Heart valve sealing device and delivery device therefor

Abstract

An exemplary valve repair device for repairing a patient's natural valve includes an expandable mating portion. One mating portion has an opening and an expandable portion configured to expand outward through the opening. An actuating element or actuating member engages the expandable portion to expand and retract it. Another expandable mating portion has a central axis, an actuating tube, and an expandable spacer. A first end of the expandable spacer is fixed to the central axis. A second end of the expandable spacer is fixed to a locking tube. Rotation of the actuating tube relative to the central axis causes the expandable spacer to expand.

Description

[0001] Related applications

[0002] This application claims the benefit of U.S. Provisional Patent 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

[0003] Natural heart valves (i.e., the aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play a crucial role in ensuring an adequate supply of blood for positive flow through the cardiovascular system. These valves can become less effective due to congenital malformations, inflammatory processes, infectious conditions, diseases, etc. Such damage to the valves can lead to serious cardiovascular injury or death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and can lead to complications. Transvascular techniques can be used to introduce and implant prosthetic devices in a much less invasive manner compared to open-heart surgery. As an example, transseptal techniques can be used, for example, involving: inserting a catheter into the right femoral vein, ascending along the inferior vena cava and into the right atrium; puncturing the septum; and advancing the catheter into the left atrium.

[0004] A healthy heart is typically conical in shape, tapering towards the lower apex. The heart has four chambers: the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The natural mitral valve of the human heart connects the left atrium to the left ventricle. The anatomy of the mitral valve is quite different from other natural heart valves. The mitral valve consists of an annular portion, which is the annular portion of the natural valve tissue surrounding the mitral orifice, and a pair of cusps or leaflets extending downwards from the annulus into the left ventricle. The mitral valve annulus can form a "D," oval, or other non-circular cross-sectional shape with long and short axes. The anterior leaflet can be larger than the posterior leaflet, and when the leaflets are close together, they form a roughly "C"-shaped boundary between their adjacent free sides.

[0005] When functioning normally, the anterior and posterior leaflets together act as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also known as "ventricular diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also known as "ventricular contraction"), the increased blood pressure in the left ventricle causes the two leaflets to come together, causing the one-way mitral valve to close, preventing blood from flowing back to the left atrium and instead draining it from the left ventricle through the aortic valve. To prevent the two leaflets from detaching under pressure and folding back towards the left atrium through the mitral valve annulus, numerous fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0006] Mitral regurgitation occurs when the natural mitral valve fails to close properly and blood flows from the left ventricle to the left atrium during the systolic phase of heart contractions. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, papillary muscle dysfunction, and stretching of the mitral valve annulus due to left ventricular dilation, among others. Mitral regurgitation located in the central portion of the leaflet is called central jet mitral regurgitation, while regurgitation located closer to a commissure (i.e., the point where the leaflets meet) is called eccentric jet mitral regurgitation. Central jet regurgitation occurs when the leaflet edges do not meet in the middle, resulting in valve failure and regurgitation.

[0007] One technique for treating mitral regurgitation and other valvular regurgitations in patients may involve directly securing the edges of the natural valve leaflets to each other. For example, clamps delivered via catheter may be used to attempt to clamp the sides of the leaflets together at their ends. However, significant challenges exist. For instance, multiple clamps may be required to eliminate regurgitation or reduce it to an acceptable level, but in some cases, this can lead to longer procedure times and may result in excessive flow restriction or undesirable stress on the natural anatomy.

[0008] Despite these existing technologies, there is still a need for improved devices and methods for treating valvular regurgitation. Summary of the Invention

[0009] This summary is intended to provide examples and is not intended to limit the scope of the invention in any way. For example, the claims do not require any features included in the examples summarized herein unless those features are expressly recited by the claim. Furthermore, the features, components, steps, concepts, etc., described in the examples described herein and in other parts of this disclosure can be combined in various ways. Various features and steps described in other parts of this disclosure may be included in the examples summarized herein.

[0010] An exemplary valve repair device for repairing a patient's natural valve includes: an occlusive element having an opening; an expandable occlusive portion extending between a proximal and a distal end and disposed within the occlusive element, the expandable occlusive portion being configured to expand outward through the opening in the occlusive element; an actuating element or actuating member engaging the expandable occlusive portion to expand and retract the expandable occlusive portion; and an anchor portion having at least one anchor configured to attach to the patient's natural valve.

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

[0012] A further understanding of the nature and advantages of the invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings, wherein like parts have like reference numerals. Attached Figure Description

[0013] To further clarify various aspects of embodiments of this disclosure, certain embodiments will be described in more detail with reference to various aspects of the accompanying drawings. It should be understood that these drawings depict only typical embodiments of this disclosure and should therefore not be considered as limiting the scope of this disclosure. Furthermore, while the drawings may be drawn to scale for some embodiments, they are not necessarily drawn to scale for all embodiments. Through the use of the drawings, embodiments and other features and advantages of this disclosure will be described and explained with additional specificity and detail, wherein:

[0014] Figure 1 An example of a cross-sectional view of the human heart during diastole;

[0015] Figure 2 An example of a cross-sectional view of a human heart during systole;

[0016] Figure 2A This is another cross-sectional view of the human heart during systole;

[0017] Figure 2B yes Figure 2A The sectional view, with annotations illustrating the natural shape of the mitral leaflet during contraction;

[0018] Figure 3 An example is a cross-sectional view of a human heart in diastole, where the chordae tendineae show the leaflets of the mitral and tricuspid valves attached to the ventricular wall;

[0019] Figure 4 An example of a healthy mitral valve with leaflet closure viewed from the atrial side.

[0020] Figure 5 An example of a dysfunctional mitral valve with visible gaps between the leaflets when viewed from the atrial side;

[0021] Figure 6 An example of a mitral valve with a wide gap between the posterior and anterior leaflets;

[0022] Figure 6A An example of the occlusal elements in the mitral valve space, viewed from the atrial side of the mitral valve;

[0023] Figure 6B An example of a valve repair device attached to the mitral valve leaflet, viewed from the ventricular side of the mitral valve, is shown, wherein the occlusal element is in the mitral valve intercostal space;

[0024] Figure 6C This is a three-dimensional view of a valve repair device attached to the mitral valve leaflet, shown from the ventricular side of the mitral valve, with the occlusal element in the mitral valve space;

[0025] Figure 6D This is a schematic diagram of the path of an example mitral valve leaflet along each side of the occlusal element of an exemplary mitral valve repair device;

[0026] Figure 6E This is a top-view schematic diagram of the path of an example mitral valve leaflet around the occlusal element of an exemplary natural valve repair device;

[0027] Figure 7 An example of the tricuspid valve viewed from the atrium.

[0028] Figure 8-14 Exemplary implementations of implantable prosthetic devices at various deployment stages are shown;

[0029] Figure 11A It showed something similar to Figure 11 The illustrated device is an exemplary embodiment of an implantable prosthesis, but in which the paddle is independently controllable;

[0030] Figure 15-20 Showing Figure 8-14 An implantable prosthesis device that is delivered and implanted within a natural valve;

[0031] Figure 21 An exemplary embodiment of an implantable prosthetic device or a frame for an implantable prosthetic device is shown;

[0032] Figure 22 An exemplary embodiment of an implantable prosthetic device or a frame for an implantable prosthetic device is shown;

[0033] Figure 23-25 Exemplary embodiments of components for implantable prosthetic devices or implantable medical devices are shown;

[0034] Figure 23A An exemplary embodiment of an implantable prosthetic spacer device is shown;

[0035] Figure 26 and 27 An exemplary implementation of a barbed fastener (clasp) for use in an implantable prosthetic device is shown;

[0036] Figure 28-32 An exemplary implementation of an implantable prosthesis device is shown;

[0037] Figure 30A An exemplary implantable prosthesis device with a covering is shown.

[0038] Figure 32A and 32B yes Figure 28-32 A three-dimensional view of the cap and mating element insert of the implantable prosthesis device in the sealed and spaced positions, respectively.

[0039] Figure 33 The barbed fastener is shown for use in implantable prosthetic devices;

[0040] Figure 34 It shows a portion of the natural valve tissue held in place by barbed fasteners;

[0041] Figures 35-46 An exemplary embodiment of an implantable prosthesis device delivered and implanted within a natural valve is shown;

[0042] Figure 47 A side view of an exemplary implantable prosthesis device without barbed fasteners in the closed position is shown.

[0043] Figure 47A A side view of an exemplary implantable prosthesis device without barbed fasteners in the closed position is shown.

[0044] Figure 48 A side view of an exemplary implantable prosthesis device with barbed fasteners in the closed position is shown.

[0045] Figure 48A A side view of an exemplary implantable prosthesis device with barbed fasteners in the closed position is shown.

[0046] Figure 48B A side view of an exemplary implantable prosthesis device with barbed fasteners in the closed position is shown, the device being attached to a deployment device.

[0047] Figure 48C Showing according to Figure 48BA side view of an exemplary implantable prosthesis device provided with a covering;

[0048] Figure 48D Showing according to Figure 48B A front view of an exemplary implantable prosthesis device attached to a deployment device;

[0049] Figure 48E Showing according to Figure 48D A front view of an exemplary implantable prosthesis device provided with a covering;

[0050] Figure 48F Showing according to Figure 48B A side view of an exemplary implantable prosthesis device, wherein the barbed fastener is in the closed position;

[0051] Figure 48G Showing according to Figure 48F A front view of an exemplary implantable prosthesis device;

[0052] Figure 48H Showing according to Figure 48F A bottom view of an exemplary implantable prosthesis device;

[0053] Figure 49 A side view of an exemplary implantable prosthesis device without barbed fasteners is shown in a partially open position;

[0054] Figure 50 A side view of an exemplary implantable prosthesis device in a partially open position is shown, with the barbed fastener in the open position;

[0055] Figure 51 A side view of an exemplary implantable prosthesis device in a partially open position is shown, with the barbed fastener in a closed position.

[0056] Figure 52 A side view of an exemplary implantable prosthesis device without barbed fasteners is shown in a semi-open position;

[0057] Figure 53 A side view of an exemplary implantable prosthesis device in a semi-open position is shown, with the barbed fastener in the closed position.

[0058] Figure 53A A side view of an exemplary implantable prosthesis device in a semi-open position is shown, with the barbed fastener in the closed position.

[0059] Figure 53B Showing according to Figure 53A A front view of an exemplary implantable prosthesis device;

[0060] Figure 53C Showing according to Figure 53A A side view of an exemplary implantable prosthesis device provided with a covering;

[0061] Figure 53D Showing according to Figure 53A A front view of an exemplary implantable prosthesis device provided with a covering;

[0062] Figure 54 A side view of an exemplary implantable prosthesis device in a semi-open position is shown, with the barbed fastener in the open position;

[0063] Figure 54A A side view of an exemplary implantable prosthesis device in a semi-open position is shown, with the barbed fastener in the open position;

[0064] Figure 54B Showing according to Figure 54A A front view of an exemplary implantable prosthesis device;

[0065] Figure 54C Showing according to Figure 54A A side view of an exemplary implantable prosthesis device provided with a covering;

[0066] Figure 54D Showing according to Figure 54A A front view of an exemplary implantable prosthesis device provided with a covering;

[0067] Figure 55 A side view of an exemplary implantable prosthesis device without barbed fasteners is shown in the three-quarters open position;

[0068] Figure 56 A side view of an exemplary implantable prosthesis device in the three-quarters open position is shown, with the barbed fastener in the closed position.

[0069] Figure 57 A side view of an exemplary implantable prosthesis device in the three-quarters open position is shown, with the barbed fastener in the open position;

[0070] Figure 58 A side view of an exemplary implantable prosthesis device without barbs is shown, in a near-full bailout position or near-fully open position.

[0071] Figure 59 A side view of an exemplary implantable prosthesis device without barbs is shown in the fully salvaged or fully open position.

[0072] Figure 60 An exemplary implantable side view is shown in the fully salvage position, with the barbed fastener in the closed position;

[0073] Figure 60A An exemplary implantable side view is shown in the fully salvage position, with the barbed fastener in the closed position;

[0074] Figure 60B Showing according to Figure 60A A front view of an exemplary implantable prosthesis device;

[0075] Figure 60C Showing according to Figure 60A A side view of an exemplary implantable prosthesis device provided with a covering;

[0076] Figure 60D Showing according to Figure 60A A front view of an exemplary implantable prosthesis device provided with a covering;

[0077] Figure 61 An exemplary implantable side view is shown in the fully salvage position, with the barbed fastener in the open position;

[0078] Figure 61A An exemplary implantable side view is shown in the fully salvage position, with the barbed fastener in the open position;

[0079] Figure 61B Showing according to Figure 61A A front view of an exemplary implantable prosthesis device;

[0080] Figure 61C Showing according to Figure 61A A side view of an exemplary implantable prosthesis device provided with a covering;

[0081] Figure 61D Showing according to Figure 61A A front view of an exemplary implantable prosthesis device provided with a covering;

[0082] Figures 62A-62B The movement of a paddle-like object is illustrated in an exemplary embodiment of an implantable prosthesis device;

[0083] Figures 63A-63C The movement of a paddle-like object is illustrated in an exemplary embodiment of an implantable prosthesis device;

[0084] Figures 64A-64C The movement of a paddle-like object is illustrated in an exemplary embodiment of an implantable prosthesis device;

[0085] Figure 65A perspective view of an exemplary implantable prosthesis device in a closed position is shown;

[0086] Figure 65A A perspective view of an exemplary implantable prosthesis device in a closed position is shown;

[0087] Figure 66 Showing Figure 65 A three-dimensional diagram of an implantable prosthesis device;

[0088] Figure 66A Showing Figure 65A A three-dimensional diagram of an implantable prosthesis device;

[0089] Figure 67 Showing Figure 65 Front view of an implantable prosthesis device;

[0090] Figure 67A Showing Figure 65A Front view of an implantable prosthesis device;

[0091] Figure 68 It shows a version with additional components. Figure 65 Front view of an implantable prosthesis device;

[0092] Figure 68A It shows a version with additional components. Figure 65A Front view of an implantable prosthesis device;

[0093] Figure 69 Showing Figure 65 Side view of an implantable prosthesis device;

[0094] Figure 70 Showing Figure 65 A top view of an implantable prosthesis device;

[0095] Figure 70A Showing Figure 65A A top view of an implantable prosthesis device;

[0096] Figure 71 Showing a component with a collar Figure 65 A top view of an implantable prosthesis device;

[0097] Figure 71A Showing a component with a collar Figure 65A A top view of an implantable prosthesis device;

[0098] Figure 72 Showing Figure 65 A bottom view of an implantable prosthesis device;

[0099] Figure 72A Showing Figure 65AA bottom view of an implantable prosthesis device;

[0100] Figure 73 Showing a cap component Figure 65 A bottom view of an implantable prosthesis device;

[0101] Figure 73A Showing a cap component Figure 65A A bottom view of an implantable prosthesis device;

[0102] Figure 74 Showing cuts taken through cross section 75 Figure 65 A three-dimensional cross-sectional view of an implantable prosthesis device;

[0103] Figure 74A Showing the section cut through cross-section 75A Figure 65A A three-dimensional cross-sectional view of an implantable prosthesis device;

[0104] Figure 75 Showing Figure 74 A top cross-sectional view of the exemplary prosthetic device shown;

[0105] Figure 75A Showing Figure 74A A top cross-sectional view of the exemplary prosthetic device shown;

[0106] Figure 76 Showing the section cut through cross-section 77 Figure 65 A three-dimensional cross-sectional view of an implantable prosthesis device;

[0107] Figure 76A Showing the section cut through cross-section 77A Figure 65A A three-dimensional cross-sectional view of an implantable prosthesis device;

[0108] Figure 77 Showing Figure 76 A top cross-sectional view of the exemplary prosthetic device shown;

[0109] Figure 77A Showing Figure 76A A top cross-sectional view of the exemplary prosthetic device shown;

[0110] Figure 78 Showing the section cut through cross-section 77 Figure 65 A three-dimensional cross-sectional view of an implantable prosthesis device;

[0111] Figure 78A Showing the section cut through cross-section 77A Figure 65A A three-dimensional cross-sectional view of an implantable prosthesis device;

[0112] Figure 79 Showing Figure 78A top cross-sectional view of the exemplary prosthetic device shown;

[0113] Figure 79A Showing Figure 78A A top cross-sectional view of the exemplary prosthetic device shown;

[0114] Figure 80 Showing the section cut through cross-section 81 Figure 65 A three-dimensional cross-sectional view of an implantable prosthesis device;

[0115] Figure 80A Showing the section cut through cross-section 81A Figure 65A A three-dimensional cross-sectional view of an implantable prosthesis device;

[0116] Figure 81 Showing Figure 80 A top cross-sectional view of the exemplary prosthetic device shown;

[0117] Figure 81A Showing Figure 80A A top cross-sectional view of the exemplary prosthetic device shown;

[0118] Figure 82 Showing the section cut through cross-section 83 Figure 65 A three-dimensional cross-sectional view of an implantable prosthesis device;

[0119] Figure 82A Showing the section cut through cross-section 83A Figure 65A A three-dimensional cross-sectional view of an implantable prosthesis device;

[0120] Figure 83 Showing Figure 82 A top cross-sectional view of the exemplary prosthetic device shown;

[0121] Figure 83A Showing Figure 82A A top cross-sectional view of the exemplary prosthetic device shown;

[0122] Figure 84 An exemplary embodiment of an implantable prosthesis device with integrated barbs is shown;

[0123] Figure 85 An exemplary embodiment of an implantable prosthesis device with integrated barbs is shown;

[0124] Figure 86 An exemplary embodiment of an implantable prosthesis device with integrated barbs is shown;

[0125] Figure 86A An exemplary embodiment of an implantable prosthesis device with integrated barbs is shown;

[0126] Figure 87 An exemplary embodiment of an implantable prosthesis device with integrated barbs is shown;

[0127] Figure 87A An exemplary embodiment of an implantable prosthesis device with integrated barbs is shown;

[0128] Figure 88 An exemplary embodiment of an implantable prosthesis device with integrated barbs is shown;

[0129] Figure 88A An exemplary embodiment of an implantable prosthesis device with integrated barbs is shown;

[0130] Figure 89 Showing Figure 65 A perspective view of the mating portion and paddle-shaped portion of an example implantable prosthesis device;

[0131] Figure 89A Showing Figure 65A A perspective view of the mating portion and paddle-shaped portion of an example implantable prosthesis device;

[0132] Figure 90 Showing Figure 65 A perspective view of the mating portion and paddle-shaped portion of an example implantable prosthesis device;

[0133] Figure 90A Showing Figure 65A A perspective view of the mating portion and paddle-shaped portion of an example implantable prosthesis device;

[0134] Figure 91 Showing Figure 65 Front view of the mate portion and paddle portion of an example implantable prosthesis device;

[0135] Figure 91A Showing Figure 65A Front view of the mate portion and paddle portion of an example implantable prosthesis device;

[0136] Figure 92 Showing Figure 65 Side view of the mate portion and paddle portion of an example implantable prosthesis device;

[0137] Figure 92A Showing Figure 65A Side view of the mate portion and paddle portion of an example implantable prosthesis device;

[0138] Figure 93 Showing Figure 65 A top view of the mate portion and paddle portion of an example implantable prosthesis device;

[0139] Figure 93A Showing Figure 65A A top view of the mate portion and paddle portion of an example implantable prosthesis device;

[0140] Figure 94 Showing Figure 65 A bottom view of the mating portion and part of an example implantable prosthesis device;

[0141] Figure 94A Showing Figure 65A A bottom view of the mating portion and part of an example implantable prosthesis device;

[0142] Figure 95 Showing Figure 65 A perspective view of the mate portion and paddle portion of an example implantable prosthesis device, wherein the cross section is cut across plane 96;

[0143] Figure 95A Showing Figure 65A A perspective view of the mate portion and paddle portion of an example implantable prosthesis device, wherein the cross section is cut across plane 96A;

[0144] Figure 96 Showing Figure 95 A cross-sectional view of the mating portion and the paddle-shaped portion;

[0145] Figure 96A Showing Figure 95A A cross-sectional view of the mating portion and the paddle-shaped portion;

[0146] Figure 97 Showing Figure 65 A perspective view of the mate portion and paddle portion of an example implantable prosthesis device, wherein the cross section is cut across plane 98.

[0147] Figure 97A Showing Figure 65A A perspective view of the mate portion and paddle portion of an example implantable prosthesis device, wherein the cross section is cut across plane 98A;

[0148] Figure 98 Showing Figure 97 A cross-sectional view of the mating portion and the paddle-shaped portion;

[0149] Figure 98A Showing Figure 97A A cross-sectional view of the mating portion and the paddle-shaped portion;

[0150] Figure 99 Showing Figure 65 A cross-sectional perspective view of the mating portion and the paddle-shaped portion of an example implantable prosthesis device, wherein the cross-section is cut across a plane of 100°.

[0151] Figure 99A Showing Figure 65A A perspective view of the mate portion and paddle portion of an example implantable prosthesis device, wherein the cross-section is taken across plane 100A;

[0152] Figure 100 Showing Figure 99 A cross-sectional view of the mating portion and the paddle-shaped portion;

[0153] Figure 100A Showing Figure 99A A cross-sectional view of the mating portion and the paddle-shaped portion;

[0154] Figure 101 Showing Figure 65 A perspective view of the mate portion and paddle portion of an example implantable prosthesis device, wherein the cross section is cut across plane 102;

[0155] Figure 101A Showing Figure 65A A cross-sectional perspective view of the mating portion and the paddle-shaped portion of an example implantable prosthesis device, wherein the cross-section is taken across plane 102A;

[0156] Figure 102 Showing Figure 101 A cross-sectional view of the mating portion and the paddle-shaped portion;

[0157] Figure 102A Showing Figure 101A A cross-sectional view of the mating portion and the paddle-shaped portion;

[0158] Figure 103 An exemplary implementation of an implantable prosthesis device is shown;

[0159] Figure 104 An exemplary implementation of an implantable prosthesis device is shown;

[0160] Figure 105 An exemplary implementation of an implantable prosthesis device is shown;

[0161] Figure 106 A side view showing an exemplary embodiment of the expandable mating element in its unexpanded state;

[0162] Figure 106A A side view showing an exemplary embodiment of the expandable mating element in its unexpanded state;

[0163] Figure 106B A side view showing an exemplary embodiment of the expandable mating element in its unexpanded state;

[0164] Figure 106CA side view showing an exemplary embodiment of the expandable mating element in its unexpanded state;

[0165] Figure 106D A side view showing an exemplary embodiment of the expandable mating element in its unexpanded state;

[0166] Figure 106E A side view showing an exemplary embodiment of the expandable mating element in its unexpanded state;

[0167] Figure 106F An exemplary implementation of an expandable mating element is shown;

[0168] Figure 106G An exemplary implementation of an expandable mating element is shown;

[0169] Figure 106H An exemplary implementation of an expandable mating element is shown;

[0170] Figure 106I An exemplary implementation of an expandable mating element is shown;

[0171] Figure 107 Showing Figure 106 End view of the expandable mating element;

[0172] Figure 108 Showing the expanded state Figure 106 Expandable mating elements;

[0173] Figure 108A Showing the expanded state Figure 106A Expandable mating elements;

[0174] Figure 108B Showing the expanded state Figure 106B Expandable mating elements;

[0175] Figure 108C Showing the expanded state Figure 106C Expandable mating elements;

[0176] Figure 108D Showing the expanded state Figure 106D Expandable mating elements;

[0177] Figure 108E Showing the expanded state Figure 106E Expandable mating elements;

[0178] Figure 109 Showing Figure 108 End view of the mating components;

[0179] Figure 110A side view of an exemplary embodiment of an implantable prosthesis device is shown;

[0180] Figure 111 Showing Figure 110 An end view of the mating element of an exemplary prosthetic device taken along line 111.

[0181] Figures 112-114 Showing Figure 65 A perspective view of an exemplary embodiment of a paddle-shaped frame for an implantable prosthesis device;

[0182] Figure 112A Showing Figure 65A A perspective view of an exemplary embodiment of a paddle-shaped frame for an implantable prosthesis device;

[0183] Figure 114A Showing Figure 112A Side view of the paddle-shaped frame;

[0184] Figure 115 Showing Figures 112-114 Front view of the paddle-shaped frame;

[0185] Figure 115A Showing Figure 112A A top view of the paddle-shaped frame;

[0186] Figure 116 Showing Figures 112-114 A top view of the paddle-shaped frame;

[0187] Figure 116A Showing Figure 112A Front view of the paddle-shaped frame;

[0188] Figure 117 Showing Figures 112-114 Side view of the paddle-shaped frame;

[0189] Figure 117A Showing Figure 112A Rear view of the paddle-shaped frame;

[0190] Figure 118 Showing Figures 112-114 A bottom view of the paddle-shaped frame;

[0191] Figure 118A Showing Figure 112A A bottom view of the paddle-shaped frame;

[0192] Figure 119 Showing Figures 112-114 Front view of the paddle-shaped frame;

[0193] Figure 120 Displaying the compressed state in the delivery device Figures 112-114Front view of the paddle-shaped frame;

[0194] Figure 121 A side view of an exemplary embodiment of an implantable prosthesis device in a closed state is shown;

[0195] Figure 122 Showing Figure 121 A front view of the paddle frame of an exemplary prosthetic device;

[0196] Figure 123 Displaying the open state Figure 121 Side view of an implantable prosthesis device;

[0197] Figure 124 Showing Figure 123 Front view of the paddle frame of the open prosthesis device;

[0198] Figure 125 A side view of an exemplary embodiment of an implantable prosthesis device in a closed state is shown;

[0199] Figure 126 Showing Figure 125 A front view of the paddle frame of an exemplary prosthetic device;

[0200] Figure 127 Showing the closed state Figure 125 Side view of an implantable prosthesis device;

[0201] Figure 128 Showing Figure 127 Front view of the paddle frame of the open prosthesis device;

[0202] Figure 129 An exemplary implementation of an implantable prosthesis device is shown;

[0203] Figures 130-131 An exemplary implementation of an implantable prosthesis device is shown;

[0204] Figure 132 An exemplary implementation of an implantable prosthesis device is shown;

[0205] Figures 133-134 An exemplary implementation of an implantable prosthesis device is shown;

[0206] Figures 135-136 An exemplary implementation of an implantable prosthesis device is shown;

[0207] Figure 137 An exemplary implementation of an implantable prosthesis device is shown;

[0208] Figures 138-143 This illustrates the application of an exemplary implementation of an implantable prosthesis device;

[0209] Figure 144 An exemplary embodiment of the delivery assembly is shown, which includes a delivery device and an exemplary prosthetic device;

[0210] Figure 145 A perspective view showing an exemplary embodiment of an implantable prosthesis device releasably coupled to a delivery device;

[0211] Figure 146 Showing Figure 145 In one embodiment, the implantable prosthesis is released from the delivery device;

[0212] Figure 147 Showing Figure 145 A cross-sectional view of the coupler;

[0213] Figure 148 Showing Figure 144 A perspective view of the delivery assembly, in which the prosthetic device is shown in a partial cross-section and some components of the delivery device are schematically shown;

[0214] Figure 149 Showing Figure 144 A plan view of the axis of the delivery device;

[0215] Figure 150 Showing Figure 144 Side elevation view of the proximal portion of the delivery device;

[0216] Figure 151 Showing Figure 144 The proximal portion of the delivery device along Figure 150 The cross-sectional view taken by line 150-150 is shown.

[0217] Figure 152 Showing Figure 144 Exploded view of the proximal portion of the delivery device;

[0218] Figure 153-160 An exemplary procedure for repairing the heart's natural valves is shown, with the heart partially displayed.

[0219] Figure 161 Showing Figure 144 An exemplary implementation of the handle of the delivery device;

[0220] Figure 162 yes Figure 161 Exploded view of the handle;

[0221] Figure 163 Showing Figure 144An exemplary embodiment of the connector and proximal collar of the delivery assembly shows that the connector can be releasably coupled to the proximal collar;

[0222] Figure 164 Showing Figure 163 A three-dimensional view of the connector and proximal collar, showing the connector being released from the proximal collar;

[0223] Figure 165 Showing Figure 144 An exemplary embodiment of the delivery assembly, including the cap, actuating element or actuating device, and release thread, shows that the cap is releasably coupled to the actuating element or actuating device via the release thread.

[0224] Figure 166 Showing Figure 163 A perspective view of the cap, actuating element or actuating device, and release thread, showing the cap being released from the actuating element or actuating device and the release thread;

[0225] Figure 167 Showing Figure 144 Exemplary embodiments of the delivery assembly's connector, proximal collar, cap, and actuating element or actuating device;

[0226] Figure 168 Showing Figure 167 A three-dimensional view of the connector and the proximal collar;

[0227] Figure 169 Showing Figure 144 An exemplary embodiment of the fastener control component of the delivery device;

[0228] Figure 170 Showing Figure 169 The fastener control components are made of Figure 169 The detailed view shown is a 170° crop of the stereoscopic view.

[0229] Figure 171 Showing Figure 169 An exemplary embodiment of the guide rail for the fastener control component;

[0230] Figure 172 Showing Figure 144 An exemplary embodiment of the shaft of the delivery device;

[0231] Figure 173 An exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device is shown;

[0232] Figure 174 An exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device is shown;

[0233] Figure 174AAn exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device is shown;

[0234] Figure 175 An exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device is shown;

[0235] Figure 175A An exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device is shown;

[0236] Figure 176 An exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device is shown;

[0237] Figures 177-178 An exemplary implementation of a connector for an exemplary implantable prosthesis device is shown;

[0238] Figures 179-181 An exemplary implementation of a connector for an exemplary implantable prosthesis device is shown;

[0239] Figures 182-183 An exemplary implementation of a connector for an exemplary implantable prosthesis device is shown;

[0240] Figures 184-185 An exemplary implementation of a connector for an exemplary implantable prosthesis device is shown;

[0241] Figure 186 An exemplary embodiment of an actuating element or actuating device for an exemplary prosthetic device is shown;

[0242] Figure 187 An actuation mechanism for an exemplary prosthetic device is shown;

[0243] Figure 188 An actuation mechanism for an exemplary prosthetic device is shown;

[0244] Figure 188A An actuation mechanism for an exemplary prosthetic device is shown;

[0245] Figure 189 An actuation mechanism for an exemplary prosthetic device is shown;

[0246] Figure 190 An actuation mechanism for an exemplary prosthetic device is shown;

[0247] Figure 191 It is a three-dimensional view of the blank used to prepare the paddle-shaped frame;

[0248] Figure 192 yes Figure 191 The blank is bent to prepare a three-dimensional view of the paddle-shaped frame;

[0249] Figure 193 It is a three-dimensional view of the shaped paddle-like frame of the cap attached to the valve repair device;

[0250] Figure 194 yes Figure 193 A three-dimensional view of a paddle-shaped frame flexed and attached to an inner and outer paddle in a closed position;

[0251] Figure 195 yes Figure 112A A three-dimensional view of two paddle-shaped frames, showing the paddle-shaped frames in a fixed position;

[0252] Figure 196 yes Figure 195 A perspective view of the paddle frame, showing the paddle frame in the loading position;

[0253] Figure 197 yes Figure 60C An enlarged side view of the device, showing the covering;

[0254] Figure 198 yes Figure 60C An enlarged side view of the device, showing the covering;

[0255] Figure 199 An exploded view of an exemplary prosthetic device is shown;

[0256] Figure 200 An enlarged perspective view of the collar of an exemplary prosthetic device is shown;

[0257] Figure 201 An enlarged perspective view of the cap of an exemplary prosthetic device is shown;

[0258] Figure 202 Showing Figure 206 An exploded view of the hat;

[0259] Figure 203 A plan view of the inner covering of an exemplary prosthetic device is shown;

[0260] Figure 204 A plan view of the outer covering of an exemplary prosthetic device is shown;

[0261] Figure 205 An enlarged view of the material strips of an exemplary prosthetic device is shown;

[0262] Figure 206 Showing Figure 205 End view of the material;

[0263] Figure 207 Showing an arrangement in multiple layers Figure 205 End view of the material;

[0264] Figure 208A An exemplary implantable prosthesis device in the gap of a natural valve is shown as viewed from the atrial side of the natural valve during diastole, wherein the exemplary expandable spacer is in a collapsed state.

[0265] Figure 208B It shows the process of ventricular systole Figure 208A The device wherein an exemplary expandable spacer is in a collapsed state;

[0266] Figure 209A It shows the diastolic process Figure 208A The apparatus wherein an exemplary expandable spacer is in an expanded state;

[0267] Figure 209B It shows the process of ventricular systole Figure 208A The apparatus wherein an exemplary expandable spacer is in an expanded state;

[0268] Figure 210A An exemplary expandable spacer in a compressed state is shown;

[0269] Figure 210B It shows that it is in an expanded state. Figure 210A Expandable spacers;

[0270] Figure 211A An exemplary implantable prosthesis device is shown, wherein an exemplary expandable spacer is in a collapsed state;

[0271] Figure 211B Showing Figure 211B The apparatus wherein an exemplary expandable spacer is in an expanded state;

[0272] Figure 212A This is a side view of an exemplary implantable prosthesis device;

[0273] Figure 212B yes Figure 212A Front / rear view of the device;

[0274] Figure 213A It is used to attach to Figure 212A A top view of an exemplary auxiliary spacer of the device;

[0275] Figure 213B yes Figure 213A Side view of the spacer;

[0276] Figure 214 It is assembled to Figure 212A , 212B device Figure 213A , 213B Side view of the spacer;

[0277] Figure 215A It is assembled to Figure 212A , 212B device Figure 213A , 213B Side view of the spacer;

[0278] Figure 215B yes Figure 215A Top view of the assembly;

[0279] Figure 216A This is a side view of an exemplary implantable prosthesis device;

[0280] Figure 216B yes Figure 216A Front / rear view of the device;

[0281] Figure 217A It is used to attach to Figure 216A A top view of an exemplary auxiliary spacer of the device;

[0282] Figure 217B yes Figure 217A Side view of the spacer;

[0283] Figure 218 These are exemplary auxiliary spacers;

[0284] Figure 219A This is a top view of an exemplary implantable prosthesis device;

[0285] Figure 219B This is a side view of an exemplary implantable prosthesis device;

[0286] Figure 220A This is a top view of an exemplary auxiliary spacer;

[0287] Figure 220B This is a top view of an exemplary auxiliary spacer;

[0288] Figure 220C This is a top view of an exemplary auxiliary spacer;

[0289] Figure 220D This is a top view of an exemplary auxiliary spacer;

[0290] Figure 220E This is a top view of an exemplary auxiliary spacer;

[0291] Figure 221 This is a plan view of an exemplary implantable prosthesis device cut from a flat sheet of material;

[0292] Figure 222 yes Figure 221 A three-dimensional view of the device;

[0293] Figure 223 This shows the space between the natural valves as viewed from the atrial side. Figures 221-222 The device;

[0294] Figure 224 This is a plan view of an exemplary implantable prosthesis device cut from a flat sheet of material;

[0295] Figure 225 yes Figure 224 A three-dimensional view of the device;

[0296] Figure 226 An exemplary embodiment of an implantable prosthesis device with a two-piece overlay is shown;

[0297] Figure 227 An exemplary embodiment of an implantable prosthesis device with a two-piece overlay is shown;

[0298] Figure 228 An exemplary embodiment of an implantable prosthesis device with a two-piece overlay is shown;

[0299] Figure 229 An exemplary embodiment of an implantable prosthesis device with a two-piece overlay is shown;

[0300] Figure 230 An exemplary embodiment of an implantable prosthesis device with a two-piece overlay is shown;

[0301] Figure 231 An exemplary embodiment of an implantable prosthesis device with a two-piece overlay is shown;

[0302] Figure 232 A front view of an exemplary embodiment of an implantable prosthesis device is shown, wherein an exemplary spacer is in a retracted state;

[0303] Figure 233 Showing Figure 232 A side view of an exemplary implantable prosthesis device;

[0304] Figure 234 It shows the process of ventricular diastole Figure 232 The device;

[0305] Figure 235 Showing the systolic phase Figure 232 The device;

[0306] Figure 236 A front view of an exemplary embodiment of an implantable prosthesis device is shown, wherein the exemplary spacer is in a symmetrically expanded state;

[0307] Figure 237 Showing Figure 236A side view of an exemplary implantable prosthesis device;

[0308] Figure 238 It shows the process of ventricular diastole Figure 236 The device;

[0309] Figure 239 It shows the process of ventricular systole Figure 236 The device;

[0310] Figure 240 A front view of an exemplary embodiment of an implantable prosthesis device is shown, wherein an exemplary spacer is in an asymmetrically expanded state;

[0311] Figure 241 Showing Figure 240 A side view of an exemplary implantable prosthesis device;

[0312] Figure 242 It shows the process of ventricular diastole Figure 240 The device;

[0313] Figure 243 It shows the process of ventricular systole Figure 240 The device;

[0314] Figure 244 A top perspective view showing an exemplary embodiment of an implantable prosthesis device;

[0315] Figure 245 Showing Figure 244 A bottom perspective view of an exemplary implantable prosthesis device;

[0316] Figure 246 Showing Figure 244 A side view of an exemplary implantable prosthesis device;

[0317] Figure 247 Showing Figure 244 A front view of an exemplary implantable prosthesis device;

[0318] Figure 248 Showing Figure 244 A top view of an exemplary implantable prosthesis device;

[0319] Figure 249 Showing Figure 244 A bottom view of an exemplary implantable prosthesis device;

[0320] Figure 250 A top view of a spacer of an exemplary implantable prosthesis device in a closed state is shown;

[0321] Figure 251 Showing Figure 250 A top-view view of the spacer;

[0322] Figure 252 Showing Figure 250 Front view of the spacer;

[0323] Figure 253 Showing Figure 250 Side view of the spacer;

[0324] Figure 254 Showing Figure 250 Top view of the spacer;

[0325] Figure 255 Showing Figure 250 A bottom view of the spacer;

[0326] Figure 256 A side view of an exemplary embodiment of the mating portion of an implantable prosthesis device is shown, wherein the exemplary spacer is in a retracted state.

[0327] Figure 257 Showing Figure 256 A side view of an exemplary implantable prosthesis device, wherein the exemplary spacer is in an expanded state;

[0328] Figure 258 A side view of an exemplary embodiment of the mating portion of an implantable prosthesis device is shown, wherein the exemplary spacer is in a retracted state.

[0329] Figure 259 Showing Figure 258 A side view of an exemplary implantable prosthesis device, wherein the exemplary spacer is in an expanded state;

[0330] Figure 260 A side view of an exemplary embodiment of the mating portion of an implantable prosthesis device is shown, wherein the exemplary spacer is in a retracted state.

[0331] Figure 261 Showing Figure 260 A side view of an exemplary implantable prosthesis device, wherein the exemplary spacer is in an expanded state;

[0332] Figure 262 A side view of an exemplary embodiment of the mating portion of an implantable prosthesis device is shown, wherein the exemplary spacer is in a retracted state.

[0333] Figure 263 Showing Figure 262 A side view of an exemplary implantable prosthesis device, wherein the exemplary spacer is in an expanded state;

[0334] Figure 264 A side view of an exemplary embodiment of the mating portion of an implantable prosthesis device is shown, wherein the exemplary spacer is in a retracted state.

[0335] Figure 265 Showing Figure 264 A side view of an exemplary implantable prosthesis device, wherein the exemplary spacer is in an expanded state;

[0336] Figure 266 A side view of an exemplary embodiment of the mating portion of an implantable prosthesis device is shown, wherein the exemplary spacer is in a retracted state.

[0337] Figure 267 Showing Figure 266 A side view of an exemplary implantable prosthesis device, wherein the exemplary spacer is in an expanded state;

[0338] Figure 268 A side view of an exemplary embodiment of the mating portion of an implantable prosthesis device is shown, wherein the exemplary spacer is in a retracted state.

[0339] Figure 269 Showing Figure 268 A side view of an exemplary implantable prosthesis device, wherein the exemplary spacer is in an expanded state;

[0340] Figure 270 A side view of an exemplary embodiment of the mating portion of an implantable prosthesis device is shown, wherein the exemplary spacer is in a retracted state.

[0341] Figure 271 Showing Figure 270 A side view of an exemplary implantable prosthesis device, wherein the exemplary spacer is in an expanded state;

[0342] Figure 272 A side view of an exemplary embodiment of the mating portion of an implantable prosthesis device is shown, wherein the exemplary spacer is in a retracted state.

[0343] Figure 273 Showing Figure 272 A side view of an exemplary implantable prosthesis device, wherein the exemplary spacer is in an expanded state;

[0344] Figure 274 This is a top-down schematic diagram of the path of the mitral valve leaflet around the occlusal element of the mitral valve repair device;

[0345] Figure 275 A top perspective view shows an exemplary embodiment of the mating portion of an implantable prosthesis device, wherein an exemplary expandable spacer is in a retracted state;

[0346] Figure 276 Showing Figure 275 An example bottom perspective view of the mating portion;

[0347] Figure 277 Showing Figure 275 A front view of an exemplary mating portion;

[0348] Figure 278 Showing Figure 275 A top view of an exemplary mating portion;

[0349] Figure 279 Showing Figure 275 A bottom view of an exemplary mating portion;

[0350] Figure 280 Showing Figure 275 Top-down exploded view of the merging parts;

[0351] Figure 281 It shows the retracted state. Figure 275 A top perspective view of an exemplary expandable spacer of an exemplary mating portion;

[0352] Figure 282 Showing Figure 281 An upward perspective view of the expandable spacer;

[0353] Figure 283 Showing Figure 281 Front view of the expandable spacer;

[0354] Figure 284 Showing Figure 281 Top view of the expandable spacer;

[0355] Figure 285 Showing Figure 275 A top perspective view of the exemplary central axis of the exemplary mating portion;

[0356] Figure 286 Showing Figure 285 An upward-viewed solid diagram of the central axis;

[0357] Figure 287 Showing Figure 285 Front view of the central axis;

[0358] Figure 288 Showing Figure 285 Top view of the central axis;

[0359] Figure 289 Showing Figure 285 A bottom view of the central axis;

[0360] Figure 290 Showing Figure 275 A top perspective view of the proximal cap of an exemplary mating portion;

[0361] Figure 291 Showing Figure 290 A top view of the cap from the near side;

[0362] Figure 292 Showing Figure 275 A top perspective view of the actuator tube of an exemplary mating portion;

[0363] Figure 293 Showing Figure 292 An overhead view of the actuator tube;

[0364] Figure 294 Showing Figure 292 Front view of the actuator tube;

[0365] Figure 295 Showing Figure 292 A top view of the actuator tube;

[0366] Figure 296 Showing Figure 275 A top perspective view of the actuator plate of an exemplary mating portion;

[0367] Figure 297 Showing Figure 296 A top view of the actuator plate;

[0368] Figure 298 Showing Figure 275 A top-view view of the mating parts, in which the expandable spacer is in an expanded state;

[0369] Figure 299 Showing Figure 298 An example bottom perspective view of the mating portion;

[0370] Figure 300 Showing Figure 298 A front view of an exemplary mating portion;

[0371] Figure 301 Showing Figure 298 A top view of an exemplary mating portion;

[0372] Figure 302 Showing Figure 298 A bottom view of an exemplary mating portion;

[0373] Figure 303 It shows that it is in an expanded state. Figure 298 A top perspective view of an exemplary expandable spacer;

[0374] Figure 304 Showing Figure 303 An upward perspective view of the expandable spacer;

[0375] Figure 305 Showing Figure 303 Front view of the expandable spacer;

[0376] Figure 306 Showing Figure 303 Top view of the expandable spacer.

[0377] Figure 307 A front view of an exemplary embodiment of an implantable prosthesis device is shown, wherein an exemplary asymmetric spacer is in an expanded state;

[0378] Figure 308 Showing Figure 307 A side view of an exemplary implantable prosthesis device;

[0379] Figure 309 It shows the process of ventricular diastole Figure 307 The device;

[0380] Figure 310 It shows the process of ventricular systole Figure 307 The device;

[0381] Figure 311 A front view of an exemplary embodiment of an implantable prosthesis device is shown, wherein an exemplary asymmetric spacer is in an expanded state;

[0382] Figure 312 Showing Figure 311 A side view of an exemplary implantable prosthesis device;

[0383] Figure 313 It shows the process of ventricular diastole Figure 311 The device;

[0384] Figure 314 It shows the process of ventricular systole Figure 311 The device;

[0385] Figure 315 A front view of an exemplary embodiment of an implantable prosthesis device is shown, wherein an exemplary spacer is in an expanded state;

[0386] Figure 316 Showing Figure 315 A side view of an exemplary implantable prosthesis device;

[0387] Figure 317 It shows the process of ventricular diastole Figure 315 The device; and

[0388] Figure 318 It shows the process of ventricular systole Figure 315 The device. Detailed Implementation

[0389] The following description refers to the accompanying drawings, which illustrate specific embodiments of the present disclosure. Other embodiments with different structures and operations do not depart from the scope of this disclosure.

[0390] Exemplary embodiments of this disclosure relate to apparatuses and methods for repairing defective heart valves. It should be noted that various embodiments of natural valve repair devices and delivery systems are disclosed herein, and any combination of these options may be performed unless specifically excluded. In other words, the individual components of the apparatuses and systems of this disclosure may be combined unless mutually exclusive or otherwise physically impossible.

[0391] As described herein, when one or more components are described as being connected, joined, fixed, linked, attached, or otherwise interconnected, such interconnection may be direct between the components or may be indirect, such as by using one or more intermediate components. Furthermore, as described herein, references to “component,” “part,” or “section” should not be limited to a single structural component, part, or element, but may include combinations of components, components, or elements. Moreover, as described herein, the terms “substantially” and “about” are defined as at least close to (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0392] Figure 1 and 2 These are cross-sectional views of the 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), respectively; these are the atrioventricular valves. Additionally, the aortic valve (AV) separates the left ventricle (LV) from the ascending aorta (AA), and the pulmonary valve (PV) separates the right ventricle from the pulmonary artery (PA). Each of these valves has a flexible leaflet extending inward across the corresponding orifice (e.g., Figure 4 and 5 As shown in leaflets 20 and 22, the flexible leaflets meet or “oppose” in the flowstream to form a one-way fluid-blocking surface. The description of the natural valve repair system in this application is primarily concerned with the mitral valve (MV). Therefore, the anatomy of the left atrium (LA) and left ventricle (LV) will be described in more detail. It should be understood that the device described herein can also be used to repair other natural valves, for example, the tricuspid valve (TV), aortic valve (AV), and pulmonary valve (PV).

[0393] The left atrium (LA) receives oxygenated blood from the lungs. During diastole, or during relaxation... Figure 1 As shown, through the dilation of the left ventricle (LV), blood previously collected in the left atrium (LA) (during systole) moves through the mitral valve (MV) and into the left ventricle (LV). During systole, or the period of contraction... Figure 2As shown, the left ventricle (LV) contracts to force blood through the aortic valve (AV) and ascending aorta (AA) into the body. During contraction, the leaflets of the mitral valve (MV) close to prevent blood from flowing back from the left ventricle (LV) and 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 facilitate the closure of the mitral valve leaflets to prevent blood from flowing back from the left ventricle (LV) and into the left atrium (LA). Unlike prior art describing the use of sutures or clamps, which typically require multiple sutures or clamps and additional supports to treat large regurgitations, the device described herein is designed to easily grasp the natural leaflets and secure them around the occlusal element, which acts as a filler in the regurgitation orifice. In this application, the terms occlusal element, spacer, spacer element, and engagement element refer to components that fill a portion of the space between natural heart valves (such as the mitral or tricuspid valve).

[0394] Now for reference Figure 1-7 The mitral valve MV comprises two leaflets, the anterior leaflet 20 and the posterior leaflet 22. The mitral valve MV also includes a valve annulus 24, which is a variablely dense fibrous ring surrounding the leaflets 20 and 22. (Reference) Figure 3 The mitral valve MV is anchored to the wall of the left ventricle (LV) via chordae tendineae 10. Chordalae 10 are band-like tendons that connect papillary muscles 12 (i.e., muscles located at the base of the chordae tendineae and within the left ventricular wall) to the leaflets 20 and 22 of the mitral valve MV. Papillary muscles 12 restrict the movement of the mitral valve MV and prevent mitral valve reversion. The mitral valve MV opens and closes in response to pressure changes in the left atrium (LA) and left ventricle (LV). The papillary muscles do not open or close the mitral valve MV. Instead, they support the mitral valve MV against the high pressure required for systemic circulation. Together with the chordae tendineae, the papillary muscles form the subvalvular mechanism, which functions to prevent the mitral valve MV from detaching into the left atrium (LA) when the mitral valve is closed.

[0395] Various disease processes can impair the normal function of one or more of the heart's natural valves (Vol. 1). These processes include degenerative processes (e.g., Barlow's disease, fibroelastosis), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). Additionally, damage to the left ventricle (LV) or right ventricle (RV) resulting from pre-cardiac attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart conditions (e.g., cardiomyopathy) can distort the geometry of the natural valve, leading to its dysfunction. However, the vast majority of patients undergoing valve surgery, such as mitral valve MV surgery, have degenerative diseases that cause dysfunction of the leaflets (e.g., leaflets 20, 22) of the natural valve (e.g., mitral valve MV), resulting in prolapse and regurgitation.

[0396] In general, natural valves can become dysfunctional in two different ways: (1) valvular stenosis; and (2) valvular regurgitation. Valvular stenosis occurs when a natural valve does not open fully, thus causing obstruction of blood flow. Generally, valvular stenosis is caused by the accumulation of calcified material on the valve leaflets, which leads to thickening of the leaflets and weakens the valve's ability to open fully to allow positive blood flow.

[0397] The second type of valvular dysfunction—valvular regurgitation—occurs when the valve leaflets do not close completely, causing blood to leak back into the previous chamber (e.g., causing blood to leak from the left ventricle into the left atrium). There are three main mechanisms by which a natural valve becomes regurgitant or incompetent, including Carpentier type I, II, and III dysfunction. Carpentier type I dysfunction involves annular dilation, causing the normally functioning leaflets to separate from each other and fail to form a tight seal (i.e., the leaflets do not properly occlude). Type I dysfunction includes leaflet perforations, as present in endocarditis. Carpentier type II dysfunction involves one or more leaflets of the natural valve prolapsing above the occlusal plane. Carpentier type III dysfunction involves restricted movement of one or more leaflets of the natural valve, causing the leaflets to be abnormally constricted below the annular plane. Leaflet restriction can be caused by rheumatic diseases (Ma) or ventricular dilatation (IIIb).

[0398] refer to Figure 4 When a healthy mitral valve (MV) is in the closed position, the anterior leaflet 20 and the posterior leaflet 22 mate, preventing blood from leaking from the left ventricle (LV) into the left atrium (LA). (Reference) Figure 5 Regurgitation occurs when the anterior leaflet 20 and / or posterior leaflet 22 of the mitral valve MV shifts into the left atrium LA during systole. This failure to align results in a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow from the left ventricle LV back to the left atrium LA during systole. As mentioned above, leaflets (e.g., leaflets 20, 22 of the bicuspid valve MV) can malfunction, leading to regurgitation in several different ways.

[0399] refer to Figure 6 In some cases, 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 the closed position (i.e., during systole). For example, the gap 26 may have a width W between approximately 2.5 mm and approximately 17.5 mm, such as between approximately 5 mm and approximately 15 mm, such as between approximately 7.5 mm and approximately 12.5 mm, such as approximately 10 mm. In some cases, the gap 26 may have a width W greater than 15 mm. In any of the above cases, a valve repair device is needed that can engage with the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent backflow of blood through the mitral valve MV.

[0400] Although stenosis or regurgitation can affect any valve, stenosis is primarily found affecting the aortic valve (AV) or pulmonary valve (PV), and regurgitation is primarily found affecting the mitral valve (MV) or tricuspid valve (TV). Both valvular 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., left atrium (LA), left ventricle (LV), mitral valve (MV), and aortic valve (AV)) is primarily responsible for systemic blood flow, mitral valve (MV) or aortic valve (AV) dysfunction is particularly problematic and often life-threatening. Therefore, due to the significantly higher pressure on the left side of the heart, mitral valve (MV) or aortic valve (AV) dysfunction is often more problematic.

[0401] Dysfunctional natural heart valves can be repaired or replaced. Repair generally involves preserving and correcting the patient's natural valve. Replacement generally involves replacing the patient's natural valve with a biological or mechanical substitute. Generally, the aortic valve (AV) and pulmonary valve (PV) are more prone to stenosis. Because the stenosis damage to the leaflets is irreversible, the most routine treatment for aortic or pulmonary valve stenosis 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 described above, can prevent the mitral or tricuspid valve from closing properly and allow blood to regurgitate or flow back from the ventricle into the atrium (e.g., a deformed mitral valve (MV) can allow regurgitation or backflow from the left ventricle (LV) to the left atrium (LA). This regurgitation or backflow of blood from the ventricle to the atrium leads to valvular insufficiency. Structural or shape deformations of the mitral valve (MV) or tricuspid valve (TV) are usually repairable. Additionally, regurgitation can occur due to chordae tendineae 10 dysfunction (e.g., stretching or rupture of the chordae tendineae), which allows the anterior leaflet 20 and posterior leaflet 22 to revert, allowing blood to flow back into the left atrium (LA). Problems arising from chordae tendineae 10 dysfunction can be repaired by repairing the chordae tendineae or mitral valve structures (e.g., by fixing the leaflets 20, 22 to the affected portion of the mitral valve).

[0402] The devices and procedures disclosed herein generally relate to the repair of the mitral valve (for example). However, it should be understood that the devices and ideas provided herein can be used to repair any natural valve, and any component of a natural valve. For example, now refer to Figure 7 Any device or concept presented herein can be used to repair tricuspid valve reflux (TV). For example, any device or idea presented herein can be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent blood regurgitation from the right ventricle into the right atrium. Alternatively, any device or idea presented herein can be used on all three leaflets 30, 32, and 34 to prevent blood regurgitation from the right ventricle into the right atrium. In other words, the valve repair device presented herein can be centrally positioned between the three leaflets 30, 32, and 34.

[0403] An exemplary implantable prosthetic device has an occlusal element and at least one anchoring element. The occlusal element is configured to be positioned within the natural heart valve orifice to help fill the space and form a more effective seal, thereby reducing or preventing the aforementioned regurgitation. The occlusal element may have a structure that prevents blood from passing through or resisting blood and allows the natural leaflets to close around the occlusal element during ventricular systole to prevent blood from flowing out of the left or right ventricle and back into the left or right atrium, respectively. The prosthetic device may be configured to seal against two or three natural valve leaflets; that is, the device may be used for natural mitral and tricuspid valves. The occlusal element is sometimes referred to herein as a spacer because it can fill the space between the leaflets of an incompletely closed, malfunctioning natural mitral or tricuspid valve.

[0404] The clasping element (e.g., spacer, coupling element, etc.) can have various shapes. In some embodiments, the clasping element can have an elongated cylindrical shape with a rounded cross-sectional shape. In other embodiments, the clasping element can have an oval cross-sectional shape, a crescent-shaped cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. The clasping element may have an atrial portion located in or adjacent to the left atrium, a ventricular portion or lower portion located in or adjacent to the left ventricle, and a lateral surface extending between the natural mitral valve leaflets. In embodiments configured for the tricuspid valve, the atrial portion or upper portion is located in or adjacent to the right atrium, and the ventricular portion or lower portion is located in or adjacent to the right ventricle, and the lateral surface extends between the natural tricuspid valve leaflets.

[0405] An anchor can be configured to secure the device to one or two natural mitral valve leaflets, such that the occlusal element is positioned between the two natural leaflets. In embodiments configured for three mitral valves, the anchor is configured to secure the device to one, two, or three tricuspid valve leaflets, such that the occlusal element is positioned between the three natural leaflets. In some embodiments, the anchor can be attached to the occlusal element at a location adjacent to the ventricular portion of the occlusal element. In some embodiments, the anchor can be attached to an actuating element, such as a shaft or actuating wire, to which the occlusal element is also attached. In some embodiments, the anchor and the occlusal element can be positioned independently of each other by moving each along the longitudinal axis of the shaft or actuating wire, respectively. In some embodiments, the anchor and the occlusal element can be positioned simultaneously by moving the anchor and the occlusal element together along the longitudinal axis of the shaft or actuating wire. The anchor can be configured to be positioned posterior to the natural leaflets upon implantation, such that the leaflets are gripped by the anchor.

[0406] The prosthetic device can be configured for implantation via a delivery sheath. The occlusal element and anchor can be compressible to a radially compressed state and self-expanding to a radially expanded state when the compressive pressure is released. The device can be configured such that the anchor initially expands radially away from the compressible occlusal element, thereby creating a gap between the occlusal element and the anchor. A natural leaflet can then be positioned within this gap. The occlusal element can be radially expanded, closing the gap between the occlusal element and the anchor and capturing the leaflet between the occlusal element and the anchor. In some embodiments, the anchor and occlusal element are optionally configured to self-expand. Implantation methods of various embodiments can be different and are discussed more fully below with respect to each embodiment. Further information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599 and U.S. Patent Application Publications Nos. 2014 / 0222136, 2014 / 0067052, and 2016 / 0331523, all of which are incorporated herein by reference in their entirety. These methods can be performed on living animals or simulations, such as on corpses, corpse hearts, simulations (e.g., simulated body parts, tissues, etc.).

[0407] The prosthetic device disclosed herein can be configured such that the anchor is connected to the leaflet, utilizing tension from the natural chordae tendineae to resist the high systolic pressure that pushes the device toward the left atrium. During diastole, the device can rely on the compressive and retaining forces applied to the leaflet held by the anchor.

[0408] Now for reference Figure 8-14 The image shows an illustrative example of an implantable prosthetic device 100 at different stages of deployment. Device 100 may include any other features used for implantable prosthetic devices discussed in this application, and device 100 may be positioned to engage valve tissues 20, 22—as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0409] Device 100 is deployed from a delivery sheath or delivery device 102 and includes an engagement portion or joining portion 104 and an anchoring portion 106. The joining portion 104 of device 100 includes an engagement element or engagement device 110 adapted for implantation between the leaflets of a natural valve (e.g., a natural mitral valve, tricuspid valve, etc.) and slidably attached to an actuating element 112 (e.g., an actuating filament, actuating shaft, actuating tube, etc.). The anchoring portion 106 is actuable between open and closed states and can take many different forms, such as clamping elements like paddles, fasteners, and / or similar forms. Actuation of the actuating element or actuating device 112 opens and closes the anchoring portion 106 of device 100 to grip the natural valve leaflets during implantation. The actuating element 112 (e.g., a filament, shaft, tube, screw, thread, etc.) can take many different forms. For example, the actuating element may be threaded, such that rotation of the actuating element (e.g., a wire, shaft, tube, screw, etc.) causes the anchor portion 106 to move relative to the mating portion 104. Alternatively, the actuating element may be unthreaded, such that pushing or pulling the actuating element 112 causes the anchor portion 106 to move relative to the mating portion 104.

[0410] The anchoring portion 106 of device 100 includes an outer paddle 120 and an inner paddle 122 connected between cap 114 and mating element or mating device 110 via portions 124, 126, and 128. Portions 124, 126, and 128 may be joined and / or flexible to move between all the positions described below. The interconnection of the outer paddle 120, inner paddle 122, mating element or mating device 110, and cap 114 via portions 124, 126, and 128 can secure the device to the position and move it as illustrated herein.

[0411] In some embodiments, the actuating element or actuating device 112 (e.g., actuating wire, actuating shaft, etc.) extends through the delivery sheath and the mating element or mating device 110 to a cap 114 at the distal connection of the anchoring portion 106. Extending and retracting the actuating element or actuating device 112 increases and decreases the spacing between the mating element or mating device 110 and the cap 114, respectively. A collar or other attachment element removably attaches the mating element or mating device 110 to the delivery sheath or delivery device 102, such that the actuating element or actuating device 112 slides through the collar or other attachment element and through the mating element or mating device 110 during actuation to open and close the paddles 120, 122 of the anchoring portion 106.

[0412] Now for reference Figure 11The anchoring portion 106 includes an attachment portion or clamping member. An example clamping member includes a fastener 130, which includes a base or fixed arm 132, a movable arm 134, barbs or other securing devices 136, and a joint portion 138. The fixed arm 132 is attached to the inner paddle 122, wherein the joint portion 138 is arranged proximate to the mating element or mating device 110. The barbed fastener has a flat surface and does not conform to the recess of the paddle. Instead, the flat portion of the barbed fastener is arranged abutting against the surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the barbed fastener 130. The joint portion 138 can be any suitable connection, such as a flexible connection, a spring connection, a pivoting connection, or a similar connection. In some embodiments, the connecting portion 138 is a flexible material element 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 to open the fastener 130 and expose the barbs or securing device 136. In some embodiments, the barbed fastener 130 is opened by applying tension to the actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to hinge, flex, or pivot on the connecting portion 138. Other actuation mechanisms are also possible.

[0413] During implantation, paddles 120, 122 are opened and closed to, for example, grasp the natural leaflet or natural mitral leaflet between the paddles 120, 122 and the occlusal element or occlusal device 110. A barbed fastener 130 can be used to grasp and / or further secure the natural leaflet by engaging the leaflet with barbs or fixation devices 136 and clamping the leaflet between the movable arm 134 and the fixed arm 132. The barbs or fixation devices 136 of the barbed fastener 130 increase friction with the leaflet or can partially or completely puncture the leaflet. Actuation lines 116 can be individually actuated so that each barbed fastener 130 can be opened and closed individually. Individual operation allows grasping one leaflet at a time, or repositioning the fastener 130 on insufficiently grasped leaflets, without altering successful grasping of other leaflets. The barbed fastener 130 can be opened and closed relative to the inner paddle 122 (as long as the inner paddle is in the open position), thus allowing the leaflet to be gripped in multiple positions as needed.

[0414] The barbed fastener 130 can be opened individually by pulling the actuating line 116 attached to the barbed fastener 130, which extends through the delivery sheath or delivery device 102. The actuating line 116 can take many different forms, such as, for example, thread, suture, silk thread, rod, conduit, or the like. The barbed fastener 130 may be spring-loaded so that, in the closed position, the barbed fastener 130 continues to provide clamping force to the grasped natural leaflet. This clamping force remains constant regardless of the position of the inner paddle 122. The barbs or fixing device 136 of the barbed fastener 130 can pierce the natural leaflet to further secure it.

[0415] Now for reference Figure 8 The device 100 is shown in either an extended or fully open state during self-delivery sheath deployment. The device 100 is loaded in the fully open position within the delivery sheath because this position occupies the least space and allows for the use of the smallest conduit (or the largest device 100 for a given conduit size). In the extended state, the cap 114 is spaced apart from the mating element or mating device 110, such that the paddles 120, 122 of the anchoring portion 106 are fully extended. In some embodiments, the angle formed between the interior of the outer paddle 120 and the inner paddle 122 is approximately 180 degrees. The barbed fastener 130 remains closed during deployment through the delivery sheath or delivery device 102, such that the barbs or securing device 136 ( Figure 11 It will not jam or damage the sheath or the tissue in the patient's heart.

[0416] Now for reference Figure 9 Displays something similar to Figure 8 The device 100 is in an elongated, detangling state, but the barbed fastener 130 is in the fully open position, with the fixed and movable portions of the barbed fastener 130 within the following ranges: approximately 140 degrees to approximately 200 degrees, approximately 170 degrees to approximately 190 degrees, or approximately 180 degrees. It has been found that fully opening the paddles 120, 122 and the fastener 130 increases the ease of detangling or separating the device from the patient's anatomy during implantation of the device 100.

[0417] Now for reference Figure 10The device 100 is shown in either 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 move the device 100 from the extended state to the shortened state, the actuating element or actuating device 112 retracts to pull the cap 114 toward the engaging element or engaging device 110. Movement of the connection or flexible link 126 between the outer paddle 120 and the inner paddle 122 is restricted, such that the compressive force exerted by the cap 114 retracting toward the engaging element or engaging device 110 on the outer paddle 120 causes the paddles or clamping elements 120, 122 to move radially outward. During the movement from the open to the closed position, the outer paddle 120 remains at an acute angle to the actuating element or actuating device 112. The outer paddle 120 may optionally be biased toward the closed position. During the same movement, the inner paddle 122 travels a considerable angle because it is oriented away from the mating element or mating device 110 in the open state and collapses along the side of the mating element or mating device 110 in the closed state. In some embodiments, the inner paddle 122 is thinner and / or narrower than the outer paddle 120, and the connecting or flexible portions 126, 128 connected to the inner paddle 122 can be thinner and / or more flexible. For example, this increased flexibility can allow more movement than the connecting or flexible portion 124 connecting the outer paddle 120 to the cap 114. In some other embodiments, the outer paddle 120 is narrower than the inner paddle 122. The connecting or flexible portions 126, 128 connected to the inner paddle 122 can be more flexible, for example, to allow more movement than the connecting or flexible portion 124 connecting the outer paddle 120 to the cap 114. In one embodiment, the inner paddle 122 may have the same or substantially the same width as the outer paddle (see example...). Figure 65A ).

[0418] Now for reference Figure 11-13 The device 100 is displayed in a partially open, gripping-ready state. To transition from a fully closed to a partially open state, the actuating element or actuating device 112 extends to push the cap 114 away from the engaging element or engaging device 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor portion 106 to partially unfold. The actuating line 116 is also retracted to open the fastener 130, allowing the leaflet to be gripped. Figure 11 In the example shown, the paired inner paddle 122 and outer paddle 120 are moved together by a single actuating element or actuating device 112, rather than moving independently. Furthermore, the position of the fastener 130 depends on the position of the paddles 122 and 120. For example, refer to... Figure 10 The closed paddle-shaped objects 122 and 120 also close the fasteners.

[0419] Figure 11AAn exemplary implementation is shown in which the paddles 120, 122 can be independently controlled. Figure 11A The example device 100A is similar to Figure 11 The example device, except that device 100A includes two independent actuating elements 112A and 112B configured to be coupled to two separate caps 114A and 114B. To change the first inner paddle and the first outer paddle from a fully closed state to a partially open state, the actuating element or actuating device 112A extends away from the engaging element or engaging device 110 to push the cap 114A, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the first anchor portion 106 to partially deploy. To change the second inner paddle and the second outer paddle from a fully closed state to a partially open state, the actuating element or actuating device 112B extends away from the engaging element or engaging device 110 to push the cap 114, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchor portion 106 to partially deploy. This can be implemented with any device disclosed in this application. Figure 11A Example of independent paddle control.

[0420] Now for reference Figure 12 This causes one of the actuation lines 116 to extend, allowing one of the fasteners 130 to close. Now refer to... Figure 13 This causes another actuation line 116 to extend, allowing another fastener 130 to close. Either or both actuation lines 116 can be repeatedly actuated to repeatedly open and close the barbed fastener 130.

[0421] Now for reference Figure 14 The image shows the device 100 in its fully closed and deployed states. The delivery sleeve or delivery device 102 and the actuating element or actuating device 112 are retracted, and the paddles 120, 122 and fastener 130 remain in the fully closed position. After deployment, the device 100 can be maintained in the fully closed position by a mechanical latch, or by being biased using a spring material such as steel, other metals, plastics, composite materials, or shape memory alloys such as nitinol. For example, connecting or flexible portions 124, 126, 128, 138, and / or inner and outer paddles 122, and / or other biasing components (see [link to documentation]). Figure 28Component 524 may be formed of a metal such as steel or a shape memory alloy such as nitinol—prepared as wire, sheet, tubing, or laser-sintered powder—and is biased to retain the outer paddle 120 closed around the mating element or mating device 110 and to retain the barbed fastener 130 clamped around the natural leaflet. Similarly, the fixing arm 132 and the movable arm 134 of the barbed fastener 130 are biased to clamp the leaflet. In some embodiments, attachment or connection portions 124, 126, 128, 138, and / or the inner and outer paddles 122, and / or other biasing components (see...) Figure 28 The components or frame (524) may be formed of any other suitable elastic material such as metal or polymer to keep the device closed after implantation.

[0422] Now for reference Figure 226-231 The implantable device 100 is shown to be provided with a cover 140. The 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 inward tissue growth. The cover 140 includes a first cover portion 142 and a second cover portion 144, each covering different portions of the device 100. In some embodiments, a portion of one of the first cover portion 142 and the second cover portion 144 overlaps with a portion of the other of the first cover portion 142 and the second cover portion 144. The first cover portion 142 and the second cover portion 144 may be arranged in various ways, and in some embodiments, an overlapping portion 146 may be included that overlaps with one of the first cover portion 142 and the second cover portion 144.

[0423] Now for reference Figures 226-229 This shows various arrangements of the first covering portion 142 and the second covering portion 144 without the overlapping portion 146. Now refer to... Figure 226 A first cover portion 142 (indicated by fine crosshairs), which may be made of a single material, extends from the cap 114 to cover the cap 114, the outer paddle 120, the inner paddle 122, and the fixing arm 132 of the fastener 130. A second cover 144 (indicated by thick crosshairs) – which may be a single material – covers the mating element or mating device 110.

[0424] Now for reference Figure 227 A first cover portion 142, which may be made of a single material piece, extends from the cap 114 to cover the cap 114, the outer paddle 120, the inner paddle 122, the fixing arm 132 of the fastener 130, and the movable arm 134. Figure 226 Like the first cover 140, the second cover 144 covers the mating element or mating device 110.

[0425] Now for reference Figure 228 A first cover portion 142, which may be made of a single material, extends from the cap 114 to cover the cap 114, the outer paddle 120, the inner paddle 122, and the fixing arm 132 of the fastener 130. A second cover 144, which may be made of a single material, covers the mating element or mating device 110 and extends from the mating element or mating device 110 to cover the movable arm 134 of the fastener 130.

[0426] Now for reference Figure 229 A first cover portion 142, which may be made of a single material, extends from the cap 114 to cover the cap 114 and the outer paddle 120. A second cover 144, which may be made of a single material, covers the mating element or mating device 110 and extends from the mating element or mating device 110 to cover the inner paddle 122 and the fixed arm 132 and movable arm 134 of the fastener 130.

[0427] Now for reference Figures 230-231 This shows the arrangement of a first covering portion 142 and a second covering portion 144, including an overlapping portion 146. Now refer to... Figure 230 A first cover portion 142, which may be made of a single material, extends from the cap 114 to cover the cap 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 and movable arm 134 of the fastener 130. A second cover 144, which may be made of a single material, covers the mating element or mating device 110 and includes an overlapping portion 146 that extends from the mating element or mating device 110 to partially overlap with the movable arm 134 and is covered by the first cover 142.

[0428] Now for reference Figure 231 A first cover portion 142, which may be made of a single material, extends from the cap 114 to cover the cap 114, the outer paddle 120, the inner paddle 122, and the fixing arm 132 of the fastener 130. A second cover 144, which may be made of a single material, covers the engaging element or engaging device 110 and the movable arm 134 of the fastener 130. The first cover 142 also includes an overlapping portion 146, which extends from the fixing arm 132 and the inner paddle 122 to overlap with portions of the movable arm 134 and the engaging element or engaging device 110 covered by the second cover 144.

[0429] Now for reference Figure 15-20 ,show Figure 8-14 The implantable device 100 is delivered and implanted within the natural mitral valve MV of the heart H. The methods and steps shown and / or discussed can be performed on living animals or simulators, such as on cadavers, cadaver hearts, simulators (e.g., simulated body parts, hearts, tissues, etc.).

[0430] Now for reference Figure 15The delivery sheath is inserted into the left atrium (LA) through the septum, and the device 100 is deployed from the delivery sheath in a fully open state. The actuating element or actuating device 112 is then retracted to move the device 100 to... Figure 16 The fully closed state is shown. (Example) Figure 17 As can be seen, device 100 is moved to the position within the mitral valve MV, entering the ventricular LV, and is partially opened, allowing leaflets 20 and 22 to be grasped. Now refer to Figure 18 This causes the actuation line 116 to extend to close one of the fasteners 130, thereby capturing the leaflet 20. Figure 19 Another actuation line 116 is shown, which is then extended to close another fastener 130, thereby capturing the remaining leaflet 22. (See image) Figure 20 As can be seen, the delivery sheath or delivery device 102 and the actuating element or actuating device 112 and actuating line 116 are then retracted, the device 100 is fully closed and deployed in the natural mitral valve MV.

[0431] Now for reference Figure 21 This illustrates an exemplary implantable prosthesis device 200 or its frame. In some embodiments, the device 200 includes an optional spacer member 202, a fabric cover (not shown), and an anchor 204 extending from the spacer member 202. The ends of each anchor 204 can be coupled to corresponding supports of the spacer member 202 via corresponding sleeves 206, which can be crimped or welded around the connection portion of the anchor 204 and the support of the spacer member 202. In one exemplary embodiment, a latching mechanism can connect the spacer member 202 within the sleeve 206 to the anchor 204. For example, the sleeve can be machined to have an internal shape that matches or is slightly smaller than the external shape of the ends of the spacer member 202 and the anchor 204, such that the sleeve can frictionally adapt to the connection portion. One or more barbs or protrusions 208 may be mounted on the frame of the spacer member 202. The free end of the barb or protrusion 208 may include various shapes, including rounded, pointed, barbed, or similar shapes. The protrusion 208 may exert a retaining force on the natural leaflet through the anchor 204, which is shaped to force the natural leaflet inward into the spacer member 202.

[0432] Now for reference Figure 22The image illustrates an exemplary implantable prosthesis device 300 or its frame. In some embodiments, the prosthesis spacer device 300 includes a spacer member 302, a fabric cover (not shown), and an anchor 304 extending from the spacer member 302, and may be configured similarly to the prosthesis spacer device 200. One or more barbs or protrusions 306 may be mounted on the frame of the spacer member 302. The ends of the protrusions 306 may include stops 308. The stops 308 of the protrusions may be configured in a variety of different ways. For example, the stops 308 may be configured to limit the extent to which the protrusions 306 can engage and / or penetrate natural lobules, and / or the stops may be configured to prevent the protrusions 306 from being removed from the tissue after they have penetrated it.

[0433] The anchors 304 of the prosthetic spacer assembly 300 can be configured similarly to the anchors 204 of the prosthetic spacer assembly 200, except that the curves of each anchor 304 include a larger radius than those of the anchors 204. Thus, the anchors 304 cover a relatively larger portion of the spacer member 302 than the anchors 204. This can, for example, distribute the clamping force of the anchors 304 on the natural leaflet over a relatively larger surface area of ​​the natural leaflet, thereby further protecting the natural leaflet tissue.

[0434] Further details regarding the prosthetic spacer device can be found, for example, in U.S. Patent Application Publication No. 2016 / 0331523 and U.S. Provisional Application No. 62 / 161,688, which are incorporated herein by reference. Devices 200, 300 may include any other features of the implantable prosthetic devices discussed in this application, and devices 200, 300 may be positioned to engage valve tissues 20, 22—as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0435] Now for reference Figure 23-27 This illustrates an exemplary embodiment of an implantable prosthetic spacer device 400 and its components. Device 400 may include any other features of the implantable prosthetic devices discussed in this application, and device 400 may be positioned to engage valve tissues 20, 22—as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0436] Now for reference Figure 23The prosthetic spacer or engagement device 400 may include an engagement portion 404 and an anchor portion 406, the anchor portion 406 including a plurality of anchors 408. The engagement portion 404 includes engagement or spacer members 410. The anchor portion 406 includes a plurality of paddles 420 (e.g., two in the example embodiment) and a plurality of fasteners 430 (e.g., two in the example embodiment). A first or proximal collar 411 and a second collar or cap 414 are used to move the engagement portion 404 and the anchor portion 406 relative to each other.

[0437] like Figure 25 As shown, the first connecting portion 425 of the anchor 408 can be connected to and extends from the first portion 417 of the mating or spacer member 410, and the second connecting portion 421 of the anchor 408 can be connected to the first collar 414. The proximal collar 411 can be connected to the second portion 419 of the mating member 410.

[0438] The mating member 410 and the anchor 408 can be joined together in various ways. For example, as shown in the example embodiment, the mating member 410 and the anchor 408 can be joined together by integrally forming the mating member 410 and the anchor 408 as a single integral component. This can be achieved, for example, by forming the mating member 410 and the anchor 408 from a braided or woven material such as braided or woven nitinol yarn. In other embodiments, the mating member 410 and the anchor 408 can be joined together by welding, fasteners, adhesives, connecting joints, stitching, friction fits, molding, and / or other joining means.

[0439] Now for reference Figure 24 Anchor 408 may include a first portion or outer paddle 420 and a second portion or inner paddle 422 separated by connecting portion 423. In this way, anchor 408 is configured similarly to a leg, with the inner paddle 422 resembling the upper part of the leg, the outer paddle 420 resembling the lower part of the leg, and the connecting portion 423 resembling the knee of the leg. In some embodiments, the inner paddle portion 422, the outer paddle portion 420, and the connecting portion 423 are formed of a continuous strip of fabric, such as a metallic fabric. In some embodiments, the fabric strip may be a composite material fabric strip.

[0440] Anchor 408 can be configured to move between various configurations—by axially moving cap 414 relative to proximal collar 411, and thus moving anchor 408 relative to mating member 410 along a longitudinal axis extending between the first or distal portion 417 and the second or proximal portion 419 of mating member 410. For example, anchor 408 can be positioned in an upright configuration by moving cap 414 away from mating member 410. In an upright configuration, the paddle portion is aligned or upright along the longitudinal axis of the device, and the connecting portion 423 of anchor 408 is adjacent to the longitudinal axis of mating member 410 (e.g., similar to...). Figure 59 (The configuration shown). By moving the oriented mating member 410, the anchor 408 can be moved from a straight configuration to a fully folded configuration (e.g., Figure 23 Initially, as the cap 414 moves toward the mating member 410, the anchor 408 bends at the connecting portions 423, 425, 421, and the connecting portion 423 moves radially outward relative to the longitudinal axis of the mating member 410 and axially toward the first portion 414 of the mating member 410, as... Figure 24-25 As shown. As the cap 414 continues to move toward the mating member 410, the connecting portion 423 moves radially inward relative to the longitudinal axis of the mating member 410 and axially toward the proximal portion 419 of the mating member 410, as... Figure 23 As shown.

[0441] In some embodiments, the angle between the inner paddle 422 of the anchor 408 and the mating member 410 is such that the anchor 408 is in a vertical configuration (see, for example, Figure 59 When the angle is approximately 180 degrees, and the angle between the inner paddle 422 of the anchor 408 and the mating member 410 is when the anchor 408 is in a fully folded configuration (see...). Figure 23 The angle can be approximately 0 degrees. Anchor 408 can be positioned in various partially folded configurations such that the angle between the inner paddle 422 of anchor 408 and the mating member 410 can be approximately 10-170 degrees or approximately 45-135 degrees.

[0442] The configuration of the prosthetic spacer device 400, allowing the anchor 408 to extend into a straight or near-straight configuration (e.g., approximately 120-180 degrees relative to the mate member 410), offers several advantages. For example, this reduces the radial crease profile of the prosthetic spacer device 400. It also leads to easier grasping of the natural leaflet by providing a larger opening for gripping it. Additionally, the relatively narrow, straight configuration can prevent or reduce the likelihood of the prosthetic spacer device 400 becoming entangled in natural anatomical structures (e.g., chordae tendineae) when positioning and / or retrieving the prosthetic spacer device 400 in a delivery device.

[0443] Refer again Figure 24 The fastener 430 may include an attachment or fixing portion 432 and an arm or movable portion 434. The attachment or fixing portion 432 may be connected to the inner paddle 422 of the anchor 408 in various ways, such as by means of stitching, adhesive, fasteners, welding, sewing, molding, friction fitting and / or other connection or fastening means.

[0444] In some implementations, the movable portion 434 may be in an open configuration (e.g., Figure 24 ) and closed configuration ( Figure 23 and 25 The fastener 430 is hinged, flexed, or pivoted relative to the fixed portion 432. In some embodiments, the fastener 430 may be biased toward a closed configuration. In some embodiments, in an open configuration, the fixed portion 432 and the movable portion 434 flex or pivot away from each other, such that the natural leaflet can be positioned between the fixed portion 432 and the movable portion 434. In some embodiments, in a closed configuration, the fixed portion 432 and the movable portion 434 flex or pivot toward each other, thereby clamping the natural leaflet between the fixed portion 432 and the movable portion 434.

[0445] refer to Figure 26-27 Fastener 430 is shown in top view and perspective view. Fixing part 432 (in...) Figure 26-27 (Only one is shown in the image) may include one or more openings 433 (e.g., three in the example embodiment). At least some of the openings 433 may be used to attach the fixing portion 432 to the anchor 408. For example, sutures and / or fasteners may extend through the openings 433 to attach the fixing portion 432 to the anchor 408, or other attachments such as welding, adhesives, etc. may be used.

[0446] 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 groove 431A. The groove 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 a barbed support portion 434B arranged opposite to the spring portion 434A.

[0447] The barb support portion 434B may include clamps or attachment elements such as barbs 436A and / or other means for frictionally engaging natural lobular tissue. The clamping element 436A may be configured to engage and / or pierce the natural lobular tissue to help retain the natural lobule between the fixed portion 432 and the movable portion 434 of the fastener 430.

[0448] The barb support portion 434B may also include an eyelet 435 for attaching the barb support portion 434B to an actuation mechanism configured to bend or pivot the movable portion 434 relative to the fixed portion 432. Further details regarding the attachment of the fastener 430 to the actuation mechanism are provided below.

[0449] In some embodiments, the fastener 430 may be formed of a shape memory material such as nitinol, stainless steel, and / or a shape memory polymer. In some embodiments, the fastener 430 may be formed by: Figure 26 The configuration shown, or similar or different configurations, are used to laser-cut flat sheet materials (e.g., Nitinol) or tubes, and then... Figure 27 The configuration shown defines the shape of fastener 430.

[0450] Shaping the fastener 430 in this way offers several advantages. For example, the fastener 430 can optionally be derived from a shaping configuration (e.g., Figure 27 ) is compressed into a flat configuration (e.g., Figure 26 Other configurations that reduce the radial crease profile of the fastener 430. For example, the barbs may optionally be compressed to a flat configuration. Reducing the radial crease profile can improve the trackability and retrievability of the prosthesis spacer device 400 relative to the catheter shaft of the delivery device, because when the prosthesis spacer device 400 is pushed through the catheter shaft or retrieved in the catheter shaft (see, for example, Figure 33 The barbs 440 point radially inward toward the anchor 408. This prevents or reduces the possibility that the fastener 430 may obstruct or scrape the guide shaft.

[0451] In addition, with Figure 27 The illustrated fixed fastener 430 can increase the clamping force of the fastener 430 when the fastener 430 is in the closed configuration. This is because the movable portion 434 is shaped to a first position relative to the fixed portion 432 (e.g., Figure 27 ), which exceeds the attachment of fastener 430 to anchor 408 (e.g., Figure 25 The movable portion 434 can only reach certain positions because the anchor 408 prevents the movable portion 434 from moving further toward the fixed configuration. This results in the movable portion 434 having a preload (i.e., clamping force greater than zero) when the fastener 430 is attached to the anchor 408 and is in a closed configuration. Therefore, compared to a fastener fixed in a closed configuration, the movable portion 434 has a preload (i.e., clamping force greater than zero). Figure 27 The configuration-fixed fastener 430 can increase the clamping force of the fastener 430.

[0452] The preload level of fastener 430 can be changed by adjusting the angle between the movable part 434 and the fixed part 432. For example, increasing the relative angle between the movable part 434 and the fixed part 432 will increase the preload, while decreasing the relative angle will decrease the preload. Adjustments can also be made in other ways, such as depending on the configuration of the connection, hinge, materials, etc.

[0453] In some embodiments, the proximal collar 411 and / or mating member 410 may include a hemostatic seal 413 configured to reduce or prevent blood flow through the proximal collar 411 and / or mating member 410. For example, in some embodiments, the hemostatic seal 413 may include a plurality of flexible flaps 413A, such as Figure 23 As shown. In some embodiments, valve 413A may be configured to pivot from a sealed configuration to an open configuration to allow the shaft of the delivery device to extend through the second collar 410. In one exemplary embodiment, valve 413A forms a seal around the shaft of the delivery device. When the shaft of the delivery device is removed, valve 413A may be configured to return from the open configuration to the sealed configuration.

[0454] Now for reference Figure 23A This illustrates an exemplary embodiment of an implantable prosthetic spacer device 400A. Device 400A may include any other features of the implantable prosthetic devices discussed in this application, and device 400A may be positioned to engage valve tissues 20, 22—as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0455] The prosthetic spacer or engagement device 400A may include an engagement portion 404A and an anchor portion 406A, the anchor portion 406A including a plurality of anchors 408A. The engagement portion 404A includes an engagement member or spacer 410A. The anchor portion 406A includes a plurality of paddles 420A (e.g., two in the example embodiment) and a plurality of fasteners 430A (e.g., two in the example embodiment). A first or proximal collar 411A and a second collar or cap 414A are used to move the engagement portion 404A and the anchor portion 406A relative to each other.

[0456] The mating member 410A extends from the proximal portion 419A of the ferrule 411A to the distal portion 417A that connects with the anchor member 408A. The mating member 410A and the anchor member 408A can be joined together in various ways. For example, as shown in the exemplary embodiment, the mating member 410A and the anchor member 408A can be joined together by integrally forming them as a single, integral component. This can be achieved, for example, by forming the mating member 410A and the anchor member 408A from a continuous strip 401A of a braided or woven material such as braided or woven nitinol yarn.

[0457] Anchor 408A is attached to mating member 410A via hinge portion 425A and to cap 414A via hinge portion 421A. Anchor 408A may include a first portion or outer paddle 420A and a second portion or inner paddle 422A separated by connecting portion 423A. Connecting portion 423A is attached to paddle frame 424A, which is hingedly attached to cap 414A. In this way, anchor 408A is configured similarly to a leg, with inner paddle 422A similar to the upper part of the leg, outer paddle 420A similar to the lower part of the leg, and connecting portion 423A similar to the knee of the leg. In an example embodiment, inner paddle portion 422A, outer paddle portion 420A, and connecting portion 423A are formed from a continuous fabric strip 401A, such as a metallic fabric.

[0458] Anchor 408A can be configured to move between various configurations—by axially moving cap 414A relative to proximal collar 411A, and thus moving anchor 408A relative to mating member 410A along a longitudinal axis extending between cap 414A and proximal collar 411A. For example, by moving cap 414A away from mating member 410A, anchor 408A can be positioned in a straight configuration (see [link to documentation]). Figure 60A In the straight configuration, the paddle-shaped portions 420A and 422A are aligned or straight along the longitudinal axis of the device, and the connecting portion 423A of the anchor 408A is adjacent to the longitudinal axis of the mating member 410A (e.g., similar to...). Figure 60A (As shown in the configuration). By moving toward the mating member 410A, the anchor 408 can be moved from a straight configuration to a fully folded configuration (e.g., Figure 23A Initially, as the cap 414A moves toward the mating member 410A, the anchor 408A bends at the connecting portions 421A, 423A, and 425A, and the connecting portion 423A moves radially outward relative to the longitudinal axis of the device 400A and axially toward the distal portion 417A of the mating member 410A, as shown. Figure 53A and 54AAs shown. As the cap 414A continues to move toward the mating member 410A, the connecting portion 423A moves radially inward relative to the longitudinal axis of the device 400A and axially toward the proximal portion 419A of the mating member 410A, as... Figure 23A As shown.

[0459] In some embodiments, the angle between the inner paddle 422A of the anchor 408A and the mating member 410A is such that the anchor 408A is in a straight configuration (see, for example, Figure 60A When the angle is approximately 180 degrees, and the angle between the inner paddle 422A of the anchor 408A and the mating member 410A is when the anchor 408A is in a fully folded configuration (see...). Figure 23A The angle can be approximately 0 degrees. Anchor 408A can be positioned in various partially folded configurations such that the angle between the inner paddle 422A of anchor 408A and the mating member 410A can be approximately 10-170 degrees or approximately 45-135 degrees.

[0460] The configuration of the prosthetic spacer device 400A, allowing the anchor 408A to extend into a straight or near-straight configuration (e.g., approximately 120-180 degrees relative to the mate member 410A), offers several advantages. For example, this reduces the radial crease profile of the prosthetic spacer device 400A. It also results in easier grasping of the natural leaflet by providing a larger opening for gripping it. Additionally, the relatively narrow, straight configuration prevents or reduces the likelihood of the prosthetic spacer device 400A becoming entangled in natural anatomical structures (e.g., chordae tendineae) when positioning and / or retrieving it in a delivery device.

[0461] Fastener 430A may include an attachment or fixing portion 432 and an arm or movable portion 434C. The attachment or fixing portion 432C may be connected to the inner paddle 422A of the anchor 408A in various ways, such as by means of stitching, adhesive, fasteners, welding, sewing, molding, friction fitting, and / or other connecting means. Fastener 430A is similar to fastener 430.

[0462] In some implementations, the movable portion 434C can be in an open configuration (e.g., Figure 54A ) and closed configuration ( Figure 53AThe fastener 430A is hinged, flexed, or pivoted relative to the fixed portion 432C. In some embodiments, the fastener 430A may be biased toward a closed configuration. In the open configuration, the fixed portion 432C and the movable portion 434C are hinged, pivoted, or flexed away from each other, such that the natural leaflet can be positioned between the fixed portion 432C and the movable portion 434C. In the closed configuration, the fixed portion 432C and the movable portion 434C are hinged, pivoted, or flexed toward each other, thereby clamping the natural leaflet between the fixed portion 432C and the movable portion 434C.

[0463] Strip 401A attaches collar 411A, cap 414A, paddle frame 424A, and fastener 430A to form both the mating portion 404A and the anchoring portion 406A of device 400A. In an example embodiment, the mating member 410A, hinge portions 421A, 423A, 425A, outer paddle 420A, and inner paddle 422A are formed from continuous strip 401A. Continuous strip 401A may be a single layer of material or may include two or more layers. In some embodiments, portions of device 400A have a single layer of material strip 401A, while other portions are formed from multiple overlapping or superimposed layers of material strip 401A. For example, Figure 23A The diagram shows an mating member 410A and an inner paddle 422A formed by multiple overlapping layers of material strips 401A. A single continuous material strip 401A can begin and end at various locations within the device 400A. The ends of the material strips 401A can be at the same or different locations within the device 400A. For example, in… Figure 23A In the embodiment shown, the material strip begins and ends at the position of the inner paddle 422A.

[0464] Now for reference Figure 30A An exemplary implantable prosthesis device 400A is shown covered with a cover 440A. The cover 440A is disposed on an engagement member 410A, a collar 411A, a cap 414A, paddles 420A, 422A, a paddle frame 424A, and a fastener 430A. The cover 440A may be configured to prevent or reduce blood flow through the prosthesis spacer device 400A and / or promote inward growth of natural tissue. In some embodiments, the cover 440A may be a cloth or fabric, such as PET, fleece, or other suitable fabric. In other embodiments, instead of fabric or in addition to fabric, the cover 440A may include a coating (e.g., a polymeric material, silicone, etc.) applied to the prosthesis spacer device 400A.

[0465] Now for reference Figures 28-30 An exemplary embodiment of an implantable prosthetic device 500 (e.g., a prosthetic spacer device) is shown. The implantable device 500 is... Figure 8-20The illustrative example of device 100 can take one of several different configurations. Device 500 may include any other features of the implantable prosthetic device discussed in this application, and device 500 may be positioned to engage valve tissues 20, 22—as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0466] The prosthetic spacer assembly 500 may include mating elements or spacer members 510, and a plurality of anchors 508, each anchor 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 assembly 500 may be configured to be the same as or substantially similar to corresponding components of the prosthetic spacer assembly 400.

[0467] The prosthetic spacer device 500 may also include a plurality of paddle-shaped extension members or paddle-shaped frames 524. The paddle-shaped frames 524 may be configured with a rounded three-dimensional shape, wherein a first connecting portion 526 connects to and extends from the cap 514, and a second connecting portion 528 is arranged opposite to the first connecting portion 526. The paddle-shaped frames 524 may be configured to extend circumferentially around the mating member 510 beyond the outer paddle 520. For example, in some embodiments, each paddle-shaped frame 524 may extend approximately half the circumference of the mating member 510 (e.g., ...). Figure 29 (as shown), and the outer paddle 520 extends less than half of the circumference of the mating member 510 (as shown). Figure 28 (As shown). The paddle frame 524 can also be configured to extend laterally (i.e., perpendicular to the longitudinal axis of the mating member 510) beyond the outer diameter of the mating member 510. In the example shown, the inner paddle portion 522 and the outer paddle portion 520 are formed by continuous fabric strips attached to the paddle frame 524. For example, the inner and outer paddle portions can be connected to a connecting portion of the paddle frame at a flexible connection between the inner and outer paddle portions.

[0468] The paddle frame 524 can be further configured such that the connecting portion 528 of the paddle frame 524 is connected to or axially adjacent to the connecting portion 523. When the prosthetic spacer assembly 500 is in a folded configuration (e.g., Figures 28-30The connecting portion of the paddle frame 524 can be positioned between the outer paddle 520 and the inner paddle 522, outside the paddle portion 520, inside the inner paddle portion, or on top of the connecting portion 523. The connection between the paddle frame 524, the individual strips forming the outer paddle 520 and the inner paddle 522, the cap 514, and the mating element can restrain each of these portions to the movement and position described herein. Specifically, the connecting portion 523 is restrained by its connection between the outer paddle 520 and the inner paddle 522 and by its connection to the paddle frame. Similarly, the paddle frame 524 is restrained by its attachment to the connecting portion 523 (and thus the inner and outer paddles) and to the cap.

[0469] This configuration of the paddle frame 524 results in an increased surface area compared to when only the outer paddle 520 is present. This can, for example, lead to easier gripping and securing of the natural leaflet. The increased surface area also allows the clamping forces of the paddle 520 and the paddle frame 524 on the natural leaflet to be distributed over a relatively large surface area of ​​the natural leaflet, further protecting the natural leaflet tissue.

[0470] The increased surface area of ​​the paddle frame 524 also allows the natural leaflet to be clamped into the prosthetic spacer device 500, so that the natural leaflet is fully engaged around the engagement member 510. This can, for example, improve the seal of the natural leaflet, thus preventing or further reducing mitral regurgitation.

[0471] refer to Figure 30 The prosthetic spacer device 500 may also include a cover 540. In some embodiments, the cover 540 may be disposed on the mating member 510, paddles 520, 522, and / or paddle frame 524. The cover 540 may be configured to prevent or reduce blood flow through the prosthetic spacer device 500 and / or promote inward growth of natural tissue. In some embodiments, the cover 540 may be cloth or fabric, such as PET, fleece, or other suitable fabric. In other embodiments, instead of fabric or in addition to fabric, the cover 540 may also include a coating (e.g., polymeric, silicone, etc.) applied to the prosthetic spacer device 500.

[0472] Figures 31-32 Example Figure 28 and 29 An implantable prosthesis device 500, wherein the anchor 508 and fastener 530 of the anchor portion 506 are in the open position. The device 500 is deployed from a delivery sheath (not shown) and includes an occlusion portion 504 and an anchor portion 506. The device 500 is loaded in the delivery sheath in a fully extended or salvage position because the fully extended or salvage position occupies minimal space and allows for the use of a minimal catheter (see [link to documentation]). Figure 35Alternatively, the fully extended position allows the use of the largest device 500 for a given catheter size. The occlusion portion 504 of the device includes an occlusion element 510—for implantation between the natural leaflets of a natural valve (e.g., mitral, tricuspid, etc.). An insert 516A is disposed within the occlusion element 510. The insert 516A and the occlusion element 510 are slidably attached to an actuating element 512 (e.g., an actuating filament, rod, shaft, tube, screw, suture, thread, etc.). The anchoring element 508 of the device 500 includes an outer paddle 520 and an inner paddle 522 flexibly connected to the cap 514 and the occlusion element 510. Actuation of the actuating element or the actuating device 512 causes the anchoring element 508 of the device 500 to open and close to grip the natural valve leaflets during implantation.

[0473] The actuating element 512 extends through the delivery sleeve (not shown), proximal collar 511, mating element 510, insert 516A, and extends to the cap 514. Extending and retracting the actuating element 512 increases and decreases the spacing between the mating element 510 and the cap 514, respectively. This change in the spacing between the mating element 510 and the cap 514 causes the anchoring portion 506 of the device to move between different positions.

[0474] The proximal collar 511 optionally includes a collar seal 513 that forms a seal around the actuating element or actuating device 512 during implantation of the device 500, and that seal closes when the actuating element 512 is removed, so as to close or substantially close the proximal end of the device 500 to blood flow through the mating element 510 after implantation. In some embodiments, the connector or coupling device 2214 (see...) Figure 145 The proximal collar 511 and the mating element 500 are removably engaged and attached to the delivery sheath. In some embodiments, the connector or coupling device 2214 is held closed around the proximal collar 511 by an actuating element 512, such that removal of the actuating element 512 allows the fingers of the connector or coupling device 2214 (see...) to... Figure 145 The proximal collar 511 is opened, thereby releasing it.

[0475] The insert 516A in the proximal collar 511 and the mating element 510 slides along the actuating element 512 during actuation to open and close the paddles 520, 522 of the anchor 508. (Reference) Figure 32A and 32B In some embodiments, cap 514 optionally includes a sealing protrusion 516 that is sealingly adapted within a sealing opening 517B of insert 516A. In one exemplary embodiment, cap 514 includes a sealing opening, and insert 516A includes a sealing protrusion. Insert 516A is sealingly adapted within a distal opening 515 of mating element 510. Figure 31Within the mating element 510, there is a hollow interior. (Reference) Figure 32A The sealing protrusion 516 of the cap 514 sealably engages the opening 517B in the insert 516A to maintain the distal end of the mating element 510 closed to blood flow or substantially closed when the device 500 is implanted and / or in the closed position.

[0476] In one exemplary embodiment, instead of a sealed engagement between the cap 514 and the insert 516A, the insert 516A may optionally include a seal, such as a collar seal 513 of a proximal collar, that forms a seal around the actuating element or actuating device 512 during implantation of the device 500, and that seal closes when the actuating element 512 is removed. This seal can close or substantially close the distal end of the occlusive element 510 to blood flow after implantation.

[0477] The mating element 510 and paddles 520, 522 are formed of a flexible material, which can be a metal fabric, such as a mesh, woven, braided, or any other suitablely formed or laser-cut or otherwise cut flexible material. The material can be cloth, shape memory alloy wires providing shape retention—such as nitinol, or any other flexible material suitable for implantation in the human body. The paddle frame 524 provides additional clamping force between the inner paddle 522 and the mating element 510 and facilitates the leaflets coiling around the sides of the mating element 510 to achieve a better seal between the mating element 510 and the leaflets. In some embodiments, Figure 30 The example cover 540 extends around the paddle frame 524.

[0478] Fastener 530 includes a base or fixed arm 532, a movable arm 534, barbs 536, and a connecting portion 538. The fixed arm 532 is attached to the inner paddle 522, with the connecting portion 538 positioned close to the mating element 510. The barbed fastener has a flat surface and does not fit into a recess in the paddle. Instead, the flat portion of the barbed fastener is positioned against the surface of the inner paddle 522. For example, the fixed arm 532 is attached to the inner paddle 522 via a hole or slot 533 using stitching (not shown). The fixed arm 532 can be attached to the inner paddle 522 or other parts of the device by any suitable means such as a screw or other fastener, a crease sleeve, a mechanical latch or snap, welding, adhesive, or similar means. The fixed arm 532 remains stationary or substantially stationary relative to the inner paddle 522 when the movable arm 534 is opened to open the barbed fastener 530 and expose the barbs 536. By applying tension to the actuation line (not shown) attached to the hole 535 in the movable arm 534, the barbed fastener 530 is opened, thereby causing the movable arm 534 to pivot or flex on the connecting portion 538.

[0479] During implantation, the anchor 508 is opened and closed to grasp the natural leaflet between the paddles 520, 522 and the occlusal element 510. The barbed fastener 530 further secures the natural leaflet by engaging the leaflet with barbs 536 and clamping it between the movable arm 534 and the fixed arm 532. The barbs 536 of the barbed fastener 530 increase friction with the leaflet or can partially or completely puncture it. Actuation lines can be individually actuated, allowing each barbed fastener 530 to be opened and closed independently. Independent operation allows for grasping one leaflet at a time, or repositioning the fastener 530 on an under-grasped leaflet, without altering successful grasping of another leaflet. The barbed fastener 530 can be opened and closed with the inner paddle 522 not closed, allowing the leaflet to be grasped in multiple positions as needed.

[0480] Now for reference Figure 33 An exemplary barbed fastener 600 for implantable prosthetic devices such as those described above is shown. However, a variety of different barbed fasteners may be used. Examples of barbed fasteners that may be used include, but are not limited to, any barbed fastener disclosed in this application and any fastener or barbed fastener of any application incorporated herein by reference and / or claimed as a priority by this application. In the example shown, the barbed fastener 600 is formed of a top layer 602 and a bottom layer 604. The double-layer design of the fastener 600 allows for the use of a thinner sheet of material, thereby increasing the flexibility of the fastener 600 relative to a fastener formed from a single, thicker sheet, while maintaining the strength of the fastener 600 required to successfully retain the natural valve leaflet.

[0481] The barbed fastener 600 includes a retaining arm 610, a connecting portion 620, and a movable arm 630 having a barbed portion 640. Top layer 602 and bottom layer 604 have similar shapes and, in some embodiments, are attached to each other at the barbed portion 640. However, top layer 602 and bottom layer 604 may be attached to each other at other or additional locations. The connecting portion 620 is spring-loaded such that, when the barbed fastener 600 is in the closed state, the retaining arm 610 and the movable arm 630 are biased towards each other. When assembled to an implantable prosthesis device, the retaining arm 610 is attached to a portion of the prosthesis device. The fastener 600 is opened by pulling the actuation line attached to the movable arm 630 until the spring force of the connecting portion 620 is overcome.

[0482] The fixed arm 610 is formed of a tongue 611 extending from a connecting portion 620 between the two side beams 631 of the movable arm 630. The tongue 611 is biased between the side beams 631 via the connecting portion 620, such that force must be applied to move the tongue 611 from a neutral position beyond the positioning of 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, which is attached to the tongue 611 and extends outward to engage the side beams 631. In one exemplary embodiment, the crossbar is omitted and the tongue 611 is attached to an inner paddle 522, which holds the fastener in the preloaded position. In double-layer fastener applications, the top layer 602 and the bottom layer 604, or only the top layer, may be attached to the inner paddle. In some embodiments, when the tongue is in a neutral position, the angle between the fixed arm 610 and the movable arm 630 is about 30 to about 100 degrees, 30 to about 90 degrees, or about 30 to about 60 degrees, or about 40 to about 50 degrees, or about 45 degrees.

[0483] The tongue-like body 611 includes a hole 612 for receiving sutures (not shown) that attach the retaining arm 610 to the implantable device. The retaining arm 610 can be attached to the implantable device—e.g., using a screw or other fastener, a crease sleeve, a mechanical latch or snap, welding, adhesive, or the like. In some embodiments, the hole 612 is an elongated slot or an oval hole to allow layers 602, 604 to slide without damaging the sutures that attach the fastener 600 to the implantable device.

[0484] The connecting portion 620 is formed by two crossbeam rings 622 extending from the tongue 611 of the fixed arm 610 to the side beam 631 of the movable arm 630. In some embodiments, the crossbeam rings 622 are narrower than the tongue 611 and the side beam 631 to provide additional flexibility. Each crossbeam ring 622 includes a central portion 624 extending from the tongue 611 and an outer portion 626 extending to the side beam 631. By bending the central portion 624 and the outer portion 626 in opposite directions, the crossbeam rings 622 are bent into a slightly spiral (spiral or helical) shape, thereby creating 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 leaflet of the natural valve—after it is gripped. In some embodiments, the step 628 is about 0.5 mm to about 1 mm, or about 0.75 mm.

[0485] When viewed from above, the beam ring has an "ω-shaped" form. This shape of the beam ring 622 allows significant movement of the fixed arm 610 and the movable arm 630 relative to each other without plastically deforming the fastener material. For example, in some embodiments, the tongue 611 can flex or pivot from approximately 45 degrees beyond the neutral position of the movable arm 630 to a fully open position within a range of approximately 140 degrees to approximately 200 degrees, to approximately 170 degrees to approximately 190 degrees, or approximately 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 significantly reducing the clamping force applied between the fixed arm and the movable arm in the closed position.

[0486] Preloading the tongue 611 enables the fastener 600 to maintain a clamping or holding force on the natural leaflet when closed. Preloading the tongue 611 provides a significant advantage over prior art clamps that provide little or no clamping force when closed. Furthermore, closing the fastener 600 by spring force is a significant improvement over clamps utilizing a one-time locking closure mechanism, as the fastener 600 can be repeatedly opened and closed to reposition itself on the leaflet while maintaining sufficient clamping force when closed. Additionally, the spring-loaded fastener allows for easier removal of the device over time compared to a device locked in the closed position (after tissue inward growth). In one exemplary embodiment, both the fastener and the paddle are spring-biased to their closed position (opposite to being locked in the closed position), which allows for easier removal of the device after tissue inward growth.

[0487] The barbed portion 640 of the movable arm 630 includes an eyelet 642, barbs 644, and a barbed support 646. The barbed portion of the end-positioning fastener 600 facing the movable arm 630 increases the space between the barbs 644 and the retaining arm 610 when the fastener 600 is opened, thereby improving the fastener 600's ability to successfully grasp the leaflet during implantation. This distance also allows the barbs 644 to more reliably disengage from the leaflet for repositioning. In some embodiments, the barbs of the fastener may be longitudinally staggered to further distribute clamping force and localize leaflet stress.

[0488] The barbs 644 are laterally spaced at the same distance from the connecting portion 620, thereby providing a superior clamping force distribution to the leaflet tissue, while also making the fastener grip the leaflet more securely than with longitudinally arranged barbs. In some embodiments, the barbs 644 may be staggered to further distribute the clamping force and localize leaflet stress.

[0489] The barb 644 is formed from the bottom layer 604, and the barb support 646 is formed from the top layer. In some embodiments, the barb is formed from the top layer 602, and the barb support is formed from the bottom layer 604. Forming the barb 644 in only one of the two layers 602, 604 allows the barb to be thinner and therefore more effectively sharper than a barb formed from the same material that is twice as thick. The barb support 646 extends along the lower portion of the barb 644 to reinforce the barb 644, thereby further improving penetration and retention into the lobular tissue. In some embodiments, the tip of the barb 644 is further sharpened using any suitable sharpening means.

[0490] The barb 644 is angled away from the movable arm 630, making it easy to penetrate the tissue of the natural lobule with minimal clamping or holding force. The barb 644 extends from the movable arm at an angle of approximately 45 degrees to approximately 75 degrees, or approximately 45 degrees to approximately 60 degrees, or approximately 48 degrees to approximately 56 degrees, or approximately 52 degrees. A further benefit provided by the angle of the barb 644 is that the force pulling the implant away from the natural lobule will promote further engagement of the barb 644 with the tissue, thereby ensuring better preservation. The preservation of the lobule in the fastener 600 can be further enhanced by the position of the T-shaped crossbar 614 near the barb 644 when the fastener 600 is closed. In this arrangement, the tissue pierced by the barb 644 is clamped against the movable arm 630 at the position of the crossbar 614, thus forming an S-shaped tortuous path as the tissue passes through the barb 644. Therefore, the force pulling the lobule away from the fastener 600 will cause the tissue to further engage the barb 644 before the lobule could escape. For example, leaflet tension during diastole can cause the barbs to pull towards the tip of the leaflet. An S-shaped path can utilize leaflet tension during diastole to more tightly engage the leaflet with the barbs.

[0491] The layers 602, 604 of the fastener 600 are laser-cut from shape memory alloy sheets such as nitinol. The top layer 602 is aligned and attached to the bottom layer 604. In some embodiments, layers 602, 604 are attached to the barbed portion 640 of the movable arm 630. For example, layers 602, 604 may be attached only to the barbed portion 640 to allow the rest of the layer to slide relative to each other. Parts combining layers 602, 604, such as the retaining arm 610, barbs 644 and barbed supports 646, and the crossbeam ring 622, are bent to the desired position. Layers 602, 604 may be bent and shaped together or may be bent and shaped separately and then combined. The fastener 600 then undergoes a shaping process such that the internal forces of the material, after being deformed by external force, tend to restore the set shape. After shaping, the tongue 611 is moved to its preloaded position so that the crossbar 614 can be attached. In one exemplary embodiment, the fastener 600 may optionally be completely flattened for delivery through a delivery sheath and allow expansion after deployment within the heart. The fastener 600 is opened and closed by applying and releasing tension to an actuating thread, suture, thread, rod, catheter, or the like (not shown) attached to the movable arm 630. In some embodiments, the actuating thread or suture is inserted into an eyelet 642 near the barbed portion 640 of the movable arm 630 and wrapped around the movable arm 630 before returning to the delivery sheath. In some embodiments, an intermediate suture loop is formed through the eyelet and the suture is inserted into this intermediate loop. Alternative embodiments of the intermediate loop may be constructed from fabric or another material attached to the movable arm, instead of a suture loop.

[0492] Compared to the friction between the actuating thread / suture and the fastener material, the intermediate loop of the suture material reduces the friction experienced by the actuating thread / suture. When the suture loops through the eyelet 642 or the intermediate loop, both ends of the actuating thread / suture extend back and pass through the delivery sheath (e.g., Figure 8 The suture can be removed by pulling one end of the suture proximally until the other end is pulled through the eyelet or intermediate loop and back to the delivery sheath.

[0493] Now for reference Figure 34 The image shows a close-up view of one of the leaflets 20 or 22 gripped by barbed fasteners such as fasteners 430 and 530. Leaflets 20 or 22 are gripped between the movable arms 434 and 534 and the fixed arms 432 and 532 of fasteners 430 and 530. Figure 34As shown, although the tissue of leaflets 20 and 22 is not punctured by barbs 436 and 536, in some embodiments, barbs 436 and 536 may partially or completely puncture through leaflets 20 and 22. The angle and height of barbs 436 and 536 relative to movable arms 434 and 534 help to secure leaflets 20 and 22 within fasteners 430 and 530. Specifically, the force pulling the implant away from the natural leaflets will cause barbs 436 and 536 to further engage the tissue, thereby ensuring better retention. When fasteners 430 and 530 are closed, the retention of leaflets 20 and 22 within fasteners 430 and 530 is further enhanced by the position of fixing arms 432 and 532 near barbs 436 and 536. In this arrangement, the tissue forms an S-shaped tortuous path through fixing arms 432 and 532, movable arms 434 and 534, and barbs 436 and 536. Therefore, the force pulling the leaflet away from the fasteners 430 and 530 will cause the tissue to further engage the barbs 436 and 536 before the leaflet can escape. For example, as described above, the leaflet tension during diastole can cause the barbs to pull towards the tip of the leaflet. The S-shaped path can utilize the tension during leaflet diastole to more tightly engage the leaflet with the barbs.

[0494] Now for reference Figures 35-46 This illustrates the delivery and implantation of an implantable device 500 into the natural mitral valve MV of the heart H. The methods and procedures shown and / or discussed can be performed on living animals or simulators, such as on cadavers, cadaver hearts, simulators (e.g., simulated body parts, hearts, tissues, etc.).

[0495] As described above, the device 500 has a cover 540 on the engaging element 510, the fastener 530, the inner paddle 522 and / or the outer paddle 520 (see above). Figure 30 The device 500 is deployed from the delivery sheath 502 and includes an occlusion portion 504 and an anchor portion 506—including multiple anchors 508 (i.e., two in the example embodiment). The occlusion portion 504 of the device includes an occlusion element 510 for implantation between the leaflets 20, 22 of the natural mitral valve MV, which is slidably attached to an actuating element or actuating device 512. Actuation of the actuating element or actuating device 512 causes the anchors 508 of the device 500 to open and close to grip the mitral valve leaflets 20, 22 during implantation.

[0496] The anchoring element 508 of the device 500 includes an outer paddle 520 and an inner paddle 522 flexibly connected to the cap 514 and the engaging element 510. The actuating element 512 extends through the capturing mechanism 503 (see [link to details]). Figure 41The delivery sleeve 502 and the mating element 510 reach the cap 514, which is connected to the anchoring portion 506. The extension and retraction of the actuating element 512 increase and decrease the gap between the mating element 510 and the cap 514, respectively. Figures 35-46 In the example shown, the paired inner paddle 522 and outer paddle 520 move together rather than independently via a single actuating element 512. Furthermore, the position of the fastener 530 depends on the positions of the paddles 522 and 520. For example, refer to... Figure 45 The closing paddles 522 and 520 also close the fasteners. In one exemplary embodiment, the device 500 may be configured to interact with... Figure 11A The paddles 520 and 522 can be controlled independently using the same implementation method.

[0497] The fingers of the capture mechanism 503 removably attach the collar 511 to the delivery sleeve 502. The collar 511 and the mating element 510 slide along the actuating element 512 during actuation to open and close the anchoring element 508 of the anchoring portion 506. In some embodiments, the capture mechanism 503 is held closed around the collar 511 by the actuating element 512, such that removal of the actuating element 512 allows the fingers of the capture mechanism 503 to open, thereby releasing the collar 511 and thus the mating element 510.

[0498] In some embodiments, the mating elements 510 and / or the paddles 520, 522 are formed of a flexible material, which may be a metal fabric, such as a mesh, woven, braided, or any other suitable formed or laser-cut or otherwise cut flexible material. The flexible material may be cloth, shape memory alloy wires providing shape retention—such as nitinol, or any other flexible material suitable for implantation in the human body. Other configurations are also possible.

[0499] The barbed fastener 530 includes a base or fixed arm 532, a movable arm 534, and barbs 536 (see [link]). Figure 41 The retaining arm 532 is attached to the inner paddle 522, with the connecting portion 538 positioned close to the mating element 510. A suture (not shown) attaches the retaining arm 532 to the inner paddle 522. The retaining arm 532 can be attached to the inner paddle 522 and / or another part of the device by any suitable means, such as a screw or other fastener, a crease sleeve, a mechanical latch or snap, welding, adhesive, or similar means. The retaining arm 532 remains stationary or substantially stationary when the movable arm 534 is opened to open the barbed fastener 530 and expose the barbs 536. The barbed fastener 530 is opened by applying tension to the fastener control member or actuation line 537 attached to the movable arm 534, causing the movable arm 534 to pivot or flex on the connecting portion 538.

[0500] During implantation, the anchor 508 is opened and closed to grip the natural valve leaflet between the paddles 520, 522 and the occlusal element 510. The outer paddle 520 has a broad, curved shape adapted to fit around the curved shape of the occlusal element 510 to more firmly clamp the leaflets 20, 22. The curved shape and rounded edges of the outer paddle 520 also prevent tearing of the leaflet tissue. The barbed fastener 530 further secures the natural leaflet by engaging the leaflet with the barbs 536 and clamping the leaflet between the movable arm 534 and the fixed arm 532. The barbs 536 of the barbed fastener 530 increase friction with the leaflet or can partially or completely puncture the leaflet. The actuation lines can be individually actuated so that each barbed fastener 530 can be opened and closed individually. Separate operation allows for the clamping of one leaf at a time, or the repositioning of fastener 530 on a leaf that is not sufficiently clamped, without affecting the successful clamping of another leaf. The barbed fastener 530 can be fully opened and closed when the inner paddle 522 is not closed, thus allowing the leaf to be clamped in multiple positions as needed.

[0501] Device 500 is loaded in the delivery sheath in either the fully open or fully extended position because the fully open or fully extended position occupies the least space and allows the use of the smallest catheter (or, for a given catheter size, the largest device 500). Now refer to... Figure 35 The delivery sheath is inserted into the left atrium LA through the septum, and the device 500 is deployed from the delivery sheath 502 in the fully open state. The actuating element 512 is then retracted to move the device 500 to... Figures 36-37 The fully closed state shown, then as Figure 38 The image is shown being manipulated toward the mitral valve MV. Now refer to... Figure 39 When the device 500 is aligned with the mitral valve MV (or other natural valve, if implanted in another type of valve), the actuating element 512 is extended to open the paddles 520, 522 to a partially open position, and the fastener control member or actuating line 537 is retracted to open the barbed fastener 530 in preparation for leaflet gripping. Next, as... Figures 40-41 As shown, the partially opened device 500 is inserted through the mitral valve MV until the leaflets 20, 22 are properly positioned between the inner paddle 522 and the mating element 510 and inside the opened barbed fastener 530. Figure 42 The device 500 is shown with both fasteners 530 closed, although one of the leaflets 22 is missing from the barb 536 of one fastener 530. Figures 42-44 As can be seen, the misaligned fastener 530 is opened and closed again to properly grip the missed leaflet 22. When both leaflets 20 and 22 are properly gripped, the actuating element 512 is retracted to move the device 500 to Figure 45The fully closed position is shown. With device 500 fully implanted in the natural mitral valve MV, actuation element 512 is withdrawn to release capture mechanism 503 from proximal collar 511. After deployment, device 500 can be maintained in the fully closed position by mechanical means such as latching, or by being biased to maintain closure by the use of spring material such as steel and / or shape memory alloy such as nitinol. For example, paddles 520, 522 can be formed of steel or nitinol shape memory alloy—prepared as wire, sheet, tube, or laser-sintered powder—and biased to keep outer paddle 520 closed around inner paddle 522, engaging element 510, and barbed fastener 530 clamped around natural leaflets 20, 22.

[0502] Device 500 can have a variety of different shapes and sizes. (Reference) Figure 6 and 6A -6E, in an exemplary embodiment, the engaging element 510 acts as a gap filler in the valve regurgitation orifice, such as Figure 6 The example shows a gap 26 in a natural valve. (Reference) Figure 6A Because the occlusal element 510 is positioned between two opposing leaflets 20, 22, the leaflets will not occlude against each other in the region of the occlusal element 510, but rather against the occlusal element 510. This reduces the approximated distance that the leaflets 20, 22 need to approach. This reduction in approximation distance has several advantages. For example, the occlusal element and the resulting reduction in approximation can facilitate the repair of severe mitral valve anatomy, such as large gaps in functional valvular disease (see, for example, Figure 6 Because the occlusive element 510 reduces the distance the natural valve needs to approach, stress in the natural valve can be reduced or minimized. The shorter approach distance of the leaflets 20, 22 requires less approach force, which can result in less leaflet tension and less annular diameter reduction. Less annular reduction (or no annular reduction) can result in less reduction in orifice area compared to a device without a spacer. Therefore, the occlusive element 510 can reduce transvalvular gradient.

[0503] In one exemplary embodiment, the paddle frame 524 conforms to the shape of the mating element 510. In one example, if the mating element 510 is wider than the paddle frame 524, a distance (gap) between the relative leaflets 20, 22 can be created by the means 500. (See reference...) Figures 6A-6E In one exemplary embodiment, the paddle is configured to conform to the shape or geometry of the occlusal element 510. Therefore, the paddle can mate with both the occlusal element 510 and the natural valve. (See reference...) Figure 6D and 6EIn one exemplary embodiment, the paddle 524 surrounds the mating element 510. Therefore, when the leaflets 20, 22 mate or press against the mating element 510, the leaflets 20, 22 completely surround or "hug" the mating element 510, thus preventing minor leaks on the medial and lateral surfaces of the mating element 510. Figure 6B and 6C An example of a valve repair device 500 is shown, which is attached from the ventricular side of the mitral valve to the natural valve leaflets 20, 22. Figure 6A An example of a valve repair device 500 is shown, which is attached from the atrial side of the mitral valve to the mitral valve leaflets 20 and 22. (Reference) Figure 6A and 6B When the paddle-shaped elements have a geometry conforming to the geometry of the mating element 510, the leaflets 20 and 22 can mate around the mating element and / or along the length of the spacer. (Reference) Figure 6E The schematic atrial / surgeon's view depicts a paddle-shaped frame conforming to the geometry of the spacer (which is actually not visible from the true atrial view). Opposite leaflets 20, 22 (whose ends are also not visible from the true atrial view) approach each other via the paddle to completely surround or "closely" mate element 510.

[0504] refer to Figure 6B-6E Because the paddle frame 524 conforms to the shape of the occlusal element 510, the leaflets 20, 22 can be fully occluded around the occlusal element via the paddle frame 524, including on the outer surface 601 and inner surface 603 of the occlusal element 510. This occlusion of the leaflets 20, 22 against the outer and inner surfaces of the occlusal element 510 would appear to contradict the statement above that the presence of the occlusal element 510 minimizes the distance the leaflets need to approach. However, if the occlusal element 510 is precisely positioned within the regurgitation gap and the regurgitation gap is smaller than the width (inner-outer) of the occlusal element 510, the distance the leaflets 20, 22 need to approach is still minimized.

[0505] refer to Figure 6A and 6E The mating element 510 can take on a variety of different shapes. In one exemplary embodiment, a cross-sectional view viewed from above (and / or from the top); see Figure 95-102 The mating element has an oval or elliptical shape. The oval or elliptical shape allows the paddle frame 524 to conform to the shape of the mating element, and / or reduces lateral leakage (see...). Figure 65-83 ).

[0506] As described above, by reducing the distance the leaflets need to approach the occlusal element 510 at positions 601, 603, the occlusal element 510 can reduce the tension relative to the leaflets. This reduced approach distance at positions 601, 603 results in reduced leaflet stress and gradient. Additionally, as also explained above, the natural valve leaflets 20, 22 may surround or "mate" with the occlusal element to prevent lateral leakage. In one exemplary embodiment, the geometry of the occlusal element may be designed to maintain and enhance both features of the device 500. Reference Figure 2A As seen from the left ventricular outflow tract (LVOT) viewpoint, the anatomical structure of leaflets 20 and 22 causes the medial ends of the leaflets to align, and leaflets 20 and 22 begin to recede or spread outwards. Leaflets 20 and 22 spread outwards along the atrial direction until each leaflet meets the mitral valve annulus.

[0507] In one exemplary embodiment, the valve repair device 500 and its occlusive element 510 are designed to conform to the geometric anatomy of the valve leaflets 20, 22. To achieve valve sealing, the valve repair device 500 may be designed to completely occlude the native leaflet to the occlusive element around it, including at inner position 601 and outer position 603 of the occlusive element 510. Furthermore, reducing the force required to bring the leaflet into contact with the occlusive element 510 at positions 601, 603 minimizes leaflet stress and gradient. Figure 2B This demonstrates how the conical or triangular shape of the occlusive element 510 will naturally adapt to the natural valve geometry and its dilated leaflet nature (towards the valve annulus).

[0508] Figure 6D The geometry of the occlusal element 510 and the paddle frame 524 is illustrated from an LVOT view. From this perspective, the occlusal element 510 has a tapered shape, with a smaller size closer to the area where the inner surfaces of the leaflets 20, 22 need to occlude, and its size increases as the occlusal element extends toward the atrium. The depicted natural valve geometry is adapted to the tapered occlusal element geometry. (Referring to...) Figure 6D The tapered mating element geometry, combined with the example of the expanded paddle frame 524 shape (facing the leaflet ring), can help achieve mating at the lower end of the leaflet, reduce stress, and minimize the translobe gradient.

[0509] refer to Figure 6C In one exemplary embodiment, the remaining shapes of the aligning element 510 and the paddle frame 524 may be defined based on the intra-commissural view of the natural valve and device 500. Two factors in these shapes are the alignment of the leaflets against the aligning element 510 and the reduction in leaflet stress resulting from this alignment. (Reference) Figure 6C and 67To facilitate the engagement of the valve leaflets 20, 22 against the occlusal element 510 and reduce the stress exerted on the valve leaflets 20, 22 by the occlusal element 510 and / or the paddle frame 524, the occlusal element 510 may have a circular or rounded shape, and the paddle frame 524 may have a full radius spanning from one leg of the paddle to the other. The circular shape of the occlusal element and / or the fully rounded shape of the paddle frame will cause the stress on the leaflets 20, 22 to be distributed across a large, curved engagement region 607. For example, in Figure 6C In the process, as the leaflet 20 attempts to open during its diastolic cycle, the force exerted by the paddle frame on the leaflets 20 and 22 extends along the entire circumferential length of the paddle frame 524.

[0510] refer to Figure 67 In one exemplary embodiment, to accommodate the full, rounded shape of the paddle frame 524, and / or to maximize the engagement of the leaflets against the engagement element 510 and the engagement of the leaflets with each other at the side or inner surfaces 601, 603 of the engagement element 510, the shape of the engagement element in the combined inner view follows a circular shape. (See reference...) Figure 67 From this perspective, the circular shape of the mating element basically follows or approximates the shape of the paddle frame 524.

[0511] In one exemplary embodiment, the overall shape of the mating element 510, viewed from the surgeon's perspective (top view - see...) Figure 70 It is an elliptical or oval cross-section, viewed from the LVOT perspective (side view - see...). Figure 69 ) is a conical shape or cross-section, and when viewed from the perspective of the communal interior (see... Figure 68 The shape is essentially circular or rounded. In one exemplary embodiment, the combination of these three combined shapes can produce a three-dimensional shape for the mating element 510 to achieve the aforementioned benefits.

[0512] In one exemplary embodiment, the size of the occlusal element is selected to minimize the number of implants (preferably one) a patient would require, while maintaining a low transvalvular gradient. In one exemplary embodiment, the anteroposterior distance X at the top of the spacer is... 47B It is approximately 5mm, and the distance between the inner and outer sides of the widest part of the spacer is X. 67D It is approximately 10 mm. In one exemplary embodiment, the overall geometry of device 510 may be based on these two dimensions and the aforementioned overall shape strategy. It should be apparent that using other front-to-back distances, such as front-to-back distance X... 47B and interior / exterior distance X 67D Using this as a starting point will result in devices having different dimensions. Furthermore, using other dimensions and the aforementioned shape strategies will also result in devices having different dimensions.

[0513] Tables A, B, and C provide device dimension values ​​and ranges and examples of device components for some exemplary embodiments. However, devices may have many different shapes and sizes and need not have all or any of the dimension values ​​or ranges provided in Tables A, B, and C. Table A provides examples of linear dimensions X in millimeters and ranges of linear dimensions in millimeters for devices and device components. Table B provides examples of radial dimensions R in millimeters and ranges of radial dimensions in millimeters for devices and device components. Table C provides examples of angular dimensions α in degrees and ranges of angular dimensions in degrees for devices and device components. The subscripts of each dimension indicate the first appearance of that dimension in the accompanying drawing.

[0514]

[0515]

[0516]

[0517] Now for reference Figure 47-61 The image shows implantable devices 500 in various positions and configurations. Implantable devices 500 may include any other features of the implantable prosthetic devices discussed in this application, and devices 500 may be positioned to engage valve tissues 20, 22—as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0518] The implantable device 500 has a proximal or attachment portion 505, an engagement 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., jointlyably attached, etc.) between the engagement element 510 and the outer paddle 520. The outer paddle 520 is attached (e.g., jointly attached, etc.) between the inner paddle 522 and the distal portion 507. The paddle frame 524 is attached at the distal portion 507 to a cap 514 and extends to a connection portion 523 between the inner paddle 522 and the outer paddle 520. In some embodiments, the paddle frame 524 is formed of a material that is more rigid and stiffer 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 rigid, relatively rigid, and has rigid portions, and / or is hardened by a hardening member or a fixing portion of the fastener 530. The hardening of the inner paddle allows the device to move to a variety of different positions shown and described herein. The inner paddle 522, the outer paddle 520, and the mating paddles can all be interconnected as described herein, such that the device 500 is secured to the movements and positions shown and described herein.

[0519] Now for reference Figures 47-48 The image shows the device 500 in the closed position. When closed, the inner paddle 522 is positioned between the outer paddle 520 and the engaging element 510. In some embodiments, the device 500 includes a fastener or clamping member 530. Figure 48 It can be opened and closed to grip the natural leaflets 20, 22 of the mitral valve MV. Fastener 530 is attached to and moves with the inner paddle 522, and is arranged between the inner paddle 522 and the mating element 510.

[0520] Now for reference Figures 49-51 The image shows the device 500 in a partially open position. The device 500 is moved to the partially open position by an actuating element or actuating device 512, which passes through the attachment portion 505 and the engaging element 510 and can removably engage the distal portion 507. The actuating element 512 extends through the attachment portion 505 such that the distance D between the attachment portion 505 and the distal portion 507 increases as the actuating element 512 extends. Figures 49-51 In the example shown, the paired inner paddle 522 and outer paddle 520 move together rather than independently via a single actuating element 512. Furthermore, the position of the fastener 530 depends on the positions of the paddles 522 and 520. For example, refer to... Figure 48 The closing paddles 522 and 520 also close the fasteners. In one exemplary embodiment, the device 500 may be configured to... Figure 11A The paddles 520 and 522 can be controlled independently using the same implementation method.

[0521] The extended actuating element 512 pulls down the bottom of the outer paddle 520 and the paddle frame 524. With the inner paddle 522 connected to the outer paddle 520 and the paddle frame 524, the outer paddle 520 and the paddle frame 524 pull down the inner paddle 522. Because the attachment portion 505 and the mating element 510 remain in place, the inner paddle 522 flexes or pivots in the opening direction. The inner paddle 522, the outer paddle 520, and the paddle frame all bend to... Figure 49 As shown in the diagram. Opening the paddles 522, 520 and the frame 524 creates a gap 520B between the mating element 510 and the inner paddle 522, which can receive and hold the natural leaflet 20.

[0522] As described above, some embodiments of the device 500 include a fastener or clamping member 530. When the device 500 is partially opened, the fastener 530 is exposed. In some embodiments, the closed fastener 530 ( Figure 50 ) can be opened ( Figure 51This creates a second opening or gap 530A to receive and capture the natural leaflets 20, 22. The extent of the gap 530A in the fastener 530 is limited by the degree of deployment of the inner paddle 522 away from the mating element 510.

[0523] Now for reference Figures 52-54 The image shows the device 500 in a laterally extended or open position. By continuing to extend the aforementioned actuating element 512, the distance D between the attachment portion 505 and the distal portion 507 is increased, moving the device 500 to the laterally extended or open position. Continuing to extend the actuating element 512 pulls down the outer paddle 520 and the paddle frame 524, causing the inner paddle 522 to extend further away from the engaging element 510. In the laterally extended or open position, the inner paddle 522 extends horizontally more than in other positions of the device 500 and forms an angle of approximately 90 degrees with the engaging element 510. Similarly, when the device 500 is in the laterally extended or open position, the paddle frame 524 is in its maximum extended position. The increased gap 520B formed in the laterally extended or open position allows the fastener 530 to open further before engaging the engaging element 510. Figure 54 This increases the size of the gap 530A.

[0524] Now for reference Figures 55-57 The image shows the device 500 in its three-quarters extended position. By continuing to extend the aforementioned actuating element 512, the distance D between the attachment portion 505 and the distal portion 507 is increased, moving the device 500 to the three-quarters extended position. Continuing to extend the actuating element 512 pulls down the outer paddle 520 and the paddle frame 524, causing the inner paddle 522 to unfold further away from the engaging element 510. In the three-quarters extended position, the inner paddle 522 opens at an angle greater than 90 degrees to approximately 135 degrees to the engaging element 510. The paddle frame 524 unfolds less than in the laterally extended or open position and begins to move inward toward the actuating element 512 as the actuating element 512 extends further. The outer paddle 520 also flexes backward toward the actuating element 512. As in the laterally extended or open position, the increased gap 520B formed in the laterally extended or open position allows the fastener 530 to open further ( Figure 57 This increases the size of the gap 530A.

[0525] Now for reference Figure 58The image shows the device 500 in its almost fully extended position. By continuing to extend the aforementioned actuating element 512, the distance D between the attachment portion 505 and the distal portion 507 is increased, causing the device 500 to move to the almost fully extended position. Continuing to extend the actuating element 512 pulls down the outer paddle 520 and the paddle frame 524, causing the inner paddle 522 to unfold further away from the engaging element 510. In the almost fully extended position, the inner paddle 522 begins to approach the engaging element 510 at approximately a 180-degree angle. Although the inner paddle has moved to this position, the outer paddle 520 and the paddle frame 524 never move or flex relative to the engaging element 510 to or beyond a 90-degree angle. In the almost fully extended position, the inner paddle 522 and the outer paddle 520 may have a slightly curved shape.

[0526] Now for reference Figures 59-61 The image shows the device 500 in its fully extended position. By continuing to extend the aforementioned actuating element 512, the distance D between the attachment portion 505 and the distal portion 507 is increased to the maximum allowable distance for the device 500, moving the device 500 to its fully extended position. Continuing to extend the actuating element 512 pulls the outer paddle 520 and paddle frame 524, causing the inner paddle 522 to unfold further away from the engaging element 510. The outer paddle 520 and paddle frame 524 move to their positions close to the actuating element. In the fully extended position, the inner paddle 522 is opened to approximately a 180-degree angle with the engaging element 510. In the fully extended position, the inner paddle 522 and outer paddle 520 are stretched straight to form an approximately 180-degree angle between the paddles 522 and 520. The fully extended position of device 500 provides the maximum dimension of the gap 520B between the paddles, and in some embodiments, allows fastener 530 to also be fully opened to approximately 180 degrees between portions of fastener 530. Figure 61 The position of device 500 is the narrowest configuration. Therefore, the fully extended position of device 500 can be the desired position for salvaging device 500 from the site of attempted implantation, or the desired position for placing the device in the delivery catheter, or a similar position.

[0527] Now for reference Figure 47A , 48A -48H, 53A-53C, 54A-54D, 60A-60D, and 61A-61D illustrate implantable devices 500A in various positions and configurations. Implantable devices 500A may include any other features of the implantable prosthetic devices discussed in this application, and devices 500A may be positioned to engage valve tissues 20, 22—as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0528] The implantable device 500A has a proximal or attachment portion 505A, an engagement 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. The inner paddle 522A is attached (e.g., connectably attached, etc.) between the engagement element 510A (e.g., via a connecting portion 525A) and the outer paddle 520A (via a connecting portion 523A). The outer paddle 520A is attached (e.g., connectably attached, etc.) between the inner paddle 522A (e.g., via a connecting portion 523A) and the distal portion 507A (via a connecting portion 521A). The paddle frame 524A is attached to the cap 514A at its distal portion 507A and extends to the connection portion 523A between the inner paddle 522A and the outer paddle 520A. In some embodiments, the paddle frame 524A is formed of a material that is more rigid and stiffer than the material forming the paddles 522A and 520A, such that the paddle frame 524A provides support for the paddles 522A and 520A. The paddle frame 524A includes a section for receiving the connection portion 523A. Figure 65A The connection part, such as the opening or slot 524B ( Figure 70A In some embodiments, the inner paddle 522A is rigid, relatively rigid, and has a rigid portion, and / or is hardened by a hardening member or a fixing portion of the fastener 530C. Hardening of the inner paddle allows the device to move to a variety of different positions shown and described herein. The inner paddle 522A, the outer paddle 520A, and the mating element can all be interconnected as described herein, such that the device 500A is secured to the movements and positions shown and described herein.

[0529] The mating element 510A, the inner paddle 522A, and the outer paddle 520A can be attached together by integrally forming the mating element 510A and the paddles 520A and 522A into a single integral component. This can be achieved, for example, by forming the mating element 510A and the paddles 520A and 522A from a continuous strip 501A of braided or woven material such as braided or woven nitinol yarn.

[0530] The continuous strip 501A is attached to the collar 511D, cap 514A, paddle frame 524A, and fastener 530C. In an example embodiment, the mating member 510A, hinge or connecting portions 521A, 523A, 525A, outer paddle 520A, and inner paddle 522A are formed of the continuous strip 501A. The continuous strip 501A may be a single layer of material or may include two or more layers. In some embodiments, portions of the device 500A have a single layer of material strip 501A, while other portions are formed of multiple overlapping or superimposed layers of material strip 501A. For example, Figure 47AThe diagram shows an mating element 510A and an inner paddle 522A formed from multiple overlapping or superimposed layers of material strips 501A. Therefore, the mating element 510A and the inner paddle 522A have increased stiffness relative to the outer paddle 520A formed from a single layer of material 501A. A single continuous material strip 501A can begin and end at various locations in the device 500A. The ends of the material strips 501A can be at the same or different locations in the device 500A. For example, in… Figure 47A In the embodiment shown, the material strip begins and ends at the position of the inner paddle 522.

[0531] Fastener 530C may include an attachment or fixing portion 532C, an arm or movable portion 535C, a barb 536, and a connecting portion 538C. The attachment or fixing portion 532C may be connected to the inner paddle 522A in various ways, such as by stitching, adhesive, fasteners, welding, sewing, molding, friction fitting, and / or other connecting means, wherein the connecting portion 538C is arranged close to the mating element 510A. Fastener 530C may be similar to fastener 430.

[0532] The movable part 534C can be in an open configuration (e.g., Figure 54A ) and closed configuration ( Figure 48A The fastener 530C pivots or flexes relative to the fixed portion 532C. In some embodiments, the fastener 530C may be biased toward a closed configuration. In the open configuration, the fixed portion 532C and the movable portion 534C pivot or flex away from each other, such that the natural leaflet can 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 flex toward each other, thereby clamping the natural leaflet between the fixed portion 532C and the movable portion 534C. The fixed arm 532C remains stationary or substantially stationary when the movable arm 534C is opened to open the barbed fastener 530C and expose the barbs 536. The barbed fastener 530C is opened by applying tension to the actuation line 537 attached to the movable arm 534C, causing the movable arm 534C to pivot or flex on the connecting portion 538C.

[0533] Now for reference Figure 47A and 48A -48H, device 500A indicates that it is in the closed position. Figure 48B , 48C A side view of device 500A is shown in Figure 48F. Figure 48D , 48E The front view is shown in 48G, while Figure 48HThe image shows a bottom view. The device 500A is narrower when viewed from the front than from the side. Viewed from the side, the device 500A has an overall inverted trapezoidal shape, which is rounded and tapers gradually towards the distal portion 507A. Viewed from the front, the device 500A has an overall rounded rectangular shape, which tapers slightly towards the distal portion 507A. Figure 48H The bottom view of the device 500A shown illustrates that the device 500A is visible when viewed from below (and when viewed from above, such as in...). Figure 70A (As can be seen in the image) It has an overall rounded rectangular shape.

[0534] In the closed configuration of device 500A, the inner paddle 522A is arranged between the outer paddle 520A and the engaging element 510A. In some embodiments, device 500A includes a fastener or clamping member 530C. Figure 48A It can be opened and closed to grip the natural leaflets 20, 22 of the mitral valve MV. Fastener 530C is attached to and moves with the inner paddle 522A and is arranged between the inner paddle 522A and the mating element 510A.

[0535] Now for reference Figure 48B-48D Device 500A is attached to delivery device 502A. Delivery device 502A has an actuable member or finger 503A that releasably engages attachment portion 505A. Actuating element 512A extends from delivery device 502A to cap 514A via attachment portion 505A and engaging element 510A of prosthetic device 500A. As described below, extending and retracting actuating element 512A causes device 500A to open and close. Actuating thread / suture 537 extends from delivery device 502A to attach to fastener 530C. Tension can be applied to suture 537 to open fastener 530C and can be released to allow fastener 530C to close. Figure 48F-48G In the middle, device 500A is shown to be separated from delivery device 502A in the deployment state.

[0536] Now for reference Figure 48C and 48EThe device 500A shows a cover 540A. The cover 540A may be formed from a single material element or from multiple segments adjacent to or connected to each other. In an example embodiment, the cover 540A has an outer or lower cover 541A and an inner or upper cover 543A. The outer cover 541A covers a cap 514A, an outer paddle 520A, an inner paddle 522A, and a fastener 530C. The inner cover 543A covers the proximal end of the mating element 510A and the inner paddle 522A and fastener 530C, where the mating element 510A meets the inner paddle 522A and fastener 530C. The cover 540A 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 inward tissue growth.

[0537] Now for reference Figures 53A-53D With 54A-54D, device 500A is shown in a laterally extended or open position. Device 500A is moved to a partially open position by an actuating element or actuating device 512A, which passes through the attachment portion 505A and the mating element 510A and can removably engage the distal portion 507A. The actuating element 512A extends through the attachment portion 505A such that the distance D between the attachment portion 505A and the distal portion 507A increases as the actuating element 512A extends. Figures 53A-53D In the examples shown in 54A-54D, the paired inner and outer paddles 520A and 522A move together rather than independently via a single actuating element 512A. Furthermore, the position of the fastener 530C depends on the position of the paddles 520A and 522A. For example, refer to... Figure 48A The closing paddles 520A and 522A also close the fastener 503C. In one exemplary embodiment, the device 500A may be configured to... Figure 11A The paddles 520A and 522A can be independently controlled in the same manner.

[0538] The extended actuating element 512A pulls down the bottom of the outer paddle 520A and the paddle frame 524A, thereby changing the device 500A from a closed position to a partially open position. With the inner paddle 522A connected to the outer paddle 520A and the paddle frame 524A, the outer paddle 520A and the paddle frame 524A pull down the inner paddle 522A. Because the attachment portion 505A and the mating element 510 remain in place, the inner paddle 522A pivots or flexes in the opening direction. The inner paddle 522A, the outer paddle 520A, and the paddle frame all flex to... Figure 53AAs shown in the diagram. Opening the paddles 522A, 520A and the frame 524A creates a gap 520D between the mating element 510A and the inner paddle 522A, which receives and grips the natural leaflet 20.

[0539] The extended actuating element 512A pulls down the outer paddle 520A and paddle frame 524A, causing the inner paddle 522A to extend further away from the engaging element 510A. In the laterally extended or open position, the inner paddle 522 extends horizontally more than in other positions of the device 500A and forms an angle of approximately 90 degrees with the engaging element 510A. Similarly, when the device 500A is in the laterally extended or open position, the paddle frame 524A is in its maximum extended position. The increased gap 520D formed in the laterally extended or open position allows the fastener 530C to open further before engaging the engaging element 510A. Figure 54A This increases the size of the gap 530D compared to the partially open position.

[0540] As described above, some embodiments of device 500A include a fastener or clamping member 530C. When device 500A is opened, the fastener 530C is exposed. In some embodiments, the closed fastener 530C ( Figures 53A-53D ) can be opened ( Figures 54A-54D This creates a second opening or gap 530D to receive and capture the natural leaflets 20, 22. The extent of the gap 530D in the fastener 530C is limited by the degree of unfolding of the inner paddle 522A away from the mating element 510A.

[0541] Now for reference Figures 60A-60D With references 61A-61D, device 500A is shown in the fully extended position. By continuing to extend the aforementioned actuating element 512A, the distance D2 between the attachment portion 505A and the distal portion 507A is increased to the maximum allowable distance for device 500A, causing device 500A to move to the fully extended position. Continuing to extend the actuating element 512A pulls the outer paddle 520A and paddle frame 524A, causing the inner paddle 522A to extend further away from the mating element 510A. The outer paddle 520A and paddle frame 524A move to a position close to the actuating element. In the fully extended position, the inner paddle 522A is opened to approximately a 180-degree angle with the mating element 510A. In the fully extended position, the inner paddle 522A and outer paddle 520A are stretched straight or substantially straight to form an approximately 180-degree angle between paddles 522A and 520A. The fully extended position of device 500A provides the maximum dimension of the gap 520D between the paddles, and in some embodiments, allows fasteners 530C to also be fully opened to approximately 180 degrees between the portions of fasteners 530C. Figure 61AThe position of device 500A is the narrowest configuration. Therefore, the fully extended position of device 500A can be the desired position for rescuing device 500A from the site of attempted implantation, or the desired position for placing the device in the delivery catheter, or a similar position.

[0542] Now for reference Figures 197-198 It shows Figure 60C A magnified view of the portion. Refer to [the image now]. Figure 197 As can be seen, the inner cover 543A covers the mating element 510A from the proximal portion 519B to the distal portion 517A. In some embodiments, the inner cover 543A is a flat sheet of fabric material such as a fine-mesh polyethylene cloth (see...). Figure 201 It is formed and folded around mating element 510A and held in place by stitch 545A. Now refer to Figure 198 The outer cover 541A covers the fastener 530C and the inner paddle 522A. The collar 548A of the inner cover 543A covers the portion of the fastener 530C and the inner paddle 522A closest to the mate element 510A. The transition portion 547A of the inner cover 543A extends from the mate element 510A to the collar portion 548A to provide a smooth transition between the mate element 510A and the fastener 530C and the inner paddle 522A, preventing natural tissue from becoming trapped on the device 500A during implantation.

[0543] Now for reference Figure 199 An exploded view of the device 500A is shown. The mating element 510A, outer paddle 520A, and inner paddle 522A are formed from a single material strip 501A, as described above. A collar 511D, a cap 514A, a paddle-shaped frame 524A, and a fastener 530C are assembled to the material strip 501A to form the device 500A. The cap 514A includes a retaining body 560A with a locking hole 561A for receiving a retaining nut 562A with a threaded hole 564A that engages the threaded portion 568A of a retaining bolt 566A. The threaded portion 568A of the retaining bolt 566A is inserted through an opening 527B to engage the retaining body and the nuts 560A and 562A, thereby attaching the cap 514A to the material strip 501A.

[0544] In some embodiments, the hardening member 539C is attached to the inner paddle 522A to harden the inner paddle 522A, thereby maintaining the inner paddle in a straight or substantially straight configuration as it moves between various positions. A cutout 539D in the hardening member 539C is shaped to receive the retaining arm 532C of the fastener 530C, such that when both the hardening member 539C and the fastener 530C are attached to the inner paddle 522A, the hardening member 539C can be fitted around the retaining arm 532C. Like the retaining arm 532C, the hardening member 539C can be coupled to the inner paddle 522A in various ways, such as using sutures, adhesives, fasteners, welding, stitching, molding, friction fitting, and / or other coupling means.

[0545] Now for reference Figure 200 This image shows an enlarged view of a collar 511A attached to the proximal portion 519B of the mating element 510A. The collar 511A includes a protrusion 511E for releasably engaging a finger 503A of a delivery device 502A. A hole 515A in the collar 511A receives an actuating element 512A. The proximal portion 519B of the mating element 510A flares outward to form two rings 519D, which are inserted through an arcuate opening 513A in the collar 511D to attach the collar 511D to the proximal portion 519B of the mating element 510A. The rings 519D are formed by folding a strip of material 501A to form a first layer 581A and a second layer 582A. In some embodiments, the arcuate opening 513A includes a similar opening (not shown).

[0546] Now for reference Figures 201-202 The images show enlarged and exploded views of the 514A cap, respectively. Figure 201 An enlarged view of the cap 514A, which is attached to the distal portion 527A of the material strip 501A, is shown. A retaining body 560A, a retaining nut 562A, and a retaining bolt 566A engage to attach the paddle frame 524A to the distal portion 527A of the material strip 501A. Specifically, the retaining bolt 566A is inserted through an opening 527B in the distal portion 527A. Figure 202 This prevents the cap 514A from moving along the material strip 501A. The channel 560B in the body 560A and the flange 567A of the bolt 566A form the distal portion 527A through the passage 514B of the cap 514A.

[0547] Now for reference Figure 202The components of cap 514A are shown in an exploded view to better illustrate the features of the components of cap 514A and paddle frame 524A and to show how these features interlock during the assembly of cap 514A to distal portion 527A. Cap 514A is formed by multiple components that can be assembled around material strip 501A, allowing cap 514A to be attached after material strip 501A has been folded to form mating elements 510A and paddles 520A, 522A, and woven through collar 511D and paddle frame 524A.

[0548] The retaining body 560A includes a locking hole 561A for receiving a retaining nut 562A. The locking hole 561A has a generally rectangular shape and includes two opposing locking channels 561B for receiving an attachment portion 524C of a paddle frame 524A. A transverse locking channel 561C formed in the bottom of the retaining body 560A has the same width as the locking channels 561B. The paddle frame 524A includes a notch 524D in the attachment portion 524C that forms an engagement with the transverse locking channel 561A to secure the paddle frame 524A to a hook 524E of a cap 514A.

[0549] The retaining nut 562A includes a rectangular locking body 563A extending distally from the flange 563B. The locking body 563A is configured to slidably engage a locking hole 561A of the retaining body 560A while leaving the locking channel 561B unobstructed. Thus, the locking body 563A can be inserted into the locking hole 561A to lock the attachment portion 524C of the paddle frame 524A within the locking channel 561B. A notch 563C in the flange 563B receives the attachment portion 524C of the paddle frame 524A. A threaded hole 564A is formed through the retaining nut 562A to receive a retaining bolt 566A.

[0550] The retaining bolt 566A includes a threaded portion 568A extending from the flange 567A. The threaded portion 568A is inserted through an opening 527B in the distal portion 505A to threadedly engage a threaded hole 564A of the retaining nut 562A. The flange 567A has a rounded shape that provides a rounded end to the distal portion 507A of the device 500A. The flange 567A includes an opening 567B for receiving a tool (not shown) for engaging the bolt 566A, such that the bolt 566A can be rotated during assembly to join the components of the cap 514A together.

[0551] To assemble the paddle frame 524A and cap 514A to the distal portion 527A, the paddle frame 524A is compressed to narrow the width of the attachment portion 524C, allowing the attachment portion 524C to be inserted into the locking channel 561B of the locking hole 561A. When the paddle frame 524A is allowed to expand, the attachment portion 524C expands outward, causing the notch 524D to engage the retaining body 560A and the hook 524E to engage the lateral locking channel 561C. A locking nut 562A is then inserted into the locking hole 561A, wherein a locking portion 563A is arranged between the two attachment portions 524C of each paddle frame 524A, thereby locking the paddle frame 524A into engagement with the retaining body 560A. The assembled paddle frame 524A, retaining body 560A, and retaining nut 562A are positioned on the distal portion 527A such that the threaded hole 564A is aligned with the opening 527B and the threaded portion 568A of the bolt 566A is inserted through the opening 527B to threadedly engage the threaded hole 564A. The bolt 566A is then tightened until the flange 567A engages the retaining body 560A and the cap 514A is securely assembled to the distal portion 527A.

[0552] Now for reference Figure 203 and 204 This image shows a portion of a cover 540A cut from a flat sheet of material. Cover 540A includes an outer cover 541A and an inner cover 543A. Each of covers 541A and 543A includes segments or portions of different shapes for attachment to different parts of device 500A. Specifically, covers 541A and 543A are shaped to smooth transitions between portions of device 500A, thereby reducing catch points and providing a smoother exterior for device 500.

[0553] Each segment of the covers 541A, 543A extends from a central portion, which is shaped to attach to an end of the device 500A. In other embodiments, portions of the covers 541A, 543A attached to the end of the device 500A are located at the end of the covers 541A, 543A, or may be located anywhere between the central and end portions of the covers 541A, 543A. Each portion of the covers 541A, 543A may be shaped to wrap around a portion of the device 500A. The cover 540A may be made of 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 may be formed from any number of pieces of material attached to the device and / or joined together by any suitable means such as sewing, adhesives, welding, or similar methods.

[0554] refer to Figure 60C and 204An outer cover 541A extends outward from the middle portion 580 to the end portion 588. The middle portion 580 is shaped to attach to the cap 514A of the device 500A. An outer paddle portion 582 extends from the middle portion 580 to the inner paddle and inner fastener portion 584. The inner paddle and inner fastener portion 584 extends from the outer paddle portion 582 to the outer movable fastener portion 586. The outer movable fastener portion 586 extends from the inner paddle and fastener portion 584 to the end portion 588.

[0555] The outer paddle portion 582 includes wings 583 that extend laterally to a width wider than the rest of the outer cover 541A, allowing the outer paddle portion 582 to be attached to the outer paddle 520A and paddle frame 524A of the device 500A. The inner paddle and fastening portion 584 is attached to the inner surfaces (the barbed side) of the inner paddle 522A, the stationary arm 532C, and the movable arm 534C. The outer fastening portion 586 is attached to the outer surface (the barbless side) of the movable arm 534C of the fastener 530C. The end 588 of the outer cover 541A terminates on the outer side of the fastener 530C near the connecting portion 538C. The inner paddle and inner fastening portion 584 includes an opening 585 that allows the barbs 536 of the fastener 530C to protrude through the outer cover 541A to engage tissue of a natural heart valve.

[0556] refer to Figure 60C and 203 An inner cover 543A extends outward from a middle portion 590 to an end portion 598. The middle portion 590 is configured to attach to a collar 511D of the device 500A. When the middle portion 590 is attached to the collar 511D, an opening 591 in the middle portion 590 exposes a protrusion 511E from the collar 511D, allowing the protrusion 511E to be engaged by the delivery device 502A. A mating portion 592 extends from the middle portion 590 to a flexible hinge portion 594. Holes 593 along the edges of the mating portions 592 allow the mating portions 592 to be joined together after folding around the mating element 510A (e.g., via stitch 545A). The flexible hinge portion 594 extends from the mating portion 592 to a transition portion 596. The transition portion 596 extends from the flexible hinge portion 594 to the end portion 598. Holes 597 along the edge of transition portions 596 allow each transition portion 596 to wrap around the ends of the inner paddle 522A and fastener 530C and be secured to itself by stitching or other suitable fastening means. When the device 500A is opened, the flexible hinge portion 594 bridges the gap between the mating element 510A and the fastener 530C, such as... Figure 198 As can be seen in the text.

[0557] Now for reference Figures 62A-64CThe implantable device 700 is shown. The implantable device 700 has a paddle-like structure 702 that opens and closes against a fastener or clamping device 704 to grasp leaflets 20, 22. The paddle-like structure 702 moves to create an opening 706 between the paddle-like structure 702 and the clamping device 704, through which leaflets 20, 22 can be grasped. The device 700 can be configured to close a wide gap 26 in a natural heart valve MV, TV. Figure 6 Additionally, the implantable device 700 may include any other features used for the device discussed in this application, and the device 700 may be positioned to engage valve leaflets 20, 22—as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). The device 700 may include any other features used for the implantable prosthetic device discussed in this application, and the 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).

[0558] refer to Figure 62A The paddle 702 of the device 700 moves, rotates, or pivots outward in direction X to create an opening 706 between the paddle 702 and the clamping member 704, which has a width W. The width W can be, for example, between about 5 mm and about 15 mm, such as between 7.5 mm and about 12.5 mm, such as about 10 mm. In an alternative embodiment, the width W can be less than 5 mm or greater than 15 mm.

[0559] refer to Figure 62B The paddle 702 of the device 700 moves outward in 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 between about 10 mm and about 20 mm, such as between about 12.5 mm and about 17.5 mm, such as about 15 mm. In some embodiments, the width H can be less than 10 mm or greater than 25 mm. In some embodiments, the ratio between width H and 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 outward in direction X, and then moves outward in direction Z to create an opening 706 with a width H between the paddle 702 and the clamping member 704. Optionally, the device 700 can be configured such that the paddle moves outward in direction Z and then moves outward or pivots in direction X to create a width H between the paddle 702 and the clamping member 704. Alternatively, the device 700 can be configured such that the paddle 702 moves outward or pivots in direction X and simultaneously moves outward in direction Z to create a width H between the paddle 702 and the clamping member 704.

[0560] Figures 63A-63C An implantable device 700 is illustrated, wherein a paddle 702 moves, rotates, or pivots outward in direction X, and then moves outward in direction Z to create a wider opening 706. Figure 63A An implantable device 700 is illustrated in a closed position such that a paddle 702 engages a clamping member 704. (See reference...) Figure 63B The paddle-shaped structure 702 moves outward or pivots in direction X to create an opening 706 with width W to receive valve tissue. (Reference) Figure 63C After the paddle 702 moves outward or pivots in direction X, it moves outward in direction Z, causing the opening 706 to have a width H. After the valve tissue is received in the opening 706 between the paddle 702 and the clamping member 704, the valve repair device returns to the closed position (e.g., Figure 63A (as shown), to secure the valve repair device 700 to the valve tissue. The implantable device 700 may include any other features used for implantable devices discussed in this application, and the implantable device 700 may be positioned to engage valve tissues 20, 22—as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0561] Figures 64A-64C An implantable device 700 is illustrated, wherein a paddle 702 moves outward in direction Z and subsequently moves outward, extends, or pivots in direction X to create a wider opening 706. Figure 64A An implantable device 700 is illustrated in a closed position, such that the paddle 702 engages the clamping member 704. (See reference...) Figure 64B The paddle-shaped prong 702 moves outward in direction Z to create an opening 706 with width W to receive valve tissue. (Reference) Figure 64C After the paddle 702 moves outward in direction Z, the paddle 702 moves outward or pivots in direction X, such that the opening 706 has a width H. After the valve tissue is received in the opening 706 between the paddle 702 and the clamping member 704, the implantable device 700 is moved back to the closed position (as described above). Figure 64A (as shown) to secure the implantable device 700 to the valve tissue. The implantable device 700 may include any other features used for implantable devices discussed in this application, and the implantable device 700 may be positioned to engage valve tissues 20, 22—as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0562] Although Figures 63A-63C An example is given of a device 700 in which the paddle 702 moves or pivots and then unfolds. Figures 64A-64CAn example is given of a device 700 in which the paddle 702 is deployed and then moved or pivoted; however, in alternative embodiments, the device 700 may include paddles 702 that are simultaneously deployable and movable or pivotable. Additionally, in some embodiments, the paddles 702 may be deployed and moved or pivoted independently of each other. That is, in Figures 63A-63C In embodiments of the valve repair device 700 shown in 64A-64C and in embodiments in which the deployment and movement or pivoting of each paddle 702 are performed simultaneously, the paddles 702 can be controlled independently of each other.

[0563] Now for reference Figure 65-83 This shows an exemplary implantable device 500 in a closed state. Now refer to... Figures 65-66 The device 500 extends from a proximal portion 505 to a distal portion 507 and includes an apposition portion 510, an inner paddle 522, an outer paddle 520, and a paddle frame 524. In some embodiments, the outer paddle 520 extends to and / or around the paddle frame 524 and may have more than one layer surrounding the paddle frame 524. The proximal portion 505 may include a collar 511 for attaching a delivery device (not shown). The distal portion 507 may include a cap 514 that attaches (e.g., connectably attaches, etc.) to the outer paddle 520 and engages via an actuating element (not shown) to open and close the device 500 to facilitate implantation in a natural valve as described in this application.

[0564] Now for reference Figures 67-68 The image shows a front view of device 500. Device 500 has a shape that is symmetrical or substantially symmetrical about a vertical anterior-posterior plane 550, and the distal portion 507 is generally narrower than the proximal portion 505. The mate element 510 and the paddle frame 524 are rounded or generally rounded in shape to prevent device 500 from getting stuck or blocked on cardiac structures such as chordae tendineae during implantation. For this reason, the proximal collar 511 ( Figure 68 ) and hat 514 ( Figure 68 It also has rounded edges. When viewed from the front or rear, the paddle frame 524 can be seen to have a rounded or generally rounded shape, extending upward and outward from the distal portion 507 to generally conform to the shape of the mating element 510 when viewed from the front or rear. Thus, the mating element 510 and the paddle frame 524 generally define the shape of the device 500 when viewed from the front or rear. In addition, the rounded shape of the paddle frame 524 and the corresponding rounded shape of the mating element allow the leaflet stress to spread across a wider surface distribution. In some exemplary embodiments, the paddle frame 524 and / or the mating element 510 may have other shapes.

[0565] Now for reference Figure 69This shows a side view of device 500. (Compared to the front and rear views.) Figure 1 Sample( Figures 67-68 When viewed from the side, device 500 has a shape that is symmetrical or substantially symmetrical about a vertical side-to-side plane 552. When viewed from the side, the distal portion 507 is also generally narrower than the proximal portion 505. The mating element 510 optionally also has a tapered or generally tapered shape that tapers towards the distal portion 507 of device 500. However, in some exemplary embodiments, the mating element does not gradually taper as it extends from the proximal portion of the device to the distal portion.

[0566] The rounded feature of device 500 is further confirmed by the circular shapes of the paddles 520 and 522 at the junction of the inner and outer paddles 522, and the circular shape of the paddle frame 524. However, the paddles 520, 522, and paddle frame 524 can take many different forms. For example, the paddles 520, 522, and paddle frame 524 can be rounded along their upper edges, but flat or substantially flat on the sides of the paddles 520, 522, and / or the paddle frame. By making the paddles 520, 522 flat or substantially flat on their sides, the two devices can be implanted side by side on the natural valve leaflet, with the two devices sitting flush or substantially flush with each other.

[0567] The closed paddle-shaped structures 520, 522 create a gap 542 between the inner paddle-shaped structure 522 and the mating element 510, the gap 542 being configured to receive natural tissue. Figure 69 As can be seen, the narrowing of the mating element 510 imparts a slightly teardrop shape to the gap 542, whose width increases as the gap 542 approaches the distal portion 507 of the device. The widening of the gap 542 toward the distal portion 507 allows the paddles 520, 522 to contact the gripped tissue in the gap 542 closer to the proximal portion 505.

[0568] The paddle frame 524 extends vertically from the distal portion 507 toward the proximal portion 505 to approximately one-third of the middle of the device 500, then bends or opens outwards such that the connecting portion of the frame 524 passes through the gap 544 formed by the inner paddle 522 folded inside the outer paddle 520. However, in other embodiments, the connection of the frame is located inside the inner paddle 522 or outside the outer paddle 520. When viewed from the front or rear, the outer paddle 520 has a rounded shape similar to the mating element 510. Figures 67-68 Therefore, device 500 has a rounded or substantially rounded shape. From the top ( Figures 70-71 ) or bottom ( Figures 72-73 When viewing the device 500, its rounded shape is particularly noticeable.

[0569] Now for reference Figures 70-71 The image shows a top view of device 500. Viewed from above, device 500 has a shape that is symmetrical or substantially symmetrical about the front-rear plane 550 and also symmetrical or substantially symmetrical about the side-side plane 552. The opening 519A in the mating element 510 is visible in the proximal portion 505 of device 500. Figure 70 It can be seen that the mating element 510 can be hollow inside. Figure 71 The proximal collar 511 shown can be fixed to the mating element 510 to close the mating element 510.

[0570] In one exemplary embodiment, the mating element is not planar and has various curved surfaces. For example, the mating element 510 exemplified herein may be formed from a series of mixed surfaces having a variety of different radii of curvature. When viewed from above, the mating element 510 has an oval or generally oval shape. However, in some exemplary embodiments, the mating element 510 may have other shapes when viewed from above. For example, the mating element may have a rectangular, square, rhomboid, elliptical, or any other shape. The paddle frames 524 each have an arcuate shape with a radius smaller than that of the mating element 510, such that the gap 542 formed between the inner paddle 522 and the paddle frames 524 and the mating element 510 gradually tapers as they approach the left side 551 and right side 553 of the device 500. Thus, natural tissues, such as leaflets 20, 22, tend to be sandwiched between the paddle frames 524 and the mating element 510 at the left side 551 and right side 553 of the device 500.

[0571] Now for reference Figures 72-73 This shows a bottom view of device 500. Similar to a top view (…). Figures 70-71 When viewed from the bottom, the device 500 has a shape that is symmetrical or substantially symmetrical about the front-rear plane 550 and also symmetrical or substantially symmetrical about the side-side plane 552. The cap 514 is shown... Figure 73 It can be connected to the outer paddle 520 and the paddle frame 524.

[0572] 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 relative to the side-to-side plane 552. As the paddle frame 524 extends toward the proximal portion of the device 500, it extends further away from the side-to-side plane 552. Figure 69 ), to ultimately form Figures 70-71 The bow shape shown.

[0573] Now for reference Figures 74-83 This shows a perspective view and a cross-sectional view of device 500. Now refer to... Figure 74This shows that the device 500 is cut by a cross-section 75 near the proximal portion of the mating element 510. Now refer to... Figure 75 , showing from Figure 74 The cross-section 75 is a cross-sectional view of the device 500. At the location of plane 75, the mating element 510 has a circular or generally circular shape, wherein circular lobes are arranged along the front-rear plane 550. The gap 542 between the paddle frame 524 and the mating element 510 forms a crescent shape with a central width 543. As described above, the gap 542 narrows as it approaches the left side 551 and the right side 553.

[0574] Now for reference Figure 76 This shows that the device 500 is cut by a cross-section 77 located approximately three-quarters of the distance between the distal portion 507 and the proximal portion 505 of the mating element 510. Now refer to... Figure 77 It shows from Figure 76 The cross-section 77 is a cross-sectional view of the device 500. At plane 75, the mating element 510 has an oval or generally oval shape oriented along the side-to-side plane 552. The gap 542 between the paddle frame 524 and the mating element 510 forms a crescent shape, with a central width 543 less than [missing information]. Figure 75 The center width 543 is shown. At position 77, the width 543 of the gap 542 narrows closer to the center of the device, widens slightly as the gap 542 approaches the left side 551 and the right side 553, and then narrows again. Therefore, the natural tissue is clamped in the center of the gap 542 at about 3 / 4 of the distance along the mating element 510.

[0575] Now for reference Figure 78 This shows that the device 500 is cut by a cross-section 79 located approximately halfway between the distal portion 507 and the proximal portion 505 of the mating element 510. Now refer to... Figure 79 , showing from Figure 78 The cross-sectional view of the device 500 is shown at plane 79. At plane 79, the mating element 510 has an oval or generally oval shape oriented along the side-to-side plane 552. The paddle frame 524 is visible very close to or in contact with the mating element 510 near the left side 551 and right side 553. The gap 542 is crescent-shaped or generally crescent-shaped and wider than the gap 542 viewed along plane 77. Figure 77 ).

[0576] Now for reference Figure 80 This shows that the device 500 is cut by a cross-section 81 located approximately one-quarter of the distance between the distal portion 507 and the proximal portion 505 of the mating element 510. Now refer to... Figure 81 , showing from Figure 80The cross-section 81 is a cross-sectional view of the device 500. At the location of plane 81, the mating element 510 has an oval or generally oval shape oriented along the side-to-side plane 552, which is narrower than... Figure 77 The oval shape is shown. The paddle-shaped frame 524 is visible very close to or in contact with the mating element 510 near the left side 551 and right side 553. The gap 542 is crescent-shaped or generally crescent-shaped, and wider than the gap 542 viewed along plane 79. Figure 79 ).

[0577] Now for reference Figure 82 This shows that the device 500 is cut by a cross-section 83 located near the distal portion 507 of the mating element 510. Now refer to... Figure 83 , showing from Figure 82 The cross-section 83 is a cross-sectional view of the device 500. At the location of plane 83, the mating element 510 has an oval or generally oval shape oriented along the side-to-side plane 552, which is narrower than... Figure 79 The oval shape shown is due to the fact that the mating element 510 becomes thinner (narrower) closer to the distal portion 507 of the device 500. The paddle frame 524 is visible very close to or in contact with the mating element 510 near the left side 551 and right side 553. Although the inner paddle 522 is... Figure 81 The gap 542 is not visible in the center, but it is crescent-shaped or generally crescent-shaped, and wider than the gap 542 viewed along plane 81. Figure 81 ).

[0578] Now for reference Figure 65A , 66A Model implantable device 500A is shown in a closed state, as shown in models 67A, 68A, 70A, 71A, 72A, 73A, 74A, 75A, 76A, 77A, 78A, 79A, 80A, 81A, 82A, and 83A. Reference now. Figure 65A and 66A The device 500A extends from a proximal portion 505A to a distal portion 507A and includes an occlusal portion 510A, an inner paddle 522A, an outer paddle 520A, and a paddle frame 524A. The proximal portion 505A may include a collar 511D for attaching a delivery device (not shown). The distal portion 507A may include a cap 514A that attaches (e.g., connectably attaches, etc.) to the outer paddle 520A and is engaged by an actuating element (not shown) to open and close the device 500A, thereby facilitating implantation in a natural valve as described in this application.

[0579] Now for reference Figure 67A and 68AThe image shows a front view of device 500A. Device 500A has a shape that is symmetrical or substantially symmetrical about a vertical anterior-posterior plane 550A, and the distal portion 507A is generally narrower than the shape along the paddle frame 524A. The mate element 510A and the paddle frame 524A are generally rounded rectangular shapes to prevent device 500A from getting stuck or blocked on cardiac structures such as chordae tendineae during implantation. For this reason, the proximal cuff 511D ( Figure 68A ) and cap 514A ( Figure 68A It also has rounded edges. When viewed from the front or rear, the paddle frame 524A has a generally rounded rectangular shape, extending upward and outward from the distal portion 507A into a shape that is wider on the sides and generally parallel to the mating element 510A when viewed from the front or rear. Therefore, the paddle frame 524A generally defines the shape of the device 500A when viewed from the front or rear. In addition, the rounded rectangular shape of the paddle frame 524A allows the leaflet stress to be distributed across a wider surface. In an exemplary embodiment, the paddle frame 524A and / or the mating element 510A may have other shapes.

[0580] With front view and rear view Figure 1 Sample( Figure 67A and 68A When viewed from the side, device 500A has a shape that is symmetrical or substantially symmetrical about the vertical side-to-side plane 552A. When viewed from the side, the distal portion 507A is also generally narrower than the proximal portion 505A. Figure 48B In the illustrated embodiment, the mating element 510A does not taper gradually as it extends from the proximal portion 505A of the device 500A to the distal portion 507A of the device 500A. However, in some exemplary embodiments, the mating element does not taper gradually as it extends from the proximal portion of the device to the distal portion of the device (e.g., Figure 47 ).

[0581] The generally rounded feature of device 500A is further confirmed by the rounded shape of the paddles 520A and 522A where the inner paddle 520A and outer paddle 522A are joined together. However, the paddles 520A, 522A and the paddle frame 524A can take many different forms. For example, the paddles 520A, 522A and the paddle frame 524A can be rounded along their upper edges and flat or substantially flat on their sides (e.g., the paddle frame 524A is arranged on the front and rear sides of device 500A). By making the paddles 520A and 522A flat or substantially flat on their sides, the two devices can be implanted side by side on the natural valve leaflet, with the two devices sitting flush or substantially flush with each other.

[0582] The closed paddle-shaped elements 520A and 522A create a gap 542A between the inner paddle-shaped element 522A and the mating element 510A, the gap 542A being configured to receive natural tissue. Figure 48B and 48F As can be seen, the proximal end of the mating element 510A has a shape similar to a dog-bone, making the gap 542A narrower towards the proximal portion 505A than the gap 542A approaches the distal portion 507A of the device. This narrowing of the gap 542A towards the attachment portion 507A allows the paddles 520A and 522A to contact the tissue gripped in the gap 542A closer to the proximal portion 505A.

[0583] The paddle frame 524A extends vertically from the distal portion 507A toward the proximal portion 505A to approximately the middle third of the device 500A, then bends or opens outwards such that the connecting portion 524B of the frame 524A passes through the gap 544A formed by the inner paddle 522A folded inside the outer paddle 520A. However, in other embodiments, the connection of the frame is located 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 the mating element 510A. Figure 67A and 68A Therefore, the device 500A has a rounded rectangular shape. When viewed from the top ( Figure 70A and 71A ) or bottom ( Figure 72A and 73A When viewing the device 500A, its rounded rectangular shape is particularly noticeable.

[0584] Now for reference Figure 70A and 71A The image shows a top view of device 500A. Viewed from above, device 500A has a shape that is symmetrical or substantially symmetrical about the front-rear plane 550A and also symmetrical or substantially symmetrical about the side-side plane 552A. A proximal opening 519C in mating element 510A is visible in the proximal portion 505A of device 500A. Actuating element 512A is received through opening 519C such that mating element 510A surrounds actuating element 512A. In some embodiments, opening 519C is formed by inserting actuating element 512A between folds and overlaps of material strip 501A (described in detail below). In other embodiments, opening 519C is formed by shaping the folds of material strip 501A forming mating element 510A around a blank or jig to give mating element 510A a rounded or substantially rounded shape. Figure 71AThe proximal collar 511D shown is secured to the mating element 510A to close the mating element 510A. The proximal collar 511D includes an attachment portion 513A that engages with an opening 546A formed by a folded layer of material strip 501A forming the mating element 510A. In some embodiments, the attachment portion 513A is a hole in the collar 511D such that the material strip 501A must be inserted through the collar 511D before folding the material strip 501A during assembly of the device 500A. In some embodiments, the attachment portion 513A is an opening slot (e.g., the attachment portion 524B of the paddle frame 524A) that receives the material strip 501A before or after folding.

[0585] As described above, when viewed from above, the mating element 510A has a generally rectangular shape. In some exemplary embodiments, the mating element 510A may have other shapes when viewed from above. For example, the mating element may be circular, square, rhomboid, elliptical, or any other shape. The paddle frames 524A each have a rounded rectangular shape when viewed from above, such that the paddle frames 524A surround the rectangular mating element 510A. Therefore, natural tissues, such as leaflets 20, 22, tend to be uniformly clamped or compressed in the gap 542A between the inner paddle 522A and the paddle frames 524A and the mating element 510A.

[0586] Now for reference Figure 72A and 73A This shows a bottom view of device 500A. (Compared to a top view...) Figure 70A and 71A Similarly, when viewed from the bottom, device 500A has a shape that is symmetrical or substantially symmetrical about the front-rear plane 550A and also symmetrical or substantially symmetrical about the side-side plane 552A. The distal portion 527A of the material strip 501A includes a receiving... Figure 73A The hole 527B of the cap 514A shown.

[0587] The paddle frame 524A extends outward from the distal portion 507A of the device 500A to the left side 551A and the right side 553A, forming a narrow angle or small angle with the side-to-side plane 552A. As the paddle frame 524A extends toward the proximal portion 505A of the device 500A, the paddle frame 524A extends further away from the side-to-side plane 552A, while maintaining a generally constant distance relative to the front-to-rear plane 550A. Figure 65A To ultimately form Figure 70A and 71A The rounded rectangular shape shown.

[0588] In one exemplary embodiment, the size of device 500A is selected to minimize the number of implants (preferably one) a patient would require, while 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 lateral-lateral distance Y67C of the spacer at its widest point is less than 6 mm. In one exemplary embodiment, the overall geometry of device 500A may be based on these two dimensions and the overall shape strategy described above. It should be apparent that using other anterior-posterior distances Y47I and lateral-lateral distances Y67C as the starting point for device 500A will result in devices with different dimensions. Furthermore, using other dimensions and the shape strategy described above will also result in devices with different dimensions.

[0589] Tables D and E provide dimensional values ​​and ranges for some exemplary embodiments of device 500A, as well as examples of components of device 500A. However, device 500A may have many 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 examples of linear dimensions Y in millimeters and ranges of linear dimensions in millimeters for device 500A and its components. Table B provides examples of radial dimensions S in millimeters and ranges of radial dimensions in millimeters for device 500A and its components. The subscripts of each dimension indicate the first appearance of that dimension in the accompanying drawing.

[0590]

[0591]

[0592] Now for reference Figure 74A , 75A Figures 76A, 77A, 78A, 79A, 80A, 81A, 82A, and 83A show perspective and cross-sectional views of device 500A. Now refer to... Figure 74A This shows that the device 500A is cut by a cross section 75A near the proximal portion of the mating element 510A. Now refer to... Figure 75A It shows from Figure 74A The cross-section 75A shows a cross-sectional view of the device 500A. At the location of plane 75A, the mating element 510A has a generally rounded rectangular shape. The gap 542A between the inner paddle 522A and the mating element 510A has a width 542B. As described above, the gap 542A has a consistent or generally consistent width.

[0593] Now for reference Figure 76A The image shows that device 500A is cut by a cross-section 77A located approximately three-quarters of the distance between the distal portion 507A and the proximal portion 505A of mating element 510A. Now refer to... Figure 77A It shows from Figure 76A The cross-sectional view of device 500A is shown in section 77A. Figure 76A and 77A As can be seen, the material strips 501A forming the device 500A are overlapped in the region of the mating element 510A to form four layers. Each single-layer material strip 501A forms one of the inner paddle 522A and the outer paddle 520A. At plane 75A, the mating element 510A has an generally rectangular shape oriented along the side-to-side plane 552A. The gap 542A between the inner paddle 522A and the mating element 510A is visible. The width 542B of the gap 542A between the inner paddle 522A and the mating element 510A is greater than... Figure 75A The width 542B seen in the diagram. The gap 544A between the outer paddle 520A and the inner paddle 522A has a consistent or generally consistent width 544B for receiving the attachment portion 524B of the paddle frame 524A.

[0594] Now for reference Figure 78A This shows that device 500A is cut by a cross-section 79A located approximately halfway between the distal portion 507A and the proximal portion 505A of device 500A. Now refer to... Figure 79A It shows from Figure 78A The cross-sectional view of device 500A as seen in cross-section 79A. (See also...) Figure 78A and 79A As can be seen, the material strips 501A of the forming device 500A are overlapped to form four layers in the region of the mating element 510A, two layers in the region of the inner paddle 522A, and one layer in the region of the outer paddle 520A. At position 79A, the mating element 510A has an generally rectangular shape oriented along the side-to-side plane 552A. The width 542B of the gap 542A between the inner paddle 522A and the mating element 510A is... Figure 77A The width seen is the same as or approximately the same as 542B.

[0595] Now for reference Figure 80A This shows that device 500A is cut by a cross section 81A located approximately one-quarter of the distance between the distal portion 507A and the proximal portion 505A of device 500A. Now refer to... Figure 81A , showing from Figure 80A The cross-sectional view of device 500A is shown in section 81A. Figure 80A and 81AAs can be seen, the material strips 501A of the forming device 500A are overlapped to form four layers in the region of the mating element 510A, two layers in the region of the inner paddle 522A, and the outer paddle 520A is formed by one layer. At the plane 81A, the mating element 510A has an generally rectangular shape oriented along the side-to-side plane 552A. The width 542B of the gap 542A between the inner paddle 522A and the mating element 510A is... Figure 79A The center width seen in the figure is approximately the same as that of 542B.

[0596] Now for reference Figure 82A This shows that device 500A is cut by a cross-section 83A located approximately one-quarter of the distance between the distal portion 507A and the proximal portion 505A of device 500A. Now refer to... Figure 83A , showing from Figure 82A The cross-sectional view of device 500A is shown in section 83A. Figure 82A and 83A As can be seen, the material strips 501A of the forming device 500A are overlapped to form four layers in the region of the mating element 510A, two layers in the region of the inner paddle 522A, and a single layer forms the outer paddle 520A. At the position of plane 83A, the mating element 510A has an overall rectangular shape oriented along the side-to-side plane 552A. The gap 542A between the inner paddle 522A and the mating element 510A forms an arc shape, the width of which is 542B. Figure 81A The center width seen in the figure is approximately the same as that of 542B.

[0597] Now for reference Figures 84-88 Examples of implantable devices 100, 500, and 500A without fasteners or hinged clamping members are shown in 86A, 87A, and 88A. Figures 84-88 The exemplary devices 100, 500, 500A shown in 86A, 87A and 88A have paddle-shaped portions integrated into the mating element or anchoring portion of the device to facilitate gripping of natural heart valve tissue. Barbs or clamping members 800 / 800A and / or 802 / 802A are also included.

[0598] Now for reference Figure 84The exemplary implantable device 100 is shown to exclude hinged fasteners or clamping elements. As described above, the device 100 is deployed from a delivery sheath or delivery device 102 and includes an engagement portion 104 and an anchoring portion 106. The engagement portion 104 of the device 100 includes an engagement element or engagement device 110, which is adapted to be implanted between the leaflets 20, 22 of a natural valve (e.g., mitral valve MV, etc.) and slidably attached to an actuating element or shaft 112 extending through the engagement element or engagement device 110 to a distal cap 114.

[0599] The anchoring portion 106 of device 100 includes an outer paddle 120 and an inner paddle 122 connected between the distal cap 114 and the occlusal element or occlusal device 110. The anchoring portion 106 is actuable between open and closed states and can take various forms, such as clamping elements like paddles, fasteners, and / or similar forms. Actuation of the actuating element or actuating device 112 causes the anchoring portion 106 of device 100 to open and close to grip the natural valve leaflets 20, 22 during implantation.

[0600] Figure 84 The illustrated device 100 includes barbed portions 800 disposed on the mating element or mating device 110, rather than hinged fasteners or clamping elements, wherein each side of the mating element or mating device 110 has at least one barbed portion 800. When the anchoring portion 106 of the device 100 is closed, the tissue gripped between the inner paddle 122 and the mating element or mating device 110 presses against the barbed portions 800. The barbed portions 800 may be sharp, such that they engage—and in some embodiments, pierce—natural tissue and prevent the tissue from retracting from the device 100. In some embodiments, the barbed portions 800 are angled downwards to increase engagement with natural tissue.

[0601] Now for reference Figure 85 This illustrates an exemplary implantable device 100 without a separate hinged fastener. As described above, the device 100 is deployed from a delivery sheath or delivery device 102 and includes an occlusion portion 104 and an anchoring portion 106. The occlusion portion 104 of the device 100 includes an occlusion element or occlusion device 110, which is adapted to be implanted between the leaflets 20, 22 of a natural valve or mitral valve MV and slidably attached to an actuating element 112 (e.g., actuating thread, shaft, rod, suture, suture, etc.) extending through the occlusion element or occlusion device 110 to a distal cap 114.

[0602] The anchoring portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 connected between the distal cap 114 and the engagement element or engagement device 110. The anchoring portion 106 is actuable between open and closed states and can take various forms, such as clamping elements, like paddles, fasteners, etc. Actuation of the actuating element or actuating device 112 causes the anchoring portion 106 of the device 100 to open and close to grasp the natural valve leaflets 20, 22 during implantation.

[0603] Figure 85 The illustrated device 100 includes barbed portions 800 disposed on inner paddles 122, rather than separate hinged fasteners or clamping elements, wherein each inner paddle 122 has at least one barbed portion 800. When the anchor portion 106 of the device 100 is closed, tissue gripped between the inner paddle 122 and the engaging element or engaging device 110 presses against the barbed portions 800. The barbed portions 800 are sharp, such that they engage—and in some embodiments, pierce—natural tissue, and prevent tissue from retracting from the device 100. In some embodiments, the barbed portions 800 are angled downwards to increase engagement with natural tissue.

[0604] Now for reference Figure 86 The exemplary implantable device 500 is shown to exclude hinged fasteners or clamping elements. As described above, the device 500 includes an engagement portion 504 and an anchoring portion 506. The engagement portion 504 of the device 500 includes an engagement element 510 adapted to be implanted between the leaflets 20, 22 of a natural valve or natural mitral valve MV and slidably attached to an actuating element or actuating device 512 extending through the engagement element 510 to a distal cap 514.

[0605] The anchoring portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 connected between the distal cap 514 and the apposition element 510. The anchoring portion 506 is actuable between open and closed states and can take various forms, such as clamping elements like paddles, fasteners, and / or similar forms. Actuation of the actuating element 512 causes the anchoring portion 506 of the device 500 to open and close to grip the natural valve leaflets 20, 22 during implantation.

[0606] The device 500 includes barbed portions 800 disposed on inner paddles 522, rather than hinged fasteners or clamping elements, wherein each inner paddle 522 optionally has more than one barbed portion 800. When the anchoring portion 506 of the device 500 is closed, the tissue gripped between the inner paddles 522 and the engaging element 510 presses against the barbed portions 800. The barbed portions 800 are sharp, such that they engage—and in some embodiments, pierce—natural tissue and prevent the tissue from retracting from the device 500. In some embodiments, the barbed portions 800 are angled downwards to increase engagement with natural tissue.

[0607] Now for reference Figure 86A The exemplary implantable device 500A is shown without a hinged fastener or clamping element. As described above, device 500A mates with element 510A, which is adapted to be implanted between the leaflets 20, 22 of a natural valve or natural mitral valve MV and slidably attached to an actuating element or actuating device (not shown) extending through element 510A to a distal cap 514A. Device 500A also includes an outer paddle 520A and an inner paddle 522A connected between the distal cap 514A and the mate 510A. Device 500A is actuable between open and closed states and can take many different forms, such as, for example, clamping elements, like paddles, fasteners, and / or similar forms. Actuation of the actuating element causes the paddles 520A, 522A of device 500A to open and close to grip the natural valve leaflets 20, 22 during implantation.

[0608] The device 500A includes barbed portions 800A disposed on inner paddles 522A, rather than hinged fasteners or clamping elements, wherein each inner paddle 522A optionally has more than one barbed portion 800A. When the device 500A is closed, the tissue gripped between the inner paddles 522A and the engaging element 510A presses against the barbed portions 800A. The barbed portions 800A are sharp, such that they engage—and in some embodiments, puncture—natural tissue and prevent the tissue from retracting from the device 500A. In some embodiments, the barbed portions 800A are angled downwards to increase engagement with natural tissue.

[0609] Now for reference Figure 87 The exemplary implantable device 500 is shown to exclude a separate hinged fastener or clamping element. As described above, the device 500 includes an engagement portion 502 and an anchoring portion 506. The engagement portion 502 of the device 500 includes an engagement element 510 adapted to be implanted between the leaflets 20, 22 of a natural valve or natural mitral valve MV and slidably attached to an actuating element or actuating device 512 extending through the engagement element 510 to a distal cap 514.

[0610] The anchoring portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 connected between the distal cap 514 and the apposition element 510. The anchoring portion 506 is actuable between open and closed states and can take various forms, such as clamping elements like paddles, fasteners, and / or similar forms. Actuation of the actuating element 512 causes the anchoring portion 506 of the device 500 to open and close to grip the natural valve leaflets 20, 22 during implantation.

[0611] The device 500 includes barbed portions 800 disposed on the engaging element 510, rather than a separate hinged fastener or clamping element, wherein each side of the engaging element 510 has more than one barbed portion 800. When the anchoring portion 506 of the device 500 is closed, the tissue gripped between the inner paddle 522 and the engaging element 510 presses against the barbed portions 800. The barbed portions 800 may be sharp, such that they engage—and in some embodiments, pierce—natural tissue, and prevent the tissue from retracting from the device 500. In some embodiments, the barbed portions 800 are angled downwards to increase engagement with natural tissue.

[0612] Now for reference Figure 87A The exemplary implantable device 500A is shown without a hinged fastener or clamping element. As described above, device 500A includes an occlusion element 510A adapted for implantation between the leaflets 20, 22 of a natural valve or natural mitral valve MV and slidably attached to an actuating element or actuating device (not shown) extending through the occlusion element 510A to a distal cap 514A. Device 500A also includes an outer paddle 520A and an inner paddle 522A connected between the distal cap 514A and the occlusion element 510A. Device 500A is actuable between an open and closed state and can take many different forms, such as, for example, clamping elements, like paddles, fasteners, and / or similar forms. Actuation of the actuating element causes the paddles 520A, 522A of device 500A to open and close to grip the natural valve leaflets 20, 22 during implantation.

[0613] The device 500A includes barbed portions 800A disposed on the engaging element 510A, rather than hinged fasteners or clamping elements, wherein each side of the engaging element 510A has more than one barbed portion 800A. When the device 500A is closed, the tissue gripped between the inner paddle 522A and the engaging element 510A presses against the barbed portions 800A. The barbed portions 800A are sharp, such that they engage—and in some embodiments, puncture—natural tissue and prevent the tissue from retracting from the device 500A. In some embodiments, the barbed portions 800A are angled downwards to increase engagement with natural tissue.

[0614] Now for reference Figure 88 The exemplary implantable device 500 is shown to exclude a separate hinged fastener or clamping element. As described above, the device 500 includes an engagement portion 502 and an anchoring portion 506. The engagement portion 502 of the device 500 includes an engagement element 510 adapted to be implanted between the leaflets 20, 22 of a natural valve or natural mitral valve MV and slidably attached to an actuating element or actuating device 512 extending through the engagement element 510 to a distal cap 514.

[0615] The anchoring portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 connected between the distal cap 514 and the apposition element 510. The anchoring portion 506 is actuable between open and closed states and can take various forms, such as clamping elements like paddles, fasteners, and / or similar forms. Actuation of the actuating element 512 causes the anchoring portion 506 of the device 500 to open and close to grip the natural valve leaflets 20, 22 during implantation.

[0616] The device 500 includes barbed portions 800 disposed on the mating element 510, rather than a hinged fastener or clamping element, with each side of the mating element 510 including at least one barbed portion 800. Similar to the above. Figure 87 The device shown, device 500, also includes barbed portions 802 disposed on inner paddles 522, each inner paddle 522 having at least one barbed portion 802.

[0617] When the anchor portion 506 of device 500 is closed, the tissue gripped between the inner paddle 522 and the engaging element 510 presses against the barbs 800, 802. The barbs 800, 802 are sharp, causing them to engage—and in some embodiments, pierce—natural tissue and prevent the tissue from retracting from device 500. In some embodiments, the barbs 800, 802 are angled downwards to increase engagement with natural tissue. The combination of the barbs 800 on the engaging element 510 and the barbs 802 on the inner paddle 522 causes the gripped tissue to form an S-shaped zigzag path as it passes the barbs 800, 802. Therefore, the force pulling the tissue away from device 500 will cause the tissue to further engage the barbs 800, 802 before it can escape.

[0618] Now for reference Figure 88AThe exemplary implantable device 500A is shown without a hinged fastener or clamping element. As described above, device 500A includes an occlusion element 510A adapted for implantation between the leaflets 20, 22 of a natural valve or natural mitral valve MV and slidably attached to an actuating element or actuating device (not shown) extending through the occlusion element 510A to a distal cap 514A. Device 500A also includes an outer paddle 520A and an inner paddle 522A connected between the distal cap 514A and the occlusion element 510A. Device 500A is actuable between an open and closed state and can take many different forms, such as, for example, clamping elements, like paddles, fasteners, and / or similar forms. Actuation of the actuating element causes the paddles 520A, 522A of device 500A to open and close to grip the natural valve leaflets 20, 22 during implantation.

[0619] The device 500A includes a barbed portion 800A disposed on the mating element 510A, instead of a hinged fastener or clamping element, wherein each side of the mating element 510A includes at least one barbed portion 800A. The device 500A also includes a barbed portion 802A disposed on the inner paddle 522A, wherein each inner paddle 522A has at least one barbed portion 802A.

[0620] When the device 500A is closed, the tissue gripped between the inner paddle 522A and the engaging element 510A presses against the barbs 800A and 802A. The barbs 800A and 802A are sharp, causing them to engage—and in some embodiments, puncture—natural tissue and prevent the tissue from retracting from the device 500A. In some embodiments, the barbs 800A and 802A are angled downwards to increase engagement with natural tissue. The combination of the barbs 800A on the engaging element 510A and the barbs 802A on the inner paddle 522A causes the gripped tissue to form an S-shaped zigzag path as it passes through the barbs 800A and 802A. Therefore, the force pulling the tissue away from the device 500A will cause the tissue to further engage the barbs 800A and 802A before it can escape.

[0621] Now for reference Figure 89-102 The illustration shows the mating element 510 and paddles 520, 522 of an exemplary device 500. The mating element 510 and paddles can be made of a variety of different materials. The mating element 510 and paddles 520, 522 can be formed from one or more of various materials, such as metallic fabrics, meshes, woven, braided, electrospun, deposited, or otherwise formed materials, laser-cut or otherwise cut materials, or flexible materials. The material can be cloth, shape memory alloy wires—such as nitinol—to provide shape retention, or any other flexible material suitable for implantation in the human body.

[0622] In one exemplary embodiment, the mating element is made of a wire mesh, such as a nitinol wire mesh. In one exemplary embodiment, the mating element 510 is made of a mesh of 25 to 100 wires, such as 40 to 85 wires, such as 45 to 60 wires, such as about 48 or 50 nitinol wires.

[0623] The mating element may be covered with a fabric, such as polyethylene fabric. The mating element 510 may be entirely surrounded by a fabric covering, such as fine-mesh polyethylene fabric. The fabric covering may provide a blood seal on the spacer surface and / or promote rapid tissue inward growth.

[0624] The use of shape memory materials such as nitinol braided wire mesh in constructing mating elements 510 results in mating elements that can be self-expanding, anisotropically flexible, and / or result in low strain when the mating elements are creased and / or bent. The material can be a single piece, two halves joined together, or multiple segments or pieces fastened or joined together in any suitable manner—such as by welding, adhesives, or similar methods.

[0625] Now for reference Figures 89-90 The device 500 extends from a proximal portion 505 to a distal portion 507 and includes an engagement element 510, an inner paddle 522, and an outer paddle 520. The engagement element 510 includes a proximal opening 519A and a distal opening 515. Figure 92 and 94 A proximal opening 519A is formed in the proximal portion 519 of the mating element 510. The mating element 510 is connectably connected to the inner paddle 522 via a connecting portion 525. The inner paddle 522 is connectably connected to the outer paddle 520 via a connecting portion 523. The outer paddle 520 is attached (e.g., connectably attached, etc.) to the distal portion 527 via a connecting portion 521. A mating gap 542 is formed between the inner paddle 522 and the mating element 510. A paddle gap 544 is formed between the inner and outer paddles 520 and 522 when the paddles 520 and 522 are folded, for example, as shown in the figure. Figure 90 As shown.

[0626] Now for reference Figure 91 The image shows a front view of device 500 (its rear view is identical). The mate element 510 includes a proximal portion 519, a middle portion 518, and a distal portion 517. The proximal portion 519 includes a proximal opening 519A. The distal portion 517 includes a distal opening 515 and connects to the connecting portion 525. The mate element 510 is rounded or generally rounded in shape to prevent the device 500 from becoming lodged or blocked on cardiac structures such as chordae tendineae during implantation.

[0627] Now for reference Figure 92 The image shows a side view of device 500. Similar to viewing device 500 from the front, when viewed from the side, the distal portion 507 of device 500 is generally narrower than the proximal portion 505. In the proximal portion 519, the mating element 510 flares outward from the proximal opening 519A to the intermediate portion 518. Then, in the intermediate portion 518, the mating element 510 tapers or narrows from the proximal portion 519 to the distal portion 517. The distal portion 517 remains narrow and then divides into two connecting portions 525. The generally rounded feature of device 500 is further confirmed by the rounded shape of the connecting portion 523 that connects the inner and outer paddles 520, 522, and the outwardly curved shape of the outer paddle 520.

[0628] The mating gap 542 formed between the inner paddle 522 and the mating element 510 is configured to receive natural tissue. The narrowing of the mating element 510 gives the gap 542 a slightly teardrop shape, with its width increasing as the gap 542 approaches the distal portion 507 of the device 500. The closer the gap 542 is to the distal portion 507, the wider it becomes, allowing the inner paddle 522 to contact the tissue gripped in the gap 542 closer to the proximal portion 505, where the clamping force is greater due to the length of the paddles 520, 522 and the mechanical benefits provided by other fixing or anchoring elements such as those described in this application.

[0629] Now for reference Figure 93 The image shows a top view of the device 500. The proximal opening 519A in the mating element 510 is visible at the proximal portion 505 of the device 500, and it is evident that the mating element 510 is internally hollow. When viewed from the top side, the mating element 510 has an oval or generally oval shape. Although the paddles 520, 522 appear as protruding rectangular shapes, they may extend laterally and have an arcuate or crescent-shaped form.

[0630] Now for reference Figure 94 The image shows a bottom view of the device 500. The distal opening 515 in the mating element 510 is visible at the distal portion 507 of the device 500, and it is evident that the mating element 510 is internally hollow. When viewed from the top, the mating element 510 has an oval or generally oval shape. Although the paddles 520, 522 appear as protruding rectangular shapes, they may extend laterally and have an arcuate or crescent-shaped form. The distal portion 517 of the mating element 510 is visible to be bisected for engagement via the connecting portion 525.

[0631] Now for reference Figure 89A , 90AFigures 91A, 92A, 93A, 94A, 95A, 96A, 97A, 98A, 99A, 100A, 101A, and 102A show portions of a device 500A formed from material strips 501A (e.g., a single continuous material strip, a composite material strip, etc.), namely, the mating element 510A and the paddles 520A and 522A. The mating element 510A and the paddles can be made of a variety of different materials. The mating element 510A and the paddles 520A and 522A can be formed from materials such as metallic fabrics, meshes, woven, braided, electrospun, deposited, or otherwise formed materials, laser-cut or otherwise cut materials, or flexible materials. The material can be cloth, shape memory alloy wires—such as nitinol—to provide shape retention, or any other flexible material suitable for implantation in the human body.

[0632] In one exemplary embodiment, the mating element 510A, the inner paddle 522A, and the outer paddle 520A are made of a single continuous material strip 501A. The material strip 501A may be formed from materials such as metallic fabrics (e.g., mesh), woven, braided, electrospun, deposited, or formed in any other suitable manner, laser-cut, or otherwise cut materials, or flexible materials. The material may be cloth, shape memory alloy wires—such as nitinol—to provide shape retention, or any other flexible material suitable for implantation in the human body. In one exemplary embodiment, the material strip 501A is made of a woven mesh of 25 to 100 strands, such as 40 to 85 strands, such as 45 to 60 strands, such as about 48 nitinol wires, or 48 nitinol wires.

[0633] Now for reference Figures 205-207 This shows an exemplary woven or braided material 4000 that can be used for material strip 501A. Now refer to... Figure 205 This shows an enlarged plan view of material 4000. Material 4000 extends from a first edge 4002 to a second edge 4004. Edges 4002 and 4004 surround a central portion or region 4006. Material 4000 is formed by weaving or knitting together center strands 4020, such as nitinol threads. Edge strands 4010 extend longitudinally through material 4000 along edges 4002 and 4004. Center strands 4020 are woven or knitted such that they surround edge strands 4010. Wrapping center strands 4020 around edge strands 4010 results in material 4000 near edges 4002 and 4004 being thicker than material in the central portion 4006, forming a cleft or dog-bone-like shape when material 4000 is viewed from the end. Figure 206As shown. Therefore, the edges 4002, 4004 of material 4000 are less flexible than the central portion 4006. The diameters of the edge strands 4010 and the central strands 4020 may be similar and may have diameters ranging from about 0.06 mm to about 0.18 mm. In some embodiments, the edge strands 4010 may have a larger diameter than the central strands 4020 to impart greater stiffness or rigidity to the edges 4002, 4004 than to the central portion 4006. For example, the edge strands 4010 may have a diameter ranging from about 0.07 mm to about 0.27 mm, or about 0.17 mm, and the central strands 4020 may have a diameter ranging from about 0.04 mm to about 0.15 mm, or about 0.009 mm. In some embodiments, the edges 4002, 4004 are made less flexible than the center portion 4006 by using different materials for the edge strands 4010 and the center strand 4020, such as, for example, a metallic material—e.g., nitinol—for the edge strand 4010, and a fabric or plastic material—e.g., polyethylene—for the center strand 4020. Alternatively, the edge strands 4010 and the center strand 4020 may be made of the same material, which undergoes different chemical and / or heat treatments to change the material's flexibility, such that the center strand 4020 is more flexible than the edge strand 4010.

[0634] Now for reference Figure 207 The folded portions of material 4000 are stacked on top of each other to form a segment with four layers 4000A, 4000B, 4000C, and 4000D. The edges 4002 and 4004, being individually thicker than the central portion 4006, form a circular slat shape that creates three gaps 4001A, 4001B, and 4001C in the central portion 4006 between the layers 4000A, 4000B, 4000C, and 4000D of material 4000. Outer gaps 4001A and 4001C are formed between the outer layers 4000A and 4000D and the adjacent intermediate layers 4000B and 4000C.

[0635] As discussed in this disclosure, the mating element 510A of the device 500A may be formed of four layers of material, such as material 4000. When the material layers 4000 are used to form the mating element 510A, the actuating element 512A of the device 500A may be inserted through an intermediate gap 4001B formed at the center of the four layers of material 4000. The actuating element 512A may have a diameter larger than the width of the gap 4001B, such that insertion of the actuating element 512A causes the intermediate gap 4001B to expand and the adjacent outer gaps 4001A, 4001C to decrease in size. 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.

[0636] The mating element 510A and the paddles 520A, 522A may be covered with a fabric, such as polyethylene fabric. The mating element 510A and the paddles 520A, 522A may be entirely surrounded by a fabric covering (e.g., covering 540A), such as fine-mesh polyethylene fabric. The fabric covering may provide a blood seal on the spacer surface and / or promote rapid tissue inward growth.

[0637] The use of shape memory materials such as nitinol braided wire mesh in the construction of mating elements 510A and paddles 520A, 522A results in the mating elements and paddles being self-expanding, anisotropically flexible, and / or resulting in low strain when the mating elements and paddles are creased and / or bent. The material can be a single piece, two halves joined together, or multiple segments or pieces fastened or joined together in any suitable manner—such as by welding, adhesives, or similar methods.

[0638] Now for reference Figure 89A and 90A The device 500A extends from a proximal portion 505A to a distal portion 507A and includes an engaging element 510A, an inner paddle 522A, and an outer paddle 520A. A single continuous material strip 501A extends between two ends 501B and is folded to form the engaging element 510A, the inner paddle 522A, and the outer paddle 520A. Some portions of the device 500A are formed by multiple layers of material strips 501A. For example, the material strips 501A are overlapped to form four layers in the region of the engaging element 510A and two layers in the region of the inner paddle 522A.

[0639] The mating element 510A is connectably connected to the paddles 520A and 522A via a connecting portion of the material strip 501A. The mating element 510A is connectably connected to the inner paddle 522A via a connecting portion 525A. The inner paddle 522A is connectably connected to the outer paddle 520A via a connecting portion 523A. The outer paddle 520A is attached (e.g., connectably attached, etc.) to the distal portion 527A via a connecting portion 521A. The hole 527B in the distal portion 527A engages with the cap 514A.

[0640] When the material strip 501A is folded into the desired shape, various gaps are formed between the parts of the device 500A. A mating gap 542A is formed between the inner paddle 522A and the mating element 510A. When the paddles 520A and 522A are folded, for example, as... Figure 90A As shown, a paddle gap 544A is formed between the inner paddle 520A and the outer paddle 522A. When the material strip 501A is folded to form the proximal portion 519B of the mating element 510A, a collar gap or opening 546A is formed.

[0641] Now for reference Figure 91A The image shows a front view of device 500A (its rear view would be identical). The occlusive element 510A includes a proximal portion 519B extending above the connecting portion 523A of the paddles 520A and 522A. When viewed from the front or rear, the distal portion 517A of the occlusive element 510A is concealed by the paddles 520A and 522A, thus giving device 500A a long, narrow, rounded rectangular shape. The shape of the occlusive element 510A helps prevent device 500A from becoming lodged or blocked on cardiac structures such as chordae tendineae during implantation.

[0642] Now for reference Figure 92A The image shows a side view of device 500A. When viewed from the side, the distal end 507A of device 500A is generally narrower than the proximal end 505A, forming an overall blunt and rounded shape. The mating element 510A includes a proximal portion 519B, a middle portion 518A, and a distal portion 517A. The proximal portion 519B flares outward from the middle portion 518A to engage the collar 511D. Figure 48A When viewed from the side, the middle portion 518A of the mating element 510A is straight or generally straight. The distal portion 517A is attached (e.g., connectably attached, etc.) to the inner paddle 522A via a connecting portion 525A. The generally rounded feature of the device 500A is further confirmed by the connecting portion 523A that connectably connects the paddles 520A and 522A. The connecting portion 521A that connects the outer paddle 520A to the distal portion 527A is also rounded and facilitates a transition in shape from the material strip 501A to the cap 514A. Figure 48A The cap 514A is assembled to the flat or generally flat distal portion 527A.

[0643] The mating gap 542A formed between the inner paddle 522A and the mating element 510A is configured to receive natural tissue. The intermediate portion 518A of the mating element 510A and the inner paddle 522A are generally straight, giving the gap 542A a consistent or generally consistent width, with a narrow upper end where the proximal portion 519B flares outward to engage the collar 511D. Figure 48A Therefore, the inner paddle 522A contacts the tissue gripped in the gap 542A closer to the proximal portion 505A, where the clamping force is greater due to the length of the paddles 520A, 522A and the mechanical benefits provided by other fixing or anchoring elements such as those described in this application.

[0644] As discussed above, the mating element 510A and paddle-shaped members 520A, 522A of device 500A are formed by folding material strip 501A. Material strip 501A is then unfolded and assembled with other components, such as collar 511D, cap 514A, and paddle frame 524A. After forming the desired shape, material strip 501A is shaped so that it returns to the desired shape after assembly with other components. In some embodiments, a clamp is used during the folding and shaping process of material strip 501A to ensure that material strip 501A is folded in place with a desired radius.

[0645] Refer again Figure 92AThis shows a portion of the clamp 570A that facilitates the folding and shaping of the device 500A. A strip of material 501A is shown folded around the clamp 570A, forming the desired shape. To fold the strip of material 501A into the shape of the device 500A using the clamp 570A, the strip of material 501A is arranged such that one of its ends 501B is positioned within the inner paddle 522A. The strip of material 501A extends from the end 501B in a distal direction 507B to form a first layer 581A of the inner paddle 522A, a first layer 581A of a connecting or hinge portion 525A is formed around the first clamp portion 572A, and then a first layer 581A of an engaging element 510A is formed in a proximal direction 505B. The first material layer 581A forms the sides of the inner paddle 522A and the engaging element 510A surrounding the engaging gap 542A. The strip 501A is then wrapped around the second clamp portion 574A to form one of the proximal portion 519B and the opening 546A of the mating element 510A. The strip 501A is then extended in the distal direction along the first layer 581A to form the second layer 582A of the mating element 510A. The strip 501A is then wrapped back around the first clamp portion 574A to form the second layer 582A of the connecting or hinged portion 525A, and then wrapped back in the proximal direction 505A to form the second layer 582A of the inner paddle 522A. The strip 501A is then wrapped around the third clamp portion 576A to form the mating portion 523A. The strip 501A then extends in the distal direction along the inner paddle 522A to form the outer paddle 520A, and is subsequently folded around the fourth clamp portion 578A to form the connecting portion 521. The strip 501A is then extended laterally to form the distal portion 527. Then, on the opposite side of the clamp 570A, the strip 501A is routed through the clamp 570A in reverse order to form the second half of the device 500A. That is, the strip 501A is then wrapped around the fourth clamp portion 578A, the third clamp portion 576A, the first clamp portion 572A, the second clamp portion 574A, and the first clamp portion (second time) 572A to form the second half of the device 500A. Once the strip 501A is wrapped around the clamp portions as described above, a shaping operation is performed. Although the portions of the clamps shown have a rounded or generally circular shape, these portions can have any shape that facilitates the folding and shaping of the material strip 501A. The clamp 570A may have more or fewer portions for engaging the material strip 501A.

[0646] Now for reference Figure 93AThe diagram shows a top view of device 500A. The first layer 581A and the second layer 582A of each half of device 500A form a four-layer mating device 510A. A proximal opening 519C of the mating device 510A is formed between the two second layers 582A. In some embodiments, the opening 519C is formed by inserting an actuating element 512A (not shown) between the folds and overlaps of the material strip 501A after the material strip 501A has been shaped. In other embodiments, the opening 519C is formed by shaping the folded layers 581A and 582A of the material strip 501A around an additional clamping portion (not shown) to give the mating element 510A a rounded or generally rounded shape when viewed from top.

[0647] Now for reference Figure 94A The image shows a bottom view of the device 500A. The distal portion 527A of the material strip 501A and the hole 527B for the receiving cap 514A are shown. When viewed from below, the mating element 510A and the outer paddle 520A have an overall rounded rectangular shape.

[0648] Now for reference Figure 95-102 This shows a perspective view and a cross-sectional view of device 500. Now refer to... Figure 95 This shows that the device 500 is cut by a cross-section 96 near the proximal portion of the mating element 510. Now refer to... Figure 96 It shows from Figure 95 The cross-sectional view of the device 500 is shown in plane 96. At position plane 96, the mating element 510 has an oval or generally oval shape, with the portion along the side of the mating element 510 being wider. The distal opening 515 is visible from the proximal portion, and the mating element 510 has a hollow interior.

[0649] Now for reference Figure 97 This shows that the device 500 is cut by a cross-section 98 located approximately halfway between the distal portion 507 and the proximal portion 505 of the mating element 510. Now refer to... Figure 98 It shows from Figure 97 The cross-sectional view of the device 500 is shown at plane 98. At position 98, the mating element 510 has an oval or generally oval shape larger than... Figure 96 It has an oval shape.

[0650] Now for reference Figure 99 This shows that the device 500 is cut by a cross-section 100 located approximately one-quarter of the distance between the distal portion 507 and the proximal portion 505 of the mating element 510. Now refer to... Figure 99 It shows from Figure 99The cross-section 100 is a cross-sectional view of the device 500. At the location of plane 100, the mating element 510 has an oval or generally oval shape narrower than [the specified value]. Figure 98 The oval shape shown.

[0651] Now for reference Figure 101 This shows that the device 500 is cut by a cross-section 102 located near the distal portion 507 of the mating element 510. Now refer to... Figure 102 It shows from Figure 101 The cross-section 102 is a cross-sectional view of the device 500. At the location of plane 102, the mating element 510 has an oval or generally oval shape smaller than... Figure 100 The oval shape shown is separated by the coupling element 510 and the connecting portion 525.

[0652] Now for reference Figure 95A , 96A Images 97A, 98A, 99A, 100A, 101A, and 102A show perspective and cross-sectional views of portions of an apparatus 500A formed from a single continuous strip of material 501A. Now refer to... Figure 95A This shows that the device 500A is cut by a cross section 96A near the proximal portion of the mating element 510A. Now refer to... Figure 96A It shows from Figure 95A The cross-sectional view of the device 500A is shown at plane 96A. At plane 96A, the mating element 510 has a rectangular or generally rectangular shape. In some embodiments, when the actuating element (not shown) is inserted between the layers 582A of the mating element 510A, the mating element 510A remains straight when viewed from the side, but curves outward to form a rounded or generally circular shape when viewed from cross-section 96A.

[0653] Now for reference Figure 97A This shows that the device 500A is cut by a cross section 98A near the proximal portion of the mating element 510A. Now refer to... Figure 98A It shows from Figure 97A The cross-sectional view of the device 500A is shown at plane 98A. At plane 98A, the mating element 510 has a rectangular or generally rectangular shape. In some embodiments, when the actuating element (not shown) is inserted between layers 582A of the mating element 510A, the mating element 510A remains straight when viewed from the side, but curves outward to form a rounded or generally circular shape when viewed from cross-section 98A.

[0654] Now for reference Figure 99A This shows that the device 500A is cut by a cross section 100A near the proximal portion of the mating element 510A. Now refer to... Figure 100A It shows from Figure 99A The cross-sectional view of the device 500A is shown at plane 100A. At plane 100A, the mating element 510 has a rectangular or generally rectangular shape. In some embodiments, when the actuating element (not shown) is inserted between the layers 582A of the mating element 510A, the mating element 510A remains straight when viewed from the side, but curves outward to form a rounded or generally circular shape when viewed from cross-section 100A.

[0655] Now for reference Figure 101A This shows that the device 500A is cut by the cross section 102A near the proximal portion of the mating element 510A. Now refer to... Figure 102A It shows from Figure 101A The cross-section 102A shows a cross-sectional view of the device 500A. At the location of plane 102A, the mating element 510 has a rectangular or generally rectangular shape. In some embodiments, when an actuating element (not shown) is inserted between layers 582A of the mating element 510A, the mating element 510A remains straight when viewed from the side, but curves outwards to form a rounded or generally circular shape when viewed from cross-section 102A.

[0656] Now for reference Figures 103-105 The illustration shows an exemplary implantable prosthetic device 100 with covered and uncovered portions. The device 100 is shown implanted into a natural mitral valve MV and secured to natural leaflets 20, 22. As described above, the device 100 includes an occlusion element or occlusion device 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 natural leaflets 20, 22 of the mitral valve MV. The proximal portion 105 of the device 100 is exposed to the left atrium LA, and the distal portion 107 of the device 100 is exposed to the left ventricle LV.

[0657] Now for reference Figure 103The device 100 is shown to have a cover 900 that covers the mating element or mating device 110 and the cap 114 as a whole. In some embodiments, the cover 900 may be a cloth or fabric or a polymer such as PET, fleece, electrospun, deposited or other suitable material. In other embodiments, instead of fabric or other than fabric, the cover may also include a coating (e.g., a polymer, such as silicone) applied to the prosthetic spacer device and / or mechanical seal mechanism, and interlocking connections may be used. The cover 900 may be formed of a metallic fabric, such as a mesh, woven, braided, or any other suitable formed or laser-cut or otherwise cut flexible material. The cover 900 may be a cloth, shape memory alloy wire—such as nitinol—to provide shape retention, or any other flexible material suitable for implantation in the human body. The cover 900 prevents blood flow through the mating element or mating device 110 at the proximal portion 105 and also provides a seal between the device 100 and the leaflets 20, 22. Therefore, the cover 900 helps prevent blood flow through the natural valve at the location of device 100. The cover 900 also prevents recirculated blood flow from entering device 100 from the distal portion 107.

[0658] Now for reference Figure 104 The image shows a device 100 having a cover 1000 that partially covers the mating element or mating device 110—from the proximal portion 105 of the device 100 to the portion where the mating element or mating device 110 engages with the natural leaflets 20, 22. In some embodiments, the cover may be cloth or fabric such as PET, fleece, or other suitable fabrics. In other embodiments, instead of fabric or other than fabric, the cover may also include a coating (e.g., a polymer) applied to the prosthetic spacer device. The cover 1000 may be formed of a metallic fabric, such as a mesh, woven, braided, or any other suitable formed or laser-cut or otherwise cut flexible material. The cover 1000 may be cloth, shape memory alloy wire—such as nitinol—to provide shape retention, or any other flexible material suitable for implantation in the human body. Thus, the cover 1000 prevents blood flow through the mating element or mating device 110 at the proximal portion 105.

[0659] Now for reference Figure 105The device 100 is shown to have a cover 1100 that partially covers the mating element or mating device 110, extending from the portion of the mating element or mating device 110 that engages with the natural leaflets 20, 22 toward the distal portion 107. The cover 1100 also covers a cap 114. In some embodiments, the cover may be cloth or fabric such as PET, fleece, or other suitable fabric. In other embodiments, instead of fabric or other than fabric, the cover may also include a coating (e.g., a polymer) applied to the prosthetic spacer device. The cover 1100 may be formed from a mesh, woven, braided, or formed in any other suitable manner. The cover 1100 may be cloth, polymer, silicone, electrospun material, deposited material, and / or shape memory alloy yarn—such as nitinol—to provide shape retention, or any other flexible material suitable for implantation in the human body. Thus, blood flow may enter the mating element or mating device 110 but is blocked through the device by the cover 1100 positioned near the distal portion 107. The covering 1100 also prevents recirculating blood flow from entering the device 100 from the distal portion 107.

[0660] Now for reference Figures 106-109 An exemplary occlusion element 1200 for an implantable prosthesis device is shown. The occlusion element 1200 can be used with any implantable prosthesis device described in this application. Reference Figure 106 The occlusive element 1200 has a cylindrical or generally cylindrical shape extending between the two caps 1201. However, the occlusive element 1200 can have any shape, as disclosed herein. In one exemplary embodiment, the expansion direction of the occlusive element 1200 can be controlled. For example, the width / size of the occlusive element along the anterior-posterior direction (at implantation), the medial-lateral direction (at implantation), or both can be expanded (or contracted) in a controlled manner. The occlusive element 1200 can be made of a mesh material. Referring now... Figure 107 The mesh wall of the cylindrical mating element 1200 extends outward from the cap 1201 by a distance 1204. Now refer to... Figure 108 An axial force 1208 is applied to the cap 1201 of the mating element 1200, causing the mating element 1200 to compress in the axial direction. The axial compression of the mating element 1200 causes the mating element 1200 to expand or bulge in the outward direction 1210, thereby increasing the distance 1204.

[0661] The mating element 1200 can be compressed in a variety of different ways. For example, a threaded connection can be used to bring the two ends of the mating element together or to push the two ends of the mating element apart. For example, collars can be provided at each end of the mating element. One collar can be threadedly engaged with a threaded shaft, while the other collar is rotatably connected to the shaft. Rotating the shaft in one direction brings the collars together. Rotating the shaft in the opposite direction moves the collars apart.

[0662] Incorporating the mate element 1200 into the implantable prosthesis device of this application allows the mate element to expand to press outward against the tissue gripped between the mate element and the paddle and / or clamping member.

[0663] Now for reference Figure 106A , 108A 106B and 108B show exemplary mating elements 1200 of implantable prostheses, similar to Figures 106-109 Example implementation. The mating element 1200 can be used in any implantable prosthetic device described in this application. Reference Figure 106A The mating element 1200 has a cylindrical or generally cylindrical shape extending between the two caps 1201. However, the mating element 1200 can have any shape, as disclosed herein. Figure 106A and 108A In the example shown, mating element 1200 includes a tube 1203 having a groove 1205. For example, the tube 1203 may be made of a shape memory alloy such as nitinol, and the groove may be cut into the tube, such as by laser cutting. The groove may be cut into the material forming the tube before the material forms the tube.

[0664] In one exemplary embodiment, the expansion direction of the mating element 1200 can be controlled. For example, the configuration of the groove 1205 and / or the shape of the tube can be selected to control the shape of the expanding mating element 1200. For example, the configuration and / or shape of the groove 1205 can determine the expansion (and / or contraction) manner of the width / dimension of the mating element in the front-to-back direction and / or the inside-to-outside direction. Reference Figure 106A Generally, the wall of the cylindrical mating element 1200 can extend outward from the cap 1201 by a distance 1204. Now refer to Figure 108A Axial force 1208 and / or rotational force 1209 may be applied to the cap 1201 of the mating element 1200, causing the mating element 1200 to move from its own position to its own position. Figure 106A The configuration of the example is expanded to Figure 108A Example configuration. In the example shown, the axially compressed mating element 1200 and the torsional mating element 1200 expand or bulge in the outward direction 1210, thereby increasing the distance 1204.

[0665] refer to Figure 106B and 108BThe mating element 1200 can be compressed in a variety of different ways. For example, the threaded connection 1221 can be used to bring the two ends of the mating element together and to twist the mating element in a first direction, or to push the two ends of the mating element apart and to twist the mating element in a second direction. For example, collars can be provided on each end of the mating element. One collar can be threadedly engaged with a threaded shaft, while the other collar is fixedly connected to the shaft. Rotating the shaft in one direction brings the collars together and rotates the collars relative to each other in the first direction. Rotating the shaft in the opposite direction moves the collars apart and rotates the collars relative to each other in the second direction. The pitch of the threaded connection can be selected to set the ratio between the compression distance of the mating element 1200 and the torsion angle of the mating element.

[0666] Will Figure 106A , 108A The mate element 1200 of examples 106B and 108B, incorporated into the implantable prosthesis device of this application, allows the mate element to expand outwards and press against the tissue gripped between the mate element and the paddle and / or clamping member.

[0667] Figure 106C and 108C Another exemplary embodiment of a controllable expansion occlusion element 1200 for an implantable prosthetic device is illustrated. The occlusion element 1200 can be used independently, in conjunction with a covering, or within any occlusion element described herein (to expand the occlusion element). The occlusion element 1200 can be used with any implantable prosthetic device described in this application. Reference Figure 106C The mating element 1200 has a pair of pivoting connecting arms 1231. Each of the pairs of pivoting connecting arms 1231 extends between and is pivotally connected to the two caps 1201. In the example shown, there are two pairs of pivoting connecting arms 1231. However, there may be one, three, four, or any number of pairs of pivoting connecting arms.

[0668] In one exemplary embodiment, the expansion direction of the mating element 1200 can be controlled. For example, two pairs (as shown in the example) of pivoting connecting arms may be included to change the width / size of the mating element in only one of the front-rear direction and / or the inside-outside direction. Four pairs of pivoting connecting arms 1231 may be included to change the width / size of the mating element in both the front-rear direction and the inside-outside direction. When four pairs of pivoting connecting arms 1231 are included, the arms may have different lengths and / or pivot point positions to cause the mating element 1200 to expand (or contract) differently in different directions. For example, the arm length may be selected to expand more in the inside-outside direction than in the front-rear direction.

[0669] Now for reference Figure 108C An axial force 1208 can be applied to the cap 1201 of the mating element 1200, causing the mating element 1200 to... Figure 106C The configuration of the example is expanded to Figure 108C Example configuration. In the example shown, axial compression of the pivot arm 1231 causes the pivot 1233 or knee to unfold in the outward direction 1210, thereby increasing the distance 1204.

[0670] refer to Figure 106C and 108C The mating element 1200 can be compressed in a variety of different ways. For example, a threaded connection 1221 can be used to bring the two ends of the mating element together or to push the two ends of the mating element apart. For example, collars can be provided on each end of the mating element. One collar can be threadedly engaged with the threaded shaft 1244, while another collar is rotatably connected to the shaft. Rotating the shaft in one direction brings the collars together. Rotating the shaft in the opposite direction moves the collars apart.

[0671] Will Figure 106C and 108C The example occlusion element 1200 incorporated into the implantable prosthesis device of this application allows the occlusion element to expand to press outward against the tissue gripped between the occlusion element and the paddle and / or clamping member.

[0672] Figure 106D and 108D An exemplary embodiment of an expandable apposition element 1200 for an implantable prosthesis device is illustrated. The apposition element 1200 can be used independently or in conjunction with a covering (see [link to documentation]). Figure 106E and 108E Or, it may be used within any of the occlusive elements described herein (to expand the occlusive element). The occlusive element 1200 may be used in any implantable prosthetic device described in this application. Reference Figure 106 The mating element 1200 has a central support member 1243, one or more pivoting connecting arms 1241, and connecting lines 1245. Each arm 1241 extends from the pivot connection to the central support member 1243. Each connecting line 1245 connects to the central support member 1243 and the pivoting connecting arm 1241. The length of the connecting line 1245 defines the degree to which the connecting arm pivots away from the central support member 1243. In the example shown, there are two pivoting connecting arms 1241. However, one, three, four, or any number of pivoting connecting arms may be present.

[0673] In one exemplary embodiment, the expansion direction of the mating element 1200 can be controlled. For example, two pivoting connecting arms may be included to change the width / size of the mating element in only one of the front-rear direction and / or the inside-outside direction. Four pivoting connecting arms 1241 may be included to change the width / size of the mating element in both the front-rear direction and the inside-outside direction. When four pivoting connecting arms 1241 are included, the arms and / or connecting lines 1245 may have different lengths and / or pivot point positions to cause the mating element 1200 to expand (or contract) differently in different directions. For example, the lengths of the arms and / or connecting lines may be selected to expand more in the inside-outside direction than in the front-rear direction.

[0674] Arm 1241 can be in the retracted position ( Figure 106D Move to the expanded position ( Figure 108D For example, arm 1241 may be biased toward the expanded position by a spring or other biasing tool. In the example shown, a restraint 1247, such as a suture, holds arm 1241 in the contracted position. The restraint 1247 may be removed or destroyed to allow the mating element 1200 to... Figure 106D The configuration of the example is expanded to Figure 108D Example configuration.

[0675] Figure 106E and 108E The exemplary implementation shown is similar to Figure 106D and 108D An example implementation—in addition to the mating elements including a cover material 1253. The cover material 1253 may extend from the central support member 1243 to each arm 1241. The cover material 1253 may be used in conjunction with the connecting wire 1245, or the cover material may eliminate the need for the connecting wire 1245.

[0676] Now for reference Figure 106F An exemplary mating element 1200 for implantable prostheses is shown, similar to... Figures 106-109 Example implementation. The mating element 1200 can be used in any implantable prosthetic device described in this application. Reference Figure 106F The mating element 1200 is defined by a coil 1263 extending between two caps 1201. The mating element 1200 may have any shape, such as any shape disclosed herein. The coil 1263 may be made of a shape memory alloy such as nitinol.

[0677] In one exemplary embodiment, the expansion direction of the mating element 1200 can be controlled. For example, the shaping of the coil 1263 can be selected to control the shape of the expanding mating element 1200. For example, the shaping configuration can determine how the mating element expands (and / or contracts) in width / size along the front-to-back and / or inside-to-outside directions. A reference axial force 1208 and / or rotational force 1209 can be applied to the cap 1201 of the mating element 1200, causing the mating element 1200 to... Figure 106F The example configuration expands or contracts. In the example shown, the axially extended coil 1263 and the torsional coil 1263 cause the coil to contract in the inward direction 1211, while the axially compressed coil 1263 and the torsional coil in the opposite direction cause the coil to expand or bulge in the outward direction.

[0678] refer to Figure 106F The mating element 1200 can be compressed in a variety of different ways. For example, the threaded connection 1221 can be used to bring the two ends of the mating element together and to twist the mating element in a first direction, or to push the two ends of the mating element apart and to twist the mating element in a second direction. For example, collars can be fixedly connected to each end of the coil 1263. One collar can be threadedly engaged with a threaded shaft, while the other collar is fixedly connected to the shaft. Rotating the shaft in one direction brings the collars together and rotates the collars relative to each other in the first direction. Rotating the shaft in the opposite direction moves the collars apart and rotates the collars relative to each other in the second direction. The pitch of the threaded connection can be selected to set the ratio between the compression distance of the mating element 1200 and the twist angle of the mating element.

[0679] Will Figure 106F The example occlusion element 1200 incorporated into the implantable prosthesis device of this application allows the occlusion element to expand to press outward against the tissue gripped between the occlusion element and the paddle and / or clamping member.

[0680] Figure 106G-106I An exemplary implementation of the expandable mating element 1200 is illustrated. Figure 106G-106I In the example shown, a fluid medium causes the mating element to expand. The fluid medium can take many different forms. Examples of fluids that can be used to expand the mating element 1200 include, but are not limited to, air, gel, water, blood, foaming materials, etc. The mating element 1200 can be used in any implantable prosthetic device described in this application.

[0681] refer to Figure 106G The copulatory element 1200 may have an outer layer 1271 (e.g., any copulatory element 110, 510 disclosed herein) and an inner layer 1273 or balloon. The copulatory element 1200 may have any shape, such as any shape disclosed herein. Figure 106GIn the example shown in 1086, the inner layer 1273 is disposed within the outer layer 1271 and may have the same or generally the same shape as the inner surface of the outer layer. The inner layer may be made of an expandable material, such as rubber or other materials conventionally used in the fabrication of balloons and angioplasty devices. The outer layer 1271 may be made of a shape memory alloy such as nitinol.

[0682] refer to Figure 106H and 106I In one exemplary embodiment, the expansion direction of the mating element 1200 is controllable. Figure 106H In the example shown, the inner layer 1273 includes two balloons optionally connected together. However, any number of balloons can be used. For example, the inner layer may include three, four, or any number of balloons. The balloons can be inflated individually to control the expansion shape of the mating element 1200. When the balloons are connected together, the connection can also affect the expansion shape. Figure 106H In the example shown, the balloons are connected together along plane 1275 or a region. Due to the connection along plane 1275, the expansion of the inner layer 1273 along direction 1277 will be less than the expansion along direction 1279. Thus, in this example, the expansion caused by inflation can be limited to or substantially limited to expansion along the medial-lateral direction.

[0683] The use of multiple balloons and the configuration of any connections between balloons can determine how the antagonistic element expands (and / or contracts) in width / size along the anterior-posterior and / or medial-lateral directions.

[0684] exist Figure 106I In the example shown, the inner layer 1273 includes one or more supports 1281 or struts. One support 1281 is shown, but any number can be used. For example, the inner layer may include two, three, four, or any number of supports. The supports 1281 may divide the inner layer into multiple independently expandable chambers, or the supports may not block individual chambers, and expansion fluid applied to any chamber will fill all chambers. When independently expandable chambers are present, these chambers can be expanded individually to control the expansion shape of the mating element 1200. The supports also affect the expansion shape. In the example shown in 106I, the supports 1281 will reduce or eliminate the expansion of the inner layer 1273 along direction 1277. Thus, in this example, the expansion caused by expansion may be limited to or substantially limited to expansion along the inside-outside direction.

[0685] The use of multiple independently expandable chambers and / or the configuration of the support component 1281 can determine how the mating element expands (and / or contracts) in width / size along the front-to-back and / or inside-to-outside directions.

[0686] Will Figure 106G-106IThe example occlusion element 1200 incorporated into the implantable prosthesis device of this application allows the occlusion element to expand to press outward against the tissue gripped between the occlusion element and the paddle and / or clamping member.

[0687] Now for reference Figure 110-111 An exemplary implantable prosthesis device 1300 is shown. Device 1300 is similar to device 100 described above and includes an engagement element 1310, a paddle 1320, and a fastener or clamping member 1330. Reference is now made to... Figure 111 This shows a top view of the mating element 1310. (As shown...) Figure 111 As can be seen, the occlusal element 1310 has an oval or generally oval cross-section. The occlusal element 1310 does not include a central opening and may be formed of a solid material, such as foam. Forming the occlusal element 1310 with a solid foam material prevents blood from flowing through the center of the occlusal element 1310, thereby substantially eliminating a site where blood can be intercepted. The device 1300 may include any other features of the implantable prosthetic device discussed in this application, and the device 1300 may be positioned to engage valve tissues 20, 22—as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). The prosthetic device 1300 may be opened and closed in a variety of different ways. For example, a sleeve may be slidably arranged on the occlusal element to engage and open the paddle. Alternatively, the paddle may be opened by pulling a line or suture to open the fastener, and movement of the fastener may open the paddle. However, any mechanism for opening and closing the device 1300 may be used.

[0688] Now for reference Figure 112-128 An exemplary paddle frame 1400 for an implantable prosthetic device is shown. The paddle frame 1400 can be used with any implantable prosthetic device described in this application. The paddle frame 1400 is formed of a material element 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, a middle portion 1424, and a distal portion 1426. In some embodiments, the paddle frame 1400 includes a means for attaching a cover (see...) Figure 30 The inner paddle 520 and / or outer paddle 522 are fixed to the attachment portion 1440 of the paddle frame 1400. In some embodiments, the paddle frame 1400 is thinner at the position of the fifth curve 1438 to facilitate bending of both sides of the paddle frame 1400 toward the central plane 1404 during, for example, device creases.

[0689] The paddle frame 1400 extends in a rounded three-dimensional shape between the first attachment portions 1412, through the proximal portion 1422, the middle portion 1424, and the distal portion 1426, and returns to the second attachment portion 1414. To form the rounded three-dimensional shape, the paddle frame 1400 bends or curves at multiple locations as it extends between the first attachment portions 1412 and the second attachment portions 1414. Attachment portions 1412 and 1414 include notches 1416 and 1418, respectively, for attachment to the cap. The paddle frame 1400 flexes at region 1419. Region 1419 may include a wider portion 1417 to distribute the stress caused by the flexing of the paddle frame 1400 over a larger area. Furthermore, notches 1416 and 1418 may include radiusd notches 1415 at each end of the notch. The rounded notch 1415 serves as a strain relief body for the area where the curved region 1419 and the paddle frame 1400 connect with the cap.

[0690] The paddle frame 1400 is located away from the middle or central plane 1404 at the first curve 1430. Figure 115 The shape is curved to broaden the shape of the paddle-shaped frame 1400. For example... Figure 117 As can be seen, the paddle frame 1400 is also curved away from the anterior plane 1406 at the position of the first curve 1430. The paddle frame 1400 curves outward from the first curve 1430 at the second curve 1432 to form the side of the frame 1400. The paddle frame continues to tilt away from the anterior plane 1406 at the position of the second curve 1432. In some embodiments, the second curve 1432 has a larger radius than the first curve 1430. When viewed from the anterior plane 1406, as the paddle frame 1400 continues to curve along the arc of the second curve 1432, the paddle frame 1400 curves away from the anterior plane 1406 at the third curve 1434. This curvature at the third curve 1434 causes the frame 1400 to gradually deviate, and thus causes the natural valve leaflets to gradually deviate from the centerline or the frontal plane 1406. This deviation from the centerline causes the leaflet tissue to spread towards the valve annulus, which can result in less stress on the leaflet tissue. As the frame 1400 continues to curve away from the front plane 1406, the paddle frame 1400 curves towards the side plane 1404 at the fourth curve 1436. The rounded three-dimensional shape of the paddle frame 1400 is closed by the fifth curve 1438, which connects the two sides of the paddle frame 1400. Figure 116 and 118As can be seen, when the frame 1400 extends away from the attachment portion 1420 and reaches the closed or distal portion 1426, the paddle frame 1400 has an arcuate or generally arcuate shape. The middle portion 1424 of the frame is closer to the front plane 1406 than the closed portion 1426, thereby giving the sides of the middle portion 1424 a rounded wing-like shape, which engages the curved surface of the mating element during the gripping process between the paddle (not shown) and the mating element (not shown) of the implantable device of the present invention.

[0691] refer to Figure 191 In an exemplary embodiment, the flat blank 1403 of the paddle frame 1400 can be cut from a flat sheet material, such as by laser cutting. (See reference...) Figure 192 The cut blank 1403 can then be bent to form a three-dimensional paddle-shaped frame 1400.

[0692] refer to Figure 193 and 194 In one exemplary embodiment, the paddle frame 1400 may be shaped to provide increased abutment or clamping force toward the mating element 510 when the paddles 520, 522 are in a closed configuration. This is because the paddle frame is positioned relative to the closed position (e.g., Figure 194 Shaped to the first position (e.g., Figure 193 The first position exceeds the position where the inner paddle 520 will engage the mating element, such as exceeding the center plane 552 of the device 500, exceeding the opposite side of the mating element, or exceeding the outer paddle on the opposite side of the mating element. (See reference) Figure 194 The paddle frame 1400 is flexed and attached to the inner and outer paddles 522, 520—for example, by stitching. This results in the paddle frame 1400 having a preload (i.e., a clamping force greater than zero against or toward the mating elements) when in a closed configuration. Therefore, with a closed configuration ( Figure 194 Compared to a fixed paddle-shaped frame, with Figure 193 The fixed-shape paddle frame 1400 can increase the clamping force of the paddle frame 1400.

[0693] The preload level of the paddle frame 1400 can be changed by adjusting the degree of shaping of the paddle frame 1400 relative to the mating element 510. The further the paddle frame 1400 is shaped beyond the closed position, the greater the preload.

[0694] The curves of the paddle frame 1400 can be independent of each other, i.e., one curve is completed and then another curve begins, or they can be combined, i.e., the paddle frame 1400 is curved in multiple directions at the same time.

[0695] Now for reference Figure 112A ,114A Images 115A, 116A, 117A, and 118A illustrate an exemplary paddle frame 1400A for an implantable prosthetic device. The paddle frame 1400A can be used with any implantable prosthetic device described in this application. Each paddle frame 1400A is formed from a material element 1402A, such as nitinol, or any other suitable material. Each paddle frame 1400A extends from a cap attachment portion 1410A to a paddle attachment portion 1420A and has a proximal portion 1422A, a middle portion 1424A, and a distal portion 1426A.

[0696] Each paddle frame 1400A extends in a rounded three-dimensional shape between the first attachment portions 1412A, through the proximal portion 1422, the middle portion 1424, and the distal portion 1426, and returns to the second attachment portion 1414. To form the rounded three-dimensional shape, each paddle frame 1400A is bent or curved at multiple locations as it extends between the first attachment portions 1412A and the second attachment portion 1414A. Attachment portions 1412A and 1414A include notches 1416A and 1418A, respectively, for attachment to the cap. The paddle frame 1400A flexes in region 1419A. Region 1419A may include a wider portion 1417A to distribute the stress generated by the flexing of the paddle frame 1400A over a larger area. In addition, notches 1416A and 1418A may include a rounded notch 1415A at each end of notches 1416A and 1418A. The rounded notch 1415A serves as a strain relief body for the bending region 1419A and the region where the paddle frame 1400A connects to the cap.

[0697] Each paddle frame 1400A is located away from the middle or central plane 1404A at the first curve 1430A. Figure 116A The shape is curved to broaden the form of the paddle-shaped frame 1400A. For example... Figure 114AAs can be seen, the paddle frame 1400A is also curved away from the front plane 1406A at the first curve 1430A. The paddle frame 1400A is curved outward from the first curve 1430A at the second curve 1432A to form the side surface 1433A of the frame 1400A, which is parallel or substantially parallel to the center plane 1404A when viewed from the front plane 1406A. The paddle frame continues to tilt away from the front plane 1406A at the second curve 1432A. In some embodiments, the second curve 1432A has a larger radius than the first curve 1430A. The paddle frame 1400A is curved towards the rear from the front plane 1406A at the third curve 1434A in the middl...

Claims

1. An expandable spacer assembly, comprising: Central axis; An actuator tube, which is rotatably arranged around the central axis; An expandable spacer having a first end fixed to the central shaft and a second end fixed to the actuating tube; The rotation of the actuating tube relative to the central axis causes the expandable spacer to expand from a retracted state to an expanded state, and The expandable spacer is configured to expand asymmetrically such that, when the expandable spacer is in the expanded state, the width of the proximal end of the expandable spacer is greater than the width of the distal end of the expandable spacer.

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

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

4. The expandable spacer assembly according to claim 1 or claim 2, wherein the proximal end of the spacer is fixed to the proximal end of the shaft, and the distal end of the spacer is fixed to the distal end of the actuation tube.

5. The expandable spacer assembly according to claim 1 or claim 2, wherein the spacer comprises a tube having a plurality of slits.

6. The expandable spacer assembly according to claim 1 or claim 2, wherein the spacer comprises a tube having a plurality of helical cuts.

7. A system for repairing a patient's natural valve, the system comprising: Delivery catheter; A valve repair device coupled to the delivery catheter, wherein the valve repair device includes: Expandable spacer assembly, comprising: Central axis; An actuator tube, which is rotatably arranged around the central axis; An expandable spacer having a first end fixed to the central shaft and a second end fixed to a locking tube; The rotation of the actuating tube relative to the central axis causes the expandable spacer to expand from a retracted state to an expanded state, and The expandable spacer is configured to expand asymmetrically such that, when the expandable spacer is in the expanded state, the width of the proximal end of the expandable spacer is greater than the width of the distal end of the expandable spacer.

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

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

10. The system of claim 7 or claim 8, wherein the proximal end of the spacer is fixed to the proximal end of the shaft, and the distal end of the spacer is fixed to the distal end of the actuation tube.

11. The system of claim 7 or claim 8, wherein the spacer comprises a tube having a plurality of slits.

12. The system of claim 7 or claim 8, wherein the spacer comprises a tube having a plurality of helical cuts.

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