Heart valve repair device and delivery device therefor - Patent application

Abstract

The implantable device or implant is configured to be positioned inside the native heart valve so that the native heart valve may form a more effective seal. In some implementations, the implantable device or implant, or one or more portions thereof, can be configured to expand and / or contract. For example, the implantable device or implant can be constricted upon delivery and can expand upon implantation over the native heart valve.

Description

[Background technology]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to both U.S. Provisional Patent Application No. 63 / 215,977, filed June 28, 2021, and U.S. Provisional Patent Application No. 63 / 130,364, filed December 23, 2020, which are incorporated by reference in their entireties for all purposes.

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform a critical function in ensuring forward flow for adequate blood supply throughout the cardiovascular system. These heart valves can be damaged, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc., which can reduce their effectiveness. Such damage to the valves can lead to serious cardiovascular problems or even death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and can result in complications. Using transvascular techniques, prosthetic devices can be introduced and implanted 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 a 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 can be used to implant a prosthetic device inside the tricuspid valve, starting similarly to the transseptal technique, but instead of puncturing the septum, a delivery catheter is guided within the right atrium towards the tricuspid valve.

[0003] A healthy heart has an overall conical shape tapering from the apex to the base. The heart is a four-chamber structure, including the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The natural mitral valve in the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure from other natural heart valves. The mitral valve includes an annulus, which is a circular portion of natural valve tissue surrounding the mitral valve opening, and a pair of cusps or leaflets extending downward from the annulus into the left ventricle. The mitral valve annulus can form a "D" shape, an ellipse, or other non-circular cross-sectional shape with a major axis and a minor axis. Because the anterior leaflet is larger than the posterior leaflet, a roughly "C"-shaped boundary can be formed between the abutting free edges of the leaflets when they are closed together.

[0004] When operating properly, the anterior and posterior leaflets function together as a one-way valve that allows blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. As the left atrial muscle contracts and the left ventricle relaxes (also called "ventricular diastole" or "diastole"), oxygenated blood collected in the left atrium flows into the left ventricle. As the left atrial muscle relaxes and the left ventricle muscle contracts (also called "ventricular systole" or "systole"), increased blood pressure in the left ventricle forces the leaflets side-to-side together, thereby closing the one-way mitral valve and preventing blood from flowing back into the left atrium. Instead, blood is expelled from the left ventricle through the aortic valve. To prevent the leaflets from prolapsing under pressure or from folding back through the mitral annulus into the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the 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 valve regurgitation occurs when the native mitral valve fails to close properly during the systolic phase of cardiac contraction, allowing blood to flow from the left ventricle into the left atrium. Mitral valve regurgitation is one of the most common forms of valvular heart disease. Mitral valve regurgitation can have many different causes, including leaflet prolapse, papillary muscle dysfunction, stretching of the mitral annulus due to left ventricular dilation, or a combination of these. Mitral valve regurgitation in the central portion of the valve leaflets can be referred to as central jet mitral regurgitation, while mitral valve regurgitation closer to one of the leaflet 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, resulting in non-closure of the valve and regurgitation. Tricuspid regurgitation is similar but can be on the right side of the heart. Summary of the Invention

[0006] This Summary is intended to provide some examples and is not intended to limit the scope of the present invention in any way. For example, any features included in an example of this Summary are not required by a claim unless the claim explicitly recites those features. Also, features, components, steps, concepts, etc. described in the examples in this Summary and elsewhere in this disclosure can be combined in various manners. Various features and steps described elsewhere in this disclosure may be included in the examples summarized herein.

[0007] The implantable device or implant (eg, implantable device, etc.) is configured to be positioned inside the native heart valve so that the native heart valve can form a more effective seal.

[0008] In some implementations, the implantable device or implant includes anchor portions, each of which includes a plurality of paddles movable between an open position and a closed position.

[0009] In some implementations, the implantable device or implant includes a spacer, a cap, and an anchor portion, where the cap is movable relative to the spacer, and each of the anchors includes a plurality of paddle members configured to move between an open position and a closed position by actuating the cap relative to the spacer.

[0010] In some implementations, the implantable device or implant includes an anchor that includes a paddle frame, the paddle frame having a thickness greater than its width, the paddle frame being in an expanded position with an expanded overall width when the anchor is in a closed position, and the paddle frame being in a constricted position with a constricted overall width when the anchor is in an open position.

[0011] In some implementations, the implantable device or implant includes an anchor that includes a paddle frame having a transition portion with a twist, where the twist places the paddle frame in an expanded position with an expanded overall width when the anchor is in a closed position, and the twist places the paddle frame in a constricted position with a constricted overall width when the anchor is in an open position.

[0012] In some implementations, the implantable device or implant includes an anchor that includes a paddle frame having an inner portion and an outer portion configured such that actuating the anchor to an open position creates tension in the inner portion of the paddle frame, which in turn drives the outer portion of the paddle frame to a constricted position, thereby causing the paddle frame to have a constricted overall width.

[0013] In some implementations, the implantable device or implant includes an anchor that includes a paddle frame. The paddle frame includes a rigid inner portion and a flexible outer portion.

[0014] In some implementations, the implantable device or implant includes an anchor including a paddle frame and a cam member, a spacer, and a drive member having the cam member. The one or more anchors are configured to attach to one or more leaflets of a native heart valve. Each of the anchors includes an inner paddle connected to a flexible portion of the spacer and an outer paddle. The paddle frame is connected to a connecting portion between the inner and outer paddles. The cam member engages the flexible portion to generate tension in the paddle frame, which drives the paddle frame from an expanded position to a constricted position.

[0015] In some implementations, the implantable device or implant includes an anchor that includes a paddle frame. The paddle frame is movable between a collapsed position and a normal position. A retention device maintains the paddle frame in the collapsed position. Releasing the retention device drives the paddle frame to the normal position.

[0016] In some implementations, the implantable device or implant includes an anchor that includes a paddle frame, and one or more drive lines are connected to the paddle frame, and applying tension to the drive lines drives the paddle frame from an expanded position to a constricted position.

[0017] In some implementations, the implantable device or implant includes an anchor that includes a paddle frame having at least two arms connected to one another at a distal connection point. One or more drive lines are connected to the paddle frame such that application of tension to the drive lines causes the at least two arms of the paddle frame to pivot, bend, and / or articulate inwardly about the distal connection point, thereby driving the paddle frame from an expanded position to a constricted position.

[0018] In some implementations, the implantable device or implant includes an anchor including a paddle frame having at least two arms disposed on a sleeve member, the proximal ends of the at least two arms being movable within the sleeve member such that the paddle frame can move between an expanded position and a constricted position.

[0019] In some implementations, the implantable device or implant includes an anchor including a paddle frame having an inner portion and an outer portion, the outer portion of the paddle frame having at least two arms extending from the inner portion, the at least two arms being inwardly biased such that when the anchor is in the closed position, the at least two arms extend across the centerline of the spacer.

[0020] In some implementations, the implantable device or implant includes an anchor and a spacer, the spacer having a frame movable from a constricted position to an expanded position.

[0021] In some implementations, the implantable device or implant includes an anchor including a paddle frame that is movable between an expanded position and a constricted position, the paddle frame having a concave shape when in the expanded position and a convex shape when in the constricted position.

[0022] In some implementations, the implantable device or implant includes a spacer and one or more elongate members connected to the spacer, the spacer elongate members configured to obtain tissue engraftment after implantation onto the native valve, and the spacer elongate members positioned to prevent or inhibit dilation of the annulus after tissue engraftment.

[0023] In some implementations, the implantable device or implant includes an inner member, an inner paddle, and an outer paddle. The inner paddle is movably connected to the inner member via a first connecting portion. The outer paddle is movably connected to the inner paddle via a second connecting portion. The device is configured to secure the leaflets between the inner paddle and the inner member at a first engagement region and at a second engagement region that is separate from and spaced apart from the first engagement region.

[0024] In some implementations, the implantable device or implant includes a frame configured to support the anchor portion. The frame is movable between an expanded position and a constricted position. The frame includes a pair of outer frame members and a pair of inner frame members. A movable member is operably attached to the outer frame members. The pair of inner frame members define first and second retention portions configured to receive the movable member. By driving the movable member toward the distal portion, the outer frame members are driven toward the constricted position.

[0025] In some implementations, the implantable device or implant includes a frame member including a post and a drive member configured to engage the post and drive the post, whereby the width of the frame member is adjusted.

[0026] In some implementations, the implantable device or implant includes a clasp including a fixation arm, a movable arm, and one or more fixation members, the one or more fixation members including a friction-enhancing member configured to generate sufficient friction between the leaflet and the movable arm to secure the leaflet within the clasp without puncturing the leaflet.

[0027] In some implementations, the implantable device or implant includes a paddle frame, a width adjustment control line, and a line retention portion. The width adjustment control line allows a user to apply tension to the drive line to drive the paddle frame from an expanded position to a constricted position. The retention portion includes a first retention member and a first elastic member. The first retention member is configured to move between a first retention position and a first non-retention position. In the first retention position, the first retention member contacts a first portion of the width adjustment control line to provide sufficient friction to slow movement of the first drive line relative to the first portion of the width adjustment control line. In the first non-retention position, the first retention member does not contact the first portion of the drive line. The first elastic member is configured to apply a sufficient elastic force to drive the first retention member from the first non-retention position to the first retention position.

[0028] In some implementations, the implantable device or implant includes a cap with a hole that traverses the cap from the proximal end to the distal end, the width of the hole at the distal end being greater than the width of the hole at the proximal end, and the paddle frame is retracted into the cap to drive the paddle frame from the expanded position to the constricted position.

[0029] In some implementations, the implantable device or implant includes a paddle frame and a rotating paddle frame control member that allows a user to apply a rotational driving force to cause the paddle frame to widen or narrow depending on the orientation of the rotation.

[0030] In some implementations, the implantable device or implant includes anchors configured to attach to one or more leaflets of a native heart valve, each of the anchors including an inner paddle and an outer paddle, the inner paddle and the outer paddle being formed from a single strip of material.

[0031] In some implementations, the implantable device or implant includes a paddle frame that is flexible enough to deflect laterally when encountering obstructing material.

[0032] In some implementations, the implantable device or implant includes a paddle frame and a biasing member that flexes to allow the paddle frame to deflect laterally and provides a restoring force that returns the paddle frame to its original position.

[0033] In some implementations, the implantable device or implant includes a spacer, an anchor portion, and a gap filler material, the anchor configured to attach to one or more leaflets of the native heart valve, and the gap filler material positioned to reduce blood flow through one or more gaps between the spacer and the native heart valve when the native heart valve is occluded.

[0034] In some implementations, the implantable device or implant includes at least one anchor having a paddle frame including a movable member attached to a rotatable shaft of a drive portion, wherein rotationally driving the rotatable shaft drives the movable member relative to the rotatable shaft within the conduit of the drive member, thereby driving the paddle frame between a constricted position and an expanded position.

[0035] In some implementations, the implantable device or implant includes at least one anchor having a paddle frame including a movable member with one or more flexible protrusions. The implantable device or implant further includes a drive portion having a post or lumen, the post or lumen including a plurality of slots or recesses configured to receive the flexible protrusions of the movable member to secure the movable member at a desired position within the post or lumen. The device or implant is configured such that driving the movable member relative to the post or lumen drives the paddle frame between a constricted position and an expanded position.

[0036] In some implementations, the device or implant includes a connection opening for removably connecting to a conduit of a delivery device. The connection opening includes a proximal portion and a distal portion, where the width of the distal portion is greater than the width of the proximal portion. The conduit is coupled to the implantable device when at least one arm of the conduit is in a normal position and disposed within the distal portion of the connection opening. The conduit is detached from the implantable device when a user moves the conduit away from the implantable device, thereby driving the at least one arm of the conduit through the proximal portion of the connection opening to a compressed position.

[0037] In some implementations, the device or implant includes at least one anchor having a paddle frame with a retaining feature including a flexible arm. The implantable device or implant further includes a drive member with a connecting feature for releasably connecting to the retaining feature of the paddle frame. The device or implant (e.g., the drive member and paddle frame) is configured to drive the drive member relative to the conduit of the implantable device or implant to drive the paddle frame between a constricted position and an expanded position.

[0038] In some implementations, the device or implant includes at least one anchor having a paddle frame including a movable member. The implantable device or implant further includes a drive portion having a drive member including a protruding sidewall movable between a normal position and a compressed position, the drive member being detachably connected to the movable member of the paddle frame. The drive portion can include a post or lumen having a plurality of holes or recesses configured to receive the protruding sidewalls of the drive member to secure the movable member at a desired position within the post or lumen. The device or implant (e.g., drive member, post, and paddle frame) is configured such that driving the drive member relative to the post or lumen drives the movable member relative to the conduit and, in turn, relative to the paddle frame, thereby driving the paddle frame between a constricted position and an expanded position.

[0039] 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 numerals and in which: [Brief explanation of the drawings]

[0040] To further clarify various aspects of the implementation of the present disclosure, a more detailed description of specific examples and implementations will be provided by reference to various aspects of the accompanying drawings. These drawings illustrate only exemplary implementations of the present disclosure and therefore should not be considered to limit the scope of the present disclosure. Moreover, while the drawings may be drawn to scale for some examples, the drawings are not necessarily drawn to scale for all examples. Examples 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.

[0041] [Figure 1] FIG. 1 illustrates a cross-sectional view of a human heart in diastole. [Figure 2]FIG. 2 illustrates a cross-sectional view of a human heart during systole. [Figure 3] FIG. 3 illustrates a cross-section of a human heart in systole, showing mitral valve regurgitation. [Figure 4] FIG. 4 is a cross-sectional view of FIG. 3, annotated to illustrate the natural shape of the mitral valve leaflets during systole. [Figure 5] FIG. 5 illustrates a healthy mitral valve with the leaflets closed when viewed from the atrial side of the mitral valve. [Figure 6] FIG. 6 illustrates a dysfunctional mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 7] FIG. 7 illustrates the tricuspid valve as viewed from the atrial side of the tricuspid valve. [Figure 8] 8-14 show an example of an implantable device or implant at various stages of deployment. [Figure 9] Same as above. [Figure 10] Same as above. [Figure 11] Same as above. [Figure 12] Same as above. [Figure 13] Same as above. [Figure 14] Same as above. [Figure 15] FIG. 15 shows an example of an implantable device or implant similar to the devices shown in FIGS. 8-14, but with independently controllable paddles. [Figure 16] 16-21 show the implantable device or implant of FIGS. 8-14 as delivered and implanted within a native valve. [Figure 17] Same as above. [Figure 18] Same as above. [Figure 19] Same as above. [Figure 20] Same as above. [Figure 21] Same as above. [Figure 22]FIG. 22 shows a perspective view of an exemplary implantable device or implant in an occluded 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. [Figure 25] FIG. 25 shows a front view of the implantable device or implant of FIG. 22 with a cover over the paddle and the abutment member or spacer. [Figure 26] FIG. 26 shows a top perspective view of the implantable device or implant of FIG. 22 in the open position. [Figure 27] FIG. 27 shows a perspective view from below of the implantable device or implant of FIG. 22 in the open position. [Figure 28A] FIG. 28A shows a clasp for use in an implantable device or implant. [Figure 28B] FIG. 28B shows 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. [Figure 30] FIG. 30 shows a side view of an exemplary implantable device or implant in a partially open position with the clasp in a closed position. [Figure 31] FIG. 31 shows a side view of an exemplary implantable device or implant in a partially open position with the clasp in the open position. [Figure 32] FIG. 32 shows a side view of an exemplary implantable device or implant in a semi-open position with the clasp in a closed position. [Figure 33]FIG. 33 shows a side view of an exemplary implantable device or implant in a semi-open position with the clasp in the open position. [Figure 34] FIG. 34 shows a side view of an exemplary implantable device or implant in a three-quarters open position with the clasp in the closed position. [Figure 35] FIG. 35 shows a side view of an exemplary implantable device or implant in a three-quarters open position with the clasp in the open position. [Figure 36] FIG. 36 shows 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 shows a side view of an exemplary implantable device in a fully open or fully bailed out position with the clasp in the open position. [Figure 38] 38-49 illustrate the exemplary implantable device or implant of FIGS. 30-38, including the cover, and shown delivered and implanted within the native valve. [Figure 39] Same as above. [Figure 40] Same as above. [Figure 41] Same as above. [Figure 42] Same as above. [Figure 43] Same as above. [Figure 44] Same as above. [Figure 45] Same as above. [Figure 46] Same as above. [Figure 47] Same as above. [Figure 48] Same as above. [Figure 49] Same as above. [Figure 50] FIG. 50 is a schematic diagram illustrating the path of the native valve leaflets along each side of a coaptation member or spacer in an exemplary valve repair device or implant. [Figure 51]FIG. 51 is a schematic view from above illustrating the path of the leaflets of a native valve around a coaptation member or spacer in an exemplary valve repair device or implant. [Figure 52] FIG. 52 illustrates the coaptation member 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 the coaptation members or spacers positioned within the interstices 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 the coaptation members or spacers positioned within the interstices 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 an occluded position. [Figure 56A] FIG. 56A illustrates an exemplary 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 with the gripping members actuated to reduce the gap between the gripping members and the paddles. [Figure 56E] 56E-56F illustrate the paddles of the valve repair device of FIG. 56A moving from an open position to a closed position. [Figure 56F] Same as above. [Figure 56G]FIG. 56G illustrates the valve repair device of FIG. 56A in an occluded position with the gripping members engaging the valve tissue. [Figure 56H] FIG. 56H illustrates the valve repair device of FIG. 56A after being detached from the delivery device and attached to valve tissue, with the valve repair device in an occluded and locked state. [Figure 57] FIG. 57 is a plan view of an exemplary implantable device or implant having multiple anchors, each anchor including multiple paddles and multiple clasps, each clasp corresponding to an associated paddle. [Figure 58] FIG. 58 shows a front view of the exemplary implantable device or implant of FIG. [Figure 59] FIG. 59 shows a side view of the exemplary implantable device or implant of FIG. [Figure 60] FIG. 60 shows a top view of an exemplary implantable device or implant similar to the exemplary implantable device of FIG. 57, except that only a portion of the paddles of each anchor include a corresponding clasp. [Figure 61] FIG. 61 shows a front view of the exemplary implantable device or implant of FIG. [Figure 62] FIG. 62 shows a side view of the exemplary implantable device or implant of FIG. [Figure 63] FIG. 63 shows a plan view of an exemplary implantable device or implant similar to the exemplary implantable device of FIG. 60, except that the inner paddle of each anchor has a longer length compared to the outer paddle of the anchor. [Figure 64] FIG. 64 shows a front view of the exemplary implantable device or implant of FIG. [Figure 65] FIG. 65 shows a side view of the exemplary implantable device or implant of FIG. [Figure 66]FIG. 66 shows a plan view of an exemplary implantable device or implant similar to the exemplary implantable device of FIG. 60, except that the inner paddle of each anchor has a shorter length compared to the outer paddle of the anchor. [Figure 67] FIG. 67 shows a front view of the exemplary implantable device or implant of FIG. [Figure 68] FIG. 68 shows a side view of the exemplary implantable device or implant of FIG. [Figure 69] 69-73 show the exemplary implantable device or implant of FIG. 57 during various stages of deployment. [Figure 70] Same as above. [Figure 71] Same as above. [Figure 72] Same as above. [Figure 73] FIG. 74 is a plan view of an exemplary implantable device or implant having multiple anchors, each anchor including multiple paddle members and multiple clasps, each clasp corresponding to an associated paddle member. [Figure 74] FIG. 75 shows a front view of the exemplary implantable device or implant of FIG. [Figure 75] FIG. 76 shows a side view of the exemplary implantable device or implant of FIG. [Figure 76] FIG. 77 shows a top view of an exemplary implantable device or implant similar to the exemplary implantable device of FIG. 74, except that only a portion of the paddle members of each anchor include a corresponding clasp. [Figure 77] FIG. 78 shows a front view of the exemplary implantable device or implant of FIG. [Figure 78] FIG. 79 shows a side view of the exemplary implantable device or implant of FIG. [Figure 79]FIG. 80 shows a plan view of an exemplary implantable device or implant similar to the exemplary implantable device of FIG. 77, except that the inner paddle member of each anchor has a longer length compared to the outer paddle member of the anchor. [Figure 80] FIG. 81 shows a front view of the exemplary implantable device or implant of FIG. [Figure 81] FIG. 82 shows a side view of the exemplary implantable device or implant of FIG. [Figure 82] FIG. 83 shows a plan view of an exemplary implantable device or implant similar to the exemplary implantable device of FIG. 77, except that the inner paddle member of each anchor has a shorter length compared to the outer paddle member of the anchor. [Figure 83] FIG. 84 shows a front view of the exemplary implantable device or implant of FIG. [Figure 84] FIG. 85 shows a side view of the exemplary implantable device or implant of FIG. [Figure 85] 86A, 87A, and 88-90 show the exemplary implantable device or implant of FIG. 57 during various stages of deployment. [Figure 86A] Same as above. [Figure 86B] Same as above. [Figure 87A] Same as above. [Figure 87B] Same as above. [Figure 88] Same as above. [Figure 89] Same as above. [Figure 90] 86B and 87B illustrate an example similar to that shown in FIGS. 86A and 87A, with the paddle portions in an extended position. [Figure 91] FIG. 91 shows a perspective view of an exemplary paddle frame for an implantable device or implant. [Figure 92]FIG. 92 shows a partial view of the paddle frame of FIG. 91 when the paddle frame is in the constricted position. [Figure 93] FIG. 93 shows the paddle frame of FIG. 91 positioned within a delivery system. [Figure 94] FIG. 94 illustrates an exemplary implantable device or implant including the paddle frame of FIG. 91 when the implantable device or implant is in an open position. [Figure 95] FIG. 95 shows the paddle frame of FIG. 91 when the paddle frame is in the constriction position. [Figure 96] FIG. 96 shows a perspective view of an exemplary paddle frame for an implantable device or implant. [Figure 97] FIG. 97 shows a partial view of the paddle frame of FIG. [Figure 98] FIG. 98 shows a partial front view of an exemplary implantable device including an exemplary paddle frame when the implantable device or implant is in an occluded position. [Figure 99] FIG. 99 shows a partial front view of an exemplary implantable device including an exemplary paddle frame when the implantable device or implant is in an occluded position. [Figure 100] FIG. 100 shows a partial front view of an exemplary implantable device including an exemplary paddle frame when the implantable device or implant is in an occluded position. [Figure 101] FIG. 101 shows a partial front view of the implantable device or implant of FIG. 98 when the implantable device or implant is in the open position. [Figure 102] FIG. 102 shows a partial front view of the implantable device or implant of FIG. 99 when the implantable device or implant is in the open position. [Figure 103]FIG. 103 shows a partial front view of the implantable device or implant of FIG. 100 when the implantable device or implant is in the open position. [Figure 104] FIG. 104 shows a partial side view of the implantable device or implant of FIG. 98 when the implantable device or implant is in an open position. [Figure 105] FIG. 105 shows a partial side view of the implantable device or implant of FIG. 99 when the implantable device or implant is in an open position. [Figure 106] FIG. 106 shows a partial side view of the implantable device or implant of FIG. 100 when the implantable device or implant is in the open position. [Figure 107] FIG. 107 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 108] FIG. 108 illustrates a front view of the exemplary paddle frame of FIG. 107 when the paddle frame is in the constricted position. [Figure 109] FIG. 109 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 110] FIG. 110 shows a front view of the exemplary paddle frame of FIG. 109 when the paddle frame is in the constricted position. [Figure 111] FIG. 111 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 112] FIG. 112 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 113] FIG. 113 shows a front view of one exemplary configuration for the exemplary paddle frame of FIG. [Figure 114] FIG. 114 shows a front view of one exemplary configuration for the exemplary paddle frame of FIG. [Figure 115] FIG. 115 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 116] FIG. 116 shows a top view of the exemplary paddle frame of FIG. [Figure 117] FIG. 117 shows a perspective view of an exemplary implantable device or implant including an exemplary paddle frame when the implantable device or implant is in an open position. [Figure 118] FIG. 118 shows a bottom view of the implantable device or implant of FIG. [Figure 119] FIG. 119 shows a front view of the implantable device or implant of FIG. 117 when the implantable device or implant is in an occluded position. [Figure 120] FIG. 120 shows a side view of the implantable device or implant of FIG. 117 attached to a native valve of the heart. [Figure 121] FIG. 121 shows a bottom view of the implantable device or implant of FIG. 117 attached to a native valve of the heart. [Figure 122] FIG. 122 shows a front view of an exemplary implantable device or implant when the implantable device or implant is in an occluded position. [Figure 123] FIG. 123 shows the exemplary implantable device or implant of FIG. 122 when the implantable device or implant is in an open position. [Figure 124] FIG. 124 illustrates an exemplary paddle frame of the implantable device or implant of FIG. 122 when the implantable device or implant is in an open position. [Figure 125] FIG. 125 shows a front view of an exemplary paddle frame of an implantable device or implant when the paddle frame is in a constricted position. [Figure 126]FIG. 126 illustrates the exemplary paddle frame of FIG. 125 when the paddle frame is in an extended position. [Figure 127] FIG. 127 shows a perspective view of an implantable device or implant including an exemplary paddle frame, where the device includes an exemplary means for actuating the paddle frame from a normal position to a constricted position. [Figure 128] FIG. 128 shows the paddle frame of FIG. 127 in the constricted position. [Figure 129] FIG. 129 shows a perspective view of the exemplary implantable device or implant of FIG. 127, except that the device includes an exemplary means for actuating the paddles from a normal position to a constricted position. [Figure 130] FIG. 130 shows a perspective view of the exemplary implantable device or implant of FIG. 127, except that the device includes an exemplary means for actuating the paddles from a normal position to a constricted position. [Figure 131] FIG. 131 shows a perspective view of an exemplary implantable device or implant including an exemplary paddle frame. [Figure 132] FIG. 132 illustrates the implantable device or implant of FIG. 131 with an exemplary means for actuating the paddle frame from a normal position to a constricted position. [Figure 133] FIG. 133 shows the implantable device or implant of FIG. 131 with an exemplary means for actuating the paddle frame from a normal position to a constricted position. [Figure 134] FIG. 134 shows the implantable device or implant of FIG. 131 with an exemplary means for actuating the paddle frame from a normal position to a constricted position. [Figure 135] FIG. 135 shows the implantable device or implant of FIG. 131 with an exemplary means for actuating the paddle frame from a normal position to a constricted position. [Figure 136]FIG. 136 shows the implantable device or implant of FIG. 131 with an exemplary means for actuating the paddle frame from a normal position to a constricted position. [Figure 137] FIG. 137 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 138] FIG. 138 shows the exemplary pair of paddle frames of FIG. 137 positioned adjacent to one another. [Figure 139] FIG. 139 shows a side view of an example of an implantable device or implant including the paddle frame of FIG. 137 when the paddle frame is in a constricted position. [Figure 140] FIG. 140 shows a side view of the implantable device or implant of FIG. 139 with the paddle frame in an expanded position. [Figure 141] FIG. 141 shows a partial side view of the implantable device or implant of FIG. 139 with the paddle frame in the constricted position. [Figure 142] FIG. 142 shows a partial side view of the implantable device or implant of FIG. 139 with the paddle frame in an expanded position. [Figure 143] FIG. 143 shows a perspective view of the implantable device or implant of FIG. 139 with the paddle frame of FIG. [Figure 144] FIG. 144 shows a front view of the implantable device or implant of FIG. 139 with the paddle frame of FIG. [Figure 145] FIG. 145 shows a perspective view of one example of an inner and outer paddle for the implantable device or implant of FIG. [Figure 146] FIG. 146 shows a side view of the inner and outer paddles of FIG. [Figure 147] FIG. 147 shows a top view of the inner and outer paddles of FIG. [Figure 148]FIG. 148 shows a perspective view of an exemplary connection between the paddle of FIG. 146 and the paddle frame of FIG. [Figure 149] FIG. 149 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 150] FIG. 150 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 151] FIG. 151 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 152] FIG. 152 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 153] 153-155 show front views of various configurations of exemplary paddle frames for implantable devices or implants. [Fig. 154] Same as above. [Figure 155] Same as above. [Figure 156] FIG. 156 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 157] FIG. 157 is a front view of an exemplary paddle frame for an implantable device or implant, the paddle frame shown in an extended position. [Figure 158] FIG. 158 is a front view of the exemplary paddle frame of FIG. 157, with the paddle frame shown in a constricted position. [Figure 159] FIG. 159 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 160] FIG. 160 shows a left side view of the paddle frame of FIG. [Figure 161] FIG. 161 shows a top view of the paddle frame of FIG. [Figure 162]FIG. 162 shows a perspective view of an example of an implantable device or implant including the paddle frame of FIG. [Figure 163] FIG. 163 shows a front view of the implantable device or implant of FIG. 162 including the paddle frame of FIG. [Fig. 164] 164-168 illustrate the implantable device or implant of FIG. 162 with exemplary means for actuating the paddle frame of FIG. 159 between expanded and constricted positions. [Figure 165] Same as above. [Figure 166] Same as above. [Figure 167] Same as above. [Figure 168] Same as above. [Figure 169] FIG. 169 shows a perspective view of an example paddle and abutment frame assembly for an implantable device or implant. [Figure 170] FIG. 170 shows a rear view of the paddle and joint frame assembly of FIG. [Figure 171] FIG. 171 is a perspective view of an example of an implantable device or implant including the paddle and abutment frame assembly of FIG. 171, with the abutment frame in a constricted position. [Fig. 172] FIG. 172 is a perspective view of the implantable device or implant of FIG. 171 with the abutment member frame in an expanded position. [Figure 173] FIG. 173 shows a top view of the implantable device or implant of FIG. 171 with the abutment member frame in the constricted position. [Fig. 174] FIG. 174 shows a top view of the implantable device or implant of FIG. 172 with the abutment member frame in an expanded position. [Figure 175]FIG. 175 is a rear view of the paddle and abutment frame assembly of FIG. 169 when in the constricted position, the paddle and abutment frame assembly attached to the inner and outer paddles of the anchor portion of the implantable device or implant. [Figure 176] FIG. 176 is a rear view of the paddle and abutment frame assembly of FIG. 169 in an expanded position, the paddle and abutment frame assembly being attached to the inner and outer paddles of the anchor portion of the implantable device or implant. [Figure 177] FIG. 177 is a perspective view of the paddle and abutment frame assembly of FIG. 169 when in a constricted position, the paddle and abutment frame assembly being attached to the inner and outer paddles of the anchor portion of the implantable device or implant. [Figure 178] FIG. 178 is a plan view of the paddle and abutment frame assembly of FIG. 169 in an expanded position, the paddle and abutment frame assembly being attached to the inner and outer paddles of the anchor portion of the implantable device or implant. [Figure 179] FIG. 179 shows a perspective view of the paddle and abutment frame assembly of FIG. 169 in the expanded position. [Figure 180] FIG. 180 is a perspective view of the abutment frame of the paddle and abutment frame assembly of FIG. 169, where the abutment frame is attached to the inner paddle of the anchor portion of the implantable device or implant. [Figure 181] FIG. 181 shows a front view of the frame of the paddle and abutment assembly of FIG. 169 when in the constricted position. [Figure 182] FIG. 182 shows a side view of the joint member frame of FIG. [Figure 183]FIG. 183 shows a plan view of the joint member frame of FIG. [Figure 184] FIG. 184 shows a perspective view of the joint member frame of FIG. [Figure 185] FIG. 185 shows a front view of the abutment member frame of FIG. 181 in the expanded position. [Figure 186] FIG. 186 shows a side view of the joint member frame of FIG. [Figure 187] FIG. 187 shows a plan view of the joint member frame of FIG. [Figure 188] FIG. 188 shows a perspective view of the joining member frame of FIG. [Figure 189] FIG. 189 shows a perspective view of an exemplary pair of paddle frames for a pair of anchors in an implantable device or implant. [Figure 190] FIG. 190 shows a front view of the paddle frame of FIG. [Figure 191] FIG. 191 shows a top view of the paddle frame of FIG. [Figure 192] FIG. 192 shows a side view of the paddle frame of FIG. [Figure 193] FIG. 193 is a top view of an example of an implantable device or implant including one of the paddle frames of FIG. 189, with the paddle frame in an extended position. [Figure 194] FIG. 194 is a top view of the implantable device or implant of FIG. 193 with the paddle frame in the constricted position. [Figure 195] FIG. 195 shows a ventricular view of the native valve with the implantable device or implant of FIG. 193 positioned to connect to the native valve. [Figure 196] FIG. 196 shows an atrial view of an exemplary implantable device or implant attached to a native valve of the heart. [Figure 197] FIG. 197 is an atrial view of the implantable device or implant of FIG. 196 attached to a native valve with tissue grafting over the device. [Figure 198] FIG. 198 is a front view of the implantable device or implant of FIG. 196 attached to a native valve with tissue grafting over the device. [Figure 199] FIG. 199 is an atrial view of an exemplary implantable device or implant attached to a native valve of the heart, the device including an exemplary coaptation extension member. [Figure 200] FIG. 200 is an atrial view of the implantable device or implant of FIG. 199 attached to a native valve with tissue engraftment covering the device. [Figure 201] FIG. 201 is an atrial view of an exemplary implantable device or implant attached to a native valve of the heart, the device including an exemplary coaptation extension member. [Figure 202] FIG. 202 is a view of the atrial side of the implantable device or implant of FIG. 201 attached to a native valve, with tissue engraftment covering the device. [Figure 203] FIG. 203 is a front view of an exemplary implantable device or implant attached to a native valve of the heart, the device including an exemplary coaptation extension member. [Figure 204] FIG. 204 is a front view of the implantable device or implant of FIG. 203 attached to a native valve with tissue grafting over the device. [Figure 205] FIG. 205 is a front view of an exemplary implantable device or implant attached to a native valve of the heart, the device including an exemplary coaptation extension member. [Figure 206] FIG. 206 is a front view of the implantable device or implant of FIG. 205 attached to a native valve with tissue grafting over the device. [Figure 207] FIG. 207 is a view of the atrial side of an exemplary implantable device or implant attached to a native valve of the heart, the device including an exemplary coaptation extension member. [Figure 208] FIG. 208 is a front view of an exemplary implantable device or implant attached to a native valve of the heart, the device including an exemplary coaptation extension member. [Figure 209] FIG. 209 is a front view of an exemplary implantable device or implant attached to a native valve of the heart, the device including an exemplary coaptation extension member. [Figure 210] Figures 210-214 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 211] Same as above. [Figure 212] Same as above. [Figure 213] Same as above. [Figure 214] Same as above. [Figure 215] Figures 215-218 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 216] Same as above. [Figure 217] Same as above. [Figure 218] Same as above. [Figure 219] Figures 219-222 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 220] Same as above. [Figure 221] Same as above. [Figure 222] Same as above. [Figure 223] Figures 223-224 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 224] Same as above. [Figure 225]Figures 225-227 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 226] Same as above. [Figure 227] Same as above. [Figure 228] Figures 228-230 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 229] Same as above. [Figure 230] Same as above. [Figure 231] Figures 231-232 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 232] Same as above. [Figure 233] FIG. 233 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 234] FIG. 234 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 235] FIG. 235 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 236] FIG. 236 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 237] FIG. 237 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 238] FIG. 238 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 239] FIG. 239 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 240]FIG. 240 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 241] FIG. 241 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 242] FIG. 242 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 243] FIG. 243 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 244] FIG. 244 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 245] Figures 245-250 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 246] Same as above. [Figure 247] Same as above. [Figure 248] Same as above. [Figure 249] Same as above. [Figure 250] Same as above. [Figure 251] Same as above. [Figure 252] Figures 251-252 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 253] Ibid. Figure 253 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 254] Figures 254-255 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 255] Same as above. [Figure 256] FIG. 256 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 257] FIG. 257 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 258] Figures 258-259 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 259] Same as above. [Figure 260] Figures 260-261 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 261] Same as above. [Figure 262] FIG. 262 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 263] Figures 263-264 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 264] Same as above. [Figure 265] Figures 265-266 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 266] Same as above. [Figure 267] Figures 267-268 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 268] Same as above. [Figure 269] Figures 269-270 illustrate one example of a connection between a drive member and a component of a device or implant. [Figure 270] Same as above. [Fig. 271] FIG. 271 illustrates one example of a connection between a drive member and a component of a device or implant. [Fig. 272]FIG. 272 ​​illustrates one example of a connection between a drive member and a component of a device or implant. [Fig. 273] FIG. 273 illustrates one example of a connection between a drive member and a component of a device or implant. [Fig. 274] FIG. 274 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 275] FIG. 275 illustrates one example of a connection between a drive member and a component of a device or implant. [Figure 276] FIG. 276 illustrates an example of a drive or control device. [Figure 277] FIG. 277 illustrates an example of a drive or control device. [Fig. 278] FIG. 278 illustrates an example of a pulley configuration. [Figure 279] FIG. 279 is a plan view of the drive or control device shown in FIG. [Figure 280] FIG. 280 is a bottom view of the drive or control device illustrated in FIG. [Figure 281] 281 and 282 illustrate an example of a drive or control device. [Figure 282] [Figure 283] 283 to 285 illustrate an example of a driving or control device. [Fig. 284] Same as above. [Figure 285] Same as above. [Figure 286] FIG. 286 illustrates an example of a paddle frame. [Figure 287] FIG. 287 illustrates an example of a drive or control device coupled to a paddle frame. [Figure 288]FIG. 288 illustrates an example of a drive or control device coupled to a paddle frame. [Figure 289] FIG. 289 illustrates one example of an adjustable paddle frame assembly. [Figure 290] FIG. 290 illustrates one example of an adjustment mechanism for the adjustable paddle assembly of FIG. [Figure 291] FIG. 291 illustrates one example of an adjustable paddle frame assembly. [Figure 292] FIG. 292 illustrates an example of a drive or control device. [Figure 293] FIG. 293 illustrates one example of an adjustable paddle frame assembly. [Fig. 294] FIG. 294 illustrates one example of an adjustable paddle frame assembly. [Figure 295] FIG. 295 illustrates one example of an adjustable paddle frame assembly. [Figure 296] FIG. 296 illustrates one example of an adjustment member in the adjustable paddle frame assembly of FIGS. 294 and 295. [Figure 297] FIG. 297 illustrates one example of an adjustable paddle frame assembly. [Figure 298] 298-300 illustrate an example of a driving or control device. [Figure 299] Same as above. [Figure 300] Same as above. [Figure 301] FIG. 301 shows a front cross-sectional view of an implantable device or implant. [Figure 302] FIG. 302 shows a perspective cross-sectional view of the device / implant of FIG. [Figure 303] FIG. 303 shows a perspective view of the device / implant of FIG. [Figure 304]FIG. 304 shows a side view of the device / implant of FIG. [Figure 305] FIG. 305 shows a top view of the device / implant of FIG. [Figure 306] Figures 306-311 show partial views of the device / implant of Figure 301 at various stages of assembly. [Figure 307] Same as above. [Figure 308] Same as above. [Figure 309] Same as above. [Figure 310] Same as above. [Figure 311] Same as above. [Figure 312] FIG. 312 shows a front view of the device / implant of 301 in the expanded position. [Figure 313] FIG. 313 shows a side view of the device / implant of 301 in the expanded position. [Figure 314] FIG. 314 shows a top view of the device / implant of 301 in the expanded position. [Figure 315] FIG. 315 shows a front view of the device / implant of 301 in the constriction position. [Figure 316] FIG. 316 shows a side view of the device / implant of 301 in the constriction position. [Figure 317] FIG. 317 shows a top view of the device / implant of 301 in the constriction position. [Figure 318] FIG. 318 shows a front cross-sectional view of one example of an implantable device or implant. [Figure 319] FIG. 319 shows a side view of the device / implant of FIG. [Figure 320] 320-323 show front views of the device / implant of FIG. 318 in various positions moving from an expanded position to a constricted position. [Figure 321] Same as above. [Figure 322] Same as above. [Figure 323] Same as above. [Figure 324] FIG. 324 shows a front view of one example of a portion of a paddle frame for an implantable device or implant. [Figure 325] FIG. 325 shows a perspective view of the frame of FIG. [Figure 326] FIG. 326 shows a plan view of the frame of FIG. [Figure 327] FIG. 327 shows a side view of the frame of FIG. [Figure 328] 328-331 show front views of the device / implant of FIG. 324 in various positions moving from an expanded position to a constricted position. [Figure 329] Same as above. [Figure 330] Same as above. [Figure 331] Same as above. [Figure 332] FIG. 332 shows a perspective view of one example of a portion of a paddle frame for an implantable device or implant. [Figure 333] FIG. 333 shows a front view of the frame of FIG. 332 attached to an anchor. [Figure 334] FIG. 334 shows a front view with partial cross section of the frame of FIG. 332 as part of an implantable device or implant. [Figure 335] FIG. 335 shows the frame of FIG. 332 attached to a drive portion of an implantable device or implant. [Figure 336] FIG. 336 shows a perspective view of an implantable device or implant using the frame of FIG. [Figure 337] FIG. 337 shows a front view of the device of FIG. 332 in the expanded position. [Figure 338]FIG. 338 shows a front view of the device of FIG. 332 in the constriction position. [Figure 339] FIG. 339 shows a side view of the device of FIG. 332 in the expanded position. [Figure 340] FIG. 340 shows a side view of the device of FIG. 332 in the constriction position. [Figure 341] FIG. 341 shows a top view of the device of FIG. 332 in the expanded position. [Figure 342] FIG. 342 shows a top view of the device of FIG. 332 in the constricted position. [Figure 343] FIG. 343 is a front view of an implantable device or implant illustrating two examples of paddle frames for the device. [Figure 344] FIG. 344 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 345] 345-347 show front views of the frame of FIG. 332 in various positions from an expanded position to a constricted position. [Figure 346] Same as above. [Figure 347] Same as above. [Figure 348] FIG. 348 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 349] FIG. 349 shows a perspective view of the frame of FIG. 348 as part of an implantable device or implant. [Figure 350] FIG. 350 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 351] FIG. 351 shows a perspective view of the frame of FIG. [Figure 352] FIG. 352 shows a top view of the frame of FIG. [Figure 353] FIG. 353 shows a side view of the frame of FIG. [Figure 354] FIG. 354 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 355] FIG. 355 shows a perspective view of the frame of FIG. [Figure 356] FIG. 356 shows a plan view of the frame of FIG. [Figure 357] FIG. 357 shows a side view of the frame of FIG. [Figure 358] FIG. 358 shows a perspective view of an exemplary paddle frame for an implantable device or implant. [Figure 359] FIG. 359 shows a cross-sectional front view of the frame of FIG. [Figure 360] FIG. 360 shows a front cross-sectional view of an exemplary paddle frame for an implantable device or implant. [Figure 361] FIG. 361 shows a plan view of the frame of FIG. [Figure 362] FIG. 362 shows a front cross-sectional view of an exemplary paddle frame for an implantable device or implant. [Figure 363] FIG. 363 shows a perspective view of the paddle frame attached to the elongated cap. [Figure 364] FIG. 364 shows a partial front view of the frame and elongated cap in FIG. [Figure 365] FIG. 365 shows a front view of one example of a connection mechanism between the rigid inner and flexible outer portions of the paddle frame. [Figure 366] FIG. 366 shows a perspective view of the paddle frame assembly of FIG. [Figure 367] FIG. 367 shows a top view of the paddle frame assembly of FIG. [Figure 368]FIG. 368 shows a side view of the paddle frame assembly of FIG. [Figure 369] FIG. 369 shows a rear view of the paddle frame assembly of FIG. [Figure 370] FIG. 370 shows a front view of one example of a connection mechanism between the rigid inner and flexible outer portions of the paddle frame. [Figure 371] FIG. 371 shows a side view of the paddle frame assembly of FIG. [Figure 372] FIG. 372 shows a rear view of the paddle frame assembly of FIG. [Figure 373] FIG. 373 shows a front view of one example of a connection between a rigid inner portion and a flexible outer portion of a paddle frame. [Figure 374] FIG. 374 shows a side view of the paddle frame of FIG. [Figure 375] FIG. 375 shows a perspective view of the paddle frame of FIG. [Figure 376] FIG. 376 shows a front view of one example of a connection between a rigid inner portion and a flexible outer portion of a paddle frame. [Figure 377] FIG. 377 shows a perspective view of the paddle frame assembly of FIG. [Figure 378] FIG. 378 shows a schematic diagram of an anchor portion of an implantable device or implant in an occluded position. [Figure 379] FIG. 379 is a schematic diagram of the anchor portion of FIG. 378 in an occluded position, showing the native valve leaflets secured by the anchor portion. [Figure 380] FIG. 380 shows a schematic diagram of an exemplary anchor portion for an implantable device or implant in an occluded position. [Figure 381] FIG. 381 is a schematic diagram of the anchor portion of FIG. 380, showing how the leaflets of the native valve are secured by the anchor portion. [Figure 382] FIG. 382 shows a schematic view of the anchor portion of FIG. 380 in a partially open position. [Figure 383] FIG. 383 shows a schematic view of the anchor portion of FIG. 380 in the open position. [Figure 384] FIG. 384 is a top view of the anchor in the anchor portion of FIG. 380, showing the anchor flattened. [Figure 385] FIG. 385 is a schematic view of the anchor in the anchor portion of FIG. 380, with the anchor in the closed position and the clasp attached to the anchor. [Figure 386] FIG. 386 is a schematic diagram of the anchors and clasps of FIG. 385 in the closed position, showing the native valve leaflets secured by the anchors and clasps. [Figure 387] FIG. 387 is a schematic view of the anchor and clasp of FIG. 385, with the anchor in the open position and the clasp in the closed position. [Figure 388] FIG. 388 is a schematic diagram of the anchor portion and clasp in the implantable device or implant in the closed position, showing the inward bias of the anchor portion relative to the outer paddle. [Figure 389] FIG. 389 is a schematic view of one side of the anchor portion of FIG. 388 in the closed position, showing the inward bias on the outer paddle. [Figure 390] FIG. 390 is a plan view of an example of a clasp for an implantable device or implant, where the clasp is flattened. [Figure 391] FIG. 391 shows an example of a clasp for an implantable device or implant. [Figure 392] FIG. 392 is a top view of one example of a clasp for an implantable device or implant, showing the clasp flattened. [Figure 393]FIG. 393 is a side view of an example of a clasp for an implantable device or implant, the clasp in a closed position. [Figure 394] FIG. 394 shows the anchor portion of FIG. 388 positioned in a shape memory alloy fixture. [Figure 395] FIG. 395 shows a perspective view of one example of an anchor portion for an implantable device or implant. [Figure 396] FIG. 396 shows a top view of one example of the inner member and inner paddle portion of the anchor portion of FIG. [Figure 397] FIG. 397 shows a left perspective view of an example of an implantable device or implant. [Figure 398] FIG. 398 shows a right-side perspective view of the device of FIG. [Figure 399] FIG. 399 shows a front view of the device of FIG. [Figure 400] FIG. 400 is a partial perspective view of the distal portion of the device of FIG. 397, showing the anchor portion attached to the cap at the distal end of the device. [Figure 401] FIG. 401 shows a perspective view of one example of a clasp for an implantable device or implant. [Figure 402] FIG. 402 shows a perspective view of one example of a clasp for an implantable device or implant. [Figure 403] FIG. 403 shows a perspective view of one example of a clasp for an implantable device or implant. [Figure 404] FIG. 404 shows a perspective view of one example of a clasp for an implantable device or implant. [Figure 405] FIG. 405 shows a perspective view of one example of a clasp for an implantable device or implant. [Figure 406]FIG. 406 shows a perspective view of one example of a clasp for an implantable device or implant. [Figure 407A] FIG. 407A shows an example of a retention or locking mechanism. [Figure 407B] FIG. 407B shows an example of the retention or locking mechanism of FIG. 407A deployed within a housing. [Figure 407C] FIG. 407C is a cross-sectional view of FIG. 407B showing the retention or locking mechanism within the housing. [Figure 408A] FIG. 408A shows an example of the cap engaged with the paddle. [Figure 408B] FIG. 408B shows a close-up view of the cap of FIG. 408A without the paddle. [Figure 408C] FIG. 408C is a perspective view of the cap and paddle shown in FIG. 408A. [Figure 408D] FIG. 408D is a cross-sectional view showing the deflection of the paddle caused by retracting the paddle into the cap to various degrees. [Figure 408E] FIG. 408E is a perspective view showing the degree of deflection of FIG. 408D. [Figure 408F] FIG. 408F is a schematic diagram showing a configuration in which the paddles are simultaneously deflected by coupled retraction into the cap. [Figure 408G] FIG. 408G is a perspective view of the cap and paddle assembly. [Figure 409A] FIG. 409A is a top perspective view of the assembly consisting of the cap and two independent adjustable paddles. [Figure 409B] FIG. 409B is a bottom perspective view of the assembly of FIG. 409A. [Figure 409C] FIG. 409C is a cross-sectional view illustrating independent controls for the dollars of FIGS. 409A and 409B. [Figure 410A] FIG. 410A is a partial cross-sectional view of an adjustable paddle assembly. [Figure 410B] FIG. 410B is a perspective view of the adjustable paddle assembly of FIG. 410A. [Figure 410C] FIG. 410C is a cross-sectional view of the adjustable paddle assembly of FIG. 410B. [Figure 410D] FIG. 410D is a cross-sectional view of the adjustable paddle assembly of FIG. 410B. [Figure 410E] FIG. 410E is a side view of the adjustable paddle assembly of FIG. 410B. [Figure 410F] FIG. 410F is a side view of the adjustable paddle assembly showing the paddle in the first drive position. [Figure 410G] FIG. 410G is a side view of the adjustable paddle assembly showing the paddle in the second drive position. [Figure 410H] FIG. 410H is a side view of the adjustable paddle assembly showing the paddle in the third drive position. [Figure 411A] FIG. 411A is a side perspective view of the adjustable paddle assembly. [Figure 411B] FIG. 411B is a side view of the adjustable paddle assembly of FIG. 411A. [Figure 411C] FIG. 411C is a front view of the adjustable paddle assembly of FIG. 411A. [Figure 411D] 411D and 411E illustrate the use of the adjustable paddle assembly of FIG. 411A in a valve repair device or implant. [Figure 412A] FIG. 412A shows an example of a paddle structure formed from sheet material. [Figure 412B] FIG. 412B is a side view of the paddle structure of FIG. 412A. [Figure 412C] FIG. 412C is a top view of the paddle structure of FIG. 412A. [Figure 412D] FIG. 412D is a bottom view of the paddle structure of FIG. 412A. [Figure 412E] FIG. 412E is another side view of the paddle structure of FIG. 412A. [Figure 412F] FIG. 412F shows details of one example of an eyelet in the paddle structure of FIG. 412A. [Figure 412G] FIG. 412G is a top view of the flat material used to form the paddle structure of FIG. 412A. [Figure 412H] FIG. 412H shows an example of a valve repair device or implant including the paddle structure of FIG. 412A in a fully retracted position. [Figure 412I] FIG. 412I shows the valve repair device or implant of FIG. 412H with the paddle structure in a partially open position. [Figure 412J] FIG. 412J shows the valve repair device or implant of FIG. 412H with the paddle structures in a laterally extended or laterally open position. [Figure 412K] FIG. 412K is a perspective view of a die that can be used to form the paddle structure of FIG. 412A. [Figure 412L] FIG. 412L is a perspective view of the die illustrated in FIG. 412K. [Figure 413] 413A and 413B show an example of a valve repair device or implant having a compressible outer paddle portion. [Figure 414A] FIG. 414A is a perspective view of one example of a valve repair device or implant having a compressible outer paddle portion. [Figure 414B] FIG. 414B is a perspective view of the paddles in the valve repair device or implant shown in FIG. 414A. [Figure 415A] FIG. 415A is a side view of an example valve repair device or implant in an open position and with a gap filling material. [Figure 415B]FIG. 415B is a view of the valve repair device or implant of FIG. 415A attached to the leaflets of the native valve as viewed from the ventricular side of the native valve. [Figure 415C] FIG. 415C is a side view of the valve repair device or implant of FIG. 415A in an occluded state. [Figure 415D] FIG. 415D is a front view of the valve repair device or implant of FIG. 415A in an occluded state. [Figure 416A] FIG. 416A is a side view of one example valve repair device or implant in an open position and with a gap filling material. [Figure 416B] FIG. 416B is a view of the valve repair device or implant of FIG. 416A attached to the leaflets of the native valve as viewed from the ventricular side of the native valve. [Figure 416C] FIG. 416C is a side view of the valve repair device or implant of FIG. 416A in an occluded state. [Figure 416D] FIG. 416D is a front view of the valve repair device or implant of FIG. 416A in an occluded state. [Figure 417] FIG. 417 shows a perspective view of one example of a portion of a paddle frame and drive device for an implantable device. [Figure 418] FIG. 418 shows a perspective cross-sectional view of a portion of the paddle frame and drive device of FIG. [Fig. 419] FIG. 419 shows a cross-sectional front view of a portion of the paddle frame and drive device of FIG. [Figure 420] FIG. 420 shows a bottom view of a portion of the paddle frame and drive device of FIG. [Figure 421] FIG. 421 shows a front cross-sectional view of one example of a portion of a paddle frame and drive device for an implantable device. [Figure 422]FIG. 422 is a front cross-sectional view of a portion of the paddle frame and drive device of FIG. 421, with the delivery device conduit attached to the drive device and the drive member attached to the paddle frame. [Figure 423] FIG. 423 shows a perspective cross-sectional view of a portion of the paddle frame of FIG. [Figure 424] FIG. 424 shows a top view of the drive device of FIG. [Figure 425] FIG. 425 shows a cross-sectional front view of a portion of the paddle frame and drive device of FIG. 421 without the conduit and drive member of FIG. [Figure 426] FIG. 426 shows a cross-sectional front view of a portion of the paddle frame and drive device of FIG. 421 with the conduit and drive member of FIG. [Figure 427] Figures 427-429 show various views of one example of a connection between a conduit of an implantable device and a component of the implantable device. [Figure 428] Same as above. [Figure 429] Same as above. [Fig. 430] Figures 430-432 show various views of the connection between the conduit and the implantable device components of Figures 427-429, with the conduit moved proximally relative to the implantable device. [Figure 431] Same as above. [Figure 432] Same as above. [Figure 433] Figures 433-435 show various views of the connection between the conduit and components of the implantable device in Figures 427-429, with the conduit disconnected from the implantable device. [Fig. 434] Same as above. [Figure 435] Same as above. [Figure 436]FIG. 436 is a front view of an exemplary coupling between a conduit of an implantable device and a component of the implantable device, with the drive member extending through the conduit and into the implantable device. [Figure 437] Figure 437 illustrates the coupling between the conduit and the component of the implantable device of Figure 436, with the drive member moved proximally relative to the conduit. [Fig. 438] Figure 438 illustrates the connection between the conduit and a component of the implantable device of Figure 436, with the conduit moved proximally relative to the implantable device. [Figure 439] Figure 439 shows the connection between the conduit and the components of the implantable device of Figure 436, with the conduit disconnected from the implantable device. [Fig. 440] FIG. 440 shows a perspective view of one example of a connection between a paddle frame and a drive member of an implantable device. [Figure 441] FIG. 441 shows a front view of an example of a coupling portion for the drive member of FIG. [Figure 442] FIG. 442 shows a side view of one example of a coupling portion for the drive member of FIG. [Figure 443] FIG. 443 shows a partial front view of the paddle frame of FIG. [Figure 444] FIG. 444 shows a front cross-sectional view of one example of a portion of a paddle frame and drive device for an implantable device. [Figure 445] FIG. 445 shows an example of a distal portion of an exemplary drive shaft for the drive device of FIG. [Figure 446] FIG. 446 is a cross-sectional view of one example of a conduit for the drive device of FIG. 444, with the distal portion of the drive shaft of FIG. 445 moving through the conduit. DETAILED DESCRIPTION OF THE INVENTION

[0042] In the following description, reference is made to the accompanying drawings that illustrate example implementations of the present disclosure. Some implementations having different structure and operation do not depart from the scope of the present disclosure.

[0043] Exemplary implementations of the present disclosure are directed to systems, devices, methods, etc. for repairing defective heart valves. For example, various implementations of implantable devices, valve repair devices, implants, and systems (including systems for delivering them) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless they are mutually exclusive or physically impossible. Furthermore, the techniques and methods herein can be performed 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.

[0044] As described herein, when one or more components are described as being connected, coupled, fastened, coupled, attached, or otherwise interconnected, such interconnection can be direct, such as between the components, or can be indirect, such as through the use of one or more intermediate components. Also, as described herein, references to a "member," "component," or "portion" are not limited to a single structural member, component, or element, but can include an assembly of components, members, or elements. Also, as described herein, the terms "substantially" and "about" 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%).

[0045] 1 and 2 illustrate 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, an aortic valve AV separates the left ventricle LV from the ascending aorta AA, and a 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 inward across their respective valve openings and merge or "coapt" together during flow to form a unidirectional fluid-blocking 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 anatomical structures of the left atrium LA and left ventricle LV will now be described in more detail. However, the devices described herein can also be used in the repair of other native valves, for example, the devices can be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0046] The left atrium LA receives oxygen-rich blood from the lungs. During the diastolic phase, as shown in FIG. 1 , blood already collected in the left atrium LA (during the contraction phase) moves into the left ventricle LV through the mitral valve MV due to the expansion of the left ventricle LV. During the systolic phase, as shown in FIG. 2 , the left ventricle LV contracts, pumping 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 devices described herein are used to restore the function of a defective mitral valve MV. That is, the devices are configured to assist in the closure of the mitral valve leaflets to prevent blood from flowing back from the left ventricle LV into the left atrium LA. Although many of the devices described in this application are designed to easily grasp and secure the native valve leaflets around a coaptation member or spacer that beneficially acts as a filler within the regurgitant opening to prevent or inhibit backflow during systole, this is not required.

[0047] Referring now to FIGS. 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 FIGS. 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 at the base of the chordae tendineae CT and within the wall of the left ventricle LV) 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 and 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 functions to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve MV is closed. 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 medial surfaces of the leaflets meet at their free ends and the leaflets 20, 22 begin to retract and splay away from each other. The leaflets 20, 22 splay away toward the atrium until each leaflet contacts the mitral annulus.

[0048] Various disease processes can impair the proper function of one or more native valves in 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 due to a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other cardiac diseases (e.g., cardiomyopathy, etc.) can distort the shape of the native valve, which can cause the native valve to malfunction. However, the majority of patients undergoing 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.

[0049] Generally, native valves can malfunction in different ways, including (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when the native valve does not open completely, causing obstruction to blood flow. Typically, valve stenosis is caused by the accumulation of calcified material on the valve leaflets, which thicken and impair the valve's ability to open completely to allow forward blood flow. Valve regurgitation occurs when the valve leaflets do not close completely, allowing blood to leak back into the previous chamber (e.g., blood leaking from the left ventricle into the left atrium).

[0050] There are three major mechanisms by which native valves become regurgitant or incompetent, including Carpentier Type I, Type II, and Type III insufficiency. Carpentier Type I insufficiency involves dilatation of the valve annulus, causing normally functioning leaflets to separate and no longer form a tight seal (i.e., the leaflets do not coapt properly). Included in Type I insufficiency is leaflet perforation, such as occurs in endocarditis. Carpentier Type II insufficiency involves prolapse of one or more native valve leaflets above the plane of coaptation. Carpentier Type III insufficiency involves restricted movement of one or more native valve leaflets, resulting in abnormal leaflet restriction below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0051] Referring to FIG. 5, when a healthy mitral valve MV is in the occluded position, the anterior leaflet 20 and the posterior leaflet 22 coapt, thereby preventing blood from leaking from the left ventricle LV into the left atrium LA. Referring to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV displace into the left atrium LA during systole, causing the edges of the leaflets 20, 22 to no longer contact each other. This lack of coaptation creates a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow back from the left ventricle LV into the left atrium LA during systole, as illustrated by the mitral regurgitation MR flow path shown in FIG. 3. Referring to FIG. 6, the gap 26 can 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, gap 26 can have a width W greater than 15 mm. As discussed above, there are several different ways in which a valve leaflet (e.g., leaflets 20, 22 of the mitral valve MV) can become incompetent, causing valve regurgitation.

[0052] In any of the above situations, a valve repair device or implant is desirable that can engage the anterior and posterior leaflets 20, 22 to close the gap 26 and prevent backflow of blood through the mitral valve MV. As can be seen in Figure 4, an abstract representation of an implantable device, valve repair device, or implant 10 is shown implanted between the leaflets 20, 22 to prevent backflow during systole (compare Figure 3 with Figure 4). In some implementations, the coaptation members (e.g., spacers, connecting members, gap fillers, etc.) of device 10 have a generally tapered or triangular shape to naturally conform to the shape of the native valve and the nature of its expanded (towards the annulus) leaflets. In this application, the terms spacer, coaptation member, connecting member, and gap filler are used interchangeably and refer to members that fill a portion of the space between the leaflets of a native valve and / or are configured to engage or "coapt" the leaflets of a native valve (e.g., to connect the leaflets not only to each other but also to the coaptation member, connecting member, spacer, etc.).

[0053] 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), while 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 strain on the heart and, if left untreated, can lead to very serious conditions, including endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. The left side of the heart (i.e., the left atrium (LA), left ventricle (LV), mitral valve (MV), and aortic valve (AV)) is primarily responsible for circulating blood throughout the body. Therefore, because pressures are substantially higher on the left side of the heart, malfunction of the mitral valve (MV) or aortic valve (AV) is particularly problematic and often life-threatening.

[0054] Dysfunctional native heart valves can be either repaired or replaced. Repair typically involves preserving and modifying a patient's native valve. Replacement typically involves replacing a patient's native valve with a biological or mechanical substitute. Typically, the aortic valve (AV) and pulmonary valve (PV) are more prone to stenosis. Because stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic or pulmonary valve can involve removal of the valve and replacement with a surgically implanted valve, or replacement 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, can prevent the mitral valve (MV) or tricuspid valve (TV) from closing properly, allowing regurgitation or backflow of blood from the ventricle into the atrium (e.g., a deformed 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. Deformities in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. Additionally, regurgitation can occur due to dysfunction of the chordae tendineae CT (e.g., the chordae tendineae CT can stretch or rupture), allowing the anterior and posterior leaflets 20 and 22 to evertate, allowing blood to flow back into the left atrium LA. Problems caused by dysfunctional chordae tendineae CT can be corrected by repairing the chordae tendineae CT or by repairing the structure of the mitral valve MV (e.g., by fixating the leaflets 20, 22 at the affected portion of the mitral valve).

[0055] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it will be understood that the devices and concepts provided herein can be used to repair any native valve, as well as any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or block the 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, septal leaflet 32, and posterior leaflet 34 to prevent or block the backflow of blood from the right ventricle into the right atrium. Additionally, any of the devices and concepts provided herein can be used together on all three leaflets 30, 32, and 34 to prevent or block the backflow of blood from the right ventricle into the right atrium. That is, the valve repair device or implant provided herein can be centrally positioned between the three leaflets 30, 32, and 34.

[0056] An exemplary implantable device (e.g., implantable device, etc.) or implant can optionally include a coaptation member (e.g., a spacer, a connecting member, a gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, an implantable device or implant can include any combination or subcombination of the features disclosed herein without a coaptation member. When included, the coaptation member (e.g., a connecting member, 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 or preventing backflow as described above. The coaptation member can be structured to be impermeable to blood (or resist blood flow therethrough) and to allow the native valve leaflets to close around the coaptation member during ventricular systole, thereby blocking backflow of blood from the left ventricle into the left atrium and from the right ventricle into the right atrium. The device or implant can be configured to seal against two or three native valve leaflets, i.e., the device may be used in native mitral (bicuspid) and native tricuspid valves. The coaptation members are sometimes referred to herein as spacers because they may fill the space between native valve leaflets (e.g., mitral valve 20, 22 or tricuspid valve leaflets 30, 32, 34) that are not completely occluded and are not functioning properly.

[0057] The optional coaptation member (e.g., spacer, connecting member, etc.) can have a variety of shapes. In some implementations, the coaptation member can have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the coaptation member can have an elliptical, oval, crescent, rectangular, or various other non-cylindrical cross-sectional shapes. In some implementations, the coaptation member can have an atrial portion positioned within or adjacent to the atrium, a ventricular or lower portion positioned within or adjacent to the ventricle, and lateral sides extending between the native tricuspid valve leaflets. In some implementations configured for use in a tricuspid valve, the atrial or upper portion is positioned within or adjacent to the right atrium, the ventricular or lower portion is positioned within or adjacent to the right ventricle, and the lateral sides extend between the native tricuspid valve leaflets.

[0058] In some implementations, the anchors can be configured to secure the device to one or both of the native valve leaflets, such that the coaptation member is positioned between two native leaflets. In some implementations configured for use in a tricuspid valve, the anchors can be configured to secure the device to one, two, or three of the tricuspid valve leaflets, such that the coaptation member is positioned between three native leaflets. In some implementations, the anchors can be attached to the coaptation member at a location adjacent to the ventricular portion of the coaptation member. In some implementations, the anchors can be attached to a drive member, such as a shaft or drive wire, to which the coaptation member is also attached. In some implementations, the anchors and coaptation member can be independently positioned relative to each other by separately moving the anchor and coaptation member along the longitudinal axis of the drive member (e.g., drive shaft, drive rod, drive tube, drive wire, etc.). In some implementations, the anchors and coaptation member can be simultaneously positioned by moving the anchor and coaptation member together along the longitudinal axis of the drive member, such as a shaft, drive wire, etc. The anchors can be configured to be positioned behind the native valve leaflets when implanted so that the leaflets are gripped by the anchors.

[0059] The device or implant can be configured to be implanted via a delivery system or other delivery means. The delivery system can include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, etc. The coaptation members and anchors can be compressible to a radially compressed state and self-expandable to a radially expanded state when the compressive pressure is released. The device can be configured such that the anchors expand radially away from the coaptation members, which are initially still compressed, to form a gap between the coaptation members and the anchors. A native valve leaflet can then be positioned within the gap. The coaptation members can radially expand to close the gap between the coaptation members and the anchors, thereby capturing the leaflet between the coaptation members and the anchors. In some implementations, the anchors and coaptation members are optionally configured to self-expand. Implantation methods for various implementations can 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 / 022136, 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, mutatis mutandis, be performed 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.

[0060] The disclosed device or implant can be configured with anchors connected to the valve leaflets, utilizing tension from the natural chordae tendineae to resist the large systolic pressures that urge the device toward the left atrium. During diastole, the device can rely on compressive and retaining forces applied to the leaflets gripped by the anchors.

[0061] 8-15, a schematic illustration of an implantable device or implant 100 (e.g., a prosthetic spacer device, a valve repair device, etc.) is shown in various stages of deployment. 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. Device 100 can include any other features of implantable devices or implants described in this or the above-cited applications, and device 100 can 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 or the above-cited applications).

[0062] 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, sheath, guide catheter / sheath, delivery catheter / sheath, steerable catheter, implant catheter, tube, channel, pathway, combinations thereof, etc. The device or implant 100 includes an interface or connecting portion 104 and an anchor portion 106.

[0063] In some implementations, the interface portion 104 of the device or implant 100 includes an interface member or interface means 110 (e.g., a spacer, plug, filler, foam, sheet, membrane, linking member, etc.) configured to be implanted between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and slidably attached to an actuation member 112 (e.g., a drive wire, drive shaft, drive tube, etc.). The anchor portion 106 includes one or more anchors 108 that are actuatable between open and closed states and can take a variety of forms, such as, for example, paddles, gripping members, or the like. Actuation of the actuation means or member 112 opens and closes the anchor portion 106 of the device 100 to grip the leaflets of the native valve during implantation. The drive means or drive member 112 (as well as other drive means and drive members herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), can be formed from a variety of different materials, and can have a variety of configurations. As one example, the drive member can be threaded such that rotationally driving the drive member moves the anchor portion 106 relative to the interface portion 104. Alternatively, the drive member can be unthreaded such that pushing or pulling the drive member 112 moves the anchor portion 106 relative to the interface portion 104.

[0064] 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 joining means or joining member 110 by portions 124, 126, 128. The portions 124, 126, 128 can be articulated and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 120, inner paddle 122, joining member 110, and cap 114 by portions 124, 126, 128 can constrain the device to the positions and movements illustrated herein.

[0065] In some implementations, the delivery system 102 includes a steerable catheter, an implant catheter, and a drive means or member 112 (e.g., a drive wire, a drive shaft, etc.), which can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the drive means or member 112 extends through the delivery catheter and through the joint means or member 110 to a distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extension and retraction of the drive member 112 increase and decrease, respectively, the spacing between the joint member 110 and the distal end of the device (e.g., the cap 114 or other attachment portion). In some implementations, a collar or other attachment member directly or indirectly removably attaches the joint member 110 to the delivery system 102, whereby the drive means or drive member 112 slides through the collar or other attachment member, and in some implementations, through the joint means or joint member 110 when actuated, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0066] In some implementations, the anchor portion 106 and / or the anchor 108 may include an attachment portion or gripping member. The illustrated gripping member may include a clasp 130 including a base or fixed arm 132, a movable arm 134, optional barbs, friction-enhancing members, or other fastening means 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesive, 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 positioned proximate to the joining means or joining member 110. In some implementations, the clasp (e.g., a barbed clasp, etc.) has a flat surface and does not fit within a recess in the inner paddle. Rather, the flat portion of the clasp is positioned against the surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the clasp 130. Joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, joint portion 138 is a flexible member of material integrally formed with fixed arm 132 and movable arm 134. Fixed arm 132 is attached to inner paddle 122 and remains stationary or substantially stationary relative to inner paddle 122 when movable arm 134 opens, thereby releasing clasp 130 and exposing friction-enhancing member, or securing means 136.

[0067] In some implementations, the clasp 130 is opened by applying tension to a drive 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 drive line 116 extends through the delivery system 102 (e.g., through a steerable catheter and / or an implant catheter). Other drive mechanisms are also possible.

[0068] The drive 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 in the closed position, the clasp 130 continues to provide a clamping force against the grasped native valve leaflet. This clamping force remains constant regardless of the position of the inner paddle 122. Optional barbs, friction-enhancing members, or other fixation means 136 of the clasp 130 can grip, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0069] During implantation, the paddles 120, 122 may open and close to capture a native valve leaflet (e.g., a native mitral valve leaflet) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation means or member 110. The clasp 130 may be used to capture and / or further secure the native valve leaflet by engaging the leaflet with barbs, friction-enhancing members, or securing means 136 and clamping the leaflet between the movable arm 134 and the securing arm 132. The barbs, friction-enhancing members, or other securing means 136 (e.g., barbs, projections, ridges, grooves, textured surfaces, adhesives, etc.) on the clasp or barbed clasp 130 may increase friction against or partially or fully pierce the leaflet. The drive line 116 may be individually actuated to allow each clasp 130 to be individually opened and closed. Individual actuation allows for grasping one leaflet at a time, or allows repositioning of clasp 130 on a leaflet that is not adequately grasped, without altering the good grip on the other leaflets. Clasp 130 can be opened and closed relative to the position of inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing for grasping of the leaflets in various positions as a particular situation requires.

[0070] Referring now to FIG. 8 , device 100 is shown in an extended or fully open state for deployment from an implant delivery catheter of delivery system 102. In the fully open position, device 100 is positioned at the end of the catheter in delivery system 102 because it takes up the least space and allows for the use of the smallest catheter (or the largest device 100 for a given catheter size). In the extended state, cap 114 is spaced from the attachment means or attachment member 110 so that paddles 120, 122 are fully extended. In some implementations, the angle formed between the interior of outer paddle 120 and inner paddle 122 is approximately 180 degrees. Clasp 130 is maintained in an occluded state during deployment through delivery system 102 to prevent barbs, friction-enhancing members, or other securing means 136 ( FIG. 9 ) from catching or damaging the delivery system 102 or tissue within the patient's heart. The drive line 116 may extend from and be attached to a movable arm 134 .

[0071] 9, device 100 is shown in an extended, uncoiled state similar to that of FIG. 8, but with clasp 130 in a fully open position, ranging from about 140 degrees to about 200 degrees, ranging from about 170 degrees to about 190 degrees, or about 180 degrees, between fixed portion 132 and movable portion 134 of clasp 130. Fully opening paddles 120, 122 and clasp 130 has been found to improve ease of release or detachment of device 100 from patient anatomical structures, such as chordae tendineae CT, upon implantation.

[0072] Referring now to FIG. 10 , the device 100 is shown in a shortened or fully occluded state. The compact size of the device 100 in the shortened state allows for easier manipulation and placement within the heart. To move the device 100 from the extended state to the shortened state, the drive means or member 112 is retracted, pulling the cap 114 toward the attachment means or member 110. The connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained in movement such that a compressive force acting from the cap 114 onto the outer paddle 120 retracts the paddle or gripping member toward the attachment means or member 110 and moves radially outward. When moving from the open position to the occluded position, the outer paddle 120 maintains an acute angle relative to the drive means or member 112. The outer paddle 120 can optionally be biased toward the occluded position. The inner paddle 122 moves through a significant angle during the same movement to orient itself away from the open joint means or joint member 110 and to fold along the side of the closed joint means or joint member 110. In some implementations, the inner paddle 122 is thinner and / or narrower than the outer paddle 120, and the connecting portions 126, 128 (e.g., joints, flexible connections, etc.) connected to the inner paddle 122 can be thinner and / or more flexible. For example, this increased flexibility can allow for greater movement compared to the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some implementations, the outer paddle 120 is narrower than the inner paddle 122. The connecting portions 126, 128 connected to the inner paddle 122 can be more flexible to allow for greater movement compared to, for example, the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some implementations, the inner paddle 122 can be the same width or substantially the same width as the outer paddle.

[0073] 11-13, the device 100 is shown in a partially open state and ready to grasp. To transition from the fully occluded state to the partially open state, the actuation means or actuation member (e.g., drive wire, drive shaft, etc.) is extended, pushing the cap 114 away from the coaptation means or actuation member 110, thereby pulling the outer paddle 120 and the inner paddle 122, partially expanding the anchor or anchor portion 106. The drive line 116 is also retracted, thereby releasing the clasp 130 so that it can grasp the leaflets. In some implementations, the pair of inner and outer paddles 122, 120 are actuated together, rather than individually, by a single actuation means or single actuation member 112. The position of the clasp 130 also depends on the position of the paddles 122, 120. 10, closing the paddles 122, 120 also closes the clasp. In some implementations, the paddles 120, 122 can be independently controllable. For example, the device 100 can have two actuation members and two independent caps (or other attachments), such that one independent actuation member (e.g., a wire, shaft, etc.) and cap (or other attachment) can be used to control one paddle, and the other independent actuation member and cap (or other attachment) can be used to control the other paddle.

[0074] 12, stretching one drive line 116 can close one clasp 130. Referring now to FIG. 13, stretching the other drive line 116 can close the other clasp 130. By repeatedly driving one or both drive lines 116, the clasps 130 can be repeatedly opened and closed.

[0075] 14, device 100 is shown in a fully occluded and deployed state. The delivery system or means 102 and drive means or member 112 are retracted, leaving paddles 120, 122 and clasp 130 in the fully occluded position. After deployment, device 100 can be maintained in the fully occluded position by a mechanical latch, or it can be biased to remain occluded using a spring material, such as steel, other metals, plastics, composites, or a shape memory alloy, such as Nitinol. For example, the connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from a metal such as steel or from a shape memory alloy such as Nitinol, which may be fabricated from wire, sheet, tube, or laser-sintered powder, and are biased to hold the outer paddle 120 in an occluded state around the coaptation means or member 110 and to clamp the clasp 130 around the native valve leaflets. Similarly, the fixed and movable arms 132, 134 of the clasp 130 are biased to clamp the 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) can be formed from a metal or any other suitable resilient material, such as a polymeric material, to maintain the device 100 in an occluded state after implantation.

[0076] Figure 15 illustrates an example in which the paddles 120, 122 are independently controllable. The device 101 illustrated in Figure 15 is similar to the device illustrated in Figure 11, except that the device 100 of Figure 15 includes an actuation member configured as two independent actuation members or actuation wires 111, 113 coupled to two independent caps 115, 117. To transition the first inner paddle 122 and the first outer paddle 120 from a fully occluded state to a partially open state, the actuation means or actuation member 111 is extended to push the cap 115 away from the abutment means or abutment member 110, thereby pulling the outer paddle 120 and pulling the inner paddle 122, thereby partially expanding the first anchor 108. To transition the second inner paddle 122 and the second outer paddle 120 from the fully closed state to the partially open state, the drive means or drive member 113 is extended to push the cap 115 away from the joining means or drive member 110, thereby pulling the outer paddle 120 and pulling the inner paddle 122, partially expanding the second anchor 108. The independent paddle control illustrated in Figure 15 can be implemented in any of the devices disclosed herein. For comparison, in the example illustrated in Figure 11, the pair of inner and outer paddles 122, 120 are driven together, rather than individually, by a single drive means or drive member 112.

[0077] 16-21, the implantable device 100 of FIGS. 8-14 is shown being delivered and implanted within the native mitral valve MV of the heart H. Referring 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 the fully open position as shown in FIG. 16. The drive means or drive member 112 is then retracted to move the implant / device to the fully occluded position shown in FIG. 17.

[0078] As can be seen in Figure 18, the implant / device is driven into a position within the mitral valve MV and into the ventricle LV, and is in a partially open state to grasp the leaflets 20, 22. For example, the steerable catheter can be advanced to steer or bend it, thereby positioning it as shown in Figure 18. An implant catheter connected to the implant / device can be advanced from within the steerable catheter, thereby positioning the implant as shown in Figure 18.

[0079] 19, the implant catheter is retracted into the steerable catheter to position the mitral valve leaflets 20, 22 within the clasps 130. The drive line 116 is extended to occlude one of the clasps 130 and capture the leaflet 20. FIG. 20 illustrates that the other drive line 116 is then extended to occlude the other clasp 130 and capture the remaining leaflet 22. Furthermore, as can be seen in FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), drive means or member 112, and drive line 116 are then retracted to fully occlude and deploy the device or implant 100 within the native mitral valve MV.

[0080] 22-27, an example of an implantable device or implant or implants 200 is shown. The implantable device 200 is one of many different configurations of the device 100 shown generally in FIGS. 8-14. The device 200 may include any other features of the implantable devices or implants described herein, and the device 200 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). The device / implant 200 may be a prosthetic spacer device, a valve repair device, or another type of implant that attaches to the leaflets of a native valve.

[0081] In some implementations, implantable device or implant 200 includes a mating or connecting portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some implementations, the mating or connecting portion 204 of the device optionally includes a mating member 210 (e.g., a spacer, connecting member, plug, membrane, sheet, etc.) for implantation between the leaflets of a native valve. In some implementations, anchor portion 206 includes multiple anchors 208. The anchors can be configured in various manners. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension or paddle frame 224, and a clasp 230. In some implementations, the attachment portion 205 includes a first or proximal collar 211 (or other attachment member) 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 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, a combination thereof, or the like.

[0082] In some implementations, the junction members 210 and paddles 220, 222 can be formed from a metal fabric such as a mesh, woven fabric, braided fabric, or any other suitable formed or laser-cut or otherwise cut flexible material, which can be cloth, shape-memory alloy wire such as Nitinol to provide shape-setting capabilities, or any other flexible material suitable for implantation within the human body.

[0083] A drive member 212 (e.g., a drive shaft, drive rod, drive tube, drive wire, drive line, etc.) extends from the delivery system 202 to engage the implantable device or implant 200 and enable drive of the implantable device or implant 200. In some implementations, the drive member 212 extends through the capture mechanism 213, the proximal collar 211, and the joint member 210 to engage the cap 214 of the distal portion 207. The drive member 212 can be configured to releasably engage the cap 214 via a threaded or similar connection, allowing the drive member 212 to be disengaged and removed from the device 200 after implantation.

[0084] The abutment member 210 extends from the proximal collar 211 (or other attachment member) to the inner paddle 222. In some implementations, the abutment member 210 has a generally elongated, circular shape, although other shapes and configurations are possible. In some implementations, the abutment member 210 has an oval 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), or a circular shape or cross-section when viewed from the side (e.g., FIG. 24). A blend of these three geometries can result in a three-dimensional shape for the illustrated abutment member 210 that achieves the benefits described herein. It can be appreciated that the circular shape of the abutment member 210 also substantially conforms to or approximates the shape of the paddle frame 224 when viewed from above.

[0085] The size and / or shape of the coaptation member 210 can be selected to minimize the number of implants (preferably one) required per patient while maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the apex of the coaptation member is approximately 5 mm, and the medial-lateral distance at the widest point of the coaptation member is approximately 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and the overall shape strategy described above. It will be readily apparent that using other anterior-posterior and medial-lateral distances as a starting point for the device will result in a device with different dimensions. Furthermore, using other size and shape strategies described above will also result in a device with different dimensions.

[0086] In some implementations, outer paddle 220 is articulably attached to cap 214 of distal portion 207 by connecting portion 221 and to inner paddle 222 by connecting portion 223. Inner paddle 222 is articulably attached to the joint member by connecting portion 225. In this manner, anchor 208 is configured similar to a leg in that inner paddle 222 resembles the upper portion of the leg, outer paddle 220 resembles the lower portion of the leg, and connecting portion 223 resembles the knee portion of the leg.

[0087] In some implementations, the inner paddle 222 is hard, relatively hard, rigid, has a rigid portion, and / or is rigidified by a reinforcing member or securing portion 232 of the clasp 230. The rigidification 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 joints can all be interconnected as described herein, thereby constraining the device 200 to the movements and positions as shown and described herein.

[0088] In some implementations, the paddle frame 224 is attached to the cap 214 at the distal portion 207 and extends to a connection portion 223 between the inner paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is formed from a stiffer and more rigid material compared to the material forming the paddles 222, 220 such that the paddle frame 224 provides support for the paddles 222, 220.

[0089] As can be seen in FIG. 51 , the paddle frame 224 provides additional clamping force between the inner paddle 222 and the coaptation member 210 and helps wrap the leaflets around the sides of the coaptation member 210 for a better seal between the coaptation member 210 and the leaflets. That is, the paddle frame 224 can 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 member 210 can 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 connection 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 outer paddle 220 ) and by its attachment to the cap 214 .

[0090] Configuring the paddle frame 224 in this manner provides an increased surface area compared to the outer paddles 220 alone, which can, for example, facilitate easier grasping and fixation of the native leaflets. The increased surface area can also distribute the clamping force of the paddles 220 and paddle frame 224 on 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 can also clamp the native leaflets against the implantable device or implant 200 such that the native leaflets are generally coapted around the coaptation or joining members 210. This can, for example, improve the sealing of the native leaflets 20, 22, thereby preventing or further reducing mitral regurgitation.

[0091] In some implementations, the clasp includes a movable arm coupled to the anchor. In some implementations, the clasp 230 includes a base or fixed arm 232, a movable arm 234, a barb 236, and a joint portion 238. The fixed arm 232 is attached to the inner paddle 222 with the joint portion 238 disposed adjacent to the joining member 210. The joint portion 238 is spring loaded so that the fixed arm 232 and the movable arm 234 are biased toward each other when the clasp 230 is in the closed position. In some implementations, the clasp 230 includes friction-enhancing members or fastening means, such as barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.

[0092] 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 can be attached to the inner paddle 222 using 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, thereby opening the clasp 230 and exposing the barb or other friction-enhancing member 236. The clasp 230 is opened by applying tension to the drive line 216 (e.g., as shown in FIGS. 43-48 ) attached to the hole 235 of the movable arm 234, thereby causing the movable arm 234 to articulate, pivot, and / or bend at a joint portion 238.

[0093] 29, an enlarged view of one of the leaflets 20, 22 grasped by a clasp, such as clasp 230, is shown. The leaflets 20, 22 are grasped between a movable arm 234 and a fixation arm of the clasp 230. The tissue of the leaflets 20, 22 is not pierced by the barbs or frictional enhancement members 236, although in some implementations, the barbs 236 may partially or completely pierce the leaflets 20, 22. The angle and height of the barbs or frictional enhancement members 236 relative to the movable arm 234 help 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 barbs or frictional enhancement members 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 positioning of the locking arms 232 near the barbs / frictional enhancement members 236 when the clasp 230 is closed. In this configuration, the tissue is molded into an S-shaped, curved path by the locking arms 232, the movable arms 234, and the barbs / frictional enhancement members 236. Thus, forces pulling the leaflets 20, 22 away from the clasp 230 encourage the tissue to further engage the barbs / frictional enhancement members 236 before the leaflets 20, 22 can prolapse. For example, tension on the leaflets during diastole can encourage the barbs 236 to pull toward the ends of the leaflets 20, 22. Thus, the S-shaped path can take advantage of leaflet tension during diastole to more tightly engage the leaflets 20, 22 against the barbs / frictional enhancement members 236.

[0094] 25 , the prosthetic device or implant 200 can also include a cover 240. In some implementations, the cover 240 can be disposed on the joint members 210, on the outer paddle 220 and inner paddle 222, and / or on the paddle frame 224. The cover 240 can be configured to prevent or reduce blood flow through the prosthetic device or implant 200 and / or to promote natural tissue engraftment. In some implementations, the cover 240 can be a cloth or fabric, such as PET, velour, or other suitable fabric. In some implementations, instead of or in addition to a cloth, the cover 240 can include a coating (e.g., a polymer) applied to the implantable device or implant 200.

[0095] During implantation, the paddles 220, 222 of the anchor 208 can be opened and closed to capture the native valve leaflets 20, 22 between the paddles 220, 222 and the coaptation member 210. The anchor 208 can be actuated between a closed position ( FIGS. 22-25 ) and various open positions ( FIGS. 26-37 ) by extending and retracting the drive member 212. Extending and retracting the drive member 212 increases and decreases the spacing between the coaptation member 210 and the cap 214, respectively. The proximal collar 211 (or other attachment member) and coaptation member 210 slide along the drive member 212 during actuation, thereby changing the spacing between the coaptation member 210 and the cap 214 and actuating the paddles 220, 220 between different positions, thereby capturing the mitral valve leaflets 20, 22 during implantation.

[0096] To open and close the device 200, the pair of inner and outer paddles 222, 220 are driven together, rather than individually, by a single drive member 212. Additionally, 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 closes 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).

[0097] In some implementations, the clasps 230 further secure the native leaflets 20, 22 by engaging the leaflets 20, 22 with barbs and / or other friction-enhancing members 236 and further by sandwiching the leaflets 20, 22 between the movable arm 234 and the fixed arm 232. In some implementations, the clasps 230 are barbed clasps that include barbs that increase friction with the leaflets 20, 22 and / or that can partially or fully pierce the leaflets 20, 22. The drive lines 216 (FIGS. 43-48) can be individually actuated to allow each clasp 230 to be opened and closed individually. 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 has not been adequately gripped without altering its good grip on the other leaflets 20, 22. The clasp 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.

[0098] 22-25, the device 200 is shown in the closed position. When closed, the inner paddle 222 is positioned between the outer paddle 220 and the coaptation member 210. The clasp 230 is positioned between the inner paddle 222 and the coaptation member 210. Upon successfully capturing the native leaflets 20, 22, the device 200 is actuated into and held in the closed position such that the leaflets 20, 22 are secured within the device 200 by the clasp 230 and pressed against the coaptation member 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 member 210 (e.g., as can be seen in FIG. 51) to more securely grip the leaflets 20, 22 when the device 200 is closed. The curved shape and rounded edges of the outer paddle 220 also prevent or inhibit tearing of the leaflet tissue.

[0099] 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 drive member 212 from a fully retracted position to a fully extended position.

[0100] 30-31, device 200 is shown in a partially open position. Device 200 is driven into the partially open position by extending drive member 212. The extension of drive member 212 pulls down the bottom of outer paddle 220 and paddle frame 224, which in turn pulls down inner paddle 222, to which it is connected. Because proximal collar 211 (or other attachment member) and abutment member 210 are held in place by capture mechanism 213, inner paddle 222 is allowed to articulate, pivot, and / or bend toward the opening. Inner paddle 222, outer paddle 220, and 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 member 210 and the inner paddle 222 that can receive and grasp 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 form a second gap for grasping 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 member 210.

[0101] 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 to extend the drive member 212 as described above, thereby increasing the distance between the joint member 210 and the cap 214 of the distal portion 207. Continued extension of the drive member 212 pulls the outer paddle 220 and the paddle frame 224 downward, thereby spreading the inner paddle 222 further away from the joint member 210. In the laterally extended or laterally open position, the inner paddle 222 extends more horizontally and forms an angle of approximately 90 degrees with respect to the joint member 210 compared to other positions of the device 200. Similarly, the paddle frame 224 is in its maximum spread position when the device 200 is in the laterally extended or laterally open position. The increased gap formed between the joining member 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 joining member 210, thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0102] 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 to extend the drive member 212 as described above, thereby increasing the distance between the joint member 210 and the cap 214 of the distal portion 207. Continuing to extend the drive member 212 pulls the outer paddle 220 and paddle frame 224 downward, thereby spreading the inner paddle 222 further away from the joint member 210. In the three-quarters extended position, the inner paddle 222 is open to an angle of greater than 90 degrees, approximately 135 degrees, relative to the joint member 210. The paddle frame 224 is less spread apart than in the laterally extended or laterally released positions and begins to move inward toward the drive member 212 as the drive member 212 is further extended. The outer paddle 220 also bends backward toward the drive member 212. Similar to the laterally extended or laterally open position, the increased gap formed between the joining member 210 and the inner paddle 222 in the laterally extended or laterally open position allows the clasp 230 to open even further (FIG. 35), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0103] 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 to extend the drive member 212 as described above, thereby increasing the distance between the joint member 210 and the cap 214 of the distal portion 207 to the maximum distance allowable by the device 200. Continuing to extend the drive member 212 pulls the outer paddle 220 and paddle frame 224 downward, thereby spreading the inner paddle 222 further away from the joint member 210. The outer paddle 220 and paddle frame 224 are driven to a position where they are closer together relative to the drive member. In the fully extended position, the inner paddle 222 is open to an angle of approximately 180 degrees relative to the joint member 210. In the fully extended position, the inner and outer paddles 222, 220 are linearly extended, forming an angle of approximately 180 degrees between them. The fully extended position of the device 200 provides the largest gap between the joint member 210 and the inner paddle 222, and in some implementations, allows the clasp 230 to also fully open to approximately 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 in its longest and narrowest configuration. Thus, the fully extended position of the device 200 may be a desired position for salvaging the device 200 from an attempted implantation, or for placement of the device within a delivery catheter, or the like.

[0104] Configuring the prosthetic device or implant 200 so that the anchors 208 can extend into a straight or nearly straight configuration (e.g., approximately 120-180 degrees relative to the coaptation members 210) can provide several advantages. For example, this configuration can reduce the radial wave profile of the prosthetic device or implant 200. It can also make it easier to grasp the native leaflets 20, 22 by providing a larger opening between the coaptation members 210 and the inner paddle 222 for grasping the native leaflets 20, 22. Additionally, the relatively narrow, straight configuration can prevent or reduce the likelihood of the prosthetic device or implant 200 becoming entangled in the native anatomy (e.g., the chordae tendineae CT shown in FIGS. 3 and 4 ) during positioning and / or retrieval of the prosthetic device or implant 200 within the delivery system 202.

[0105] 38-49, an exemplary implantable device 200 is shown being delivered and implanted into the native mitral valve MV of the heart H. As described above, the device 200 shown in FIGS. 38-49 includes an optional cover 240 (e.g., FIG. 25) over the coaptation member 210, the clasp 230, and 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 a drive member 212. Fingers of the capture mechanism 213 removably attach a 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 drive member 212, so that after the device 200 is successfully implanted, the drive member 212 can be removed, allowing the fingers of the capture mechanism 213 to open and release the collar 211, thereby detaching the capture mechanism 213 from the device 200.

[0106] 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., an implant catheter holding the device / implant can be expanded to deploy the device / implant from the steerable catheter). The drive member 212 is then retracted, driving the device 200 through a partially occluded state (FIG. 39) to a fully occluded state as shown in FIGS. 40-41. The delivery system or catheter then steers the device / implant 200 toward the mitral valve MV, as shown in FIG. 41. 42, when the device 200 is aligned with the mitral valve MV, the drive member 212 is extended, releasing the paddles 220, 222 to a partially open position, and the drive line 216 (FIGS. 43-48) is retracted, opening 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 member 210 and within the open clasp 230, as shown in FIGS. 43-44.

[0107] FIG. 45 shows the device 200 with both clasps 230 in an occluded state, but with the barb 236 of one clasp 230 not engaged with 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. Once both leaflets 20, 22 are properly grasped, retraction of the drive member 212 drives the device 200 to the fully occluded position shown in FIG. 48. Once the device 200 is fully occluded and implanted within the native valve, the drive member 212 can be disengaged and withdrawn from the cap 214, releasing 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. After deployment, the device 200 can be maintained in the fully occluded position by mechanical means, such as a latch, or may be biased to remain occluded 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 can be formed from steel or from Nitinol shape memory alloy, which can be fabricated from wire, sheet, tube, or laser-sintered powder, and bias the outer paddle 220 in the occluded state around the inner paddle 222, coaptation members 210, and / or clasps 230, which circumferentially clamp the native leaflets 20, 22.

[0108] 50-54, after device 200 is implanted within a native valve, coaptation member 210 functions as a gap filler within a valve regurgitation opening, such as gap 26 in the mitral valve MV illustrated in FIG. 6 or within another native valve. In some implementations, when device 200 is deployed between two opposing leaflets 20, 22, the leaflets 20, 22 no longer coapt to each other in the region of coaptation member 210, but instead coapt to coaptation member 210. This reduces the distance that the leaflets 20, 22 must approach to occlude the mitral valve MV during systole, thereby facilitating repair of functional valve disease that can cause mitral regurgitation. Reducing leaflet coaptation can also result in several other benefits. For example, the reduced coaptation required of leaflets 20, 22 reduces or minimizes stress experienced by the native valve. The shorter approximation distance for the leaflets 20, 22 also requires less approximation force, which may result in less tension experienced by the leaflets 20, 22 and less annular diameter reduction. Less annular diameter reduction, or no annular diameter reduction at all, may result in less reduction in valve orifice area compared to devices without a coaptation member or spacer. In this manner, the coaptation member 210 may reduce transvalvular gradients.

[0109] To adequately fill the gap 26 between the leaflets 20, 22, the device 200 and its components can have a variety of different shapes and sizes. For example, the outer paddle 220 and paddle frame 224 can be configured to conform to the shape or geometry of the coaptation member 210, as shown in FIGS. 50-54 . As a result, the outer paddle 220 and paddle frame 224 can engage both the coaptation member 210 and the native valve leaflets 20, 22. In some implementations, when the leaflets 20, 22 are coapted against the coaptation member 210, the leaflets 20, 22 can completely surround or “cradle” the coaptation member 210, preventing small leaks at the outer and inner surfaces 201, 203 of the coaptation member 210. 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 perspective view showing a paddle frame 224 (which would not actually be visible from a true atrial view, e.g., Figure 52) conforming to the geometry of the coaptation member 210. The opposing leaflets 20, 22 (whose edges would also not be visible from a true atrial view, e.g., Figure 52) are driven closer together by the paddle frame 224 to completely surround or "embrace" the coaptation member 210.

[0110] This coaptation of the leaflets 20, 22 against the lateral and medial surfaces 201, 203 of the coaptation member 210 (shown from the atrial side in FIG. 52 and from the ventricular side in FIG. 53 ) may seem to contradict the statement above that the presence of the coaptation member 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 member 210 is positioned precisely at the regurgitation gap 26, and if the regurgitation gap 26 is smaller than the width (medial-lateral) of the coaptation member 210.

[0111] FIG. 50 illustrates the geometry of the coaptation member 210 and paddle frame 224 from the perspective of the LVOT. As can be seen from this figure, the coaptation member 210 has a tapered shape, with smaller dimensions in the area near where the inner surfaces of the leaflets 20, 22 are desired to coapt and increasing in size as the coaptation member 210 extends toward the atrium. Thus, the challenges of the illustrated native valve geometry are addressed by the tapered coaptation member shape. Still referring to FIG. 50, the tapered coaptation member geometry, combined with the illustrated expanded paddle frame 224 shape (toward the annulus), can help achieve capture at the inferior edge of the leaflets, reduce stress, and minimize transvalvular gradients.

[0112] 54, the shapes of the coaptation members 210 and paddle frame 224 can be determined based on the inner commissure diagram of the native valve and the device 200. Two factors contribute to these shapes: coaptation of the leaflets to the coaptation members 210 and reducing stress on the leaflets due to coaptation. Referring to FIGS. 54 and 24, the coaptation members 210 can have a circular or round shape, and the paddle frame 224 can have a full radius that spans nearly the entire length of the paddle frame 224, both to coapt the leaflets 20, 22 to the coaptation members 210 and to reduce stress applied to the leaflets 20, 22 by the coaptation members 210 and / or paddle frame 224. The round shape of the coaptation members 210 and / or the fully round shape of the paddle frame 224 shown distributes stress on the leaflets 20, 22 over the highly 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.

[0113] 55, an example of an implantable device or implant 300 is shown. The implantable device 300 is one of many different configurations of the device 100 shown generally in FIGS. 8-14. The device 300 may include any other features of the implantable devices or implants described herein, and the device 300 may be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0114] 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 an interface portion 304, which optionally includes an interface member 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 multiple anchors 308. In some implementations, each anchor 308 can include one or more paddles, such as an outer paddle 320, an inner paddle 322, and a paddle extension or paddle frame 324. The anchors can also include and / or be coupled to clasps 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) of a delivery system (e.g., a delivery system such as the systems shown in Figures 38-42 and 49).

[0115] The anchors 308 can be attached to other portions of the device and / or to each other in a variety of different ways (e.g., directly, indirectly, by welding, by stitching, by adhesive, by linking, by latching, by integral formation, by some or all of these combinations, etc.) In some implementations, the anchors 308 are attached to the joining member or joining element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0116] Anchor 308 can include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connecting portion 323. Connecting portion 323 can be attached to a paddle frame 324 that is hingedly attached to cap 314 or to another attachment portion. In this manner, anchor 308 is configured similar to a leg in that inner paddle 322 is like the upper portion of a leg, outer paddle 320 is like the lower portion of a leg, and connecting portion 323 is like the knee portion of the leg.

[0117] In implementations including a joining member or element 310, the joining member or element 310 and the anchor 308 can be coupled together in various ways. For example, as shown in the illustrated example, the joining member 310 and the anchor 308 can be coupled together by integrally forming the joining member 310 and the anchor 308 as a single, unitary component. This can be accomplished by forming the joining member 310 and the anchor 308 from a continuous strip 301 of braided or woven material, such as braided or woven Nitinol wire. In the illustrated example, the joining member 310, outer paddle portion 320, inner paddle portion 322, and connecting portions 321, 323, and 325 are formed from a continuous strip of fabric 301.

[0118] Similar to the anchor 208 in the implantable device or implant 200 described above, the anchor 308 can be configured to move between various configurations by axially moving the distal end of the device (e.g., cap 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311 or other attachment member, etc.), thereby moving the anchor 308 relative to the midpoint of the device. This movement can be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and proximal end (e.g., collar 311 or other attachment member, etc.) of the device. For example, the anchor 308 can be positioned in a fully extended configuration or a straightened configuration (e.g., similar to the configuration of device 200 shown in FIG. 36 ) by moving the distal end (e.g., cap 314, etc.) away from the proximal end of the device.

[0119] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or linear 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 to the longitudinal axis of the joint member 310 (e.g., similar to the configuration of device 200 shown in FIG. 36). From the straight configuration, the anchor 308 can be actuated into the fully collapsed configuration (e.g., FIG. 55), for example, by actuating 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 ).

[0120] In some implementations, the clasp includes a movable arm coupled to the anchor. In some implementations, clasp 330 (shown in detail in FIG. 28B ) includes a base or fixed arm 332, a movable arm 334, optional barbs / friction-enhancing members 336, and a joint portion 338. Fixed arm 332 is attached to inner paddle 322 with joint portion 338 positioned proximate joining member 310. Joint portion 338 is spring loaded so that fixed arm 332 and movable arm 334 are biased toward each other when clasp 330 is in the closed state.

[0121] The fixed arm 332 is attached to the inner paddle 322 through a hole or slot 331 using a suture (not shown). The fixed arm 332 may be attached to the inner paddle 322 by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, welding, an adhesive, or the like. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is opened, thereby opening the clasp 330 and exposing the barb 336. The clasp 330 is opened by applying tension to a drive line (e.g., drive line 216 shown in FIGS. 43-48 ) attached to a hole 335 in the movable arm 334, thereby causing the movable arm 334 to articulate, pivot, and / or bend at a joint portion 338.

[0122] 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 joining member 310, outer paddle 320, inner paddle 322, and connecting portions 321, 323, 325 are formed from a single strip of material 301. In some implementations, the strip of material 301 is attached to the proximal collar 311, cap 314, and paddle frame 324 by weaving or inserting it through openings in the proximal collar 311, cap 314, and paddle frame 324 configured to receive the continuous strip of material 301. The continuous strip 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, while other portions are formed from multiple overlapping or superimposed layers of the strip of material 301.

[0123] For example, Figure 55 shows a joining member 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 start 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 starts and ends at the inner paddle 322.

[0124] As with the implantable device or implant 200 described above, the size of the junction member 310 can be selected to minimize the number of implants (preferably one) required per patient while maintaining a low transvalvular gradient. In particular, forming many components of device 300 from strips of material 301 allows device 300 to be smaller than device 200. For example, in some implementations, the anterior-posterior distance at the top of junction member 310 is less than 2 mm, and the medial-lateral distance at the widest point of device 300 (i.e., the width of paddle frame 324, which is wider than junction member 310) is approximately 5 mm.

[0125] 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 can be applied. The valve repair system 40056 includes a delivery device 40156 and a valve repair device 40256.

[0126] The valve repair device 40256 includes a base assembly 40456, a pair of paddles 40656, and a pair of gripping members 40856. In one example, the paddles 40656 can be integrally formed with the base assembly. For example, the paddles 40656 can be formed as extensions of links in the base assembly. In the illustrated example, the base assembly 40456 of the valve repair device 40256 includes 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 paddles 40656 such that movement of the coupler 40556 along the shaft 40356 drives the paddles between an open position and a closed position. In this manner, the coupler 40556 serves as a means for mechanically coupling the paddles 40656 to the shaft 40356, and when driven along the shaft 40356, drives the paddles 40656 between their open and closed positions.

[0127] In some implementations, the gripping member 40856 is pivotally connected to the base assembly 40456 such that the width of the opening 41456 between the paddle 40656 and the gripping member 40856 can be adjusted by actuating the gripping member (e.g., the gripping member 40856 can be pivotally connected to the shaft 40356 or to any other suitable member of the base assembly). The gripping member 40856 can include barbed portions 40956 for attaching the gripping member to the 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, leaflet tissue) using an anchoring means or portion such as the barbed portions 40956. When the paddle 40656 is in the closed position, the paddle engages the gripping member 40856, such that when 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 against the gripping member and secure 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 secure the valve repair device 40256 to the valve tissue member. For example, in certain circumstances, it may be advantageous for the paddle 40656 to maintain an open position and for the gripping member 40856 to move outward toward the paddle 40656 to engage the valve tissue with the paddle 40656.

[0128] Although the example shown in Figures 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 may include any suitable number of paddles and gripping members.

[0129] 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. After the valve repair device 40256 is secured to the valve tissue, the deployment shaft 41356 can be removed from the shaft 40356, thereby removing the valve repair device 40256 from the rest of the valve repair system 40056, which can leave the valve repair device 40256 attached to the valve tissue and allow the delivery device 40156 to be removed from the patient's body.

[0130] 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 an open position and a closed position. The paddle control mechanism 41056 can take any suitable form, such as, for example, a shaft or rod. For example, the paddle control mechanism can include a hollow shaft, a catheter tube, or a sleeve that fits over the deployment shaft 41356 and over the shaft 40356 and connected to the coupler 40556.

[0131] The gripping member control mechanism 41156 is configured to drive the gripping member 40856 to vary the width of the opening 41456 between the gripping member and the paddle 40656. The gripping member control mechanism 41156 may take any suitable form, such as, for example, a line, a suture or wire, a rod, a catheter, etc.

[0132] 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 variety of different forms, with the type of lock control mechanism 41256 being dictated by the type of lock used. In one example, the lock 40756 takes the form of a lock often used on caulking guns. That is, the lock 40756 includes a rotatable plate with a hole, and the shaft 40356 of the valve repair device 40256 is positioned within the hole in the rotatable plate. In this example, when the rotatable plate is in a tilted position, it engages with the shaft 40356 to maintain its position on the shaft 40356, but when the rotatable plate is in a substantially non-tilted position, the rotatable 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 from moving in 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 allowed to move in direction Y along the shaft 40356 when the pivotable plate is in the substantially non-tilted position (or unlocked position). In examples where 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).

[0133] 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 mounted relative to a 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. Alternatively, the paddles 40656a, 40656b may be connected to the links 102356, 102456 or may be extensions of the links 102356, 102456.

[0134] To drive the valve repair device from the open position (shown in FIG. 56E) to the closed position (shown in FIG. 56F), the coupler 40556 is driven along the shaft 40356 in 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 the portion of the first link 102156 located near point A in direction H and drives the 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 405 (and pivot point A) in direction Y drives the portion of the second link 102256 located near point A in direction L and drives the 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. FIG. 56F illustrates the final position of the valve repair device 40256 after the coupler 40556 has been actuated as shown in FIG. 56E.

[0135] 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 the illustrated example, the gripping member control mechanism 41156 includes a line, such as a suture, wire, etc., attached through an opening in the end of the gripping member 40856. Both ends of the line extend through the 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, widening the opening 41456 between the gripping member and the paddle 40656.

[0136] 56C , the valve repair device 40256 is shown with the valve tissue 20, 22 positioned within the opening 41456 between the grasping member 40856 and the paddle 40656. Referring to FIG. 56D , after the valve tissue 20, 22 is positioned between the grasping member 40856 and the paddle 40656, the grasping member control mechanism 41156 is used to narrow the opening 41456 between the grasping member and the paddle. That is, in the illustrated example, the line of the grasping member control mechanism 41156 is released or pushed out of the delivery member opening 51656 in direction H, allowing the grasping member 40856 to move in 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 position valve tissue within the opening 41456. However, in certain circumstances, it may be necessary to widen the opening 41456 between the paddle 40656 and the gripping member 40856 to receive valve tissue.

[0137] 56G, the valve repair device 40256 is in an occluded 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 barbed portions 40956 of the gripping members 40856a, 40856b, and the paddles 40656a, 40656b engage the gripping members 40856, securing the valve repair device 40256 relative to the valve tissue 20, 22.

[0138] To drive the valve repair device 40256 from the open position to the 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 the illustrated example, the paddle control mechanism 41056 drives the coupler 40556 along the shaft in direction Y, thereby driving one paddle 40656a in direction X and the other paddle 40656b in direction Z. Driving the paddle 40656a in direction X and the paddle 40656b in direction Z engages the paddles with the gripping members 40856a, 40856b and secures the valve repair device 40256 to the valve tissue 20, 22.

[0139] 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 ). In addition, the valve repair device 40256 is decoupled from the paddle control mechanism 41056 ( FIG. 56G ), the gripping member control mechanism 41156 ( FIG. 56G ), and the lock control mechanism 41256. Detaching 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.

[0140] When implanting an implantable device or implant into a native heart valve, drive of the device into the implantation position can be hindered or impeded by native heart structures. 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) can rub, become temporarily caught, or become temporarily blocked by the chordae tendineae CT (shown in FIGS. 3 and 4 ) extending to the valve leaflets. Exemplary implantable devices or implants can be configured to reduce the likelihood of the device or implant becoming temporarily caught or blocked by the CT. For example, the implantable device or implant can have a variety of different configurations that can be configured to actively or passively constrict, thereby reducing the width of the paddle frame at the anchor portion of the device and thereby reducing the surface area of ​​the device, thereby facilitating movement of the device / implant over and / or through the CT.

[0141] 57-68, various configurations of an example implantable device or implant 400 are shown. The device / implant 400 is configured to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device / implant 400 and natural structures of the heart, such as chordae. The device / implant 400 can include any other features of an implantable device or implant as described herein or in the applications or patent documents incorporated herein by reference, and the device 400 can 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). Additionally, any of the devices or implants described herein can include the features of the device / implant 400.

[0142] The device / implant 400 can include an interface or connecting portion 404 and an anchor portion 406. The anchor portion can include two or more anchors 408. In some implementations, the interface portion 404 optionally includes one or more interface members 410 (e.g., spacers, connecting members, gap fillers, etc.). The spacers, connecting members, connecting members, etc. 410 can take any suitable form, such as any of the forms described herein.

[0143] Each of the anchors 408 includes a plurality of paddles 420 (e.g., three in each of the illustrated examples) and one or more clasps 430 (e.g., three in the illustrated examples shown in FIGS. 57-59). The clasps 430 can take any suitable form, such as any of the forms described herein.

[0144] Although the illustrated example shows anchors 408 each including three paddles 420, it will be appreciated that anchors 408 may include any suitable number of paddles 420, such as, for example, two or more paddles, three or more paddles, four or more paddles, five or more paddles, etc.

[0145] In some implementations, each of the anchors 408 can include a corresponding clasp 430 for each of the paddles 420 (as shown in FIGS. 57-59), or each anchor 408 can include only a single clasp 430 corresponding to only a single paddle of the plurality of paddles 420 (e.g., as shown in FIGS. 60-68). However, it will be understood that each anchor 408 can include any number of paddles 420 that include corresponding clasps 430, and any number of paddles 420 that do not include corresponding clasps 430.

[0146] The junction member 410 and the anchor 408 can be coupled together in various manners. For example, as shown in the illustrated example, the junction member 410 and the anchor 408 can optionally be coupled together by integrally forming the junction member 410 and the anchor 408 as a single, unitary component. This can be achieved, for example, by forming the junction member 410 and the anchor 408 from a continuous strip of braided or woven material, such as braided or woven nitinol wire. In some implementations, multiple components are formed separately and attached to one another.

[0147] The device or implant 400 can also include an attachment portion 405 for attaching the device 400 to a delivery system 402 (FIGS. 69-73). The delivery system 402 can be the same as or similar to other delivery systems described herein, such as 102, 202, and can 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 pathway, combinations thereof, etc. The attachment portion 405 can include a proximal collar 411 for engaging the delivery system 402 (e.g., to an implant catheter of the delivery system). For example, the proximal collar 411 can be configured to engage a capture mechanism (e.g., capture mechanism 213 shown in FIGS. 43-49) of the delivery system 402 (e.g., a capture mechanism of an implant catheter).

[0148] The anchor 408 is configured to reduce contact and / or friction between the anchor 408 and the heart's natural structures, such as a cord, thereby allowing the device or implant 400 to be more easily maneuvered into position for implantation within the heart. The anchor 408 includes multiple paddles 420 such that one or more gaps G are formed between the paddles 420. Contact between the heart's natural structures and the anchor 408 is reduced because the heart's natural structures may extend into the gaps G as the device 400 is driven through the heart. This allows the device or implant 400 to be more easily maneuvered within the heart. Additionally, the gaps G allow the paddles to flex toward each other upon contact between the anchor 408 and the heart's natural structures, such as a cord. This flexing also allows the device / implant 400 to be more easily maneuvered through the heart. The device / implant can also be configured to open and close the paddles 420 to drive the paddles toward each other. This drive of the paddles towards each other also allows the device / implant 400 to be more easily maneuvered through the heart.

[0149] The anchor 408 can have a total width TW of 4 mm to 20 mm, such as, for example, 6 mm to 15 mm, such as, for example, 8 mm to 12 mm, such as, for example, about 10 mm. Each of the paddles 420 can have a width W of 0.2 mm to 2 mm, such as, for example, 0.5 mm to 1 mm, such as, for example, 0.3 mm to 1.5 mm. Although each of the paddles 420 is shown as having the same width W, it will be understood that the width W of any paddle 420 may not be equal to the width W of any other paddle 420. The ratio of the total width TW to the width W can be 5 / 1 to 20 / 1, such as, for example, about 10 / 1, such as, for example, 7 / 1 to 15 / 1. The ratio of the total width to the sum of the widths W for the paddles 420 can be about 2 / 1 to 15 / 1, such as, for example, about 4 / 1, such as, for example, 3 / 1 to 10 / 1.

[0150] In the illustrated example, an inner paddle axis IPA for an inner paddle 420 of the plurality of paddles 420 is substantially aligned with a central axis CA of the device 400, and an outer paddle axis OPA of one or more outer paddles 420 extends at an angle α away from the inner paddle axis IPA of the inner paddle 420. The angle α may be between 5 degrees and 60 degrees, such as between 15 degrees and 45 degrees, for example, between 20 degrees and 35 degrees.

[0151] 57-62, each of the paddles 420 has a length L of 6 mm to 18 mm, such as 8 mm to 16 mm, such as 10 mm to 14 mm, such as about 12 mm. Although each of the paddles 420 is shown as having the same length L, it will be understood that the length L of any one paddle 420 may not be equal to the length L of the other paddles (see, e.g., FIGS. 63-68).

[0152] 60-62 illustrate one exemplary implementation of the implantable device or implant 400 shown in FIGS. 57-59. In this example, the device or implant 400 is identical to the example shown in FIGS. 57-59, except that each anchor 408 includes only a single clasp 430 connected to one of the paddles 420. In the illustrated example, the clasp 430 is connected to the inner paddle 420 of each anchor 408, and the outer paddle of each anchor 408 does not include a corresponding clasp. In some implementations, each of the outer paddles 420 can include a corresponding clasp 430, and the inner paddle 420 can be free of a corresponding clasp. It will be understood that any number of the paddles 420 can include a corresponding clasp 430, and any number of the paddles 420 can be free of a corresponding clasp 430.

[0153] 63-65 illustrate one exemplary implementation of the implantable device or implant 400 shown in FIGS. 60-62. In this example, the device 400 is identical to the example shown in FIGS. 60-62, except that the inner paddle 420 of each anchor 408 has a length IL that is longer than the length OL of the outer paddle 420. The length IL can be between 6 mm and 18 mm, such as between 10 mm and 14 mm, such as between 8 mm and 16 mm, such as between 10 mm and 14 mm, such as between 4 mm and 16 mm, such as between 8 mm and 12 mm, such as between 6 mm and 14 mm, such as between 8 mm and 12 mm, such as between 4 mm and 16 mm, such as between 8 mm and 16 mm, such as between 8 mm and 16 mm, such as between 6 ...

[0154] 66-68 illustrate one exemplary implementation of the implantable device or implant 400 shown in FIGS. 60-62. In this example, the device 400 is identical to the example shown in FIGS. 60-62, except that the inner paddle 420 of each anchor 408 has a length IL that is shorter than the length OL of the outer paddle 420. The length OL can be between 6 mm and 18 mm, such as between 10 mm and 14 mm, such as between 8 mm and 16 mm, such as between 10 mm and 14 mm, such as between 4 mm and 16 mm, such as between 8 mm and 12 mm, such as between 6 mm and 14 mm, such as between 8 mm and 12 mm, such as between 4 mm and 16 mm, such as between 8 mm and 12 mm, such as between 6 mm and 14 mm. The ratio of the length OL to the length IL can be between 10 / 9 and 2 / 1, such as between 8 / 7 and 3 / 2, such as between 6 / 5.

[0155] Although the examples shown in Figures 63-68 illustrate each anchor 408 having a single clasp 430 corresponding to the inner paddle 420, it will be understood that each paddle 420 of the anchor 408 may include a corresponding clasp 430 (e.g., as shown in Figures 57-59), or any number of the paddles 420 may include a corresponding clasp 430, or any number of the paddles 420 may not include a corresponding clasp 430.

[0156] 69-73, device 400 is shown at various stages in its deployment from delivery system 402. Delivery system 402 may take any suitable form, such as any of the forms described herein. While the example device / implant 400 depicted in FIGS. 57-59 is shown with reference to FIGS. 69-73, it will be understood that the deployment of device / implant 400 from delivery system 402 also applies to the example device / implant 400 depicted in FIGS. 60-68.

[0157] 69, the device / implant 400 is shown in a compressed position within the delivery system 402. The joint members 410 and paddles 420 are formed from a compressible material that allows the device 400 to be in the compressed position as the device 400 is driven to a desired location within the patient's heart. A capture mechanism 413 is connected to the collar 411 of the device / implant 400 while the device / implant 400 is within the delivery system 402 and until the device / implant 400 is implanted onto a native heart valve (e.g., a native mitral valve, a native tricuspid valve, etc.) after the device / implant 400 is deployed from the delivery system 402.

[0158] 70 shows the device or implant 400 in a deployed, closed position. Upon deployment of the device / implant 400 from the delivery system 402, the joint members 410 expand outward in direction M, and the outer paddles 420 of each anchor 408 pivot or articulate outward in direction N to a normal position such that a gap G (FIGS. 57 and 59) exists between the inner paddle 420 and each outer paddle 420.

[0159] The drive shaft 412 extends from the delivery system 402 to engage the paddle 420 and drive it from the closed position to the open position. Referring to FIG. 71 , driving the drive shaft 412 in direction Y engages and applies a force to the paddle 420, driving the paddle 420 outward in direction X to the open position. That is, the paddle 420 may be pivotally or flexibly connected to the abutment member 410 at a connection point 470 such that the paddle 420 may pivot, bend, and / or articulate outward relative to the abutment member 410 when a force is applied to the paddle 420. Referring again to FIG. 71 , the clasp 430 is maintained in the open position relative to the paddle 420 by the corresponding drive line 416 applying a tension force F on the clasp 430 so that a tissue capture region exists between the paddle 420 and the clasp 430.

[0160] 72, after leaflet tissue is positioned within the tissue capture region between the clasp 430 and the paddle 420, the clasp 430 is actuated in direction Z to capture the tissue and secure the device 400 relative to the tissue. The clasp 430 can be biased toward the closed position by releasing tension F (FIG. 71) from the drive line 416, which can drive the clasp 430 into the closed position, or the drive line 416 can be actively controllable by a user to drive the clasp 430 into the closed position.

[0161] 73 , after the device 400 is secured to the leaflet tissue by the paddles 420 and clasps 430, the drive shaft 412 is decoupled from the paddles 420 and driven back into the delivery system 402, which drives the paddles 420 back to their normal occluded position. After the device 400 is secured to the tissue and the anchors 408 are in the occluded position, the capture mechanism 413 is detached from the collar 411 so that the device 400 is no longer attached to the delivery system 402, and the delivery system 402 can be removed from the patient.

[0162] 74-85, various configurations of an example implantable device or implant 500 are shown. The device or implant 500 is configured to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device or implant 500 and natural structures of the heart, such as chordae. The device or implant 500 can include any other features of an implantable device or implant as described herein or in the applications or patent documents incorporated herein by reference, and the device 500 can 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). Additionally, any of the devices or implants described herein can include the features of the device / implant 500.

[0163] The implantable device or implant 500 includes an interface or joining portion 504, a proximal or attachment portion 505, an anchor portion 506, and a distal portion 507. In some implementations, the interface portion 504 includes an interface member 510 (e.g., a spacer, a joining member, a gap filler, etc.) that can be used to implant, for example, between the leaflets 20, 22 of a native mitral valve MV. The interface member 510 can take any suitable form, such as, for example, any of the forms described herein. The attachment portion 205 includes a first or proximal collar 511 for engaging a capture feature 513 of the delivery sheath or delivery system 202 (see FIGS. 86A, 86B, 87A, 87B, 88, and 89). The proximal collar 511 can take any suitable form, such as, for example, any of the forms described herein.

[0164] Anchor portion 506 can include two or more anchors 508, each anchor 508 including a plurality of paddle members 519 (e.g., three in each of the illustrated examples) and one or more clasps 530 (e.g., three in the illustrated examples shown in FIGS. 74-76). Clasps 530 can take any suitable form, such as any of the forms described herein. Distal portion 507 includes a cap 514 attached to paddle portion 519 such that actuation of cap 514 can actuate paddle portion 519 between an open position and a closed position. Cap 514 can take any suitable form, such as any of the forms described herein.

[0165] The paddle members 519 can include an outer paddle 520 and an inner paddle 522, respectively. The paddle members 519 can be formed, for example, from a metal fabric such as a mesh, a woven fabric, a braid, or any other suitable formed, or laser-cut or otherwise cut flexible material. The material can be cloth, a shape-memory alloy wire such as Nitinol to provide shape-setting capabilities, or any other flexible material suitable for implantation within the human body. In some implementations, the paddle members 519 further include a paddle frame (not shown) that supports the inner paddle 522 and the outer paddle 520. The paddle frame can take any suitable form, such as any of the forms for paddle frames described herein.

[0166] Junction member 510 is optional. In the illustrated example, junction member 510 and paddle member 519 are formed from a continuous strip of material. The material can be, for example, any of the materials described herein for paddle member 519. In some implementations, multiple components are formed separately and attached to one another. Junction member 510 extends from proximal collar 511 to inner paddle 522.

[0167] The joining member 510 has a generally elongated, rounded shape. In particular, the joining member 510 can have an oval shape or cross-section when viewed from above (e.g., as shown in FIG. 74), a tapered shape or cross-section when viewed from the front (e.g., as shown in FIG. 75), or a rounded shape or cross-section when viewed from the side (e.g., as shown in FIG. 76). A mixture of these three geometries can result in a three-dimensional shape for the illustrated joining member 510 that achieves the advantages described herein.

[0168] Although the illustrated example shows anchors 508 each including three paddle members 519, it will be understood that anchors 508 may include any suitable number of paddle members 519, such as, for example, two or more paddle members, three or more paddle members, four or more paddle members, five or more paddle members, etc. Additionally, each of anchors 508 may include a corresponding clasp 530 for each of the paddle members 519 (as shown in FIGS. 74-76), or each anchor 508 may include only a single clasp 530 corresponding to only a single paddle member of the multiple paddle members 519 (as shown in FIGS. 77-79, for example). However, it will be understood that each anchor 508 may include any number of paddle members 519 including corresponding clasps 530, and any number of paddle members 519 without corresponding clasps 530.

[0169] The anchor 508 is configured to reduce contact and / or friction between the anchor 508 and the heart's native structures, such as a cord, thereby allowing the device 500 to be more easily maneuvered into position for implantation within the heart. The anchor 508 includes multiple paddles 520 such that one or more gaps G are formed between the paddles 520. Contact between the heart's native structures and the anchor 508 is reduced because the heart's native structures may extend into the gaps G as the device 500 is driven through the heart. This allows the device 500 to be more easily maneuvered within the heart. Additionally, the gaps G allow the paddles to flex toward each other upon contact between the anchor 508 and the heart's native structures, such as a cord. This flexing also allows the device 500 to be more easily maneuvered through the heart. The device can also be configured to open and close the paddles 520, 522 to drive the paddles toward each other. This drive of the paddles towards each other also allows the device 500 to be more easily maneuvered through the heart.

[0170] The anchor 508 can have a total width TW of 4 mm to 20 mm, such as, for example, about 10 mm, such as, for example, about 6 mm to 15 mm, such as, for example, about 8 mm to 12 mm. Each of the paddles 519 can have a width W of 0.2 mm to 2 mm, such as, for example, about 0.5 mm to 1 mm, such as, for example, about 6 mm to 15 mm. Although each of the paddles 519 is shown as having the same width W, it will be understood that the width W of any one paddle 519 may not be equal to the width W of any other paddle 519. The ratio of the total width TW to the width W can be 5 / 1 to 20 / 1, such as, for example, about 10 / 1, such as, for example, about 7 / 1 to 15 / 1. The ratio of the total width to the sum of the widths W for the paddles 519 can be 2 / 1 to 15 / 1, such as, for example, about 4 / 1, such as, for example, about 3 / 1 to 10 / 1.

[0171] 74-79, each of the inner paddles 522 has a length L of 6 mm to 18 mm, such as 8 mm to 16 mm, such as 10 mm to 14 mm, such as about 12 mm. Although each of the inner paddles 522 is shown as having the same length L, it will be understood that the length L of any one of the inner paddles 522 may not be equal to the length L of the other inner paddles (see, e.g., FIGS. 63-68).

[0172] 77-79 illustrate an example of the implantable device or implant 500 shown in FIGS. 74-76. In this example, the device 500 is identical to the example shown in FIGS. 74-76, except that each anchor 508 includes only a single clasp 530 attached to one of the paddle members 519. In the illustrated example, the clasp 530 is aligned with a central one of the inner paddles 522 of each anchor 508, while the outer one of the inner paddle members 522 does not include a corresponding clasp. In some implementations, the outer one of the paddle members 519 may include a corresponding clasp 530, while the inner one of the paddle members 519 may not include a corresponding clasp. It will be understood that any number of the paddle members 519 may include a corresponding clasp 530, and any number of the paddle members 519 may not include a corresponding clasp 530.

[0173] 80-82 illustrate one exemplary implementation of the implantable device or implant 500 shown in FIGS. 77-79. In this example, the device / implant 500 is identical to the example shown in FIGS. 77-79, except that the inner paddles 519 of the anchors 508 have a length IL that is longer than the length OL of the outer paddles 519. The length IL can be between 6 mm and 18 mm, such as between 8 mm and 16 mm, such as between 10 mm and 14 mm, such as between 10 mm and 14 mm, such as between 4 mm and 16 mm, such as between 8 mm and 12 mm, such as between 6 mm and 14 mm, such as between 8 mm and 12 mm, such as between 4 mm and 16 mm, such as between 8 mm and 16 mm, such as between 8 mm and 16 mm, such as between 8 mm and 16 mm, such as between 8 mm and 16 mm, such as between 6 ...

[0174] 83-85 illustrate one exemplary implementation of the implantable device or implant 500 shown in FIGS. 77-79. In this example, the device 500 is identical to the example shown in FIGS. 77-79, except that the inner paddle member 519 of each anchor 508 has a length IL that is shorter than the length OL of the outer paddle member 519. The length OL can be between 6 mm and 18 mm, such as between 8 mm and 16 mm, such as between 10 mm and 14 mm, such as between 10 mm and 14 mm, such as between 4 mm and 16 mm, such as between 8 mm and 12 mm, such as between 6 mm and 14 mm, such as between 8 mm and 12 mm, such as between 4 mm and 16 mm, such as between 8 mm and 12 mm, such as between 6 mm and 14 mm. The ratio of the length OL to the length IL can be between 10 / 9 and 2 / 1, such as between 8 / 7 and 3 / 2, such as between 6 / 5.

[0175] Although the examples shown in Figures 80-85 illustrate each anchor 508 having a single clasp 530 associated with the inner paddle member 519, it will be understood that each paddle member 519 of an anchor 508 may include a corresponding clasp 530 (e.g., as shown in Figures 74-76), or any number of paddle members 519 may include a corresponding clasp 530, or any number of paddle members 519 may not include a corresponding clasp 530.

[0176] 86A, 87A, and 88-90, a device or implant 500 is shown at various stages in its deployment from a delivery system 502. The delivery system 502 may take any suitable form and may be the same as or similar to other delivery systems herein, such as 102, 202, 402, etc., and may further include one or more of a catheter, sheath, guide catheter / sheath, delivery catheter / sheath, steerable catheter, implant catheter, tube, channel, pathway, combinations thereof, etc. Although the example of the device or implant 500 illustrated in FIGS. 74-76 is shown with reference to FIGS. 86A, 87A, and 88-90, it will be understood that the deployment of the device / implant 500 from the delivery system 502 also applies to the example of the device / implant 500 shown in FIGS. 77-85.

[0177] 86A, the device or implant 500 is shown in a compressed position within a delivery system 502. The coaptation members 510 and paddle members 519 are formed from a compressible material that allows the device 500 to be in the compressed position as the device 500 is driven to a desired location within the patient's heart. A capture mechanism 513 is connected to the collar 511 of the device 500 while the device 500 is within the delivery system 502 and until the device 500 is implanted onto the native mitral valve MV (or other native heart valve) after the device 500 is deployed from the delivery system 502.

[0178] 87A shows device 500 in a deployed, closed position. Upon deployment of device 500 from delivery system 502, joint members 510 expand outward in direction M, and outer members 519 of each anchor 508 rotate outward in direction N to a normal position such that a gap G ( FIGS. 74 and 76 ) exists between inner and outer paddle members 519.

[0179] Figure 86B shows an example similar to that of Figure 86A in which the paddle members 519 are in an extended position within the delivery system 502. This allows the device / implant 500 to be compressed to a smaller size compared to the example of Figure 86A because the paddles are not positioned around the outside of the joint members 510. As a result, the example illustrated in Figure 86B allows the same size device to be delivered using a smaller delivery system 502 (compared to the delivery system used in the example illustrated in Figure 86A).

[0180] Figure 87B shows the device or implant 500 in the configuration of Figure 86B being deployed from the delivery system 502. Upon deployment of the device / implant 500 from the delivery system 502, the joint members 510 expand outward M and the paddle members 519 remain in an elongated state. After being deployed from the delivery system, the paddle members 519 can be occluded (i.e., moved to the position shown in Figure 87A).

[0181] A drive member 512 (e.g., a drive wire, drive shaft, etc.) extends from the delivery system 502 to engage the cap 514 and drive the paddle member 519 from the closed position to the open position. Referring to FIG. 88 , driving the drive member 512 engages the cap 514 and drives the cap 514 in direction Y, thereby driving the paddle member 519 outward in direction X to the open position (e.g., similar to the engagement between the drive member 212 and cap 214 to drive the anchor 208 shown in FIGS. 22-37 ). The clasp 530 is maintained in the open position relative to the paddle member 519 by the corresponding drive line 516 applying a tension force F on the clasp 530 so that a tissue capture region exists between the paddle member 519 and the clasp 530.

[0182] 89, after the leaflet tissue is positioned within the tissue capture region between the clasp 530 and the paddle member 519, the clasp 530 is actuated in direction Z to capture the tissue and secure the device / implant 500 relative to the tissue. The clasp 530 can be biased toward the closed position by releasing tension F (FIG. 88) from the drive line 516 to drive the clasp 530 into the closed position, or the drive line 516 can be actively controllable by a user to drive the clasp 530 into the closed position.

[0183] 90 , after the device or implant 500 is secured against the leaflet tissue by the paddle members 519 and clasp 530, the drive member 512 drives the cap 514 back toward the normal position toward D, thereby driving the paddle members 519 to the closed position, and the drive member 512 is disengaged from the cap 514 and driven back into the delivery system 502. After the device 500 is secured against the tissue and the anchor 508 is in the closed position, the capture mechanism 513 is detached from the collar 511 so that the device 500 is no longer attached to the delivery system 502, and the delivery system 502 can be removed from the patient.

[0184] 91-95, one exemplary implementation of an implantable device or implant 600 (FIG. 94) includes an anchor portion 606 having one or more paddle frames 624. The paddle frames 624 are configured to more easily maneuver the device or implant 600 into position for implantation within the heart by reducing contact and / or friction between the device 600 and natural structures of the heart, such as cords. That is, the paddle frames 624 are configured to be actuated between an expanded position (when the device 600 is in an occluded position) and a constricted position (when the device 600 is in an open position), where contact between the device 600 and natural structures of the heart is reduced when the paddle frames 624 are in the constricted position. Device or implant 600 can include any other features of an implantable device or implant as described herein or in the applications or patent documents incorporated herein by reference, and device 600 can 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). Additionally, any device or implant described herein can include the features of device or implant 600.

[0185] 94 , implantable device or implant 600 includes a coaptation or attachment portion 604, a proximal or attachment portion 605, an anchor portion 606, and a distal portion 607. Coaptation portion 604, attachment portion 605, and distal portion can take any suitable form, such as those for these portions of device 200 shown in FIGS. 22-37 or any other form described herein. In some implementations, coaptation portion 604 optionally includes a coaptation member 610 (e.g., a spacer, coupling member, gap filler, etc.) that can be used, for example, for implantation between leaflets 20, 22 of a native mitral valve MV. Spacer, coaptation member, coupling member, etc. 610 can take any suitable form, such as any form described herein.

[0186] The attachment portion 605 includes a first or proximal collar 611 for engaging a capture mechanism (e.g., capture mechanism 213 shown in FIGS. 44-49) of a delivery sheath or delivery system (e.g., delivery system 202 shown in FIGS. 38-49). The proximal collar 611 can take any suitable form, such as any of the forms described herein.

[0187] Distal portion 607 includes a cap 614 attached to anchor 608 of anchor portion 606 such that actuation of cap 614 can actuate anchor 608 between open and closed positions. Cap 614 can take any suitable form, such as any of the forms described herein. Cap 614 can actuate drive member 612, such as a drive wire, drive shaft, or the like, by extending or retracting it (e.g., as described herein with respect to device 200 and drive member 212 shown in FIGS. 22-37).

[0188] Anchor portion 606 of device 600 can take any suitable form, such as, for example, the form of anchor portion 206 in device 200 shown in Figures 22-37 (except that paddle frame 224 is replaced by paddle frame 624 as shown in Figures 91-95 and described in more detail below), or any other form described herein that may include paddle frame 624. Anchor portion 606 can include multiple anchors 608, each anchor 608 including an outer paddle 620, an inner paddle 622, a paddle extension or paddle frame 624, and a clasp (e.g., clasp 230 shown in Figures 22-37).

[0189] The outer paddle 620 is articulably attached to the inner paddle 622 and to the cap 614 of the distal portion 607 by connecting portion 623, and the inner paddle 622 is articulably attached to the joint member 610. In this manner, the anchor 608 is configured similar to a leg, in that the inner paddle 622 is like the upper part of the leg, the outer paddle 620 is like the lower part of the leg, and the connecting portion 623 is like the knee part of the leg.

[0190] The paddle frame 624 has a first connecting member 601 ( FIGS. 91 and 95 ) for attaching the paddle frame 624 at the distal portion 607 to the cap 614 such that the paddle frame 624 is fixedly connected to the cap 614. The connecting member 601 can be, for example, a notch that engages with a corresponding notch in the cap. The paddle frame 624 has one or more second connecting members 603 ( FIGS. 91 and 95 ) that connect to a connecting portion 623 between the inner paddle 622 and the outer paddle 620 such that the paddle frame 624 is fixedly connected to the anchor 608. The connecting member 603 can be, for example, an eyelet that allows the paddle frame 624 to be sewn to the cover and also to the inner and outer paddles 622, 620. In some implementations, the paddle frame 624 is formed from a stiffer and more rigid material compared to the material forming the paddles 622, 620 so that the paddle frame 624 provides support for the paddles 622, 620.

[0191] The paddle frame 624 provides additional clamping force between the inner paddle 622 and the coaptation member 610. The paddle frame helps wrap the leaflets around the sides of the coaptation member 610 for a better seal between the coaptation member 610 and the leaflets. That is, the paddle frame 624 can be configured with a rounded, three-dimensional shape extending from the cap 614 to the connecting portion 623 of the anchor 608. The connections between the paddle frame 624, the outer and inner paddles 620 and 622, the cap 614, and the coaptation member 610 can constrain the movement of each of these members (e.g., to the movements and positions described with reference to FIGS. 22-37 ). In particular, the connecting portion 623 is constrained by its connections between the outer and inner paddles 620 and 622 and by its connection to the paddle frame 624. Similarly, paddle frame 624 is constrained by its attachment to connecting portion 623 (and thus inner paddle 622 and outer paddle 620 ) and by its attachment to cap 614 .

[0192] Configuring the paddle frame 624 in this manner provides an increased surface area compared to the inner paddles 622 alone, which can, for example, facilitate easier grasping and fixation of the native leaflets. The increased surface area can also distribute the clamping force of the paddles 620 and paddle frame 624 on the native leaflets over a larger surface area of ​​the native leaflets to further protect the native leaflet tissue. In some implementations, the increased surface area of ​​the paddle frame 624 can also clamp the native leaflets against the implantable device or implant 200 so that they fully coapt around the coaptation members 610. This can, for example, improve the sealing of the native leaflets, thereby preventing or further reducing mitral regurgitation.

[0193] The paddle frame 624 is configured to be actuated between an expanded position (e.g., as shown in FIG. 91 ) and a constricted position (e.g., as shown in FIGS. 92 and 95 ). When in the expanded position, the paddle frame 624 has an increased surface area that provides the aforementioned advantages for securing the device 600 to the heart's native valve. When in the constricted position, the paddle frame 624 has a reduced width compared to the paddle frame in the expanded position, which allows the device 600 to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device 600 and the heart's native structures, such as chordae. Actuating the anchors 608 between the open and closed positions acts to actuate the paddle frame 624 between the expanded and constricted positions.

[0194] In the illustrated example, a drive member 612 (e.g., a drive wire, drive shaft, etc.) extends from a delivery system (e.g., any delivery system described herein) and engages the cap 614 to drive the cap 614 in direction Y relative to the joint member or spacer 610, thereby enabling actuation of the device 600. The drive member 612 may engage and drive the cap by any suitable means, such as any of the means provided herein. Driving the cap 614 away from the joint member 610 drives the anchor 608 to an open position (as shown in FIG. 94 ), and driving the joint member 610 towards the joint member 610 drives the anchor to a closed position.

[0195] Based on the configuration of the paddle frame 624 and its connection to the cap 614 and to the connecting portion 623 of the anchor 608, the paddle frame 624 is in an expanded position when the anchor 608 is in the closed position and in a constricted position when the anchor 608 is in the open position. That is, referring to FIG. 91 , actuating the anchor 608 to the open position causes the cap 614 to be driven in direction Y ( FIG. 94 ) away from the joint member 610, and because the paddle frame 624 is fixedly connected to the cap 614 and to the connecting portion 623 of the anchor 608, a tension force F is applied to the paddle frame 624.

[0196] 91 and 92, paddle frame 624 has a width W and a thickness T that is greater than width W. Because thickness T is greater than width W, the degree to which paddle frame 624 is compressed in direction X increases when tension F is applied to paddle frame 624. This is because the stiffness of the paddle frame in the direction of width W is less than the stiffness in the direction of thickness T. In some implementations, the ratio of thickness T to width W is 10 / 9 to 3 / 1, such as 5 / 4 to 2 / 1, for example, 4 / 3 to 3 / 2.

[0197] Referring to FIG. 95, the paddle frame 624 has a length L2 and an overall width W2 when in the constricted position. The length L2 can be 9 mm to 21 mm, such as about 15 mm, such as about 12 mm to 18 mm. The width W2 can be 3 mm to 12 mm, such as about 8 mm, such as about 5 mm to 10 mm, such as about 7 mm to 9 mm. The ratio of the overall width (not shown) of the paddle frame 624 in the expanded position to the overall width W2 can be 10 / 9 to 3 / 1, such as about 5 / 4 to 2 / 1, such as about 4 / 3 to 3 / 2. The ratio of the length (not shown) of the paddle frame 624 in the expanded position to the length L2 of the paddle frame 624 can be 10 / 9 to 3 / 1, such as about 5 / 4 to 2 / 1, such as about 4 / 3 to 3 / 2.

[0198] 93, paddle frame 624 is shown in a compressed position within delivery system 602. Delivery system 602 can take any suitable form, for example, delivery system 602 can be the same as or similar to other delivery systems herein, such as 102, 202, 402, 502, etc., and can further include one or more of a catheter, sheath, guide catheter / sheath, delivery catheter / sheath, steerable catheter, implant catheter, tube, channel, passageway, combinations thereof, etc. The configuration of paddle frame 624 allows it to more easily maintain a compressed position within delivery system 602. That is, because paddle frame 624 has a thickness T (FIG. 91) that is greater than its width W (FIG. 91), paddle frame 624 can be more easily compressed because the paddle frame is less stiff in the direction of width W than in the direction of thickness T.

[0199] 96-98, 101, and 104, an example paddle frame 724 for an implantable device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 785, a first connecting member 701 for attachment to a cap of the implantable device or implant, a second connecting member 703 for attachment to an anchor of the device, and a transition portion 771 located between the first connecting member 701 and the main support section 785. The paddle frame 724 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form; for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0200] The connecting member 701 of the paddle frame 724 includes an extension portion 773 configured to extend into the cap of the implantable device or implant, thereby connecting the paddle frame 724 to the cap. In this example, the outer surface 775 of the main support section 785, the outer surface 777 of the transition portion 771, and the outer surface 779 of the connecting member 701 are substantially aligned such that each of these outer surfaces faces in the same direction Z (FIG. 104).

[0201] 98, the paddle frame 724 is shown in a closed position relative to the implantable device or implant joint member or spacer 710. With reference to FIGS. 101 and 104, the paddle frame is shown in an open position relative to the joint member 710. The joint member 710 can take any suitable form, such as any of the forms described in this application.

[0202] 99, 102, and 105, an example paddle frame 824 for an implantable device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 885, a first connecting member 801 for attachment to a cap of the implantable device or implant, a second connecting member (e.g., connecting member 603 shown in FIG. 91) for attachment to an anchor of the device, and a transition portion 871 located between first connecting member 801 and main support section 885. Paddle frame 824 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form; for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0203] Connecting member 801 of paddle frame 824 includes extension portion 873 configured to extend into the cap of an implantable device or implant, thereby connecting paddle frame 824 to the cap. In this example, outer surface 879 of connecting member 801 is positioned at an angle of approximately 45 degrees from outer surface 875 of main support section 885, allowing transition portion 871 to twist about its axis.

[0204] The paddle frame can be shape-set with the twist illustrated in Figures 99 and 102. In some implementations, the paddle frame can be shape-set in the configuration shown in Figures 96, 98, and 101, and the connecting members 801 can be twisted into the position illustrated in Figures 99 and 102 and held in the twisted orientation by attachment to the cap. In some implementations, the paddle frame 824 can be shape-set with the connecting members 801 set in the position illustrated in Figures 99 and 102, but can be shape-set in a twisted state back to the position illustrated in Figures 96, 98, and 101 by connection to the cap.

[0205] 99, the paddle frame 724 is shown in a closed position relative to the abutment member or spacer 810 of the implantable device or implant. With reference to FIGS. 102 and 105, the paddle frame is shown in an open position relative to the abutment member 810. The abutment member 810 can take any suitable form, such as any of the forms described in this application.

[0206] The angle between the outer surface 879 of the connecting member 801 and the outer surface 875 of the main support section 885 (and the corresponding twisted transition portion 871) causes torque to build up and stress to develop within the material making up the paddle frame 824 as the paddle frame is driven from the closed to the open position. This torque buildup and stress development within the material making up the paddle frame results from the paddle frame being fixedly connected to both the inner and outer paddles (at the transitions between them) and to the cap of the implantable device or implant. When the cap pulls on the outer paddle, the twist in the transition portion 871 propagates along the length of the paddle frame. As a result, the paddle frame 824 becomes narrower when the cap pulls on the paddle to the open position compared to a paddle frame that does not include the twisted translating portion 871. This additional reduction in the width of the paddle frame allows the implantable device or implant to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device and the heart's natural structures, such as cords.

[0207] Although the illustrated example shows outer surface 879 positioned at an angle of approximately 45 degrees from outer surface 875, it will be understood that outer surface 879 may be positioned at any other suitable angle relative to outer surface 875 to apply a torque to drive the paddle frame to a narrower position (compared to a paddle frame not having a twisted translation portion) when the paddle frame is driven from a closed position to an open position.

[0208] Generally, the greater the amount of twist, the greater the torque and stress generated, resulting in greater constriction of the paddle. For example, in FIGS. 100, 103, and 106, an example paddle frame 924 has a 90-degree twist. In the example illustrated in FIGS. 100, 103, and 106, an implantable device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 985, a first connecting member 901 for attachment to a cap of the implantable device or implant, a second connecting member (e.g., connecting member 603 shown in FIG. 91) for attachment to an anchor of the device, and a transition portion 971 located between the first connecting member 901 and the main support section 985. The paddle frame 924 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in Figures 91-95), or the width can be greater than the thickness.

[0209] The connecting member 901 of the paddle frame 924 includes an extension portion 973 configured to extend into the cap of the implantable device or implant, thereby connecting the paddle frame 924 to the cap. In this example, the outer surface 979 of the connecting member 901 is disposed at an angle of approximately 90 degrees from the outer surface 975 of the main support section 985, allowing the transition portion 971 to twist about its axis.

[0210] The paddle frame can be shape-set with the twist illustrated in FIGS. 100 and 103. In some implementations, the paddle frame can be shape-set in the configuration shown in FIGS. 96, 98, and 101, and the connecting members 901 can be twisted into the position illustrated in FIGS. 100 and 103 and held in the twisted orientation by attachment to the cap. In some implementations, the paddle frame 924 can be shape-set with the connecting members 901 set in the position illustrated in FIGS. 100 and 103, but can be shape-set in a twisted state back to the position illustrated in FIGS. 96, 98, and 101 by connection to the cap.

[0211] 100, the paddle frame 924 is shown in a closed position relative to the joint member or spacer 910 of the implantable device or implant. With reference to FIGS. 103 and 106, the paddle frame is shown in an open position relative to the joint member 910. The joint member 910 can take any suitable form, such as any of the forms described in this application.

[0212] The angle between the outer surface 979 of the connecting member 901 and the outer surface 975 of the main support section 985 (and the corresponding twisted transition portion 971) causes torque to build up and stress to develop within the material making up the paddle frame 924 as the paddle frame is driven from the closed to the open position. This torque buildup and stress development within the material making up the paddle frame results from the paddle frame being fixedly connected to both the inner and outer paddles (at the transitions between them) and to the cap of the implantable device or implant. When the cap pulls on the outer paddle, the twist in the transition portion 971 propagates along the length of the paddle frame. As a result, the paddle frame 924 becomes narrower when the cap pulls on the paddle to the open position compared to a paddle frame that does not include the twisted translating portion 971. This additional reduction in the width of the paddle frame allows the implantable device or implant to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device and the heart's natural structures, such as cords.

[0213] 107 and 108, an example paddle frame 1024 for an implantable device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 1085, a first connecting member 1001 for attachment to a cap of the implantable device or implant, and a second connecting member 1003 for attachment to an anchor of the device. The paddle frame 1024 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form; for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0214] Main support section 1085 includes an inner portion 1072 and an outer portion 1074. Inner portion 1072 is connected to connecting member 1001 at connection point 1076 and to connecting member 1003 at connection point 1078. Inner portion 1072 is configured to drive paddle frame 1024 from a normally expanded position ( FIG. 107 ), when the anchors of the implantable device or implant are in an occluded position, to a constricted position ( FIG. 108 ), when the anchors of the device are driven to an open position. Outer portion 1074 is connected to inner portion 1072 at connection point 1080, and outer portion 1074 defines an overall width of paddle frame 1024 (e.g., expanded width EW shown in FIG. 107 and constricted width NW shown in FIG. 108 ).

[0215] In the illustrated example, the inner portion 1072 of the main support section 1085 is diamond-shaped. Referring to FIG. 108 , when the anchor of the implantable device or implant is actuated to the open position, the paddle frame 1024 is subjected to a tension force F due to the paddle frame 1024 being fixedly connected to the cap and to the transition portion between the inner and outer paddles of the device. This tension force F applied to the paddle frame 1024 drives the connection points 1076, 1078 outward OD, thereby driving the connection point 1080 inward ID. Driving the connection point 1080 inward ID drives the outer portion 1074 inward ID, thereby driving the overall width of the paddle frame 1024 from the expanded width EW ( FIG. 107 ) to the narrowed width NW ( FIG. 108 ). By driving the paddle frame 1024 into the constricted position, the implantable device or implant can be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device and the heart's natural structures, such as cords.

[0216] The expanded width EW of the paddle frame 1024 can be 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, such as about 10 mm. The narrowed width NW of the paddle frame 1024 can be 3 mm to 12 mm, such as 5 mm to 10 mm, such as 7 mm to 9 mm, such as about 8 mm. The ratio of the expanded width EW to the narrowed width NW can be 10 / 9 to 3 / 1, such as 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2.

[0217] Although the illustrated example shows the inner portion 1072 of the main support section 1085 to be diamond shaped, it will be understood that the inner portion 1072 may take any form that can drive the paddle frame 1024 into a constricted position when tension F is applied to the paddle frame 1024, so that the paddle frame can more easily maneuver the implantable device or implant into position for implantation within the heart.

[0218] 109 and 110, an example paddle frame 1124 for an implantable device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 1185, a first connecting member 1101 for attachment to a cap of the implantable device or implant, and a second connecting member 1103 for attachment to an anchor of the device. The paddle frame 1124 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form; for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0219] The main support section 1185 includes an inner portion 1172 and an outer portion 1174. The inner portion 1172 is connected to the connecting member 1103 at a connection point 1178. The outer portion 1174 is connected to the inner portion 1172 at a connection point 1180, with the outer portion 1174 extending to the connecting member 1101. The outer portion 1174 defines the overall width of the paddle frame 1124 (e.g., an expanded width EW shown in FIG. 109 and a narrowed width NW shown in FIG. 110). The inner portion 1172 is configured to actuate the paddle frame 1124 from a normally expanded position ( FIG. 109 ), when the anchors of the implantable device or implant are in the closed position, to a narrowed position ( FIG. 110 ), when the anchors of the device are actuated to the open position.

[0220] In the illustrated example, inner portion 1172 of main support section 1185 includes arms 1182 that extend inward from connection point 1180 and meet at connection point 1178 such that inner portion 1172 has a triangular shape. Referring to FIG. 110 , when the anchor of the implantable device or implant is actuated to the open position, paddle frame 1124 is subjected to a tension force F due to the paddle frame 1124 being fixedly connected to the cap and to the transition portion between the inner and outer paddles of the device. This tension force F applied to paddle frame 1124 drives connection point 1178 and connecting member 1101 outward OD, thereby driving connection point 1080 inward ID. Driving connection points 1080 inward ID drives outer portion 1174 inward ID, which drives the overall width of paddle frame 1124 from an expanded width EW (FIG. 109) to a narrowed width NW (FIG. 110). Driving paddle frame 1124 to a narrowed position may more easily maneuver the implantable device or implant into position for implantation within the heart by reducing contact and / or friction between the device and natural structures of the heart, such as chordae.

[0221] The expanded width EW of the paddle frame 1124 can be 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, or about 10 mm. The narrowed width NW of the paddle frame 1124 can be 3 mm to 12 mm, such as 5 mm to 10 mm, such as 7 mm to 9 mm, or about 8 mm. The ratio of the expanded width EW to the narrowed width NW can be 10 / 9 to 3 / 1, such as 5 / 4 to 2 / 1, or 4 / 3 to 3 / 2.

[0222] Although the illustrated example shows the inner portion 1172 of the main support section 1185 having arms 1182 extending inward from connection point 1180 and meeting at connection point 1178 so that the inner portion 1172 has a triangular shape, it will be understood that the inner portion 1172 may take any form that can drive the paddle frame 1124 into a constricted position when tension force F is applied to the paddle frame 1124 so that the paddle frame can more easily maneuver the implantable device or implant into position for implantation within the heart.

[0223] In the illustrated example, inner portion 1172 of main support section 1185 includes arms 1182 that extend inward from connection point 1180 and meet at connection point 1178 such that inner portion 1172 has a triangular shape. Referring to FIG. 110 , when the anchor of the implantable device or implant is actuated to the open position, paddle frame 1124 is subjected to a tension force F due to the paddle frame 1124 being fixedly connected to the cap and to the anchor of the device. This tension force F applied to paddle frame 1124 drives connection point 1178 and connecting member 1101 outward OD, thereby driving connection point 1180 inward ID. Driving connection point 1180 inward ID drives outer portion 1174 inward ID, thereby driving the overall width of paddle frame 1124 from an expanded width EW ( FIG. 109 ) to a narrowed width NW ( FIG. 110 ). By driving the paddle frame 1124 into the constricted position, the implantable device or implant can be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device and the heart's natural structures, such as cords.

[0224] Although the illustrated example shows the inner portion 1172 of the main support section 1185 having arms 1182 extending inward from connection point 1180 and meeting at connection point 1178 so that the inner portion 1172 has a triangular shape, it will be understood that the inner portion 1172 may take any form that can drive the paddle frame 1124 into a constricted position when tension force F is applied to the paddle frame 1124 so that the paddle frame can more easily maneuver the implantable device or implant into position for implantation within the heart.

[0225] Referring to FIG. 111 , an example paddle frame 1224 for an implantable device or implant (e.g., device 200 shown in FIGS. 22-37 , device 600 shown in FIG. 94 , or any other suitable device) includes a main support section 1285, a first connecting member 1201 for attachment to a cap of the implantable device or implant, and a second connecting member 1203 for attachment to an anchor of the device. The paddle frame 1224 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form; for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95 ), or the width can be greater than the thickness.

[0226] Main support section 1285 includes an inner portion 1272 and an outer portion 1274. Inner portion 1272 is connected to connecting member 1203 at connection point 1278. Outer portion 1274 is connected to inner portion 1272 at connection point 1280, with outer portion 1274 extending to connecting member 1201. Outer portion 1274 defines an overall width TW of paddle frame 1224. Inner portion 1272 is configured to actuate paddle frame 1224 from a normally expanded position ( FIG. 111 ), when the anchors of the implantable device or implant are in an occluded position, to a constricted position, when the anchors of the device are actuated to an open position.

[0227] In the illustrated example, inner portion 1272 of main support section 1185 includes arms 1282 and round member 1284. Arms 1282 extend inward from connection point 1280, and round member 1284 is connected to each of arms 1282 and to connection point 1278. When the anchor of the implantable device or implant is actuated to the open position, paddle frame 1224 is subjected to tension (e.g., tension force F shown in FIGS. 108 and 110 ) due to the paddle frame 1224 being fixedly connected to the cap and to the anchor of the device. This tension force F applied to paddle frame 1224 drives connection point 1278 and connecting member 1201 outward, which in turn drives connection point 1280 inward. Driving the connection points 1280 inward drives the outer portions 1274 inward, thereby driving the overall width TW of the paddle frame 1224 into a constricted position, thereby making it easier to maneuver the implantable device or implant into position for implantation within the heart by reducing contact and / or friction between the device and the heart's natural structures, such as chordae.

[0228] The overall width TW of the paddle frame 1224 when in the normal, expanded position can be 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, such as about 10 mm. The constriction width of the paddle frame 1124 can be 3 mm to 12 mm, such as 5 mm to 10 mm, such as 7 mm to 9 mm, such as about 8 mm. The ratio of the overall width TW to the constriction width can be 10 / 9 to 3 / 1, such as 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2.

[0229] Although the illustrated example shows inner portion 1272 of main support section 1285 having arms 1282 extending inward from connection point 1280 and connected to round members 1284 connected to connection point 1278, it will be understood that inner portion 1272 may take any form that can drive paddle frame 1224 into a constricted position when tension force F is applied to paddle frame 1224 so that the paddle frame can more easily maneuver the implantable device or implant into position for implantation within the heart.

[0230] 112-114, an example paddle frame 1324 for an implantable device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 1385, a first connecting member 1301 for attachment to a cap of the implantable device or implant, and a second connecting member 1303 for attachment to an anchor of the device. The paddle frame 1324 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form; for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0231] Main support section 1385 includes an inner portion 1372 and an outer portion 1374. Inner portion 1372 is connected to connecting member 1303 at connection point 1378. Outer portion 1374 is connected to inner portion 1372 at connection point 1380, with outer portion 1374 extending to connecting member 1301. Outer portion 1374 defines an overall width TW of paddle frame 1324. Inner portion 1372 is configured to actuate paddle frame 1324 from a normally expanded position ( FIGS. 112-114 ), when the anchors of the implantable device or implant are in an occluded position, to a constricted position, when the anchors of the device are actuated to an open position.

[0232] In the illustrated example, inner portion 1372 of main support section 1385 includes arms 1382 and round member 1384. The arms 1382 extend inward from connection point 1380, and round member 1384 is connected to each of the arms 1382 and to connection point 1378. The configurations of paddle frame 1324 shown in Figures 112-114 are similar to each other, except that connection point 1380 between inner portion 1372 and outer portion 1374 of paddle frame 1324 is located at a different location from connecting member 1301 for each of these configurations. For example, connection points 1380 for the configuration of paddle frame 1324 shown in FIG. 112 are located farther from connecting member 1301 than the configuration of paddle frame shown in FIG. 113, and connection points 1380 for the configuration of paddle frame 1324 shown in FIG. 113 are located farther from connecting member 1301 than the configuration of paddle frame shown in FIG. 114. These different configurations result in a different width Z between connection points 1380 for each configuration. For example, width Z for the configuration of paddle 1324 shown in FIG. 112 is larger than width Z for the configuration of paddle 1324 shown in FIG. 113, and width Z for the configuration of paddle 1324 shown in FIG. 113 is larger than width Z for the configuration of paddle 1324 shown in FIG. 114.

[0233] When the anchors of the implantable device or implant are actuated to the open position, the paddle frame 1324 is subjected to tension (e.g., tension F shown in FIGS. 108 and 110 ) due to the paddle frame 1324 being fixedly connected to the cap and to the transition portion between the inner and outer paddles of the device. This tension F applied to the paddle frame 1324 drives the connection points 1378 and connecting members 1301 outward, which in turn drives the connection points 1380 inward. Driving the connection points 1380 inward drives the outer portions 1374 inward, which in turn drives the overall width TW of the paddle frame 1324 to a constricted position, thereby allowing the implantable device or implant to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device and natural structures of the heart, such as cords.

[0234] The overall width TW of the paddle frame 1324 when in the normal, expanded position can be 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, such as about 10 mm. The constriction width of the paddle frame 1124 can be 3 mm to 12 mm, such as 5 mm to 10 mm, such as 7 mm to 9 mm, such as about 8 mm. The ratio of the overall width TW to the constriction width can be 10 / 9 to 3 / 1, such as 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2.

[0235] Although the illustrated example shows inner portion 1372 of main support section 1385 having arms 1382 extending inward from connection point 1380 and connected to round member 1384 connected to connection point 1378, it will be understood that inner portion 1372 may take any form that can drive paddle frame 1324 into a constricted position when tension force F is applied to paddle frame 1324 so that the paddle frame can more easily maneuver the implantable device or implant into position for implantation within the heart.

[0236] 115-116, an example paddle frame 1424 for an implantable device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 1485, a first connecting member 1401 for attachment to a cap of the implantable device or implant, and a second connecting member 1403 for attachment to an anchor of the device. The paddle frame 1424 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form; for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0237] The main support section 1485 includes an inner portion 1472 and an outer portion 1474. The inner portion 1472 of the main support section 1485 includes an arm 1482 extending inward from a connection point 1480 and connected to a connection point 1478. The outer portion 1474 is connected to the inner portion 1472 at the connection point 1480 and to the connection point 1478 via a biasing member 1484, which extends to the connecting member 1401. The biasing member 1484 curves at least a portion of the outer portion 1474 such that the paddle has curved lateral edges 1486 ( FIG. 16 ). The curved lateral edges 1486 can be configured to abut against the outer shape of a spacer or abutment member (e.g., any of the abutment members described herein) in an implantable device or implant. The biasing member 1484 may be, for example, a spring member, or any other member that may cause the paddle frame 1474 to have curved side edges 1486 .

[0238] The outer portion 1474 defines an overall width TW of the paddle frame 1424. The inner portion 1472 and the biasing member 1484 are configured to urge the paddle frame 1424 from a normally expanded position (FIGS. 115-116), when the anchors of the implantable device or implant are in an occluded position, to a constricted position, when the anchors of the device are driven to an open position.

[0239] When the anchor of the implantable device or implant is actuated to the open position, the paddle frame 1424 is subjected to a tension force (e.g., tension force F shown in FIGS. 108 and 110 ) due to the paddle frame 1424 being fixedly connected to the cap and to the transition portion between the inner and outer paddles of the device. This tension force F applied to the paddle frame 1424 drives the connection point 1478 and the connection member 1401 outward, thereby driving the connection point 1480 inward. Driving the connection point 1478 inward drives the outer portion 1474 inward, thereby driving the overall width T of the paddle frame 1424 to the constricted position. Additionally, driving the connection point 1478 outward causes the biasing member 1484 to bend the curved lateral edges 1486 in direction B ( FIG. 116 ), thereby driving the overall width T of the paddle frame 1424 to the constricted position. By driving the paddle frame 1424 into the constricted position, the implantable device or implant can be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device and the heart's natural structures, such as cords.

[0240] The overall width TW of the paddle frame 1424 when in the normal, expanded position can be 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, such as about 10 mm. The constriction width of the paddle frame 1124 can be 3 mm to 12 mm, such as 5 mm to 10 mm, such as 7 mm to 9 mm, such as about 8 mm. The ratio of the overall width TW to the constriction width can be 10 / 9 to 3 / 1, such as 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2.

[0241] In some implementations, the biasing member 1484 can passively allow the anchors of the implantable device or implant to open more when needed, and can also cooperate with leaflet movement to assist in coaptation when the implantable device or implant is attached to the heart's native valve leaflets.

[0242] Although the illustrated example shows inner portion 1472 of main support section 1485 having arms 1482 extending inward from connection point 1480 and connected to connection point 1478, it will be understood that inner portion 1472 may take any form that can drive paddle frame 1424 into a constricted position when tension force F is applied to paddle frame 1424 so that the paddle frame can more easily maneuver an implantable device or implant into position for implantation within the heart.

[0243] 117-121 , an example implantable device or implant 1500 includes an anchor portion 1506 having one or more paddle frames 1524. The paddle frames 1524 are configured to allow the device 1500 to be more easily manipulated into position for implantation within the heart by reducing contact and / or friction between the device 1500 and natural structures of the heart, such as chords. That is, the paddle frames 1524 are configured to be actuated between an expanded position (when the device 1500 is in an occluded position) and a constricted position (when the device 1500 is in an open position), and / or the paddle frames include flexible outer portions that flex inward to reduce the width of the paddles when the flexible outer portions contact natural structures of the heart, such as chords.

[0244] When the paddle frame 1524 is in the constricted position, friction between the heart's natural structure and the device 1500 is reduced. The device 1500 can include any other features of an implantable device or implant as described herein or in the applications or patent documents incorporated herein by reference, and the device 1500 can be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein). Additionally, any of the devices described herein can include the features of the device 1500.

[0245] The implantable device or implant 1500 includes a joining or connecting portion 1504, a proximal or attachment portion 1505, an anchor portion 1506, and a distal portion 1507. The joining portion 1504, the attachment portion 1505, and the distal portion 1507 can take any suitable form, such as those for these portions of the device 200 shown in FIGS. 22-37 or any other form described herein. In some implementations, the joining portion 1504 optionally includes a joining member 1510 (e.g., a spacer, a joining member, a gap filler, etc.) that can be used, for example, for implantation between the leaflets 20, 22 of a native mitral valve MV. The spacer, joining member, joining member, etc. 1510 can take any suitable form, such as any form described herein. In the illustrated example, the joining member is formed from woven wire.

[0246] The attachment portion 1505 includes a first or proximal collar 1511 for engaging a capture mechanism 1513 ( FIG. 119 ) of a delivery system (e.g., delivery system 502 shown in FIGS. 86A , 87A , 88 , and 89 ). The proximal collar 1511 can take any suitable form, such as, for example, any of the forms described herein. The capture mechanism 1513 can take any suitable form, such as, for example, any of the forms described herein.

[0247] The distal portion 1507 includes a cap 1514 attached to the anchor 1508 of the anchor portion 1506 such that actuation of the cap 1514 can actuate the anchor 1508 between an open position and a closed position. The cap 1514 can take any suitable form, such as, for example, any of the forms described herein. In the illustrated example, a drive member 1512 (e.g., a drive wire, drive shaft, etc.) extends from a delivery system (e.g., any of the delivery systems described herein) and engages the cap 1514 to actuate the cap 1514 relative to the joint member or spacer 1510, thereby enabling actuation of the device 1500. The drive member 1512 can engage and actuate the cap by any suitable means, such as, for example, any of the means provided herein.

[0248] The anchor portion 1506 of the device 1500 can take any suitable form, such as, for example, the form of the anchor portion 206 in the device 200 shown in Figures 22-37 (except that the paddle frame 224 is replaced by a paddle frame 1524 as shown in Figures 91-95 and described in more detail below), or any other form described herein that may include a paddle frame 1524. The anchor portion 1506 can include multiple anchors 1508, each including an outer paddle 1520, an inner paddle 1522, a paddle extension or paddle frame 1524, and a clasp 1530.

[0249] The paddle frame 1524 includes a main support section 1585, a first connecting member (e.g., connecting member 601 shown in FIGS. 91-95 or any other connecting member described herein) for attachment to the cap of the implantable device or implant, and a second connecting member (e.g., connecting member 603 shown in FIGS. 91-95 or any other connecting member described herein) for attachment to the anchor of the device. The paddle frame 1524 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form; for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0250] The main support section 1585 includes a rigid inner portion 1572 and a flexible outer portion 1574. The rigid inner portion 1572 has a first end 1581 that connects to the cap 1514 and a second end 1583 that connects to the anchor 1508. Referring to FIGS. 120 and 121 , the rigid inner portion is configured to support the anchor paddles 1520, 1522 and to provide sufficient force to facilitate coaptation of the native leaflets 20, 22 to the coaptation member 1510 when the anchor 1508 is in the closed position. The rigid inner portion 1572 can be formed, for example, from metal, plastic, etc.

[0251] 117-121 , the flexible outer portion 1574 connects to the rigid inner portion and defines the overall width of the paddle frame 1524. That is, the flexible outer portion 1574 has a greater overall width than the rigid inner portion 1572. The flexible outer portion 1574 is configured to allow forces (e.g., from the flexible outer portion 1574 contacting a cord during implantation of the device 1500) to cause the flexible outer portion 1574 to bend, further allowing the device 1500 to be more easily maneuvered into position for implantation in the heart. Referring again to FIGS. 120 and 121 , when the anchors 1508 are in the occluded position, coapting the leaflets against the coaptation members 1510, the flexible outer portion 1574 maintains its normal overall width, thereby providing a larger surface area (compared to the rigid inner portion 1572) in contact with the leaflets to hold them against the coaptation members 1510. The flexible outer portion 1574 can be formed from, for example, metal and plastic.

[0252] The overall width of the flexible outer portion 1574 can be between 5 mm and 15 mm, such as between 7 mm and 12 mm, such as between 9 mm and 11 mm, such as about 10 mm. The width of the inner portion 1572 can be between 2 mm and 8 mm, such as between 4 mm and 6 mm, such as about 5 mm.

[0253] In some implementations, the flexible outer portion 1574 is shaped inwardly so that the overall width of the outer portion 1574 is narrowed when the anchor 1508 is in the open position, and so that the outer portion is driven back to its normal overall width when the anchor 1508 is driven to the closed position.

[0254] Although the illustrated example shows a rigid inner portion 1572 having a rounded shape and a flexible inner portion 1574 having a rounded shape, it will be understood that the inner portion 1572 and the outer portion 1574 may take any form that allows the device 1500 to be more easily maneuvered into position for implantation within the heart while providing sufficient support to facilitate coaptation of the leaflets of the native heart valve against the coaptation member 1510.

[0255] 122-124 , one exemplary implementation of an implantable device or implant 1600 includes a joint portion 1604, a proximal or attachment portion 1605, an anchor portion 1606, and a distal portion 1607. The implantable device or implant 1600 is configured to allow the device 1600 to be more easily maneuvered into position for implantation within the heart by driving the paddle frame 1624 of the anchor portion 1606 into a constricted position ( FIG. 124 ), thereby reducing contact and / or friction between the device 1600 and natural structures of the heart, such as cords. That is, the paddle frame 1624 is configured to be driven between an expanded position ( FIG. 122 ) when the device 1600 is in an occluded position and a constricted position ( FIG. 123 ) when the device 1600 is in an open position, such that contact between the device 1600 and natural structures of the heart is reduced when the paddle frame 1624 is in the constricted position. Device 1600 can include any other features of an implantable device or implant as described herein or in the applications or patent documents incorporated herein by reference, and device 1600 can 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). In addition, any of the devices described herein can include the features of device 1600.

[0256] The attachment portion 1605 includes a first or proximal collar 1611 for engaging a capture mechanism (e.g., capture mechanism 213 shown in FIGS. 44-49) of a delivery system (e.g., delivery system 202 shown in FIGS. 38-49). The proximal collar 1611 can take any suitable form, such as any of those described herein. The distal portion 1607 includes a cap 1614 attached to an outer paddle 1620 of the anchor 1608 such that actuation of the cap 1614 can actuate the anchor 1608 between an open position and a closed position. The cap 1614 can take any suitable form, such as any of those described herein.

[0257] Anchor portion 1606 may take any suitable form, such as that of anchor portion 206 in device 200 shown in Figures 22-37, or any other form described herein that may comprise paddle frame 1524. Anchor portion 1606 may include multiple anchors 1608, each including an outer paddle 1620, an inner paddle 1622, a paddle extension or paddle frame 1624, and a clasp 1630. In the illustrated example, inner paddle 1622 is formed from a material having a greater hardness than the material of outer paddle 1620.

[0258] Referring to FIG. 124 , the paddle frame 1624 includes a main support section 1685, a first connecting member 1601 for attachment to the cap 1614 of the device 1600, and a second connecting member 1603 for attachment to a connecting portion 1623 between the inner paddle 1622 and the outer paddle 1620 of the anchor 1608. The paddle frame 1624 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness. However, the paddle frame 1624 can take any suitable form, such as any of the forms described herein.

[0259] In some implementations, the coaptation or connecting portion 1604 includes a coaptation member 1610 (e.g., a coaptation member 1610 that can be used to implant between the leaflets 20, 22 of a native mitral valve MV). The spacer, coaptation member, connecting member, etc. 1610 can take any suitable form, such as any of those described herein. The coaptation member 1610 is connected to a connecting portion 1623 of an inner paddle 1622 of the anchor 1608. In the illustrated example, the coaptation member 1610 includes one or more flexible portions 1687 connected to the inner paddle 1622. The flexible portion 1687 may be formed from a woven material having a looser weave compared to the inner paddle portion and / or compared to the remainder of the joining member 1610, or may be formed from an elastic material that is more resilient compared to the inner paddle portion and / or compared to the remainder of the joining member 1610, or may be formed in any other manner that makes the flexible portion 1687 more flexible and / or more stretchable compared to the inner paddle portion and / or compared to the remainder of the joining member 1610.

[0260] During implantation, the paddles 1620, 1622 of the anchor 1608 can be opened and closed to grip the native valve leaflets between the paddles 1620, 1622 and the coaptation member 1610. The anchor 1608 is actuated between a closed position ( FIG. 122 ) and various open positions (e.g., positions shown in FIG. 123 ) by extending and retracting the drive member 1612 (e.g., drive wire, drive shaft, etc.). Extending and retracting the drive member 1612 increases and decreases the spacing between the coaptation member 1610 and the cap 1614, respectively. When actuated, the proximal collar 1611 and coaptation member 1610 slide along the drive wire 1612, which changes the spacing between the coaptation member 1610 and the cap 1614 and drives the paddles 1620, 1622 between different positions, thereby gripping the native valve leaflets during implantation.

[0261] In the illustrated example, the drive wire 1612 includes a widened portion 1689 to facilitate driving the paddle frame 1624 into the constricted position. Referring to FIG. 123 , when the drive wire 612 is driven downward through the joint member 610 in direction Y to drive the anchor 1608 from the closed position to the open position, the widened portion 1689 of the drive wire 1612 engages the flexible portion 1687 of the joint member 1610, driving the flexible portion 1687 outward in direction Z. This driving of the flexible portion 1687 in outward direction Z drives the connecting portion 1625 of the inner paddle 1622 outward in direction D relative to the cap 1614, which in turn drives the connecting portion 1623 of the anchor 1608 (to which the paddle frame 1624 is connected) in direction D as well. The rigidity of the inner paddle 1622 helps facilitate actuation of the connecting portion 1623. Because the paddle frame 1624 is connected to the cap 1614 and to the connecting portion 1623 of the anchor 1608, this actuation of the connecting portion 1623 in orientation D applies a tension force F ( FIG. 124 ) to the paddle frame 1624, thereby driving the paddle frame 1624 to the constricted position ( FIG. 124 ). In the illustrated example, the widened portion 1689 of the drive wire 1612 has a tapered shape to engage the flexible portion 1687 of the joint member 1610 and thereby easily drive the paddle frame 1624 to the constricted position. In some implementations, the widened portion 1689 can have a spherical shape or any other suitable shape.

[0262] In some implementations, the widened portion 1689 is configured to widen the transition portion 1625 for only a small portion of the drive wire's travel. For example, the drive wire's travel path can include a travel path having a beginning portion corresponding to full occlusion of the device and an end portion corresponding to full occlusion of the device. The widened portion 1689 can be configured to keep the transition portion 1625 at its original width along the beginning of the travel path, drive the transition portion 1625 to a wider width during an intermediate portion of the travel path, and return the transition portion 1625 to its original width along the end of the travel path.

[0263] Referring to FIG. 124, the paddle frame 1624 has a length L2 and an overall width W2 when in the constricted position. The width of the paddle frame 1424 when in the normal, expanded position can be 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, or about 10 mm. The constricted width W2 of the paddle frame 1124 can be 3 mm to 12 mm, such as 5 mm to 10 mm, such as 7 mm to 9 mm, or about 8 mm. The ratio of the normal width to the constricted width W2 can be 10 / 9 to 3 / 1, such as 5 / 4 to 2 / 1, or 4 / 3 to 3 / 2.

[0264] 125 and 126, an example paddle frame 1724 for an implantable device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or any other suitable device) includes a main support section 1785, a first connecting member 1701 for attachment to a cap of the implantable device or implant, and a second connecting member for attachment to an anchor of the device (e.g., connecting member 603 shown in FIGS. 91-95, or any other connecting member described herein). The paddle frame 1724 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form; for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0265] The main support section 1785 includes an inner portion 1772 and an outer portion 1774. The inner portion 1772 is connected to the outer portion 1774 at connection points 1780, which extend to the connecting member 1701. In the illustrated example, the inner portion 1772 includes arms 1782 that extend inward from each connection point 1780 and meet at a connecting portion 1778 such that the arms 1782 have a V-shape when the paddle frame 1724 is in the expanded position ( FIG. 126 ). The connecting portion 1780 between the inner portion 1772 and the outer portion 1774 can include openings 1773 for receiving a retention device (e.g., suture, pin, or other suitable device) to connect the openings 1773 to one another to maintain the paddle frame 1724 in the constricted position ( FIG. 125 ). When the retention device is removed from the openings 1773 such that the openings 1773 are no longer connected, the paddle frame 1724 is configured to be driven outward in direction Z toward its normal, extended position. That is, the paddle frame 1724 can be formed from a material that is preformed into the extended position (as shown in FIG. 126 ). A retention device can be used to connect the openings 1773 at connection points 1780, thereby maintaining the paddle frame 1724 in the collapsed, constricted position (as shown in FIG. 125 ). Removal of the retention device then causes the paddle frame 1724 to return to its normal, extended position under spring force.

[0266] When driving the implantable device or implant into position for implantation onto the patient's native valve leaflets (e.g., mitral valve leaflets 20, 22, tricuspid valve leaflets 30, 32, 34, or other valve leaflets), the paddle frame 1724 is maintained in a constricted position, thereby making it easier to maneuver the implantable device or implant into position for implantation within the heart by reducing contact and / or friction between the device and the heart's native structures, such as chordae. After the device is positioned for implantation, the retention device is removed from the openings 1773, which drives the paddle frame 1724 to an expanded position so that the anchors of the device have a larger surface area for capturing the native valve leaflets.

[0267] The outer portion 1774 defines the overall width of the paddle frame 1724 (e.g., the expanded width EW shown in FIG. 126 and the narrowed width NW shown in FIG. 125). When in the normally expanded position, the expanded width EW of the paddle frame 1424 can be 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, or about 10 mm. The narrowed width NW of the paddle frame 1124 can be 3 mm to 12 mm, such as 5 mm to 10 mm, such as 7 mm to 9 mm, or about 8 mm. The ratio of the normal width to the narrowed width W2 can be 10 / 9 to 3 / 1, such as 5 / 4 to 2 / 1, or 4 / 3 to 3 / 2.

[0268] Although the illustrated example shows the inner portion 1772 of the main support section 1785 as having arms 1782 that form a V-shape, it will be understood that the inner portion 1772 may take any form that allows the paddle frame 1724 to be folded into and maintained in a constricted position when engaged by a retention device, and that allows the paddle frame 1724 to be driven to an extended position when the retention device is released from the paddle frame 1724.

[0269] 127-130 , one exemplary implementation of an implantable device or implant 1800 includes an anchor portion 1806 having one or more paddle frames 1824 that are drivable into a constricted position so that the device 1800 may be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device 1800 and the heart's native structures, such as cords. That is, when the device 1800 is positioned for implantation onto the native leaflets of a native valve, a drive line 1890 is controlled by a user to generate a compressive force C ( FIG. 128 ) on the paddle frame 1824 to drive the paddle frame 1824 into the constricted position, thereby reducing contact and / or friction between the device 1800 and the heart's native structures. Device 1800 can include any other features of an implantable device or implant as described herein or in the applications or patent documents incorporated herein by reference, and device 1800 can 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). In addition, any of the devices described herein can include the features of device 1800.

[0270] Implantable device or implant 1800 includes a coaptation or joining portion 1804, a proximal or attachment portion 1805, an anchor portion 1806, and a distal portion 1807. Coaptation portion 1804, attachment portion 1805, and distal portion 1807 can take any suitable form, such as those for these portions of device 200 shown in FIGS. 22-37 or any other form described herein. In some implementations, coaptation portion 1804 includes a coaptation member 1810 (e.g., a spacer, a coupling member, a gap filler, etc.) that can be used, for example, for implantation between leaflets 20, 22 of a native mitral valve MV. Coaptation member 1810 can take any suitable form, such as any form described herein.

[0271] The attachment portion 1805 includes a first or proximal collar 1811 for engaging a capture mechanism (e.g., capture mechanism 213 shown in FIGS. 44-49) of a delivery system (e.g., delivery system 202 shown in FIGS. 38-49). The proximal collar 1811 can take any suitable form, such as any of the forms described herein.

[0272] Distal portion 1807 includes a cap 1814 attached to anchor 1808 of anchor portion 1806 such that actuation of cap 1814 can actuate anchor 1508 between open and closed positions. Cap 1814 can take any suitable form, such as, for example, any of the forms described herein. In the illustrated example, drive member 1812 (e.g., a drive wire, drive shaft, etc.) extends from a delivery system (e.g., any of the delivery systems described herein) and engages cap 1814 to actuate cap 1814 relative to joint member or spacer 1810, thereby enabling actuation of device 1800. Drive member 1812 can engage and actuate the cap by any suitable means, such as, for example, any of the means provided herein.

[0273] Anchor portion 1806 can take any suitable form, such as that of anchor portion 206 in device 200 shown in FIGS. 22-37 , or any other form described herein. Anchor portion 1806 can include a plurality of anchors 1808, each anchor 1808 including an outer paddle 1820, an inner paddle 1822, a paddle extension member or paddle frame 1824, and a clasp 1830. Paddle frame 1824 can include a main support section 1885, a first connecting member for attachment to cap 1814, and a second connecting member for attachment to connecting portion 1823 of anchor 1808. Paddle frame 1824 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame 1824 can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in Figures 91-95), or the width can be greater than the thickness.

[0274] The paddle frame 1824 includes an end 1801 configured to attach to the cap 1814 and a free end 1803. The paddle frame 1824 includes a first opening 1891 and a second opening 1892 for receiving one or more drive lines 1890 of a delivery system. With reference to FIGS. 127-129 , in some examples, a single drive line 1890 extends into the delivery system through the first opening 1891 and the second opening 1892 of each paddle frame 1824, allowing a user to pull on the drive line 1890 to drive the paddle frame 1824 into a constricted position. With reference to FIG. 129 , the drive line 1890 can also extend through an opening 1893 in the clasp 1830 of each paddle 1808 before extending into the delivery system. 128, when a user pulls on drive line 1890, a force is generated at each end of drive line 1890 in direction Y as the drive line extends through openings 1891, 1892, applying a compressive force C to paddle frame 1824. Compressive force C drives paddle frame 1824 into a constricted position.

[0275] 129, the drive line 1890 can also extend through an opening 1893 in the clasp 1830 on each paddle 1808 before extending into the delivery system. When the user pulls on the drive line 1890, the clasp 1830 is opened and the paddle frame 1824 is driven to the constricted position.

[0276] 130, in some examples, the connecting drive lines 1889 extend in a closed loop between the first opening 1891 and the second opening 1892 of each paddle frame 1824, and a single drive line 1890 extends through the closed loop of each connecting line 1889, allowing a user to drive both paddle frames 1824 into the constricted position by simply pulling on the single drive line 1890. That is, pulling on the single drive line 1890 generates a compressive force (e.g., a compressive force similar to compressive force C shown in FIG. 128) on each of the paddle frames 1824, simultaneously driving the paddle frames 1824 into the constricted position. In the illustrated example, the single drive line 1890 extends through the junction member 1810 before extending into the delivery system. Referring to FIGS. 127-130, the drive lines 1889, 1890 can be, for example, sutures.

[0277] Referring to FIG. 128, the paddle frame 1824 has a length L2 and an overall width W2 when in the constricted position. When in the normal, expanded position, the width of the paddle frame 1424 can be 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, or about 10 mm. The constricted width W2 of the paddle frame 1124 can be 3 mm to 12 mm, such as 5 mm to 10 mm, such as 7 mm to 9 mm, or about 8 mm. The ratio of the normal width to the constricted width W2 can be 10 / 9 to 3 / 1, such as 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2. While the dimensions described above for the paddle frame 1824 in the constricted and expanded positions are made with reference to the example shown in FIGS. 127-129, it will be understood that the same dimensions are applicable to the example shown in FIG. 130.

[0278] 131-136, one exemplary implementation of an implantable device or implant 1900 includes an anchor portion 1906 having one or more paddle frames 1924 that are drivable into a constricted position so that the device 1900 may be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device 1900 and the heart's native structures, such as cords. That is, when the device 1900 is positioned for implantation onto the leaflets of a native valve, a drive line 1990 is controlled by a user to generate a compressive force on the paddle frame 1924 (e.g., a compressive force similar to compressive force C in FIG. 128) to drive the paddle frame 1924 into the constricted position, thereby reducing contact and / or friction between the device 1900 and the heart's native structures. Device 1900 can include any other features of an implantable device or implant as described herein or in the applications or patent documents incorporated herein by reference, and device 1900 can be positioned to engage valve tissue (e.g., leaflets 20, 22, etc.) as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein). In addition, any device described herein can include the features of device 1900.

[0279] Implantable device or implant 1900 includes a coaptation or joining portion 1904, a proximal or attachment portion 1905, an anchor portion 1906, and a distal portion 1907. Coaptation portion 1904, attachment portion 1905, and distal portion 1907 can take any suitable form, such as those for these portions of device 200 shown in FIGS. 22-37 or any other form described herein. In some implementations, coaptation portion 1904 includes a coaptation member 1910 (e.g., a spacer, a bonding member, a gap filler, etc.) that can be used, for example, for implantation between leaflets 20, 22 of a native mitral valve MV. Spacer, coaptation member, bonding member, etc. 1910 can take any suitable form, such as any form described herein.

[0280] The attachment portion 1905 includes a first or proximal collar 1911 for engaging a capture mechanism (e.g., capture mechanism 213 shown in FIGS. 44-49) of a delivery system (e.g., delivery system 202 shown in FIGS. 38-49). The proximal collar 1911 can take any suitable form, such as any of the forms described herein.

[0281] Distal portion 1907 includes a cap 1914 attached to anchor 1908 of anchor portion 1906 such that actuation of cap 1914 can actuate anchor 1908 between an open position and a closed position. Cap 1914 can take any suitable form, such as, for example, any of the forms described herein. In the illustrated example, a drive member 1912 (e.g., a drive wire, drive shaft, etc.) extends from a delivery system (e.g., any of the delivery systems described herein) and engages cap 1914 to actuate device 1900 by driving cap 1914 relative to joint member or spacer 1910. Drive member 1912 can engage and actuate the cap by any suitable means, such as, for example, any of the means provided herein.

[0282] Anchor portion 1906 can take any suitable form, such as that of anchor portion 206 in device 200 shown in FIGS. 22-37 , or any other form described herein. Anchor portion 1906 can include a plurality of anchors 1908, each anchor 1908 including an outer paddle 1920, an inner paddle 1922, a paddle extension member or paddle frame 1924, and a clasp 1930. Paddle frame 1924 can include main support section 1985, a first connecting member 1901 for attachment to cap 1914, and a second connecting member 1903 for attachment to connecting portion 1923 of anchor 1908. Paddle frame 1924 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame 1924 may take any suitable form, for example, the thickness may be substantially the same as the width, the thickness may be greater than the width (as shown in Figures 91-95), or the width may be greater than the thickness.

[0283] The main support section 1985 includes an inner portion 1972 and an outer portion 1974 connected to a connecting member 1901. In the illustrated example, the inner portion 1972 has a pair of arms 1982 extending from connecting member 1901 to connecting member 1903, the arms 1982 providing support for the anchor 1908. The outer portion 1974 has a pair of arms 1980 extending outward from the connecting member 1901 further than the arms 1982 of the inner portion 1972, such that the arms 1980 define the overall width of the paddle frame 1924 (e.g., overall width W2 shown in FIG. 128). Referring to FIG. 131, each of the arms 1983 includes an opening 1992 for receiving one or more drive lines 1990 (FIGS. 132-136) of the delivery system. The arms 1982 may also include an opening 1991 for receiving the one or more drive lines 1990. The opening 1991 may be an opening in the connecting member 1903 for connecting to the connecting portion 1923 of the anchor 1908 (as shown in the illustrated example), or the opening 1991 may be an opening separate from the connecting member 1903.

[0284] 132 and 133 , in some examples, a single drive line 1990 corresponds to each paddle frame 1924 to drive the paddle frames 1924 into the constricted position. In the example shown, the drive line 1990 extends through openings 1991, 1992 in the paddle frames 1924, allowing a user to apply a pulling force to the drive line 1990 to drive the paddle frames 1924 into the constricted position. Each drive line 1990 has a first end 1993 and a second end 1994. A first end 1993 extends from the delivery system through an opening 1991 in one arm 1982 of the inner portion 1972, through an opening 1992 in one arm 1980 of the outer portion 1974, through an opening 1992 in the other arm 1980 of the outer portion 1974, and through an opening 1991 in the other arm 1982 of the inner portion 1972, and a second end 1994 of the drive line 1990 extends into the delivery system. In the example shown in FIG. 132, applying a tension force to both ends 1993, 1994 of the drive line 1990 creates a compression force on the arm 1980 of the outer portion 1974 ( FIG. 131 ), driving the arm 1980 toward the inner portion 1972 of the paddle frame 1924, thereby driving the paddle frame into the constricted position.

[0285] 133, the drive line 1990 can also extend through an opening 1931 in the clasp 1930 of each paddle 1908 before extending into the delivery system. In the example shown in FIG. 132, applying a pulling force to both ends 1993, 1994 of the drive line 1990 drives the paddle frame into the constricted position and opens the clasp.

[0286] 134 , a single drive line 1990 is associated with each paddle frame 1924 to drive the paddle frames 1924 into the constricted position. Each drive line 1990 has a first end (not shown) extending from the delivery system, through the junction member 1910, through an opening 1992 in one arm 1980 in the outer portion 1974, through an opening 1991 in one arm 1982 in the inner portion 1972, through an opening 1991 in the other arm 1982 in the inner portion 1972, and through an opening 1992 in the other arm 1980 in the outer portion 1974, and a second end (not shown) of the drive line 1990 extending through the junction member 1910 into the delivery system. Applying a tension force to both ends of the drive line 1990 generates a compression force on the arm 1980 (FIG. 131) of the outer portion 1974, driving the arm 1980 toward the inner portion 1972 of the paddle frame 1924, thereby driving the paddle frame 1924 into the constricted position.

[0287] 135 and 136, in some implementations, a connecting drive line 1989 is connected to each paddle frame 1924, and a drive line 1990 is connected to the connecting drive line 1989, such that a user can drive the paddle frame 1924 into a constricted position by pulling on the drive line 1990. Referring to FIG. 135, in some implementations, the connecting drive line 1989 extends in a closed loop between an opening 1991 in the inner portion 1972 of the paddle frame 1924 and an opening 1992 in the outer portion 1974. Referring to FIG. 136, in some implementations, the connecting drive line 1989 extends in a closed loop between the openings 1992 in the outer portion 1974 of the paddle frame 1924, but the connecting drive line 1989 does not extend through the opening 1991 in the inner portion 1972.

[0288] In both examples shown in FIGS. 135 and 136, applying a tension force to the drive line 1990 generates a compression force on the arm 1980 (FIG. 131) of the outer portion 1974, driving the arm 1980 toward the inner portion 1972 of the paddle frame 1924, thereby driving the paddle frames into the constricted position. Although the examples shown in FIGS. 135 and 136 show separate drive lines 1990 attached to the drive connection line 1989 of each paddle frame 1924, in some implementations a single drive line (e.g., a drive line similar to line 1890 shown in FIG. 130) can be attached to the connecting drive line 1989 of each paddle frame 1924 such that pulling on the end of the single drive line drives both paddle frames 1924 into the constricted position. With reference to FIGS. 131-136, the drive lines 1989, 1990 can be, for example, sutures.

[0289] 131-136, the overall width of paddle frame 1924 (defined by outer portion 1974 of paddle frame 1924) when in the normally extended position can be 5 mm to 15 mm, such as, for example, 7 mm to 12 mm, such as, for example, 9 mm to 11 mm, such as, for example, about 10 mm. The narrowed width of paddle frame 1124 can be 3 mm to 12 mm, such as, for example, 5 mm to 10 mm, such as, for example, 7 mm to 9 mm, such as, for example, about 8 mm. The ratio of normal width to narrowed width can be 10 / 9 to 3 / 1, such as, for example, 5 / 4 to 2 / 1, such as, for example, 4 / 3 to 3 / 2.

[0290] 137-148, one exemplary implementation of an implantable device or implant 2000 (FIGS. 139-144) includes an anchor portion 2006 having one or more paddle frames 2024. The paddle frames 2024 are configured to allow the device 2000 to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device 2000 and the heart's native structures, such as cords. For example, the drive lines are controlled by a user to exert a compressive force (e.g., compressive force C shown in FIG. 128) on the paddle frames 2024 to move the paddle frames 2024 from a normal expanded position (FIGS. 140 and 142) to a stenotic position (FIGS. 139 and 141) when the device 2000 is positioned for implantation over the leaflets of a native valve such that friction between the heart's native structures and the device 2000 is reduced. Device 2000 can include any other features of an implantable device or implant as described herein or in the applications or patent documents incorporated herein by reference, and device 2000 can 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). Additionally, any of the devices described herein can include the features of device 2000.

[0291] 143-144 , implantable device or implant 2000 includes a coaptation or attachment portion 2004, a proximal or attachment portion 2005, an anchor portion 2006, and a distal portion 2007. Coaptation portion 2004, attachment portion 2005, and distal portion 2007 can take any suitable form, such as those for these portions in device 200 shown in FIGS. 22-37 , or any other form described herein. In some implementations, coaptation portion 2004 optionally includes a coaptation member 2010 (e.g., a spacer, coupling member, gap filler, etc.) that can be used, for example, for implantation between leaflets 20, 22 in a native mitral valve MV. Spacer, coaptation member, coupling member, etc. 2010 can take any suitable form, such as any form described herein.

[0292] The attachment portion 2005 includes a first or proximal collar 2011 for engaging a capture mechanism (e.g., capture mechanism 213 shown in FIGS. 44-49) of a delivery system (e.g., delivery system 202 shown in FIGS. 38-49). The proximal collar 2011 can take any suitable form, such as any of the forms described herein.

[0293] Distal portion 2007 includes a cap 2014 attached to anchor 2008 of anchor portion 2006 such that actuation of cap 2014 can actuate anchor 2008 between an open position and a closed position. Cap 2014 can take any suitable form, such as, for example, any of the forms described herein. A drive member (e.g., a drive member the same as or similar to drive member 212 shown in FIGS. 22-37 ) extends from a delivery system (e.g., any of the delivery systems described herein) through opening 2009 ( FIG. 143 ) and interface member 2010 and engages cap 2014 to actuate cap 2014 relative to interface member 2010, thereby enabling actuation of device 2000. The drive member can engage and actuate the cap by any suitable means, such as, for example, any of the means provided herein.

[0294] Anchor portion 2006 can take any suitable form, such as that of anchor portion 206 in device 200 shown in FIGS. 22-37 , or any other form described herein. Anchor portion 2006 can include a plurality of anchors 2008, each including an outer paddle 2020, an inner paddle 2022, a paddle extension member or paddle frame 2024, and a clasp (e.g., clasp 230 shown in FIGS. 22-37 ). Referring to FIGS. 137 and 138 , paddle frame 2024 can include main support section 2085 and connecting member 2003 for attachment to cap 2014. Paddle frame 2024 can be attached to cap 2014 by any suitable means, such as any of the means described herein. 145-148 , in the illustrated example, both of the anchors 2008 are defined by a paddle ribbon 2001 including an inner paddle 2022 and an outer paddle 2020 of each anchor 2008. The inner paddle 2022 of each anchor 2008 is attached by a connecting portion 2025 configured to connect the inner paddle 2022 to the joint member 2010 (as shown in FIG. 148 ). In the illustrated example, the connecting portion 2025 includes an opening 2094 for receiving a distal portion of the joint member 2010. The outer paddle 2020 of each anchor 2008 is attached by a connecting portion 2021 configured to connect the outer paddle 2020 to the cap 214 (as shown in FIG. 148 ). In the illustrated example, the connecting portion 2021 includes an opening 2096 for receiving a portion of the cap 2014. Each inner paddle 2022 is attached to a corresponding outer paddle 2020 by a connecting portion 2023 .

[0295] 137 and 138 , the paddle frame 2024 includes two or more arms 2080 that define an overall width TW of the anchor 2008, where at least some of the arms 2080 are connected at a distal portion of the paddle frame 2024 (e.g., a portion of the paddle frame 2024 proximal to the connecting member 2003). Each of the arms 2080 includes one or more openings 2091, 2092 for receiving one or more drive lines (e.g., drive line 1890 shown in FIGS. 127-130 ) such that a user can pull on the drive lines to drive the paddle frame 2024 into the constricted position. The illustrated example includes two arms 2080, each including a proximal opening 2091 and a distal opening 2092. In some implementations, a single drive line can extend through each opening 2091, 2092 such that the single drive line can drive the paddle frame 2024 into the constricted position. However, it will be appreciated that any suitable number of drive lines may extend through the openings 2091, 2092 in driving the paddle frame 2024 into the constricted position.

[0296] 137, the arms 2080 are connected to one another at a distal portion of the paddle frame 2024 via a connecting link 2083. This connection between the two arms 2080 causes the arms 2080 to pivot, bend, and / or articulate inwardly Z about the connecting link 2083 when a user applies tension F to the paddle frame 2024 by pulling on one or more drive lines extending through the openings 2091, 2092. This pivoting, bending, and / or articulation of the arms 2080 drives the main support section 2085 of the arms 2080 inwardly X, thereby placing the paddle frame 2024 in a constricted position. In the illustrated example, the connecting link 2083 includes a first member 2087 attached to one arm 2080, a second member 2089 attached to the other arm 2080, and a thin, arched member 2086 connecting the first member 2087 to the second member 2089. However, the connecting link 2083 can take any suitable form that allows the arms to pivot, bend, and / or articulate inwardly Z when tension F is applied to the paddle frame 2024. In some embodiments, the connecting link 2083 is integral to the arms 2080 of the paddle frame 2024.

[0297] 137, the overall width TW of paddle frame 1924 when in the normally extended position can be 5 mm to 15 mm, such as, for example, 7 mm to 12 mm, such as, for example, 9 mm to 11 mm, such as, for example, about 10 mm. The narrowed width of paddle frame 1124 can be 3 mm to 12 mm, such as, for example, 5 mm to 10 mm, such as, for example, 7 mm to 9 mm, such as, for example, about 8 mm. The ratio of normal width to narrowed width W2 can be 10 / 9 to 3 / 1, such as, for example, 5 / 4 to 2 / 1, such as, for example, 4 / 3 to 3 / 2.

[0298] 149-156 illustrate various exemplary implementations of a paddle frame 2024 that may be used with the implantable device or implant 2000 shown in FIGS. 139-144. Referring to FIG. 149, the device 2000 may include a paddle frame 2124 having an inner portion 2172 and an outer portion 2174. The outer portion 2174 has two arms 2180, each including an opening 2192 for receiving one or more drive lines (e.g., the drive line 1890 shown in FIGS. 27-30) so that a user can pull the drive lines to drive the paddle frame into a constricted position. The arms 2180 define the overall width TW of the anchor in the device 2000.

[0299] The arms 2180 are connected to one another at a distal portion of the paddle frame 2124 via a connecting link 2183. This connection between the two arms 2180 causes the arms 2180 to pivot, bend, and / or articulate inwardly Z about the connecting link 2183 when a user applies tension F to the paddle frame 2124 by pulling on one or more drive lines extending through the openings 2192. This pivoting, bending, and / or articulation of the arms 2180 drives the main support section 2185 of the arms 2180 inwardly X, thereby placing the paddle frame 2124 in a constricted position. In the illustrated example, the connecting link 2183 has a first member 2187 attached to one arm 2180, a second member 2189 attached to the other arm 2180, and a thin arcuate member 2186 connecting the first member 2187 to the second member 2189. The connecting link 2183 can take any suitable form, such as any of the forms described with respect to the connecting link 2083 shown in FIG.

[0300] The inner portion 2172 of the paddle frame 2124 has two arms 2182 that extend inward and downward from the proximal portion of the arms 2180 to help easily drive the paddle frame 2124 into the constricted position. The arms 2182 are connected to the arms 2180 at a connection point 2197. In some implementations, the connection point 2197 includes a thin, arched portion that helps easily drive the arms 2180, 2182 in the inward X direction. The arms 2182 are connected to each other at a connection point 2198. The connection point 2198 can include a thin, rounded portion that further helps easily drive the arms 2180, 2182 in the inward X direction.

[0301] 150, in some implementations, device 2000 can include a paddle frame 2224 having an inner portion 2272 and an outer portion 2274. Outer portion 2274 has two arms 2280, each including an opening 2292 for receiving one or more drive lines (e.g., drive line 1890 shown in FIGS. 27-30) so that a user can pull the drive lines to drive the paddle frame into a constricted position. Arms 2280 define an overall width TW of the anchor in device 2000.

[0302] The arms 2280 are connected to one another at a distal portion of the paddle frame 2224 via connecting link 2283. This connection between the two arms 2280 causes the arms 2280 to pivot, bend, and / or articulate inwardly Z about connecting link 2283 when a user applies tension F to the paddle frame 2224 by pulling on one or more drive lines extending through opening 2292. This pivoting, bending, and / or articulation of the arms 2280 drives the main support section 2285 of the arms 2280 inwardly X, thereby placing the paddle frame 2224 in a constricted position. In the illustrated example, the connecting link 2283 has a first member 2287 attached to one arm 2280, a second member 2289 attached to the other arm 2280, and a thin arcuate member 2286 connecting the first member 2287 to the second member 2289. The connecting link 2283 may take any suitable form, such as any of the forms described with respect to the connecting link 2083 shown in FIG.

[0303] The inner portion 2272 of the paddle frame 224 has two arms 2282 extending inward and downward from the proximal portion of the arms 2280 to help facilitate driving the paddle frame 2224 into the constricted position. The arms 2282 are connected to the arms 2280 at connection point 2297. In some implementations, connection point 2297 includes a thin, arched portion that helps facilitate driving the arms 2280, 2282 in the inward X direction. The arms 2282 are connected to each other at connection point 2298. Connection point 2298 can include a thin, arched portion that further helps facilitate driving the arms 2280, 2282 in the inward X direction. In the illustrated example, each of the arms 2282 is attached to each other at the thin, arched portion of connection point 2298, which includes a recess that helps facilitate bending the arms 2282 in the inward X direction.

[0304] 151 , in some implementations, device 2000 can include a paddle frame 2324 having an inner portion 2372 and an outer portion 2374. Outer portion 2374 has two arms 2380, each including an opening 2392 for receiving one or more drive lines (e.g., drive line 1890 shown in FIGS. 27-30 ) so that a user can pull the drive lines to drive the paddle frame into a constricted position. Arms 2380 define an overall width TW of the anchor in device 2000.

[0305] The arms 2380 are connected to one another at a distal portion of the paddle frame 2324 via connecting link 2383. This connection between the two arms 2380 causes the arms 2380 to pivot, bend, and / or articulate inwardly Z about connecting link 2383 when a user applies tension F to the paddle frame 2324 by pulling on one or more drive lines extending through opening 2392. This pivoting, bending, and / or articulation of the arms 2380 drives the main support section 2385 of the arms 2280 inwardly X, thereby placing the paddle frame 2324 in a constricted position. In the illustrated example, the connecting link 2283 has a first member 2387 attached to one arm 2380, a second member 2389 attached to the other arm 2380, and a thin arcuate member 2386 connecting the first member 2387 to the second member 2389. The connecting link 2383 may take any suitable form, such as any of the forms described with respect to the connecting link 2083 shown in FIG.

[0306] The inner portion 2372 of the paddle frame 2324 has two arms 2382 extending inward and upward from the arm 2380 to help easily drive the paddle frame 2324 into the constricted position. The arms 2382 are connected to the arm 2380 at a connection point 2397. In some implementations, the connection point 2397 includes a thin, arched portion that helps easily drive the arms 2380, 2382 in the inward X direction. The arms 2382 are connected to each other at a connection point 2398. The connection point 2398 may include a thin, rounded portion that further helps easily drive the arms 2380, 2382 in the inward X direction. Each of the arms 2382 includes a distal opening 2391 and a proximal opening 2393 that may receive one or more drive lines. In some implementations, the opening 2393 can be connected to the connecting portion 2023 (FIG. 145) of the anchor 2008 so that driving the anchor to the open position applies additional tension F on the paddle frame 2324, thereby easily driving the paddle frame 2324 to the constricted position.

[0307] 152, device 2000 can include a paddle frame 2424 having an inner portion 2472 and an outer portion 2474. Outer portion 2474 has two arms 2480, each including a distal opening 2492 and a proximal opening 2491, for receiving one or more drive lines (e.g., drive line 1890 shown in FIGS. 27-30) so that a user can pull on the drive lines to drive the paddle frame into a constricted position. Arms 2480 define an overall width TW of the anchor in device 2000.

[0308] The arms 2480 are connected to one another at a distal portion of the paddle frame 2424 via a connecting link 2483. This connection between the two arms 2480 causes the arms 2480 to pivot, bend, and / or articulate inwardly Z about the connecting link 2483 when a user applies tension F to the paddle frame 2424 by pulling on one or more drive lines extending through the openings 2492. This pivoting, bending, and / or articulation of the arms 2480 drives the main support section portions 2485 of the arms 2480 inwardly X, thereby placing the paddle frame 2424 in a constricted position. In the illustrated example, the connecting link 2483 has a first member 2487 attached to one arm 2480, a second member 2489 attached to the other arm 2480, and a thin arcuate member 2486 connecting the first member 2487 to the second member 2489. The connecting link 2483 may take any suitable form, such as any of the forms described with respect to the connecting link 2083 shown in FIG.

[0309] The inner portion 2472 of the paddle frame 2424 has two arms 2482 extending inward and downward from the proximal portion of the arms 2480 to help easily drive the paddle frame 2424 into the constricted position. The arms 2482 are connected to the arms 2480 at connection point 2497. In some implementations, connection point 2497 includes a thin, arched portion that helps easily drive the arms 2480, 2482 in the inward X direction. The arms 2482 are connected to each other at connection point 2498. Connection point 2498 may include a thin, rounded portion that further helps easily drive the arms 2480, 2482 in the inward X direction. Each of the arms 2482 includes an opening 2493 that may receive one or more drive lines.

[0310] 153-155, in some implementations, device 2000 can include a paddle frame 2524 having an inner portion 2572 and an outer portion 2574. Outer portion 2574 has two arms 2580, each including a distal opening 2592 and a proximal opening 2591, for receiving one or more drive lines (e.g., drive line 1890 shown in FIGS. 27-30) so that a user can pull the drive lines to drive the paddle frame into a constricted position. The arms 2580 define an overall width TW of the anchor in device 2000.

[0311] The arms 2580 are connected to one another at a distal portion of the paddle frame 2524 via a connecting link 2583. This connection between the two arms 2580 causes the arms 2580 to pivot, bend, and / or articulate inwardly Z about the connecting link 2583 when a user applies tension F to the paddle frame 2524 by pulling on one or more drive lines extending through the openings 2591, 2592. This pivoting, bending, and / or articulation of the arms 2580 drives the main support section 2585 of the arms 2580 inwardly X, thereby placing the paddle frame 2524 in a constricted position. In the illustrated example, the connecting link 2583 has a first member 2587 attached to one arm 2580, a second member 2589 attached to the other arm 2580, and a thin arcuate member 2586 connecting the first member 2587 to the second member 2589. The connecting link 2583 can take any suitable form, such as any of the forms described with respect to the connecting link 2083 shown in FIG.

[0312] Inner portion 2572 of paddle frame 2524 has two arms 2582 extending inward and upward from arm 2580 to help easily drive paddle frame 2524 into the constricted position. Arms 2582 are connected to arm 2580 at connection point 2597. In some implementations, connection point 2597 includes a thin, arched portion that helps easily drive arms 2580, 2582 in the inward X direction. Arms 2582 are connected to each other at connection point 2598. Connection point 2598 can include a thin, rounded portion that further helps easily drive arms 2580, 2582 in the inward X direction. Connection point 2598 includes an opening 2593 that can receive one or more drive lines. In some implementations, the opening 2593 can be connected to the connecting portion 2023 (FIG. 145) of the anchor 2008 so that driving the anchor to the open position applies additional tension F on the paddle frame 2524, thereby easily driving the paddle frame 2524 to the constricted position.

[0313] In some implementations, there is an angle α between each arm 2582 of the inner portion 2372 of the paddle frame 2524 and an axis A that bisects the paddle frame 2524. With reference to FIG. 153, the angle α can be approximately 60 degrees. With reference to FIG. 154, the angle α can be approximately 65 degrees. With reference to FIG. 155, the angle α can be approximately 70 degrees. While the angles are shown as being 60, 65, or 70 degrees, it will be understood that the angle α can take any suitable form that can drive the paddle frame 2524 into the constricted position when a force F is applied thereto, for example, between 50 degrees and approximately 80 degrees.

[0314] 156, device 2000 can include a paddle frame 2624 having two arms 2680, each including an opening 2692 for receiving one or more drive lines (e.g., drive line 1890 shown in FIGS. 27-30) so that a user can pull on the drive lines to drive the paddle frame into a constricted position. The arms 2680 define an overall width TW of the anchor in device 2000. Proximal portions 2670 of the arms 2680 are offset from one another so that one arm 2680 can extend beyond the other arm 2680 when the arms 2680 are driven inward X, and further so that the proximal portions 2670 of the arms 2680 can be driven away from one another back to their normally extended positions.

[0315] The arms 2680 are connected to one another at a distal portion of the paddle frame 2624 via a connecting link 2683. This connection between the two arms 2680 causes the arms 2680 to pivot, bend, and / or articulate inwardly Z about the connecting link 2683 when a user applies tension F to the paddle frame 2624 by pulling on one or more drive lines extending through the openings 2692. This pivoting, bending, and / or articulation of the arms 2680 drives the main support section 2685 of the arms 2680 inwardly X, thereby placing the paddle frame 2624 in a constricted position. In the illustrated example, the connecting link 2683 has a first member 2687 attached to one arm 2680, a second member 2689 attached to the other arm 2680, and a thin arcuate member 2686 connecting the first member 2687 to the second member 2689. The connecting link 2683 can take any suitable form, such as any of the forms described with respect to the connecting link 2083 shown in FIG.

[0316] 149-156, the overall width TW of the paddle frames 2024-2524 when in the normal expanded position can be 5-15 mm, such as 7-12 mm, such as 9-11 mm, or about 10 mm. The narrowed width of the paddle frame 1124 can be 3-12 mm, such as 5-10 mm, such as 7-9 mm, or about 8 mm. The ratio of the normal width TW to the narrowed width can be 10 / 9-3 / 1, such as 5 / 4-2 / 1, or 4 / 3-3 / 2.

[0317] 157 and 158, an example paddle frame 2724 for an implantable device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or any other suitable device described herein) includes a main support section 2785 and connecting members 2701 for attachment to a cap of the implantable device or implant. The paddle frame 2724 is configured to allow the device to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device and natural structures of the heart, such as cords. For example, when the device is positioned for implantation onto the leaflets of a native valve, a drive line (e.g., drive line 1890 shown in Figures 127-130) is controlled by a user to generate a compressive force on the paddle frame 2724, driving the paddle frame 2724 from a normal expanded position (Figure 157) to a constricted position (Figure 158), thereby reducing contact and / or friction between the device and the heart's native structures.

[0318] Connecting member 2701 can take any suitable f...

Claims

1. 1. An implantable device comprising: an anchor portion including at least one anchor, the anchor including a paddle frame including a movable member having one or more flexible protrusions, the at least one anchor configured to attach to one or more leaflets of a native heart valve; a drive portion including a post or bore including a plurality of slots configured to receive the flexible protrusions of the movable member of the paddle frame to secure the movable member in a desired position within the post or bore; driving the movable member of the paddle frame relative to the post or the lumen of the drive portion in a first orientation to drive the paddle frame into a constricted position; An implantable device, wherein the paddle frame is driven to an expanded position by driving the movable member of the paddle frame relative to the post or the lumen of the drive portion in a second orientation opposite to the first orientation.

2. The implantable device of claim 1 , wherein the paddle frame is a W-shaped frame.

3. The implantable device of claim 1 or 2, wherein the movable member of the paddle frame includes a post, and the one or more flexible protrusions extend from the post.

4. An implantable device according to any one of claims 1 to 3, wherein the movable member is configured to receive a drive member such that a user can engage the drive member to drive the movable member within the column or the lumen of the drive portion.

5. The implantable device of claim 4 , wherein the movable member includes a threaded receiving portion configured to receive the drive member and further connect the drive member to the movable member.

6. An implantable device as described in any one of claims 1 to 5, wherein the column or inner cavity of the drive portion includes one or more channels positioned to align with one or more flexible protrusions on the movable member of the paddle frame, such that when a user drives the flexible protrusion from a first slot of the plurality of slots to a second slot of the plurality of slots, the flexible protrusion can move through the one or more channels.

7. further comprising a connection feature at a proximal end of said implantable device for receiving a conduit of a delivery device; the connection feature includes a threaded receiving portion; The implantable device of any one of claims 1 to 6, wherein the movable member includes a second threaded receiving portion configured to receive a drive member and further connect the drive member to the movable member, thereby enabling a user to engage the drive member to drive the movable member within the column or inner cavity of the drive portion, and the threaded receiving portion and the second threaded receiving portion of the connection feature have threads in opposite directions to each other.

8. The implantable device of any one of claims 1 to 7, wherein when the paddle frame is driven to the constricted position, the distal end of the paddle frame is driven into the column or the lumen of the drive portion.

9. The implantable device of any one of claims 1 to 8, wherein at least a portion of the paddle frame is formed from a flexible material that allows a distal end of the paddle frame to be driven into the post or the lumen of the drive portion when the paddle frame is driven into the constricted position.

10. The implantable device of any one of claims 1 to 9, wherein at least a portion of the paddle frame is formed from nitinol.

11. The implantable device of any one of claims 1 to 10, wherein at least a portion of the paddle frame is formed from at least one of metal, plastic, fabric, and suture.

12. The implantable device of any one of claims 1 to 11, further comprising a distal portion including a cap, said cap connected to a distal end of said post or said lumen of said drive portion.

13. The implantable device of claim 12 , wherein the post or the lumen of the drive portion is integrally formed with the cap.

14. The implantable device of claim 12 , further comprising an abutment member, wherein the cap is actuated relative to the abutment member to actuate the anchor between an open position and a closed position.

15. The implantable device of any one of claims 1 to 14, wherein the anchor further comprises an inner paddle and an outer paddle.

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