Heart valve sealing devices and delivery devices therefor

Abstract

To solve the problem in which some circumstances may cause longer operation time, an over-restricted flow or undesirable stresses on the native anatomy.SOLUTION: Example valve repair devices for repairing a native valve of a patient include expandable coaptation portions. One coaptation portion has an opening and an expandable portion that is configured to expand outward through the opening. An actuation element or actuation member engages the expandable portion to expand and retract the expandable portion. Another expandable coaptation portion has a central shaft, an actuation tube, and an expandable spacer. A first end of the expandable spacer is secured to the central shaft, and a second end of the expandable spacer is secured to a locking tube. Rotation of the actuation tube relative to the central shaft causes the expandable spacer to expand.SELECTED DRAWING: Figure 245

Description

[Technical Field]

[0001] Related Applications This application claims the benefit of U.S. Provisional Application No. 62 / 908,538, filed September 30, 2019, entitled "Heart Valve Sealing Devices and Delivery Devices Therefor," which is incorporated herein by reference in its entirety. [Background technology]

[0002] Natural heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) play a critical role in ensuring proper forward flow of blood supply through the cardiovascular system. These heart valves can be damaged and therefore less effective due to congenital malformations, inflammatory processes, infectious conditions, disease, etc. Such valve damage can lead to serious cardiovascular risks and death. Damaged valves can be surgically repaired or replaced in open-heart surgery. However, such open-heart surgery is highly invasive and can result in complications. Transvascular techniques can be used to introduce and implant prosthetic devices in a manner that is significantly less invasive than open-heart surgery. As an example, a transseptal technique can be used, including inserting a catheter into the right femoral vein, advancing it up the inferior vena cava, and into the right atrium, puncturing the septum, and threading the catheter into the left atrium.

[0003] A healthy heart has a generally conical shape that tapers toward the inferior apex. The heart has four chambers: the left atrium, the right atrium, the left ventricle, and the 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 right ventricle. The mitral valve has a very different anatomical form from other natural heart valves. The mitral valve comprises an annulus, which is a circular portion of natural valve tissue surrounding the mitral orifice, and a pair of cusps, or leaflets, that extend downward from the annulus into the left ventricle. The mitral annulus may form a "D" shape, an oval, or another cross-sectional shape that is not a perfect circle with long and short axes. The anterior leaflet is larger than the posterior leaflet, and when they close together, they may form a generally "C"-shaped boundary between the abutting sides of each leaflet.

[0004] When functioning properly, the anterior and posterior leaflets function together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle expands (also called "ventricular diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricular muscle contracts (also called "ventricular systole" or "systole"), increased blood pressure in the left ventricle forces the sides of the two leaflets together, thereby closing the one-way mitral valve. As a result, blood cannot flow back into the left atrium and instead exits the left ventricle through the aortic valve. To prevent the leaflets from prolapsing under pressure and folding back from the mitral annulus toward the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles of the left ventricle.

[0005] Mitral 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 regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, including leaflet prolapse, papillary muscle insufficiency, mitral annular elongation, or a combination thereof, resulting from left ventricular dilation. Mitral regurgitation in the center of the valve leaflets can be referred to as central jet mitral regurgitation, while mitral regurgitation closer to the commissure of one of the leaflets (i.e., where the leaflets meet) can be referred to as eccentric jet mitral regurgitation. Central jet mitral regurgitation occurs when the edges of the leaflets do not meet midway, thus preventing valve closure and allowing regurgitation.

[0006] Techniques for treating mitral and other valvular regurgitation in patients can involve directly securing the edges of the native valve leaflets together. For example, catheter-delivered clips may be used to attempt to fasten the sides of the leaflets together at their ends. However, significant problems exist. For example, multiple clips may be required to eliminate or reduce regurgitation to an acceptable level, which in some circumstances can increase surgical time, excessively restrict flow, or place undesirable stress on the native anatomy.

[0007] Despite these conventional techniques, there is a continuing need for improved devices and methods for treating valvular regurgitation. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Patent No. 8,449,599 [Patent Document 2] US Patent Application Publication No. 2014 / 0222136 [Patent Document 3] US Patent Application Publication No. 2014 / 0067052 [Patent Document 4] US Patent Application Publication No. 2016 / 0331523 [Patent Document 5] U.S. Provisional Patent Application No. 62 / 161688 [Patent Document 6] US Patent Application Publication No. 2016 / 0155987 [Patent Document 7] U.S. Provisional Patent Application No. 62 / 418,528 Summary of the Invention [Means for solving the problem]

[0009] This Summary of the Invention is intended to present several examples and is not intended to limit the scope of the invention in any way. For example, features included in the examples of this Summary of the Invention are not required in the claims unless they are explicitly characterized in the claims. Also, features, components, steps, concepts, etc. described in the examples in this Summary of the Invention and elsewhere in this disclosure may be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples summarized here.

[0010] An exemplary valve repair device for repairing a patient's native valve includes a coaptation element having an opening, an expandable coaptation portion disposed within the coaptation element extending between a proximal end and a distal end and configured to expand outwardly through the opening in the coaptation element, an actuation element or member that engages the expandable coaptation portion to expand and retract the expandable coaptation portion, and an anchor portion having at least one anchor configured to attach to the patient's native valve.

[0011] The expandable spacer assembly includes a central shaft, an actuation tube, and an expandable spacer. A first end of the expandable spacer is secured to the central shaft. In some embodiments, a second end of the expandable spacer is secured to a locking tube. Rotation of the actuation tube relative to the central shaft expands the expandable spacer.

[0012] A further understanding of the nature and advantages of the present invention will become apparent from the following description and claims, particularly when considered in conjunction with the accompanying drawings, in which like parts are marked with like reference numerals.

[0013] To further clarify various aspects of embodiments of the present invention, a more particular description of some embodiments will be provided with reference to various aspects of the accompanying drawings. It should be understood that these drawings illustrate only typical embodiments of the present disclosure and are therefore not to be considered limiting of the scope of the present disclosure. Furthermore, while the figures may be drawn to scale in some embodiments, they are not drawn to scale in all embodiments. The embodiments and features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0014] [Figure 1] FIG. 1 is a cutaway view of a human heart in diastole. [Figure 2] FIG. 1 is a cutaway view of a human heart during systole. [Figure 2A] FIG. 2 is another cutaway view of the human heart during systole. [Figure 2B] FIG. 2B is a cutaway view of FIG. 2A annotated to show the natural shape of the mitral valve leaflets during systole. [Figure 3] FIG. 1 is a cutaway view of a human heart in diastole, showing the chordae tendineae that attach the leaflets of the mitral and tricuspid valves to the vertical walls. [Figure 4] FIG. 1 illustrates a healthy mitral valve with the leaflets closed, viewed from the atrial side of the mitral valve. [Figure 5] FIG. 1 shows a dysfunctional mitral valve with visible gaps between the leaflets as viewed from the atrial side of the mitral valve. [Figure 6] FIG. 1 illustrates a mitral valve with a wide gap between the posterior and anterior leaflets. [Figure 6A] FIG. 1 shows the coaptation elements of the mitral valve gap as viewed from the atrial side of the mitral valve. [Figure 6B]FIG. 10 shows a valve repair device attached to the mitral valve leaflets by coaptation elements in the mitral valve gap, viewed from the ventricular side of the mitral valve. [Figure 6C] FIG. 1 is a perspective view of a valve repair device applied to the mitral valve leaflets, showing the coaptation elements of the mitral valve gap from the ventricular side of the mitral valve. [Figure 6D] 1A-1C are schematic diagrams illustrating the passage of the mitral valve along each side of the coaptation element of an exemplary mitral valve repair device. [Figure 6E] 1A-1C are top schematic views illustrating the passage of mitral valve leaflets around coaptation elements of an exemplary native valve repair device. [Figure 7] FIG. 1 is a diagram illustrating the tricuspid valve as seen from the atrial side of the tricuspid valve. [Figure 8] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device at different stages of deployment. [Figure 9] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device at different stages of deployment. [Figure 10] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device at different stages of deployment. [Figure 11] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device at different stages of deployment. [Figure 11A] 12A-12C show an exemplary embodiment of an implantable prosthetic device similar to the device shown in FIG. 11, but with independently controllable paddles. [Figure 12] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device at different stages of deployment. [Figure 13] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device at different stages of deployment. [Figure 14] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device at different stages of deployment. [Figure 15] FIG. 15 shows the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native mitral valve. [Figure 16]FIG. 15 shows the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native mitral valve. [Figure 17] FIG. 15 shows the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native mitral valve. [Figure 18] FIG. 15 shows the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native mitral valve. [Figure 19] FIG. 15 shows the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native mitral valve. [Figure 20] FIG. 15 shows the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native mitral valve. [Figure 21] 1A-1C illustrate exemplary embodiments of an implantable prosthetic device or a frame of an implantable prosthetic device. [Figure 22] 1A-1C illustrate exemplary embodiments of an implantable prosthetic device or a frame of an implantable prosthetic device. [Figure 23] 1A-1D illustrate exemplary embodiments of components of an implantable prosthetic or medical device. [Figure 23A] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic spacer device. [Figure 24] 1A-1D illustrate exemplary embodiments of components of an implantable prosthetic or medical device. [Figure 25] 1A-1D illustrate exemplary embodiments of components of an implantable prosthetic or medical device. [Figure 26] 1A-1C illustrate an exemplary embodiment of a barbed fastener for use in an implantable prosthetic device. [Figure 27] 1A-1C illustrate an exemplary embodiment of a barbed fastener for use in an implantable prosthetic device. [Figure 28] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 29]1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 30] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 30A] 1A-1C are diagrams of an exemplary implantable prosthetic device with a cover. [Figure 31] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 32] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 32A] FIG. 33 is a perspective view of the cap and coaptation element insert of the implantable prosthetic device of FIGS. 28-32 in the sealed position. [Figure 32B] FIG. 33 is a perspective view of the cap and coaptation element insert of the implantable prosthetic device of FIGS. 28-32 in a spaced apart position. [Figure 33] 1A-1C illustrate barbed fasteners for use in implantable prosthetic devices. [Figure 34] FIG. 10 illustrates a portion of native valve tissue captured by a barbed fastener. [Figure 35] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 36] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 37] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 38] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 39] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 40] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 41]1A-1C illustrate an exemplary embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 42] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 43] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 44] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 45] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 46] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device being delivered and implanted into a native mitral valve. [Figure 47] FIG. 1B is a side view of an exemplary implantable prosthetic device with the barbed fasteners not in the closed position. [Figure 47A] FIG. 1B is a side view of an exemplary implantable prosthetic device with the barbed fasteners not in the closed position. [Figure 48] FIG. 1 is a side view of an exemplary implantable prosthetic device with a barbed fastener in a closed position. [Figure 48A] FIG. 1 is a side view of an exemplary implantable prosthetic device with a barbed fastener in a closed position. [Figure 48B] FIG. 1B is a side view of an exemplary implantable prosthetic device with the barbed fasteners in a closed position and attached to a deployment device. [Figure 48C] FIG. 48C is a side view of an exemplary implantable prosthetic device according to FIG. 48B provided with a cover. [Figure 48D] FIG. 48C is a front view of an exemplary implantable prosthetic device according to FIG. 48B attached to a deployment device. [Figure 48E] FIG. 48E is a front view of an exemplary implantable prosthetic device according to FIG. 48D provided with a cover. [Figure 48F]FIG. 48C is a side view of an exemplary implantable prosthetic device according to FIG. 48B with the barbed fastener in a closed position. [Figure 48G] FIG. 48F is a front view of an exemplary implantable prosthetic device according to FIG. 48F. [Figure 48H] FIG. 48F is a bottom view of an exemplary implantable prosthetic device according to FIG. 48F. [Figure 49] FIG. 1B is a side view of an exemplary implantable prosthetic device with the barbed fasteners not in a partially open position. [Figure 50] FIG. 1B is a side view of an exemplary implantable prosthetic device in a partially open position with the barbed fasteners in the open position. [Figure 51] FIG. 1B is a side view of an exemplary implantable prosthetic device in a partially open position with the barbed fasteners in a closed position. [Figure 52] FIG. 1B is a side view of an exemplary implantable prosthetic device with the barbed fasteners not in a half-open position. [Figure 53] FIG. 1B is a side view of an exemplary implantable prosthetic device in a half-open position with the barbed fasteners in a closed position. [Figure 53A] FIG. 1B is a side view of an exemplary implantable prosthetic device in a half-open position with the barbed fasteners in a closed position. [Figure 53B] FIG. 53B is a front view of an exemplary implantable prosthetic device according to FIG. 53A. [Figure 53C] FIG. 53B is a side view of an exemplary implantable prosthetic device according to FIG. 53A provided with a cover. [Figure 53D] FIG. 53B is a front view of an exemplary implantable prosthetic device according to FIG. 53A provided with a cover. [Figure 54] FIG. 1B is a side view of an exemplary implantable prosthetic device in a half-open position with the barbed fasteners in the open position. [Figure 54A] FIG. 1B is a side view of an exemplary implantable prosthetic device in a half-open position with the barbed fasteners in the open position. [Figure 54B] FIG. 54B is a front view of an exemplary implantable prosthetic device according to FIG. 54A. [Figure 54C]FIG. 54B is a side view of an exemplary implantable prosthetic device according to FIG. 54A provided with a cover. [Figure 54D] FIG. 54B is a front view of an exemplary implantable prosthetic device according to FIG. 54A provided with a cover. [Figure 55] FIG. 1B is a side view of an exemplary implantable prosthetic device without the barbed fasteners in the 3 / 4 open position. [Figure 56] FIG. 1B is a side view of an exemplary implantable prosthetic device in a 3 / 4 open position with the barbed fasteners in a closed position. [Figure 57] FIG. 1B is a side view of an exemplary implantable prosthetic device in a 3 / 4 open position with the barbed fasteners in the open position. [Figure 58] FIG. 1B is a side view of an exemplary implantable prosthetic device with the barbed fasteners not near a fully escaped or fully open position. [Figure 59] FIG. 1B is a side view of an exemplary implantable prosthetic device with the barbed fasteners not in a fully escaped or fully open position. [Figure 60] FIG. 1B is a side view of an exemplary implantable prosthetic device in a fully ejected position with the barbed fasteners in a closed position. [Figure 60A] FIG. 1B is a side view of an exemplary implantable prosthetic device in a fully ejected position with the barbed fasteners in a closed position. [Figure 60B] FIG. 60B is a front view of an exemplary implantable prosthetic device according to FIG. 60A. [Figure 60C] FIG. 60B is a side view of an exemplary implantable prosthetic device according to FIG. 60A provided with a cover. [Figure 60D] FIG. 60B is a front view of an exemplary implantable prosthetic device according to FIG. 60A provided with a cover. [Figure 61] FIG. 1B is a side view of an exemplary implantable prosthetic device in a fully ejected position with the barbed fasteners in an open position. [Figure 61A] FIG. 1B is a side view of an exemplary implantable prosthetic device in a fully ejected position with the barbed fasteners in an open position. [Figure 61B]FIG. 61B is a front view of an exemplary implantable prosthetic device according to FIG. 61A. [Figure 61C] FIG. 61B is a side view of an exemplary implantable prosthetic device according to FIG. 61A provided with a cover. [Figure 61D] FIG. 61B is a front view of an exemplary implantable prosthetic device according to FIG. 61A provided with a cover. [Figure 62A] 10A-10C illustrate the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 62B] 10A-10C illustrate the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 63A] 10A-10C illustrate the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 63B] 10A-10C illustrate the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 63C] 10A-10C illustrate the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 64A] 10A-10C illustrate the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 64B] 10A-10C illustrate the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 64C] 10A-10C illustrate the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 65] FIG. 1 is a perspective view of an exemplary implantable prosthetic device in a closed position. [Figure 65A] FIG. 1 is a perspective view of an exemplary implantable prosthetic device in a closed position. [Figure 66] FIG. 66 is a perspective view of the implantable prosthetic device of FIG. 65. [Figure 66A] FIG. 65B is a perspective view of the implantable prosthetic device of FIG. 65A. [Figure 67] FIG. 66 is a front view of the implantable prosthetic device of FIG. 65. [Figure 67A] FIG. 65B is a front view of the implantable prosthetic device of FIG. 65A. [Figure 68]FIG. 66 is a front view of the implantable prosthetic device of FIG. 65 with additional components. [Figure 68A] FIG. 65B is a front view of the implantable prosthetic device of FIG. 65A with additional components. [Figure 69] FIG. 66 is a side view of the implantable prosthetic device of FIG. 65. [Figure 70] FIG. 66 is a top view of the implantable prosthetic device of FIG. 65. [Figure 70A] FIG. 65B is a top view of the implantable prosthetic device of FIG. 65A. [Figure 71] FIG. 66 is a top view of the implantable prosthetic device of FIG. 65 with a collar component. [Figure 71A] FIG. 65B is a top view of the implantable prosthetic device of FIG. 65A with a collar component. [Figure 72] FIG. 66 is a bottom view of the implantable prosthetic device of FIG. 65. [Figure 72A] FIG. 65B is a bottom view of the implantable prosthetic device of FIG. 65A. [Figure 73] FIG. 66 is a bottom view of the implantable prosthetic device of FIG. 65 with a cap component. [Figure 73A] FIG. 65B is a bottom view of the implantable prosthetic device of FIG. 65A with a cap component. [Figure 74] 66 is a cross-sectional perspective view of the implantable prosthetic device of FIG. 65 taken at cross-sectional plane 75. FIG. [Figure 74A] 65B is a cross-sectional perspective view of the implantable prosthetic device of FIG. 65A taken at cross-sectional plane 75A. [Figure 75] FIG. 75 is a top cross-sectional view of the exemplary implantable prosthetic device shown in FIG. 74. [Figure 75A] 74B is a top cross-sectional view of the exemplary implantable prosthetic device shown in FIG. 74A. [Figure 76] 66 is a cross-sectional perspective view of the implantable prosthetic device of FIG. 65 taken at cross-sectional plane 77. FIG. [Figure 76A] 65B is a cross-sectional perspective view of the implantable prosthetic device of FIG. 65A taken through cross-sectional plane 77A. [Figure 77]FIG. 77 is a top cross-sectional view of the exemplary prosthetic device shown in FIG. 76. [Figure 77A] FIG. 76B is a top cross-sectional view of the exemplary prosthetic device shown in FIG. 76A. [Figure 78] 66 is a cross-sectional perspective view of the implantable prosthetic device of FIG. 65 taken at cross-sectional plane 77. FIG. [Figure 78A] 65B is a cross-sectional perspective view of the implantable prosthetic device of FIG. 65A taken through cross-sectional plane 77A. [Figure 79] FIG. 79 is a top cross-sectional view of the exemplary prosthetic device shown in FIG. 78. [Figure 79A] FIG. 78B is a top cross-sectional view of the exemplary prosthetic device shown in FIG. 78A. [Figure 80] 66 is a cross-sectional perspective view of the implantable prosthetic device of FIG. 65 taken at cross-sectional plane 81. FIG. [Figure 80A] 65B is a cross-sectional perspective view of the implantable prosthetic device of FIG. 65A taken through cross-sectional plane 81A. [Figure 81] FIG. 81 is a top cross-sectional view of the exemplary prosthetic device shown in FIG. 80. [Figure 81A] FIG. 80B is a top cross-sectional view of the exemplary prosthetic device shown in FIG. 80A. [Figure 82] 66 is a cross-sectional perspective view of the implantable prosthetic device of FIG. 65 taken at cross-sectional plane 83. FIG. [Figure 82A] 65B is a cross-sectional perspective view of the implantable prosthetic device of FIG. 65A taken through cross-sectional plane 83A. [Figure 83] FIG. 83 is a top cross-sectional view of the exemplary prosthetic device shown in FIG. 82. [Figure 83A] FIG. 82B is a top cross-sectional view of the exemplary prosthetic device shown in FIG. 82A. [Figure 84] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device with integral barbs. [Figure 85] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device with integral barbs. [Figure 86] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device with integral barbs. [Figure 86A] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device with integral barbs. [Figure 87] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device with integral barbs. [Figure 87A] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device with integral barbs. [Figure 88] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device with integral barbs. [Figure 88A] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device with integral barbs. [Figure 89] FIG. 66 is a perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65. [Figure 89A] FIG. 65B is a perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A. [Figure 90] FIG. 66 is a perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65. [Figure 90A] FIG. 65B is a perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A. [Figure 91] FIG. 66 is a front view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65. [Figure 91A] FIG. 65B is a front view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A. [Figure 92] FIG. 66 is a side view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65. [Figure 92A] FIG. 65B is a side view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A. [Figure 93] FIG. 66 is a top view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65. [Figure 93A] FIG. 65B is a top view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A. [Figure 94]FIG. 66 is a bottom view of the joints and portions of the implantable prosthetic device shown in FIG. 65. [Figure 94A] FIG. 65B is a bottom view of the joints and portions of the implantable prosthetic device shown in FIG. 65A. [Figure 95] 66 is a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65, taken along plane 96. FIG. [Figure 95A] FIG. 66A is a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A, taken along plane 96A. [Figure 96] FIG. 96 is a cross-sectional view of the joint and paddle portion of FIG. 95. [Figure 96A] FIG. 95B is a cross-sectional view of the joint and paddle portion of FIG. 95A. [Figure 97] 66 is a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65, taken along plane 98. FIG. [Figure 97A] FIG. 68A is a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A, taken along plane 98A. [Figure 98] FIG. 98 is a cross-sectional view of the joint and paddle portion of FIG. 97. [Figure 98A] FIG. 97B is a cross-sectional view of the joint and paddle portion of FIG. 97A. [Figure 99] 66 is a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65, taken across plane 100. FIG. [Figure 99A] FIG. 65B is a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A, taken along plane 100A. [Figure 100] FIG. 99 is a cross-sectional view of the joint and paddle portion of FIG. [Figure 100A] FIG. 99B is a cross-sectional view of the joint and paddle portion of FIG. 99A. [Figure 101] 66 is a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65, taken along plane 102A. FIG. [Figure 101A]65B is a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A, taken along plane 102A. FIG. [Figure 102] FIG. 102 is a cross-sectional view of the joint and paddle portion of FIG. 101. [Figure 102A] FIG. 101B is a cross-sectional view of the joint and paddle portion of FIG. 101A. [Figure 103] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 104] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 105] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 106] FIG. 1B is a side view of an exemplary embodiment of an expandable coaptation element in an unexpanded state. [Figure 106A] FIG. 1B is a side view of an exemplary embodiment of an expandable coaptation element in an unexpanded state. [Figure 106B] FIG. 1B is a side view of an exemplary embodiment of an expandable coaptation element in an unexpanded state. [Figure 106C] FIG. 1B is a side view of an exemplary embodiment of an expandable coaptation element in an unexpanded state. [Figure 106D] FIG. 1B is a side view of an exemplary embodiment of an expandable coaptation element in an unexpanded state. [Figure 106E] FIG. 1B is a side view of an exemplary embodiment of an expandable coaptation element in an unexpanded state. [Figure 106F] 1A-1C illustrate an exemplary embodiment of an expandable coaptation element. [Figure 106G] 1A-1C illustrate an exemplary embodiment of an expandable coaptation element. [Figure 106H] 1A-1C illustrate an exemplary embodiment of an expandable coaptation element. [Figure 106I] 1A-1C illustrate an exemplary embodiment of an expandable coaptation element. [Figure 107] FIG. 107 is an end view of the expandable coaptation element of FIG. 106. [Figure 108] FIG. 107 shows the expandable coaptation element of FIG. 106 in an expanded state. [Figure 108A]FIG. 106B shows the expandable coaptation element of FIG. 106A in an expanded state. [Figure 108B] FIG. 106C shows the expandable coaptation element of FIG. 106B in an expanded state. [Figure 108C] FIG. 106D shows the expandable coaptation element of FIG. 106C in an expanded state. [Figure 108D] FIG. 106E shows the expandable coaptation element of FIG. 106D in an expanded state. [Figure 108E] FIG. 106F shows the expandable coaptation element of FIG. 106E in an expanded state. [Figure 109] FIG. 109 is an end view of the joining element of FIG. 108. [Figure 110] 1 is a side view of an exemplary embodiment of an implantable prosthetic device. [Figure 111] 111 is an end view of the joint element of the exemplary prosthetic device of FIG. 110 along line 111. FIG. [Figure 112] 66 is a perspective view of an exemplary embodiment of a paddle frame of the implantable prosthetic device of FIG. 65. [Figure 112A] 65B is a perspective view of an exemplary embodiment of a paddle frame of the implantable prosthetic device of FIG. 65A. [Figure 113] 66 is a perspective view of an exemplary embodiment of a paddle frame of the implantable prosthetic device of FIG. 65. [Figure 114] 66 is a perspective view of an exemplary embodiment of a paddle frame of the implantable prosthetic device of FIG. 65. [Figure 114A] FIG. 113 is a side view of the paddle frame of FIG. 112. [Figure 115] FIG. 115 is a front view of the paddle frame of FIGS. 112 to 114. [Figure 115A] FIG. 112B is a top view of the paddle frame of FIG. 112A. [Figure 116] FIG. 115 is a top view of the paddle frame of FIGS. 112 to 114. [Figure 116A] FIG. 112B is a front view of the paddle frame of FIG. 112A. [Figure 117] FIG. 115 is a side view of the paddle frame of FIGS. 112 to 114. [Figure 117A]FIG. 112B is a rear view of the paddle frame of FIG. 112A. [Figure 118] FIG. 115 is a bottom view of the paddle frame of FIGS. 112 to 114. [Figure 118A] FIG. 112B is a bottom view of the paddle frame of FIG. 112A. [Figure 119] FIG. 115 is a front view of the paddle frame of FIGS. 112 to 114. [Figure 120] FIG. 115 is a front view of the paddle frame of FIGS. 112-114 in a compressed state within a delivery device. [Figure 121] FIG. 1 is a side view of an exemplary embodiment of an implantable prosthetic device in a closed state. [Figure 122] FIG. 122 is a front view of a paddle frame of the exemplary prosthetic device of FIG. 121. [Figure 123] FIG. 122 is a side view of the implantable prosthetic device of FIG. 121 in an open state. [Figure 124] FIG. 124 is a front view of the paddle frame of the open prosthetic device of FIG. 123. [Figure 125] FIG. 1 is a side view of an exemplary embodiment of an implantable prosthetic device in a closed state. [Figure 126] FIG. 126 is a front view of a paddle frame of the exemplary prosthetic device of FIG. 125. [Figure 127] FIG. 126 is a side view of the implantable prosthetic device of FIG. 125 in a closed state. [Figure 128] FIG. 128 is a front view of the paddle frame of the open prosthetic device of FIG. 127. [Figure 129] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 130] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 131] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 132] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 133] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 134]1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 135] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 136] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 137] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device. [Figure 138] 1A-1C illustrate the use of an exemplary embodiment of an implantable prosthetic device. [Figure 139] 1A-1C illustrate the use of an exemplary embodiment of an implantable prosthetic device. [Figure 140] 1A-1C illustrate the use of an exemplary embodiment of an implantable prosthetic device. [Figure 141] 1A-1C illustrate the use of an exemplary embodiment of an implantable prosthetic device. [Figure 142] 1A-1C illustrate the use of an exemplary embodiment of an implantable prosthetic device. [Figure 143] 1A-1C illustrate the use of an exemplary embodiment of an implantable prosthetic device. [Figure 144] 1A-1C illustrate an exemplary embodiment of a delivery assembly including a delivery device and an exemplary prosthetic device. [Figure 145] 1A and 1B are perspective views of an exemplary embodiment of an implantable prosthetic device releasably coupled to a delivery device. [Figure 146] FIG. 146 shows the embodiment of FIG. 145 in which the implantable prosthetic device is released from the delivery device. [Figure 147] FIG. 146 is a cross-sectional view of the coupler of FIG. 145; [Figure 148] FIG. 145 is a perspective view of the delivery assembly of FIG. 144, with the prosthetic device shown in partial cross-section and some components of the delivery apparatus shown schematically. [Figure 149] FIG. 145 is a plan view of the shaft of the delivery device of FIG. 144. [Figure 150] FIG. 145 is a side elevational view of the proximal end of the delivery device of FIG. 144. [Figure 151] 151 is a cross-sectional view of the proximal end of the delivery device of FIG. 144 taken along line 151-151 shown in FIG. 150. [Figure 152] FIG. 145 is an exploded view of the proximal end of the delivery device of FIG. 144. [Figure 153] 1A-1C illustrate an exemplary procedure used to repair a natural valve of the heart, partially shown. [Fig. 154] 1A-1C illustrate an exemplary procedure used to repair a natural valve of the heart, partially shown. [Figure 155] 1A-1C illustrate an exemplary procedure used to repair a natural valve of the heart, partially shown. [Figure 156] 1A-1C illustrate an exemplary procedure used to repair a natural valve of the heart, partially shown. [Figure 157] 1A-1C illustrate an exemplary procedure used to repair a natural valve of the heart, partially shown. [Figure 158] 1A-1C illustrate an exemplary procedure used to repair a natural valve of the heart, partially shown. [Figure 159] 1A-1C illustrate an exemplary procedure used to repair a natural valve of the heart, partially shown. [Figure 160] 1A-1C illustrate an exemplary procedure used to repair a natural valve of the heart, partially shown. [Figure 161] 145A-145C illustrate an exemplary embodiment of a handle of the delivery device of FIG. 144. [Figure 162] FIG. 162 is an exploded view of the handle of FIG. 161. [Figure 163] 145A-145C illustrate an exemplary embodiment of the coupler and proximal collar of the delivery assembly of FIG. 144, showing the coupler releasably coupled to the proximal collar. [Fig. 164] 164 is a perspective view of the coupler and proximal collar of FIG. 163, showing the coupler released from the proximal collar. [Figure 165]A figure showing an exemplary embodiment of the cap, actuation element or actuation means, and release wire of the delivery assembly of Figure 144, showing the cap releasably coupled to the actuation element or actuation means by the release wire. [Figure 166] 164 is a perspective view of the cap, actuation element or actuation means, and release wire of FIG. 163, showing the cap and release wire released from the actuation element or actuation means. [Figure 167] 145A-145C show exemplary embodiments of the coupler, proximal collar, cap, and actuation element or actuation means of the delivery assembly of FIG. 144. [Figure 168] FIG. 168 is a perspective view of the coupler and proximal collar of FIG. 167; [Figure 169] 145A-145C illustrate an exemplary embodiment of a fastener control member of the delivery device of FIG. 144. [Figure 170] 169 from the perspective 170 shown in FIG. 169. FIG. [Figure 171] 169A and 169B show an exemplary embodiment of a guide rail of the fastener control member. [Fig. 172] 145A-145C illustrate an exemplary embodiment of the shaft of the delivery device of FIG. 144. [Figure 173] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device. [Fig. 174] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device. [Figure 174A] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device. [Figure 175] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device. [Figure 175A]1A-1C illustrate an exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device. [Figure 176] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device. [Figure 177] 1A-1C illustrate an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 178] 1A-1C illustrate an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 179] 1A-1C illustrate an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 180] 1A-1C illustrate an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 181] 1A-1C illustrate an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 182] 1A-1C illustrate an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 183] 1A-1C illustrate an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 184] 1A-1C illustrate an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 185] 1A-1C illustrate an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 186] 1A-1C illustrate exemplary embodiments of actuation elements or means for an exemplary prosthetic device. [Figure 187] 1A-1C illustrate an actuation mechanism of an exemplary prosthetic device. [Figure 188] 1A-1C illustrate an actuation mechanism of an exemplary prosthetic device. [Figure 188A] 1A-1C illustrate an actuation mechanism of an exemplary prosthetic device. [Figure 189] 1A-1C illustrate an actuation mechanism of an exemplary prosthetic device. [Figure 190] 1A-1C illustrate an actuation mechanism of an exemplary prosthetic device. [Figure 191] FIG. 1 is a perspective view of a blank used to make a paddle frame. [Figure 192] 191 is a perspective view of the semi-finished product of FIG. 191 bent to form a paddle frame. [Figure 193] FIG. 16 is a perspective view of a shape-setting paddle frame attached to the cap of a valve repair device. [Figure 194] FIG. 194 is a perspective view of the paddle frame of FIG. 193 bent and attached to the inner and outer paddles in the closed position. [Figure 195] 112B is a perspective view of two of the paddle frames of FIG. 112A showing the paddle frames in a shape-setting position. FIG. [Figure 196] FIG. 196 is a perspective view of the paddle frame of FIG. 195 showing the paddle frame in a loading position. [Figure 197] FIG. 60D is an enlarged side view of the device of FIG. 60C showing the cover. [Figure 198] FIG. 60D is an enlarged side view of the device of FIG. 60C showing the cover. [Figure 199] FIG. 1 is an exploded view of an exemplary prosthetic device. [Figure 200] FIG. 1 is an enlarged perspective view of a collar of an exemplary prosthetic device. [Figure 201] FIG. 1 is an enlarged perspective view of a cap of an exemplary prosthetic device. [Figure 202] FIG. 207 is an exploded view of the cap of FIG. 206. [Figure 203] FIG. 1 is a plan view of an inner cover for an exemplary prosthetic device. [Figure 204] FIG. 1 is a plan view of an outer cover for an exemplary prosthetic device. [Figure 205] FIG. 1 is an enlarged view of a strip of material for an exemplary prosthetic device. [Figure 206] FIG. 206 is an end view of the material of FIG. 205. [Figure 207] FIG. 206 is an end view of the material of FIG. 205 arranged in multiple layers. [Figure 208A] 1A shows an exemplary implantable prosthetic device within the natural valve gap as viewed from the atrial side of the native valve during diastole, with an exemplary expandable spacer in a deflated state. FIG. [Figure 208B] FIG. 208B shows the device of FIG. 208A during ventricular systole with the exemplary expandable spacer in a deflated state. [Figure 209A] FIG. 208B illustrates the device of FIG. 208A during diastole, with the exemplary expandable spacer in an inflated state. [Figure 209B] FIG. 208B shows the device of FIG. 208A during ventricular systole with the exemplary expandable spacer in an inflated state. [Figure 210A] FIG. 1 illustrates an exemplary expandable spacer in a compressed state. [Figure 210B] FIG. 210B shows the expandable spacer of FIG. 210A in an expanded state. [Figure 211A] 1A-1C illustrate an exemplary implantable prosthetic device with an exemplary expandable spacer in a deflated state. [Figure 211B] FIG. 211C shows the device of FIG. 211B with the exemplary expandable spacer in an inflated state. [Figure 212A] FIG. 1 is a side view of an exemplary implantable prosthetic device. [Figure 212B] FIG. 212B is a front / back view of the device of FIG. 212A. [Figure 213A] 212B is a top view of an exemplary auxiliary spacer for attachment to the device of FIG. 212A. FIG. [Figure 213B] FIG. 213B is a side view of the spacer of FIG. 213A. [Figure 214] 213A and 213B being assembled into the device of FIGS. 212A and 212B. FIG. [Figure 215A] 213A and 213B assembled to the device of FIGS. 212A and 212B. FIG. [Figure 215B] FIG. 215B is a top view of the assembly of FIG. 215A. [Figure 216A]FIG. 1 is a side view of an exemplary implantable prosthetic device. [Figure 216B] FIG. 216B is a front / back view of the device of FIG. 216A. [Figure 217A] FIG. 216B is a top view of an exemplary auxiliary spacer for attachment to the device of FIG. 216A. [Figure 217B] FIG. 217B is a side view of the spacer of FIG. 217A. [Figure 218] 1A and 1B are diagrams of exemplary auxiliary spacers. [Figure 219A] FIG. 1 is a top view of an exemplary implantable prosthetic device. [Figure 219B] FIG. 1 is a side view of an exemplary implantable prosthetic device. [Figure 220A] FIG. 10 is a top view of an exemplary auxiliary spacer. [Figure 220B] FIG. 10 is a top view of an exemplary auxiliary spacer. [Figure 220C] FIG. 10 is a top view of an exemplary auxiliary spacer. [Figure 220D] FIG. 10 is a top view of an exemplary auxiliary spacer. [Figure 220E] FIG. 10 is a top view of an exemplary auxiliary spacer. [Figure 221] FIG. 1 is a plan view of an exemplary implantable prosthetic device cut from a single flat sheet of material. [Figure 222] FIG. 222 is a perspective view of the device of FIG. [Figure 223] 221-222 within the native valve gap as viewed from the atrial side of the native valve. FIG. [Figure 224] FIG. 1 is a plan view of an exemplary implantable prosthetic device cut from a single flat sheet of material. [Figure 225] FIG. 225 is a perspective view of the device of FIG. 224. [Figure 226] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device with a two-piece cover. [Figure 227] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device with a two-piece cover. [Figure 228]1A-1C illustrate an exemplary embodiment of an implantable prosthetic device with a two-piece cover. [Figure 229] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device with a two-piece cover. [Figure 230] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device with a two-piece cover. [Figure 231] 1A-1C illustrate an exemplary embodiment of an implantable prosthetic device with a two-piece cover. [Figure 232] FIG. 1 is a front view of an exemplary embodiment of an implantable prosthetic device with an exemplary spacer in a retracted position. [Figure 233] FIG. 233 is a side view of the exemplary implantable prosthetic device of FIG. 232. [Figure 234] FIG. 233 shows the device of FIG. 232 during ventricular diastole. [Figure 235] FIG. 233 shows the device of FIG. 232 in systole. [Figure 236] FIG. 1 is a front view of an exemplary embodiment of an implantable prosthetic device with an exemplary spacer in a symmetrically expanded state. [Figure 237] FIG. 237 is a side view of the exemplary implantable prosthetic device of FIG. 236. [Figure 238] FIG. 237 shows the device of FIG. 236 during ventricular diastole. [Figure 239] FIG. 237 shows the device of FIG. 236 during ventricular systole. [Figure 240] FIG. 1 is a front view of an exemplary embodiment of an implantable prosthetic device with an exemplary spacer in an asymmetrically expanded state. [Figure 241] FIG. 241 is a side view of the exemplary implantable prosthetic device of FIG. 240. [Figure 242] FIG. 241 shows the device of FIG. 240 during ventricular diastole. [Figure 243] FIG. 241 shows the device of FIG. 240 during ventricular systole. [Figure 244] 1A and 1B are top perspective views of an exemplary embodiment of an implantable prosthetic device. [Figure 245] FIG. 245 is a bottom perspective view of the exemplary implantable prosthetic device of FIG. 244. [Figure 246] FIG. 245 is a side view of the exemplary implantable prosthetic device of FIG. 244. [Figure 247] FIG. 245 is a front view of the exemplary implantable prosthetic device of FIG. 244. [Figure 248] FIG. 245 is a top view of the exemplary implantable prosthetic device of FIG. 244. [Figure 249] FIG. 245 is a bottom view of the exemplary implantable prosthetic device of FIG. 244. [Figure 250] FIG. 1 is a top perspective view of a spacer of an exemplary implantable prosthetic device in a closed state. [Figure 251] FIG. 251 is a bottom perspective view of the spacer of FIG. 250. [Figure 252] FIG. 251 is a front view of the spacer of FIG. 250. [Figure 253] FIG. 251 is a side view of the spacer of FIG. 250. [Figure 254] FIG. 251 is a top view of the spacer of FIG. 250. [Figure 255] FIG. 251 is a bottom view of the spacer of FIG. 250. [Figure 256] FIG. 1B is a side view of an exemplary embodiment of a joint of an implantable prosthetic device with an exemplary spacer in a retracted position. [Figure 257] FIG. 257 is a side view of the exemplary implantable prosthetic device of FIG. 256 with the exemplary spacer in an expanded state. [Figure 258] FIG. 1B is a side view of an exemplary embodiment of a joint of an implantable prosthetic device with an exemplary spacer in a retracted position. [Figure 259] FIG. 259 is a side view of the exemplary implantable prosthetic device of FIG. 258 with the exemplary spacer in an expanded state. [Figure 260] FIG. 1B is a side view of an exemplary embodiment of a joint of an implantable prosthetic device with an exemplary spacer in a retracted position. [Figure 261]FIG. 261 is a side view of the exemplary implantable prosthetic device of FIG. 260 with the exemplary spacer in an expanded state. [Figure 262] FIG. 1B is a side view of an exemplary embodiment of a joint of an implantable prosthetic device with an exemplary spacer in a retracted position. [Figure 263] FIG. 263 is a side view of the exemplary implantable prosthetic device of FIG. 262 with the exemplary spacer in an expanded state. [Figure 264] FIG. 1B is a side view of an exemplary embodiment of a joint of an implantable prosthetic device with an exemplary spacer in a retracted position. [Figure 265] FIG. 265 is a side view of the exemplary implantable prosthetic device of FIG. 264 with the exemplary spacer in an expanded state. [Figure 266] FIG. 1B is a side view of an exemplary embodiment of a joint of an implantable prosthetic device with an exemplary spacer in a retracted position. [Figure 267] FIG. 267 is a side view of the exemplary implantable prosthetic device of FIG. 266 with the exemplary spacer in an expanded state. [Figure 268] FIG. 1B is a side view of an exemplary embodiment of a joint of an implantable prosthetic device with an exemplary spacer in a retracted position. [Figure 269] FIG. 269 is a side view of the exemplary implantable prosthetic device of FIG. 268 with the exemplary spacer in an expanded state. [Figure 270] FIG. 1B is a side view of an exemplary embodiment of a joint of an implantable prosthetic device with an exemplary spacer in a retracted position. [Fig. 271] FIG. 271 is a side view of the exemplary implantable prosthetic device of FIG. 270 with the exemplary spacer in an expanded state. [Fig. 272] FIG. 1B is a side view of an exemplary embodiment of a joint of an implantable prosthetic device with an exemplary spacer in a retracted position. [Fig. 273] FIG. 273 is a side view of the exemplary implantable prosthetic device of FIG. 272 ​​with the exemplary spacer in an expanded state. [Fig. 274]1A-1C are schematic top views illustrating the passage of the native mitral valve leaflets around the coaptation elements of the mitral valve repair device. [Figure 275] FIG. 1B is a top perspective view of an exemplary embodiment of a joint of an implantable prosthetic device with an exemplary expandable spacer in a retracted position. [Figure 276] FIG. 276 is a bottom perspective view of the exemplary joint of FIG. 275. [Figure 277] FIG. 276 is a front view of the exemplary joint of FIG. 275. [Fig. 278] FIG. 276 is a top view of the exemplary joint of FIG. 275. [Figure 279] FIG. 276 is a bottom view of the exemplary joint of FIG. 275. [Figure 280] FIG. 276 is an exploded top perspective view of the joint of FIG. 275; [Figure 281] FIG. 276 is a top perspective view of the exemplary expandable spacer of the exemplary joint of FIG. 275 in a retracted state. [Figure 282] FIG. 282 is a bottom perspective view of the expandable spacer of FIG. 281; [Figure 283] FIG. 282 is a front view of the expandable spacer of FIG. 281; [Fig. 284] FIG. 282 is a top view of the expandable spacer of FIG. 281; [Figure 285] FIG. 276 is a top perspective view of an exemplary central shaft of the exemplary joint of FIG. 275; [Figure 286] FIG. 286 is a bottom perspective view of the central shaft of FIG. 285; [Figure 287] FIG. 286 is a front view of the central shaft of FIG. 285. [Figure 288] FIG. 286 is a top view of the central shaft of FIG. 285. [Figure 289] FIG. 286 is a bottom view of the central shaft of FIG. 285. [Figure 290] FIG. 276 is a top perspective view of the proximal cap of the exemplary joint of FIG. 275; [Figure 291] FIG. 291 is a top view of the proximal cap of FIG. 290; [Figure 292] FIG. 276 is a top perspective view of the actuation tube of the exemplary joint of FIG. 275; [Figure 293]FIG. 293 is a bottom perspective view of the actuation tube of FIG. 292. [Fig. 294] FIG. 293 is a front view of the actuation tube of FIG. 292. [Figure 295] FIG. 293 is a top view of the actuation tube of FIG. 292. [Figure 296] FIG. 276 is a top perspective view of an actuation plate of the exemplary joint of FIG. 275; [Figure 297] FIG. 297 is a top view of the actuation plate of FIG. 296; [Figure 298] FIG. 276 is a top perspective view of the joint of FIG. 275, with the expandable spacer in an expanded state. [Figure 299] FIG. 299 is a bottom perspective view of the exemplary joint of FIG. 298. [Figure 300] FIG. 299 is a front view of the exemplary joint of FIG. 298. [Figure 301] FIG. 299 is a top view of the exemplary joint of FIG. 298. [Figure 302] FIG. 299 is a bottom view of the exemplary joint of FIG. 298. [Figure 303] FIG. 299 is a top perspective view of the exemplary expandable spacer of FIG. 298 in an expanded state. [Figure 304] FIG. 304 is a bottom perspective view of the expandable spacer of FIG. 303; [Figure 305] FIG. 304 is a front view of the expandable spacer of FIG. 303. [Figure 306] FIG. 304 is a top view of the expandable spacer of FIG. 303. [Figure 307] FIG. 1 is a front view of an exemplary embodiment of an implantable prosthetic device with an exemplary asymmetric spacer in an expanded state. [Figure 308] FIG. 308 is a side view of the exemplary implantable prosthetic device of FIG. 307. [Figure 309] FIG. 308 shows the device of FIG. 307 during ventricular diastole. [Figure 310] FIG. 308 shows the device of FIG. 307 during ventricular systole. [Figure 311]FIG. 1 is a front view of an exemplary embodiment of an implantable prosthetic device with an exemplary asymmetric spacer in an expanded state. [Figure 312] FIG. 312 is a side view of the exemplary implantable prosthetic device of FIG. 311. [Figure 313] FIG. 312 shows the device of FIG. 311 during ventricular diastole. [Figure 314] FIG. 312 shows the device of FIG. 311 during ventricular systole. [Figure 315] FIG. 1 is a front view of an exemplary embodiment of an implantable prosthetic device with an exemplary spacer in an expanded state. [Figure 316] FIG. 316 is a side view of the exemplary implantable prosthetic device of FIG. 315. [Figure 317] FIG. 316 shows the device of FIG. 315 during ventricular diastole. [Figure 318] FIG. 316 shows the device of FIG. 315 during ventricular systole. DETAILED DESCRIPTION OF THE INVENTION

[0015] In the following description, reference is made to the accompanying drawings which illustrate specific embodiments of the present disclosure. Other embodiments which differ in structure and operation do not depart from the scope of the present disclosure.

[0016] Exemplary embodiments of the present disclosure are directed to devices and methods for repairing defective heart valves. It should be noted that various embodiments of delivery native valve repair devices and systems are disclosed herein, and any combination of these options can be achieved 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.

[0017] As used herein, when one or more components are described as being coupled, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection may be direct, such as between the components, or indirect, such as through the use of one or more intermediate components. Also, as used herein, references to a "member," "component," or "portion" are not limited to a single structural member, component, or element, but may include assemblies of components, members, or elements. Further, as used herein, the terms "substantially" and "about" are defined as at least near (and including) a given value or state (preferably within 10% of, more preferably within 1%, and most preferably within 0.1%).

[0018] 1 and 2 are cutaway views of a human heart H during diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, i.e., atrioventricular valves, respectively. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in FIGS. 4 and 5 ) that extend inward across their respective openings, and these leaflets come together, or "coapt," during flow to form a one-way fluid-blocking surface. The native valve repair system of the present application is described primarily with respect to the mitral valve MV. Accordingly, the anatomy of the left atrium LA and left ventricle LV is described in great detail. It should be understood that the devices described herein can also be used to repair other native valves, for example, the tricuspid valve TV, aortic valve AV, and pulmonary valve PV.

[0019] The left atrium LA receives oxygenated blood from the lungs. During diastole (diastolic phase) as seen in FIG. 1 , blood previously collected in the left atrium LA (during systole) passes through the mitral valve MV and enters the left ventricle LV as the left ventricle LV expands. During systole (systolic phase) as seen in FIG. 2 , the left ventricle LV contracts, forcing blood through the aortic valve AV and the ascending aorta into the body. During systole, the leaflets of the mitral valve MV close to prevent 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 one exemplary embodiment, the device described herein is used to restore the function of a defective mitral valve MV. That is, the device is configured to help prevent the leaflets of the mitral valve from closing to prevent blood from flowing back from the left ventricle LV into the left atrium LA. Unlike prior art techniques describing the use of sutures or clips, which often require multiple sutures or clips and additional support to treat significant regurgitation, the devices described in this application are designed to easily grasp and secure the native valve leaflets around the coaptation elements, which act as fillers for the regurgitation openings. In this application, the terms coaptation element, spacer, spacer element, and coaptation element refer to components that fill a portion of the space between native heart valves, such as the mitral or tricuspid valve.

[0020] Referring now to Figures 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24, a fibrous ring of tissue of variable density surrounding the leaflets 20, 22. Referring to Figure 3, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae 10. The chordae tendineae 10 are cord-like tendons that connect the papillary muscles 12 (i.e., muscles at the base of the chordae tendineae and within the wall of the left ventricle) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles 12 function to limit the movement of the mitral valve MV and prevent the mitral valve from retracting. The mitral valve MV opens and closes in response to pressure changes within the left atrium LA and left ventricle LV. The papillary muscles do not open or close the mitral valve MV; rather, they stabilize the mitral valve MV against the high pressures required to circulate blood throughout the body. The papillary muscles and chordae tendineae, collectively known as the subvalvular apparatus, function to prevent herniation of the mitral valve MV into the left atrium LA when the mitral valve is closed.

[0021] Various disease processes can impair the proper function of one or more of the heart's natural valves. These disease processes include degenerative processes (e.g., Barlow's disease, fibroelastic deficiency), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). In addition, damage to the left ventricle (LV) or right ventricle (RV) from a previous heart attack (i.e., myocardial infarction following coronary artery disease) or other cardiac diseases (e.g., cardiomyopathies) can deform the geometry of the natural valve, causing it to malfunction. However, the majority of patients who undergo valve surgery, such as mitral valve (MV) surgery, suffer from a degenerative disease that causes malfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve (MV)), resulting in prolapse and regurgitation.

[0022] Generally, natural valves can fail to function properly in two distinct conditions: (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when the natural valve does not open fully, thereby causing impaired blood flow. Typically, valve stenosis results from the accumulation of calcified material on the valve leaflets, which thickens the leaflets and impairs the valve's ability to fully open to allow forward blood flow.

[0023] The second type of valve dysfunction, valve regurgitation, occurs when the valve leaflets do not close completely, allowing blood to leak back into the anterior chamber (e.g., blood leaking from the left ventricle into the left atrium). There are three main mechanisms by which native valves become regurgitant, or incompetent, including Carpentier's types I, II, and III insufficiency. Carpentier's type I insufficiency involves dilation of the valve annulus, such that normally functioning leaflets deviate from one another and fail to form a tight seal (i.e., the leaflets do not coapt properly). Type I insufficiency includes leaflet perforation, such as occurs in endocarditis. Carpentier's type II insufficiency involves prolapse of one or more leaflets of the native valve above the coaptation plane. Carpentier's type III insufficiency involves restriction of the movement of one or more leaflets of the native valve, such that the leaflets are abnormally confined below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0024] Referring to Figure 4, when a healthy mitral valve MV is closed, 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 Figure 5, regurgitation 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. This impaired coaptation creates a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow backward from the left ventricle LV into the left atrium LA during systole. As previously discussed, there are a variety of different ways that a valve leaflet (e.g., the leaflets 20, 22 of the mitral valve MV) can malfunction, thereby resulting in regurgitation.

[0025] 6 , in some situations, a patient's mitral valve MV may have a wide gap 26 between the anterior leaflet 20 and the posterior leaflet 22 when the mitral valve is in a closed state (i.e., during systole). For example, the gap 26 may have a width W of between about 2.5 mm and about 17.5 mm, such as between about 5 mm and about 15 mm, such as between about 7.5 mm and about 12.5 mm, such as about 10 mm. In some situations, the gap may have a width W greater than 15 mm. In any of the above situations, a valve repair device is desired that can engage the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent backflow of blood through the mitral valve MV.

[0026] While stenosis or regurgitation can affect any valve, stenosis is primarily found to affect the aortic valve (AV) or pulmonary valve (PV), while regurgitation is primarily found to affect the mitral valve (MV) or tricuspid valve (TV). Both valve stenosis and regurgitation increase the workload of the heart (H) and, if left untreated, can lead to very serious conditions, such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium (LA), left ventricle (LV), mitral valve (MV), and aortic valve (AV)) are primarily responsible for circulating blood throughout the body, insufficiency of the mitral valve (MV) or aortic valve (AV) is particularly problematic and often life-threatening. Accordingly, due to the significantly higher pressures on the left side of the heart, insufficiency of the mitral valve (MV) or aortic valve (AV) is often more problematic.

[0027] Malfunctioning native heart valves can be repaired or replaced. Repair typically involves preserving and correcting a patient's native valve. Replacement typically involves replacing a patient's native valve with a biological or mechanical substitute. The aortic valve (AV) and pulmonary valve (PV) are typically more prone to stenosis. Because stenotic damage to the valve leaflets is irreversible, the most common treatment for a stenotic aortic or pulmonary valve is to remove the valve and replace it with a surgically implanted heart valve or a transcatheter heart valve. The mitral valve (MV) and tricuspid valve (TV) are more prone to leaflet deformation, which, as discussed above, can prevent the mitral or tricuspid valve from closing properly and allow blood to regurgitate, or backflow, from the ventricle to the atrium (e.g., a deformed mitral valve (MV) allows blood to regurgitate, or backflow, from the left ventricle (LV) to the left atrium (LA)). Regurgitation, or backflow, of blood from the ventricle to the atrium can lead to 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 dysfunctional chordae tendineae 10 (e.g., the chordae can stretch or tear), causing the anterior and posterior leaflets 20 and 22 to retract, allowing blood to flow back into the left atrium LA. These problems caused by dysfunctional chordae tendineae 10 can be corrected by repairing the chordae or mitral valve structures (e.g., by fixating the leaflets 20, 22 in the affected portion of the mitral valve).

[0028] The devices and procedures disclosed herein refer to repairing the structure of the mitral valve for illustrative purposes. However, it should be understood that the devices and concepts presented herein can be used to repair any native valve, as well as any component of a native valve. For example, referring now to FIG. 7 , any of the devices and concepts presented herein can be used to repair a tricuspid valve TV. For example, any of the devices and concepts presented herein can be used between any two of the anterior leaflets 30, septal leaflets 32, and posterior leaflets 34 to prevent backflow of blood from the right ventricle to the right atrium. In addition, any of the devices and concepts presented herein can be used on all three leaflets 30, 32, and 34 together to prevent backflow of blood from the right ventricle to the right atrium. That is, the valve repair device presented herein can be placed centrally between the three leaflets 30, 32, and 34.

[0029] An exemplary implantable prosthetic device includes a coaptation element and at least one anchor. The coaptation element is configured to be positioned within the native heart valve orifice to fill the space and help form a more effective seal, thereby reducing or preventing the aforementioned backflow. The coaptation element can have a blood-impermeable or blood-resistant structure that allows the native valve leaflets to close around the coaptation element during ventricular contraction, preventing blood from flowing back from the left or right ventricle into the left or right atrium, respectively. The prosthetic device can be configured to seal two or three native valve leaflets. That is, the device can be used with native mitral (bicuspid) and tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because it can fill the space between improperly functioning native mitral or tricuspid valves without completely closing.

[0030] The coaptation element (e.g., spacer, coaptation portion element, etc.) can have a variety of shapes. In other embodiments, the coaptation element can have an elongated cylindrical shape with a circular cross-section. In some embodiments, the coaptation element can have an elliptical cross-sectional shape, a crescent-shaped cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. The coaptation element can have an atrial portion positioned in or near the left atrium, a ventricular or inferior portion positioned in or near the left ventricle, and lateral portions extending between the native mitral valve leaflets. In embodiments configured for use with a tricuspid valve, the atrial or superior portion is positioned in or near the right atrium, the ventricular or inferior portion is positioned in or near the right ventricle, and the lateral portions extend between the native tricuspid valve leaflets.

[0031] The anchors can be configured to secure the device to one or both of the native mitral valve leaflets, such that the coaptation element is positioned between two native leaflets. In embodiments configured for use with tricuspid valves, the anchors are configured to secure the device to one, two, or three of the tricuspid valve leaflets, such that the coaptation element is positioned between three native leaflets. In some embodiments, the anchors can be attached to the coaptation element adjacent to the ventricular portion of the coaptation element. In some embodiments, the anchors can be attached to an actuation element, such as a shaft or actuation wire, to which the coaptation element is also attached. In some embodiments, the anchors and coaptation element can be positioned independently of each other by moving them separately along the longitudinal axis of the shaft or actuation wire. In some embodiments, the anchors and coaptation element can be positioned simultaneously by moving them together along the longitudinal axis of the shaft or actuation wire. The anchors can be configured to be positioned behind the native valve leaflets when implanted so that the leaflets are grasped by the anchors.

[0032] The prosthetic device can be configured to be implanted through a delivery sheath. The coaptation elements 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 so that the anchors are initially radially expanded from a statically compressed coaptation element to create a gap between the coaptation element and the anchor. The native valve leaflets are then positioned in the gap. The coaptation elements can radially expand to close the gap between the coaptation element and the anchor, capturing the leaflets between the coaptation element and the anchor. In some embodiments, the anchors and coaptation elements are optionally configured to self-expand. The implantation methods for various embodiments may vary, and each embodiment is discussed more fully below. Additional information regarding these and other delivery methods is described in U.S. Patent Nos. 5,629,599; 5,729,599; 5,729,599; and 5,729,599, each of which is incorporated herein by reference in its entirety. These methods can be performed in live animals or in simulated experiments, such as cadavers, cadaver hearts, or simulated experimental devices (e.g., simulated body parts, tissues, etc.).

[0033] The disclosed prosthetic device can be configured such that anchors are coupled to the valve leaflets to utilize tension from the natural axons to withstand the high contractile pressures that urge the device toward the left atrium. During diastole, the device can rely on compressive and retaining forces on the leaflets that are gripped by the anchors.

[0034] 8-14, a schematic representation of an implantable prosthetic device 100 is shown in various stages of deployment. Device 100 may include any other features of implantable prosthetic devices discussed herein, and device 100 may be positioned to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any of the repair systems disclosed herein).

[0035] Device 100 is deployed from a delivery sheath or means for delivery 102 and includes a coaptation portion or coaptation section 104 and an anchoring portion 106. Coaptation portion 104 of device 100 is adapted to be implanted between the leaflets of a native valve (e.g., a native mitral valve, tricuspid valve, etc.) and includes a coaptation element or means for coaptation 110 slidably attached to an actuation element 112 (e.g., an actuation wire, actuation shaft, actuation tube, etc.). Anchor portion 106 is actuated between an open state and a closed state and can take a wide variety of forms, such as a grasping element, e.g., a paddle, catch, and / or the like. Activation of actuation element or means for actuation 112 opens and closes anchoring portion 106 of device 100 to grasp the native valve leaflets during implantation. Actuation element 112 (e.g., a wire, shaft, tube, screw, line, etc.) can take a wide variety of different forms. For example, the actuation element can be threaded such that when the actuation element (e.g., a wire, shaft, tube, screw, etc.) is rotated, the anchor portion 106 moves relative to the joint 104. Alternatively, the actuation element can be unthreaded such that when the actuation element 112 is pushed or pulled, the anchor portion 106 moves relative to the joint 104.

[0036] The anchor portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 connected by portions 124, 126, and 128 between the cap 114 and the joining element or means for joining 110. The portions 124, 126, and 128 may be coupled and / or flexible to move between all positions described below. By interconnecting the outer paddle 120, the inner paddle 122, the joining element or means for joining 110, and the cap 114 by portions 124, 126, and 128, the device can be constrained to the positions and movements shown herein.

[0037] In some implementations, the actuation element or means for actuation 112 (e.g., actuation wire, actuation shaft, etc.) extends through the delivery sheath and the joining element or means for joining 110 to the cap 114 of the distal connection of the anchor portion 106. Extending and retracting the actuation element or means for actuation 112 increases and decreases the spacing, respectively, between the joining element or means for joining 110 and the cap 114. A collar or other attachment element removably attaches the joining element or means for joining 110 to the delivery sheath or means for delivery 102, such that the actuation element or means for actuation 112 slides through the collar or other attachment element and the joining element or means for joining 110 upon actuation to open and close the paddles 120, 122 of the anchor portion 106.

[0038] Referring now to FIG. 11 , the anchor portion 106 includes an attachment portion or gripping member. The illustrated gripping member comprises a barbed fastener 130 including a base or fixed arm 132, a movable arm 134, a barb or other means for fastening 136, and a coupling portion 138. The fixed arm 132 is attached to the inner paddle 122, and the coupling portion 138 is positioned adjacent to the joining element or means for joining 110. The barbed fastener has a flat surface and does not fit into a recess in the paddle. Rather, the flat portion of the barbed fastener is positioned against the surface of the inner paddle 122. The coupling portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the barbed fastener 130. The coupling portion 138 can be any suitable coupling, such as a flexible coupling, a spring coupling, a pivot coupling, or the like. In some embodiments, the coupling portion 138 is a flexible piece of material integrally formed with the fixed arm 132 and the movable arm 134. The fixed arm 132 is attached to the inner paddle 122 and remains stationary relative to the inner paddle 122 when the movable arm 134 is opened, opening and barbed catch 130 and exposing means for barbing or securing 136. In some implementations, barbed catch 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, causing the movable arm 134 to articulate, bend, or pivot about a joint 138. Other actuation mechanisms are possible.

[0039] During implantation, the paddles 120, 122 can be opened and closed to grasp the native valve leaflets or native mitral valve leaflets, for example, between the paddles 120, 122 and the coaptation element or means for coaptation 110. The barbed fasteners 130 can be used to grasp and / or further secure the native valve leaflets by engaging the leaflets with the barbed or securement means 136 and by pinching the leaflets between the movable arm 134 and the securement arm 132. The barbs or securement means 136 of the barbed fasteners 130 can increase friction with the leaflets or partially or completely perforate the leaflets. The actuation lines 116 can be actuated separately, allowing each barbed fastener 130 to open and close separately. Separate actuation allows leaflets to be grasped one at a time or allows the fastener 130 of a poorly grasped leaflet to be repositioned without altering the successful grasp of the other leaflet. The barbed catch 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in the open position), thereby allowing the leaflets to be grasped in various ways as needed for particular situations.

[0040] The barbed fasteners 130 can be separately opened by pulling on the attached actuation line 116, which extends through the delivery sheath or means for delivery 102 to the barbed fasteners 130. The actuation line 116 can take a variety of forms, such as a line, thread, wire, rod, catheter, etc. The barbed fasteners 130 can be spring loaded so that in the closed position, the barbed fasteners 130 continuously apply a pinching force to the grasped native valve leaflets. This pinching force remains constant regardless of the position of the inner paddle 122. The barbs or means for securing 136 of the barbed fasteners 130 can pierce the native leaflets to further secure them.

[0041] Referring now to FIG. 8 , the device 100 is shown in an elongated, or fully open, configuration for deployment from a delivery sheath. The device 100 is loaded into the delivery sheath in the fully open configuration because it takes up the least space, allowing for the use of the smallest catheter (or the largest device 100 for a given catheter size). In the elongated configuration, the cap 114 is spaced from the joining element or means for joining 110 so that the paddles 120, 122 of the anchoring portion 106 are fully extended. In some embodiments, the angle formed between the inside of the outer paddle 120 and the inside of the inner paddle 122 is approximately 180 degrees. The barbed fasteners 130 are held closed during deployment by the delivery sheath or means for delivering 102, thereby preventing the barbs or means for securing 136 ( FIG. 11 ) from catching or damaging the sheath or the patient's heart tissue.

[0042] 9, device 100 is shown in an elongated and entangled state similar to that of FIG. 8, but with barbed fasteners 130 in a fully open position, with the angle between the fixed and movable positions of barbed fasteners 130 ranging from about 140 degrees to about 200 degrees, from about 170 degrees to about 190 degrees, or about 180 degrees. It has been found that fully opening paddles 120, 122 and barbed fasteners 130 improves the ease of disentanglement or detachment of device 100 from a patient's anatomy upon implantation.

[0043] Referring now to FIG. 10 , the device 100 is shown in a shortened, or fully closed, state. The compact size of the device 100 in the shortened state allows for easier manipulation and placement within the heart. To transition the device 100 from the elongated state to the shortened state, the actuation element or means for actuation 112 is retracted, pulling the cap 114 toward the coaptation element or means for coaptation 110. The joint or flexible connection 126 between the outer paddle 120 and the inner paddle 122 is constrained from movement such that compressive forces acting on the outer paddle 120 from the cap 114 being retracted toward the coaptation element or means for coaptation 110 cause the paddles 120, 122, or gripping elements, to move radially outward. During movement from the open position to the closed position, the outer paddle 120 maintains an acute angle with the actuation element or means for actuation 112. The outer paddle 120 can optionally be biased toward the closed position. During the same movement, the inner paddle 122 moves through a significantly larger angle as it faces away from the interface element or means for joining 110 in the open position and folds along the side of the interface element or means for joining 110 in the closed position. In some embodiments, the inner paddle 122 is thinner and / or narrower than the outer paddle 120, and the couplings or flexible portions 126, 128 coupled to the inner paddle 122 can be thinner and / or more flexible. For example, this increased flexibility allows for greater movement than the couplings or flexible portions 124 coupling the outer paddle 120 to the cap 114. In some other embodiments, the outer paddle 120 is thinner than the inner paddle 122. The couplings or flexible portions 126, 128 coupled to the inner paddle 122 can be more flexible to allow for greater movement than the couplings or flexible portions 120 coupling the outer paddle 124 to the cap 114. In one embodiment, the inner paddle 122 can be the same width as, or substantially the same width as, the outer paddle (see, eg, FIG. 65A).

[0044] 11-13, the device 100 is shown in a partially open, ready-to-grasp state. To move from the fully closed state to the partially open state, the actuation element or means for actuation 112 is extended to push the cap 114 away from the coaptation element or means for coaptation 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, partially expanding the anchoring portion 106. The actuation line 116 is also pulled to open the catch 130, which can then grasp the valve leaflets. In the example shown in FIG. 11, the pair of inner and outer paddles 122, 120 move in unison, rather than separately, with a single actuation element or means for actuation 112. Additionally, the position of the catch 130 depends on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 also closes the catch.

[0045] FIG. 11A shows an exemplary embodiment in which the paddles 120, 122 are independently controllable. The device 100A shown in FIG. 11A is similar to the device shown in FIG. 11 except that the device 100A includes actuation elements configured as two independent actuation elements 112A, 112B coupled to two separate caps 114A, 114B. To move the first inner and first outer paddles from a fully closed state to a partially open state, the actuation element or means for actuation 112A is extended to push the cap 114A away from the joining element or means for joining 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, partially expanding the first anchor portion 106. To move the second inner and outer paddles from the fully closed state to the partially open state, the actuation element or means for actuation 112B is extended to push the cap 114 away from the joining element or means for joining 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, partially expanding the second anchor portion 106. The independent paddle control shown in Figure 11A can be implemented in any of the devices disclosed by the present application.

[0046] 12, one of the actuation lines 116 is stretched, allowing one of the fasteners 130 to close. Referring now to FIG. 13, the other actuation line 116 is stretched, allowing the other fastener 130 to close. Either or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the barbed fasteners 130.

[0047] 14, device 100 is shown in a fully closed, deployed state. Delivery sheath or means for delivering 102 and actuation element or means for actuation 112 are retracted, while paddles 120, 122 and catches 130 remain in the fully closed position. After deployment, device 100 can be maintained in the fully closed position by a mechanical latch, or can be biased to remain closed by using a spring material such as steel, other metals, plastics, composites, or shape memory alloys such as Nitinol. For example, the jointed or flexible portions 124, 126, 128, 138, and / or the inner and outer paddles 122, and / or additional biasing components (see component 524 in FIG. 28) can be formed of a metal such as steel or a shape memory alloy such as Nitinol (produced as a wire, sheet, tube, or laser-sintered powder) and are biased to keep the outer paddle 120 closed around the coaptation element or means for coaptation 110 and to keep the barbed fasteners 130 clamped around the native valve leaflets. Similarly, the fixed arms 132 and movable arms 134 of the barbed fasteners 130 are biased to clamp the leaflets. In some embodiments, the attachments or couplings 124, 126, 128, 138, and / or the inner and outer paddles 122 and / or additional biasing components (see component or frame 524 in FIG. 28) can be formed of metal or any other suitable resilient material, such as a polymeric material, to maintain the device in a closed state after implantation.

[0048] 226-231, implantable device 100 is shown with a cover 140. Cover 140 may be a fabric material, such as a fine mesh polyethylene fabric. The fabric cover may provide a blood seal on the surface of the spacer and / or promote rapid tissue ingrowth. Cover 140 includes a first cover portion 142 and a second cover portion 144, each covering a different portion of device 100. In some embodiments, a portion of one of first cover portion 142 and second cover portion 144 overlaps a portion of the other of first cover portion 142 and second cover portion 144. First cover portion 142 and second cover portion 144 may include an overlap portion 146 that overlaps one of first cover portion 142 and second cover portion 144.

[0049] 226-229, various arrangements of the first cover portion 142 and the second cover portion 144 are illustrated without overlapping portions 146. Referring now to FIG. 226, the first cover portion 142 (represented by thin cross-hatching), which may be made from a single piece of material, extends from the cap 114 and covers the cap 114, the outer paddle 120, the inner paddle 122, and the securing arm 132 of the fastener 130. The second cover 144 (represented by thin cross-hatching), which may be a single piece of material, covers the joining element or means for joining 110.

[0050] 227, a first cover portion 142, which can be made from a single piece of material, extends from the cap 114 and covers the cap 114, the outer paddle 120, the inner paddle 122, and the fixed and movable arms 132, 134 of the fastener 130. Similar to the cover 140 of FIG. 226, a second cover 144 covers the joining element or means for joining 110.

[0051] 228, a first cover portion 142, which may be made from a single piece of material, extends from the cap 114 to cover the cap 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 of the fastener 130. A second cover 144, which may be made from a single piece of material, covers the joining element or means for joining 110 and extends from the joining element or means for joining 110 to cover the movable arm 134 of the fastener 130.

[0052] 229, a first cover portion 142, which may be made from a single piece of material, extends from the cap 114 to cover the cap 114 and the outer paddle 120. A second cover 144, which may be made from a single piece of material, covers the joining element or means for joining 110 and extends from the joining element or means for joining 110 to cover the inner paddle, as well as the fixed arm 132 and the movable arm 134 of the fastener 130.

[0053] 230-231 , the arrangement of first cover portion 142 and second cover portion 144 is illustrated to include an overlapping portion 146. Referring now to FIG. 230 , first cover portion 142, which may be made from a single piece of material, extends from cap 114 to cover cap 114, outer paddle 120, inner paddle 122, and fixed arm 132 and movable arm 134 of fastener 130. Second cover 144, which may be made from a single piece of material, covers joining element or means for joining 110 and includes an overlapping portion 146 that extends from joining element or means for joining 110 and overlaps with a portion of movable arm 134 covered by first cover 142.

[0054] 231 , a first cover portion 142, which may be made from a single piece of material, extends from the cap 114 and covers the cap 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 of the fastener 130. A second cover 144, which may be made from a single piece of material, covers the joining element or means for joining 110 and the movable arm 134 of the fastener 130. The first cover 142 also includes an overlapping portion 146 that extends from the fixed arm 132 and the inner paddle 122 and overlaps a portion of the movable arm 134 and joining element or means for joining 110 that are covered by the second cover 144.

[0055] 15-20, the implantable device 100 of FIGS. 8-14 is shown delivered and implanted into the native mitral valve MV of a heart H. The methods and steps shown and / or described may be performed in a live animal or a simulated experiment, such as a cadaver, a cadaver heart, or a simulated experimental device (e.g., a simulated body part, heart, tissue, etc.).

[0056] Referring now to FIG. 15 , a delivery sheath is inserted transseptally into the left atrium LA, and device 100 is deployed from the delivery sheath in a fully open state. The actuating element or means for actuation 112 is then retracted, moving device 100 to the fully closed state shown in FIG. 16 . As seen in FIG. 17 , device 100 is in place within the mitral valve MV into the ventricle LV and partially opens, thereby capturing the leaflets 20, 22. Referring now to FIG. 18 , the actuating line 116 is extended to close one of the fasteners 130, thereby capturing leaflet 20. FIG. 19 shows the other actuating line 116, which is then extended to close the other fastener 130, thereby capturing the remaining leaflet 22. As seen in FIG. 20 , the delivery sheath or means for delivery 102, the actuating element or means for actuation 112, and the actuating line 116 are then retracted, and device 100 is fully closed and deployed within the native mitral valve MV.

[0057] Referring now to FIG. 21 , an exemplary implantable prosthetic device 200 or its frame is shown. In some embodiments, the device 200 includes an optional spacer member 202, a fabric cover (not shown), and anchors 204 extending from the spacer member 202. The ends of each anchor 204 can be coupled to a respective post of the spacer member 202 by a respective sleeve 206, which can be crimped or welded around the linkages of the anchors 204 and the posts of the spacer member 202. In one exemplary embodiment, a latching mechanism can connect the spacer member 202 to the anchors 204 within the sleeve 206. For example, the sleeve can be machined to have an inner shape that matches or is slightly smaller than the outer shape of the ends of the spacer member 202 and anchors 204, allowing the sleeve to frictionally fit over the linkages. One or more barbs or projections 208 can be attached to the frame of the spacer member 202. The free ends of the barbs or projections 208 can have a variety of shapes, such as rounded, pointed, or barbed. The protrusions 208 can exert a retaining force on the native leaflets by means of the anchors 204 , which are configured to force the native leaflets inward into the spacer member 202 .

[0058] 22 , an exemplary implantable prosthetic device 300 or frame thereof is shown. In some embodiments, the prosthetic spacer device 300 includes an annular spacer member 302, a fabric cover (not shown), and anchors 304 extending from the spacer member 302 and can be configured similarly to the prosthetic spacer member 200. One or more barbs or protrusions 306 can be attached to the frame of the spacer member 302. The ends of the protrusions 306 can include stops 308. The protrusion stops 308 can be configured in a variety of different ways. For example, the stops 308 can be configured to limit the extent to which the protrusions 306 can engage and / or pierce the natural valve leaflets and / or the stops can be configured to prevent the protrusions 306 from disengaging from the tissue after they have pierced the tissue.

[0059] Anchors 304 of prosthetic spacer device 300 may be configured similarly to anchors 204 of prosthetic spacer device 200, except that the curve of each anchor 304 includes a larger radius than anchors 204. As such, anchors 304 cover a relatively larger portion of spacer member 302 than anchors 204. This may, for example, allow the clamping force of anchors 304 against the native leaflets to be distributed over a larger surface of the native leaflets to further protect the native leaflet tissue.

[0060] Further details regarding prosthetic spacer devices can be found, for example, in U.S. Patent Nos. 6,275,999 and 6,275,999, which applications are incorporated herein by reference. Devices 200, 300 can include any other features of the implantable prosthetic devices discussed herein, and devices 200, 300 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).

[0061] 23-27, an exemplary embodiment of an implantable prosthetic spacer device 400 and its components is shown. Device 400 may include any other features of the implantable prosthetic devices discussed herein, and device 400 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).

[0062] 23 , a prosthetic spacer or joint device 400 can include a joint portion 404 and an anchor portion 406, where the anchor portion 406 includes a plurality of anchors 408. The joint portion 404 includes a joint or spacer member 410. The anchor portion 406 includes a plurality of paddles 420 (e.g., two in the illustrated embodiment) and a plurality of fasteners 430 (e.g., two in the illustrated embodiment). A first or proximal collar 411 and a second collar or cap 414 are used to move the joint portion 404 and the anchor portion 406 relative to one another.

[0063] 25 , a first link 425 of the anchor 408 can be coupled to and extend from a first portion 417 of the joint or spacer member 410, and a second link 421 of the anchor 408 can be coupled to a first collar 414. A proximal collar 411 can be coupled to a second portion 419 of the joint member 410.

[0064] The junction members 410 and anchors 408 can be coupled in a variety of ways. For example, as shown in the illustrated embodiment, the junction members 410 and anchors 408 can be coupled by integrally forming the junction members 410 and anchors 408 as a single, unitary component. This can be achieved, for example, by forming the junction members 410 and anchors 408 from a braided or woven material, such as braided or woven nitinol wire. In other embodiments, the junction members 410 and anchors 408 can be coupled by welding, fasteners, adhesives, bonded joints, threads, friction fit, crimping, and / or other means of coupling.

[0065] 24, anchor 408 can include a first portion, or outer paddle 420, and a second portion, or inner paddle 422, separated by a joint 423. In this embodiment, anchor 408 is configured similar to a leg, in that inner paddle 422 resembles the upper part of the leg, outer paddle 420 resembles the lower part of the leg, and joint 423 resembles the knee of the leg. In some embodiments, inner paddle portion 422, outer paddle portion 420, and joint 423 are formed from a continuous strip of fabric, such as a metallic fabric. In some embodiments, the strip of fabric is a composite strip of fabric.

[0066] The anchor 408 can be configured to move between various configurations by moving the cap 414 axially relative to the proximal collar 411, and thus the anchor 408, relative to the joint member 410 along a longitudinal axis extending between the first or distal portion 417 and the second or proximal portion 419 of the joint member 410. For example, the anchor 408 can be positioned in a straight configuration by moving the cap 414 away from the joint member 410. In the straight configuration, the paddle portions are aligned with the longitudinal axis of the device, i.e., straight, and the bond portion 423 of the anchor 408 is adjacent the longitudinal axis of the joint member 410 (e.g., similar to the configuration shown in FIG. 59). From the straight configuration, the anchor 408 can be moved to a fully collapsed configuration (e.g., FIG. 23) by moving it toward the joint member 410. Initially, as the cap 414 moves toward the junction member 410 and / or another portion of the device, the anchor 408 folds at the joints 423, 425, 421, and the joints 423 move radially outward relative to the longitudinal axis of the junction member 410 and axially toward the first portion 414 of the junction member 410, as shown in Figures 24-25. As the cap 414 continues to move toward the junction member 410, the joints 423 move radially inward relative to the longitudinal axis of the junction member 410 and axially toward the proximal portion 419 of the junction member 410, as shown in Figure 23.

[0067] In some embodiments, when the anchor 408 is in a straight configuration (see, for example, FIG. 59), the angle between the inner paddle 422 of the anchor 408 and the junction member 410 can be approximately 180 degrees, and when the anchor 408 is in a fully collapsed configuration (see FIG. 23), the angle between the inner paddle 422 of the anchor 408 and the junction member 410 can be approximately 0 degrees. The anchor 408 can be arranged in various partially collapsed configurations such that the angle between the inner paddle 422 of the anchor 408 and the junction member 410 can be between approximately 10 degrees and 170 degrees, or between approximately 45 degrees and 135 degrees.

[0068] Configuring the prosthetic spacer device 400 so that the anchors 408 can extend to a straight or substantially straight configuration (e.g., approximately 120-180 degrees relative to the coaptation members 410) can provide several advantages. For example, this can reduce the radial pleat profile of the prosthetic spacer device 400 and can facilitate grasping the natural valve leaflets by providing larger openings for grasping the natural valve leaflets. Additionally, the relatively slim, straight configuration can prevent or reduce the likelihood of the prosthetic spacer device 400 becoming entangled with natural anatomical structures (e.g., chordae tendineae) when the prosthetic spacer device 400 is placed and / or retrieved from a delivery apparatus.

[0069] 24, the fastener 430 can include an attachment or fixed portion 432 and an arm or movable portion 434. The attachment or fixed portion 432 can be coupled to the inner paddle 422 of the anchor 408 in a variety of ways, such as with threads, adhesives, fasteners, welding, stitching, crimping, a friction fit, and / or other bonding or fastening means.

[0070] In some embodiments, the movable portion 434 can articulate, bend, or pivot relative to the fixed portion 432 between an open configuration (e.g., FIG. 24 ) and a closed configuration ( FIGS. 23 and 25 ). In some embodiments, the catch 430 can be biased to the closed configuration. In some embodiments, in the open configuration, the fixed portion 432 and the movable portion 434 bend or pivot away from each other to allow the natural valve leaflets to be positioned between the fixed portion 432 and the movable portion 434. In some embodiments, in the closed configuration, the fixed portion 432 and the movable portion 434 bend or pivot toward each other, thereby securing the natural valve leaflets between the fixed portion 432 and the movable portion 434.

[0071] 26-27, fastener 430 is shown in a top perspective view. Fixation portion 432 (only one shown in FIGS. 26-27) can include one or more openings 433 (e.g., three in the illustrated embodiment). At least some of openings 433 can be used to couple fixation portion 432 to anchor 408. For example, threads and / or fasteners can extend through openings 433 to couple fixation portion 432 to anchor 408, or other attachment methods can be used, such as welding, adhesives, etc.

[0072] The movable portion 434 may include one or more side beams 431. When two side beams are included as shown, the side beams may be spaced apart to form a slot 431A. The slot 431A may be configured to receive the fixed portion 432. The movable portion 434 may also include a spring portion 434A coupled to the fixed portion 432 and to a barb support 434A disposed opposite the spring portion 434A.

[0073] The barb support 434B can include gripper or attachment elements, such as barbs 436A and / or other means for frictionally engaging the native leaflet tissue. The gripper elements 436A can be configured to engage and / or pierce the native leaflet tissue to help retain the leaflet between the fixed portion 432 and the movable portion 434 of the fastener 430.

[0074] The barb support 434B may also include an eyelet 435 that may be used to couple the barb support 434B to an actuation mechanism configured to flex or pivot the movable portion 434 relative to the fixed portion 432. Further details regarding coupling the fastener 430 to an actuation mechanism are provided below.

[0075] In some embodiments, fastener 430 can be formed from a shape memory material such as nitinol, stainless steel, and / or a shape memory polymer. In some embodiments, fastener 430 can be formed by laser cutting a piece of flat sheet material (e.g., nitinol) or tubing into the configuration shown in FIG. 26, or a similar or different configuration, and then shape-setting fastener 430 into the configuration shown in FIG. 27.

[0076] Shaping the fasteners 430 in this manner can provide several advantages. For example, the fasteners 430 can be optionally compressed from a shaped configuration (e.g., FIG. 27 ) to a flat configuration (e.g., FIG. 26 ) or other configuration that reduces the radial pleat profile of the fasteners 430. For example, the barbs can optionally be compressed to a flat configuration. Reducing the radial pleat profile can improve the trackability and retrievability of the prosthetic spacer device 400 on the catheter shaft of a delivery apparatus because the barbs 440 face radially inward toward the anchors 408 as the prosthetic spacer device 400 is advanced through or retrieved into the catheter shaft (see, e.g., FIG. 33 ). This can prevent or reduce the likelihood of the barbs 430 catching or scraping the catheter shaft.

[0077] Additionally, shape-setting the fastener 430 into the configuration shown in FIG. 27 can increase the clamping force of the fastener 430 when the fastener 430 is in the closed configuration. This is because the anchor 408 prevents the movable portion 434 from moving further toward the shape-set configuration, so the movable portion 434 is shape-set relative to the fixed portion 432 to a first position (e.g., FIG. 27) that exceeds the position that the movable portion 434 can achieve when the fastener 430 is attached to the anchor 408 (e.g., FIG. 25). As a result, when the fastener 430 is attached to the anchor 408 and in the closed configuration, the movable portion 434 has a preload (i.e., a clamping force greater than zero). Therefore, shape-setting the fastener 430 into the configuration shown in FIG. 27 can increase the clamping force of the fastener 430 compared to a fastener shape-set in the closed configuration.

[0078] The amount of preload on the fastener 430 can be varied by adjusting the angle at which the movable portion 434 is shaped relative to the fixed portion 432. For example, increasing the relative angle between the movable portion 434 and the fixed portion 432 increases the preload, and decreasing the relative angle between the movable portion 434 and the fixed portion 432 decreases the preload. This can also be adjusted in other ways, such as based on the form of the joints, hinges, materials, etc.

[0079] In some embodiments, the proximal collar 411 and / or the junction member 410 can include a hemostatic seal 413 configured to reduce or prevent blood from flowing out of the proximal collar 411 and / or the junction member 410. For example, in some embodiments, the hemostatic seal 413 can include a plurality of flexible flaps 413A, as shown in FIG. 23 . In some embodiments, the flaps 413A can be configured to pivot from a sealed configuration to an open configuration to allow the delivery device shaft to extend through the second collar 410. In one exemplary embodiment, the flaps 413A form a seal around the delivery device shaft. When the delivery device shaft is removed, the flaps 413A can be configured to return from the open configuration to the sealed configuration.

[0080] 23A, an exemplary embodiment of an implantable prosthetic spacer device 400A is shown. Device 400A may include any other feature of the implantable prosthetic devices discussed herein, and device 400A 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).

[0081] The prosthetic spacer or bonding device 400A can include a joint portion 404A and an anchor portion 406A, where the anchor portion 406A includes multiple anchors 408A. The joint portion 404A includes a joint or spacer member 410A. The anchor portion 406A includes multiple paddles 420A (e.g., two in the illustrated embodiment) and multiple fasteners 430A (e.g., two in the illustrated embodiment). A first or proximal collar 411A and a second collar or cap 414A are used to move the joint portion 404A and the anchor portion 406A relative to one another.

[0082] Junction member 410A extends from a proximal portion 419A assembled to collar 411A to a distal portion 417A connecting to anchor 408A. Junction member 410A and anchor 408A can be coupled together in a variety of ways. For example, as shown in the illustrated embodiment, junction member 410A and anchor 408A can be coupled by integrally forming junction member 410A and anchor 408A as a single, unitary component. This can be accomplished, for example, by forming junction member 410A and anchor 408A from a continuous strip 401A of braided or woven material, such as braided or woven nitinol wire.

[0083] The anchor 408A is attached to the joining member 410A by a hinge portion 425A and to the cap 414A by a hinge portion 421A. The anchor 408A can include a first or outer paddle portion 420A and a second or inner paddle portion 422A separated by a joint portion 423A. The joint portion 423A is attached to a paddle frame 424A, which is hingedly attached to the cap 414A. In this embodiment, the anchor 408A is configured similar to a leg, in that the inner paddle 422A resembles the upper part of a leg, the outer paddle 420A resembles the lower part of a leg, and the joint portion 423A resembles the knee of a leg. In the illustrated example, the inner paddle portion 422A, the outer paddle portion 420A, and the joint portion 423A are formed from a continuous strip of fabric 410A, such as a metal fabric.

[0084] The anchor 408A can be configured to move between various configurations by moving the cap 414A axially relative to the proximal collar 411A, and thus the anchor 408A axially relative to the joint member 410A along a longitudinal axis extending between the cap 414A and the proximal collar 411A. For example, the anchor 408 can be positioned in a straight configuration (see FIG. 60A ) by moving the cap 414A away from the joint member 410A. In the straight configuration, the paddle portions 420A, 422A are aligned or straightened along the longitudinal axis of the device, and the bond portion 423A of the anchor 408A is adjacent to the longitudinal axis of the joint member 410A (e.g., similar to the configuration shown in FIG. 60A ). From the straight configuration, the anchor 408 can be moved to a fully collapsed configuration (e.g., FIG. 23A ) by moving it toward the joint member 410A. Initially, as cap 414A moves toward junction member 410A, anchor 408A folds at joints 421A, 423A, and 425A, and joint 423A moves radially outward relative to the longitudinal axis of device 400A and axially toward distal portion 417A of junction member 410A, as shown in Figures 53A-54A. As cap 414A continues to move toward junction member 410A, joint 423A moves radially inward relative to the longitudinal axis of device 400A and axially toward proximal portion 419A of junction member 410A, as shown in Figure 23A.

[0085] In some embodiments, when the anchor 408A is in a straight configuration (see, for example, FIG. 60A), the angle between the inner paddle 422A of the anchor 408A and the junction member 410A can be approximately 180 degrees, and when the anchor 408A is in a fully collapsed configuration (see FIG. 23A), the angle between the inner paddle 422A of the anchor 408A and the junction member 410A can be approximately 0 degrees. The anchor 408A can be arranged in various partially collapsed configurations such that the angle between the inner paddle 422A of the anchor 408A and the junction member 410A can be between approximately 10 degrees and 170 degrees, or between approximately 45 degrees and 135 degrees.

[0086] Configuring the prosthetic spacer device 400A so that the anchors 408A can extend to a straight or substantially straight configuration (e.g., approximately 120-180 degrees relative to the coaptation members 410A) can provide several advantages. For example, this can reduce the radial pleat profile of the prosthetic spacer device 400A and can facilitate grasping the natural valve leaflets by providing larger openings for grasping the natural valve leaflets. Additionally, the relatively slim, straight configuration can prevent or reduce the likelihood of the prosthetic spacer device 400A becoming entangled with natural anatomical structures (e.g., chordae tendineae) when the prosthetic spacer device 400A is placed and / or retrieved from a delivery apparatus.

[0087] Fastener 430A can include an attachment or fixed portion 432C and an arm or movable portion 434C. Attachment or fixed portion 432C can be coupled to inner paddle 422A of anchor 408A in a variety of ways, such as with threads, adhesives, fasteners, welding, stitching, crimping, a friction fit, and / or other means of coupling. Fastener 430A is similar to fastener 430.

[0088] In some embodiments, the movable portion 434C can articulate, pivot, or pivot relative to the fixed portion 432C between an open configuration (e.g., FIG. 54A) and a closed configuration ( FIG. 53A). In some embodiments, the catch 430A can be biased to the closed configuration. In the open configuration, the fixed portion 432C and the movable portion 434C can articulate, pivot, or bend away from each other to allow the native valve leaflets to be positioned between the fixed portion 432A and the movable portion 434A. In the closed configuration, the fixed portion 432C and the movable portion 434C articulate, pivot, or bend toward each other, thereby securing the native valve leaflets between the fixed portion 432C and the movable portion 434C.

[0089] The strip 401A is attached to the collar 411A, cap 414A, paddle frame 424A, and fastener 430A to form both the joint portion 404A and the anchor portion 406A of the device 400A. In the illustrated embodiment, the joint member 410A, hinge portions 421A, 423A, 425A, outer paddle 420A, and inner paddle 422A are formed from a continuous strip 401A. The continuous strip 401A can be a single layer of material or can include two or more layers. In some embodiments, one portion of the device 400A has a single layer of strip of material 401A, while another portion is formed from multiple overlapping or overlying layers of strip of material 401A. For example, FIG. 23A shows the joint member 410A and inner paddle 422A formed from multiple overlapping layers of strip of material 401A. A single continuous strip of material 401A may begin and end at various locations on the device 400A. The ends of the strip of material 401A may be at the same location or at different locations on the device 400A. For example, in the illustrated embodiment of Figure 23A, the strip of material begins and ends at the location of the inner paddle 422A.

[0090] 30A, an exemplary implantable device 400A is shown covered with a cover 440A. The cover 440A is disposed over the joint members 410A, collar 411A, cap 414A, paddles 420A, 422A, paddle frame 424A, and fasteners 430A. The cover 440A can be configured to prevent or reduce blood flow through the prosthetic spacer device 400A and / or promote natural tissue ingrowth. In some embodiments, the cover 440A can be a cloth or fabric, such as PET, velour, or other suitable fabric. In other embodiments, instead of or in addition to a fabric, the cover 440A can include a coating (e.g., a polymeric material, silicone, etc.) applied to the prosthetic spacer device 400A.

[0091] 28-30, an exemplary embodiment of an implantable prosthetic device 500 (e.g., a prosthetic spacer device) is shown. The implantable device 500 is one of many different forms that the device 100, shown generally in FIGS. 8-20, can take. The device 500 can include any other features of the implantable prosthetic devices discussed herein, and the device 500 can be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0092] The prosthetic spacer device 500 may include a joint element or spacer member 510, a plurality of anchors 508 including an outer paddle 520, an inner paddle 522, a fastener 530, a first or proximal collar 511, and a second collar or cap 514. These components of the prosthetic spacer device 500 may be configured the same as or substantially similar to the corresponding components of the prosthetic spacer device 400.

[0093] The prosthetic spacer device 500 may also include a plurality of paddle extension members or paddle frames 524. The paddle frames 524 may be configured with a rounded, three-dimensional shape, with a first link 526 coupled to and extending from the cap 514 and a second link 528 disposed opposite the first link 526. The paddle frames 524 may be configured to extend more circumferentially around the joint member 510 than the outer paddles 520. For example, in some embodiments, each of the paddle frames 524 extends around approximately half of the circumference of the joint member 510 (as shown in FIG. 29), while the outer paddles 520 extend around less than half of the circumference of the joint member 510 (as shown in FIG. 28). The paddle frames 524 may also be configured to extend laterally (i.e., perpendicular to the longitudinal axis of the joint member 510), for example, beyond the outer diameter of the joint member 510. In the illustrated example, the inner paddle 522 and outer paddle 520 may be formed from a continuous strip of fabric that is connected to a paddle frame 524. For example, the inner and outer paddle portions may be connected to a connection on the paddle frame at a flexible connection between the inner and outer paddle portions.

[0094] The paddle frame 524 can further be configured such that the linkage 528 of the paddle frame 524 is connected to or axially adjacent to the coupling 523. The linkage of the paddle frame 524 can be located between the outer paddle 520 and the inner paddle 522, on the outside of the paddle portion 520, on the inside of the inner paddle portion, or on top of the coupling 523 when the prosthetic spacer device 500 is in the collapsed configuration (see, for example, FIGS. 28-30 ). The linkage between each paddle frame 524, the single strip forming the outer paddle 520 and the inner paddle 522, the cap 514, and the interface elements can constrain each of these portions to the movements and positions described herein. In particular, the coupling 523 is constrained by its connection between the outer paddle 520 and the inner paddle 522 and by its connection with the paddle frame. Similarly, the paddle frame 524 is constrained by its attachment to the coupling 523 (and thus the inner and outer paddles) and the cap.

[0095] Configuring the paddle frame 524 in this manner provides an increased surface area compared to the outer paddle 520 alone. This increased surface area facilitates grasping and securing the native valve leaflets. The increased surface area also allows the clamping force of the paddles 520 and paddle frame 524 against the native leaflets to be distributed over a larger area of ​​the native leaflets to further protect the native leaflet tissue.

[0096] The increased surface area of ​​the paddle frame 524 also allows the natural valve leaflets to be secured to the prosthetic spacer device 500 so that they coapt generally around the coaptation member 510. This can, for example, improve the sealing of the natural valve leaflets and thus prevent or further reduce mitral regurgitation.

[0097] 30 , the prosthetic spacer device 500 can also include a cover 540. In some embodiments, the cover 540 can be disposed on the joint members 510, the paddles 520, 522, and / or the paddle frame 524. The cover 540 can be configured to prevent or reduce blood flow through the prosthetic spacer device 500 and / or to promote natural tissue ingrowth. In other embodiments, the cover 540 can be a cloth or fabric such as PET, velour, or other suitable fabric. In some embodiments, instead of or in addition to a fabric, the cover 540 can include a coating (e.g., a polymer, silicone, etc.) applied to the prosthetic device 500.

[0098] 31-32 show the implantable prosthetic device 500 of FIGS. 28 and 29 with the anchor 508 and fastener 530 of the anchor portion 506 in the open position. The device 500 is deployed from a delivery sheath (not shown) and includes a coaptation portion 504 and an anchor portion 506. The device 500 is loaded into the delivery sheath in a fully extended or prolapsed state because the fully extended or prolapsed state takes up the least space and allows for the use of the smallest catheter (see FIG. 35). Alternatively, the fully extended position allows for the use of the largest device 500 for a given catheter size. The coaptation portion 504 of the device includes a coaptation element 510 for implantation between the native leaflets of a native valve (e.g., mitral valve, tricuspid valve, etc.). An insert 516A is positioned inside the coaptation element 510. The insert 516A and coaptation element 510 are slidably attached to an actuation element 512 (e.g., an actuation wire, rod, shaft, tube, screw, thread, line, etc.). The anchor 508 of the device 500 includes an outer paddle 520 and an inner paddle 522 that are flexibly coupled to the cap 514 and the coaptation element 510. Actuation of the actuation element or means for actuation 512 opens and closes the anchor 508 of the device 500 to grip the native valve leaflets during implantation.

[0099] Actuation element 512 extends through a delivery sheath (not shown), proximal collar 511, coaptation element 510, insert 516A, and into cap 514. Extending and retracting actuation element 512 increases and decreases, respectively, the spacing between coaptation element 510 and cap 514. This change in spacing between coaptation element 510 and cap 514 moves anchor portion 506 of the device between different positions.

[0100] The proximal collar 511 optionally includes a collar seal 513 that forms a seal around the actuating element or means for actuating 512 during implantation of the device 500 and that seals when the actuating element 512 is removed to close or substantially close the proximal end of the device 500 to blood flow through the interior of the coaptation element 510 after implantation. In some embodiments, a coupler or means for coupling 2214 (see FIG. 145) removably engages and attaches the proximal collar 511 and coaptation element 510 to a delivery sheath. In some embodiments, the coupler or means for coupling 2214 is held closed around the proximal collar 511 by the actuating element 512 such that removal of the actuating element 512 allows fingers (see FIG. 145) of the coupler or means for coupling 2214 to open and release the proximal collar 511.

[0101] The proximal collar 511 and insert 516A within the coaptation element 510 slide along the actuation element 512 during actuation to open and close the paddles 520, 522 of the anchor 508. Referring to FIGS. 32A and 32B, in some embodiments, the cap 514 optionally includes a sealing protrusion 516 that sealingly fits within a sealing opening 517 of the insert 516A. In one exemplary embodiment, the cap 514 includes a sealing opening and the insert 516A includes a sealing protrusion. The insert 516A can sealingly fit inside a distal opening 515 ( FIG. 31 ) of the coaptation element 510, which is hollow internally. Referring to FIG. 32A, the sealing projection 516 of the cap 514 sealingly engages the opening 517B of the insert 516A to close or substantially close the distal end of the coaptation element 510 to blood flow when the device 500 is implanted and / or in the closed position.

[0102] In one exemplary embodiment, instead of a sealing engagement between cap 514 and insert 516A, insert 516A can optionally include a seal, such as collar seal 513 on the proximal collar, which forms a seal around actuating element or means for actuation 512 during implantation of device 500 and closes tightly when actuating element 512 is removed. Such a seal can close or substantially close the distal end of coaptation element 510 to blood flow after implantation.

[0103] The coaptation element 510 and paddles 520, 522 can be formed from a flexible material, which may be a metal fabric, such as a woven, knitted, or any other suitable mesh, or a laser-cut or otherwise cut flexible material. The material may be a cloth, a shape-memory alloy wire (such as Nitinol) for shape-setting functionality, or any other flexible material suitable for implantation in the human body. The paddle frame 524 provides additional pinching force between the inner paddle 522 and the coaptation element 510 and helps wrap the leaflets around the sides of the coaptation element 510 for a better seal between the coaptation element 510 and the leaflets. In some embodiments, the cover 540 shown in FIG. 30 extends around the paddle frame 524.

[0104] Fastener 530 includes a base or fixed arm 532, a movable arm 534, a barb 536, and a coupling portion 538. Fixed arm 532 is attached to inner paddle 522, and coupling portion 538 is positioned adjacent to interface element 510. The barbed fastener has a flat surface and does not fit into a recess in the paddle. Rather, the flat portion of the barbed fastener is positioned against the surface of inner paddle 522. For example, fixed arm 532 is attached to inner paddle 522 with thread (not shown) through hole or slot 533. Fixed arm 532 can be attached to inner paddle 522 or another portion of the device by any suitable means, such as screws or other fasteners, a locking sleeve, a mechanical hook or clasp, welding, adhesive, etc. Fixed arm 532 remains fixed or substantially fixed relative to inner paddle 522 when movable arm 534 is opened to open barbed fastener 530 and expose barb 536. The barbed fastener 530 is opened by applying tension to an actuation line (not shown) attached to a hole 535 in the movable arm 534, causing the movable arm 534 to pivot or bend about a joint 538.

[0105] During implantation, the anchor 508 is opened and closed to grasp the native mitral valve leaflets between the paddles 520, 522 and the coaptation element 510. The barbed fasteners 530 further secure the native leaflets by engaging the leaflets with their barbs 536 and pinching the leaflets between the movable arm 534 and the fixed arm 532. The barbs 536 of the fasteners 530 can increase friction with the leaflets or partially or completely perforate the leaflets. The actuation lines can be separately actuated, allowing each barbed fastener 530 to be opened and closed separately. Separate actuation allows the leaflets to be grasped one at a time or allows the fastener 530 of a poorly grasped leaflet to be repositioned without altering the successful grasp of the other leaflets. The barbed fasteners 530 can be opened and closed when the inner paddle 522 is not closed, thereby allowing the leaflets to be grasped in various positions as needed for specific situations.

[0106] Referring now to FIG. 33 , an exemplary barbed fastener 600 for use in an implantable prosthetic device such as those described above is shown. However, a wide variety of different barbed fasteners can be used. Examples of barbed fasteners that can be used include, but are not limited to, any of the barbed fasteners disclosed in this application and any of the applications incorporated by reference herein and / or from which this application claims priority. In the illustrated example, the barbed fastener 600 is formed from an upper layer 602 and a lower layer 604. The two-layer design of the fastener 600 allows for the use of a thin sheet of material, thereby improving the flexibility of the fastener 600 compared to fasteners formed from a single, thick sheet, while maintaining the strength of the fastener 600 necessary to successfully retain the native valve leaflets.

[0107] The barbed fastener 600 includes a fixed arm 610, a connecting portion 620, and a movable arm 630 having a barb portion 640. The upper and lower layers 602 and 604 have similar shapes and, in some embodiments, are attached to one another at the barb portion 640. However, the upper and lower layers 602 and 604 can be attached to one another at different or additional locations. The connecting portion 620 is spring-loaded, which biases the fixed arm 610 and the movable arm 630 toward one another when the barbed fastener 600 is in a closed state. When mated with an implantable prosthetic device, the fixed arm 610 is attached to a portion of the prosthetic device. The fastener 600 is opened by pulling an actuation line attached to the movable arm 630 until it overcomes the spring force of the connecting portion 620.

[0108] The fixed arm 610 is formed from a tongue 611 of material extending from a joint 620 between two side beams 631 of the movable arm 630. The tongue 611 is biased between the side beams 631 by the joint 620 so that a force must be applied to move the tongue 611 from a neutral position beyond the side beams 631 to a preloaded position parallel or substantially parallel to the side beams 631. The tongue 611 is held in the preloaded position by an optional T-shaped crossbar 614 attached to the tongue 611 and extending outward to engage the side beams 631. In one exemplary embodiment, the crossbar is omitted and the tongue 611 is attached to the inner paddle 522, which maintains the fastener in the preloaded position. In two-layer fastener applications, the top layer 602 and bottom layer 604, or just the top layer, can be attached to the inner paddle. In some embodiments, the angle between the fixed arm 610 and the movable arm 630 when the tongue is in a neutral position is from about 30 degrees to about 100 degrees, from 30 degrees to about 90 degrees, or from about 30 degrees to about 60 degrees, or from about 40 degrees to about 50 degrees, or about 45 degrees.

[0109] Tongue 611 includes a hole 612 for receiving a thread (not shown) that attaches fixation arm 610 to the implantable device. Fixation arm 610 can be attached to the implantable device using a screw or other fastener, a fixation sleeve, a mechanical latch or clasp, welding, adhesive, etc. In some embodiments, hole 612 is an elongated slot or oval hole to accommodate sliding movement of layers 602, 604 without damaging the thread attaching fastener 600 to the implantable device.

[0110] The joint 620 is formed by two beam loops 622 that extend from the tongue 611 of the fixed arm 610 to the side beam 631 of the movable arm 630. In some embodiments, the beam loops 622 are thinner than the tongue 611 and the side beam 631 to provide additional flexibility. Each beam loop 622 includes a central portion 624 that extends from the tongue 611 and an outer portion 626 that extends to the side beam 631. The beam loops 622 are bent into a somewhat spiral or helical shape by bending the central portion 624 and the outer portion 626, thereby forming an offset or step 628 between the tongue 611 and the side beam 631. The step 628 provides space between the arms 610, 630 to accommodate the natural leaflets of the native valve after they have been grasped. In some embodiments, the step 628 is about 0.5 millimeters to about 1 millimeter, or about 0.75 millimeters.

[0111] When viewed from a top view, the beam loop has an "Omega-like" shape. This shape of the beam loop 622 allows the fixed arm 610 and the movable arm 630 to move significantly relative to one another without plastically deforming the fastener material. For example, in some embodiments, the tongue 611 can bend or pivot from a neutral position of about 45 degrees beyond the movable arm 630 to a fully open position ranging from about 140 degrees to about 200 degrees, from about 170 degrees to about 190 degrees, or even about 180 degrees from the movable arm 630, without plastically deforming the fastener material. In some embodiments, the fastener material plastically deforms during opening without reducing or substantially reducing the pinch force between the fixed and movable arms in the closed position.

[0112] Preloading the tongue 611 allows the fastener 600 to maintain a pinching or clipping force on the native valve leaflets when closed. Preloading the tongue 611 provides a significant advantage over prior art clips, which provide little or no pinching force when closed. Additionally, using spring force to close the fastener 600 is a significant improvement over clips that use a one-time locking closure mechanism because the fastener 600 can be repeatedly opened and closed for repositioning on the leaflets while still maintaining sufficient pinching force when closed. Additionally, spring-loaded fasteners also allow for easier removal of the device over a period of time compared to devices that lock in a closed position (after tissue ingrowth). In one exemplary embodiment, both the fastener and paddle are spring-biased toward their closed positions (as opposed to being locked in a closed position), which can allow for easier removal of the device after tissue ingrowth.

[0113] The barbs 640 of the movable arms 630 include grommets 642, barbs 644, and barb supports 646. Locating the barbs of the fastener 600 toward the ends of the movable arms 630 increases the spacing between the barbs 644 and the fixation arms 630 when the fastener 600 is opened, thereby improving the ability of the fastener 600 to successfully grasp the leaflets during implantation. This spacing also allows the barbs 644 to more reliably disengage from the leaflets for repositioning. In some embodiments, the barbs of the fastener can be staggered along the longitudinal axis to further distribute pinch forces and localized leaflet stresses.

[0114] The barbs 644 are laterally spaced the same distance from the bond 620 to provide a stronger leaflet gripping feature than barbs spaced longitudinally, while still providing better distribution of pinch forces on the leaflet tissue. In some embodiments, the barbs 644 can be staggered to further distribute pinch forces and local leaflet stresses.

[0115] The barbs 644 are formed from the bottom layer 604, and the barb supports 646 are formed from the top layer. In some embodiments, the barbs are formed from the top layer 602, and the barb supports are formed from the bottom layer 604. Forming the barbs 644 on only one of the two layers 602, 604 allows the barbs to be thinner, and therefore effectively sharper, than barbs formed from the same material that are twice as thick. The barb supports 646 extend along the bottom of the barbs 644 to stiffen them, further improving leaflet tissue puncture and retention. In some embodiments, the ends of the barbs 644 are further sharpened using any suitable sharpening means.

[0116] The barbs 644 are angled from the movable arm 630 to easily pierce the tissue of the native valve leaflet with minimal pinching or clipping force. The barbs 644 extend from the movable arm at an angle of about 45 degrees to about 75 degrees, or about 45 degrees to about 60 degrees, or about 48 degrees to about 56 degrees, or about 52 degrees. The angle of the barbs 644 provides an additional benefit in that forces pulling the implant away from the native leaflet encourage the barbs 644 to further engage the tissue, thereby ensuring a more adequate retention. Retention of the leaflet to the barbs 600 can be further improved by positioning a T-shaped crossbar near the barb 644 when the fastener 600 is closed. In this arrangement, tissue pierced by the barb 644 is pinched by the movable arm 630 at the crossbar 614, thereby forming an S-shaped, serpentine path as the tissue passes over the barb 644. Thus, the force pulling the leaflet away from the fastener 600 encourages the tissue to further engage the barbs 644 before the leaflet can escape. For example, leaflet tension during diastole can encourage the barbs to be pulled toward the end portions of the leaflet. In an S-shaped pathway, leaflet tension during diastole can be used to more tightly engage the leaflet with the barbs.

[0117] Each layer 602, 604 of the fastener 600 is laser cut from a sheet of a shape-memory alloy, such as Nitinol. The top layer 602 is aligned and attached to the bottom layer 604. In some embodiments, the layers 602, 604 are attached at the barb 640 of the movable arm 630. For example, the layers 602, 604 can be attached only at the barb 640, allowing the remaining layers to slide relative to one another. Portions of the combined layers 602, 604, such as the fixed arm 610, the barb 644 and barb support 646, and the beam loop 622, are bent to a desired state. The layers 602, 604 can be bent and shape-set together or bent and shape-set separately and then joined together. The fastener 600 then undergoes a shape-setting process, which causes the internal forces of the material to tend to return to a set shape after being deformed by an external force. After shape-setting, the tongue 611 moves to its preloaded position, allowing the crossbar 614 to be attached. In one exemplary embodiment, fastener 600 can optionally be fully flattened for delivery through a delivery sheath and expanded after deployment in the heart. Fastener 600 is opened and closed by applying and releasing tension to an actuating line, thread, wire, rod, catheter, etc. (not shown) attached to movable arm 630. In some embodiments, the actuating line or thread is inserted into eyelet 642 near barb 640 of movable arm 630 and wrapped around movable arm 630 before returning to the delivery sheath. In some embodiments, an intermediate thread loop is made through the eyelet and the line / thread is inserted into the intermediate loop. Alternative embodiments of the intermediate loop can be constructed from a fabric or another material attached to the movable arm instead of a thread loop.

[0118] The intermediate loop of thread material reduces the friction experienced by the actuation line / thread relative to the friction between the actuation line / thread and the fastener material. Once the thread is looped through the eyelet 642 or intermediate loop, both ends of the actuation line / thread return into the delivery sheath (e.g., FIG. 8). The thread can be removed by pulling one end of the thread proximally until the other end of the thread is pulled back through the eyelet or intermediate loop and into the delivery sheath.

[0119] Referring now to FIG. 34 , a close-up view of one of the leaflets 20, 22 is shown being grasped by a barbed fastener, such as fastener 430, 530. The leaflets 20, 22 are grasped between the movable arms 434, 534 and the fixed arms 432, 532 of the fastener 430, 530. As shown in FIG. 34 , the tissue of the leaflets 20, 22 is not perforated by the barbs 436, 536; however, in some embodiments, the barbs 436, 536 can partially or completely perforate the leaflets 20, 22. The angle and height of the barbs 436, 536 relative to the movable arms 434, 534 aid in securing the leaflets 20, 22 within the fastener 430, 530. In particular, the force of pulling the implant away from the native leaflets encourages the barbs 436, 536 to further engage the tissue, thereby ensuring a better retention. Retention of the leaflets 20, 22 on the barbs 430, 530 is further improved by positioning the anchoring arms 432, 532 near the barbs 436, 536 when the clasps 430, 530 are closed. In this arrangement, the tissue is forced into an S-shaped, serpentine path by the anchoring arms 432, 532, the movable arms 434, 534, and the barbs 436, 536. Thus, the force pulling the leaflets away from the clasps 430, 530 encourages the tissue to further engage the barbs 436, 536 before the leaflets can escape. For example, as described above, leaflet tension during diastole can encourage the barbs to pull toward the end portions of the leaflets. In an S-shaped path, leaflet tension during diastole can be utilized to more tightly engage the leaflets with the barbs.

[0120] 35-46, there is shown implantable device 500 being delivered and implanted into the native mitral valve MV of heart H. The methods and steps shown and / or described may be performed in a live animal or in a simulated experiment, such as a cadaver, a cadaver heart, or a simulated experimental device (e.g., a simulated body part, heart, tissue, etc.).

[0121] As described above, device 500 includes a cover 540 (see FIG. 30 ) covering coaptation element 510, a fastener 530, an inner paddle 522, and / or an outer paddle 520. Device 500 is deployed from a delivery sheath 502 and can include an anchor portion 506 including a coaptation portion 504 and multiple anchors 508 (i.e., two in the illustrated embodiment). Coaptation portion 504 of the device includes coaptation elements 510 for implantation between the leaflets 20, 22 of the native mitral valve MV that are slidably attached to an actuation element or means for actuation 512. Actuation of actuation element or means for actuation 512 opens and closes the anchors 508 of device 500 to grip the mitral valve leaflets 20, 22 during implantation.

[0122] The anchor 508 of the device 500 includes an outer paddle 520 and an inner paddle 522 that are flexibly coupled to a cap 514 and a coaptation element 510. The actuation element 512 extends through a capture mechanism 503 (see FIG. 41 ), a delivery sheath 502, and the coaptation element 510 to a cap 514 coupled to the anchor portion 506. Extending and retracting the actuation element 512 increases and decreases the spacing between the coaptation element 510 and the cap 514, respectively. In the example shown in FIGS. 35-46 , the pair of inner and outer paddles 522 and 520 are moved in unison, rather than separately, by a single actuation element 512. Additionally, the position of the catch 530 depends on the positions of the paddles 522, 520. For example, referring to FIG. 45 , closing the paddles 522, 520 also closes the catch. In one exemplary embodiment, device 500 can be fabricated so that paddles 520, 522 are independently controllable similar to the embodiment of Figure 11A.

[0123] Fingers of capture mechanism 503 removably attach collar 511 to delivery sheath 502. Collar 511 and coaptation element 510 slide along actuation element 512 during actuation to open and close anchors 508 of anchor portion 506. In some embodiments, capture mechanism 503 is held closed around collar 511 by actuation element 512 such that removal of actuation element 512 allows the fingers of capture mechanism 503 to open and release collar 511, and therefore coaptation element 510.

[0124] In some embodiments, the joint element 510 and / or paddles 520, 522 can be formed from a flexible material, which can be a metal fabric, such as a woven, knitted, or any other suitable formed mesh, or a laser-cut or otherwise cut flexible material. The flexible material can be cloth, a shape-memory alloy wire (such as Nitinol) for shape-setting functionality, or any other flexible material suitable for implantation in the human body. Other configurations are possible.

[0125] The barbed fastener 530 includes a base or fixed arm 532, a movable arm 534, a barb 536 (see FIG. 41 ), and a coupling portion 538. The fixed arm 532 is attached to the inner paddle 522, with the coupling portion 538 being located near the joining element 510. A thread (not shown) attaches the fixed arm 532 to the inner paddle 522. The fixed arm 532 may be attached to the inner paddle 522 and / or another portion of the device by any suitable means, such as a screw or other fastener, a locking sleeve, a mechanical latch or clasp, welding, adhesive, etc. The fixed arm 532 remains fixed or substantially fixed when the movable arm 534 is opened to open the barbed fastener 530 and expose the barb 536. The barbed fastener 530 is opened by applying tension to a fastener control member or actuation line 537 attached to the movable arm 534 , which causes the movable arm 534 to pivot or bend about a joint 538 .

[0126] During implantation, the anchor 508 is opened and closed to capture the native valve leaflets between the paddles 520, 522 and the coaptation element 510. The outer paddle 520 has a wide, curved shape that fits around the curved coaptation element 510 to more securely grip the leaflets 20, 22. The curved shape and rounded edges of the outer paddle 520 also prevent tearing of the leaflet tissue. The barbed fasteners 530 further secure the native valve leaflets by engaging the leaflets with the barbs 536 and pinching the leaflets between the movable arm 534 and the fixed arm 532. The barbs 536 of the fasteners 530 can increase friction with the leaflets or partially or completely perforate the leaflets. The actuation lines can be separately actuated, allowing each barbed fastener 530 to open and close separately. The separate operation allows the leaflets to be grasped one at a time, or the clasp 530 of a poorly grasped leaflet can be repositioned without altering the successful grasp of the other leaflet. The barbed clasp 530 can be fully opened and closed when the inner paddle 522 is not closed, thereby allowing the leaflets to be grasped in various positions as required by a particular situation.

[0127] The device 500 is loaded into the delivery sheath in a fully open or fully extended position because it takes up the least space and allows the smallest catheter (or the largest device 500 for a given catheter size) to be used. Referring now to FIG. 35, the delivery sheath is inserted transseptally into the left atrium LA, and the device 500 is deployed from the delivery sheath 502 in a fully open position. The actuating element 512 is then retracted, moving the device 500 to the fully closed position shown in FIGS. 36-37, and then moved toward the mitral valve MV, as shown in FIG. 38. 39, once the device 500 is aligned with the mitral valve MV (or other native valve, if implanted in another valve), the actuation element 512 is extended to open the paddles 520, 522 to a partially open position, and the clasp control member or actuation line 537 is retracted to open the barbed clasps 530 in preparation for leaflet grasping. The partially open device 500 is then inserted into the mitral valve MV until the leaflets 20, 22 are properly positioned between the inner paddle 522 and the interior of the coaptation element 510 and the open barbed clasps 530, as shown in FIGS. 40-41. FIG. 42 shows the device 500 with both clasps 530 closed, but the barb 536 of one clasp 530 misses one leaflet 22. As can be seen in Figures 42-44, the out-of-place catch 530 is again opened and closed to properly grasp the missed leaflet 22. Once both leaflets 20, 22 are properly grasped, the actuating element 512 is retracted, moving the device 500 to the fully closed position shown in Figure 45. With the device 500 fully implanted in the native mitral valve MV, the actuating element 512 is withdrawn, releasing the capture mechanism 503 from the proximal collar 511. After deployment, the device 500 can be maintained in the fully closed position using mechanical means, such as a latch, or can be biased closed using a spring material, such as steel, and / or a shape memory alloy, such as Nitinol.For example, the paddles 520, 522 can be formed of steel or Nitinol shape memory alloy (produced as wire, sheet, tube, or laser sintered powder) and are biased to hold the outer paddle 520 closed around the inner paddle 522, the coaptation element 510, and the barbed clasp 530 clamped around the native leaflets 20, 22.

[0128] The device 500 can have a wide variety of different shapes and sizes. Referring to FIGS. 6 and 6A-6E, in an exemplary embodiment, the coaptation element 510 functions as a gap filler for a valve regurgitation opening, such as the gap 26 in the native valve shown in FIG. 6. Referring to FIG. 6A, the coaptation element 510 is deployed between two opposing valve leaflets 20, 22, so that the leaflets do not coapt within the region of the coaptation element 510 but instead coapt to the coaptation element 510. This coaptation reduces the distance the leaflets 20, 22 must approximate. The reduced leaflet approximation distance can result in several advantages. For example, the coaptation element and the resulting approximation can facilitate repair of severe mitral valve anatomy, such as the large gaps of functional valve disease (see, e.g., FIG. 6). Because the coaptation element 510 reduces the distance the native valve must approximate, stress on the native valve can be reduced or minimized. Shorter approximation of the leaflets 20, 22 may require less approximation force, resulting in less leaflet tension and less annular diameter reduction. Less annular contraction (or no annular contraction) may result in less reduction in valve orifice area compared to a device without a spacer. As a result, the coaptation element 510 may reduce the transvalvular gradient.

[0129] In one exemplary embodiment, the paddle frame 524 conforms to the shape of the coaptation element 510. In one example, if the coaptation element 510 is wider than the paddle frame 524, a gap (gap) may be created by the device 500 between the opposing leaflets 20, 22. With reference to FIGS. 6A-6E, in one exemplary embodiment, the paddles are configured to conform to the shape or geometry of the coaptation element 510. As a result, the paddles can fit both the coaptation element 510 and the native valve. With reference to FIGS. 6D and 6E, in one exemplary embodiment, the paddles 524 surround the coaptation element 510. Thus, when the leaflets 20, 22 are coapted or pressed against the coaptation element 510, the leaflets 20, 22 completely surround, or "embraces," the coaptation element 510 with their entirety, thus preventing minor leakage along the medial and lateral surfaces of the coaptation element 510. Figures 6B and 6C show the valve repair device 500 attached to the native valve leaflets 20, 22 from the ventricular side of the mitral valve. Figure 6A shows the valve repair device 500 attached to the mitral valve leaflets 20, 22 from the atrial side of the mitral valve. With reference to Figures 6A and 6B, if the paddles have a geometry that matches the geometry of the coaptation element 510, the leaflets 20, 22 can coapt around the coaptation element and / or along the entire length of the spacer. With reference to Figure 6E, a schematic atrial / surgical view shows the paddle frame (not actually visible from the true atrial view) that matches the spacer geometry. The opposing leaflets 20, 22 (whose ends are also not visible from the true atrial view), brought together by the paddles, surround or "embrace" the coaptation element 510.

[0130] 6B-6E, because the paddle frame 524 conforms to the shape of the coaptation element 510, the paddle frame 524 allows the leaflets 20, 22 to fully coapt around the coaptation element, including the lateral and medial surfaces 601, 603 of the coaptation element 510. This coaptation of the leaflets 20, 22 to the lateral and medial surfaces of the coaptation element 510 may seem to contradict what was stated above, that the presence of the coaptation element 510 minimizes the distance the leaflets must approach. However, the distance the leaflets 20, 22 must approach is still minimized when the coaptation element 510 is precisely positioned at the regurgitation gap, and the regurgitation gap is smaller than the width (medial-lateral) of the coaptation element 510.

[0131] 6A and 6E, the coaptation element 510 can take on a wide variety of different shapes. In one exemplary embodiment, when viewed from the top (and / or in cross section from the top; see FIGS. 95-102), the coaptation element has an oval or elliptical shape. The oval or elliptical shape allows the paddle frame 524 to conform to the shape of the coaptation element and / or reduces lateral leakage (see FIGS. 65-83).

[0132] As discussed above, the coaptation element 510 can reduce tension on the opposing leaflets by reducing the distance the leaflets must approach the coaptation element 510 at locations 601, 603. Reducing the distance of leaflet approximation at locations 601, 603 can result in reduced leaflet stresses and gradients. Additionally, as discussed above, the leaflets 20, 22 of the native valve can surround or "embrace" the coaptation element to prevent lateral leakage. In one exemplary embodiment, the geometric characteristics of the coaptation element can be designed to preserve and enhance these two characteristics of the device 500. Referring to FIG. 2A , as can be seen in the left ventricular outflow tract (LVOT) view, the anatomy of the leaflets 20, 22 is such that the medial sides of the leaflets coapt at their free end portions and the leaflets 20, 22 begin to retract or diverge away from each other. The leaflets 20, 22 diverge toward the atrium until each leaflet meets the mitral annulus.

[0133] In one exemplary embodiment, the valve repair device 500 and its coaptation elements 510 are designed to match the geometric anatomy of the valve leaflets 20, 22. To achieve valve sealing, the valve repair device 500 can be designed to completely surround the coaptation elements 510, including the central and lateral positions 601, 603 of the coaptation elements, to coapt the native leaflets to the coaptation elements. Additionally, reducing the force required to contact the leaflets with the coaptation elements 510 at positions 601, 603 can minimize leaflet stress and tilt. Figure 2B shows how the tapered or triangular shape of the coaptation elements 510 naturally fits the geometry of the native valve and its tendency to expand (toward the annulus).

[0134] Figure 6D shows the geometry of the coaptation element 510 and paddle frame 524 from an LVOT perspective. As can be seen in this figure, the coaptation element 510 has a tapered shape that reduces in size near the areas where the inner surfaces of the leaflets 20, 22 must coapt and increases in size as the coaptation element extends toward the atrium. The illustrated geometry of the native valve is accommodated by the tapered coaptation element geometry. Still referring to Figure 6D, the tapered coaptation element geometry, along with the illustrated expanding (toward the annulus) paddle frame 524 shape, can help achieve coaptation at the inferior ends of the leaflets, reduce stress, and minimize transvalvular gradients.

[0135] Referring to FIG. 6C , in one exemplary embodiment, the shapes of the coaptation element 510 and the remainder of the paddle frame 524 can be defined based on the native valve and the commissure view of the device 500. These shapes are driven by two factors: leaflet coaptation with the coaptation element 510 and reduced stress on the leaflets due to coaptation. Referring to FIGS. 6C and 67 , the coaptation element 510 can have a rounded or rounded shape, and the paddle frame 524 can have a full radius extending from one paddle leg to the other, both to coapt both the leaflets 20, 22 to the coaptation element 510 and to reduce stress on the leaflets 20, 22 by the coaptation element 510 and / or the paddle 524. The rounded shape of the coaptation element and / or the overall rounded shape of the illustrated paddle frame distributes stress on the leaflets 20, 22 over a wide, curved engagement area 607. For example, in FIG. 6C, as the leaflets 20 attempt to open during the diastolic cycle, the force exerted by the paddle frame on the leaflets 20, 22 is distributed along the entire rounded length of the paddle frame 524.

[0136] 67, in one exemplary embodiment, the shape of the coaptation elements in the intra-commissural view follows a rounded shape to cooperate with the generally rounded shape of the paddle frame 524 and / or to maximize leaflet coaptation with the coaptation elements 510 and leaflet-to-leaflet coaptation at the lateral or medial faces 601, 603 of the coaptation elements 510. Referring to FIG. 67, the rounded shape of the coaptation elements in this view substantially follows or approximates the shape of the paddle frame 524.

[0137] In one exemplary embodiment, the overall shape of the coaptation element 510 is an oval or elliptical cross-section when viewed from the surgical view (top view - see FIG. 70), a tapered shape or cross-section when viewed from the LVOT view (side view - see FIG. 69), and a substantially round or rounded shape when viewed from the transcommissural view (see FIG. 68). In one exemplary embodiment, a blend of these three geometries results in the three-dimensional shape of the coaptation element 510 shown that achieves the benefits discussed above.

[0138] In one exemplary embodiment, the dimensions of the coaptation elements are selected to minimize the number of implants required per patient (preferably one) while simultaneously maintaining a low transvalvular gradient. In one exemplary embodiment, the anterior-posterior distance X47B of the top of the spacer is approximately 5 mm, and the central lateral distance X67D of the spacer at its widest point is approximately 10 mm. In one exemplary embodiment, the overall geometry of device 500 can be based on these two dimensions and the overall shape strategies described above. It should be readily apparent that using different anterior-posterior distances X47B and central lateral distances X67D as a starting point for the device will result in devices with different dimensions. Furthermore, using other dimensions and the shape strategies described above will also result in devices with different dimensions.

[0139] Tables A (Table 1A and Table 1B), Table B (Table 2), and Table C (Table 3) provide example dimensional values ​​and ranges for devices and device components of some exemplary embodiments. However, devices can have a wide variety of different shapes and sizes and need not have all or any of the dimensional values ​​or dimensional ranges provided in Tables A (Table 1A and Table 1B), Table B (Table 2), and Table C (Table 3). Table A (Table 1A and Table 1B) provides example linear dimensions X in millimeters and ranges of linear dimensions in millimeters for devices and device components. Table B (Table 2) provides example radial dimensions R in millimeters and ranges of radial dimensions in millimeters for devices and device components. Table C (Table 3) provides example angular dimensions α in degrees and ranges of angular dimensions in degrees for devices and device components. The subscript for each dimension indicates the drawing in which the dimension first appears.

[0140] [Table 1A] [Table 1B]

[0141] [Table 2]

[0142] [Table 3]

[0143] 47-61, implantable device 500 is shown in various states and configurations. Implantable device 500 may include any other features of the implantable prosthetic devices discussed herein, and device 500 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).

[0144] The implantable device 500 has a proximal or mounting portion 505, a joint element 510 (e.g., a spacer, etc.), an inner anchor portion or inner paddle 522, an outer anchor portion or outer paddle 520, an anchor extension member or paddle frame 524, and a distal portion 507. The inner paddle 522 is attached (e.g., connectably attached, etc.) between the joint element 510 and the outer paddle 520. The outer paddle 520 is attached (e.g., connectably attached, etc.) between the inner paddle 522 and the distal portion 507. The paddle frame 524 is attached to the cap 514 at the distal portion 507 and extends to a joint 523 between the inner paddle 522 and the outer paddle 520. In some embodiments, the paddle frame 524 is formed from a material that is stiffer and more rigid than the material forming the paddles 522, 520, such that the paddle frame 524 provides support for the paddles 522, 520. In one exemplary embodiment, the inner paddle 522 is stiff, relatively stiff, rigid, has rigid portions, and / or is stiffened by fasteners or fasteners 530. Stiffening the inner paddle allows the device to move to a variety of different positions as shown and described herein. The inner paddle 522, outer paddle 520, and joints can all be interconnected as described herein such that the device 500 is constrained to the movements and positions shown and described herein.

[0145] 47-48, device 500 is shown in a closed configuration. When closed, inner paddle 522 is positioned between outer paddle 520 and coaptation element 510. In some embodiments, device 500 includes a catch or gripping member 530 (FIG. 48) that can be opened and closed to grip the native leaflets 20, 22 of the mitral valve MV. Catch 530 is attached to inner paddle 522, moves with the inner paddle, and is positioned between inner paddle 522 and coaptation element 510.

[0146] 49-51, the device 500 is shown in a partially open state. The device 500 is moved to the partially open position by an actuation element or means for actuation 512, which passes through the mounting portion 505 and the interface element 510 and can removably engage the distal portion 507. The actuation element 512 is extended through the mounting portion 505 such that the distance D between the mounting portion 505 and the distal portion 507 increases as the actuation element 512 is extended. In the example shown in FIGS. 49-51, the pair of inner and outer paddles 522 and 520 are moved in unison, rather than separately, by the single actuation element 512. Additionally, the position of the catch 530 depends on the position of the paddles 522, 520. For example, referring to FIG. 48, closing the paddles 522, 520 also closes the catch. In one exemplary embodiment, device 500 can be fabricated so that paddles 520, 522 are independently controllable in the same manner as in Figure 11A.

[0147] Extending the actuation element 512 pulls down on the bottom of the outer paddle 520 and paddle frame 524. The outer paddle 520 and paddle frame 524 pull down on the inner paddle 522, which is connected to the outer paddle 520 and paddle frame 524. Because the mounting portion 505 and coaptation element 510 are held in place, the inner paddle 522 bends or pivots in an opening direction. The inner paddle 522, outer paddle 520, and paddle frame all bend to the state shown in FIG. 49. Opening the paddles 522, 520, and frame 524 creates a gap 520A between the coaptation element 510 and the inner paddle 522 that receives and grips the native valve leaflet 20.

[0148] As described above, some embodiments of the device 500 include a catch or gripping member 530. When the device 500 is slightly opened, the catch 530 is exposed. In some embodiments, the closed catch 530 ( FIG. 50 ) can be opened ( FIG. 51 ), thereby creating a second opening or gap 530A for receiving and capturing the native valve leaflets 20, 22. The extent of the gap 530A in the catch 530 is limited to the extent that the inner paddle 522 opens from the coaptation element 510.

[0149] 52-54, the device 500 is shown in a laterally extended, or open, state. The device 500 is transitioned to the laterally extended, or open, state by continuing to extend the actuation element 512, described above, thereby increasing the distance D between the mounting portion 505 and the distal portion 507. Continued extension of the actuation element 512 pulls the outer paddle 520 and paddle frame 524 downward, thereby further opening the inner paddle 522 away from the interface element 510. In the laterally extended, or open, state, the inner paddle 522 extends horizontally to a greater extent than in other states of the device 500, forming an angle of approximately 90 degrees with respect to the interface element 510. Similarly, the paddle frame 524 is in its maximum extended state when the device 500 is in the laterally extended, or open, state. The enlarged gap 520B formed in the laterally stretched, i.e., open, state allows the fastener 530 to open further before engaging the joining element 510 (FIG. 54), thereby increasing the size of the gap 530A.

[0150] 55-57, the device 500 is shown in a three-quarters extended position. The device 500 is moved to the three-quarters extended position by continuing to extend the actuation element 512, as described above, thereby increasing the distance D between the mounting portion 505 and the distal portion 507. Continued extension of the actuation element 512 pulls the outer paddle 520 and paddle frame 524 downward, thereby further opening the inner paddle 522 away from the interface element 510. In the three-quarters extended position, the inner paddle 522 opens beyond 90 degrees to approximately 135 degrees relative to the interface element 510. The paddle frame 524 is less spread apart laterally than in the extended, or open, position and begins to move inward toward the actuation element 512 as the actuation element 512 is further extended. The outer paddle 520 also bends back toward the actuation element 512. Similar to the laterally stretched or open state, the enlarged gap 520B formed in the laterally stretched or open state allows the fastener 530 to open further (FIG. 57), thereby increasing the size of the gap 530A.

[0151] 58 , the device 500 is shown in an almost fully extended state. The device 500 is moved to the almost fully extended state by continuing to extend the actuation element 512 described above, thereby increasing the distance D between the mounting portion 505 and the distal portion 507. Continued extension of the actuation element 512 pulls the outer paddle 520 and paddle frame 524 down, thereby causing the inner paddle 522 to open further away from the interface element 510. In the almost fully extended state, the inner paddle 522 begins to approach approximately 180 degrees relative to the interface element 510. While the inner paddle moves to this state, the outer paddle 520 and paddle frame 524 never move or bend more than 90 degrees relative to the interface element 510. In the almost fully extended state, the inner paddle 522 and outer paddle 520 may have a somewhat curved shape.

[0152] 59-61 , the device 500 is shown in a fully extended state. The device 500 moves to a nearly fully extended state by continuing to extend the actuation element 512, as described above, thereby increasing the distance D between the mounting portion 505 and the distal portion 507 to a distance acceptable for the device 500. Continued extension of the actuation element 512 pulls the outer paddle 520 and paddle frame 524 down, thereby further opening the inner paddle 522 away from the interface element 510. The outer paddle 520 and paddle frame 524 move closer to the actuation element. In the fully extended state, the inner paddle 522 opens to approximately 180 degrees relative to the interface element 510. The inner paddle 522 and outer paddle 520 are straightened out in the fully extended state, forming an approximately 180-degree angle between the paddles 522, 520. In the fully extended state of device 500, the size of the gap 520B between the paddles is maximized, and in some embodiments, the catch 530 is also allowed to fully open to approximately 180 degrees ( FIG. 61 ) between portions of catch 530. This state of device 500 is in its slimmest configuration. That is, the fully extended state of device 500 may be the desired state for expelling device 500 from an attempted implantation or for loading the device into a delivery catheter.

[0153] 47A, 48A-48H, 53A-53C, 54A-54D, 60A-60D, and 61A-61D, implantable device 500A is shown in various states and configurations. Implantable device 500A may include any other features of the implantable prosthetic devices discussed herein, and device 500A 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).

[0154] Implantable device 500A has a proximal or attachment portion 505A, a joint element 510A, an inner anchor portion or inner paddle 522A, an outer anchor portion or outer paddle 520A, an anchor extension member or paddle frame 524A, and a distal portion 507A. Inner paddle 522A is attached (e.g., connectably attached, etc.) between joint element 510A, e.g., by coupling portion 525A, and outer paddle 520A, e.g., by coupling portion 523A. Outer paddle 520A is attached (e.g., connectably attached, etc.) between inner paddle 522A, e.g., by coupling portion 523A, and distal portion 507A, e.g., by coupling portion 521A. The paddle frame 524A is attached to the cap 514A ( FIG. 48A ) at the distal portion 507A and extends to the joint 523A between the inner paddle 522A and the outer paddle 520A. In some embodiments, the paddle frame 524A is formed from a material that is stiffer and more rigid than the material forming the paddles 522A, 520A, thereby providing support for the paddles 522A, 520A. The paddle frame 524A includes a connection, such as an opening or slot 524B ( FIG. 70A ), for receiving the joint 523A ( FIG. 65A ). In some embodiments, the inner paddle 522A is stiff, relatively stiff, rigid, has a rigid portion, and / or is stiffened by a fastener or fastener 530C. Stiffening the inner paddle allows the device to be moved to the various different positions shown and described herein. The inner paddle 522A, outer paddle 520A, and interface elements may all be interconnected as described herein such that the device 500A is constrained to the movements and positions shown and described herein.

[0155] The interface element 510A, inner paddle 522A, and outer paddle 520A can be attached by integrally forming the interface element 510A and paddles 520A, 522A as a single, unitary component, which can be accomplished, for example, by forming the interface element 510A and paddles 520A, 522A from a continuous strip 501A of braided or woven material, such as braided or woven nitinol wire.

[0156] The continuous strip 501A is attached to the collar 511D, cap 514A, paddle frame 524A, and fastener 530C. In the illustrated embodiment, the interface element 510A, hinge portions or coupling portions 521A, 523A, 525A, outer paddle 520A, and inner paddle 522A are formed from the continuous strip 501A. The continuous strip 501A can be a single layer of material or can include two or more layers. In some embodiments, one portion of the device 500A has a single layer of strip of material 501A, while another portion is formed from multiple overlapping or overlying layers of strip of material 501A. For example, FIG. 47A shows the interface element 510A and inner paddle 522A formed from multiple overlapping or overlying layers of strip of material 501A. As a result, the joining element 510A and the inner paddle 522A are rigid relative to the outer paddle 520A, which is formed from a single layer of material 501A. The single, continuous strip of material 501A may begin and end at various locations on the device 500A. The ends of the strip of material 501A may be at the same or different locations on the device 500A. For example, in the illustrated embodiment of FIG. 47A , the strip of material begins and ends at the location of the inner paddle 522.

[0157] The fastener 530C can include an attachment or fixed portion 532C, an arm or movable portion 534C, a barb 536C, and a coupling portion 538C. The attachment or fixed portion 532C can be coupled to the inner paddle 522A in a variety of ways, such as with threads, adhesives, fasteners, welding, stitching, crimping, a friction fit, and / or other means for coupling with the coupling portion 538C located near the joining element 510A. The fastener 530C can be similar to the fastener 430.

[0158] The movable portion 534C can pivot or bend relative to the fixed portion 532C between an open configuration (e.g., FIG. 54A) and a closed configuration ( FIG. 48A). In some embodiments, the catch 530C can be biased to the closed configuration. In the open configuration, the fixed portion 532C and the movable portion 534C pivot or bend away from each other to allow the native valve leaflets to be positioned between the fixed portion 532C and the movable portion 534C. In the closed configuration, the fixed portion 532C and the movable portion 534C pivot or bend toward each other, thereby securing the native valve leaflets between the fixed portion 532C and the movable portion 534C. The fixed arm 532C remains fixed or substantially fixed when the movable arm 534C is opened to open the barbed catch 530C and expose the barbs 536C. Barbed catch 530C is opened by applying tension to actuation line 537A attached to movable arm 534C, which causes movable arm 534C to pivot or bend about joint 538C.

[0159] 47 and 48A-48H, device 500A is shown in a closed position. Side views of device 500A are shown in FIGS. 48B, 48C, and 48F, front views in FIGS. 48D, 48E, and 48G, and a bottom view in FIG. 48H. Device 500A is narrower when viewed from the front than from the side. From the side, device 500A has a rounded, generally inverted trapezoidal shape that tapers toward a distal portion 507A of device 500A. From the front, device 500A has a generally rounded, rectangular shape that tapers somewhat toward distal portion 507A. As can be seen in the bottom view of device 500A shown in FIG. 48H, device 500A has a generally rounded, rectangular shape when viewed from the bottom (and also when viewed from the top, for example, as can be seen in FIG. 70A).

[0160] In the closed configuration of device 500A, inner paddle 522A is positioned between outer paddle 520A and coaptation element 510A. In some embodiments, device 500A includes a catch or gripping member 530C ( FIG. 48 ) that can be opened and closed to grip the native leaflets 20, 22 of the mitral valve MV. Catch 530C is attached to inner paddle 522A, moves with inner paddle 522A, and is positioned between inner paddle 522A and coaptation element 510A.

[0161] 48B-48D, device 500A is shown attached to delivery device 502A. Delivery device 502A has an actuable member or finger 503A that releasably engages mounting portion 505A. Actuating element 512A extends from delivery device 502A to cap 514A through mounting portion 505A and joining element 510A of prosthetic device 500A. Extending and retracting actuating element 512 opens and closes device 500A, as described below. Actuating line / thread 537A extends from delivery device 502A and attaches to fastener 530C. Tension can be applied to thread 537 to open fastener 530C and released to allow fastener 530C to close. Device 500A is shown separated from delivery device 502A in a deployed state in FIGS. 48F-48G.

[0162] 48C and 48E, device 500A is shown with cover 540A. Cover 540A can be formed from a single piece of material or from multiple segments that abut or are joined together. In the illustrated embodiment, cover 540A has an outer or lower cover 541A and an inner or upper cover 543A. Outer cover 541A covers cap 514A, outer paddle 520A, inner paddle 522A, and fastener 530C. Inner cover 543A covers interface element 510A and the proximal ends of inner paddle 522A and fastener 530C, with interface element 510A contacting inner paddle 522A and fastener 530C. Cover 540A can be a fabric material, such as a fine-mesh polyethylene fabric. The fabric cover can provide a blood seal on the surface of the spacer and / or promote rapid tissue ingrowth.

[0163] 53A-53D and 54A-54D, device 500A is shown in a laterally extended, or open, position. Device 500A is moved to the open position by an actuating element or means for actuation 512A that passes through mounting portion 505A and interface element 510A and is removably engageable with distal portion 507A. Actuating element 512A is extended through mounting portion 505A such that distance D2 between mounting portion 505A and distal portion 507A increases as actuating element 512A is extended. In the example shown in FIGS. 53A-53D and 54A-54D, the pair of inner and outer paddles 520A and 522A move in unison, rather than separately, with a single actuating element 512A. Additionally, the position of catch 530C depends on the positions of paddles 520A, 522A. For example, referring to Figure 48A, closing paddles 520A, 522A also closes catch 530C. In one exemplary embodiment, device 500A can be fabricated so that paddles 520A, 522A are independently controllable, similar to the embodiment of Figure 11A.

[0164] Extending the actuation element 512A pulls down the bottom of the outer paddle 520A and paddle frame 524A, moving the device 500A from the closed position to a partially open position. The outer paddle 520A and paddle frame 524A pull down the inner paddle 522A, which is connected to the outer paddle 520A and paddle frame 524A. Because the mounting portion 505A and coaptation element 510A are held in place, the inner paddle 522A pivots or bends in an opening direction. The inner paddle 522A, outer paddle 520A, and paddle frame all bend to the position shown in FIG. 53A. Opening the paddles 522A, 520A, and frame 524 creates a gap 520D between the coaptation element 510A and the inner paddle 522A that can receive and grasp the native valve leaflet 20.

[0165] Continued extension of actuation element 512A pulls outer paddle 520A and paddle frame 524A downward, causing inner paddle 522A to further open away from interface element 510A. In the laterally extended, or open, position, inner paddle 522A extends horizontally to a greater extent than in other positions of device 500A, forming an approximately 90-degree angle with interface element 510A. Similarly, paddle frame 524A is at its maximum extension when device 500A is in the laterally extended, or open, position. The enlarged gap 520D formed in the laterally extended, or open, position allows catch 530C to open further before engaging interface element 510A ( FIG. 54A ), thereby increasing the size of gap 530D compared to the incompletely open position.

[0166] As described above, some embodiments of device 500A include a catch or gripping member 530C. When device 500A is opened, catch 530C is exposed. In some embodiments, closed catch 530C (FIGS. 53A-53D) can be opened (FIGS. 54A-54D), thereby creating a second opening or gap 530D for receiving and capturing native valve leaflets 20, 22. The extent of catch 530C gap 530D is limited to the extent that inner paddle 522A is opened from coaptation element 510A.

[0167] 60A-60D and 61A-61D, the device 500A is shown in a fully extended position. The device 500A is moved to the fully extended state by continuing to extend the actuation element 512A described above, thereby increasing the distance D2 between the mounting portion 505A and the distal portion 507A to the maximum distance allowable by the device 500A. Continued extension of the actuation element 512A pulls the outer paddle 520A and paddle frame 524A downward, thereby extending the inner paddle 522A further away from the interface element 510A. The outer paddle 520A and paddle frame 524A move closer to the actuation element. In the fully extended state, the inner paddle 522A is open to approximately 180 degrees relative to the interface element 510A. Inner paddle 522A and outer paddle 520A are stretched straight or substantially straight in the fully extended state, forming an approximately 180-degree angle between paddles 522A, 520A. In the fully extended state of device 500A, the size of gap 520D between the paddles is maximized, and in some embodiments, catch 530C is also allowed to fully open to approximately 180 degrees ( FIG. 61A ) between portions of catch 530C. This state of device 500A is in its slimmest configuration. Thus, the fully extended state of device 500A may be the desired state for expelling device 500A from an attempted implantation or for loading the device into a delivery catheter.

[0168] 197-198, which show an enlarged view of a portion of FIG. 60C. Referring now to FIG. 197, an inner cover 543A can be seen covering the interface element 510A from the proximal portion 519B to the distal portion 517A. In some embodiments, the inner cover 543A is formed from a flat sheet of fabric material, such as a fine mesh polyethylene fabric (see FIG. 201), which is folded around the interface element 510A and held in place with stitching 545A. Referring now to FIG. 198, an outer cover 541A can be seen covering the fastener 530C and the inner paddle 522A. A collar portion 548A of the inner cover 543A covers the portion of the fastener 530C and the inner paddle 522A that is closest to the interface element 510A. A transition portion 547A of the inner cover 543A extends from the joining element 510A to the collar portion 548A, providing a smooth transition between the joining element 510A and the fastener 530C and inner paddle 522A so that natural tissue does not get caught on the device 500A during implantation.

[0169] Referring now to FIG. 199, an exploded view of device 500A is shown. Interface element 510A, outer paddle 520A, and inner paddle 522A are formed from a single strip of material 501A, as described above. Collar 511D, cap 514A, paddle frame 524A, and fastener 530C are assembled to strip of material 501A to form device 500A. Cap 514A includes a retaining body 560A with a locking aperture 561A for receiving a retaining nut 562A having a threaded bore 564A that engages with a threaded portion 568A of a retaining bolt 566A. The threaded portion 568A of retaining bolt 566A is inserted into aperture 527B to engage retaining body 560A and nut 562A and attach cap 514A to strip of material 501A.

[0170] In some embodiments, the stiffening member 539C is attached to the inner paddle 522A and stiffens the inner paddle 522A to maintain the inner paddle in a straight or substantially straight configuration as the inner paddle moves between various positions. A notch 539D in the stiffening member 539C is shaped to receive the locking arm 532C of the fastener 530C such that the stiffening member 539C can fit around the locking arm 532C when both the stiffening member 539C and the fastener are attached to the inner paddle 522A. Similar to the locking arm 532C, the stiffening member 539C can be attached to the inner paddle 522A in a variety of ways, such as with threads, adhesives, fasteners, welding, stitching, crimping, a friction fit, and / or other means of attachment.

[0171] Referring now to FIG. 200, a close-up view of a collar 511A attached to a proximal portion 519B of a coaptation element 510A is shown. The collar 511A includes a protrusion 511E for releasably engaging a finger 503A of a delivery device 502A. An aperture 515A in the collar 511A receives an actuation element 512A. The proximal portion 519B of the coaptation element 510A flares outward to form two loops 519D that are inserted into arcuate openings 513A in the collar 511D to attach the collar 511D to the proximal portion 519B of the coaptation element 510A. The loops 519D are formed by folding the strip of material 501A, thereby forming the first layer 581A and the second layer 582A. In some embodiments, the arcuate openings 513A include openings (not shown) similar to

[0172] 201-202, which show close-up and exploded views, respectively, of cap 514A. FIG. 201 shows a close-up view of cap 514A attached to distal portion 527A of strip of material 501A. Retaining body portion 560A, retaining nut 562A, and retaining bolt 566A cooperate to attach paddle frame 524A to distal portion 527A of strip of material 501A. In particular, retaining bolt 566A is inserted into aperture 527B in distal portion 527A (FIG. 202) to prevent movement of cap 514A along strip of material 501A. Channel 560B in retaining body portion 560A and flange 567A of bolt 566A form passageway 514B through cap 514A relative to distal portion 527A.

[0173] 202, the components of cap 514A are shown in an exploded view to better illustrate the component features of cap 514A and paddle frame 524A and how those features interlock during assembly of cap 514A to distal portion 527A. Cap 514A is formed from multiple components that can be assembled around strip of material 501A, which can be folded to form interface element 510A and paddles 520A, 522A and woven through collar 511D and paddle frame 524A before cap 514A is attached.

[0174] Retention body portion 560A includes a locking aperture 561A for receiving a retention nut 562A. Locking aperture 561A has a generally rectangular shape and includes two opposing locking channels 561B that receive mounting portions 524C of paddle frame 524A. A lateral locking channel 561C formed in the bottom of retention body portion 560A has the same width as locking channels 561B. Paddle frame 524A includes notches 524D in mounting portions 524C that form hook portions 524E that engage with lateral locking channels 561C to secure paddle frame 524A to cap 514A.

[0175] Retention nut 562A includes a rectangular locking body 563A extending distally from flange 563B. Locking body 563A is configured to slidably engage locking aperture 561A of retention body 560A while leaving locking channel 561B unobstructed. Thus, locking body 563A can be inserted into locking aperture 561A to lock mounting portion 524C of paddle frame 524A within locking channel 561B. Notch 563C in flange 563B accommodates mounting portion 524C of paddle frame 524A. A threaded bore 564A is formed through retention nut 562A to receive retention bolt 566A.

[0176] Retaining bolt 566A includes a threaded portion 568A extending from flange 567A. Threaded portion 568A is inserted into aperture 527B in distal portion 527A and threadedly engages threaded bore 564A in retaining nut 562A. Flange 567A has a rounded shape that provides a rounded end to distal portion 507A of device 500A. Flange 567A includes an opening 567B for receiving a tool (not shown) that engages bolt 566A so that bolt 566A can be turned during assembly to couple the components of cap 514A together.

[0177] To assemble paddle frame 524A and cap 514A to distal portion 527A, paddle frame 524A is tightened to narrow mounting portion 524C so that mounting portion 524C can be inserted into locking channel 561B of locking aperture 561A. When paddle frame 524A is allowed to expand, mounting portion 524C expands outward, with notch 524D engaging retaining body portion 560A and hook portion 524E engaging lateral locking channel 561C. Retaining nut 562A is then inserted into locking aperture 561A with locking portion 563A positioned between the two mounting portions 524C of each paddle frame 524A, thereby engaging and locking paddle frame 524A with retaining body portion 560A. The assembled paddle frame 524A, retention body 560A, and retention nut 562A are placed onto distal portion 527A so that threaded bore 564A is aligned with aperture 527B, and threaded portion 568A of bolt 566A is inserted into aperture 527B and threadedly engages threaded bore 564A. Bolt 566A is then tightened until flange 567A engages retention body 560A, securely assembling cap 514A to distal portion 527A.

[0178] 203 and 204, a portion of a cover 540A is shown cut from a flat sheet of material. Cover 540A includes an outer cover 541A and an inner cover 543A. Each of covers 541A, 543A includes differently shaped segments or portions for attachment to different portions of device 500A. In particular, covers 541A, 543A are shaped to smooth the transitions between portions of device 500A, reducing catch points and providing a sleek appearance to device 500A.

[0179] The various segments of the covers 541A, 543A extend from a middle portion that is shaped to attach to the ends of the device 500A. In other embodiments, the portions of the covers 541A, 543A that attach to the ends of the device 500A can be located at the ends of the covers 541A, 543A, or anywhere between the middle and ends of the covers 541A, 543A. The various portions of the covers 541A, 543A can be shaped to encase those portions of the device 500A. The cover 540A can be made from any suitable material, such as a fine mesh polyethylene fabric. In some embodiments, the cover is formed from a single piece of material. In other embodiments, the cover can be formed from any number of pieces of material that are attached to the device and / or bonded together by any suitable means, such as stitching, adhesive, welding, or similar means.

[0180] 60C and 204, outer cover 541A extends outward from intermediate portion 580 to end portion 588. Intermediate portion 580 is shaped to attach to cap 514A of device 500A. Outer paddle portion 582 extends from intermediate portion 580 to inner paddle and inner fastener portion 584. Inner paddle and inner fastener portion 584 extends from outer paddle portion 582 to outer movable fastener portion 586. Outer movable fastener portion 586 extends from inner paddle and inner fastener portion 584 to end portion 588.

[0181] The outer paddle portion 582 includes wings 583 that extend laterally wider than the remainder of the outer cover 541A to allow the outer paddle portion 582 to attach to the outer paddle 520A and paddle frame 524A of the device 500A. The inner paddle and inner fastener portion 584 are attached to the inner paddle 522A, the fixed arm 532C, and the inner (barbed) surface of the movable arm 534C. The outer fastener portion 586 is attached to the outer (unbarbed) surface of the movable arm 534C of the fastener 530C. An end 588 of the outer cover 541A terminates near the coupling portion 538C of the fastener 530C, which is outside the fastener 530C. The inner paddle and inner fastener portion 584 includes an opening 585 that allows the barb 536C of the fastener 530C to protrude through the outer cover 541A and engage the tissue of the native heart valve.

[0182] 60C and 203, inner cover 543A extends outward from intermediate portion 590 to end portion 598. Intermediate portion 590 is configured to attach to collar 511D of device 500A. Opening 591 in intermediate portion 590 exposes protrusion 511E from collar 511D so that protrusion 511E can be engaged by delivery device 502A when intermediate portion 590 is attached to collar 511D. Joint portions 592 extend from intermediate portion 590 to flexible hinge portions 594. Holes 593 along the edges of joint portions 592 allow each of joint portions 592 to be joined together after being folded around joint element 510A, for example, by stitches 545A. Flexible hinge portions 594 extend from joint portions 592 to transition portion 596. Transition sections 596 extend from flexible hinge portions 594 to ends 598. Holes 597 along the edges of transition sections 596 allow each of transition sections 596 to wrap around the ends of inner paddle 522A and fastener 530C and be secured to itself by stitching or other suitable fastening means. Flexible hinge portions 594 bridge the gap between joint element 510A and fastener 530C when device 500A is open, as seen in FIG. 198.

[0183] 62A-64C, an implantable device 700 is shown. The implantable device 700 has paddles 702 that open and close to grip the valve leaflets 20, 22 against a barbed catch or grasping device 704. The paddles 702 move to create openings 706 between the paddles 702 and the grasping device 704 through which the leaflets 20, 22 can be grasped. The device 700 can be configured to close the wide gaps 26 ( FIG. 6 ) of the native heart valves MV and TV. Additionally, the implantable device 700 can include any other features of the devices discussed herein, and the device 700 can be positioned to engage the valve leaflets 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein). Device 700 may include any other features of the implantable prosthetic devices discussed in this application, and device 700 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0184] 62A , paddle 702 of device 700 moves, rotates, or pivots in an outward direction X to create an opening 706 of width W between paddle 702 and gripping member 704. Width W can be, for example, between about 5 mm and about 15 mm, such as about 10 mm, such as between 7.5 mm and about 12.5 mm. In alternative embodiments, width W can be less than 5 mm or greater than 15 mm.

[0185] 62B , the paddle 702 of the device 700 moves in an outward direction Z such that the opening 706 has a width H. The width H can be, for example, between about 10 mm and about 25 mm, such as about 15 mm, such as between about 10 mm and about 20 mm, such as between about 12.5 mm and about 17.5 mm. In some embodiments, the width H can be less than 10 mm or greater than 25 mm. In some embodiments, the ratio of the width H to the width W can be about 5:1 or less, such as about 4:1 or less, such as about 3:1 or less, such as about 2:1 or less, such as about 1.5:1 or less, such as about 1.25:1 or less, such as about 1:1. The device 700 can be configured such that the paddle 702 moves, rotates, or pivots in the outward direction X and then moves in the outward direction Z to create the opening 706 of width H between the paddle 702 and the gripping member 704. Optionally, device 700 can be configured so that the paddle moves in outward direction Z and then moves or pivots in outward direction X to create width H between paddle 702 and gripping member 704. Additionally, device 700 can be configured so that paddle 702 moves or pivots in outward direction X and simultaneously moves in outward direction Z to create width H between paddle 702 and gripping member 704.

[0186] 63A-63C show implantable device 700 with paddles 702 moving, rotating, or pivoting in outward direction X and then moving in outward direction Z to create a wider opening 706. FIG. 63A shows implantable device 700 in a closed state such that paddles 702 engage gripping members 704. Referring to FIG. 63B, paddles 702 move or pivot in outward direction X to create opening 706 of width W for receiving valve tissue. Referring to FIG. 63C, after paddles 702 move or pivot in outward direction X, paddles 702 move in outward direction Z such that opening 706 now has a width of H. After valve tissue is received in opening 706 between paddles 702 and gripping members 704, the valve repair device is returned to the closed state (shown in FIG. 63A) to secure valve repair device 700 to the valve tissue. The implantable device 700 may include any other features of the implantable devices discussed in this application, and the implantable device 700 may be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0187] 64A-64C show implantable device 700 with paddles 702 moving in outward direction Z and then moving, stretching, or pivoting in outward direction X to create a wider opening 706. FIG. 64A shows implantable device 700 in a closed state such that paddles 702 engage gripping members 704. Referring to FIG. 64B, paddles 702 move in outward direction Z to create opening 706 of width W for receiving valve tissue. Referring to FIG. 64C, after paddles 702 move in outward direction Z, paddles 702 move or pivot in outward direction X such that opening 706 now has a width H. After valve tissue is received in opening 706 between paddles 702 and gripping members 704, implantable device 700 is returned to the closed state (shown in FIG. 64A) to secure implantable device 700 to the valve tissue. The implantable device 700 may include any other features of the implantable devices discussed in this application, and the implantable device 700 may be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0188] While Figures 63A-63C show device 700 in which paddles 702 move or pivot and then spread apart, and Figures 64A-64C show device 700 in which paddles 702 spread and then move or pivot, in alternative embodiments, device 700 can include paddles 702 that can spread and move or pivot simultaneously. Additionally, in some embodiments, paddles 702 can spread, move, or pivot independently of one another. That is, in the embodiments of valve repair device 700 shown in Figures 63A-63C and 64A-64C, as well as in embodiments in which the spreading and movement or pivoting of each paddle 702 is completed simultaneously, paddles 702 can be controlled independently of one another.

[0189] 65-83, an exemplary implantable device 500 is shown in a closed state. Referring now to FIGS. 65-66, device 500 extends from a proximal portion 505 to a distal portion 507 and includes a joint portion 510, an inner paddle 522, an outer paddle 520, and a paddle frame 524. In some embodiments, outer paddle 520 extends to and / or around paddle frame 524 and can have multiple layers to surround paddle frame 524. Proximal portion 505 can include a collar 11 (not shown) for attaching a delivery device. Distal portion 507 can include a cap 514 that is attached (e.g., matably attached, etc.) to outer paddle 520 and engages an actuation element (not shown) to open and close device 500, facilitating implantation into a native valve as described herein.

[0190] 67-68, a front view of device 500 is shown. Device 500 is symmetrical or substantially symmetrical in shape about a vertical anterior-posterior plane 550 and is generally narrower at its distal portion 507 than at its proximal portion 505. The shapes of coaptation element 510 and paddle frame 524 are rounded or generally rounded to prevent device 500 from catching or snagging on cardiac structures, such as chordae tendineae, during implantation. For this reason, proximal collar 511 (FIG. 68) and cap 514 (FIG. 68) also have rounded edges. When viewed from the front or rear, paddle frame 524 can be seen to extend upward and outward from distal end 507 with a rounded or generally rounded shape that generally matches the shape of coaptation element 510 when viewed from the front and rear. Thus, the coaptation elements 510 and paddle frame 524 generally define the shape of the device 500 when viewed from the anterior or posterior side. Additionally, the rounded shape of the paddle frame 524 and the corresponding rounded shape of the coaptation elements allows leaflet stress to be distributed over a larger surface. In some exemplary embodiments, the paddle frame 524 and / or the coaptation elements 510 can have alternative shapes.

[0191] 69, a side view of device 500 is shown. Similar to the front and rear views (FIGS. 67-68), device 500 has a shape that is symmetrical, or substantially symmetrical, about a vertical inter-side plane 552 when viewed from the side. Distal portion 507 is also generally narrower than proximal portion 505 when device 500 is viewed from the side. Coaptation element 510 also optionally has a tapered or generally tapered shape that narrows toward distal portion 507 of device 500. However, in some exemplary embodiments, the coaptation element does not taper as it extends from the proximal portion of the device to the distal portion of the device.

[0192] The rounded appearance of device 500 is further evidenced by the rounded shape of paddles 520, 522, where inner and outer paddles 520 are joined, and the rounded shape of paddle frame 524. However, paddles 520, 522 and paddle frame 524 can take on a wide variety of different shapes. For example, paddles 520, 522 and paddle frame 524 can be rounded along their top edges, while the sides of paddles 520, 522 and / or paddle frame can be flat or substantially flat. By making paddles 520, 522 flat or substantially flat, the two devices can be implanted side-by-side in the leaflets of a native valve, with the two devices being flush or substantially flush with one another.

[0193] The closed paddles 520, 522 form a gap 542 between the inner paddle 522 configured to receive natural tissue and the coaptation element 510. As can be seen in Figure 69, the narrowing of the coaptation element 510 gives the gap 542 a somewhat teardrop shape that increases in width as the gap 542 approaches the distal portion 507 of the device. The increased width of the gap 542 toward the distal portion 507 allows the paddles 520, 522 to contact the tissue grasped in the gap 542 closer to the proximal portion 505.

[0194] The paddle frame 524 extends vertically from the distal portion 507 toward the proximal portion 505 approximately down the middle third of the device 500 before bending or flaring outward, such that the linking portions of the frame 524 pass through the gap 544 formed by the inner paddle 522 folded inside the outer paddle 520. However, in other embodiments, the linking portions of the frame are positioned inside the inner paddle 522 or outside the outer paddle 520. The outer paddle 520 has a rounded shape similar to that of the joint element 510 when viewed from the front or back ( FIGS. 67-68 ). That is, the device 500 has a rounded or substantially round shape. The rounded shape of the device 500 is particularly visible when the device 500 is viewed from the top ( FIGS. 70-71 ) or the bottom ( FIGS. 72-73 ).

[0195] 70-71 , a top view of the device 500 is shown. When viewed from the top, the device 500 is symmetrical or substantially symmetrical in shape about a front-to-back plane 550 and about a side-to-side plane 552. An opening 519A in the coaptation element 510 is visible in the proximal portion 505 of the device 500. As can be seen in FIG. 70 , the coaptation element 510 can be hollow. A proximal collar 511, shown in FIG. 71 , can be secured to the coaptation element 510 to close it.

[0196] In one exemplary embodiment, the coaptation element is not flat, but rather curved on all sides. For example, the coaptation element 510 described herein can be formed from a series of mixed surfaces with a variety of different radii of curvature. The coaptation element 510 has an elliptical or generally elliptical shape when viewed from above. However, in some exemplary embodiments, the coaptation element 510 can have another shape when viewed from above. For example, the coaptation element can have a rectangular, square, diamond, oval, or any other shape. The paddle frames 524 each have an arcuate shape with a smaller radius than the coaptation element 510, such that the gap 542 formed between the inner paddle 522 and paddle frame 524 and the coaptation element 510 narrows as it approaches the left and right sides 551 and 553 of the device 500. Therefore, natural tissue, such as the valve leaflets 20 and 22, tends to be pinched between the paddle frame 524 and the coaptation element 510 toward the left and right sides 551 and 553 of the device 500.

[0197] 72-73, there is shown a bottom view of device 500. Similar to the top views (FIGS. 70-71), device 500 has a shape that is symmetrical or substantially symmetrical about a front-to-back plane 550 when viewed from the bottom, and also symmetrical or substantially symmetrical about a side-to-side plane 552. Cap 514 is shown in FIG. 73 and is seamably attachable to outer paddle 520 and paddle frame 524.

[0198] The paddle frame 524 extends outward from the distal portion 507 of the device 500 to the left side 551 and right side 553 at a narrow or slight angle from the inter-side plane 552. The paddle frame 524 diverges further from the inter-side plane 552 as the paddle frame 524 extends toward the proximal portion of the device 500 (FIG. 69), ultimately forming the arcuate shape seen in FIGS.

[0199] 74-83, perspective and cross-sectional views of device 500 are shown. Referring now to FIG. 74, device 500 is shown cut at plane 75 near the proximal portion of coaptation element 510. Referring now to FIG. 75, a cross-section of device 500 is shown taken through plane 75 of FIG. 74. At plane 75, coaptation element 510 has a round or generally round shape, with lobes disposed along anterior-posterior surfaces 550. Gap 542 between paddle frame 524 and coaptation element 510 forms a crescent-like shape with a center width 543. As noted above, gap 542 narrows as gap 542 approaches left and right sides 551, 553.

[0200] 76, device 500 is shown taken at cross section 77 located approximately three-quarters of the way between distal portion 507 and proximal portion 505 of coaptation element 510. Referring now to FIG. 77, a cross section of device 500 is shown as viewed from cross section 77 of FIG. 76. At plane 75, coaptation element 510 has an elliptical, or generally elliptical, shape oriented along inter-lateral plane 552. Gap 542 between paddle frame 524 and coaptation element 510 forms a crescent, or crescent-like, shape with a central width 543 that is smaller than the central width 543 seen in FIG. 75. At plane 77, width 543 of gap 542 narrows toward the center of the device, widens somewhat as gap 542 approaches left and right sides 551 and 553, and then narrows again. Thus, natural tissue is pinched at the center of gap 542, approximately three-quarters of the way up coaptation element 510.

[0201] 78, device 500 is shown taken at plane 79 located approximately halfway between distal portion 507 and proximal portion 505 of coaptation element 510. Referring now to FIG. 79, a cross-section of device 500 as viewed from plane 79 of FIG. 78 is shown. At plane 79, coaptation element 510 has an elliptical, or generally elliptical, shape oriented along inter-side plane 552. Paddle frame 524 can be seen very close to or in contact with coaptation element 510 near left side 551 and right side 553. Gap 542 is crescent, or generally crescent, shaped, and is wider than gap 542 (FIG. 77) viewed along plane 77.

[0202] 80, device 500 is shown taken at plane 81 located approximately one-quarter of the way between distal portion 507 and proximal portion 505 of coaptation element 510. Referring now to FIG. 81, a cross-section of device 500 as viewed from plane 81 of FIG. 80 is shown. At plane 81, coaptation element 510 has an elliptical, or generally elliptical, shape that is narrower than the elliptical shape seen in FIG. 77, with its orientation along inter-side plane 552. Paddle frame 524 can be seen very close to or in contact with coaptation element 510 near left side 551 and right side 553. Gap 542 is crescent, or generally crescent, shaped, and is wider than gap 542 (FIG. 79) viewed along plane 79.

[0203] 82, device 500 is shown taken at plane 83 located near the distal portion 507 of coaptation element 510. Referring now to FIG. 83, a cross-section of device 500 as viewed from plane 83 of FIG. 82 is shown. At plane 83, coaptation element 510 has an elliptical, or generally elliptical, shape oriented along inter-lateral plane 552, which narrows from the elliptical shape seen in FIG. 79 as coaptation element 510 tapers toward the distal portion 507 of device 500. Paddle frame 524 can be seen very close to or in contact with coaptation element 510 near left side 551 and right side 553. While inner paddle 522 is not visible in FIG. 81, gap 542 is crescent, or generally crescent, shaped, and is wider than gap 542 (FIG. 81) viewed along plane 81.

[0204] 65A, 66A, 67A, 68A, 70A, 71A, 72A, 73A, 74A, 75A, 76A, 77A, 78A, 79A, 80A, 81A, 82A, and 83A, an exemplary implantable device 500A is shown in a closed state. Referring now to FIGS. 65A and 66A, device 500A extends from a proximal portion 505A to a distal portion 507A and includes a joint portion 510A, an inner paddle 522A, an outer paddle 520A, and a paddle frame 524A. Proximal portion 505A may include a collar 511D (not shown) for attaching a delivery device. The distal portion 507A can include a cap 514A that is attached (e.g., seamably attached, etc.) to the outer paddle 520 and engaged with an actuation element (not shown) to open and close the device 500A, facilitating implantation into the mitral valve as described herein.

[0205] 67A and 68A, a front view of device 500A is shown. Device 500A is symmetrical or substantially symmetrical about a vertical anterior-posterior plane 550A and has a generally narrower shape at its distal portion 507A than along the paddle frame 524A. The shape of the coaptation element 510A and paddle frame 524A is generally rounded rectangular to prevent device 500A from catching or snagging on cardiac structures such as chordae tendineae during implantation. For this reason, the proximal collar 511D (FIG. 68A) and cap 514A (FIG. 68A) may also have rounded edges. When viewed from the front or rear, paddle frame 524A can be seen to have a generally rounded rectangular shape that extends upward and outward from the distal portion 507A to a shape that is wider than coaptation element 510A and has roughly parallel sides when viewed from the front and rear. Thus, the paddle frame 524A generally defines the shape of the device 500A when viewed from the anterior or posterior side. Additionally, the rounded rectangular shape of the paddle frame 524 can distribute leaflet stress over a larger surface. In some exemplary embodiments, the paddle frame 524A and / or the coaptation element 510A can have alternative shapes.

[0206] Similar to the front and rear views (FIGS. 67A and 68A), device 500A has a shape that is symmetrical or substantially symmetrical about vertical inter-side plane 552A (FIG. 70A) when viewed from the side (e.g., FIG. 47A). Distal portion 507A is also generally narrower than proximal portion 505A when device 500A is viewed from the side. In the embodiment illustrated in FIG. 48B, coaptation element 510A does not taper as it extends from proximal portion 505A of device 500A to distal portion 507A of device 500A. However, in some exemplary embodiments, coaptation element tapers as it extends from the proximal portion of the device to the distal portion of the device (e.g., FIG. 47).

[0207] The generally rounded nature of device 500A is further evidenced by the rounded shape of paddles 520A, 522A, where inner and outer paddles 520A, 522A are joined together. However, paddles 520A, 522A and paddle frame 524A can take on a wide variety of different shapes. For example, paddles 520A, 522A and paddle frame 524A can be rounded along their upper edges and flat or substantially flat on their sides (e.g., the sides of paddle frame 524A located on the anterior and posterior sides of device 500A). By making paddles 520A, 522A flat or substantially flat on their sides, the two devices can be implanted side-by-side into the native valve leaflets, with the two devices being flush or substantially flush with each other.

[0208] The closed paddles 520A, 522A form a gap 542A between the inner paddle 522A and the coaptation element 510A, which is configured to receive natural tissue. As can be seen in Figures 48B and 48F, the proximal end of the coaptation element 510A has a rough dogbone shape such that the gap 542A narrows toward the proximal portion 505A as the gap approaches the distal portion 507A of the device. The narrowing of the gap 542A toward the attachment portion 507A allows the paddles 520A, 522A to contact the tissue grasped in the gap 542 closer to the proximal portion 505A.

[0209] The paddle frame 524A extends vertically from the distal portion 507A toward the proximal portion 505A approximately one-third of the way down the device 500A before bending or flaring outward, allowing the linking portion 524B of the frame 524A to pass through the gap 544A formed by the inner paddle 522A folded inside the outer paddle 520A. However, in other embodiments, the linking portion of the frame is positioned inside the inner paddle 522A or outside the outer paddle 520A. When viewed from the front or rear, the outer paddle 520A has a rounded rectangular shape similar to that of the joint element 510A (FIGS. 67A and 68A). Thus, the device 500A has a rounded rectangular shape. The rounded rectangular shape of device 500A is particularly visible when device 500A is viewed from the top (FIGS. 70A and 71A) or the bottom (FIGS. 72A and 73A).

[0210] 70A and 71A, a top view of device 500A is shown. When viewed from the top, device 500A is symmetrical or substantially symmetrical in shape about a front-to-back plane 550A and about a side-to-side plane 552A. A proximal opening 519C of interface element 510A is visible in the proximal portion 505A of device 500A. Actuating element 512A is received through opening 519C such that interface element 510A wraps around actuating element 512A. In some embodiments, opening 519C is formed by inserting actuating element 512A between folded, overlapping layers of a strip of material (described in more detail below). In other embodiments, opening 519C is formed by shaping the folded layers of strip 501A of material forming interface element 510A around a blank or fixture such that interface element 510A has a round or generally round shape. The proximal collar 511D shown in FIG. 71A can be secured to the interface element 510A to close the interface element 510A. The proximal collar 511D includes a mounting portion 513A that engages with an opening 546A formed by the folded layers of the strip of material 501A that forms the interface element 510A. In some embodiments, the mounting portion 513A is a hole in the collar 511D, and the strip of material 501A must be inserted into the collar 511D before folding the strip of material 501A during assembly of the device 500A. In some embodiments, the mounting portion 513A is an open slot (e.g., mounting portion 524B of paddle frame 524A) that receives the strip of material 501A before or after folding the strip of material 501A.

[0211] As noted above, the coaptation element 510A has a generally rectangular shape when viewed from the top. In some exemplary embodiments, the coaptation element 510A may have another shape when viewed from the top. For example, the coaptation element may be round, square, diamond, oval, or any other shape. The paddle frames 524A each have a rounded rectangular shape when viewed from the top such that the paddle frames 524A surround the rectangular coaptation element 510A. Thus, natural tissue, such as the leaflets 20, 22, tends to be evenly pinched or compressed within the gaps 542A formed between the inner paddle 522A and the paddle frames 524A and the coaptation element 510A.

[0212] 72A and 73A, a bottom view of device 500A is shown. Similar to the top views (FIGS. 70A and 71A), device 500A has a shape that is symmetrical or substantially symmetrical about a front-to-back plane 550A and a side-to-side plane 552A when viewed from the bottom. Distal portion 527A of strip of material 501A includes aperture 527B for receiving cap 514A, shown in FIG. 73A.

[0213] The paddle frame 524A extends outward from the distal portion 507A of the device 500A to the left side 551A and right side 553A at a narrow or slight angle from the side-to-side plane 552A. The paddle frame 524A extends further away from the side-to-side plane 552A, maintaining a generally constant distance from the anterior-posterior plane 550A, as the paddle frame 524A extends toward the proximal portion 505A of the device 500A (FIG. 65A), ultimately forming the rounded rectangular shape shown in FIGS. 70A and 71A.

[0214] In one exemplary embodiment, the dimensions of device 500A are selected to minimize the number of implants required per patient (preferably one) while simultaneously maintaining a low transvalvular gradient. In one exemplary embodiment, the anterior-posterior distance Y47I of device 500A is less than 10 mm at its widest point, and the spacer's central lateral distance Y67C is less than 6 mm at its widest point. In one exemplary embodiment, the overall geometry of device 500A can be based on these two dimensions and the overall shape strategies described above. It should be readily apparent that using different anterior-posterior distances Y47I and central lateral distances Y67C as a starting point for device 500A will result in devices with different dimensions. Furthermore, using other dimensions and the shape strategies described above will also result in devices with different dimensions.

[0215] Tables D and E provide example dimensional values ​​and ranges for device 500A and components of device 500A according to some exemplary embodiments. However, device 500A can have a wide variety of different shapes and sizes and need not have all or any of the dimensional values ​​or ranges provided in Tables D and E. Table D provides example linear dimensions Y in millimeters and ranges of linear dimensions in millimeters for device 500A and components of device 500A. Table B provides example radial dimensions S in millimeters and ranges of radial dimensions in millimeters for device 500A and components of device 500A. The subscript for each dimension indicates the drawing in which the dimension first appears.

[0216] [Table 4]

[0217] [Table 5]

[0218] 74A, 75A, 76A, 77A, 78A, 79A, 80A, 81A, 82A, and 83A, perspective and cross-sectional views of device 500A are shown. Referring now to FIG. 74A, device 500A is shown taken at plane 75A near the proximal portion of coaptation element 510A. Referring now to FIG. 75A, a cross-sectional view of device 500A as seen through plane 75A of FIG. 74A is shown. At plane 75A, coaptation element 510A has a generally rounded rectangular shape. Gap 542A between inner paddle 522A and coaptation element 510A has width 542B. As noted above, gap 542A has a consistent, or generally consistent, width.

[0219] Referring now to FIG. 76A, device 500A is shown taken at cross section 77A, located approximately three-quarters of the way between distal portion 507A and proximal portion 505A of coaptation element 510A. Referring now to FIG. 77A, a cross-sectional view of device 500A is shown taken through cross section 77A of FIG. 76A. As can be seen in FIGS. 76A and 77A, strips of material 501A forming device 500A are layered to form four layers within the area of ​​coaptation element 510A. A single layer of strip of material 501A forms each of inner paddle 522A and outer paddle 520A. In the position of plane 75A, coaptation element 510A has a generally rectangular shape oriented along inter-side plane 552A. A gap 542A between inner paddle 522A and coaptation element 510A is visible. The gap 542A between the inner paddle 522A and the interface element 510A has a width 542B that is larger than the width 542B shown in FIG. 75A. The gap 544A between the outer paddle 520A and the inner paddle 522A has a consistent or generally consistent width 544B to receive the mounting portion 524B of the paddle frame 524A.

[0220] Referring now to FIG. 78A, device 500A is shown taken at cross section 79A located approximately one-half way between distal portion 507A and proximal portion 505A of device 500A. Referring now to FIG. 79A, a cross-sectional view of device 500A as seen through cross section 79A of FIG. 78A is shown. As can be seen in FIGS. 78A and 79A, strips of material 501A forming device 500A are layered to form four layers in the region of the coaptation elements 510A, two layers in the region of the inner paddles 522A, and one layer in the region of the outer paddles 520A. At plane 79A, coaptation elements 510A have a generally rectangular shape oriented along inter-side plane 552A. Gap 542A between inner paddle 522A and coaptation elements 510A has a width 542B that is the same as or approximately the same as width 542B shown in FIG. 77A.

[0221] Referring now to FIG. 80A , device 500A is shown taken at cross section 81A, located approximately one-quarter of the way between distal portion 507A and proximal portion 505A of device 500A. Referring now to FIG. 81A , a cross-sectional view of device 500A is shown as seen through cross section 81A of FIG. 80A . As can be seen in FIGS. 80A and 81A , strips of material 501A forming device 500A are layered to form four layers in the region of the coaptation elements 510A, two layers in the region of the inner paddles 522A, and the outer paddles 520A are formed by a single layer. At plane 81A, coaptation elements 510A have a generally rectangular shape oriented along inter-side plane 552A. Gap 542A between inner paddles 522A and coaptation elements 510A has a width 542B that is approximately the same as the central width 542B shown in FIG. 79A .

[0222] Referring now to FIG. 82A , device 500A is shown taken at cross section 83A, located approximately one-quarter of the way between distal portion 507A and proximal portion 505A of device 500A. Referring now to FIG. 83A , a cross-sectional view of device 500A is shown as seen through cross section 83A of FIG. 82A . As can be seen in FIGS. 82A and 83A , strips 501A of material forming device 500A are layered to form four layers in the region of the coaptation elements 510A, two layers in the region of the inner paddles 522A, and a single layer forming the outer paddle 520A. At the location of plane 83A, coaptation elements 510A have a generally rectangular shape oriented along inter-side plane 552A. Gap 542A between inner paddle 522A and coaptation element 510A forms an arcuate shape with a width 542B that is approximately the same as the central width 542B shown in FIG. 81A .

[0223] 84-88, 86A, 87A, and 88A, exemplary implantable devices 100, 500, 500A are shown that lack fasteners or articulatable gripping members. Rather, the exemplary devices 100, 500, 500A shown in Figures 84-88, 86A, 87A, and 88A have barbs or gripping members 800 / 800A and / or 802 / 802A integrated into the articulation elements or paddle portions of the anchor portion of the device to facilitate gripping of the native heart valve tissue.

[0224] 84 , an exemplary implantable device 100 is shown that does not include a coaptable fastener or gripping element. As described above, device 100 is deployed from a delivery sheath or means for delivery 102 and includes a coaptation portion 104 and an anchor portion 106. The coaptation portion 104 of device 100 includes a coaptation element or means for coaptation 110, which is adapted to be implanted between the leaflets 20, 22 of a native valve (such as the mitral valve MV) and is slidably attached to an actuation element or shaft 112 that extends through the coaptation element or means for coaptation 110 to a distal cap 114.

[0225] The anchor portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 coupled between the distal cap 114 and the coaptation element or means for coaptation 110. The anchor portion 106 is actuatable between an open state and a closed state and can take a variety of forms, such as, for example, a gripping element, such as a paddle, catch, and / or the like. Actuation of the actuation element or means for actuation 112 opens and closes the anchor portion 106 of the device 100 to grip the native valve leaflets 20, 22 during implantation.

[0226] 84 includes barbs 800 disposed on the joining element or means for joining 110 rather than on a joinable fastener or grasping element, with at least one barb 800 on each side of the joining element or means for joining 110. When the anchor portion 106 of the device 100 is closed, tissue grasped between the inner paddle 122 and the joining element or means for joining 110 is pressed against the barbs 800. The barbs 800 can be sharpened to engage, and in some embodiments, pierce, the natural tissue and prevent the tissue from backing out of the device 100. In some embodiments, the barbs 800 are angled downward to improve engagement with the natural tissue.

[0227] 85 , an exemplary implantable device 100 without a separate coaptable fastener is shown. As described above, device 100 is deployed from a delivery sheath or means for delivery 102 and includes a coaptation portion 104 and an anchor portion 106. The coaptation portion 104 of device 100 includes a coaptation element or means for coaptation 110, which is adapted to be implanted between the leaflets 20, 22 of a native or mitral valve MV and is slidably attached to an actuating element 112 (e.g., an actuating wire, shaft, rod, thread, line, etc.) that extends through the coaptation element or means for coaptation 110 to a distal cap 114.

[0228] The anchor portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 coupled between the distal cap 114 and the coaptation element or means for coaptation 110. The anchor portion 106 is actuatable between an open and a closed state and can take a variety of forms, such as, for example, a gripping element, such as a paddle, a catch, etc. Actuation of the actuation element or means for actuation 112 opens and closes the anchor portion 106 of the device 100 to grip the native valve leaflets 20, 22 during implantation.

[0229] Rather than a separate joinable fastener or gripping element, the device 100 shown in FIG. 85 includes barbs 800 disposed on the inner paddle 122, with at least one barb 800 on each side of the inner paddle 122. When the anchor portion 106 of the device 100 is closed, tissue grasped between the inner paddle 122 and the joining element or means for joining 110 is pressed against the barbs 800. The barbs 800 are sharp, thereby engaging, and in some embodiments piercing, the natural tissue and preventing the tissue from backing out of the device 100. In some embodiments, the barbs 800 are angled downward to improve engagement with the natural tissue.

[0230] 86 , an exemplary implantable device 500 is shown that does not include a coaptable fastener or gripping element. As described above, device 500 includes a coaptation portion 504 and an anchor portion 506. The coaptation portion 504 of device 500 includes a coaptation element 510 that is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to an actuation element or means for actuation 512 that extends through the coaptation element 510 to a distal cap 514.

[0231] The anchor portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 coupled between the distal cap 514 and the coaptation element 510. The anchor portion 506 is actuatable between open and closed states and can take a variety of forms, such as, for example, a gripping element, such as a paddle, catch, and / or the like. Actuation of the actuation element 512 causes the anchor portion 506 of the device 500 to open and close to grip the leaflets 20, 22 of the native valve during implantation.

[0232] Rather than an articulatable fastener or gripping element, device 500 includes barbs 800 disposed on inner paddle 522, optionally with multiple barbs 800 on each side of inner paddle 522. When anchor portion 506 of device 500 is closed, tissue grasped between inner paddle 522 and articulation element 550 is pressed against barbs 800. Barbs 800 are sharp, thereby engaging, and in some embodiments piercing, the natural tissue and preventing the tissue from backing out of device 500. In some embodiments, barbs 800 are angled downward to improve engagement with the natural tissue.

[0233] Referring now to FIG. 86A, an exemplary implantable device 500A is shown that does not include a coaptable fastener or gripping element. As described above, in device 500A, a coaptation element 510A is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to an actuation element or means for actuation (not shown) that extends through the coaptation element 510A and to a distal cap 514A. Device 500 also includes an outer paddle 520A and an inner paddle 522A connected between the distal cap 514A and the coaptation element 510A. Device 500A is actuatable between open and closed states and can take a variety of forms, such as gripping elements, e.g., paddles, fasteners, and / or the like. Actuation of the actuation elements opens and closes the paddles 520A, 522A of device 500A to grip the native valve leaflets 20, 22 during implantation.

[0234] Rather than an articulatable fastener or gripping element, device 500A includes barbs 800A disposed on inner paddle 522A, optionally with multiple barbs 800A on each side of inner paddle 522A. When device 500A is closed, tissue grasped between inner paddle 522A and articulation element 510A is pressed against barbs 800A. Barbs 800A are sharp, thereby engaging, and in some embodiments piercing, the natural tissue and preventing the tissue from backing out of device 500A. In some embodiments, barbs 800A are angled downward to improve engagement with the natural tissue.

[0235] 87 , an exemplary implantable device 500 is shown that does not include a separate coaptable fastener or gripping element. As described above, device 500 includes a coaptation portion 502 and an anchor portion 506. The coaptation portion 502 of device 500 includes a coaptation element 510 that is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to an actuation element or means for actuation 512 that extends through the coaptation element 510 to a distal cap 514.

[0236] The anchor portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 coupled between the distal cap 514 and the coaptation element 510. The anchor portion 506 is actuatable between an open state and a closed state and can take a variety of forms, such as, for example, a gripping element, such as a paddle, catch, and / or the like. Actuation of the actuation element 512 causes the anchor portion 506 of the device 500 to open and close to grip the leaflets 20, 22 of the native valve during implantation.

[0237] Rather than a separate joinable fastener or gripping element, device 500 includes barbs 800 disposed on joining element 510, with multiple barbs 800 on each side of joining element 510. When anchor portion 506 of device 500 is closed, tissue grasped between inner paddle 522 and joining element 510 is pressed against barbs 800. Barbs 800 are sharp, thereby engaging, and in some embodiments piercing, the natural tissue and preventing the tissue from backing out of device 500. In some embodiments, barbs 800 are angled downward to improve engagement with the natural tissue.

[0238] Referring now to FIG. 87A, an exemplary implantable device 500A is shown that does not include a coaptable fastener or gripping element. As described above, the device 500A can have a coaptation element 510A adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and slidably attached to an actuation element or means for actuation (not shown) that extends through the coaptation element 510A to a distal cap 514A. The device 500 also includes an outer paddle 520A and an inner paddle 522A connected between the distal cap 514A and the coaptation element 510A. The device 500A is actuatable between open and closed states and can take a variety of forms, such as gripping elements, e.g., paddles, fasteners, and / or the like. Actuation of the actuation elements causes the paddles 520A, 522A of the device 500A to open and close to grip the native valve leaflets 20, 22 during implantation.

[0239] Rather than a separate articulatable fastener or gripping element, device 500A includes barbs 800A disposed on coaptation element 510A, with multiple barbs 800A on each side of coaptation element 510A. When device 500A is closed, tissue grasped between inner paddle 522A and coaptation element 510A is pressed against barbs 800A. Barbs 800A are sharp, thereby engaging, and in some embodiments piercing, the natural tissue and preventing the tissue from retracting from device 500A. In some embodiments, barbs 800A are angled downward to improve engagement with the natural tissue.

[0240] 88 , an exemplary implantable device 500 is shown that does not include a separate coaptable fastener or gripping element. As described above, device 500 includes a coaptation portion 502 and an anchor portion 506. The coaptation portion 502 of device 500 includes a coaptation element 510 that is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to an actuation element or means for actuation 512 that extends through the coaptation element 510 to a distal cap 514.

[0241] The anchor portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 coupled between the distal cap 514 and the coaptation element 510. The anchor portion 506 is actuatable between an open state and a closed state and can take a variety of forms, such as, for example, a gripping element, such as a paddle, a catch, and / or the like. Actuation of the actuation element 512 causes the anchor portion 506 of the device 500 to open and close to grip the native valve leaflets 20, 22 during implantation.

[0242] Rather than a joinable fastener or gripping element, device 500 includes barbs 800 disposed on joining element 510, with at least one barb 800 on each side of joining element 510. Similar to device 500 shown in FIG. 87 above, device 500 also includes barbs 802 disposed on inner paddles 522, with each inner paddle 522 having at least one barb 802.

[0243] When the anchor portion 506 of the device 500 is closed, tissue grasped between the inner paddle 522 and the coaptation element 550 is pressed against the barbs 800, 802. The barbs 800, 802 are sharp, thereby engaging, and in some embodiments piercing, the natural tissue and preventing the tissue from backing out of the device 500. In some embodiments, the barbs 800, 802 are angled downward to improve engagement with the natural tissue. The combination of the barbs 800 of the coaptation element 510 and the barbs 802 of the inner paddle 522 causes the grasped tissue to form an S-shaped, tortuous path as it passes over the barbs 800, 802. Thus, the force pulling the tissue away from the device 500 encourages the tissue to further engage the barbs 800, 802 before it can escape.

[0244] Referring now to FIG. 88A, an exemplary implantable device 500A is shown that does not include a coaptable fastener or gripping element. As described above, the device 500A can have a coaptation element 510A adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and slidably attached to an actuation element or means for actuation (not shown) that extends through the coaptation element 510A to a distal cap 514A. The device 500 also includes an outer paddle 520A and an inner paddle 522A connected between the distal cap 514A and the coaptation element 510A. The device 500A is actuatable between open and closed states and can take a variety of forms, such as gripping elements, e.g., paddles, fasteners, and / or the like. Actuation of the actuation elements causes the paddles 520A, 522A of the device 500A to open and close to grip the native valve leaflets 20, 22 during implantation.

[0245] Rather than a joinable fastener or gripping element, device 500A includes barbs 800A disposed on joining element 510A, each side of joining element 510A having at least one barb 800A. Device 500A also includes barbs 802A disposed on inner paddles 522A, each inner paddle 522A having at least one barb 802A.

[0246] When the device 500A is closed, tissue grasped between the inner paddle 522A and the coaptation element 510A is pressed against the barbs 800A, 802A. The barbs 800A, 802A are sharp, thereby engaging and, in some embodiments, piercing the natural tissue and preventing the tissue from retracting from the device 500A. In some embodiments, the barbs 800A, 802A are angled downward to enhance engagement with the natural tissue. The combination of the barbs 800A of the coaptation element 510A and the barbs 802A of the inner paddle 522A causes the grasped tissue to form an S-shaped, tortuous path as it passes over the barbs 800A, 802A. Thus, the force pulling the tissue away from the device 500A encourages the tissue to further engage the barbs 800A, 802A before it can escape.

[0247] 89-102, the joint elements 510 and paddles 520, 522 of an exemplary device 500 are shown. The joint elements 510 and paddles 520, 522 can be made from a wide variety of different materials. The joint elements 510 and paddles 520, 522 can be formed from one or more of a variety of materials, for example, a metal fabric, such as a woven, knitted, electrospun, or any other suitable deposited or formed mesh, or a laser-cut or otherwise cut or flexible material. The material can be a cloth, a shape-memory alloy wire (such as Nitinol) for shape-setting functionality, or any other flexible material suitable for implantation in the human body.

[0248] In one exemplary embodiment, the joining element is made from a woven mesh of metal wires, such as a woven mesh of Nitinol wires. In one exemplary embodiment, the joining element 510 is made from a woven mesh of between 25 and 100 wires, such as between 40 and 85 wires, such as between 45 and 60 wires, such as about 48 or 48 Nitinol wires.

[0249] The coaptation element 510 can be covered with a fabric, such as a polyethylene fabric. The coaptation element 510 can be entirely surrounded by a fabric covering, such as a fine mesh polyethylene fabric. The fabric covering can provide a blood seal on the surface of the spacer and / or promote rapid tissue ingrowth.

[0250] The use of a shape memory material, such as a woven nitinol wire mesh, to construct the joint element 510 results in a joint element that can be self-expanding, flexible in all directions, and / or has low stress when the joint element is crimped and / or bent. The material can be a single piece, two halves joined together, or multiple sections or pieces secured or bonded together in any suitable manner, such as by welding, adhesive, etc.

[0251] 89-90 , device 500 extends from proximal portion 505 to distal portion 507 and includes a coaptation element 510, an inner paddle 522, and an outer paddle 520. Coaptation element 510 includes a proximal opening 519A and a distal opening 515 ( FIGS. 92 and 94 ). The proximal opening 519A of coaptation element 510 is formed in the proximal portion 519 of coaptation element 510. Coaptation element 510 is seamably coupled to inner paddle 522, for example, by coupling portion 525. Inner paddle 522 is seamably coupled to outer paddle 520, for example, by coupling portion 523. Outer paddle 520 is attached (e.g., seamably attached, etc.) to distal portion 527 by coupling portion 521. Coaptation gap 542 is formed between inner paddle 522 and coaptation element 510. A paddle gap 544 is formed between the inner paddle 522 and the outer paddle 520 when the paddles 520, 522 are folded, for example as shown in FIG.

[0252] 91 , a front view of device 500 is shown (the rear view is identical). Coaptation element 510 includes a proximal portion 519, an intermediate portion 518, and a distal portion 517. Proximal portion 519 includes a proximal opening 519A. Distal portion 517 includes a distal opening 515 and is connected to a coupling portion 525. The shape of coaptation element 510 is rounded or generally rounded to prevent device 500 from catching or snagging cardiac structures, such as chordae tendineae, during implantation.

[0253] 92 , a side view of device 500 is shown. Similar to device 500 viewed from the front, distal portion 507 of device 500 is generally narrower than proximal portion 505 of device 500 when device 500 is viewed from the side. Coaptation element 510 flares outward at proximal portion 519 from proximal opening 519A to intermediate portion 518. Coaptation element 510 then tapers, or narrows, at intermediate portion 518 from proximal portion 519 to distal portion 517. Distal portion 517 remains narrow before splitting into two joint portions 525. The generally rounded appearance of device 500 is further evidenced by the rounded shape of joint portion 523, which splices together inner and outer paddles 522 and 520, and the outwardly curved shape of outer paddle 520.

[0254] A coaptation gap 542 formed between the inner paddle 522 and the coaptation element 510 is configured to receive a natural valve leaflet. The narrowing of the coaptation element 510 gives the gap 542 a somewhat teardrop shape that increases in width as the gap 542 approaches the distal portion 507 of the device 500. The increased width of the gap 542 toward the distal portion 507 allows the inner paddle 522 to contact tissue grasped in the gap 542 closer to the proximal portion 505, increasing the pinch force as a result of the mechanical advantage provided by the length of the paddles 520, 522 and other fixation or anchor elements, such as those described herein.

[0255] 93, a top view of the device 500 is shown. The proximal opening 519A of the coaptation element 510 can be seen at the proximal portion 505 of the device 500, and it can be seen that the coaptation element 510 is hollow inside. The coaptation element 510 has an elliptical or generally elliptical shape when viewed from the top. The paddles 520, 522 appear to have a protruding rectangular shape, although the paddles 520, 522 can extend laterally and have an arcuate, or crescent-like, shape.

[0256] 94, a bottom view of the device 500 is shown. The distal opening 515 of the coaptation element 510 can be seen at the distal portion 507 of the device 500, revealing that the coaptation element 510 is hollow. The coaptation element 510 has an elliptical or generally elliptical shape when viewed from the top. The paddles 520, 522 appear to have a protruding rectangular shape, although the paddles 520, 522 can extend laterally, resulting in an arcuate, or crescent-like, shape. The distal portion 517 of the coaptation element 510 can be seen bifurcating to mate with the mate 525.

[0257] 89A, 90A, 91A, 92A, 93A, 94A, 95A, 96A, 97A, 98A, 99A, 100A, 101A, and 102A, there is shown portions of device 500A formed by a strip of material 501A (e.g., a single continuous strip of material, a composite strip of material, etc.), namely, joining element 510A and paddles 520A, 522A. Joint element 510A and paddles 520A, 522A can be made from a wide variety of different materials. Joint element 510A and paddles 520A, 522A can be formed from a material that may be a metal fabric, such as a woven, knitted, electrospun, or any other suitable deposited or formed mesh, or a laser-cut or otherwise cut or flexible material. This material may be fabric, shape memory alloy wire (such as Nitinol) to provide shape setting functionality, or any other flexible material suitable for implantation in the human body.

[0258] In one exemplary embodiment, the joint element 510A, inner paddle 522A, and outer paddle 520A are made from a single continuous strip 501A of material. The strip 501A can be formed from a material that may be a metal fabric, such as a woven, knitted, electrospun, or any other suitable deposited or formed mesh, or a laser-cut or otherwise cut or flexible material. The material may also be a cloth, a shape-memory alloy wire (such as Nitinol) for shape-setting functionality, or any other flexible material suitable for implantation in the human body. In one exemplary embodiment, the strip 501A is made from a woven mesh of between 25 and 100 strands, such as between 40 and 85 strands, such as between 45 and 60 strands, or about 48 or 48 Nitinol wires.

[0259] 205-207, an exemplary woven or knitted material 4000 that can be used for the strip of material 501A is shown. Referring now to FIG. 205, an enlarged plan view of the material 4000 is shown. The material 4000 extends from a first edge 4002 to a second edge 4004. The edges 4002, 4004 surround a central portion or field 4006. The material 4000 is formed by braiding or weaving together a central cord 4020, such as Nitinol wire. The edge cords 4010 extend longitudinally through the material 4000 along the edges 4002, 4004. The central cord 4020 is woven or knitted such that the central cord 4020 wraps around the edge cords 4010. By wrapping the center cord 4020 around the edge cord 4010, the material 4000 near the edges 4002, 4004 is thicker than the material in the central portion 4006, forming a lobed or dogbone-like shape when the material 4000 is viewed from its end, as shown in FIG. 206. Thus, the edges 4002, 4004 of the material 4000 are less flexible than the central portion 4006. The edge cords 4010 and the center cord 4020 may be similar in diameter and may have diameters ranging from about 0.06 millimeters to about 0.18 millimeters. In some embodiments, the edge cord 4010 has a larger diameter than the center cord 4020, which may make the edges 4002, 4004 stiffer or more rigid than the central portion 4006. For example, the edge cords 4010 can have a diameter ranging from 0.07 millimeters to about 0.27 millimeters, or about 0.17 millimeters, and the center cord 4020 can have a diameter ranging from about 0.04 millimeters to about 0.15 millimeters, or about 0.009 millimeters. In some embodiments, the edges 4002, 4004 are made less flexible than the center portion 4006 by using different materials for the edge cords 4010 and the center cord 4020, such as, for example, a metallic material for the edge cords 4010, e.g., nitinol, and a cloth or plastic material for the center cord 4020, e.g., polyethylene.Alternatively, the edge cords 4010 and the center cords 4020 can be made from the same material that is subjected to different chemical and / or thermal processes that change the flexibility of the material such that the center cords 4020 are more flexible than the edge cords 4010.

[0260] Referring now to FIG. 207, the folded portion of material 4000 is layered on top of each other to form a section having four layers 4000A, 4000B, 4000C, and 4000D. The lobed shape of the individual layers, with thicker edges 4002 and 4004 relative to the central portion 4006, forms three gaps 4001A, 4001B, and 4001C between layers 4000A, 4000B, 4000C, and 4000D of material 4000 in the configuration of the central portion 4006. Outer gaps 4001A and 4001C are formed between outer layers 4000A and 4000D and adjacent middle layers 4000B and 4000C.

[0261] As described in this disclosure, the interface element 510A of device 500A can be formed from four layers of material, such as material 4000. When a layer of material 4000 is used to form the interface element 510A, the actuating element 512A of device 500A can be inserted into an intermediate gap 4001B formed in the center of the four layers of material 4000. The actuating element 512A can have a diameter larger than the width of gap 4001B, such that insertion of the actuating element 512A opens the intermediate gap 4001B, stretching and reducing the size of the adjacent outer gaps 4001A, 4001C. In some embodiments, insertion of the actuating element 512A causes the central body portion 4006 on either side to bulge outward to a thickness greater than the thickness of the four stacked edge portions 4002, 4004.

[0262] The joint element 510A and paddles 520A, 522A can be covered with a fabric, such as a polyethylene fabric. The joint element 510A and paddles 520A, 522A can be entirely surrounded by a fabric cover (e.g., cover 540A), such as a fine mesh polyethylene fabric. The fabric cover can blood seal the surface of the spacer and / or promote rapid tissue ingrowth.

[0263] The use of a shape memory material, such as a woven nitinol wire mesh, to construct the joint elements 510A and paddles 520A, 522A results in joint elements and paddles that can be self-expanding, flexible in all directions, and / or have low strain when crimped and / or bent. The material can be a single piece, two halves joined together, or multiple sections or pieces secured or bonded together in any suitable manner, such as by welding, adhesive, etc.

[0264] 89A and 90A, device 500A extends from proximal portion 505A to distal portion 507A and includes a joint element 510A, an inner paddle 522A, and an outer paddle 520A. A single continuous strip of material 501A extends between two ends 501B and is folded over to form joint element 510A, inner paddle 522A, and outer paddle 520A. Some portions of device 500A are formed from multiple layers of strip of material 501A. For example, strip of material 501A is overlapped to form four layers in the area of ​​joint element 510A and two layers in the area of ​​inner paddle 522A.

[0265] The interface element 510A and paddles 520A, 522A are seamably coupled together by a bond in the strip of material 501A. The interface element 510A is seamably coupled to the inner paddle 522A by a bond 525A. The inner paddle 522A is seamably coupled to the outer paddle 520A by a bond 523A. The outer paddle 520A is attached (e.g., seamably attached, etc.) to the distal portion 527A by a bond 521A. An aperture 527B in the distal portion 527A engages with the cap 514A.

[0266] Various gaps are formed between portions of the device 500A when the strip of material 501A is folded into a desired shape. A joint gap 542A is formed between the inner paddle 522A and the joint element 510A. A paddle gap 544A is formed between the inner paddle 520A and the outer paddle 522A when the paddles 520A, 522A are folded, for example, as shown in FIG. 90A. A collar gap or opening 546A is formed when the strip of material 501A is folded to form the proximal portion 519B of the joint element 510A.

[0267] 91A, a front view of device 500A is shown (the rear view is identical). Coaptation element 510A includes a proximal portion 519B that extends above the junction 523A of paddles 520A, 522A. Distal portion 517A of coaptation element 510A is hidden by paddles 520A, 522A when viewed from the front or back, giving device 500A a long, narrow, rounded rectangular shape. The shape of coaptation element 510A helps prevent device 500A from catching or snagging cardiac structures, such as chordae tendineae, during implantation.

[0268] Referring now to FIG. 92A, a side view of device 500A is shown. Distal end 507A of device 500A is generally narrower and generally less sharp than proximal end 505A of device 500A when viewed from the side, forming a rounded shape. Coaptation element 510A includes proximal portion 519B, intermediate portion 518A, and distal portion 517A. Proximal portion 519B flares outward from intermediate portion 518A and engages collar 511D ( FIG. 48A ). Intermediate portion 518A of coaptation element 510A is straight or generally straight when viewed from the side. Distal portion 517A is attached (e.g., seamably attached, etc.) to inner paddle 522A, for example, by coupling portion 525A. The generally rounded nature of device 500A is further evidenced by the rounded shape of joint 523A, which splicably connects paddles 520A, 522A. Joint 521A, which connects outer paddle 520A to distal portion 527A, is also rounded, facilitating a shape transition from strip of material 501A to cap 514A (FIG. 48A), which is assembled to flat or generally flat distal portion 527A.

[0269] The coaptation gap 542A formed between the inner paddle 522A and the coaptation element 510A is configured to receive natural tissue. Due to the generally straight nature of the intermediate portion 518A and inner paddle 522A of the coaptation element 510A, the gap 542A is consistent, or generally consistent, with a narrow upper end that flares outward so that the proximal portion 519B engages the collar 511D ( FIG. 48A ). Thus, the inner paddle 522A contacts tissue grasped within the gap 542A closer to the proximal portion 505A, where the clamping force is greater as a result of the length of the paddles 520A, 522A, and the mechanical advantage provided by other fixation or anchor elements, such as those described herein.

[0270] As described above, the interface element 510A and paddles 520A, 522A of device 500A are formed by folding a strip of material 501A. The folded strip of material 501A is then unfolded and assembled with other components, such as a collar 511D, a cap 514A, and a paddle frame 524A. After being formed into the desired shape, the strip of material 501A is shape-set, which causes the strip of material 501A to return to the desired shape after assembly with the other components. In some embodiments, a jig is used when the strip of material 501A is folded and shape-set to ensure that the strip of material 501A is folded into the proper configuration at the desired radius.

[0271] Referring again to FIG. 92A , a portion of a jig 570A is shown to assist in folding and shaping device 500A. A strip of material 501A is shown folded around jig 570A to form the desired shape. To use jig 570A to fold strip of material 501A into the shape of device 500A, strip of material 501A is positioned with one end 501B in alignment with inner paddle 522A. Strip 501A is stretched distally 507B from end 501B to form first layer 581A of inner paddle 522A, stretched around first jig portion 572A to form first layer 581A of hinge portion 525A, and then stretched proximally 505B to form first layer 581A of joint element 510A. The first layer 581A of material forms the inner paddle 522A and the sides of the interface element 510A surrounding the interface gap 542A. The strip 501A is then wrapped around the second fixture part 574A to form the proximal portion 519B of the interface element 510A and one of the openings 546A. The strip 501A is then stretched distally along the first layer 581A to form the second layer 582A of the interface element 510A. The strip 501A is then unwound around the first fixture part 572A to form the second layer 582A of the joint or hinge portion 525A and returned proximally 505A to form the second layer 582A of the inner paddle 522A. The strip 501A is then wrapped around the third fixture part 576A to form the joint 523A. Strip 501A is then stretched distally along inner paddle 522A to form outer paddle 520A, before being folded around fourth jig portion 578A to form joint 521. Strip 501A is then stretched laterally to form distal portion 527. The routing of strip 501A through jig 570A is then performed in reverse order on the other side of jig 570A to form the second half of device 500A.That is, strip 501A is then wrapped around fourth, third, first, second, and first jig portions 578A, 576A, 574A, 572A (a second time) to form the second half of device 500A. After strip 501A is wrapped around the jig portions as described above, a shape-setting operation is performed. While the jig portions illustrated have rounded or generally circular shapes, the portions can have any shape to assist in folding and shaping strip of material 501A. Jig 570A can have more or fewer portions to engage strip of material 501A.

[0272] 93A, a top view of device 500A is shown. The first and second layers 581A, 582A of each half of device 500A form the four layers of joining device 510A. A proximal opening 519C of joining device 510A is formed between the two second layers 582A. In some embodiments, opening 519C is formed by inserting actuation element 512A (not shown) between the folded overlapping layers of strip of material 501A after shaping strip of material 501A. In other embodiments, opening 519C is formed by shaping folded layers 581A, 582A of strip of material 501A around an additional fixture portion (not shown) so that joining element 510A has a round or generally round shape when viewed from above.

[0273] 94A, a bottom view of device 500A is shown. Distal portion 527A of strip of material 501A is shown, as is aperture 527B for receiving cap 514A. Coaptation element 510A and outer paddle 520A have a generally rounded rectangular shape when viewed from below.

[0274] 95-102, perspective and cross-sectional views of device 500 are shown. Referring now to FIG. 95, device 500 is shown cut at plane 96 near the proximal portion of coaptation element 510. Referring now to FIG. 96, a cross-section of device 500 as viewed from plane 96 of FIG. 95 is shown. At plane 96, coaptation element 510 has an elliptical or generally elliptical shape with thickened portions along the sides of coaptation element 510. Distal opening 515 is visible from the proximal portion, and coaptation element 510 is hollow internally.

[0275] 97, device 500 is shown cut at plane 98 located approximately halfway between distal portion 507 and proximal portion 505 of coaptation element 510. Referring now to FIG. 98, a cross section of device 500 is shown as seen through plane 98 of FIG. 97. At plane 98, coaptation element 510 has a shape that is more elliptical than, or generally elliptical than, the elliptical shape of FIG. 96.

[0276] 99, device 500 is shown cut at plane 100 located approximately one-quarter of the way between distal portion 507 and proximal portion 505 of coaptation element 510. Referring now to FIG. 100, a cross section of device 500 is shown as seen through plane 100 of FIG. 99. In the position of plane 100, coaptation element 510 has a narrower, or generally elliptical, shape than the elliptical shape seen in FIG.

[0277] 101, device 500 is shown cut at plane 102 located near distal portion 507 of coaptation element 510. Referring now to FIG. 102, a cross section of device 500 is shown as viewed from plane 102 of FIG. 101. In the position of plane 102, coaptation element 510 has an elliptical, or generally elliptical, shape that is smaller than the elliptical shape seen in FIG. 100 and that separates when coaptation element 510 couples with coupling portion 525.

[0278] 95A, 96A, 97A, 98A, 99A, 100A, 101A, and 102A, perspective and cross-sectional views of a portion of a device 500A formed by a single, continuous strip of material 501A are shown. Referring now to FIG. 95A, the device 500A is shown cut at cross section 96A near a proximal portion of a coaptation element 510A. Referring now to FIG. 96A, a cross-sectional view of the device 500A as viewed from cross section 96A of FIG. 95A is shown. In the position of plane 96A, the coaptation element 510A has a rectangular or generally rectangular shape. In some embodiments, when an actuation element (not shown) is inserted between the layers 582A of the coaptation element 510A, the coaptation element 510A remains straight when viewed from the side, but bends outward to form a rounded or generally rounded shape when viewed from the cross-sectional plane 96A.

[0279] 97A, device 500A is shown taken at cross section 98A near a proximal portion of coaptation element 510A. Referring now to FIG. 98A, a cross-sectional view of device 500A is shown as seen through cross section 98A of FIG. 97A. At the location of plane 98A, coaptation element 510A has a rectangular or generally rectangular shape. In some embodiments, when an actuation element (not shown) is inserted between layers 582A of coaptation element 510A, coaptation element 510A remains straight when viewed from the side, but bends outward to form a rounded or generally rounded shape when viewed from cross-sectional plane 98A.

[0280] 99A, device 500A is shown taken at cross section 100A near a proximal portion of coaptation element 510A. Referring now to FIG. 100A, a cross-sectional view of device 500A is shown taken from cross section 100A of FIG. 99A. In position at plane 100A, coaptation element 510A has a rectangular or generally rectangular shape. In some embodiments, when an actuation element (not shown) is inserted between layers 582A of coaptation element 510A, coaptation element 510A remains straight when viewed from the side, but bends outward to form a rounded or generally rounded shape when viewed from cross-sectional plane 100A.

[0281] 101A, device 500A is shown taken at cross section 102A near a proximal portion of coaptation element 510A. Referring now to FIG. 102A, a cross-sectional view of device 500A is shown as seen from cross section 102A of FIG. 101A. At the location of plane 102A, coaptation element 510A has a rectangular or generally rectangular shape. In some embodiments, when an actuation element (not shown) is inserted between layers 582A of coaptation element 510A, coaptation element 510A remains straight when viewed from the side, but bends outward to form a rounded or generally rounded shape when viewed from cross-sectional plane 102A.

[0282] 103-105, an exemplary implantable prosthetic device 100 having covered and uncovered portions is shown. The device 100 is shown implanted into a native mitral valve MV and secured to the native leaflets 20, 22. As described above, the device 100 includes a coaptation element or means for coaptation 110, a paddle 120, a fastener 130, and a cap 114. The paddle 120 and fastener 130 are in a closed position to secure the device 100 to the grasped native leaflets 20, 22 of the mitral valve MV. A proximal portion 105 of the device 100 is exposed to the left atrium LA, and a distal portion 107 of the device 100 is exposed to the left ventricle LV.

[0283] Referring now to FIG. 103 , device 100 is shown with a cover 900 covering the entire joining element or means for joining 110 and cap 114. In some embodiments, cover 900 can be a cloth or fabric or polymer, such as PET, velour, electrospun, laminated, or other suitable material. In other embodiments, instead of or in addition to a fabric, the cover can include a coating (e.g., a polymer), such as silicone, applied to the prosthetic spacer device and / or mechanical sealing mechanism, and interlocking bonds can be used. Cover 900 can be formed from a metal fabric, such as a woven, knitted, or any other suitable formed mesh, or a laser-cut or otherwise cut flexible material. Cover 900 can be a cloth, a shape-memory alloy wire (such as Nitinol) for shape-setting functionality, or any other flexible material suitable for implantation in the human body. The cover 900 prevents blood flow through the coaptation elements or means for coaptation 110 at the proximal portion 105 and also provides a seal between the device 100 and the valve leaflets 20, 22. Thus, the cover 900 helps prevent blood flow through the native valve at the location of the device 100. The cover 900 also prevents recirculating blood flow from entering the device 100 from the distal portion 107.

[0284] Referring now to FIG. 104 , device 100 is shown with a cover 1000 that partially covers the coaptation elements or means for coaptation 110 from the proximal portion 105 of device 100 to the portion of coaptation elements or means for coaptation 110 that engages the native valve leaflets 20, 22. In some embodiments, the cover can be a cloth or fabric, such as PET, velour, or other suitable fabric. In other embodiments, instead of or in addition to a fabric, the cover can include a coating (e.g., a polymer) applied to the prosthetic spacer device. Cover 1000 can be formed from a metal fabric, such as a woven, knitted, or any other suitable formed mesh, or a laser-cut or otherwise cut flexible material. Cover 1000 can also be a cloth, a shape-memory alloy wire (e.g., Nitinol) for shape-setting functionality, or any other flexible material suitable for implantation in the human body. Thus, cover 1000 prevents blood flow through coaptation elements or means for coaptation 110 at the proximal portion 105.

[0285] Referring now to FIG. 105 , device 100 is shown with a cover 1100 that partially covers coaptation element or means for coaptation 110, extending from the portion of coaptation element or means for coaptation 110 that engages the native valve leaflets 20, 22 toward the distal portion 107. Cover 1100 also covers cap 114. In some embodiments, the cover can be a cloth or fabric, such as PET, velour, or other suitable fabric. In other embodiments, instead of or in addition to a fabric, the cover can include a coating (e.g., a polymer) applied to the prosthetic spacer device. Cover 1100 can be formed from a mesh that is woven, knitted, or formed in any other suitable manner. Cover 1100 can also be a cloth, polymer, silicone, electrospun material, deposited material, and / or shape-memory alloy wire (such as Nitinol) for shape-setting functionality, or any other flexible material suitable for implantation in the human body. Thus, blood flow can enter the joining element or means for joining 110 but is prevented from passing through the device by the cover 1100 positioned towards the distal portion 107. The cover 1100 also prevents recirculating blood flow from entering the device 100 from the distal portion 107.

[0286] 106-109, an exemplary coaptation element 1200 of an implantable prosthetic device is shown. The coaptation element 1200 can be used with any of the implantable prosthetic devices described herein. With reference to FIG. 106, the coaptation element 1200 has a cylindrical or generally cylindrical shape extending between two caps 1201. However, the coaptation element 1200 can have any shape, such as any of the shapes described herein. In one exemplary embodiment, the direction of expansion of the coaptation element 1200 can be controlled. For example, the width / size of the coaptation element in the anterior and posterior directions (as implanted), the medial and lateral directions (as implanted), or both directions can be expanded (or contracted) in a controlled manner. The coaptation element 1200 can be made from a mesh material. With reference to FIG. 107, the mesh wall of the generally cylindrical coaptation element 1200 extends outward from the caps 1201 a distance 1204. 108, an axial force 1208 is applied to the cap 1201 of the coaptation element 1200, axially compressing the coaptation element 1200. The axial compression of the coaptation element 1200 causes the coaptation element 1200 to expand or bulge in an outward direction 1210 such that the distance 1204 increases.

[0287] The interface element 1200 can be compressed in a variety of different ways. For example, a threaded connection can be used to pull the two ends of the interface element together, or the two ends of the interface element can be pushed apart. For example, a collar can be provided on each end of the interface element. One of the collars can be threadedly engaged with a threaded shaft, and the other collar is rotatably coupled to that shaft. Rotating the shaft in one direction pulls the collars together. Rotating the shaft in the opposite direction moves the collars apart.

[0288] Incorporation of the coaptation element 1200 into an implantable prosthetic device of the present application allows the coaptation element to expand and compress outwardly tissue grasped between the coaptation element and the paddles and / or grasping members.

[0289] 106A , 108A , 106B , and 108B , an exemplary joint element 1200 for an implantable prosthetic device similar to the embodiment shown in FIGS. 106-109 is shown. The joint element 1200 can be used with any of the implantable prosthetic devices described herein. With reference to FIG. 106A , the joint element 1200 has a cylindrical or generally cylindrical shape extending between two caps 1201. However, the joint element 1200 can have any shape, such as any of the shapes disclosed herein. In the example shown in FIGS. 106A and 108A , the joint element 1200 comprises a tube 1203 with a slot 1205. For example, the tube 1203 can be made from a shape memory alloy such as Nitinol, and the slot can be cut into the tube, such as by laser cutting. The slot can be cut into the material forming the tube before the material is formed into the tube.

[0290] In one exemplary embodiment, the direction of expansion of the coaptation element 1200 can be controlled. For example, the configuration of the slot 1205 and / or the shape setting of the tube can be selected to control the shape of the expanded coaptation element 1200. For example, the configuration of the slot 1205 and / or the shape setting can determine the manner in which the width / size of the coaptation element expands (and / or contracts) in the anterior and posterior directions and / or the medial and lateral directions. Referring to FIG. 106A , the tube wall of the generally cylindrical coaptation element 1200 can extend a distance 1204 outward from the cap 1201. Referring now to FIG. 108A , an axial force 1208 and / or a rotational force 1209 can be applied to the cap 1201 of the coaptation element 1200 to expand the coaptation element 1200 from the configuration shown in FIG. 106A to the configuration shown in FIG. 108A . In the illustrated example, when the coaptation element 1200 is compressed axially and the coaptation element is twisted, the coaptation element 1200 expands or bulges in an outward direction 1210 such that the distance 1204 increases.

[0291] 106B and 108B, the interface element 1200 can be compressed in a variety of different ways. For example, the threaded connection 1221 can be used to pull the two ends of the interface element together and twist the interface element in a first direction, or to push the two ends of the interface element apart and twist the interface element in a second direction. For example, a collar can be provided at each end of the interface element. One of the collars can be threadedly engaged with a threaded shaft, while the other collar is fixedly coupled to the shaft. Rotating the shaft in one direction pulls the collars together and rotates them relative to one another in a first direction. Rotating the shaft in the opposite direction moves the collars apart and rotates them relative to one another in a second direction. The pitch of the threaded connection can be selected to set the ratio between the distance the interface element 1200 is compressed and the angle the interface element is twisted.

[0292] When the coaptation element 1200 shown in Figures 106A, 108A, 106B, and 108B is incorporated into an implantable prosthetic device of the present application, the coaptation element can expand to press outward against tissue grasped between the coaptation element and the paddles and / or grasping members.

[0293] 106C and 108C show an exemplary embodiment of a controllably expandable coaptation element 1200 of an implantable prosthetic device. The coaptation element 1200 can be used by itself with a cover or within any of the coaptation elements described herein (to expand the coaptation element). The coaptation element 1200 can be used with any of the implantable prosthetic devices described herein. Referring to FIG. 106C, the coaptation element 1200 has pairs of pivotally connected arms 1231. Each pair of pivotally connected arms 1231 extends between and is pivotally connected to two caps 1201. In the illustrated example, there are two pairs of pivotally connected arms 1231. However, there can be one, three, four, or any number of pairs of pivotally connected arms.

[0294] In one exemplary embodiment, the direction of expansion of the coaptation element 1200 can be controlled. For example, two pairs of pivotally connected arms (shown) can be included to change the width / size of the coaptation element only in one of the anterior and posterior directions and / or the medial and lateral directions. Four pairs of pivotally connected arms 1231 can be included to change the width / size of the coaptation element in both the anterior and posterior directions and the medial and lateral directions. When four pairs of pivotally connected arms 1231 are included, the arms can have different lengths and / or pivot point positions to separately expand (contract) the coaptation element 1200 in different directions. For example, the arm lengths can be selected to expand more in the medial and lateral directions than in the anterior and posterior directions.

[0295] 108C, an axial force 1208 can be applied to the cap 1201 of the joint element 1200 to expand the joint element 1200 from the configuration shown in FIG. 106C to the configuration shown in FIG. 108C. In the illustrated example, axial compression of the pivotally connected arm 1231 causes the pivotable link 1233, or knee joint, to expand in an outward direction 1210 such that the distance 1204 increases.

[0296] 106C and 108C, the interface element 1200 can be compressed in a variety of different ways. For example, a threaded connection 1221 can be used to pull the two ends of the interface element together or push the two ends of the interface element apart. For example, a collar can be provided on each end of the interface element. One of the collars can be threadedly engaged with a threaded shaft 1244, and the other collar is rotatably coupled to that shaft. Rotating the shaft in one direction pulls the collars together. Rotating the shaft in the opposite direction moves the collars apart.

[0297] When the coaptation element 1200 shown in Figures 106C and 108C is incorporated into an implantable prosthetic device of the present application, the coaptation element can expand to press outward against tissue grasped between the coaptation element and the paddles and / or grasping members.

[0298] 106D and 108D show an exemplary embodiment of an expandable coaptation element 1200 of an implantable prosthetic device. The coaptation element 1200 can be used by itself (with a cover) (see FIGS. 106E and 108E) or within any of the coaptation elements described herein (to expand the coaptation element). The coaptation element 1200 can be used with any of the implantable prosthetic devices described herein. Referring to FIG. 106, the coaptation element 1200 has a central support member 1243, one or more pivotally connected arms 1241, and connecting lines 1245. Each arm 1241 extends from a pivotal connection to the central support member 1243. Each connecting line 1245 connects the central support member 1243 and a pivotally connected arm 1241. The length of the connecting line 1245 sets the angle at which the connecting arm pivots from the central support member 1243. In the example shown, there are two pivotally connected arms 1241. However, there could be one, three, four, or any number of pivotally connected arms.

[0299] In one exemplary embodiment, the direction of expansion of the coaptation element 1200 can be controlled. For example, two pivotally connected arms can be included to change the width / size of the coaptation element in only one of the anterior and posterior directions and / or the medial and lateral directions. Four pivotally connected arms 1241 can be included to change the width / size of the coaptation element in both the anterior and posterior directions and the medial and lateral directions. When four pivotally connected arms 1241 are included, the arms and / or connecting lines 1245 can have different lengths and / or pivot point positions to separately expand (contract) the coaptation element 1200 in different directions. For example, the lengths of the arms and / or connecting lines can be selected to expand more in the medial and lateral directions than in the anterior and posterior directions.

[0300] The arms 1241 can be moved from a retracted position ( FIG. 106D ) to an extended position ( FIG. 108D ). For example, the arms 1241 can be biased toward the extended position by a spring or other biasing means. In the illustrated example, a restraint 1247, such as a string, holds the arms 1241 in the retracted position. The restraint 1247 can be removed or broken to expand the coaptation element 1200 from the configuration shown in FIG. 106D to the configuration shown in FIG. 108D .

[0301] 106E and 108E show an exemplary embodiment similar to the embodiment shown in FIGS. 106D and 108D, except that the joining element includes a cover material 1253. The cover material 1253 can extend from the central support member 1243 to each arm 1241. The cover material 1253 can be used in conjunction with connecting lines 1245, or the cover material can eliminate the need for connecting lines 1245.

[0302] Referring now to FIG. 106F, an exemplary coaptation element 1200 of an implantable prosthetic device is shown, similar to the embodiment shown in FIGS. 106-109. The coaptation element 1200 can be used with any of the implantable prosthetic devices described herein. Referring to FIG. 106F, the coaptation element 1200 is defined by a coil 1263 extending between two caps 1201. The coaptation element 1200 can have any shape, such as any of the shapes disclosed herein. The coil 1263 can be made from a shape memory alloy, such as Nitinol.

[0303] In one exemplary embodiment, the direction of expansion of the coaptation element 1200 can be controlled. For example, the shape setting of the coil 1263 can be selected to control the shape of the expanded coaptation element 1200. For example, the shape setting configuration can determine how the width / size of the coaptation element expands (and / or contracts) in the anterior and posterior directions and / or the medial and lateral directions. An axial force 1208 and / or a rotational force 1209 can be applied to the cap 1201 of the coaptation element 1200 to expand or contract the coaptation element 1200 from the configuration shown in FIG. 106F. In the illustrated example, axially stretching the coil 1263 and twisting the coil 1263 causes the coil to contract in an inward direction 1211, while axially compressing the coil 1263 and twisting the coil in the opposite direction causes the coil to expand, or bulge, in an outward direction.

[0304] Referring to FIG. 106F, the interface element 1200 can be compressed in a variety of different ways. For example, the threaded connection 1221 can be used to pull the two ends of the interface element together and twist the interface element in a first direction, or to push the two ends of the interface element apart and twist the interface element in a second direction. For example, a collar can be fixedly connected to each end of the coil 1263. One of the collars can be threadedly engaged with a threaded shaft, while the other collar is fixedly connected to the shaft. Rotating the shaft in one direction pulls the collars together and rotates them relative to one another in a first direction. Rotating the shaft in the opposite direction moves the collars apart and rotates them relative to one another in a second direction. The pitch of the threaded connection can be selected to set the ratio between the distance the interface element 1200 is compressed and the angle the interface element is twisted.

[0305] When the coaptation element 1200 shown in FIG. 106F is incorporated into an implantable prosthetic device of the present application, the coaptation element can expand to press outward against tissue grasped between the coaptation element and the paddles and / or grasping members.

[0306] 106G-106I illustrate an exemplary embodiment of an expandable coaptation element 1200. In the example shown in FIGS. 106G-106I, the coaptation element is inflated with a fluid medium to expand the coaptation element. The fluid medium can take a wide variety of different forms. Examples of fluids that can be used to inflate the coaptation element 1200 include, but are not limited to, air, gel, water, blood, foam, etc. The coaptation element 1200 can be used with any of the implantable prosthetic devices described herein.

[0307] Referring to FIG. 106G, the coaptation element 1200 can have an outer layer 1271 (e.g., any of the coaptation elements 110, 510 disclosed herein) and an inner layer 1273, i.e., a balloon. The coaptation element 1200 can have any shape, such as any of the shapes disclosed herein. In the example shown in FIG. 106G and FIG. 1086, the inner layer 1273 is disposed within the outer layer 1271 and can have the same or generally the same shape as the inner surface of the outer layer. The inner layer can be made from an expandable material, such as rubber or other materials traditionally used to make balloons and angioplasty devices. The outer layer 1271 can be made from a shape memory alloy, such as Nitinol.

[0308] 106H and 106I, in one exemplary embodiment, the direction of expansion of coaptation element 1200 can be controlled. In the example shown in FIG. 106H, inner layer 1273 includes two balloons that can be optionally connected. However, any number of balloons can be used. For example, inner layer 1273 can include three, four, or any number of balloons. Each balloon can be individually inflated to control the shape of the expansion of coaptation element 1200. When balloons are connected together, the connection can also affect the shape of the expansion. In the example shown in FIG. 106H, the balloons are connected along plane 1275, i.e., area. Expansion of inner layer 1273 in direction 1277 is less than expansion in direction 1279 due to the connection along plane 1275. Therefore, in this example, expansion upon inflation can be limited, or substantially limited, to expansion in the medial and lateral directions.

[0309] The use of multiple balloons and the optional connections between the balloons can determine how the width / size of the coaptation element expands (and / or contracts) in the anterior and posterior directions and / or medial and lateral directions.

[0310] In the example shown in FIG. 106I, the inner layer 1273 includes one or more supports 1281, or struts. While one support 1281 is shown, any number can be used. For example, the inner layer can include two, three, four, or any number of supports. The supports 1281 can divide the inner layer into multiple individually inflatable chambers, or the supports can be non-sealing, such that inflation fluid added to any chamber fills all chambers. If there are individually inflatable chambers, the chambers can be individually inflated to control the shape of the expansion of the coaptation element 1200. The supports can also affect the shape of the expansion. In the example shown in FIG. 106I, the supports 1281 reduce or eliminate expansion of the inner layer 1273 in direction 1277. Thus, in this example, expansion due to inflation can be limited, or substantially limited, to expansion in the medial and lateral directions.

[0311] The use of multiple individually inflatable chambers and / or the configuration of the support 1281 can determine how the width / size of the joint element expands (and / or contracts) in the anterior and posterior directions and / or in the medial and lateral directions.

[0312] When the coaptation element 1200 shown in Figures 106G-106I is incorporated into an implantable prosthetic device of the present application, the coaptation element can expand to compress outwardly tissue grasped between the coaptation element and the paddles and / or grasping members.

[0313] 110-111, an exemplary implantable prosthetic device 1300 is shown. The device 1300 is similar to the previously described device 100 and includes a coaptation element 1310, a paddle 1320, and a fastener or gripping member 1330. Referring now to FIG. 111, a top view of the coaptation element 1310 is shown. As can be seen in FIG. 111, the coaptation element 1310 has an elliptical or generally elliptical cross-section. The coaptation element 1310 does not include a central opening and can be formed from a solid piece of material, such as foam. Forming the coaptation element 1310 from a solid piece of foam material prevents blood from flowing through the center of the coaptation element 1310, thereby substantially eliminating areas where blood can become trapped. Device 1300 can include any other features of the implantable prosthetic devices discussed herein, and device 1300 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein). Prosthetic device 1300 can be opened and closed in a variety of different ways. For example, a sleeve can be slidably positioned over the coaptation elements to engage and open the paddles. Alternatively, the paddles can be opened by pulling a line or string that opens a fastener, which movement of the fastener opens the paddle. However, any mechanism for opening and closing device 1300 can be used.

[0314] 112-128, an exemplary paddle frame 1400 for an implantable prosthetic device is shown. The paddle frame 1400 can be used with any of the implantable prosthetic devices described herein. The paddle frame 1400 is formed from a single piece of material 1402, such as nitinol or any other suitable material. The paddle frame 1400 extends from a cap attachment portion 1410 to a paddle connection portion 1420 and has a proximal portion 1422, an intermediate portion 1424, and a distal portion 1426. In some embodiments, the paddle frame 1400 includes an attachment portion 1440 for securing a cover (see FIG. 30), an inner paddle 520, and / or an outer paddle 522 to the paddle frame 1400. In some embodiments, the paddle frame 1400 is narrowed at a fifth curved portion 1438 to facilitate bending the sides of the paddle 1400 toward the central plane 1404, for example, during crimping of the device.

[0315] The paddle frame 1400 extends in a rounded, three-dimensional shape between a first mounting portion 1412 and back to a second mounting portion 1414 via a proximal portion 1422, an intermediate portion 1424, and a distal portion 1426. To create the rounded, three-dimensional shape, the paddle frame 1400 is bent, or curved, in multiple locations as the paddle frame 1400 extends between the first mounting portion 1412 and the second mounting portion 1414. The mounting portions 1412, 1414 each include notches 1416, 1418 for attachment to a cap. The paddle frame 1400 bends in a region 1419. The region 1419 may include a widened portion 1417 that distributes stresses caused by bending the paddle frame 1400 over a wider area. The notches 1416, 1418 may also include rounded notches 1415 at each end of the notch. The radiused notches 1415 act as strain reliefs for the bending area 1419 and the area where the paddle frame 1400 connects to the cap.

[0316] The paddle frame 1400 curves from the mid-plane or central plane 1404 (FIG. 115) at a first curved portion 1430, widening the shape of the paddle frame 1400. As can be seen in FIG. 117, the paddle frame 1400 also curves from the front plane 1406 at the first curved portion 1430. The paddle frame 1400 curves from the outward direction of the first curved portion 1430 at a second curved portion 1432, forming the sides of the frame 1400. The paddle frame continues to slope from the front plane 1406 at the second curved portion 1432. In some embodiments, the second curved portion 1432 has a larger radius than the first curved portion 1430. The paddle frame 1400 curves away from the frontal plane 1406 at a third curve 1434 as the paddle frame 1400 continues to curve in the arc of the second curve 1432 when viewed from the frontal plane 1406. This curvature at the third curve 1434 moves the frame 1400, and therefore the natural valve leaflets, progressively away from the centerline or frontal plane 1406. This movement away from the centerline may cause the leaflet tissue to spread toward the annulus, resulting in less stress on the leaflet tissue. The paddle frame 1400 curves toward the lateral plane 1404 at a fourth curve 1436 as the frame 1400 continues to curve away from the frontal plane 1406. The rounded, three-dimensional shape of the paddle frame 1400 is closed by a fifth curve 1438, which joins both sides of the paddle frame 1400. 116 and 118, the paddle frame 1400 is arcuate or generally arcuate in shape as the frame 1400 extends from the mounting portion 1420 to the closed or distal portion 1426. The intermediate portion 1424 of the frame, closer to the front plane 1406 than the closed portion 1426, is given a rounded, wing-like shape on either side of the intermediate portion 1424, which engages the curved surface of the joint element (not shown) during gripping of natural tissue between the paddle and the joint element of the implantable device of the present invention.

[0317] 191, in an exemplary embodiment, a flat blank 1403 of the paddle frame 1400 can be cut, e.g., laser cut, from a flat sheet of material. Referring to FIG. 192, the cut blank 1403 can then be folded to form the three-dimensional shape of the paddle frame 1400.

[0318] 193 and 194, in one exemplary embodiment, the paddle frame 1400 can be configured to increase the clamping force against or toward the interface elements 510 when the paddles 520, 522 are in the closed configuration. This is because the paddle frame is configured for a closed position (e.g., FIG. 194) and a first position (e.g., FIG. 139) that is beyond the location where the inner paddle 520 engages the interface elements, such as beyond the center plane 552 of the device 500, such as beyond the opposite side of the interface elements, such as beyond the outer paddle on the opposite side of the interface elements. Referring to FIG. 194, the paddle frame 1400 is bent and secured and attached to the inner and outer paddles 522, 520, for example, by stitching. This causes the paddle frame to have a preload (i.e., a clamping force against or toward the interface elements that is greater than zero) when the paddle frame 1400 is in the closed configuration. Thus, when the paddle frame 1400 is configured in the configuration of FIG. 193, the clamping force of the paddle frame 1400 can be increased compared to a paddle frame configured in the closed configuration (FIG. 194).

[0319] The amount of preload on the paddle frame 1400 can be varied by adjusting the angle at which the paddle frame 1400 is configured relative to the interface element 510. The further the paddle frame 1400 is configured past the closed position, the greater the preload.

[0320] Each bend in the paddle frame 1400 may be independent of the others, i.e., one bend is completed before another bend begins, or the bends may be joined together, i.e., the paddle frame 1400 bends in multiple directions simultaneously.

[0321] 112A, 114A, 115A, 116A, 117A, and 118A, an exemplary paddle frame 1400A for an implantable prosthetic device is shown. The paddle frame 1400A can be used with any of the implantable prosthetic devices described herein. Each paddle frame 1400A is formed from a single piece of material 1402A, such as Nitinol or any other suitable material. Each paddle frame 1400A extends from a cap attachment portion 1410A to a paddle connection portion 1420A and has a proximal portion 1422A, an intermediate portion 1424A, and a distal portion 1426A.

[0322] Each paddle frame 1400A extends in a rounded, three-dimensional shape between a first mounting portion 1412A and back to a second mounting portion 1414 via a proximal portion 1422, an intermediate portion 1424, and a distal portion 1426. To create the rounded, three-dimensional shape, each paddle frame 1400A is bent or curved in multiple locations as the paddle frame 1400A extends between the first mounting portion 1412A and the second mounting portion 1414A. The mounting portions 1412A, 1414A include notches 1416A, 1418A, respectively, for attachment to a cap. The paddle frame 1400A bends in region 1419A. Region 1419A can include a widened portion 1417A, which distributes stresses caused by bending the paddle frame 1400A over a wider area. The notches 1416A, 1418A may also include a radiused notch 1415A at each end of the notches 1416A, 1418A. The radiused notches 1415A act as strain reliefs for the bending region 1419A and the area where the paddle frame 1400A connects to the cap.

[0323] Each paddle frame 1400A curves from a mid-plane or central plane 1404A (FIG. 116A) at a first curved portion 1430A, widening the shape of the paddle frame 1400A. As can be seen in FIG. 114A, the paddle frame 1400A also curves from a front plane 1406A at the location of the first curved portion 1430A. The paddle frame 1400A curves from the outward direction of the first curved portion 1430 at a second curved portion 1432 to form a side surface 1433A of the frame 1400A that is parallel or substantially parallel to the central plane 1404A when viewed from the front plane 1406A. The paddle frame continues to slope from the front plane 1406A at the location of the second curved portion 1432A. In some embodiments, the second curved portion 1432A has a larger radius than the first curved portion 1430A. The paddle frame 1400A curves back from the front plane 1406A at a third curved section 1434A in the middle section 1424A, while the side surfaces 1433A of the paddle frame 1400A remain parallel or substantially parallel to the central plane 1404A. The paddle frame 1400A curves away from the central plane 1404A a second time at a fourth curved section 1436A and continues to curve from the central plane 1404A throughout the remainder of the middle section 1424A and distal section 1426A. The rounded three-dimensional shape of the paddle frame 1400A is closed by an end 1442A that is connected to the side surfaces 1433A by a fifth curved section 1438A, which forms a rounded corner at the distal end 1426A of the paddle frame 1400A.

[0324] End 1442A can be wider than the rest of paddle frame 1400A to accommodate features that allow paddle frame 1400A to be attached to a paddle (not shown) and a cover (not shown). For example, end 1442A can include a slot 1444A for receiving a portion of a strip of material, such as strips of material 401A, 501A described above. An opening 1446A in end 1442A allows the strip of material to be inserted into slot 1444A. End 1442A can also include mounting holes 1440A for securing a cover (see FIG. 30A) to paddle frame 1400A.

[0325] 116A and 117A, the paddle frame 1400A has a generally rounded rectangular shape as the frame 1400 extends from the mounting portion 1410A to the closed end of the paddle coupling portion 1420A. The intermediate portion 1424A of the frame is closer to the front plane 1406A than the distal portion 1426A and is given a rounded, wing-like shape on either side of the intermediate portion 1424A, which engages the anterior and posterior surfaces of the abutment element (not shown) during grasping of native tissue between the paddle (not shown) and the abutment element of the implantable devices described herein.

[0326] 195 and 196, a paddle frame 1400A is shown assembled to a collar 514A of an exemplary implantable device, such as device 500A described above. In one exemplary embodiment, the paddle frame 1400A can be configured to increase clamping force on or toward the coaptation element 510A when the paddles 520A, 522A are in a closed configuration because the paddle frame 1400A is configured for a closed position (e.g., FIG. 196) to a first position (e.g., FIG. 195) that is beyond the position where the inner paddle 522A engages the coaptation element 510A, such as beyond the center plane 552A of the device 500A (e.g., FIG. 70A), such as...

Claims

1. 1. An expandable spacer assembly comprising: A central shaft; an actuation tube rotatably disposed about the central shaft; an expandable spacer having a first end secured to the central shaft and a second end secured to the locking tube; Equipped with An expandable spacer assembly, wherein rotation of the actuation tube relative to the central shaft expands the expandable spacer.

2. 2. The expandable spacer assembly of claim 1, wherein a locking portion of the central shaft engages a locking portion of the expandable spacer to hold the spacer in a retracted position, an extended position, and multiple positions between the retracted position and the expanded position.

3. 3. The expandable spacer assembly of claim 1 or claim 2, wherein teeth on the central shaft engage teeth on the expandable spacer to hold the spacer in a retracted position, an extended position, and multiple positions between the retracted position and the extended position.

4. The expandable spacer assembly of any one of claims 1 to 3, wherein a proximal end of the spacer is fixed to a proximal end of the central shaft and a distal end of the spacer is fixed to a distal end of the actuation tube.

5. The expandable spacer assembly of any one of claims 1 to 4, wherein the spacer comprises a tube having a plurality of slits.

6. The expandable spacer assembly of any one of claims 1 to 5, wherein the spacer comprises a tube having a plurality of helical shaped cuts.

7. 1. A system for repairing a patient's native valve, comprising: A delivery catheter; a valve repair device coupled to the delivery catheter; wherein the valve repair device comprises: an expandable spacer assembly, the expandable spacer assembly comprising: A central shaft; an actuation tube rotatably disposed about the central shaft; an expandable spacer having a first end secured to the central shaft and a second end secured to the locking tube; Equipped with A system for expanding the expandable spacer by rotation of the actuation tube relative to the central shaft.

8. The system of claim 7 , wherein a locking portion of the central shaft engages a locking portion of the expandable spacer to hold the spacer in a retracted position, an expanded position, and multiple positions between the retracted position and the expanded position.

9. 9. The system of claim 7 or claim 8, wherein teeth on the central shaft engage teeth on the expandable spacer to hold the spacer in a retracted position, an extended position, and multiple positions between the retracted and extended positions.

10. The system of any one of claims 7 to 9, wherein a proximal end of the spacer is fixed to a proximal end of the central shaft and a distal end of the spacer is fixed to a distal end of the actuation tube.

11. The system of any one of claims 7 to 10, wherein the spacer comprises a tube having a plurality of cuts.

12. The system of any one of claims 7 to 11, wherein the spacer comprises a tube having a plurality of helical cuts.

13. 1. A valve repair device for repairing a native valve in a patient, comprising: a joining element having an aperture; an expandable joint disposed within the coaptation element and configured to expand outwardly through the opening of the coaptation element, the expandable joint extending between a proximal end and a distal end; an actuation member that engages the expandable joint to expand and retract the expandable joint; an anchor portion having at least one anchor configured to be attached to the patient's native valve; 16. A valve repair device comprising:

14. The valve repair device of claim 13 , wherein the expandable coaptation portion expands symmetrically through two openings in the coaptation element.

15. 14. The valve repair device of claim 13, wherein the expandable joint expands asymmetrically through two openings in the coaptation element such that the distal end of the expandable joint extends to a greater width than the proximal end of the expandable joint or the proximal end of the expandable joint extends to a greater width than the distal end of the expandable joint.

16. the expandable joint includes a first expandable joint and a second expandable joint; the first expandable joint extends a first distance through a first opening in the joint element; 16. The valve repair device of claim 13 or 15, wherein the second expandable coaptation portion extends a second distance through a second opening in the coaptation element.

17. The valve repair device of any one of claims 13 to 16, wherein the actuating member pushes or pulls one of the proximal and distal ends of the expandable joint, causing the expandable joint to expand, and preferably the actuating member also pulls the other of the proximal and distal ends of the expandable joint, causing the expandable joint to expand.

18. The valve repair device of any one of claims 13 to 17, wherein the actuation member is a flexible actuation member that is routed through the distal end of the expandable joint and to the proximal end.

19. The valve repair device of any one of claims 13 to 18, wherein the expandable coaptation portion is attached to one of a distal portion of the coaptation element and a proximal portion of the coaptation element.

20. The valve repair device of any one of claims 13 to 19, further comprising a biasing member extending between the proximal and distal ends of the expandable joint and biasing the expandable joint toward one of the retracted state and the extended state.

21. The valve repair device comprises: a locking member extending between the proximal and distal ends of the expandable joint; a lock having a locked state and an unlocked state; Further equipped with in the unlocked state, the lock allows the locking member to change length as the proximal and distal ends move together or apart; The valve repair device of any one of claims 13 to 20, wherein in the locked state, the lock prevents the locking member from changing length as the proximal and distal ends move together or apart.

22. 22. The valve repair device of any one of claims 13 to 21, wherein the actuation member comprises a rotatable cam member rotatable between a first position and a second position to expand the expandable joint from a retracted state to an extended state.

23. The valve repair device comprises: A shaft, a collar through which the shaft extends, the collar being attached to the interface element; a cap attached to the shaft, the cap being movable by the shaft away from the collar; and a plurality of paddle portions movable between an open position and a closed position and configured for attachment to the patient's native valve; Equipped with 23. The valve repair device of any one of claims 13 to 22, wherein movement of the cap towards the collar moves the paddle portions to the closed position, and movement of the cap away from the collar moves the paddle portions to the open position.

24. 24. The valve repair device of claim 23, wherein the shaft extends through the expandable junction and / or the expandable junction expands toward the paddle portion of the valve repair device.

25. The valve repair device of any one of claims 13 to 24, wherein the width of the expandable junction is inversely proportional to the length of the expandable junction.

26. The valve repair device of any one of claims 13 to 25, wherein the expandable joint is formed from a tube of braided material and / or one of a shape memory alloy and an elastomeric material.

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