the paddle arms 930 may be disposed in an unbiased or rotatable position, where the first coupling portion 936 of the first leg portion 934 is rotatably disposed within the first receiving portion 954 of the paddle arm connector 950. In the first position, the paddle arms 930 are free to rotate.

[0320] 112, the paddle arms 930 can be rotated or actuated from an open position proximally toward the coaptation element 920, such as around the native leaflets 20, 22, to a closed position when the device 900 is deployed, as described below. In some implementations, the paddle arms 930 can be rotated via an actuation element (e.g., an actuation shaft, an actuation wire, etc.), an actuation line (e.g., a line, a suture, a wire, a rod, a catheter, etc.), or any other manner described in this application or any other application incorporated herein by reference. In some implementations, the first connecting portion 936 can then be moved from the first receiving portion 954 to the second receiving portion 956, thereby moving the paddle arms 930 to a biased or locked position. For example, once the native leaflets 20, 22 are properly positioned between the paddles 908 and the coaptation element 920, the first connecting portion 936 can be moved from the first receiving portion 954 to the second receiving portion 956.

[0321] While the illustrated paddles 908 move simultaneously between open and closed positions, it will be understood that the paddle arms 930 of each paddle 908 can move independently between the open and closed positions. Additionally, each paddle 908 can move independently between an unbiased or rotatable position and a biased or locked position. Additionally, in some implementations, the interface element 920 can include one or more slots or passages extending through a body of the interface element 920 such that one or more actuation elements can extend through a central portion of the device 900 and attach or otherwise couple to a paddle 908, such as an end portion 932 of the paddle arm 930.

[0322] As shown in FIGS. 113-116 , each paddle 908 can be configured to allow the paddle arm 930 to move between an unbiased position and a biased position of the paddle arm connector 950. In some implementations, the paddle arm connector 950 can include a paddle channel 958 connecting the first and second receiving portions 954, 956. In some implementations, the paddle channel 958 is configured to allow the first connecting portion 936 of the first leg portion 934 to move between the first receiving portion 954 and the second receiving portion 956 to move the paddle arm 930 between the unbiased configuration and the biased configuration. In some implementations, the paddle channel 958 can be configured to allow the first connecting portion 936 to be retained within the first or second receiving portion 954, 956 until acted upon by an external force, such as by a user with an actuation element. While the illustrated paddle channel 958 is substantially L-shaped, it will be understood that the paddle channel 958 can have other shapes. For example, the paddle channel 958 may have an arcuate shape, a serpentine shape, a zigzag shape, etc. Any shape that allows the first connecting portion 936 to move between a first (unbiased or unlocked) stable position and a second (biased or locked) stable position (i.e., the position remains the same unless an external force is applied), where the first connecting portion 936 is aligned with the second connecting portion in the first (unbiased or unlocked) stable position and the first connecting portion 936 is offset from the second connecting portion in the second (biased or locked) stable position.

[0323] In some implementations, the first and second coupling portions 936, 940 are angled or otherwise outwardly from the first and second leg portions 934, 938, respectively, such that the first coupling portion 936 can be received within a first paddle connector 952 of the paddle arm connector 950 and the second coupling portion 940 can be received within a second paddle connector 966 of the paddle arm connector 950 opposite the first paddle connector 952. In some implementations, the first coupling portion 936 can be angled away from the first and second leg portions 934, 938 and received within a paddle channel 958 of the first paddle connector 952, such as the first receiving portion 954 or the second receiving portion 956. In some implementations, the second coupling portion 940 can be angled away from the first and second leg portions 934, 938 and received inwardly or within a fixed retaining portion 968 extending through the second paddle connector 966. In some implementations, the fixed retaining portion 968 can be substantially aligned with the first receiving portion 954 of the first paddle connector 952 and can be configured to retain the second coupling portion 940 and allow the second coupling portion 940 to rotate about a fixed axis extending through the fixed retaining portion 968. For example, the fixed retaining portion 968 can be a hole, opening, or passageway extending into or through the second paddle connector 966.

[0324] In some implementations, the fixed retaining portion 968 may be positioned or configured to allow the paddle arm 930 to rotate relatively freely when the first connecting portion 936 is disposed within the first receiving portion 954 (unbiased position) and to provide a biasing force to prevent the paddle arm 930 from rotating when the first connecting portion 936 is disposed within the second receiving portion 956 (biased position). For example, the fixed retaining portion 968 may be substantially aligned with the first receiving portion 954 and radially and laterally offset from the second receiving portion 956.

[0325] In some implementations, the fixed retaining portion 968 may be disposed within the second paddle connector 966 at a first height H1 from a bottom of the paddle arm connector 950 (e.g., the portion connected to the interface element 920), and the first receiving portion 954 may be disposed within the first paddle connector 952 at a first height H1 from a bottom of the paddle arm connector 950. In some implementations, the second receiving portion 956 may be disposed within the first paddle connector 952 at a second height H2 above the bottom of the paddle arm connector 950. In some implementations, the difference between the first height H1 and the second height H2 may be such that the difference in the axis of rotation of the first leg portion 934 when the paddle arm 930 is in a biased configuration (e.g., the first connecting portion 936 of the second receiving portion 956) may be sufficiently offset from the axis of rotation of the second leg portion 938 (e.g., the second connecting portion 940 within the fixed retaining portion 968) that rotation of the paddle arm 930 is inhibited or limited.

[0326] In some implementations, the second receiving portion 956 may also be laterally offset from the fixed holding portion 968. For example, the axes of rotation of the first and second leg portions 934, 938 when the paddle arm 930 is in an unbiased position (e.g., the second connecting portion 940 of the fixed holding portion 968 and the first connecting portion 936 of the first receiving portion 954) may be substantially aligned such that the paddle arm 930 is free to rotate about a shared axis, and the axes of rotation of the first and second leg portions 934, 938 when the paddle arm 930 is in a biased position (e.g., the second connecting portion 940 of the fixed holding portion 968 and the first connecting portion 936 of the second receiving portion 956) may be offset such that the paddle arm 930 and / or the paddle arm connector 950 exert a biasing force that prevents or otherwise limits rotation of the paddle arm 930.

[0327] Although the illustrated first and second connecting portions 936, 940 are substantially perpendicular to the first and second leg portions 934, 938, the first and second connecting portions 936, 940 may have other sizes, shapes, and configurations to further secure the first and second connecting portions 936, 940 within the paddle arm connector 950. For example, the first and second connecting portions 936, 940 may include a protrusion, flange, or curvature disposed at an end of the first and second connecting portions 936, 940 opposite the first and second leg portions 934, 938 (opposite the leg portions 934, 938) of the paddle channel 958 and fixed retaining portion 968 such that the first and second connecting portions 936, 940 do not have to be retracted through or from the paddle channel 958 or fixed retaining portion 968, respectively.

[0328] In some implementations, the paddle channel 958 is configured such that the first coupling portion 936 can be retained within the first receiving portion 954 at a first height H1, moved to the second receiving portion 956, such as via an actuation element, and retained within the second receiving portion 956 at a second height H2. In some implementations, the paddle channel 958 can include a first channel portion 960 extending upwardly (e.g., toward the interface element 920) from the first receiving portion 954, a second channel portion 962 extending laterally from an end of the first channel portion 960 opposite the first receiving portion 954, and a third channel portion 964 extending downwardly (e.g., away from the interface element 920) from an end of the second channel portion 962 opposite the first channel portion 960 that extends to the second receiving portion 956.

[0329] In some implementations, the first channel portion 960 can extend substantially vertically or proximally from the first receiving portion 954 at a first height H1 to a height greater than the second height H2. In some implementations, the second channel portion 962 can extend substantially laterally from a top of the first channel portion 960. In some implementations, the third channel portion 964 can extend downwardly or distally from the second channel portion 962 to a second height H2. In some implementations, the third channel portion 964 can have a length between the second channel portion 962 and the second receiving portion 956 such that the first link portion 936 can be held within the second receiving portion 956 until an upward or proximal force is applied to the first leg portion 934, such as via an actuation element.

[0330] In some implementations, the device 900 may be disposed in a first or unbiased position with the paddle arm 930 of each paddle 908, with the first connecting portion 936 of the first leg portion 934 disposed within the first receiving portion 954 of the paddle arm connector 950 (FIG. 113). In some implementations, the first connecting portion 936 of the first leg portion 934 of the paddle arm 930 may be disposed within the first receiving portion 954 of the paddle arm connector 950 at a first height H1 and substantially aligned with the second connecting portion 940 of the second leg portion disposed within the fixed retaining portion 968 at the first height H1. In some implementations, the first and second leg portions 934, 938 of the paddle arm 930 may be substantially free to pivot or rotate about a common axis of rotation extending through the first and second connecting portions 936, 940. For example, the device 900 can deploy the paddles 908 in an open position extending outward from the coaptation elements 920 such that the paddle arms 930 can be actuated to grasp the native leaflets 20,22.

[0331] In some implementations, the paddle 908 can then be moved from an unbiased or rotatable position to a biased or locked position, such as by applying one or more forces to the paddle arm 930. For example, the forces can be applied via an actuation element. A force, such as an upward or proximal force applied to the end portion 932, the first leg portion 934, and / or the second leg portion 938, can be applied to the paddle arm 930 to move the first coupling portion 936 upward along the length of the first channel portion 960 from the first receiving portion 954 to the height of the second channel portion 962 above the second height H2 (FIG. 114). A force, such as a lateral force, can then be applied to the paddle arm 930 to move the first coupling portion 936 laterally along the length of the second channel portion 962 such that the first coupling portion 936 aligns with the third channel portion 964 (FIG. 115). A force, such as a downward force (e.g., toward the interface element 920), can then be applied to the paddle arm 930 to move the first connecting portion 936 downward along the length of the third channel portion 964 from the height of the second channel portion 962 to the second receiving portion 956 ( FIG. 116 ).

[0332] In some implementations, the paddle 908 can be in a biased or locked position when the first connecting portion 936 is disposed within the second receiving portion 956 ( FIG. 116 ). In some implementations, the first connecting portion 936 of the first leg portion 934 of the paddle arm 930 can be disposed at a second height H2 of the second receiving portion 956, and the second connecting portion 940 of the second leg portion 938 can be disposed at a first height H1 of the fixed retaining portion 968. In some implementations, the first connecting portion 936 disposed within the second receiving portion 956 can also be laterally offset from the second connecting portion 940 disposed within the fixed retaining portion 968. As such, the pivot or rotation axis of the first leg portion 934 (first connecting portion 936) is offset from the pivot or rotation axis of the second leg portion 938 (second connecting portion 940), and the configuration of the paddle arm 930 and / or paddle arm connector 950 provides a biasing force, such as a leaf spring biasing force, that prevents or otherwise limits rotation of the paddle arm 930.

[0333] In some implementations, the paddle 908 can also be moved from a biased or locked position to an unbiased or rotatable position. For example, when the first connecting portion 936 is disposed within the second receiving portion 956 (FIG. 116), an outward force can be applied to the paddle arm 930 to move the first connecting portion 936 upward to the top of the third channel portion 964 (FIG. 115), a lateral force can be applied to the paddle arm 930 to move the first connecting portion 936 along the second channel portion 962 to the top of the first channel portion 960 (FIG. 114), and an inward force can be applied to the paddle arm 930 to move the first connecting portion 936 downward along the first channel portion 960 to the first receiving portion 954.

[0334] Although the movements and forces are described in relative terms, such as upward, downward, lateral, outward, and inward, it will be understood that the direction of the movements and forces may differ based on the position and orientation of the paddle 908. For example, a movement or force described as being upward or downward may also be lateral, and a movement or force described as being lateral may be upward or downward when the paddle 908 is positioned on the device 900, such as on the joint element 920.

[0335] 117A-117C illustrate the amount of force applied to the paddle arm 930 when the first connecting portion 936 of the paddle arm 930 is disposed in the first receiving portion 954 (unbiased position) to rotate the paddle arm 930 about the paddle arm connector 950 by an angle Φ. As shown, the first connecting portion 936 disposed in the first receiving portion 954 is substantially aligned with the second connecting portion 940 disposed in the fixed retaining portion 968. When a force F is applied laterally to the end portion 932 of the paddle arm 930, the paddle arm 930 can rotate the angle Φ about the axis of rotation of the first and second connecting portions 936, 940. When the first and second connecting portions 936, 940 are substantially aligned, the force F required to rotate the paddle arm 930 becomes zero or negligible as the angle Φ increases. For example, the force F required to rotate the paddle arm 930 may be increased slightly or negligibly due to frictional forces between the first coupling portion 936 and the first receiving portion 954, and between the second coupling portion 940 and the fixed retaining portion 968. As such, the paddle arm 930 may be substantially free to rotate about the paddle arm connector 950.

[0336] 118A-118C illustrate forces applied to the paddle arm 930 when the first connecting portion 936 of the paddle arm 930 is disposed within the second receiving portion 956 (biased position) and the paddle arm 930 rotates about the paddle arm connector 950 by an angle Φ. As shown, the first connecting portion 936 disposed within the second receiving portion 956 is offset from the second connecting portion 940 disposed within the fixed retaining portion 968. When a force F is applied laterally to the end portion 932 of the paddle arm 930, the paddle arm 930 can rotate an angle Φ about the axis of rotation of the first and second connecting portions 936, 940. When the first and second connecting portions 936, 940 are offset, the axis of rotation of the first leg portion 934 (e.g., first connecting portion 936) is offset from the axis of rotation of the second leg portion 938 (e.g., second connecting portion 940). As such, the configuration of the paddle arm connector 950 and / or the paddle arm 930 provides a bias against rotation of the paddle arm 930. In some implementations, the force required to rotate the paddle arm 930 increases as the paddle arm 930 rotates further, such as by resisting deformation of the paddle arm 930. Thus, the force F required to rotate the paddle arm 930 further may increase as the rotation angle Φ increases. For example, the force F required to rotate the paddle arm 930 may increase proportionally as the rotation angle Φ increases. As such, the paddle arm 930 may be prevented, restricted, or locked from rotating about the paddle arm connector 950.

[0337] 119-124, the device 900 may be deployed or implanted within the native heart, such as implanted between the leaflets 20, 22 of the native valve. The device 900 may be connected to a delivery system 910. In some implementations, the delivery system 910 may include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, a tube, a channel, a pathway, combinations thereof, and the like. In some implementations, the delivery system 910 may be configured to position the device 900, close the device to capture one or more leaflets of the native valve, close and lock the device, and release the device 900 from the delivery system.

[0338] In some implementations, the delivery system 910 can include one or more actuating elements 912 (e.g., actuating lines, actuating wires, actuating shafts, etc.) that extend through the delivery system (e.g., guide catheter / sheath, etc.) and connect to one or more of the paddles 908, such as paddle arms 930. In some implementations, the actuating elements can extend through the interface elements 920 and connect to the paddles 908, such as through slots or passages in the body of the interface elements 920. In some implementations, the actuating elements 912 can connect to the paddles 908 with connecting portions 914, such as loops, hooks, or other connecting components that can be removably connected to the paddles 908 and / or the actuating elements 912.

[0339] As shown in FIG. 119 , the device 900 can be deployed from the delivery system 910 with the paddles 908 in an open and unbiased position. For example, the paddle arms 930 can extend distally away from the interface element 920 and the paddle arm connector 950, and a first coupling portion 936 of each paddle arm 930 can be disposed within a first receiving portion 954 of the paddle arm connector 950. As such, the paddle arms 930 can be freely rotated, such as by actuation of one of the actuation elements 912. Although the illustrated paddle arms 930 are oriented substantially distally from the interface element 920 when the device 900 is in the open position, the paddle arms 930 can have other orientations in the open position. For example, the paddle arms 930 can be rotated more than 180° from the interface element 920, or the paddle arms 930 can be rotated less than 180° from the interface element 920 in the open position.

[0340] 120, one of the paddles 908 can be moved from an open position to a closed position. For example, the paddle 908 can be moved to a closed position to capture one of the leaflets 20, 22 between the paddle arm 930 and the coaptation element 920. The actuation element 912 can be actuated, such as by a user, to rotate the paddle arm 930 about the paddle arm connector 950. For example, the actuation element 912 can be retracted proximally through the device 900 and delivery system 910 to rotate the paddle arm 930 about the paddle arm connector 950 toward the coaptation element 920.

[0341] As shown in FIG. 121 , the paddle 908 in the closed position can be moved from an unbiased position to a biased position to bias or lock the paddle arm 930 in place. For example, the paddle 908 can be moved to the biased position once the leaflets 20, 22 are properly positioned between the paddle arm 930 and the coaptation element 920. The actuation element 912 can be actuated, such as by a user, to move the first connecting portion 936 of the paddle arm 930 from the first receiving portion 954 of the paddle arm connector 950 to the second receiving portion 956 of the paddle arm connector 950. For example, the actuation element 912 can apply a force as described in FIGS. 113-116 to move the first connecting portion 936 from the first receiving portion 954 of the paddle arm connector 950 to the second receiving portion 956 of the paddle arm connector 950. In some implementations, the second coupling portion 940 of the second leg portion 938 of the paddle arm 930 can remain within the fixed retaining portion 968 (see FIG. 118 ). In this manner, the offset alignment between the first coupling portion 936 and the second coupling portion 940 can apply a biasing force to the paddle arm 930 that substantially prevents or limits rotation of the paddle arm 930, thereby locking the paddle 908 in place.

[0342] 122, the second paddle 908 can be moved from an open position to a closed position to capture the second leaflet 20, 22 between the paddle arm 930 of the second paddle 908 and the coaptation element 920. For example, the paddle arm 930 of the second paddle 908 can be rotated from an open position to a closed position about the paddle arm connector 950, as described above in FIG.

[0343] 123, the second paddle 908 can be moved from an unbiased position to a biased position to bias the second paddle 908 after the second leaflet 20, 22 is properly positioned between the second paddle 908 and the coaptation element 920. For example, the first connecting portion 936 of the paddle arm 930 of the second paddle 908 can be moved from the first receiving portion 954 to the second receiving portion 956 of the paddle arm connector 950, as described above in FIG.

[0344] As shown in FIG. 123, the device 900 can be in a fully closed and deployed state. The delivery system 910 and actuation element 912 are retracted and the paddle 908 remains in a fully closed and biased (locked) position. For example, the connecting portion 914 of the actuation element 912 can be separated from the paddle 908 and / or the actuation element 912 such that the actuation element 912 can be retracted from the device 900. Once deployed, the device 900 can be maintained in a fully closed position with the biasing force exerted by the offset rotational axis of the first and second leg portions 934, 938 of the paddle arm 930 disposed within the paddle arm connector 950 preventing the paddle 908 from reopening. Similarly, the configuration of the paddle arm 930 in the biased position can exert a bias to pinch the leaflets 20, 22.

[0345] Although the device 900 is illustrated as actuating two paddles 908 separately to capture the leaflets 20, 22, it will be understood that the paddles 908 may be actuated and locked simultaneously. For example, the paddle arms 930 of each paddle 908 may be coupled to a single actuating element, such as an actuating element similar to actuating element 812 of FIG. 106, such that the paddles 908 can move cooperatively from an open position to a closed position to capture the leaflets 20, 22, and from an unbiased position to a biased position to lock the paddles 908 in place.

[0346] Additionally, the concepts of device 900 can be combined with any of the individual components of the disclosed devices and systems described in this application or any of the applications incorporated herein by reference. For example, device 900 can include any of the attachment portions, clasps, or gripping members (e.g., gripping arms, clasp arms, etc.) that can move between open and closed positions, as described above, and that can include friction enhancing elements or other fastening structures (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.).

[0347] The above methods may be performed on live animals or in simulations, such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., simulated body parts, hearts, tissues), etc.

[0348] Any of the various systems, devices, apparatus, etc. disclosed herein can be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on patients, and the methods herein can include sterilization (e.g., sterilization by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of the associated systems, devices, apparatus, etc.

[0349] Although various inventive aspects, concepts, and features of the present disclosure may be described and illustrated herein as embodied in combination in the examples herein, these various aspects, concepts, and features may be used in many alternatives, either individually or in various combinations and subcombinations thereof. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of the present application. Still further, various alternatives for the various aspects, concepts, and features of the present disclosure, such as alternative materials, structures, configurations, methods, devices, and components, form, compatibility, and function, may be described herein, but such descriptions are not intended to be a complete or exhaustive list of available alternatives, whether currently known or later developed. Those skilled in the art may readily incorporate one or more of the aspects, concepts, or features of the present invention into additional embodiments and uses, even if such embodiments are not expressly disclosed herein.

[0350] Additionally, although some features, concepts, or aspects of the disclosure may be described herein as being preferred configurations or methods, such description is not intended to imply that such features are essential or indispensable unless expressly stated.Furthermore, while exemplary or representative values, and even exemplary or representative ranges, may be included to aid in understanding the present application, such values ​​and ranges should not be construed in a limiting sense, and are intended to be critical values ​​or ranges only if expressly stated as such.

[0351] Furthermore, although various aspects, features, and concepts may be expressly identified herein as being inventive or forming part of the disclosure, such identification is not intended to be exclusive; rather, there may be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a particular disclosure, the disclosure being instead set forth in the appended claims. Descriptions of exemplary methods or processes are not limited to including all steps as essential in all cases, nor should the order in which steps are presented be construed as essential or essential unless expressly stated. Furthermore, the techniques, methods, operations, steps, etc. of procedures as described or suggested herein may be performed on live animals, or may be performed on non-living simulations, such as cadavers, cadaver hearts, simulators (e.g., where body parts, hearts, tissues, etc. are simulated), etc. The terms used in the claims are to be given their full ordinary meaning and are not to be limited in any way by the description of the examples herein.

Claims

1. 1. A valve repair device for repairing a native valve in a patient, comprising: a first retaining hinge; a second retention hinge disposed proximally of the first retention hinge; A paddle, a paddle arm having a first paddle member with a stop and a paddle fastener rotatably retained within the first retaining hinge; a paddle comprising a driven arm having a driven fastener rotatably retained within the second retaining hinge and a paddle connector slidable along a portion of the first paddle member; the paddle is rotatable from an open position to a first position in which the paddle connector abuts the stop, a central position in which the paddle arm and the driven arm are substantially aligned, and a closed position; At least one of the first retention hinge, the second retention hinge, and the follower arm biases the paddle arm to the closed position when the paddle rotates past the center position.

2. The valve repair device of claim 1 , wherein at least one of the first retention hinge and the second retention hinge biases the paddle arm toward the closed position when the paddle rotates past the center position.

3. The valve repair device of claim 1 , wherein one of the first retention hinge and the second retention hinge biases the paddle arm toward the closed position when the paddle rotates past the center position.

4. The valve repair device of claim 1 , wherein the second retaining hinge biases the paddle arm to the closed position when the paddle rotates past the center position.

5. The valve repair device of claim 1 , wherein the paddle arm further comprises a second paddle member disposed opposite the first paddle member.

6. 3. The valve repair device of claim 1 or 2, wherein the first paddle member is a wire loop and the stop comprises a rod disposed between legs of the first paddle member.

7. The valve repair device of any one of claims 1 to 5, wherein at least one of the paddle arm and the driven arm comprises nitinol.

8. The valve repair device of any one of claims 1 to 5, wherein the paddle further comprises a gripping member having a movable arm movable between a closed position and an open position.

9. 9. The valve repair device of claim 8, wherein the gripping member further comprises a collar disposed around the coaptation element and a joint portion between the collar and the movable arm, the joint portion biasing the movable arm to the closed position.

10. 9. The valve repair device of claim 8, wherein the gripping member further comprises a fixed arm attached to the first paddle member and a joint portion between the fixed arm and the movable arm, the joint portion biasing the movable arm to the closed position.

11. The valve repair device of claim 5 , wherein the second paddle member is disposed at an obtuse angle from the first paddle member.

12. The valve repair device of any one of claims 1 to 5, wherein the follower arm applies a leaf spring biasing force to the paddle when the paddle rotates proximally past a first point.

13. The valve repair device of any one of claims 1 to 5, further comprising coaptation elements attached to the first and second retention hinges.

14. 1. A valve repair device for repairing a native valve in a patient, comprising: With the base, A paddle, a paddle arm having a first leg portion with a first connecting portion and a second leg portion with a second connecting portion; a paddle comprising a paddle arm connector having a fixed holding portion for receiving the second connecting portion and first and second receiving portions for receiving the first connecting portion; A valve repair device, wherein the paddle arm is rotatable about the paddle arm connector when the first connecting portion is disposed within the first receiving portion and is biased against rotation when the first connecting portion is disposed within the second receiving portion.

15. The valve repair device of claim 14 , wherein the paddle arm connector includes a channel connecting the first and second receiving portions.

16. 16. The valve repair device of claim 15, wherein the first receiving portion and the fixed retaining portion are positioned at a first height, and the second receiving portion is positioned at a second height, the second height being greater than the first height.

17. The valve repair device of claim 15 , wherein the channel is L-shaped.

18. 16. The valve repair device of claim 15, wherein the channel further includes a first channel portion extending upward from the first receiving portion, a second channel portion extending laterally from the first channel portion, and a third channel portion extending downward from an end of the second channel portion opposite the first channel portion to the second receiving portion.

19. 20. The valve repair device of claim 18, wherein the first channel portion extends to a third height greater than the second height.

20. 20. The valve repair device of any one of claims 14 to 19, wherein the force required to rotate the paddle arm when the first receiving portion is positioned within the second receiving portion is proportional to the amount the paddle arm rotates about the paddle arm connector.

21. The valve repair device of any one of claims 14 to 19, wherein the base comprises a coaptation element.

Images