Heart valve sealing device and delivery device thereof

Abstract

An example implantable prosthetic device has an apposition element and at least one anchor. The apposition element is configured to be positioned within a native heart valve orifice to help fill the space of native valve regurgitation and form a more effective seal. The apposition element can have a blood-impermeable structure. The apposition element can be connected to the leaflet of the native valve through the anchor.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 744,031, filed October 10, 2018, which is incorporated herein by reference for all purposes. Background Art

[0003] Natural heart valves (i.e. aortic valve, pulmonary valve, tricuspid valve and mitral valve) play a key role in ensuring the forward flow of adequate blood supply through the cardiovascular system. These heart valves may be damaged due to congenital malformations, inflammatory processes, infectious conditions, diseases, and thus lead to reduced effectiveness. This damage to the valve can lead to serious cardiovascular damage or death. The damaged valve can be surgically repaired or replaced during open heart surgery. However, open heart surgery is highly invasive and complications may occur. Transvascular technology can be used to introduce and implant prosthetic devices in a much less invasive manner than open heart surgery. As an example, a transseptal technique can be used, such as including inserting a catheter into the right femoral vein, upward along the inferior vena cava and entering the right atrium, piercing the septum, and the catheter is passed into the left atrium.

[0004] A healthy heart is generally conical in shape, tapering to a lower tip. The heart is four-chambered and includes a left atrium, a right atrium, a left ventricle, and a right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The natural mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has an anatomical structure that is distinct from other natural heart valves. The mitral valve includes an annular portion and a pair of cusps or leaflets, which are annular portions of natural valve tissue surrounding the mitral valve orifice, and the pair of cusps or leaflets extend downward from the annulus into the left ventricle. The mitral valve annulus can form a "D"-shaped, oval, or otherwise rounded cross-sectional shape with a major axis and a minor axis. The anterior leaflet can be larger than the posterior leaflet, thereby forming a roughly "C"-shaped boundary between their adjacent sides when the two are closed together.

[0005] When operating correctly, the anterior and posterior leaflets act together as a one-way valve to allow 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 expands (also called "ventricular diastole" or "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 called "ventricular systole" or "systole"), the increased blood pressure in the left ventricle pushes the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back into the left atrium, but instead is discharged from the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding in half toward the left atrium through the mitral valve annulus, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0006] During the systolic phase of contracture of the heart, mitral regurgitation occurs when the native mitral valve fails to close properly, and blood flows back from the left ventricle into the left atrium. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation may have different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral annulus caused by left ventricular dilation, more than one of these, and the like. Mitral regurgitation at the central portion of the leaflet may be referred to as central jet mitral regurgitation, while mitral regurgitation near one of the leaflets' commissures (i.e., the location where the leaflets meet) may be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle, and therefore the valve does not close and there is regurgitation.

[0007] One technique for treating mitral and other valve regurgitation in patients may include securing the edges of native valve leaflets directly to each other. For example, catheter-delivered clips have been used to attempt to clamp the sides of the leaflets together at the end portions of the leaflets. However, there are significant challenges. For example, multiple clips may be required to eliminate or reduce regurgitation to an acceptable level, but in some cases this may result in longer procedure times and may result in overly restricted flow or undesirable stress on the native anatomy.

[0008] Despite the prior art, there remains a need for improved devices and methods for treating valvular regurgitation. Summary of the invention

[0009] The summary of the invention is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any feature included in the examples of the summary of the invention is not necessary for the claims unless the claims clearly state these features. In addition, the features, components, steps, concepts, etc. described in the examples of the summary of the invention and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples outlined here.

[0010] An example implantable prosthetic device has a coaptation element (although the term coaptation element is used throughout this application, this may also be referred to as a coaptation element, a spacer, etc.) and at least one anchor. The coaptation element is configured to be positioned within a native heart valve orifice to help fill the space of native valve regurgitation and form a more effective seal. The coaptation element may have a blood-impermeable structure. The coaptation element may be connected to the leaflet of the native valve via the anchor.

[0011] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a material strip and a pair of paddles. The apposition element is formed by or includes the material strip. The pair of paddles are formed by or include the material strip and are connected to the apposition element. The pair of paddles can move between an open position and a closed position.

[0012] The "strip of material" in various embodiments described throughout this disclosure may be a single integral strip of material or piece of material. However, in some embodiments, a "strip of material" may be formed by multiple smaller discrete pieces of one or more materials that are combined into a larger composite strip.

[0013] In one example method of manufacturing a valve repair device, a strip of material is folded to form an apposition element and a pair of paddles connected to the apposition element. The paddles are movable between an open position and a closed position and are configured to attach to a patient's native valve. A portion of the strip of material forming the apposition element is attached to a collar. A portion of the strip of material forming the paddles is attached to a cover. Movement of the cover toward the collar causes the pair of paddles to move to the closed position. Movement of the cover away from the collar causes the pair of paddles to move to the open position.

[0014] In one exemplary embodiment, a valve repair device for repairing a patient's natural valve has an apposition element and a pair of paddles. The apposition element has four layers. A pair of paddles are connected to the apposition element. The paddles can move between an open position and a closed position and are configured to be attached to the patient's natural valve.

[0015] In one example embodiment, a valve repair device for repairing a patient's native valve includes a strip of material and a collar. An apposition element is formed from the strip of material. The collar is connected to the apposition element. A pair of paddles are formed from the strip of material and connected to the apposition element. The paddles can be moved between an open position and a closed position by moving the collar toward and away from the paddles.

[0016] In one example embodiment, a valve repair device for repairing a patient's natural valve includes a liner, an apposition element, and a pair of paddles. The liner has a plurality of engagement portions configured to releasably engage a delivery device. The apposition element is attached to the liner. A pair of paddles are connected to the apposition element and are movable between an open position and a closed position. The paddles are circumferentially disposed between the engagement portions. The paddles are configured to attach to the patient's natural valve.

[0017] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes an apposition element, a pair of paddles, and a covering. The pair of paddles are connected to the apposition element. The paddles can move between an open position and a closed position. When the paddles are in the open position, a stop point (e.g., a point that may get caught or hooked on a portion of a delivery system and interfere with the deployment and / or recapture of the device) is formed by or between a portion of at least one of the apposition element and the pair of paddles. A covering connected to the apposition element and the paddles covers the stop point.

[0018] In one exemplary embodiment, a valve repair device for repairing a patient's natural valve includes an apposition element, a pair of paddles, a first cover, and a second cover. The pair of paddles are connected to the apposition element and can move between an open position and a closed position. The first cover extends from the distal end of the device and covers at least a portion of the paddles. The second cover extends from the proximal end of the device and covers at least a portion of the apposition element.

[0019] In one exemplary embodiment, a valve repair device for repairing a patient's native valve is made of a strip of material. The strip of material has a first edge and a second edge surrounding a central portion. An apposition element is formed by the strip of material. A pair of paddles are formed by the strip of material. The pair of paddles are connected to the apposition element. The paddles are movable between an open position and a closed position.

[0020] In an exemplary embodiment, a valve repair device for repairing a patient's natural valve includes a material strip, a pair of attachment portions, a pair of extension members, and a cover. The apposition element is formed by the material strip. The pair of extension members have an attachment portion. A pair of paddles are formed by the material strip. A pair of paddles are connected to the apposition element. The paddles can move between an open position and a closed position. The paddles are arranged above the extension member. The cover is attached to the paddles. Movement of the cover toward the apposition element causes the pair of paddles to move to the closed position. Movement of the cover away from the apposition element causes the pair of paddles to move to the open position. The cover includes a retaining body, a retaining nut, and a retaining bolt. The retaining body has a locking opening for receiving the attachment portion of the extension member. The retaining nut is inserted into the locking opening. The retaining bolt fixes the retaining nut in the locking opening.

[0021] In an example method of manufacturing a valve repair device for repairing a patient's natural valve, a strip of material is folded to form an apposition element and a pair of paddles connected to the apposition element. The paddles can move between an open position and a closed position and are configured to be attached to the patient's natural valve. A portion of the strip of material that forms the paddles is attached to a cover. Movement of the cover toward the apposition element causes a pair of paddles to move to a closed position. Movement of the cover away from the apposition element causes a pair of paddles to move to an open position. The cover includes a retaining body, a retaining nut, and a retaining bolt. The retaining body has a locking opening for receiving an attachment portion of an extension member. The retaining nut is configured to be inserted into the locking opening. The retaining bolt fixes the retaining nut in the locking opening. A pair of extension members are attached to the retaining body of the cover via the attachment portion of the extension member so that the paddles are arranged above the extension member. The retaining bolt and the retaining nut are assembled to fix the cover to the material strip.

[0022] In an exemplary embodiment, a valve repair device for repairing a patient's natural valve includes a material strip, a cover, and a pair of extension members. The apposition element is formed by the material strip. A pair of paddles are formed by the material strip and connected to the apposition element. The paddles can move between an open position and a closed position and are configured to be attached to the patient's natural valve. The cover is attached to the paddles. Movement of the cover toward the apposition element causes the pair of paddles to move to the closed position. Movement of the cover away from the apposition element causes the pair of paddles to move to the open position. A pair of extension members are connected to the cover and can move between an open position and a closed position. In the closed position, the extension member is biased in the closed direction.

[0023] In one example method of manufacturing a valve repair device for repairing a patient's native valve, a strip of material formed of a shape memory alloy is folded around a fixture to form an apposition element and a pair of paddles connected to the apposition element. The paddles are movable between an open position and a closed position and are configured to attach to the patient's native valve. The strip of shape memory material is heat treated to shape the strip of material into the shape of the apposition element and the paddles.

[0024] In an exemplary embodiment, a valve repair device for repairing a patient's natural valve includes a material strip, a cover, and a pair of extension members. The apposition element is formed by the material strip. A pair of paddles are formed by the material strip and connected to the apposition element. The paddles can move between an open position and a closed position and are configured to be attached to the patient's natural valve. The cover is attached to the paddles. Movement of the cover toward the apposition element causes the pair of paddles to move to the closed position. Movement of the cover away from the apposition element causes the pair of paddles to move to the open position. The pair of extension members are connected to the cover and the paddles. The extension member extends from an attachment portion for attaching the extension member to the cover to an end portion of the paddle attached to the strip material. The end portion of the extension member extends beyond the material strip.

[0025] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a main coaptation element, at least one auxiliary coaptation element, and a pair of paddles. At least one auxiliary coaptation element is connected to the coaptation element. A pair of paddles is connected to the main coaptation element. The paddles can move between an open position and a closed position.

[0026] In an exemplary embodiment, a valve repair device for repairing a patient's natural valve includes an apposition element, a pair of paddles connected to the apposition element, and a pair of paddle frames. The paddles can move between an open position and a closed position. The paddles are configured to be attached to the patient's natural valve. The first paddle frame and the second paddle frame have spaced apart frame portions that are parallel or substantially parallel when the paddles are in the closed position to form a rectangular-shaped leaflet engagement region.

[0027] In an exemplary method for repairing a natural heart valve, a first repair device and a second repair device are mounted on a pair of leaflets of a natural heart valve. Each repair device has a rectangular or substantially rectangular frame. The paddle frames of the mounted repair devices are adjacent to each other and parallel or substantially parallel to each other.

[0028] The foregoing methods and other treatment methods herein can be performed on a living animal or on a mimetic, such as a cadaver, a cadaver heart, a mimetic (eg, utilizing a simulated body part, tissue, etc.), or the like.

[0029] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a pair of paddles and a pair of hooks. The paddles are movable between an open position and a closed position. Each hook has at least one barb, a barb support portion, a movable arm, and a flexible portion between the barb support portion and the movable arm. The flexible portion is configured to allow the barb support portion to flex away from the movable arm.

[0030] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts have like reference numerals. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to further illustrate various aspects of the embodiments of the present 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 the present disclosure and should not be considered as limiting the scope of the present disclosure. In addition, although the drawings may be drawn to scale for certain embodiments, they are not necessarily drawn to scale for all embodiments. Through the use of the accompanying drawings, the embodiments and other features and advantages of the present disclosure will be described and explained in conjunction with additional features and details, wherein:

[0032] Figure 1 shows a cross-sectional view of a human heart in diastole;

[0033] Figure 2 showing a cross-sectional view of a human heart in the systolic phase;

[0034] Figure 2A is another cross-sectional view of a human heart during the systolic phase;

[0035] Figure 2B yes Figure 2A sectional view of a mitral valve leaflet annotated to illustrate the natural shape of the mitral valve leaflet during the systolic phase;

[0036] Figure 3 A cross-sectional view of a human heart in diastole is shown, wherein chordae tendineae are shown attaching the leaflets of the mitral and tricuspid valves to the ventricular wall;

[0037] Figure 4 A healthy mitral valve with leaflet closure viewed from the atrial side of the mitral valve is shown;

[0038] Figure 5 A dysfunctional mitral valve with visible gaps between leaflets is shown as viewed from the atrial side of the mitral valve;

[0039] Figure 6 The mitral valve is shown with a wide gap between the posterior and anterior leaflets;

[0040] Fig. 6A showing the coaptation elements in the gap of the mitral valve as viewed from the atrial side of the mitral valve;

[0041] Figure 6B showing a valve repair device attached to a mitral valve leaflet as viewed from the ventricular side of the mitral valve, with the coaptation element in the interspace of the mitral valve;

[0042] Figure 6C is a perspective view of a valve repair device attached to a mitral valve leaflet shown from the ventricular side of the mitral valve with the apposition elements in the interspace of the mitral valve;

[0043] Fig.6D is a schematic diagram illustrating the path of a mitral valve leaflet along each side of an apposition element of an example mitral valve repair device;

[0044] Fig. 6E is a top schematic diagram showing the path of a mitral valve leaflet around an apposition element of an example native valve repair device;

[0045] Figure 7 The tricuspid valve is shown as viewed from the atrial side of the tricuspid valve;

[0046] Figures 8 to 14 illustrates an example embodiment of an implantable prosthetic device in various stages of deployment;

[0047] Fig.11A An exemplary embodiment of an implantable prosthetic device is shown, which is similar to Fig.11 The device shown, but in which the paddles are independently controllable;

[0048] Figures 15 to 20 Delivered and implanted in a native valve Figures 8 to 14 implantable prosthetic devices;

[0049] Fig.21 An example embodiment of an implantable prosthetic device or a frame for an implantable prosthetic device is shown;

[0050] Fig. 22 An example embodiment of an implantable prosthetic device or a frame for an implantable prosthetic device is shown;

[0051] Figure 23 to Figure 25 illustrates example embodiments of components of an implantable prosthetic device or implantable medical device;

[0052] Fig.23A An exemplary embodiment of an implantable prosthetic device is shown, which is similar to Fig.23 The device shown, but in which at least the engaging elements and the paddles are formed from strips of material;

[0053] Fig.26 and 27 An example embodiment of a barbed hook for use in an implantable prosthetic device is shown;

[0054] Figure 28 to Figure 32 An example embodiment of an implantable prosthetic device is shown;

[0055] Fig. 30A A cover is provided thereon. Fig.23A An exemplary embodiment of an implantable prosthetic device is shown;

[0056] Fig.32A and 32B yes Figure 28 to Figure 32 A perspective view of a cap and an apposition element insert of an implantable prosthetic device in sealed and spaced-apart positions, respectively;

[0057] Fig.33 A barbed hook is shown for use in an implantable prosthetic device;

[0058] Fig.34 A portion of native valve tissue is shown grasped by a barbed hook;

[0059] Figures 35 to 46An example embodiment of an implantable prosthetic device is shown being delivered and implanted within a native valve;

[0060] Fig.47 A side view of an example implantable prosthetic device without a barbed hook is shown in a closed position;

[0061] Fig.47A A side view of an example implantable prosthetic device without barbs is shown in a closed position;

[0062] Fig.48 A side view of an example implantable prosthetic device having a barbed hook is shown in a closed position;

[0063] Fig.48A A side view of an example implantable prosthetic device having a barbed hook is shown in a closed position;

[0064] Fig.48B A side view of an example implantable prosthetic device having a barbed hook is shown in a closed position, the device being coupled to a deployment device;

[0065] Fig.48C Show according to Fig.48B A side view of an example implantable prosthetic device having a cover;

[0066] Fig.48D Show according to Fig.48B A front view of an example implantable prosthetic device attached to a deployment device;

[0067] Fig.48E Show according to Fig.48D A front view of an example implantable prosthetic device having a cover;

[0068] Fig.48F Show according to Fig.48B A side view of an example implantable prosthetic device having a barbed hook in a closed position;

[0069] Figure 48G Show according to Fig.48F A front view of an example implantable prosthetic device;

[0070] Figure 48H Show according to Fig.48F A bottom view of an example implantable prosthetic device;

[0071] Fig.49 A side view of an example implantable prosthetic device without a barbed hook is shown in a partially open position;

[0072] Fig.50showing a side view of an example implantable prosthetic device in a partially open position with the barbed hook in a closed position;

[0073] Fig.51 A side view of an example implantable prosthetic device is shown in a partially open position, wherein the barbed hook is in an open position;

[0074] Fig.52 A side view of an example implantable prosthetic device without a barbed hook is shown in a semi-open position;

[0075] Fig.53 A side view of an example implantable prosthetic device is shown in a semi-open position with the barbed hook in a closed position;

[0076] Fig.53A A side view of an example implantable prosthetic device is shown in a semi-open position with the barbed hook in a closed position;

[0077] Fig.53B Show according to Fig.53A A front view of an example implantable prosthetic device;

[0078] Fig.53C Show according to Fig.53A A side view of an example implantable prosthetic device provided with a cover;

[0079] Fig.53D Show according to Fig.53A A front view of an example implantable prosthetic device provided with a cover;

[0080] Fig.54 A side view of an example implantable prosthetic device is shown in a semi-open position with the barbed hook in an open position;

[0081] Fig.54A A side view of an example implantable prosthetic device is shown in a semi-open position with the barbed hook in an open position;

[0082] Fig.54B Show according to Fig.54A A front view of an example implantable prosthetic device;

[0083] Fig.54C Show according to Fig.54A A side view of an example implantable prosthetic device having a cover;

[0084] Fig.54D Show Fig.54A A front view of an example implantable prosthetic device having a cover;

[0085] Fig.55A side view of an example implantable prosthetic device without a barbed hook is shown in a three-quarter open position;

[0086] Fig.56 showing a side view of an example implantable prosthetic device in a three-quarter open position with the barbed hook in a closed position;

[0087] Fig.57 A side view of an example implantable prosthetic device is shown in a three-quarter open position with the barbed hook in an open position;

[0088] Fig.58 A side view of an example implantable prosthetic device without a barbed hook is shown near a fully salvaged position or near a fully open position;

[0089] Fig.59 A side view of an example implantable prosthetic device without a barbed hook is shown in a fully salvaged or fully open position;

[0090] Fig.60 A side view of an example implantable device is shown in a fully salvaged position with the barbed hooks in a closed position;

[0091] Fig.60A A side view of an example implantable device is shown in a fully salvaged position with the barbed hooks in a closed position;

[0092] Fig.60B Show according to Fig.60A A front view of an example implantable prosthetic device;

[0093] Fig.60C Show according to Fig.60A A side view of an example implantable prosthetic device provided with a cover;

[0094] Fig.60D Show according to Fig.60A A front view of an example implantable prosthetic device having a cover;

[0095] Fig.61 A side view of an example implantable device is shown in a fully salvaged position with the barbed hook in an open position;

[0096] Fig.61A A side view of an example implantable device is shown in a fully salvaged position with the barbed hook in an open position;

[0097] Fig.61B Show according to Fig.61A A front view of an example implantable prosthetic device;

[0098] Fig.61C Show according to Fig.61A A side view of an example implantable prosthetic device provided with a cover;

[0099] Fig.61D Show according to Fig.61A A front view of an example implantable prosthetic device having a cover;

[0100] FIG. 62A to FIG. 62B illustrates movement of a paddle of an example embodiment of an implantable prosthetic device;

[0101] Figures 63A to 63C illustrates movement of a paddle of an example embodiment of an implantable prosthetic device;

[0102] Figures 64A to 64C illustrates movement of a paddle of an example embodiment of an implantable prosthetic device;

[0103] Fig.65 showing a perspective view of an example implantable prosthetic device in a closed position;

[0104] Fig.65A showing a perspective view of an example implantable prosthetic device in a closed position;

[0105] Fig.66 Show Fig.65 A perspective view of an implantable prosthetic device;

[0106] Fig.66A Show Fig.65A A perspective view of an implantable prosthetic device;

[0107] Fig.67 Show Fig.65 A front view of an implantable prosthetic device;

[0108] Fig.67A Show Fig.65A A front view of an implantable prosthetic device;

[0109] Fig.68 Shown with additional components Fig.65 A front view of an implantable prosthetic device;

[0110] Fig.68A Shown with additional components Fig.65A A front view of an implantable prosthetic device;

[0111] Fig.69 Show Fig.65 A side view of an implantable prosthetic device;

[0112] Fig.70 Show Fig.65 A top view of an implantable prosthetic device;

[0113] Fig.70A Show Fig.65A A top view of an implantable prosthetic device;

[0114] Fig.71 Shown is a liner component Fig.65 A top view of an implantable prosthetic device;

[0115] Fig.71A Shown is a liner component Fig.65A A top view of an implantable prosthetic device;

[0116] Fig.72 Show Fig.65 A bottom view of an implantable prosthetic device;

[0117] Fig.72A Show Fig.65A A bottom view of an implantable prosthetic device;

[0118] Fig.73 Shown is a cover member Fig.65 A bottom view of an implantable prosthetic device;

[0119] Fig.73A Shown is a cover member Fig.65A A bottom view of an implantable prosthetic device;

[0120] Fig.74 The cross-sectional plane 75 is shown. Fig.65 A cut-away perspective view of an implantable prosthetic device;

[0121] Fig.74A The cross-sectional plane 75A is shown. Fig.65A A cut-away perspective view of an implantable prosthetic device;

[0122] Fig.75 Show Fig.74 a top cross-sectional view of an example prosthetic device shown;

[0123] Fig.75A Show Fig.74A a top cross-sectional view of an example prosthetic device shown;

[0124] Fig.76 The cross-sectional plane 77 is shown. Fig.65 A cut-away perspective view of an implantable prosthetic device;

[0125] Fig.76A The cross-sectional plane 77A is shown. Fig.65A A cut-away perspective view of an implantable prosthetic device;

[0126] Fig.77 Show Fig.76a top cross-sectional view of an example prosthetic device shown;

[0127] Fig.77A Show Fig.76A a top cross-sectional view of an example prosthetic device shown;

[0128] Fig.78 The cross-sectional plane 77 is shown. Fig.65 A cut-away perspective view of an implantable prosthetic device;

[0129] Fig.78A The cross-sectional plane 77A is shown. Fig.65A A cut-away perspective view of an implantable prosthetic device;

[0130] Fig.79 Show Fig.78 a top cross-sectional view of an example prosthetic device shown;

[0131] Fig.79A Show Fig.78A a top cross-sectional view of an example prosthetic device shown;

[0132] Fig.80 The cross-sectional plane 81 is shown. Fig.65 A cut-away perspective view of an implantable prosthetic device;

[0133] Fig.80A The cross-sectional plane 81A is shown. Fig.65A A cut-away perspective view of an implantable prosthetic device;

[0134] Fig.81 Show Fig.80 a top cross-sectional view of an example prosthetic device shown;

[0135] Fig.81A Show Fig.80A a top cross-sectional view of an example prosthetic device shown;

[0136] Fig.82 The cross-sectional plane 83 is shown. Fig.65 A cut-away perspective view of an implantable prosthetic device;

[0137] Fig.82A The cross-sectional plane 83A is shown. Fig.65A A cut-away perspective view of an implantable prosthetic device;

[0138] Fig.83 Show Fig.82 a top cross-sectional view of an example prosthetic device shown;

[0139] Fig.83A Show Fig.82Aa top cross-sectional view of an example prosthetic device shown;

[0140] Fig.84 An example embodiment of an implantable prosthetic device having integral barbs is shown;

[0141] Fig.85 An example embodiment of an implantable prosthetic device having integral barbs is shown;

[0142] Fig.86 An example embodiment of an implantable prosthetic device having integral barbs is shown;

[0143] Fig.86A An exemplary embodiment of an implantable prosthetic device having integrated barbs is shown;

[0144] Fig.87 An example embodiment of an implantable prosthetic device having integral barbs is shown;

[0145] Fig.87A An exemplary embodiment of an implantable prosthetic device having integrated barbs is shown;

[0146] Fig.88 An example embodiment of an implantable prosthetic device having integral barbs is shown;

[0147] Fig.88A An exemplary embodiment of an implantable prosthetic device having integrated barbs is shown;

[0148] Fig.89 Show Fig.65 a perspective view of an apposition portion and a paddle portion of an implantable prosthetic device;

[0149] Fig.89A Show Fig.65A a perspective view of an apposition portion and a paddle portion of an implantable prosthetic device;

[0150] Fig.90 Show Fig.65 a perspective view of an apposition portion and a paddle portion of an implantable prosthetic device;

[0151] Fig.90A Show Fig.65A a perspective view of an apposition portion and a paddle portion of an implantable prosthetic device;

[0152] Fig.91 Show Fig.65 A front view of the apposition portion and the paddle portion of the implantable prosthetic device is shown;

[0153] Fig.91A Show Fig.65AA front view of the apposition portion and the paddle portion of the implantable prosthetic device is shown;

[0154] Fig.92 Show Fig.65 A side view of the apposition portion and the paddle portion of the implantable prosthetic device is shown;

[0155] Fig.92A Show Fig.65A A side view of the apposition portion and the paddle portion of the implantable prosthetic device is shown;

[0156] Fig.93 Show Fig.65 A top view of the apposition portion and the paddle portion of the implantable prosthetic device is shown;

[0157] Fig.93A Show Fig.65A A top view of the apposition portion and the paddle portion of the implantable prosthetic device is shown;

[0158] Fig.94 Show Fig.65 a bottom view of the apposed portion and the paddle portion of the implantable prosthetic device shown;

[0159] Fig.94A Show Fig.65A a bottom view of the apposed portion and the paddle portion of the implantable prosthetic device shown;

[0160] Fig.95 Show Fig.65 A cutaway perspective view of the apposition portion and the paddle portion of the implantable prosthetic device is shown, wherein the section is taken through plane 96;

[0161] Fig.95A Show Fig.65A A cutaway perspective view of the apposition and slurry portions of the implantable prosthetic device is shown, wherein the section is taken through plane 96A;

[0162] Fig.96 Show Fig.95 A cross-sectional view of the mate portion and the blade portion of the paddle;

[0163] Fig.96A Show Fig.95A A cross-sectional view of the mate portion and the blade portion of the paddle;

[0164] Fig.97 Show Fig.65 A cutaway perspective view of the apposition portion and the paddle portion of the implantable prosthetic device is shown, wherein the section is taken through plane 98;

[0165] Fig.97A Show Fig.65AA cutaway perspective view of the apposition and slurry portions of the implantable prosthetic device is shown, wherein the section is taken through plane 98A;

[0166] Fig.98 Show Fig.97 A cross-sectional view of the mate portion and the blade portion of the paddle;

[0167] Fig.98A Show Fig.97A A cross-sectional view of the mate portion and the blade portion of the paddle;

[0168] Fig.99 Show Fig.65 A cutaway perspective view of the apposition portion and the paddle portion of the implantable prosthetic device is shown, wherein the section is taken through plane 100;

[0169] Fig.99A Show Fig.65A A cutaway perspective view of the apposition portion and the paddle portion of the implantable prosthetic device is shown, wherein the section is taken through plane 100A;

[0170] Fig.100 Show Fig.99 A cross-sectional view of the mate portion and the blade portion of the paddle;

[0171] Fig.100A Show Fig.99A A cross-sectional view of the mate portion and the blade portion of the paddle;

[0172] Fig.101 Show Fig.65 A cutaway perspective view of the apposition portion and the paddle portion of the implantable prosthetic device is shown, wherein the section is taken through plane 102;

[0173] Fig.101A Show Fig.65A A cutaway perspective view of the apposition portion and the paddle portion of the implantable prosthetic device is shown, wherein the section is taken through plane 102A;

[0174] Fig.102 Show Fig.101 A cross-sectional view of the mate portion and the blade portion of the paddle;

[0175] Fig.102A Show Fig.101A A cross-sectional view of the mate portion and the blade portion of the paddle;

[0176] Fig.103 An example embodiment of an implantable prosthetic device is shown;

[0177] Fig.104 An example embodiment of an implantable prosthetic device is shown;

[0178] Fig.105An example embodiment of an implantable prosthetic device is shown;

[0179] Fig.106 A side view showing an example embodiment of an expandable apposition element in an unexpanded state;

[0180] Fig.106A A side view showing an example embodiment of an expandable apposition element in an unexpanded state;

[0181] Fig.106B A side view showing an example embodiment of an expandable apposition element in an unexpanded state;

[0182] Fig.106C A side view showing an example embodiment of an expandable apposition element in an unexpanded state;

[0183] Fig.106D A side view showing an example embodiment of an expandable apposition element in an unexpanded state;

[0184] Fig.106E A side view showing an example embodiment of an expandable apposition element in an unexpanded state;

[0185] Fig.106F An example implementation of an expandable involution element is shown;

[0186] Figure 106G An example implementation of an expandable involution element is shown;

[0187] Fig.106H An example implementation of an expandable involution element is shown;

[0188] Fig.106I An example implementation of an expandable involution element is shown;

[0189] Fig.107 Show Fig.106 An end view of an expandable integrative element;

[0190] Fig.108 Shows the expanded state Fig.106 Scalable involution elements;

[0191] Fig.108A Shows the expanded state Fig.106A Scalable involution elements;

[0192] Fig.108B Shows the expanded state Fig.106B Scalable involution elements;

[0193] Fig.108C Shows the expanded state Fig.106C Scalable involution elements;

[0194] Fig.108D Shows the expanded state Fig.106D Scalable involution elements;

[0195] Fig.108E Shows the expanded state Fig.106E Scalable involution elements;

[0196] Fig.109 Show Fig.108 An end view of the mating element;

[0197] Fig.110 showing a side view of an example embodiment of an implantable prosthetic device;

[0198] Fig.111 Shown is a view taken along line 111 Fig.110 An end view of an apposition element of an example prosthetic device.

[0199] Figures 112 to 114 Shown for Fig.65 A perspective view of an example embodiment of a paddle frame of an implantable prosthetic device is shown;

[0200] Fig.112A Shown for Fig.65A A perspective view of an example embodiment of a paddle frame of an implantable prosthetic device;

[0201] Fig.114A Show Fig.112A A side view of a blade frame;

[0202] Fig.115 Show Figures 112 to 114 A front view of a blade frame;

[0203] Fig.115A Show Fig.112A A top view of a blade frame;

[0204] Fig.116 Show Fig.112 and Fig.114 A top view of a blade frame;

[0205] Fig.116A Show Fig.112A A front view of a blade frame;

[0206] Fig.117 Show Fig.112 and Fig.114 A side view of a blade frame;

[0207] Fig.117A Show Fig.112A A rear view of the blade frame;

[0208] Fig.118 Show Fig.112 and Fig.114 A bottom view of a blade frame;

[0209] Fig.118A Show Fig.112A A bottom view of a blade frame;

[0210] Fig.119 Show Figures 112 to 114 A front view of a blade frame;

[0211] Fig.120 Shown in a compressed state within a delivery device Figures 112 to 114 A front view of a blade frame;

[0212] Fig.121 showing a side view of an example embodiment of an implantable prosthetic device in a closed state;

[0213] Fig.122 Show Fig.121 A front view of a paddle frame of an example prosthetic device;

[0214] Fig.123 Shows the open state Fig.121 a side view of an implantable prosthetic device as shown;

[0215] Fig.124 Show Fig.123 a front view of an opened paddle frame of a prosthetic device;

[0216] Fig.125 showing a side view of an example embodiment of an implantable prosthetic device in a closed state;

[0217] Fig.126 Show Fig.125 A front view of a paddle frame of an example prosthetic device;

[0218] Fig.127 Shown in closed state Fig.125 A side view of an implantable prosthetic device;

[0219] Fig.128 Show Fig.127 a front view of an opened paddle frame of a prosthetic device;

[0220] Fig.129 An example embodiment of an implantable prosthetic device is shown;

[0221] Figure 130 to Figure 131 An example embodiment of an implantable prosthetic device is shown;

[0222] Fig.132An example embodiment of an implantable prosthetic device is shown;

[0223] Figure 133 to Figure 134 An example embodiment of an implantable prosthetic device is shown;

[0224] Figure 135 to Figure 136 An example embodiment of an implantable prosthetic device is shown;

[0225] Fig.137 An example embodiment of an implantable prosthetic device is shown;

[0226] Figures 138 to 143 illustrates the use of an example embodiment of an implantable prosthetic device;

[0227] Fig.144 An example embodiment of a delivery assembly including a delivery device and an example prosthetic device is shown;

[0228] Fig.145 showing a perspective view of an example embodiment of an implantable prosthetic device releasably coupled to a delivery device;

[0229] Fig.146 Show Fig.145 An embodiment wherein the implantable prosthetic device is released from a delivery device;

[0230] Fig.147 Show Fig.145 A cross-sectional view of a connector;

[0231] Fig.148 Show Fig.144 a perspective view of a delivery assembly of , wherein a prosthetic device is shown in partial cross-section and certain components of the delivery apparatus are schematically shown;

[0232] Fig.149 Show Fig.144 A plan view of an axis of a delivery device;

[0233] Fig.150 Show Fig.144 a side view of a proximal end portion of a delivery device;

[0234] Fig.151 Show Fig.144 The proximal end portion of the delivery device is along Fig.150 A cross-sectional view taken along line 151-151 is shown;

[0235] Fig.152 Show Fig.144 an exploded view of a proximal end portion of a delivery device;

[0236] Figures 153 to 160 An example procedure for repairing a native valve of a heart is shown, which is partially illustrated;

[0237] Fig.161 Shown for Fig.144 Example embodiments of a handle of a delivery device;

[0238] Fig.162 yes Fig.161 An exploded view of the handle;

[0239] Fig.163 Shown for Fig.144 Example embodiments of a coupler and a proximal collar of a delivery assembly of , showing the coupler releasably coupled to the proximal collar;

[0240] Fig.164 Show Fig.163 A perspective view of a coupling and a proximal collar of , showing the coupling released from the proximal collar;

[0241] Fig.165 Shown for Fig.144 Example embodiments of a cover, an actuation element or an actuation instrument, and a release wire of a delivery assembly of the invention, showing a cover releasably coupled to an actuation element or a device actuated by a release wire.

[0242] Fig.166 Show Fig.163 A perspective view of a cover, an actuating element or an actuating device, and a release wire showing the cover and the release wire released from the actuating element or the actuating device;

[0243] Fig.167 Show Fig.144 Example embodiments of a coupler, a proximal collar, a cover, and an actuation element or actuation instrument of a delivery assembly of;

[0244] Fig.168 Show Fig.167 A perspective view of a coupling and a proximal bushing;

[0245] Fig.169 Show Fig.144 Example embodiments of hook control members of a delivery device;

[0246] Fig.170 Shown from Fig.169 Perspective shown Fig.170 The intercepted Fig.169 A detailed view of the hook control member;

[0247] Fig.171 Shown for Fig.169 An example embodiment of a guide rail of a hook control member in;

[0248] Fig.172 Show Fig.144 Example embodiments of a shaft of a delivery device;

[0249] Fig.173 Example embodiments of implantable prosthetic devices and delivery devices for releasing and recapturing the prosthetic devices are shown;

[0250] Fig.174 Example embodiments of implantable prosthetic devices and delivery devices for releasing and recapturing the prosthetic devices are shown;

[0251] Fig.174A Embodiments of implantable prosthetic devices and delivery devices for releasing and recapturing the prosthetic devices are shown;

[0252] Fig.175 Example embodiments of implantable prosthetic devices and delivery devices for releasing and recapturing the prosthetic devices are shown;

[0253] Figure 175A Embodiments of implantable prosthetic devices and delivery devices for releasing and recapturing the prosthetic devices are shown;

[0254] Fig.176 Example embodiments of implantable prosthetic devices and delivery devices for releasing and recapturing the prosthetic devices are shown;

[0255] Figures 177 to 178 An example embodiment of a coupler for an example implantable prosthetic device is shown;

[0256] Figures 179 to 181 An example embodiment of a coupler for an example implantable prosthetic device is shown;

[0257] Figure 182 to Figure 183 An example embodiment of a coupler for an example implantable prosthetic device is shown;

[0258] Figure 184 to Figure 185 An example embodiment of a coupler for an example implantable prosthetic device is shown;

[0259] Fig.186 An example embodiment of an actuation element or actuation instrument for an example prosthetic device is shown;

[0260] Fig.187 An actuation mechanism for an example prosthetic device is shown;

[0261] Fig.188 An actuation mechanism for an example prosthetic device is shown;

[0262] Fig.188A An actuation mechanism of an example prosthetic device is shown;

[0263] Fig.189 An actuation mechanism for an example prosthetic device is shown;

[0264] Fig.190 An actuation mechanism for an example prosthetic device is shown;

[0265] Fig.191 is a perspective view of a blank for making a blade frame;

[0266] Fig.192 yes Fig.191 A perspective view of a blank being bent to form a blade frame;

[0267] Fig.193 is a perspective view of a shaped paddle frame attached to a cover of a valve repair device;

[0268] Fig.194 yes Fig.193 A perspective view of a blade frame flexed and attached to an inner blade and an outer blade in a closed position;

[0269] Fig.195 yes Fig.112A A perspective view of two blade frames of FIG. 1 , showing the blade frames in a shaped position;

[0270] Fig.196 yes Fig.195 A perspective view of a blade frame of FIG. 1 , showing the blade frame in a stowed position;

[0271] Fig.197 yes Fig.60C An enlarged side view of the device showing the cover;

[0272] Fig.198 yes Fig.60C an enlarged side view of the device shown, showing the cover;

[0273] Fig.199 showing an exploded view of an example prosthetic device;

[0274] Fig.200 an enlarged perspective view showing a bushing of an example prosthetic device;

[0275] Fig.201 an enlarged perspective view showing a cover of an example prosthetic device;

[0276] Fig.202 Show Fig.206 Exploded view of the cover;

[0277] Fig.203 showing a plan view of an inner cover for an example prosthetic device;

[0278] Fig.204 showing a plan view of an outer cover of an example prosthetic device;

[0279] Fig.205 shows an enlarged view of a strip of material for an example prosthetic device;

[0280] Fig.206 Show Fig.205 an end view of a material;

[0281] Fig.207 Shown is arranged in multiple layers Fig.205 an end view of a material;

[0282] Fig.208A An example implantable prosthetic device is shown in a gap of a native valve as viewed from the atrial side of the native valve during diastole with an example expandable spacer in a deflated state;

[0283] Fig.208B Shown during contraction Fig.208A The device, wherein the example expandable spacer is in a deflated state;

[0284] Fig.209A Shown during diastole Fig.208A The device, wherein the example expandable spacer is in an expanded state;

[0285] Fig.209B Shown during contraction Fig.208A The device, wherein the example expandable spacer is in an expanded state;

[0286] Fig.210A An example expandable spacer is shown in a compressed state;

[0287] Fig.210B Shows the expanded state Fig.210A Expandable spacers;

[0288] Fig.211A An example implantable prosthetic device is shown with an example expandable spacer in a deflated state;

[0289] Fig.211B Show Fig.211B The device, wherein the example expandable spacer is in an expanded state;

[0290] Fig.212A is a side view of an example implantable prosthetic device;

[0291] Fig.212B for Fig.212A Front / rear view of the device;

[0292] Fig.213A is used to attach to Fig.212A A top view of an example auxiliary spacer of a device;

[0293] Fig.213B yes Fig.213A A side view of a spacer;

[0294] Fig.214 Is assembled to Fig.212A , 212B Device Fig.213A , 213B A side view of a spacer;

[0295] Fig.215A Is assembled to Fig.212A , 212B on the device Fig.213A , 213B A side view of a spacer;

[0296] Fig.215B yes Fig.215A A top view of a component;

[0297] Fig.216A is a side view of an example implantable prosthetic device;

[0298] Fig.216B for Fig.216A Front / rear view of the device;

[0299] Fig.217A is used to attach to Fig.216A A top view of an example auxiliary spacer of a device;

[0300] Fig.217B yes Fig.217A A side view of a spacer;

[0301] Fig.218 is an example auxiliary spacer;

[0302] Fig.219A is a top view of an example implantable prosthetic device;

[0303] Fig.219B is a side view of an example implantable prosthetic device;

[0304] Figure 220A is a top view of an example auxiliary spacer;

[0305] Fig.220B is a top view of an example auxiliary spacer;

[0306] Fig.220C is a top view of an example auxiliary spacer;

[0307] Fig.220D is a top view of an example auxiliary spacer;

[0308] Figure 220E is a top view of an example auxiliary spacer;

[0309] Fig.221 is a plan view of an example implantable prosthetic device cut from a flat sheet;

[0310] Fig.222 yes Fig.221 A perspective view of the device;

[0311] Fig.223 The figure shows the gap in the native valve when viewed from the atrial side of the native valve. Figure 221 to Figure 222 Devices;

[0312] Fig.224 is a plan view of an example implantable prosthetic device cut from a flat sheet;

[0313] Fig.225 yes Fig.224 A perspective view of the device;

[0314] Fig.226 An example embodiment of an implantable prosthetic device having a two-piece cover is shown;

[0315] Fig.227 An example embodiment of an implantable prosthetic device having a two-piece cover is shown;

[0316] Fig.228 An example embodiment of an implantable prosthetic device having a two-piece cover is shown;

[0317] Fig.229 An example embodiment of an implantable prosthetic device having a two-piece cover is shown;

[0318] Fig.230 An example embodiment of an implantable prosthetic device having a two-piece cover is shown;

[0319] Fig.231 An example embodiment of an implantable prosthetic device having a two-piece cover is shown;

[0320] Figure 232A is a front view of an implantable prosthetic device including a barbed hook and substantially parallel paddle frame members according to an example embodiment;

[0321] Fig.232B is along Figure 232A A cross-sectional view taken along the plane shown by line 232B-232B;

[0322] Figure 233A is with Figure 232A A similar view, noting the spaces between the substantially parallel sections of the blade frame elements;

[0323] Fig.233B is along Figure 233A A cross-sectional view taken along the plane indicated by line 233B-233B;

[0324] Fig.234A is with Figure 232A A similar view showing engagement of a portion of a native leaflet between substantially parallel paddle frame elements;

[0325] Fig.234B is along Fig.234A A cross-sectional view taken along a plane indicated by line 234B-234B in FIG.

[0326] Figure 235A For Fig.234A a similar view showing misaligned native valve leaflets;

[0327] Fig.235B is along Figure 235A A cross-sectional view taken along the plane indicated by line 235B-235B;

[0328] Fig.236 is a side view of an implantable prosthetic device according to an example embodiment;

[0329] Fig.237 is a side view of two adjacent implantable prosthetic devices according to an example embodiment;

[0330] Figure 238A is a side view of an implantable prosthetic device mounted on a native valve according to an example embodiment;

[0331] Figure 238B is along Figure 238A A cross-sectional view taken along the plane indicated by line 238B-238B;

[0332] Fig.239A is a side view of two adjacent implantable prosthetic devices installed on a mitral valve according to an example embodiment;

[0333] Fig.239B is along Fig.239A A cross-sectional view taken along the plane indicated by line 239B-239B;

[0334] Figure 240A is similar to Fig.239A , showing two adjacent but misaligned implantable prosthetic devices;

[0335] Figure 240B is along Figure 240A A cross-sectional view taken along the plane shown by line 240B-240B;

[0336] Fig.241 is a perspective view of a portion of a hook having a flexible barb support according to an example embodiment;

[0337] Fig.242 yes Fig.241 A portion of a hook of the embodiment of the present invention, wherein the barb support is bent backward to illustrate the flexible nature of the barb support in the exemplary embodiment;

[0338] Figures 243A to 243H yes Fig.242 Schematic diagram of a hook with a flexible barbed support being released from a valve leaflet;

[0339] Figures 244A to 244E is a schematic diagram of an implantable prosthetic device with hooks and flexible barb supports released from valve leaflets;

[0340] Figures 245A to 245E is an illustration of an implantable prosthetic device with hooks and flexible barb supports released from valve leaflets; and

[0341] Fig.246 is an illustration of an implantable device applying force on a single leaflet to illustrate a situation in which the hooks may be released from the native valve leaflet. DETAILED DESCRIPTION

[0342] The following description refers to the accompanying drawings, which illustrate specific embodiments of the present disclosure. Other embodiments having different structures and operations do not depart from the scope of the present disclosure.

[0343] Example embodiments of the present disclosure relate to devices and methods for repairing defective heart valves. It should be noted that various embodiments of native valve repair devices and systems for delivery are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, the various components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible.

[0344] As described herein, when one or more components are described as being connected, linked, attached, coupled, attached, or otherwise interconnected, such interconnection may be a direct interconnection between the components, or may be an indirect interconnection (such as through the use of one or more intermediate components). Also as described herein, references to "member," "component," or "portion" should not be limited to a single structural member, component, or element, but may include an assembly of components, components, or elements. Also as described herein, the terms "substantially" and "approximately" 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%).

[0345] Figure 1 and Figure 2sectional views of a human heart H in diastole and systole, respectively. The right ventricle RV and the left ventricle LV are separated from the right atrium RA and the left atrium LA by the tricuspid valve TV and the mitral valve MV (i.e., the atrioventricular valves), respectively. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., Figure 4 and Figure 5 , 20, 22), the flexible leaflets extend inwardly across the corresponding orifices, which meet or "combine" in the flow stream to form a one-way fluid blocking surface. The native valve repair system of the present application is mainly described with respect to the mitral valve MV. Therefore, the anatomical structure of the left atrium LA and the left ventricle LV will be explained in more detail. It should be understood that the device described herein can also be used to repair other native valves, for example, the device can be used to repair the tricuspid valve TV, the aortic valve AV and the pulmonary valve PV.

[0346] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase or relaxation, as Figure 1 As shown, blood previously collected in the left atrium LA (during the systolic phase) moves through the mitral valve MV and enters the left ventricle LV through the expansion of the left ventricle LV. Figure 2 As shown, the left ventricle LV contracts to force blood into the body through the aortic valve AV and the ascending aorta AA. During contraction, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV and back into the left atrium LA, and blood is collected in the left atrium from the pulmonary veins. In an exemplary embodiment, the devices described in the present application are used to repair the function of a defective mitral valve MV. That is, these devices are configured to help close the leaflets of the mitral valve to prevent blood from flowing back from the left ventricle LV and back into the left atrium LA. Unlike the prior art that describes the use of sutures or clips, which typically require multiple sutures or clips and additional supports to handle large regurgitations, the devices described in the present application are designed to easily grasp and secure the natural leaflets around the apposition elements that act as fillers in the regurgitation orifices.

[0347] Reference now Figures 1 to 7 , the mitral valve MV includes two leaflets, namely an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24, which is a variable density fibrous ring of tissue surrounding the leaflets 20, 22. Figure 3, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae 10. The chordae tendineae 10 are cord-like tendons that connect papillary muscles 12 (i.e., muscles located at the base of the chordae tendineae and within the wall of the left ventricle) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles 12 serve to limit the movement of the mitral valve MV and prevent the mitral valve from reversing. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles cannot open or close the mitral valve MV. Instead, the papillary muscles support the mitral valve MV against the high pressures required to circulate blood throughout the body. Together, the papillary muscles and chordae tendineae are referred to as the subvalvular structures, which serve to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed.

[0348] Various disease processes can impair the normal function of one or more native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, fibroelastic defects), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). In addition, damage to the left ventricle LV or right ventricle RV from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy) can distort the geometry of the native valve, which can cause native valve dysfunction. However, the vast majority of patients who undergo valve surgery (such as surgery on the mitral valve MV) suffer from a degenerative disease that causes dysfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), which leads to prolapse and regurgitation.

[0349] Generally speaking, native valves can malfunction in two different ways: (1) valvular stenosis; and (2) valvular regurgitation. Valvular stenosis occurs when the native valve does not open fully and thus causes blood flow obstruction. Typically, valvular stenosis is caused by the accumulation of calcified material on the valve leaflets, which causes the leaflets to thicken and impairs the ability of the valve to open fully to allow forward blood flow.

[0350] The second type of valve dysfunction, i.e., valve regurgitation, occurs when the leaflets of the valve are not completely closed, causing blood to leak back into the previous chamber (e.g., causing blood to leak from the left ventricle to the left atrium). There are three main mechanisms by which the native valve becomes regurgitant (or incompetent), including Carpentier Type I, Type II, and Type III dysfunctions. Carpentier Type I dysfunction involves expansion of the ring, causing the normally functioning leaflets to separate from each other and fail to form a tight seal (i.e., the leaflets cannot properly appose). Type I mechanism dysfunction includes leaflet perforations present in endocarditis. Carpentier Type II dysfunction involves prolapse of one or more leaflets of the native valve above the apposition plane. Carpentier Type III dysfunction involves limiting the movement of one or more leaflets of the native valve, causing the leaflets to be abnormally constrained below the plane of the ring. Leaflet restriction may be caused by rheumatic disease (Ma) or ventricular dilatation (IIIb).

[0351] refer to Figure 4 , when the healthy mitral valve MV is in the closed position, the anterior leaflet 20 and the posterior leaflet 22 coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Figure 5 Regurgitation occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV are displaced into the left atrium LA during systole. This failure to coapt causes a gap 26 between the anterior leaflet 20 and the posterior leaflet 22 that allows blood to flow from the left ventricle LV back into the left atrium LA during systole. As described above, there are several different ways that a leaflet (e.g., the leaflets 20, 22 of the mitral valve MV) may malfunction, thereby causing regurgitation.

[0352] refer to Figure 6 In some cases, when the mitral valve is in a closed position (i.e., during the systolic phase), the patient's mitral valve MV may have a wide gap 26 between the anterior leaflet 20 and the posterior leaflet 22. For example, the gap 26 may have a width W between about 2.5 mm and about 17.5 mm, such as between about 5 mm and about 15 mm, such as between about 7.5 mm and about 12.5 mm (such as about 10 mm). In some 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 the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent blood from flowing back through the mitral valve MV.

[0353] Although stenosis or regurgitation can affect any valve, stenosis is primarily found to affect the aortic valve AV or the pulmonary valve PV, and regurgitation is primarily found to affect the mitral valve MV or the tricuspid valve TV. Both valvular stenosis and valvular 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. Since the left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) are primarily responsible for circulating blood throughout the body, malfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening. Therefore, due to the significantly higher pressures on the left side of the heart, dysfunction of the mitral valve MV or the aortic valve AV tends to be more problematic.

[0354] Dysfunctional native heart valves can be repaired or replaced. Repair generally involves the preservation and correction of the patient's native valve. Replacement generally involves replacing the patient's native valve with a biological or mechanical substitute. Generally, the aortic valve AV and the pulmonary valve PV are more prone to stenosis. Because the stenotic damage maintained by the leaflets is irreversible, the most conventional treatment for a stenotic aortic valve or a stenotic pulmonary valve is to remove the valve and replace it with a surgically implanted heart valve, or to replace the above valve with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more prone to leaflet deformation, which, as described above, prevents the mitral valve or tricuspid valve from closing correctly and allows blood to flow back or reverse from the ventricle to the atrium (for example, a deformed mitral valve MV can allow reverse or reverse flow from the left ventricle LV to the left atrium LA). The reverse or reverse flow of blood from the ventricle to the atrium causes valvular insufficiency. Deformation of the structure or shape of the mitral valve MV or the tricuspid valve TV is generally repairable. Additionally, backflow may occur as a result of the chordae 10 becoming dysfunctional (e.g., the chordae may stretch or rupture), which allows the anterior and posterior leaflets 20, 22 to reverse, allowing blood to flow back into the left atrium LA. Problems caused by dysfunctional chordae 10 may be repaired by repairing the structure of the chordae or mitral valve (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0355] For purposes of illustration, the devices and procedures disclosed herein are generally directed to repairing the mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve and any component of a native valve. For example, reference is now made to Figure 7, any device and concept provided herein can be used to repair the tricuspid valve TV. For example, any device and concept provided herein can be used between any two of the anterior leaflet 30, the septal leaflet 32, and the posterior leaflet 34 to prevent blood from flowing back from the right ventricle to the right atrium. In addition, any device and concept provided herein can be used together on all three of the leaflets 30, 32, and 34 to prevent blood from flowing back from the right ventricle to the right atrium. That is, the valve repair device provided herein can be located in the center between the three leaflets 30, 32, and 34.

[0356] An example implantable prosthetic device has an apposition element and at least one anchor. The apposition 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 above-mentioned backflow. The apposition element can have a structure that is impermeable to blood or resistant to blood and allows the natural leaflets to close around the apposition element during ventricular contraction to prevent blood from flowing back into the left atrium or right atrium from the left ventricle or right ventricle, respectively. The prosthetic device can be configured to seal against two or three natural valve leaflets; that is, the device can be used for natural mitral (mitral or bicuspid) valves and tricuspid valves. The apposition element is sometimes referred to as a spacer in this article because the apposition element can fill the space between the functionally abnormal natural mitral or tricuspid valve leaflets that are not completely closed.

[0357] The apposition element (e.g., a spacer, an apposition element, etc.) can have various shapes. In some embodiments, the apposition element can have an elongated cylindrical shape having a circular cross-sectional shape. In other embodiments, the apposition element can have an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. The apposition element can have an atrial portion positioned in or adjacent to the left atrium, a ventricular portion or lower portion positioned in or adjacent to the left ventricle, and a side surface extending between the natural mitral valve leaflets. In an embodiment constructed for the tricuspid valve, the atrial portion or upper portion is positioned in or adjacent to the right atrium, and the ventricular portion or lower portion is positioned in or adjacent to the right ventricle, and the side surface extends between the natural tricuspid valve leaflets.

[0358] The anchor can be configured to fix the device to one or two of the natural mitral valve leaflets so that the apposition element is positioned between the two natural leaflets. In the embodiment configured for the tricuspid valve, the anchor is configured to fix the device to one, two or three of the tricuspid valve leaflets so that the apposition element is positioned between the three natural leaflets. In some embodiments, the anchor can be attached to the apposition element at a position adjacent to the ventricular portion of the apposition element. In some embodiments, the anchor can be attached to an actuating element, such as an axis or an actuating wire, and the apposition element is also attached to the actuating element. In some embodiments, by moving each of the anchor and the apposition element separately along the longitudinal axis of the axis or the actuating wire, the anchor and the apposition element can be positioned independently relative to each other. In some embodiments, by moving the anchor and the apposition element together along the longitudinal axis of the axis or the actuating wire, the anchor and the apposition element can be positioned simultaneously. The anchor can be configured to be positioned behind the natural leaflet when implanted so that the leaflet is grasped by the anchor.

[0359] Prosthetic device can be configured to be implanted via delivery sheath.The apposition element and anchoring member can be compressed to radial compression state, and can self-expand to radial expansion state when releasing compression pressure.The device can be configured to make anchoring member initially radially expand away from the apposition element that is still compressed, so that a gap is produced between the apposition element and the anchoring member.Then the natural leaflet can be positioned in the gap.The apposition element can be radially expanded, thereby closing the gap between the apposition element and the anchoring member, and capturing the leaflet between the apposition element and the anchoring member.In some embodiments, anchoring member and apposition element are optionally configured to self-expand.The implantation method for various embodiments can be different, and will be discussed more comprehensively for each embodiment below.Additional information about these and other delivery methods can be found in U.S. Patent No. 8,449,599 and U.S. Patent Application Publication No. 2014 / 0222136 and 2014 / 0067052, 2016 / 0331523, each of which is incorporated herein by reference in its entirety. These methods can be performed on a live animal or on a simulated object, such as a cadaver, a cadaver heart, a simulated body (eg, utilizing simulated body parts, tissues, etc.), and the like.

[0360] The disclosed prosthetic device can be configured so that the anchors are connected to the leaflets, thereby using tension from the natural chordae tendineae to resist high systolic pressures that urge the device toward the left atrium. During diastole, the device can rely on compression and retention forces exerted on the leaflets grasped by the anchors.

[0361] Reference now Figures 8 to 14, shows a schematically illustrated implantable prosthetic device 100 at various stages of deployment. Device 100 may include any other features for implantable prosthetic devices discussed herein, and device 100 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0362] The device 100 is deployed from a delivery sheath or an apparatus for delivery 102 and includes an apposition portion 104 and an anchoring portion 106. The apposition portion 104 of the device 100 includes an apposition element or an apparatus for apposition 110 adapted to be implanted between leaflets of a native valve (e.g., a native mitral valve, tricuspid valve, etc.) and slidably attached to an actuating element 112 (e.g., an actuating wire, an actuating shaft, an actuating tube, etc.). The anchoring portion 106 is actuable between an open state and a closed state and may take a variety of forms such as a paddle, a gripping element, etc. The actuation of the actuating element or the apparatus for actuation 112 opens and closes the anchoring portion 106 of the device 100 to grip the native valve leaflets during implantation. The actuating element 112 (e.g., a wire, a shaft, a tube, a screw, a wire, etc.) may take a variety of different forms. For example, the actuation element can be threaded, such that rotation of the actuation element (e.g., a wire, shaft, tube, screw, etc.) moves the anchor portion 106 relative to the mate portion 104. Alternatively, the actuation element can be non-threaded, such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the mate portion 104.

[0363] The anchoring portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122, which are connected between the cover 114 and the apposition element or device for apposition 110 through portions 124, 126, 128. Portions 124, 126, 128 can be connected and / or flexible to move between all positions described below. The interconnection of the outer paddle 120, the inner paddle 122, the apposition element or device for apposition 110, and the cover 114 through portions 124, 126, and 128 can constrain the device to the positions and movements shown herein.

[0364] In some embodiments, an actuation element or means for actuation 112 (e.g., an actuation wire, an actuation shaft, etc.) extends through the delivery sheath and the apposition element or means for actuation 110 to a cover 114 at a distal connection of the anchoring portion 106. Extending and retracting the actuation element or means for actuation 112 increases and decreases the spacing between the apposition element or means for actuation 110 and the cover 114, respectively. A collar or other attachment element removably attaches the apposition element or means for actuation 110 to the delivery sheath or means for delivery 102 such that during actuation to open and close the paddles 120, 122 of the anchoring portion 106, the actuation element or means for actuation 112 slides through the collar or other attachment element and through the apposition element or means for actuation 110.

[0365] Reference now Fig.11 , the anchoring portion 106 includes an attachment portion or gripping member. The gripping member shown includes a barbed hook 130, which includes a base or fixed arm 132, a movable arm 134, a barb or a device for fixing 136, and a joint portion 138. The fixed arm 132 is attached to the inner paddle 122, wherein the joint portion 138 is arranged adjacent to the mating element or the device for mating 110. The barbed hook has a flat surface and does not fit in the recess of the paddle. Instead, the flat portion of the barbed hook is arranged 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 hook 130. The joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, etc. In some embodiments, the joint portion 138 is a flexible material sheet formed integrally with the fixed arm 132 and the movable arm 134. The fixed arms 132 are attached to the inner paddle 122 and remain stationary relative to the inner paddle 122 as the movable arms 134 open to open the barbed hooks 130 and expose the barbs or means for securing 136. In some embodiments, the barbed hooks 130 are opened by applying tension to the actuation wires 116 attached to the movable arms 134, causing the movable arms 134 to articulate, flex, or pivot on the joint portions 138. Other actuation mechanisms are also possible.

[0366] During implantation, the paddles 120, 122 can be opened and closed, for example, to grasp the native leaflet or the native mitral valve leaflet between the paddles 120, 122 and the apposition element or the device for apposition 110. The barbed hook 130 can be used to grasp and / or further secure the native leaflet by engaging the leaflet with the barb or the device for securing 136 and squeezing the leaflet between the movable arm 134 and the fixed arm 132. The barbs of the barbed hook 130 or the device for securing 136 increase friction with the leaflet, or can partially or completely pierce the leaflet. The actuation wire 116 can be actuated individually so that each barbed hook 130 can be opened and closed individually. The individual operations allow grasping of one leaflet at a time, or allow repositioning of the hook 130 on a leaflet that is not fully grasped without changing the successful grasping of another leaflet. The barbed hook 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in the open position), thereby allowing the leaflet to be grasped in a variety of positions as required for a particular situation.

[0367] The barbed hook 130 can be opened individually by pulling the actuation wire 116 extending through the delivery sheath or the device for delivery 102 to the attachment of the barbed hook 130. The actuation wire 116 can take a variety of forms, such as a wire, a suture, a wire, a rod, a catheter, etc. The barbed hook 130 can be spring loaded so that in the closed position, the barbed hook 130 continues to provide a compressive force on the grasped natural leaflet. Regardless of the position of the inner paddle 122, the compressive force remains constant. The barbs of the barbed hook 130 or the device for fixation 136 can perforate the natural leaflet to further fix the natural leaflet.

[0368] Reference now Figure 8 , the device 100 is shown in an elongated or fully open state for deployment from a delivery sheath. The device 100 is loaded into the delivery sheath in the fully open position because the fully open position takes up the least space and allows the smallest catheter to be used (or the largest device 100 to be used for a given catheter size). In the elongated state, the cover 114 is spaced apart from the mate element or device for mate 110 so that the paddles 120, 122 of the anchoring portion 106 are fully extended. In some embodiments, the angle formed between the outer paddle 120 and the interior of the inner paddle 122 is approximately 180 degrees. During deployment through the delivery sheath or device for delivery 102, the barbed hook 130 is maintained in a closed state so that the barb or device for fixation 136 ( Fig.11 ) will not snag or damage the sheath or tissue in the patient's heart.

[0369] Reference now Fig. 9 , the device 100 is shown in a state similar to Figure 8The device 100 is in an elongated disentangled state, but the barbed hook 130 is in a fully open position, ranging from about 140 degrees to about 200 degrees to about 170 degrees to about 190 degrees, or about 180 degrees between the fixed portion and the movable portion of the barbed hook 130. It has been found that fully opening the paddles 120, 122 and the hook 130 can improve the ease of disentanglement or disengagement from the patient's anatomical structure during implantation of the device 100.

[0370] Reference now Fig.10 , the device 100 is shown in a shortened or fully closed state. The compact size of the device 100 in the shortened state allows for easier manipulation and placement within the heart. In order to move the device 100 from the elongated state to the shortened state, the actuating element or the device for actuation 112 is retracted to pull the cover 114 toward the apposition element or the device for apposition 110. The joint or flexible connector 126 between the outer paddle 120 and the inner paddle 122 is constrained to move so that the compressive force acting on the outer paddle 120 from the cover 114 retracted toward the apposition element or the device for apposition 110 causes the paddles or gripping elements 120, 122 to move radially outward. During the movement from the open position to the closed position, the outer paddle 120 maintains an acute angle with the actuating element or the device for actuation 112. The outer paddle 120 can optionally be biased toward the closed position. During the same movement, the inner paddles 122 move through considerable angles because they are oriented away from the engagement element or device for engagement 110 in the open state and collapsed along the sides of the engagement element or device for engagement 110 in the closed state. In certain embodiments, the inner paddles 122 are thinner and / or narrower than the outer paddles 120, and the joints or flexible portions 126, 128 connected to the inner paddles 122 can be thinner and / or more flexible. For example, this increased flexibility can allow more movement than the joints or flexible portions 124 connecting the outer paddles 120 to the cover 114. In certain other embodiments, the outer paddles 120 are narrower than the inner paddles 122. The joints or flexible portions 126, 128 connected to the inner paddles 122 can be more flexible, for example, to allow more movement than the joints or flexible portions 124 connecting the outer paddles 120 to the cover 114. In one embodiment, the inner paddles 122 can have the same or substantially the same width as the outer paddles (e.g., see Fig.65A ).

[0371] Reference now Figures 11 to 13, the device 100 is shown in a partially open, ready-to-grasp state. To transition from the fully closed state to the partially open state, the actuating element or means for actuating 112 is extended to push the cover 114 away from the apposition element or means for apposition 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchoring portion 106 to partially deploy. The actuating wire 116 is also retracted to open the hook 130 so that the leaflet can be grasped. Fig.11 In the example shown, the pair of inner and outer blades 122, 120 are moved in unison rather than independently by a single actuating element or device for actuation 112. Likewise, the position of the hook 130 depends on the position of the blades 122, 120. For example, referring to Fig.10 , closing the paddles 122, 120 also closes the hook.

[0372] Fig.11A An example embodiment is shown in which the blades 120, 122 are independently controllable. Fig.11A The device 100A shown is similar to Fig.11 The device shown, except that the device 100A includes an actuation element, which is configured as two independent actuation elements 112A, 112B, which are coupled to two independent covers 114A, 114B. To convert the first inner and outer paddles from a fully closed state to a partially open state, the actuation element or means for actuation 112A extends to push the cover 114A away from the mate element or means for actuation 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the first anchoring portion 106 to partially deploy. To convert the second inner and second outer paddles from a fully closed state to a partially open state, the actuation element or means for actuation 112B extends to push the cover 114 away from the mate element or means for actuation 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchoring portion 106 to partially deploy. Fig.11A The individual blade controls shown may be implemented on any of the devices disclosed herein.

[0373] Reference now Fig.12 , one of the actuation lines 116 extends to allow one of the hooks 130 to close. Fig.13 , the other actuation wire 116 extends to allow the other hook 130 to close. Any one or both of the actuation wires 116 can be repeatedly actuated to repeatedly open and close the barbed hooks 130.

[0374] Reference now Fig.14, the device 100 is shown in a fully closed and deployed state. The delivery sheath or device for delivery 102 and the actuating element or device for actuation 112 are retracted, and the paddles 120, 122 and the hook 130 are maintained in the fully closed position. Once deployed, the device 100 can be maintained in the fully closed position with a mechanical latch, or can be biased to remain closed by using a spring material, such as steel, other metals, plastics, composite materials, etc., or a shape memory alloy, such as Nitinol. The connecting or flexible portions 124, 126, 128, 138 and / or the inner and outer paddles 122 and / or additional biasing components (see Fig.28 The component 524 in the figure can be formed of a metal, such as steel or a shape memory alloy (such as Nitinol made of wire, sheet, tube or laser sintered powder), and is biased to hold the outer paddle 120 closed around the apposition element or device for apposition 110 and the barbed hook 130 pressed around the natural leaflet. Similarly, the fixed arm 132 and movable arm 134 of the barbed hook 130 are biased to compress the leaflet. In some embodiments, the attachment or joint portion 124, 126, 128, 138 and / or the inner and outer paddles 122, 120 and / or additional biasing components (see Fig.28 Component 524) in may be formed from any other suitably resilient material, such as a metal or polymer material, to maintain the device in a closed state after implantation.

[0375] Reference now Fig.226 and 231 , the implantable device 100 is shown as being provided with a cover 140. The cover 140 can be a cloth such as a fine mesh polyethylene cloth. The cloth cover can provide a blood seal on the surface of the spacer, and / or promote rapid tissue ingrowth. The cover 140 includes a first cover portion 142 and a second cover portion 144, each of which covers a different portion of the device 100. In some embodiments, a portion of one of the first cover portion 142 and the second cover portion 144 overlaps 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 can be arranged in various ways, and in some embodiments, can include an overlapping portion 146 that overlaps with one of the first cover portion 142 and the second cover portion 144.

[0376] Reference now Figure 226 to Figure 229 , showing various arrangements of first cover portion 142 and second cover portion 144 without overlapping portion 146. Referring now to Fig.226A first cover portion 142 (indicated by thin cross-hatching) that may be made of a single piece of material extends from the cover 114 to cover the cover 114, the outer paddle 120, the inner paddle 122, and the securing arm 132 of the hook 130. A second cover 144 (indicated by thick cross-hatching) that may be a single piece of material covers the engagement element or the device 110 for engagement.

[0377] Reference now Fig.227 A first cover portion 142, which may be made of a single piece of material, extends from the cover 114 to cover the cover 114, the outer blade 120, the inner blade 122, the fixed arm 132 of the hook 130, and the movable arm 134. Fig.226 Like the cover 140 , the second cover 144 covers the mating element or the device 110 for mating.

[0378] Reference now Fig.228 A first cover portion 142, which may be made of a single piece of material, extends from the cover 114 to cover the cover 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 of the hook 130. A second cover 144, which may be made of a single piece of material, covers the mating element or the device for mating 110 and extends from the mating element or the device for mating 110 to cover the movable arm 134 of the hook 130.

[0379] Reference now Fig.229 A first cover portion 142, which may be made of a single piece of material, extends from the cover 114 to cover the cover 114 and the outer paddle 120. A second cover 144, which may be made of a single piece of material, covers the mating element or the device for mating 110 and extends from the mating element or the device for mating 110 to cover the inner paddle 122 and the fixed arm 132 and the movable arm 134 of the hook 130.

[0380] Reference now Figure 230 to Figure 231 , showing an arrangement of a first cover portion 142 and a second cover portion 144 including an overlapping portion 146. Referring now to Fig.230 A first cover portion 142, which may be made of a single piece of material, extends from the cover 114 to cover the cover 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 and the movable arm 134 of the hook 130. A second cover 144, which may be made of a single piece of material, covers the mating element or the device for mating 110, and includes an overlapping portion 146 extending from the mating element or the device for mating 110 to overlap a portion of the movable arm 134 covered by the first cover 142.

[0381] Reference now Fig.231A first cover portion 142, which may be made of a single piece of material, extends from the cover 114 to cover the cover 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 of the hook 130. A second cover 144, which may be made of a single piece of material, covers the mating element or the device for mating 110 and the movable arm 134 of the hook 130. The first cover 142 also includes an overlapping portion 146 extending from the fixed arm 132 and the inner paddle 122 to overlap a portion of the movable arm 134 and the mating element or the device for mating 110 covered by the second cover 144.

[0382] Reference now Figures 15 to 20 , Figures 8 to 14 The implantable device 100 is shown as being delivered and implanted within the native mitral valve MV of the heart H, and the methods and steps shown and / or discussed can be performed on a living animal or on a simulator, such as a cadaver, a cadaver heart, a simulator (e.g., utilizing a simulated body part, tissue, etc.), etc.

[0383] Reference now Fig.15 , the delivery sheath is inserted through the septum into the left atrium LA, and the device 100 is deployed from the delivery sheath in a fully open state. The actuating element or instrument for actuation 112 is then retracted to move the device 100 to Fig.16 The fully closed state shown. Fig.17 As can be seen in FIG. 1 , the device 100 is moved into position within the mitral valve MV, into the ventricle LV and is partially opened so that the leaflets 20, 22 can be grasped. Referring now to FIG. Fig.18 , the actuation wire 116 extends to close one of the hooks 130 , thereby capturing the leaflet 20 . Fig.19 Another actuation wire 116 is shown, which then extends to close another hook 130, thereby capturing the remaining leaflet 22. Fig. 20 As shown, the delivery sheath or instrument for delivery 102 and actuation element or instrument for actuation 112 and actuation wire 116 are then retracted and the device 100 is fully closed and deployed in the native mitral valve MV.

[0384] Reference now Fig.21, showing an example implantable prosthetic device 200 or its frame. In certain embodiments, the device 200 includes an annular 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 a corresponding strut of the spacer member 202 by a corresponding sleeve 206, which can be crimped or welded around the connecting portion of the anchor 204 and the strut of the spacer member 202. In an example embodiment, a latch mechanism can constrain the spacer member 202 to the anchor 204 within the sleeve 206. 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 so that the sleeve can be frictionally fitted on the connecting portion. One or more barbs or protrusions 208 can be mounted on the frame of the spacer member 202. The free end of the barb or protrusion 208 can include various shapes, including rounded, pointed, barbed, etc. The protrusions 208 can exert a retaining force on the native leaflets by virtue of the anchors 204 , which are shaped to force the native leaflets inwardly into the spacer member 202 .

[0385] Reference now Fig. 22 , showing an example implantable prosthetic device 300 or its frame. In certain embodiments, the prosthetic spacer device 300 includes an annular spacer member 302, a fabric cover (not shown), and an anchor 304 extending from the spacer member 302, and can be constructed similarly to the prosthetic spacer device 200. One or more barbs or protrusions 306 can be mounted on the frame of the spacer member 302. The end of the protrusion 306 may include a stop 308. The stop 308 of the protrusion can be constructed in a variety of different ways. For example, the stop 308 can be configured to limit the range of the protrusion 306 that can engage and / or penetrate the natural leaflet, and / or the stop can be configured to prevent the protrusion 306 from being removed from the tissue after the protrusion 306 has penetrated the tissue.

[0386] The anchors 304 of the prosthetic spacer device 300 can be configured similarly to the anchors 204 of the prosthetic spacer device 200, except that the curvature of each anchor 304 has a larger radius than the anchor 204. In this way, the anchors 304 cover a relatively larger portion of the spacer 302 than the anchors 204. This can, for example, distribute the clamping force of the anchors 304 against the native leaflets over a relatively larger surface of the native leaflets so as to further protect the native leaflet tissue.

[0387] Additional details about prosthetic spacer devices 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 can include any other features for implantable prosthetic devices discussed in this application, and devices 200, 300 can 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).

[0388] Reference now Figure 23 to Figure 27 , an exemplary embodiment of an implantable prosthetic spacer device 400 and its components is shown. The device 400 may include any other features used in the implantable prosthetic devices discussed in this application, and the device 400 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0389] Reference now Fig.23 , a prosthetic spacer or apposition device 400 may include an apposition portion 404 and an anchor portion 406, the anchor portion 406 including a plurality of anchors 408. The apposition portion 404 includes an apposition member or spacer member 410. The anchor portion 406 includes a plurality of paddles 420 (e.g., two in the embodiment shown) and a plurality of hooks 430 (e.g., two in the embodiment shown). A first collar or proximal collar 411 and a second collar or cover 414 are used to move the apposition portion 404 and the anchor portion 406 relative to each other.

[0390] like Fig.25 As shown, the first connection portion 425 of the anchor 408 can be coupled to and extend from the first portion 417 of the apposition member or spacer member 410, and the second connection portion 421 of the anchor 408 can be coupled to the second collar 414. The proximal collar 411 can be coupled to the second portion 419 of the apposition member 410.

[0391] The apposition member 410 and the anchor 408 can be coupled together in various ways. For example, as shown in the illustrated embodiment, the apposition member 410 and the anchor 408 can be coupled together by integrally forming the apposition member 410 and the anchor 408 as a single, integral part. For example, this can be achieved by forming the apposition member 410 and the anchor 408 from a braided or woven material, such as a braided or woven nitinol wire. In other embodiments, the apposition member 410 and the anchor 408 can be coupled together by welding, fasteners, adhesives, joint connections, sutures, friction fits, swaging, and / or other means for coupling.

[0392] Reference now Fig.24 , anchor 408 may include a first portion or outer paddle 420 and a second portion or inner paddle 422 separated by a joint portion 423. In this manner, anchor 408 is configured to resemble a leg, as inner paddle 422 resembles an upper portion of a leg, outer paddle 420 resembles a lower portion of a leg, and joint portion 423 resembles a knee portion of a leg. In some embodiments, inner paddle portion 422, outer paddle portion 420, and joint portion 423 are formed from a continuous strip of fabric, such as a metallic fabric. In some embodiments, the fabric strip is a composite fabric strip.

[0393] The anchor 408 can be configured to move between various configurations by axially moving the cap 414 relative to the proximal collar 411, and therefore relative to the mate member 410, along a longitudinal axis extending between a first portion or distal portion 417 and a second portion or proximal portion 419 of the mate member 410. For example, the anchor 408 can be positioned in a straight configuration by moving the cap 414 away from the mate member 410. In the straight configuration, the paddle portion is aligned or straight in the direction of the longitudinal axis of the device, and the joint portion 423 of the anchor 408 is adjacent to the longitudinal axis of the mate member 410 (e.g., similar to the longitudinal axis of the mate member 410). Fig.59 By moving toward the apposition member 410, the anchor member 408 can be moved from the straight configuration to the fully folded configuration (e.g., Fig.23 Initially, as the cap 414 moves toward the mate member 410, the anchor 408 bends at the joint portions 423, 425, 421, and the joint portion 423 moves radially outward relative to the longitudinal axis of the mate member 410 and axially toward the first portion 417 of the mate member 410, as shown in FIG. Figure 24 to Figure 25 As the cap 414 continues to move toward the apposition member 410, the joint portion 423 moves radially inward relative to the longitudinal axis of the apposition member 410 and axially toward the proximal portion 419 of the apposition member 410, as shown. Fig.23 shown.

[0394] In some embodiments, when the anchor 408 is in a straight configuration (see, e.g., Fig.59 ), the angle between the inner paddle 422 of the anchor 408 and the apposition member 410 can be approximately 180 degrees, and when the anchor 408 is in a fully folded configuration (see, e.g. Fig.23 ), the angle between the inner blade 422 of the anchor 408 and the apposition member 410 can be about 0 degrees. The anchor 408 can be positioned in various partially folded configurations so that the angle between the inner blade 422 of the anchor 408 and the apposition member 410 can be about 10 to 170 degrees or about 45 to 135 degrees.

[0395] Configuring the prosthetic spacer device 400 so that the anchor 408 can extend to a straight or nearly straight configuration (e.g., approximately 120 to 180 degrees relative to the apposition member 410) can provide several advantages. For example, this can reduce the radial crimping profile of the prosthetic spacer device 400. By providing a larger opening to grasp the natural leaflet therein, it can also make it easier to grasp the natural leaflet. In addition, the relatively narrow straight configuration can prevent or reduce the possibility that the prosthetic spacer device 400 will be entangled in the natural anatomical structure (e.g., chordae tendineae) when the prosthetic spacer device 400 is positioned and / or retracted into the delivery device.

[0396] Reference again Fig.24 , the hook 430 may include an attachment or fixed portion 432 and an arm or movable portion 434. The attachment or fixed portion 432 may be coupled to the inner paddle 422 of the anchor 408 in a variety of ways, such as by sutures, adhesives, fasteners, welding, stitching, swaging, friction fit, and / or other means for coupling or fastening.

[0397] In some embodiments, the movable portion 434 can be in an open configuration (e.g., Fig.24 ) and the closed configuration ( Fig.23 and Fig.25 ) are hinged, flexed, or pivoted between the fixed portion 432 and the movable portion 434. In some embodiments, the hook 430 can be biased to a closed configuration. In some embodiments, in the open configuration, the fixed portion 432 and the movable portion 434 flex or pivot away from each other so that the natural leaflet can be positioned between the fixed portion 432 and the movable portion 434. In some embodiments, in the closed configuration, the fixed portion 432 and the movable portion 434 flex or pivot toward each other, thereby clamping the natural leaflet between the fixed portion 432 and the movable portion 434.

[0398] refer to Figure 26 to Figure 27 , showing the hook 430 in top view and perspective view. The fixing portion 432 ( Figure 26 to Figure 27 The anchor 408 may include one or more openings 433 (e.g., three in the illustrated embodiment). At least some of the openings 433 may be used to connect the fixation portion 432 to the anchor 408. For example, sutures and / or fasteners may extend through the openings 433 to couple the fixation portion 432 to the anchor 408, or other attachments may be used, such as welding, adhesives, etc.

[0399] The movable portion 434 may include one or more side beams 431. When two side beams are included as shown, the side beams may be spaced apart to form a slot 431A. The slot 431A may be configured to receive the fixed portion 432. The movable portion 434 may also include a spring portion 434A coupled to the fixed portion 432 and a barb support portion 434B disposed opposite the spring portion 434A.

[0400] The barb support portion 434B can include a gripper or attachment element, such as a barb 436 and / or other means for frictionally engaging native leaflet tissue. The gripper element can be configured to engage and / or penetrate native leaflet tissue to help retain the native leaflet between the fixed portion 432 and the movable portion 434 of the hook 430.

[0401] Barb support portion 434B may also include eyelet 435 that may be used to couple barb support portion 434B to an actuation mechanism configured to flex or pivot movable portion 434 relative to fixed portion 432. Additional details regarding coupling hook 430 to an actuation mechanism are provided below.

[0402] In some embodiments, the hook 430 can be formed of a shape memory material, such as nitinol, stainless steel, and / or a shape memory polymer. In certain embodiments, the hook 430 can be formed by laser cutting a flat sheet (e.g., nitinol) or in a Fig.26 The configuration shown or a tube of similar or different configuration is then formed into the hook 430. Fig. 27 The configuration shown is formed.

[0403] Shaping the hook 430 in this manner may provide several advantages. For example, the hook 430 may be optionally shaped from a shaped configuration (e.g., Fig. 27 ) is compressed to a flat configuration (e.g., Fig.26 ), or another configuration that reduces the radial crimping profile of the hook 430. For example, the barbs can be optionally compressed into a flat configuration. Reducing the radial crimping profile can improve the followability and retractability of the prosthetic spacer device 400 relative to the catheter shaft of the delivery device because the barbs 436 are directed radially inwardly toward the anchor 408 when the prosthetic spacer device 400 is advanced through or retracted into the catheter shaft (see, e.g., Fig.33 ). This can prevent or reduce the possibility that the hook 430 may hook or scrape the catheter shaft.

[0404] Furthermore, when the hook 430 is in the closed configuration, the hook 430 is shaped as Fig. 27 The configuration shown can increase the clamping force of the hook 430. This is because the movable portion 434 is shaped relative to the fixed portion 432 to a first position (e.g., Fig. 27), the first position exceeds the position when the hook 430 is attached to the anchor 408 (e.g., Fig.25 ) The movable portion 434 can be positioned because the anchor 408 prevents the movable portion 434 from moving further toward the shaped configuration. This results in the movable portion 434 having a preload (i.e., a clamping force greater than zero) when the hook 430 is attached to the anchor 408 and in the closed configuration. Thus, compared to a hook shaped in the closed configuration, the movable portion 434 is more likely to be in a closed configuration. Fig. 27 The shaped hook 430 in the structure can increase the clamping force of the hook 430.

[0405] The preload magnitude of the hook 430 can be changed by adjusting the shaping angle of the movable portion 434 relative to the fixed portion 432. For example, increasing the relative angle between the movable portion 434 and the fixed portion 432 increases the preload, while decreasing the relative angle between the movable portion 434 and the fixed portion 432 decreases the preload. It can also be adjusted in other ways, such as based on the configuration of the joint, hinge, material, etc.

[0406] In some embodiments, the proximal collar 411 and / or the apposition member 410 may include a hemostatic seal 413 configured to reduce or prevent blood flow through the proximal collar 411 and / or the apposition member 410. For example, in some embodiments, the hemostatic seal 413 may include a plurality of flexible flaps 413A, such as Fig.23 In some embodiments, flap 413A can be configured to pivot from a sealing configuration to an open configuration to allow the shaft of the delivery device to extend through second bushing 414. In an example embodiment, flap 413A forms a seal around the shaft of the delivery device. When the shaft of the delivery device is removed, flap 413A can be configured to return from the open configuration to the sealing configuration.

[0407] Reference now Fig.23A , showing an example embodiment of an implantable prosthetic spacer device 400A. The device 400A may include any other features for implantable prosthetic devices discussed in this application, and the device 400A 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).

[0408] The prosthetic spacer or apposition device 400A can include an apposition portion 404A and an anchor portion 406A, the anchor portion 406A including a plurality of anchors 408A. The apposition portion 404A includes an apposition member or spacer 410A. The anchor portion 406A includes a plurality of paddles 420A (e.g., two in the embodiment shown) and a plurality of hooks 430A (e.g., two in the embodiment shown). A first collar or proximal collar 411A and a second collar or cap 414A are used to move the apposition portion 404A and the anchor portion 406A relative to each other.

[0409] The apposition member 410A extends from a proximal portion 419B assembled to the collar 411A to a distal portion 417A connected to the anchor 408A. The apposition member 410A and the anchor 408A can be coupled together in various ways. For example, as shown in the illustrated embodiment, the apposition member 410A and the anchor 408A can be coupled together by integrally forming the apposition member 410A and the anchor 408A as a single integral part. For example, this can be achieved by forming the apposition member 410A and the anchor 408A from a continuous strip 401A of a braided or woven material, such as a braided or woven nitinol wire.

[0410] Anchor 408A is attached to mate member 410A by hinge portion 425A and to cover 414A by hinge portion 421A. Anchor 408A may include a first portion or outer paddle 420A and a second portion or inner paddle 422A separated by a joint portion 423A. Joint portion 423A is attached to paddle frame 424A, which may be hingedly attached to cover 414A. In this manner, anchor 408A is configured to resemble a leg in that inner paddle 422A resembles an upper portion of a leg, outer paddle 420A resembles a lower portion of a leg, and joint portion 423A resembles a knee portion of a leg. In the example shown, inner paddle portion 422A, outer paddle portion 420A, and joint portion 423A are formed by a continuous strip of fabric 401A, such as a metallic fabric.

[0411] The anchor 408A can be configured to move between various configurations by axially moving the cap 414A relative to the proximal collar 411A, and thus relative to the mate member 410A along a longitudinal axis extending between the cap 414A and the proximal collar 411A. For example, the anchor 408 can be positioned in a straight configuration (see FIG. 1 ) by moving the cap 414A away from the mate member 410A. Fig.60A In the straight configuration, the paddle portions 420A, 422A are aligned or straight in the direction of the longitudinal axis of the device, and the joint portion 423A of the anchor 408A is adjacent to the longitudinal axis of the apposition member 410A (e.g., similar to Fig.60A By moving toward the apposition member 410A, the anchor member 408 can be moved from the straight configuration to the fully folded configuration (e.g., Fig.23A Initially, as the cap 414A moves toward the apposition member 410A, the anchor 408A bends at the joint portions 421A, 423A, 425A, and the joint portion 423A moves radially outward relative to the longitudinal axis of the device 400A and axially toward the distal portion 417A of the apposition member 410A, as shown in FIG. Fig.53A and Fig.54A As the cap 414A continues to move toward the apposition member 410A, the joint portion 423A moves radially inward relative to the longitudinal axis of the device 400A and axially toward the proximal portion 419A of the apposition member 410A, as shown. Fig.23A shown.

[0412] In some embodiments, when the anchor 408A is in the straight configuration (see Fig.60A ), the angle between the inner blade 422A of the anchor 408A and the apposition member 410A can be about 180 degrees, and when the anchor 408A is in a fully folded configuration (see Fig.23A ), the angle between the inner blade 422A of the anchor 408A and the apposition member 410A can be about 0 degrees. The anchor 408A can be positioned in various partially folded configurations so that the angle between the inner blade 422A of the anchor 408A and the apposition member 410A can be about 10 to 170 degrees or about 45 to 135 degrees.

[0413] Configuring the prosthetic spacer device 400A so that the anchor 408A can extend to a straight or nearly straight configuration (e.g., approximately 120 to 180 degrees relative to the apposition member 410A) can provide several advantages. For example, this can reduce the radial crimping profile of the prosthetic spacer device 400A. By providing a larger opening to grasp the natural leaflet therein, it can also make it easier to grasp the natural leaflet. In addition, the relatively narrow straight configuration can prevent or reduce the possibility that the prosthetic spacer device 400A will be entangled in the natural anatomical structure (e.g., chordae tendineae) when the prosthetic spacer device 400A is positioned and / or retracted into the delivery device.

[0414] Hook 430A may include an attachment or fixed portion 432C and an arm or movable portion 434C. Attachment or fixed portion 432C may be coupled to inner paddle 422A of anchor 408A in a variety of ways, such as by sutures, adhesives, fasteners, welding, stitching, swaging, friction fit, and / or other means for coupling. Hook 430A is similar to hook 430.

[0415] In some embodiments, the movable portion 434C can be in an open configuration (e.g., Fig.54A ) and the closed configuration ( Fig.53A ). In some embodiments, hook 430A can be biased to a closed configuration. In the open configuration, fixed portion 432C and movable portion 434C are hinged, pivoted, or flexed away from each other so that the natural leaflet can be positioned between fixed portion 432C and movable portion 434C. In the closed configuration, fixed portion 432C and movable portion 434C are hinged, pivoted, or flexed toward each other, thereby clamping the natural leaflet between fixed portion 432C and movable portion 434C.

[0416] Strip 401A is attached to collar 411A, cover 414A, paddle frame 424A, hook 430A to form both mate portion 404A and anchor portion 406A of device 400A. In the illustrated embodiment, mate member 410A, hinge portions 421A, 423A, 425A, outer paddle 420A, and inner paddle 422A are formed from a continuous strip 401A. Continuous strip 401A may be a single layer of material or may include two or more layers. In certain embodiments, portions of device 400A have a single layer of strip 401A of material, and other portions are formed from multiple overlapping or superimposed layers of strip 401A of material. For example, Fig.23A The juxtaposed member 410A and the inner paddle 422A are shown formed from multiple overlapping layers of the material strip 401A. The single continuous material strip 401A can start and end at various locations in the device 400A. The ends of the material strip 401A can be at the same location or different locations in the device 400A. For example, at Fig.23A In the illustrated embodiment, the strip of material begins and ends at the location of the inner blade 422A.

[0417] Reference now Fig. 30A , showing an example implantable prosthetic device 400A covered with a cover 440A. The cover 440A is arranged on the apposition member 410A, the liner 411A, the cover 414A, the paddles 420A, 422A, the paddle frame 424A and the hook 430A. The cover 440A can be configured to prevent or reduce blood flow through the prosthetic spacer device 400A and / or promote natural tissue ingrowth. In some embodiments, the cover 440A can be a cloth or fabric, such as PET, velvet or other suitable fabric. In other embodiments, instead of or in addition to the fabric, the cover 440A may include a coating (e.g., a polymeric material, silicone, etc.) applied to the prosthetic spacer device 400A.

[0418] Reference now Figures 28 to 30, showing an example embodiment of an implantable prosthetic device 500 (e.g., a prosthetic spacer device). The implantable device 500 is Figures 8 to 20 1 and 2. The device 100 schematically shown in FIG. 5 is one of many different configurations that the device 100 can take. The device 500 can include any other features used in the implantable prosthetic devices discussed in this application, and the device 500 can be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0419] Prosthetic spacer device 500 may include an apposition element or spacer member 510, a plurality of anchors 508 including an outer paddle 520, an inner paddle 522, a hook 530, a first or proximal collar 511, and a second collar or cap 514. These components of prosthetic spacer device 500 may be configured the same as or substantially similar to corresponding components of prosthetic spacer device 400.

[0420] The prosthetic spacer device 500 may also include a plurality of paddle extension members or paddle frames 524. The paddle frames 524 may be configured to have a circular three-dimensional shape, wherein a first connection portion 526 is coupled to and extends from the cover 514, and a second connection portion 528 is disposed opposite the first connection portion 526. The paddle frames 524 may be configured to extend circumferentially further around the apposition member 510 than the outer paddles 520. For example, in some embodiments, each paddle frame 524 extends about approximately half of the circumference of the apposition member 510 (e.g., Fig.29 ), and the outer blades 520 extend around less than half of the circumference of the merging member 510 (as shown in Fig.28 ). The blade frame 524 may also be configured to extend transversely (i.e., perpendicular to the longitudinal axis of the mate member 510) beyond the outer diameter of the mate member 510. In the example shown, the inner blade portion 522 and the outer blade portion 520 may be formed from a continuous fabric strip connected to the blade frame 524. For example, the inner blade portion and the outer blade portion may be connected to the connecting portion of the blade frame at a flexible connection between the inner blade portion and the outer blade portion.

[0421] Paddle frame 524 can also be configured such that connection portion 528 of paddle frame 524 is connected to or axially adjacent to joint portion 523. When prosthetic spacer device 500 is in a folded configuration (e.g., Figures 28 to 30), the connection portion of blade frame 524 can be located between outer blade 520 and inner blade 522, on the outside of blade portion 520, on the inside of inner blade portion, or on top of joint portion 523. The connection between blade frame 524, the single strip forming outer blade 520 and inner blade 522, cover 514, and the mating element can constrain each of these components to the movement and position described herein. In particular, joint portion 523 is constrained by its connection between outer blade 520 and inner blade 522 and by its connection to the blade frame. Similarly, blade frame 524 is constrained by its attachment to mating portion 523 (and therefore to the inner and outer blades) and the cover.

[0422] Configuring paddle frame 524 in this manner provides increased surface area compared to individual outer paddles 520. This can, for example, make it easier to grasp and secure the native leaflet. The increased surface area can also distribute the clamping force of paddle 520 and paddle frame 524 against the native leaflet over a relatively larger surface of the native leaflet to further protect the native leaflet tissue.

[0423] The increased surface area of ​​paddle frame 524 may also allow the native leaflets to be clamped to prosthetic spacer device 500 such that the native leaflets fully appose around apposition member 510. This may, for example, improve the sealing of the native leaflets and thereby prevent or further reduce mitral regurgitation.

[0424] refer to Fig.30 , the prosthetic spacer device 500 may further include a covering 540. In some embodiments, the covering 540 may be disposed on the apposition member 510, the paddles 520, 522, and / or the paddle frame 524. The covering 540 may be configured to prevent or reduce blood flow through the prosthetic spacer device 500 and / or promote natural tissue ingrowth. In some embodiments, the covering 540 may be a cloth or fabric, such as PET, velvet, or other suitable fabric. In other embodiments, instead of or in addition to a fabric, the covering 540 may include a coating (e.g., a polymer, silicone, etc.) applied to the prosthetic device 500.

[0425] Figure 31 to Figure 32 Show Fig.28 and 29 The implantable prosthetic device 500 is shown in FIG. 5 , wherein the anchor 508 and the hook 530 of the anchoring portion 506 are in an open position. The device 500 is deployed from a delivery sheath (not shown) and includes the apposition portion 504 and the anchoring portion 506. The device 500 is loaded into the delivery sheath in a fully extended or rescue position because the fully extended or rescue position occupies the least space and allows the smallest catheter to be used (see FIG. 5 ). Fig.35). Alternatively, the fully extended position allows the largest device 500 to be used for a given catheter size. The apposition portion 504 of the device includes an apposition element 510 for implantation between the natural leaflets of a natural valve (e.g., mitral valve, tricuspid valve, etc.). An insert 516A is disposed inside the apposition element 510. The insert 516A and the apposition element 510 are slidably attached to an actuating element 512 (e.g., an actuating wire, rod, shaft, tube, screw, suture, wire, etc.). The anchor 508 of the device 500 includes an outer paddle 520 and an inner paddle 522, which are flexibly connected to the cover 514 and the apposition element 510. Actuation of the actuating element or the instrument for actuation 512 opens and closes the anchor 508 of the device 500 to grasp the natural valve leaflets during implantation.

[0426] The actuation element 512 extends through the delivery sheath (not shown), the proximal collar 511, the engagement element 510, the insert 516A, and to the cap 514. Extending and retracting the actuation element 512 increases and decreases, respectively, the spacing between the engagement element 510 and the cap 514. This change in spacing between the engagement element 510 and the cap 514 causes the anchoring portion 506 of the device to move between different positions.

[0427] The proximal collar 511 optionally includes a collar seal 513 that forms a seal around the actuating element or actuating means 512 during implantation of the device 500 and seals closed when the actuating element 512 is removed to close or substantially close the proximal end of the device 500 after implantation to allow blood flow through the interior of the apposition element 510. In some embodiments, the coupler or means for coupling 2214 (see Fig.145 ) removably engages and attaches the proximal collar 511 and the apposition element 510 to the delivery sheath. In some embodiments, the coupler or device for coupling 2214 is held closed around the proximal collar 511 by the actuation element 512, such that removal of the actuation element 512 allows the fingers of the coupler or device for coupling 2214 (see Fig.145 ) opens, thereby releasing the proximal liner 511.

[0428] During actuation to open and close the paddles 520, 522 of the anchor 508, the proximal collar 511 and the insert 516A in the apposition element 510 slide along the actuation element 512. Fig.32A and 32BIn some embodiments, the cover 514 optionally includes a sealing protrusion 516 that sealingly fits within a sealing opening 517 of the insert 516A. In an example embodiment, the cover 514 includes a sealing opening, and the insert 516A includes a sealing protrusion. The insert 516A can be sealingly fitted within a distal opening 515 of the mating element 510, which has a hollow interior. Fig.32A , the sealing protrusion 516 of the cover 514 sealingly engages the opening 517 in the insert 516A to maintain the distal end of the apposition element 510 closed or substantially closed to blood flow when the device 500 is implanted and / or in a closed position.

[0429] In an exemplary embodiment, instead of a sealing engagement between the cap 514 and the insert 516A, the insert 516A may optionally include a seal, such as a proximal collar seal 513, that forms a seal around the actuating element or means for actuation 512 during implantation of the device 500 and seals closed when the actuating element 512 is removed. Such a seal may close or substantially close the distal end of the apposition element 510 to blood flow after implantation.

[0430] The apposition element 510 and paddles 520, 522 are formed of a flexible material, which may be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable manner, or formed of a flexible material cut by laser or otherwise. The material is cloth, a shape memory alloy wire (such as Nitinol) to provide shape-holding ability, or any other flexible material suitable for implantation in the human body. The paddle frame 524 provides additional compression between the inner paddle 522 and the apposition element 510, and helps wrap the leaflets around the sides of the apposition element 510 to obtain a better seal between the apposition element 510 and the leaflets. In some embodiments, Fig.30 The cover 540 is shown extending around the blade frame 524.

[0431] The hook 530 includes a base or fixed arm 532, a movable arm 534, a barb 536, and a joint portion 538. The fixed arm 532 is attached to the inner blade 522, wherein the joint portion 538 is disposed proximate to the mating element 510. The barbed hook has a flat surface and does not fit in a recessed portion of the blade. Instead, the flat portion of the barbed hook is disposed against the surface of the inner blade 522. For example, the fixed arm 532 is attached to the inner blade 522 with a suture (not shown) through a hole or slot 533. The fixed arm 532 can be attached to the inner blade 522 or another portion of the device by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, welding, an adhesive, etc. When the movable arm 534 is opened to open the barbed hook 530 and expose the barb 536, the fixed arm 532 remains fixed or substantially stationary relative to the inner blade 522. The barbed hook 530 is opened by applying tension to an actuation wire (not shown) attached to a hole 535 in the movable arm 534 , causing the movable arm 534 to pivot or flex on the joint portion 538 .

[0432] During implantation, the anchor 508 is opened and closed to grasp the native valve leaflet between the paddles 520, 522 and the apposition element 510. The barbed hook 530 further secures the native leaflet by engaging the leaflet with the barb 536 and squeezing the leaflet between the movable arm 534 and the fixed arm 532. The barbs 536 of the barbed hook 530 increase the friction with the leaflet, or can partially or completely pierce the leaflet. The actuation wire can be actuated individually so that each barbed hook 530 can be opened and closed individually. Individual operations allow grasping of one leaflet at a time, or allow repositioning of the hook 530 on a leaflet that is not fully grasped without changing the successful grasping of another leaflet. When the inner paddle 522 is not closed, the barbed hook 530 can be opened and closed, allowing the leaflet to be grasped in a variety of positions depending on the specific situation.

[0433] Reference now Fig.33 , an example barbed hook 600 for use in an implantable prosthetic device such as the above-described device is shown. However, a variety of different barbed hooks may be used. Examples of barbs that may be used include, but are not limited to, any barb disclosed in this application and any application incorporated herein by reference and / or claiming priority from this application. In the example shown, the barbed hook 600 is formed by a top layer 602 and a bottom layer 604. The two-layer design of the hook 600 allows for the use of thinner sheets of material, thereby increasing the flexibility of the hook 600 relative to a hook formed by a single thicker sheet, while maintaining the strength of the hook 600 required to successfully retain the native valve leaflet.

[0434] The barbed hook 600 includes a fixed arm 610, a connecting portion 620, and a movable arm 630 having a barbed portion 640. The top layer 602 and the bottom layer 604 have similar shapes and are attached to each other at the barbed portion 640 in certain embodiments. However, the top layer 602 and the bottom layer 604 can be attached to each other at other or additional locations. The connecting portion 620 is spring loaded so that when the barbed hook 600 is in a closed state, the fixed arm 610 and the movable arm 630 are offset from each other. When assembled to an implantable prosthetic device, the fixed arm 610 is attached to a portion of the prosthetic device. The hook 600 is opened by pulling an actuation line connected to the movable arm 630 until the spring force of the engaging portion 620 is overcome.

[0435] The fixed arm 610 is formed of a tongue 611 of material extending from a mating portion 620 between two side beams 631 of the movable arm 630. The tongue 611 is biased between the side beams 631 by the joint portion 620 so that a force must be applied to move the tongue 611 from a neutral position located outside 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 that is connected to the tongue 611 and extends outward to engage the side beams 631. In an example embodiment, the crossbar is omitted and the tongue 611 is attached to the inner paddle 522, and the inner paddle 522 holds the hook in the preloaded position. In a two-layer hook application, the top layer 602 and the bottom layer 604 or only the top layer can 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 degrees to about 100 degrees, 30 degrees to about 90 degrees, or about 30 degrees to about 60 degrees, or about 40 degrees to about 50 degrees, or about 45 degrees.

[0436] Tongue 611 includes a hole 612 for receiving a suture (not shown) connecting fixation arm 610 to an implantable device. Fixation arm 610 can be attached to the implantable device, for example, using screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, etc. In some embodiments, hole 612 is an elongated slot or oval hole to accommodate sliding of layers 602, 604 without damaging the suture attaching hook 600 to the implantable device.

[0437] The apposition portion 620 is formed by two beam rings 622 extending from the tongue 611 of the fixed arm 610 to the side beams 631 of the movable arm 630. In some embodiments, the beam rings 622 are narrower than the tongue 611 and the side beams 631 to provide additional flexibility. The beam rings 622 each include a central portion 624 extending from the tongue 611 and an outer portion 626 extending to the side beams 631. The beam rings 622 are bent into a slight spiral or helical shape by bending the central and outer portions 624, 626 in opposite directions, thereby forming an offset or step 628 between the tongue 611 and the side beams 631. The step 628 provides space between the arms 610, 630 to accommodate the native leaflets of the native valve after they are grasped. In some embodiments, the step 628 is about 0.5 mm to about 1 mm, or about 0.75 mm.

[0438] The beam ring has an "Ω-like" shape when viewed in a top plan view. This shape of the beam ring 622 allows the fixed arm 610 and the movable arm 630 to move significantly relative to each other without plastically deforming the hook material. For example, in some embodiments, the tongue 611 can be flexed or pivoted from a neutral position of approximately 45 degrees beyond the movable arm 630 to a fully open position within a range of approximately 140 degrees to approximately 200 degrees, approximately 170 degrees to approximately 190 degrees, or approximately 180 degrees relative to the movable arm 630 without plastically deforming the hook material. In some embodiments, the hook material plastically deforms during opening without reducing or substantially reducing the compressive force applied between the fixed arm and the movable arm in the closed position.

[0439] Preloading the tongue 611 enables the hook 600 to maintain a compressive or clamping force on the native leaflet when closed. Preloading the tongue 611 provides a significant advantage over prior art clips, which provide little or no compressive force when closed. In addition, closing the hook 600 with a spring force is a significant improvement over clips that use a one-time locking closure mechanism because the hook 600 can be repeatedly opened and closed to be repositioned on the leaflet while still maintaining sufficient compressive force when closed. In addition, the spring-loaded hook also allows for easier removal of the device over time compared to a device that is locked in a closed position (after tissue ingrowth). In an exemplary embodiment, both the hook and the paddle are spring biased to their closed position (as opposed to being locked in a closed position), which can allow for easier removal of the device after tissue ingrowth.

[0440] The barbed portion 640 of the movable arm 630 includes an eyelet 642, a barb 644, and a barb support 646. Positioning the barbed portion of the hook 600 toward the end of the movable arm 630 increases the space between the barb 644 and the fixed arm 610 when the hook 600 is open, thereby improving the ability of the hook 600 to successfully grasp the leaflet during implantation. This distance also allows the barb 644 to more reliably disengage from the leaflet for repositioning. In some embodiments, the barbs of the hook can be staggered longitudinally to further distribute the compressive force and localized leaflet stress.

[0441] The barbs 644 are laterally spaced apart from the connector portion 620 at the same distance, providing excellent distribution of the compressive forces on the leaflet tissue while also allowing the hooks to have a more secure grip on the leaflet than barbs arranged in longitudinal rows. In some embodiments, the barbs 644 can be staggered to further distribute the compressive forces and local leaflet stresses.

[0442] Barbs 644 are formed from the bottom layer 604 and barb supports 646 are formed from the top layer. In certain embodiments, the barbs are formed from the top layer 602 and the barb supports are formed from the bottom layer 604. Forming barbs 644 in only one of the two layers 602, 604 allows the barbs to be thinner and therefore effectively sharper than barbs formed from twice as thick a material. Barb supports 646 extend along the lower portion of barbs 644 to stiffen barbs 644, further improving penetration and retention of leaflet tissue. In certain embodiments, the ends of barbs 644 are further sharpened using any suitable sharpening device.

[0443] The barbs 644 are angled away from the movable arm 630 so that they easily penetrate the tissue of the natural leaflet with minimal squeezing or clamping force. The barbs 644 extend from the movable arm at an angle of about 45 degrees to about 75 degrees, or about 45 degrees to about 60 degrees, or about 48 to about 56 degrees, or about 52 degrees. The angle of the barbs 644 provides additional benefits because the force of pulling the implant away from the natural leaflet will promote the barbs 644 to further engage the tissue, thereby ensuring better retention. When the hook 600 is closed, the retention force of the leaflet in the hook 600 can be further improved by positioning the T-shaped crossbar 614 near the barbs 644. In this arrangement, the tissue pierced by the barbs 644 is pressed against the movable arm 630 at the crossbar 614 position, thereby forming the tissue into an S-shaped curved path when the tissue passes through the barbs 644. Thus, the force pulling the leaflet away from the hook 600 will cause the tissue to further engage the barb 644 before the leaflet can disengage. For example, leaflet tension during diastole can promote the barb to be pulled toward the end portion of the leaflet. The S-shaped path can take advantage of leaflet tension during diastole to bring the leaflet into closer engagement with the barb.

[0444] Each layer 602, 604 of the hook 600 is laser cut from a shape memory alloy, such as a sheet of nitinol. The top layer 602 is aligned with the bottom layer 604 and attached thereto. In certain embodiments, the layers 602, 604 are attached to the barbed portion 640 of the movable arm 630. For example, the layers 602, 604 may be attached only to the barbed portion 640 to allow the remaining layers to slide relative to each other. The parts of the combined layers 602, 604, such as the fixed arm 610, the barbs 644 and the barb supports 646 and the beam ring 622, are bent to the desired position. The layers 602, 604 can be bent and shaped together, or can be bent and shaped separately and then connected together. Then, the hook 600 is subjected to a shaping process so that the internal force of the material will tend to return to the set shape after being deformed by external forces. After shaping, the tongue 611 is moved to its preloaded position so that the crossbar 614 can be attached. In one exemplary embodiment, the hook 600 can optionally be completely flattened for delivery through a delivery sheath and allowed to expand once deployed within the heart. The hook 600 is opened and closed by applying and releasing tension on an actuation wire, suture, wire, rod, catheter, etc. (not shown) attached to the movable arm 630. In some embodiments, the actuation wire or suture is inserted through 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 certain embodiments, an intermediate suture loop is made through the eyelet and the suture is inserted through the intermediate suture loop. An alternative embodiment of the intermediate loop can be made of fabric or other material that is attached to the movable arm instead of a suture loop.

[0445] The intermediate loop of suture material reduces the friction experienced by the actuation wire / suture relative to the friction between the actuation wire / suture and the hook material. When the suture is looped through the eyelet 642 or the intermediate loop, both ends of the actuation wire / suture extend back into the delivery sheath and 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 of the suture is pulled through the eyelet or intermediate collar and back into the delivery sheath.

[0446] Reference now Fig.34 , shows a close-up view of one of the leaflets 20, 22 being grasped by a barbed hook, such as the hook 430, 530. The leaflet 20, 22 is grasped between the movable arm 434 and the fixed arm 532 of the hook 430, 530. Fig.34As shown in the figure, the tissue of the leaflet 20, 22 is not pierced by the barbs 436, 536, but in some embodiments, the barbs 436, 536 can partially or completely pierce through the leaflets 20, 22. The angle and height of the barbs 436, 536 relative to the movable arms 434, 534 help to fix the leaflets 20, 22 in the hooks 430, 530. In particular, the force that pulls the implant away from the native leaflet will promote the barbs 436, 536 to further engage the tissue, thereby ensuring better retention. When the hooks 430, 530 are closed, the retention force of the leaflets 20, 22 in the hooks 430, 530 is further improved by the position of the fixed arms 432, 532 close to the barbs 436, 536. In this arrangement, the tissue is formed into an S-shaped curved path by the fixed arms 432, 532 and the movable arms 434, 534 and the barbs 436, 536. Thus, the force pulling the leaflet away from the hooks 430, 530 will cause the tissue to further engage the barbs 436, 536 before the leaflet can disengage. For example, as described above, leaflet tension during diastole can promote the barbs to be pulled toward the end portions of the leaflets. The S-shaped path can take advantage of leaflet tension during diastole to bring the leaflets into tighter engagement with the barbs.

[0447] Reference now Figures 35 to 46 , implantable device 500 is shown as being delivered and implanted within the native mitral valve MV of heart H, and the methods and steps shown and / or discussed can be performed on a living animal or on a simulator, such as a cadaver, a cadaver heart, a simulator (e.g., utilizing a simulated body part, tissue, etc.), etc.

[0448] As described above, the device 500 has a covering 540 (see FIG. 5A ) on the engaging element 510, the hook 530, the inner blade 522, and / or the outer blade 520. Fig.30 ). The device 500 is deployed from a delivery sheath 502 and includes an apposition portion 504 and an anchoring portion 506 including a plurality of anchors 508 (i.e., two in the illustrated embodiment). The apposition portion 504 of the device includes an apposition element 510 for implantation between the leaflets 20, 22 of the native mitral valve MV, slidably attached to an actuation element or instrument for actuation 512. Actuation of the actuation element or instrument for actuation 512 opens and closes the anchors 508 of the device 500 to grasp the mitral valve leaflets 20, 22 during implantation.

[0449] The anchor 508 of the device 500 includes an outer paddle 520 and an inner paddle 522 that are flexibly connected to the cover 514 and the engaging element 510. The actuating element 512 extends through the capture mechanism 503 (see Fig.41), the delivery sheath 502 and the engaging element 510 reach the cover 514 connected to the anchoring portion 506. Extending and retracting the actuating element 512 increases and decreases the spacing between the engaging element 510 and the cover 514, respectively. Figures 35 to 46 In the example shown, the pair of inner blades 522 and outer blades 520 are moved in unison rather than independently by a single actuating element 512. Likewise, the position of the hook 530 depends on the position of the blades 522, 520. For example, referring to Fig.45 , closing the paddles 522, 520 also closes the hook. In an exemplary embodiment, the device 500 may have Fig.11A The paddles 520, 522 are independently controllable in the same manner as in the embodiments of the present invention.

[0450] The fingers of the capture mechanism 503 removably attach the collar 511 to the delivery sheath 502. The collar 511 and the engagement element 510 slide along the actuation element 512 during actuation to open and close the anchors 508 of the anchor portion 506. In some embodiments, the capture mechanism 503 is held closed around the collar 511 by the actuation element 512, so that removal of the actuation element 512 allows the fingers of the capture mechanism 503 to open, thereby releasing the collar 511, and therefore releasing the engagement element 510.

[0451] In some embodiments, the apposition element 510 and the paddles 520, 522 are formed of a flexible material, which may be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable manner, or formed of a flexible material cut by a laser or otherwise. The flexible material may be cloth, a shape memory alloy wire (such as Nitinol) to provide shape-holding capabilities, or any other flexible material suitable for implantation in the human body. Other configurations are also possible.

[0452] The barbed hook 530 includes a base or fixed arm 532, a movable arm 534, a barb 536 (see Fig.41 ) and a joint portion 538. The fixed arm 532 is attached to the inner paddle 522, wherein the joint portion 538 is disposed proximate to the mating element 510. A suture (not shown) attaches the fixed arm 532 to the inner paddle 522. The fixed arm 532 can be attached to the inner paddle 522 and / or another portion of the device by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, welding, an adhesive, etc. The fixed arm 532 remains stationary or substantially stationary when the movable arm 534 is opened to open the barbed hook 530 and expose the barb 536. The barbed hook 530 is opened by applying tension to a hook control member or actuation wire 537 attached to the movable arm 534, thereby causing the movable arm 534 to pivot or flex on the joint portion 538.

[0453] During implantation, the anchor 508 is opened and closed to grasp the natural valve leaflet between the paddles 520, 522 and the coaptation element 510. The outer paddle 520 has a wide curved shape that fits around the curved shape of the coaptation element 510 to more securely grasp the leaflets 20, 22. The curved shape and rounded edges of the outer paddle 520 also prevent tearing of the leaflet tissue. The barbed hook 530 further secures the natural leaflet by engaging the leaflet with the barb 536 and squeezing the leaflet between the movable arm 534 and the fixed arm 532. The barb 536 of the barbed hook 530 increases friction with the leaflet, or can partially or completely pierce the leaflet. The actuation wire can be actuated individually so that each barbed hook 530 can be opened and closed individually. Individual operation allows grasping of one leaflet at a time, or allows repositioning of the hook 530 on a leaflet that is not fully grasped without changing the successful grasping of another leaflet. When the inner paddle 522 is not closed, the barbed hook 530 can be fully opened and closed, thereby allowing the leaflet to be grasped in a variety of positions depending on the particular situation.

[0454] The device 500 is loaded into the delivery sheath in a fully open or fully extended position because the fully open or fully extended position takes up the least space and allows the smallest catheter to be used (or the largest device 500 to be used for a given catheter size). Fig.35 , the delivery sheath is inserted through the septum into the left atrium LA, and the device 500 is deployed from the delivery sheath 502 in a fully open state. The actuating element 512 is then retracted to move the device 500 to Figure 36 to Figure 37 The fully closed state shown in Fig.38 MV manipulation toward the mitral valve is shown. Fig.39 When the device 500 is aligned with the mitral valve MV (or other native valve if implanted in another valve), the actuation element 512 is actuated to open the paddles 520, 522 to a partially open position, and the hook control member or actuation wire 537 is retracted to open the barbed hooks 530 in preparation for leaflet grasping. Next, as Figure 40 to Figure 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 paddles 522 and the coaptation element 510 , and within the opened barbed hooks 530 . Fig.42 The device 500 is shown with both hooks 530 closed, although the barb 536 of one hook 530 has missed one of the leaflets 22. Figure 42 to Figure 44 As shown, the hook 530 that is out of position opens and closes again to properly grasp the missing leaflet 22. When the two leaflets 20, 22 are properly grasped, the actuator 512 retracts to move the device 500 to the position shown in FIG. Fig.45The fully closed position is shown. With the device 500 fully implanted in the native mitral valve MV, the actuating element 512 is withdrawn to release the capture mechanism 503 from the proximal collar 511. Once deployed, the device 500 can be maintained in the fully closed position by a mechanical device such as a latch, or can be biased to remain closed using a spring material such as steel and / or a shape memory alloy such as Nitinol. For example, the paddles 520, 522 can be formed of steel or a Nitinol shape memory alloy (such as Nitinol made of wire, sheet, tubing or laser sintered powder) and biased to hold the outer paddle 520 closed around the inner paddle 522, the apposition element 510 and the barbed hook 530 pressed against the native leaflets 20, 22.

[0455] Device 500 may have a variety of shapes and sizes. Figure 6 and FIG. 6A to FIG. 6E In an exemplary embodiment, the apposition element 510 is used as a gap filler in the valve regurgitation orifice, such as by Figure 6 The gap 26 in the native valve is shown. Fig. 6A , since the coaptation element 510 is deployed between two opposing valve leaflets 20, 22, the leaflets will not coapt against each other in the region of the coaptation element 510, but will instead coapt against the coaptation element 510. This reduces the distance that the leaflets 20, 22 need to be approached. The reduction in the distance that the leaflets are approached can bring several advantages. For example, the coaptation element and the resulting reduced approach can facilitate the repair of severe mitral valve anatomy, such as large gaps in functional valvular disease (see, e.g., Figure 6 ). Because the coaptation element 510 reduces the distance that the native valve must approximate, stress in the native valve can be reduced or minimized. A shorter approximation distance of the valve leaflets 20, 22 can require a smaller approximation force, which can result in less tensioning of the leaflets and a smaller diameter reduction of the valve annulus. A smaller reduction in the valve annulus (or no reduction in the valve annulus) can result in a smaller reduction in the valve orifice area compared to a device without a spacer. Therefore, the coaptation element 510 can reduce the transvalvular gradient.

[0456] In an exemplary embodiment, the paddle frame 524 conforms to the shape of the engagement element 510. In an example, if the engagement element 510 is wider than the paddle frame 524, the device 500 can create a distance (gap) between the opposing leaflets 20, 22. FIG. 6A to FIG. 6E In an exemplary embodiment, the paddle is configured to conform to the shape or geometry of the coaptation element 510. Thus, the paddle can cooperate with both the coaptation element 510 and the native valve. Fig.6D and Fig. 6EIn one example embodiment, the paddle 524 surrounds the apposition element 510. Thus, when the leaflets 20, 22 are appositioned or pressed against the apposition element 510, the leaflets 20, 22 completely surround or "hug" the entirety of the apposition element 510, thereby preventing small leaks on the medial and lateral sides of the apposition element 510. Figure 6B and 6C The valve repair device 500 is shown attached to the native valve leaflets 20, 22 from the ventricular side of the mitral valve. Fig. 6A The valve repair device 500 is shown attached to the mitral valve leaflets 20, 22 from the atrial side of the mitral valve. Fig. 6A and Figure 6B , when the paddle has a geometry that conforms to the geometry of the engagement element 510, the leaflets 20, 22 can be engaged around the engagement element and / or along the length of the spacer. Fig. 6E , the schematic atrial view / surgeon's view depicts a paddle frame that conforms to the septum geometry (which is not actually visible from a true atrial view). The opposing leaflets 20, 22 (whose ends would also not be visible in a true atrial view) are approximated by the paddles to completely surround or "hug" the apposition element 510.

[0457] refer to FIG. 6B to FIG. 6E , because the paddle frame 524 conforms to the shape of the apposition element 510, the leaflets 20, 22 can be apposed completely around the apposition element by the paddle frame 524, including on the lateral side 601 and the medial side 603 of the apposition element 510. This apposition of the leaflets 20, 22 against the lateral side and the medial side of the apposition element 510 seems to contradict the above statement that the presence of the apposition element 510 minimizes the distance the leaflets need to approach. However, if the apposition element 510 is precisely placed at the regurgitation gap and the regurgitation gap is less than the width (medial-lateral) of the apposition element 510, the distance the leaflets 20, 22 need to approach is still minimized.

[0458] refer to Fig. 6A and 6E , the mate element 510 can take a variety of different shapes. In one exemplary embodiment, when viewed from the top (and / or a cross-sectional view from the top, see Figures 95 to 102 ), the mating element has an oval shape or an elliptical shape. The oval or elliptical shape can allow the blade frame 524 to conform to the shape of the mating element and / or can reduce lateral leakage (refer to Figure 65 to Figure 83 ).

[0459] As described above, the apposition element 510 can reduce tension on opposing leaflets by reducing the distance that the leaflets need to be approximated to the apposition element 510 at positions 601, 603. The reduction in the distance of leaflet approximation at positions 601, 603 can result in a reduction in leaflet stress and gradients. In addition, as described above, the native valve leaflets 20, 22 can surround or "hug" the apposition element to prevent lateral leakage. In an exemplary embodiment, the geometric properties of the apposition element can be designed to retain and enhance these two properties of the device 500. Reference Figure 2A , as viewed from the left ventricular outflow tract (LVOT) view, the anatomy of the leaflets 20, 22 is such that the inner sides of the leaflets coapt at the free end portions and the leaflets 20, 22 begin to recede or spread apart from one another. The leaflets 20, 22 spread apart in the atrial direction until each leaflet meets the mitral annulus.

[0460] In an exemplary embodiment, the valve repair device 500 and its apposition 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 can be designed to apposition the native leaflets to the apposition element completely around the apposition element, including at the medial 601 and lateral 603 locations of the apposition element 510. In addition, reducing the force required to bring the leaflets into contact with the apposition element 510 at the locations 601, 603 can minimize leaflet stresses and gradients. Figure 2B It shows how the tapered or triangular shape of the apposition element 510 will naturally adapt to the native valve geometry and its expanded leaflet nature (towards the annulus).

[0461] Fig.6D The geometry of the coaptation element 510 and the paddle frame 524 is shown from the perspective of the LVOT. As can be seen from this view, the coaptation element 510 has a tapered shape that is smaller in size near the inner surface of the leaflets 20, 22 where coaptation is desired, and increases in size as the coaptation element extends toward the atrium. The depicted native valve geometry is accommodated by the tapered coaptation element geometry. Still referring to Fig.6D , the tapered coaptation element geometry, together with the illustrated expanded paddle frame 524 shape (toward the annulus) can help achieve coaptation of the inferior ends of the leaflets, reduce stress, and minimize transvalvular gradients.

[0462] refer to Figure 6C In one example embodiment, the remaining shapes of the coaptation element 510 and paddle frame 524 can be defined based on an internal view of the commissure of the native valve and the device 500. Two factors in these shapes are the coaptation of the leaflets against the coaptation element 510 and the reduction of stress on the leaflets due to coaptation. Figure 6C and Fig.67In order to apposition the valve leaflets 20, 22 against the apposition element 510 and reduce the stress applied to the valve leaflets 20, 22 by the apposition element 510 and / or the paddle 524, the apposition element 510 can have a circular or rounded shape and the paddle frame 524 can have a full radius spanning from one leg of the paddle to the other leg of the paddle. The circular shape of the apposition element and / or the fully rounded shape of the paddle frame shown will distribute the stress on the leaflets 20, 22 over the large curved coaptation area 607. For example, in Figure 6C , the forces acting on leaflets 20 , 22 by the paddle frame 524 are dispersed along the entire rounded length of the paddle frame 524 as the leaflets 20 attempt to open during the diastolic cycle.

[0463] refer to Fig.67 In one example embodiment, to mate with the fully circular shape of paddle frame 524 and / or to maximize leaflet coaptation against coaptation element 510 and leaflet-to-leaflet coaptation at sides 601, 603 of coaptation element 510, the shape of the coaptation element follows a circular shape in an internal commissure view. Fig.67 , in this view, the circular shape of the mating elements substantially follows or approximates the shape of the blade frame 524.

[0464] In one example embodiment, when viewed from the surgeon's view (top view - see Fig.70 ) the overall shape of the apposition element 510 is an elliptical or oval cross section when viewed from the LVOT view (side view - see Fig.69 ) is conical in shape or cross-section and when viewed from the commissure end-view (see Fig.68 ) is generally circular or round in shape. In an exemplary embodiment, the combination of these three geometric shapes can produce the three-dimensional shape of the illustrated juxtaposition element 510 that achieves the above-mentioned benefits.

[0465] In an exemplary embodiment, the size of the apposition element is selected to minimize the number of implants (preferably one) that a single patient will need, while maintaining a low gradient through the valve. In an exemplary embodiment, the front-back distance X47B at the top of the spacer is about 5mm, and the inside-outside distance X67D of the spacer at the widest part of the spacer is about 10mm. In an exemplary embodiment, the overall geometry of device 500 can be based on these two sizes and the above-mentioned overall shape strategy. It should be easily understood that using other front-back distances X47B and inside-outside distances X67D as the starting point of the device will cause the device to have different sizes. In addition, using other sizes and the above-mentioned shape strategy will also result in devices with different sizes.

[0466] Tables A, B and C provide examples of values ​​and ranges of dimensions of devices and components of devices of some example embodiments. However, the device can have a variety of different shapes and sizes, and need not have all or any of the dimensional values ​​or dimensional ranges provided in Tables A, B and C. Table A provides examples of linear dimensions X in millimeters and linear dimensional ranges in millimeters for devices and device components. Table B provides examples of radial dimensions R in millimeters and radial dimensional ranges in millimeters for devices and device components. Table C provides examples of degrees of angles α and degrees of angles α for devices and device components. The subscript for each dimension indicates the figure in which the dimension first appears.

[0467]

[0468]

[0469] Reference now Figures 47 to 61 , showing implantable device 500 in various positions and configurations. Implantable device 500 may include any other features for implantable prosthetic devices discussed in this application, and device 500 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0470] Implantable device 500 has a proximal or attachment portion 505, an apposition element 510 (e.g., a spacer, etc.), an inner anchoring portion or inner paddle 522, an outer anchoring portion or outer paddle 520, an anchor extension member or paddle frame 524, and a distal portion 507. Inner paddle 522 is attached (e.g., engagably attached, etc.) between apposition element 510 and outer paddle 520. Outer paddle 520 is attached (e.g., engagably attached, etc.) between inner paddle 522 and distal portion 507. Paddle frame 524 is attached to cap 514 at distal portion 507 and extends to a joint portion 523 between inner paddle 522 and outer paddle 520. In some embodiments, paddle frame 524 is formed of a material that is more rigid and harder than the material from which paddles 522, 520 are formed, such that paddle frame 524 provides support for paddles 522, 520. In an example embodiment, inner paddle 522 is hard, relatively hard, rigid, has a rigid portion, and / or is hardened by a hardening member or a fixed portion of hook 530. The hardening of the inner paddle allows the device to move to the various different positions shown and described herein. Inner paddle 522, outer paddle 520, and counter-pieces can all be connected to each other as described herein so that device 500 is constrained to the movements and positions shown and described herein.

[0471] Reference now Figure 47 to Figure 48, the device 500 is shown in a closed position. When closed, the inner paddle 522 is disposed between the outer paddle 520 and the apposition element 510. In some embodiments, the device 500 includes a hook or gripping member 530 ( Fig.48 The hook 530 is attached to the inner blade 522 and moves with the inner blade, and is disposed between the inner blade 522 and the engaging element 510 .

[0472] Reference now Figures 49 to 51 , the device 500 is shown in a partially open position. The device 500 is moved to the partially open position by an actuating element or a device for actuation 512, which passes through the attachment portion 505 and the engagement element 510 and can removably engage the distal portion 507. The actuating element 512 extends through the attachment portion 505 so that the distance between the attachment portion 505 and the distal portion 507 increases as the actuating element 512 extends. Figures 49 to 51 In the example shown, the pair of inner blades 522 and outer blades 520 are moved in unison rather than independently by a single actuating element 512. Likewise, the position of the hook 530 depends on the position of the blades 522, 520. For example, referring to Fig.48 , closing the paddles 522, 520 also closes the hook. In an exemplary embodiment, the device 500 may have Fig.11A The paddles 520, 522 are independently controllable in the same manner as in the embodiments of the present invention.

[0473] Extending actuating element 512 pulls the bottom portion of outer blade 520 and blade frame 524 downward. Outer blade 520 and blade frame 524 pull inner blade 522 downward, where inner blade 522 is connected to outer blade 520 and blade frame 524. Since attachment portion 505 and mating element 510 are held in place, inner blade 522 is caused to flex or pivot in the opening direction. Inner blade 522, outer blade 520, and blade frame are all flexed to Fig.49 The opening of the paddles 522, 520 and the paddle frame 524 forms a gap 520A between the apposition element 510 and the inner paddle 522, which can receive and grasp the native leaflet 20.

[0474] As described above, some embodiments of the device 500 include a hook or gripping member 530. When the device 500 is partially opened, the hook 530 is exposed. In some embodiments, the closed hook 530 ( Fig.50 ) can be opened ( Fig.51), thereby creating a second opening or gap 530A for receiving and capturing the native leaflets 20, 22. The extent of the gap 530A in the hook 530 is limited to the extent that the inner paddle 522 has been deployed away from the apposition element 510.

[0475] Reference now Figure 52 to Figure 54 , the device 500 is shown as being in a laterally extended or open position. By continuing to extend the above-mentioned actuating element 512, the device 500 is moved to the laterally extended or open position, thereby increasing the distance D between the attachment portion 505 and the distal portion 507. Continuing to extend the actuating element 512 pulls the outer paddle 520 and the paddle frame 524 downward, causing the inner paddle 522 to further unfold from the mating element 510. In the laterally extended position or open position, the inner paddle 522 extends more horizontally than in other positions of the device 500 and forms an angle of approximately 90 degrees with the mating element 510. Similarly, when the device 500 is in the laterally extended position or open position, the paddle frame 524 is in its maximum extended position. The increased gap 520A formed in the laterally extended or open position allows the hook 530 to open further ( 520A) before engaging the mating element 510. Fig.54 ), thereby increasing the size of gap 530A.

[0476] Reference now Figure 55 to Figure 57 , the device 500 is shown in a three-quarter extended position. By continuing to extend the above-mentioned actuating element 512, the device 500 is moved to the three-quarter extended position, thereby increasing the distance D between the attachment portion 505 and the distal portion 507. Continuing to extend the actuating element 512 pulls the outer paddle 520 and the paddle frame 524 downward, causing the inner paddle 522 to further unfold from the mating element 510. In the three-quarter extended position, the inner paddle 522 opens more than 90 degrees and forms an angle of approximately 135 degrees with the mating element 510. The paddle frame 524 stretches less than when in the lateral extension or open position, and begins to move inward toward the actuating element 512 as the actuating element 512 is further extended. The outer paddle 520 also flexes backward toward the actuating element 512. As with the lateral extension or open position, the increased gap 520A formed in the lateral extension or open position allows the hook 530 to open further ( Fig.57 ), thereby increasing the size of gap 530A.

[0477] Reference now Fig.58, the device 500 is shown in an almost fully extended position. By continuing to extend the above-mentioned actuating element 512, the device 500 is moved to the almost fully extended position, thereby increasing the distance D between the attachment portion 505 and the distal portion 507. Continued extension of the actuating element 512 pulls the outer paddle 520 and the paddle frame 524 downward, thereby causing the inner paddle 522 to further deploy from the mating element 510. In the almost fully extended position, the inner paddle 522 begins to approach an angle of approximately 180 degrees with the mating element 510. Although the inner paddle moves to this position, the outer paddle 520 and the paddle frame 524 never move or flex to or exceed a ninety degree angle relative to the mating element 510. In the almost fully extended position, the inner paddle 522 and the outer paddle 520 can have a slightly curved shape.

[0478] Reference now Figure 59 to Figure 61 , the device 500 is shown in a fully extended position. By continuing to extend the above-mentioned actuating element 512, the device 500 is moved to the fully extended position, thereby increasing the distance D between the attachment portion 505 and the distal portion 507 to the maximum distance allowed by the device 500. Continuing to extend the actuating element 512 pulls the outer paddle 520 and the paddle frame 524 downward, thereby causing the inner paddle 522 to further unfold from the mating element 510. The outer paddle 520 and the paddle frame 524 move to their positions close to the actuating element. In the fully extended position, the inner paddle 522 is opened to an angle of approximately 180 degrees with the mating element 510. The inner paddle 522 and the outer paddle 520 are stretched straight in the fully extended position to form an angle of approximately 180 degrees between the paddles 522, 520. The fully extended position of the device 500 provides the maximum size of the gap 520A between the blades and, in some embodiments, allows the gap 530 between the portions of the hook 530 to also be fully opened to approximately 180 degrees ( Fig.61 ). The position of device 500 is the narrowest configuration. Thus, the fully extended position of device 500 may be a desired position to salvage device 500 from an attempted implant, or may be a desired position to place the device in a delivery catheter, etc.

[0479] Reference now Fig.47A , 48A -48H, 53A-53C, 54A-54D, 60A-60D, and 61A-61D, showing implantable device 500A in various positions and configurations. Implantable device 500A may include any other features for implantable prosthetic devices discussed in this application, and device 500A 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).

[0480] Implantable device 500A has a proximal or attachment portion 505A, abutment elements 510A, an inner anchoring portion or inner paddle 522A, an outer anchoring portion or outer paddle 520A, an anchor extension member or paddle frame 524A, and a distal portion 507A. Inner paddle 522A is attached (e.g., engagably attached, etc.) between abutment elements 510A, for example, by abutment portions 525A, and is attached (e.g., engagably attached, etc.) between outer paddle 520A by abutment portions 523A. Outer paddle 520A is attached (e.g., engagably attached, etc.) between inner paddle 522A (e.g., by engagement portions 523A) and distal portion 507A (by engagement portions 521A). Paddle frame 524A is attached to cap 514A ( Fig.48A ) and extends to a joint portion 523A between inner and outer blades 522A, 520A. In some embodiments, blade frame 524A is formed of a material that is more rigid and harder than the material forming blades 522A, 520A, so that blade frame 524A provides support for blades 522A, 520A. Blade frame 524A includes a connector for receiving joint portion 523A ( Fig.65A ) opening or slot 524B. In some embodiments, inner paddle 522A is hard, relatively hard, rigid, has a rigid portion, and / or is hardened by a hardening member or fixed portion of hook 530C. The hardening of the inner paddle allows the device to move to the various different positions shown and described herein. Inner paddle 522A, outer paddle 520A, and the mate element can all be interconnected as described herein so that device 500A is constrained to the movement and position shown and described herein.

[0481] The apposition element 510A, the inner paddle 522A, and the outer paddle 520A may be attached together by integrally forming the apposition element 510A and the paddles 520A, 522A as a single unitary component. For example, this may be accomplished by forming the apposition element 510A and the paddles 520A, 522A from a continuous strip 501A of braided or woven material, such as a braided or woven Nitinol wire.

[0482] Continuous strip 501A is attached to collar 511D, cover 514A, paddle frame 524A, hook 530C. In the illustrated embodiment, mating element 510A, hinge portions 521A, 523A, 525A, outer paddle 520A, and inner paddle 522A are formed from continuous strip 501A. Continuous strip 501A may be a single layer of material or may include two or more layers. In certain embodiments, portions of device 500A have a single layer of strip 501A of material, and other portions are formed from multiple overlapping or superimposed layers of strip 501A of material. For example, Fig.47AThe juxtaposed element 510A and inner paddle 522A are shown formed from multiple overlapping or stacked layers of material strip 501A. Thus, the juxtaposed element 510A and inner paddle 522A have increased stiffness relative to outer paddle 520A formed from a single layer of material 501A. A single continuous strip of material 501A may begin and end at various locations on device 500A. The ends of the strip of material 501A may be at the same location or at different locations on device 500A. For example, at Fig.47A In the embodiment shown, the strip of material begins and ends at the location of the inner paddle 522.

[0483] Hook 530C may include an attachment or fixing portion 532C, an arm or movable portion 534C, a barb 536C, and a joint portion 538C. Attachment or fixing portion 532C may be coupled to inner blade 522A in a variety of ways, such as by sutures, adhesives, fasteners, welding, stitching, swaging, friction fit, and / or other means for coupling with joint portion 538C disposed adjacent to mating element 510A. Hook 530C may be similar to hook 430.

[0484] The movable portion 534C can be in an open configuration (e.g., Fig.54A ) and the closed configuration ( Fig.48A ) pivot or flex between the fixed portion 532C and the movable portion 534C. In some embodiments, the hook 530C may be biased to a closed configuration. In the open configuration, the fixed portion 532C and the movable portion 534C pivot or flex away from each other so 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. When the movable arm 534C opens to open the barbed hook 530C and expose the barb 536C, the fixed arm 532C remains stationary or substantially stationary. The barbed hook 530C is opened by applying tension to the actuation line 537A attached to the movable arm 534C, so that the movable arm 534C pivots or flexes on the joint portion 538C.

[0485] Reference now Fig.47A and Figures 48A-48H , the device 500A is shown in a closed position. A side view of the device 500A is shown in Fig.48B , 48C and 48F, the front view is shown in Fig.48D , 48E and 48G, the bottom view is shown in Figure 48HWhen viewed from the front, the device 500A is narrower than from the side. From the side, the device 500A has a generally inverted trapezoidal shape that is rounded and tapers toward the distal portion 507A of the device 500A. From the front, the device 500A has a generally rounded rectangular shape that tapers slightly toward the distal portion 507A. Figure 48H The bottom view of the device 500A shown can be seen when viewed from below (and when viewed from above, as can be seen in, for example Fig.70A ), device 500A has a generally rounded rectangular shape.

[0486] In the closed configuration of the device 500A, the inner paddle 522A is disposed between the outer paddle 520A and the apposition element 510A. In some embodiments, the device 500A includes a hook or grasping member 530C ( 530C ) that can be opened and closed to grasp the native leaflets 20, 22 of the mitral valve MV. Fig.48A The hook 530C is attached to the inner blade 522A and moves with the inner blade, and is disposed between the inner blade 522A and the engaging element 510A.

[0487] Reference now FIG. 48B to FIG. 48D , device 500A is shown connected to a delivery device 502A. The delivery device 502A has an actuatable member or finger 503A that releasably engages an attachment portion 505A. An actuating element 512A extends from the delivery device 502A through the attachment portion 505A and the engaging element 510A of the prosthetic device 500A to 514A. As described below, extending and retracting the actuating element 512A causes the device 500A to open and close. An actuating wire / suture 537A extends from the delivery device 502A to attach to the hook 530C. Tension can be applied to the suture 537A to open the hook 530C, and the tension can be released to close the hook 530C. In Figures 48F to 48G , device 500A is shown separated from delivery device 502A in a deployed state.

[0488] Reference now Fig.48C and 48E, device 500A is shown as having a cover 540A. Cover 540A can be formed by a single piece of material, or by a plurality of parts that are adjacent or connected to each other. In the illustrated embodiment, cover 540A has an outer or lower cover 541A and an inner or upper cover 543A. Outer cover 541A covers cap 514A, outer paddle 520A, inner paddle 522A and hook 530C. Inner cover 543A covers the proximal end of apposition element 510A and inner paddle 522A and hook 530C, wherein apposition element 510A intersects with inner paddle 522A and hook 530C. Cover 540A can be a cloth such as a fine mesh polyethylene cloth. The cloth cover can provide a blood seal on the surface of the spacer, and / or promote rapid in-growth of tissue.

[0489] Reference now Figures 53A-53D and Figures 54A-54D , the device 500A is shown in a laterally extended or open position. The device 500A is moved to the open position by an actuating element or instrument for actuation 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 so that the distance D2 between the attachment portion 505A and the distal portion 507A increases as the actuating element 512A is extended. Figures 53A-53D and Figures 54A-54D In the example shown, the pair of inner blades 520A and outer blades 522A are moved in unison by a single actuating element 512A rather than independently. Likewise, the position of hook 530C depends on the position of blades 520A, 522A. For example, referring to Fig.48A , closing the paddles 520A, 522A also closes the hook 530C. In an exemplary embodiment, the device 500A may have Fig.11A The paddles 520A, 522A are independently controllable in the same manner as in the embodiments of the present invention.

[0490] Extending actuation element 512A pulls downward on the bottom of outer paddle 520A and paddle frame 524A to transition device 500A from the closed position to the partially open position. Outer paddle 520A and paddle frame 524A pull down on inner paddle 522A, to which inner paddle 522A is connected. Because attachment portion 505A and mating element 510A are held in place, inner paddle 522A is caused to pivot or flex in the opening direction. Inner paddle 522A, outer paddle 520A, and paddle frame all flex to the partially open position. Fig.53A Opening the paddles 522A, 520A and the frame 524 forms a gap 520D between the apposition element 510A and the inner paddle 522A, which can receive and grasp the native leaflet 20.

[0491] Continued extension of actuating element 512A pulls outer paddle 520A and paddle frame 524A downward, causing inner paddle 522A to further deploy from mating element 510A. In the laterally extended or open position, inner paddle 522A extends more horizontally than in other positions of device 500A and forms an angle of approximately 90 degrees with mating element 510A. Similarly, when device 500A is in the laterally extended or open position, paddle frame 524A is in its most extended position. The increased gap 520D formed in the laterally extended or open position allows hook 530C to open further (before mating element 510A) Fig.54A ), thereby increasing the size of gap 530D compared to the partially open position.

[0492] As described above, some embodiments of the device 500A include a hook or gripping member 530C. When the device 500A is open, the hook 530C is exposed. In some embodiments, the closed hook 530C ( FIG. 53A to FIG. 53D ) can be opened ( FIG. 54A to FIG. 54D ), thereby creating a second opening or gap 530D for receiving and capturing the native leaflets 20, 22. The extent of the gap 530D in the hook 530C is limited to the extent that the inner paddle 522A has been extended away from the apposition element 510A.

[0493] Reference now Figures 60A-60D and Figures 61A-61D , the device 500A is shown in a fully extended position. By continuing to extend the above-mentioned actuating element 512A, the device 500A moves to the fully extended position, thereby increasing the distance D2 between the attachment portion 505A and the distal portion 507A to the maximum distance allowed by the device 500A. Continuing to extend the actuating element 512A pulls the outer paddle 520A and the paddle frame 524A downward, thereby extending the inner paddle 522A further away from the mating element 510A. The outer paddle 520A and the paddle frame 524A move to their positions close to the actuating element. In the fully extended position, the inner paddle 522A is opened to an angle of approximately 180 degrees with the mating element 510A. The inner paddle 522A and the outer paddle 520A are stretched straight or substantially straight in the fully extended position to form an angle of approximately 180 degrees between the paddles 522A, 520A. The fully extended position of the device 500A provides the maximum size of the gap 520D between the blades and, in some embodiments, allows the hook 530C to also fully open to approximately 180 degrees ( Fig.61A ). The position of device 500A is the narrowest configuration. Thus, the fully extended position of device 500A may be a desired position to salvage device 500A from an attempted implant, or may be a desired position to place the device in a delivery catheter, etc.

[0494] Reference now Figure 197 to Figure 198 , showing Fig.60C Now refer to Fig.197 , it can be seen that the inner cover 543A covers the apposition element 510A from the proximal portion 519B to the distal portion 517A. In some embodiments, the inner cover 543A is made of a flat sheet of fabric material such as a fine mesh polyethylene fabric (see Fig.201 ) is formed and folded around the apposition element 510A and held in place by suture 545A. Fig.198 , the outer cover 541A covering the hook 530C and the inner paddle 522A can be seen. The collar portion 548A of the inner cover 543A covers the portion of the hook 530C and the inner paddle 522A closest to the abutment element 510A. The transition portion 547A of the inner cover 543A extends from the abutment element 510A to the collar portion 548A to provide a smooth transition between the abutment element 510A and the hook 530C and the inner paddle 522A so that natural tissue will not be caught on the device 500A during implantation.

[0495] Reference now Fig.199 , showing an exploded view of the device 500A. As described above, the mating element 510A, the outer paddle 520A, and the inner paddle 522A are formed from a single strip of material 501A. The collar 511D, the cover 514A, the paddle frame 524A, and the hook 530C are assembled to the strip of material 501A to form the device 500A. The cover 514A includes a retaining body 560A having a locking aperture 561A for receiving a retaining nut 562A having a threaded hole 564A that engages with a threaded portion 568A of a retaining bolt 566A. The threaded portion 568A of the retaining bolt 566A is inserted through the opening 527B to engage the retaining body and the nut 560A, 562A, thereby attaching the cover 514A to the strip of material 501A.

[0496] In some embodiments, a stiffening member 539C is attached to the inner blade 522A to stiffen the inner blade 522A to maintain the inner blade in a straight or substantially straight configuration as the inner blade moves between various positions. A cutout 539D in the stiffening member 539C is shaped to receive a fixed arm 532C of the hook 530C so that the stiffening member 539C can be assembled around the fixed arm 532C when both the stiffening member 539C and the hook 530C are attached to the inner blade 522A. Similar to the fixed arm 532C, the stiffening member 539C can be coupled to the inner blade 522A in various ways, such as by sutures, adhesives, fasteners, welding, stitching, swaging, friction fit, and / or other means for coupling.

[0497] Reference now Fig.200 , showing an enlarged view of a collar 511D attached to a proximal portion 519B of an apposition element 510A. The collar 511D includes a protrusion 511B for releasably engaging a finger 503A of a delivery device 502A. An opening 515A in the collar 511D receives an actuation element 512A. The proximal portion 519B of the apposition element 510A flares outward to form two loops 519D, which are inserted through an arcuate opening 513A of the collar 511D to attach the collar 511D to the proximal portion 519B of the apposition element 510A. The loops 519D are formed by folding a strip of material 501A to form a first layer 581A and a second layer 582A.

[0498] Reference now Figure 201 to Figure 202 , respectively show an enlarged and exploded view of cover 514A. Fig.201 527A of the distal portion 527A of the strip of material 501A. Retaining body 560A, retaining nut 562A, and retaining bolt 566A cooperate to connect paddle frame 524A to the distal portion 527A of the strip of material 501A. In particular, retaining bolt 566A is inserted through opening 527B ( Fig.202 ) to prevent the cover 514A from moving along the strip of material 501 A. The channel 560B in the retaining body 560A and the flange 567A of the bolt 566A form a passage 514B through the cover 514A for the distal portion 527A.

[0499] Reference now Fig.202 , showing the components of cover 514A in an exploded view to better illustrate features of the components of cover 514A and paddle frame 524A and to illustrate how these features interlock during assembly of cover 514A to distal portion 527A. Forming cover 514A from multiple components that can be assembled around strip of material 501A allows cover 514A to be attached after strip of material 501A has been folded to form apposition element 510A and paddles 520A, 522A and has been woven through collar 51 ID and paddle frame 524A.

[0500] Retaining body 560A includes locking aperture 561A for receiving retaining nut 562A. Locking aperture 561A has a generally rectangular shape and includes two opposing locking channels 561B that receive attachment portion 524C of paddle frame 524A. Transverse locking channel 561C formed in the bottom of retaining body 560A has the same width as locking channel 561B. Paddle frame 524A includes notch 524D formed in attachment portion 524C that engages hook portion 524E of transverse locking slot 561C to secure paddle frame 524A to cover 514A.

[0501] Retaining nut 562A includes a rectangular locking body 563A extending distally from flange 563B. Locking body 563A is configured to slidably engage locking aperture 561A of retaining body 560A while leaving locking channel 561B unobstructed. Thus, locking body 563A can be inserted into locking aperture 561A to lock attachment portion 524C of blade frame 524A within locking channel 561B. Recess 563C in flange 563B accommodates attachment portion 524C of blade frame 524A. Threaded hole 564A is formed through retaining nut 562A to receive retaining bolt 566A.

[0502] The retaining bolt 566A includes a threaded portion 568A extending from the flange 567A. The threaded portion 568A is inserted through the opening 527B in the distal portion 527A to threadably engage the threaded hole 564A of the retaining nut 562A. The flange 567A has a circular shape that provides a circular end for the distal portion 507A of the device 500A. The flange 567A includes an opening 567B for receiving a tool (not shown) engaged with the bolt 566A so that the bolt 566A can be rotated during assembly to couple the components of the cover 514A together.

[0503] To assemble paddle frame 524A and cover 514A to distal portion 527A, paddle frame 524A is squeezed to narrow the width of attachment portion 524C so that attachment portion 524C can be inserted into locking channel 561B of locking aperture 561A. When paddle frame 524A is allowed to expand, attachment portion 524C expands outward so that notch 524D engages retaining body 560A and hook portion 524E engages transverse locking channel 561C. Retaining nut 562A is then inserted into locking aperture 561A with locking portion 563A disposed between the two attachment portions 524C of each paddle frame 524A, thereby locking paddle frame 524A into engagement with retaining body 560A. Assembled paddle frame 524A, retaining body 560A, and retaining nut 562A are placed on distal portion 527A so that threaded hole 564A is aligned with opening 527B, and threaded portion 568A of bolt 566A is inserted through opening 527B to threadably engage threaded hole 564A. Bolt 566A is then tightened until flange 567A engages with retaining body 560A, and cover 514A is securely assembled to distal portion 527A.

[0504] Reference now Fig.203 and Fig.204, showing a portion of a cover 540A cut from a flat sheet. The cover 540A includes an outer cover 541A and an inner cover 543A. Each of the covers 541A, 543A includes differently shaped segments or portions to attach to different portions of the device 500A. In particular, the covers 541A, 543A are shaped to smooth transitions between portions of the device 500A to reduce sticking points and provide a smoother exterior for the device 500.

[0505] The various sections of the covers 541A, 543A extend from a middle portion of the end of the device 500A that is shaped to be attached. In other embodiments, the portion of the covers 541A, 543A attached to the end of the device 500A is located at the end of the covers 541A, 543A or can be located at any position between the middle and the end of the covers 541A, 543A. The various portions of the covers 541A, 543A can be shaped as a portion of the wrapping device 500A. The covers 540A can be made of any suitable material, such as a fine mesh polyethylene fabric. In certain embodiments, the covers are formed of a single piece of material. In other embodiments, the covers can be formed of any number of pieces of material, which are attached to the device and / or joined together in any suitable manner, such as by suturing, adhesives, welding, etc.

[0506] refer to Fig.60C and Fig.204 , the outer cover 541A extends outwardly from the middle portion 580 to the end portion 588. The middle portion 580 is shaped to be attached to 514A of the device 500A. The outer paddle portion 582 extends from the middle portion 580 to the inner paddle and inner hook portion 584. The inner hook and the inner hook portion 584 extend from the outer hook portion 582 to the outer movable hook portion 586. The outer movable hook portion 586 extends from the inner hook portion 584 to the end portion 588.

[0507] The outer paddle portion 582 includes a wing 583 that extends laterally to a wider width than the rest of the outer cover 541A so that the outer paddle portion 582 can be attached to the outer paddle 520A and paddle frame 524A of the device 500A. The inner paddle portion 584 is connected to the inner paddle 522A, the fixed arm 532C, and the inner surface of the movable arm 534C (the side with the barb). The outer hook portion 586 is attached to the outer surface of the movable arm 534C of the hook 530C (the side without the barb). The end 588 of the outer cover 541A terminates at the outside of the hook 530C near the joint portion 538C of the hook 530C. The inner paddle and inner hook portion 584 include an opening 585 that allows the barb 536C of the hook 530C to protrude through the outer cover 541A to engage the tissue of the natural heart valve.

[0508] refer to Fig.60C and Fig.203 , the inner cover 543A extends outwardly from the middle portion 590 to the end portion 598. The middle portion 590 is configured to be attached to the collar 511D of the device 500A. When the middle portion 590 is attached to the collar 511D, the opening 591 in the middle portion 590 exposes the protrusion 511E from the collar 511D so that the protrusion 511E can be engaged by the delivery device 502A. The apposition portion 592 extends from the middle portion 590 to the flexible hinge portion 594. The holes 593 along the edges of the apposition portions 592 allow each of the apposition portions 592 to be joined together, for example, by sutures 545A, after being folded around the apposition element 510A. The flexible hinge portion 594 extends from the apposition portion 592 to the transition portion 596. The transition portion 596 extends from the flexible hinge portion 594 to the end portion 598. Holes 597 along the edges of transition portions 596 allow each transition portion 596 to be wrapped around the ends of inner paddle 522A and hook 530C and secured to itself by sutures or other suitable securing means. When device 500A is opened, flexible hinge portion 594 bridges the gap between engaging element 510A and hook 530C, as shown in FIG. Fig.198 as shown in .

[0509] Reference now Figures 62A to 64C , showing an implantable device 700. The implantable device 700 has paddles 702 that open and close to grasp the leaflets 20, 22 against barbed hooks or gripping devices 704. The paddles 702 move to form an opening 706 between the paddles 702 and the gripping devices 704, in which the leaflets 20, 22 can be grasped. The device 700 can be configured to close the wide gap 26 ( Figure 6 ). In addition, the implantable device 700 may include any other features used in the devices discussed in the present application, and the device 700 may be positioned to engage the valve leaflets 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). The device 700 may include any other features used in the implantable prosthetic devices discussed in the present application, and the device 700 may be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application).

[0510] refer to Fig.62A, the paddle 702 of the device 700 moves, rotates or pivots outwardly in the X direction to form an opening 706 with a width W between the paddle 702 and the gripping member 704. 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 alternative embodiments, the width W can be less than 5 mm or greater than 15 mm.

[0511] refer to Fig.62B , the paddle 702 of the device 700 moves outward in the direction Z so that the opening 706 has a width H, which 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 certain embodiments, the ratio between the width H and the width W can be about 5:1 or less, such as about 4:1 or less, such as about 3:1 or less, such as about 2:1 or less, such as about 1.5:1 or less, such as about 1.25:1 or less, such as about 1:1. The device 700 can be configured so that the paddle 702 moves, rotates, or pivots outward in the X direction and then moves outward in the Z direction so as to form an opening 706 having a width H between the paddle 702 and the gripping element 704. Alternatively, the device 700 can be configured to move the paddle outward in the Z direction and then move or pivot outward in the X direction to form a width H between the paddle 702 and the gripping member 704. Additionally, the device 700 can be configured to move or pivot outward in the X direction and simultaneously move outward in the Z direction to form a width H between the paddle 702 and the gripping member 704.

[0512] Figures 63A to 63C Implantable device 700 is shown with paddles 702 moved, rotated, or pivoted outward in the X-direction and then moved outward in the Z-direction to form a wider opening 706 . Fig.63A Implantable device 700 is shown in a closed position such that paddle 702 is engaged with gripping member 704. Fig.63B , the paddle 702 moves or pivots outwardly along the direction X to form an opening 706 having a width W for receiving valve tissue. Fig.63C After paddle 702 moves or pivots outwardly along direction X, paddle 702 moves outwardly along direction Z so that opening 706 has width H. After valve tissue is received in opening 706 between paddle 702 and gripping member 704, valve repair device moves back to closed position (eg, Fig.63A) to secure the valve repair device 700 to the valve tissue. The implantable device 700 may include any other features for the implantable devices discussed in this application, and the implantable device 700 may be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0513] Figures 64A to 64C Implantable device 700 is shown with paddle 702 moved outward in direction Z and then moved, extended, or pivoted outward in direction X to form a wider opening 706 . Fig.64A Implantable device 700 is shown in a closed position such that paddle 702 is engaged with gripping member 704. Fig.64B , the paddle 702 moves outwardly along the Z direction to form an opening 706 having a width W for receiving valve tissue. Fig.64C After paddle 702 moves outward in direction Z, paddle 702 moves or pivots outward in direction X so that opening 706 has width H. After valve tissue is received in opening 706 between paddle 702 and gripping member 704, implantable device 700 moves back to the closed position (eg, Fig.64A ) to secure the implantable device 700 to the valve tissue. The implantable device 700 may include any other features for the implantable devices discussed in this application, and the implantable device 700 may be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0514] Although Figures 63A to 63C shows a device 700 in which a paddle 702 is moved or pivoted and then deployed, Figures 64A to 64C The device 700 is shown in which the paddles 702 are deployed and then moved or pivoted, but in alternative embodiments, the device 700 can include paddles 702 that can be deployed and moved or pivoted at the same time. In addition, in some embodiments, the paddles 702 can be deployed and moved or pivoted independently of each other. That is, in Figures 63A-63C and Figures 64A-64C In the illustrated embodiment of valve repair device 700, and in embodiments where deployment and movement or pivoting of each paddle 702 are accomplished simultaneously, paddles 702 may be controlled independently of one another.

[0515] Reference now Figure 65 to Figure 83 , the exemplary implantable device 500 is shown in a closed state. Referring now to Figure 65 to Figure 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 to surround 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 cover 514 that is attached (e.g., engageably attached, etc.) to the outer paddle 520 and engaged by an actuation element (not shown) to open and close the device 500 for implantation into a native valve as described herein.

[0516] Reference now Figure 67 to Figure 68 , showing a front view of device 500. Device 500 has a symmetrical or substantially symmetrical shape about a vertical anterior-posterior plane 550 and is generally narrower at distal portion 507 than at proximal portion 505. The shapes of apposition element 510 and paddle frame 524 are circular or substantially circular to prevent device 500 from catching or snagging on cardiac structures, such as chordae tendineae, during implantation. To this end, proximal collar 511 ( Fig.68 ) and cover 514( Fig.68 ) also has rounded edges. When viewed from the front or rear, the paddle frame 524 can be viewed as having a circular or substantially circular shape, extending upward and outward from the distal portion 507 to generally conform to the shape of the apposition element 510 when viewed from the front or rear. Therefore, the apposition 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 circular shape of the paddle frame 524 and the corresponding circular shape of the apposition element can distribute the leaflet stress over a wider surface. In some example embodiments, the paddle frame 524 and / or the apposition element 510 can have other shapes.

[0517] Reference now Fig.69 , showing a side view of the device 500. As in the front view and the rear view ( Figure 67 to Figure 68 ), when viewed from the side, the device 500 has a symmetrical or substantially symmetrical shape about a vertical side-to-side plane 552. When the device 500 is viewed from the side, the distal portion 507 is also generally narrower than the proximal portion 505. The apposition element 510 optionally also has a tapered or substantially tapered shape that narrows toward the distal portion 507 of the device 500. However, in some example embodiments, the apposition element does not taper as it extends from the proximal portion of the device to the distal portion of the device.

[0518] The circular feature of device 500 is further demonstrated by the circular shape of the paddles 520, 522 and the circular shape of the paddle frame 524 where the inner paddle 520 and the outer paddle 522 are joined together. However, the paddles 520, 522 and the paddle frame 524 can take a variety of different forms. For example, the paddles 520, 522 and the paddle frame 524 can be rounded along the top 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 the sides, two devices can be implanted side by side on the native valve leaflets, with the two devices positioned flush or substantially flush with each other.

[0519] The closed paddles 520, 522 form a gap 542 between the inner paddle 522 and the apposition element 510, which is configured to receive natural tissue. Fig.69 As shown, the narrowing of the apposition element 510 gives the gap 542 a slight teardrop shape that increases in width 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 tissue grasped in the gap 542 closer to the proximal portion 505.

[0520] The paddle frame 524 extends vertically from the distal portion 507 toward the proximal portion 505 until approximately the middle third of the device 500, and then bends or flares outwardly so that the connection 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. The outer paddle 520 has a circular shape that is similar to the circular shape of the apposition element 510 when viewed from the front or back ( Figure 67 to Figure 68 ). Thus, the device 500 has a circular shape or a substantially circular shape. When viewed from the top ( Figure 70 to Figure 71 ) or bottom ( Figure 72 to Figure 73 )When observing device 500, the circular shape of device 500 is particularly visible.

[0521] Reference now Figure 70 to Figure 71 , showing a top view of the device 500. When viewed from the top, the device 500 has a shape that is symmetrical or substantially symmetrical about the anterior-posterior plane 550 and also symmetrical or substantially symmetrical about the lateral-lateral plane 552. The opening 519A in the apposition element 510 is visible at the proximal portion 505 of the device 500. Fig.70 As can be seen in FIG. 5 , the mating element 510 may be hollow inside. Fig.71 The proximal collar 511 shown in FIG. 5 can be secured to the engaging element 510 to close the engaging element 510 .

[0522] In an exemplary embodiment, the apposition element is not planar and has all curved surfaces. For example, the apposition element 510 shown herein can be formed by a series of mixed surfaces with various different radii of curvature. The apposition element 510 has an oval or roughly oval shape when viewed from the top. However, in some exemplary embodiments, when viewed from the top, the apposition element 510 can have other shapes. For example, the apposition element can have a rectangular, square, rhombus, elliptical or any other shape. The paddle frame 224 each has an arc shape with a radius less than the apposition element 510, so that the gap 542 formed between the inner paddle 522 and the paddle frame 524 and the apposition element 510 is gradually reduced as they approach the left side 551 and the right side 553 of the device 500. Therefore, natural tissues such as leaflets 20, 22 tend to be grasped between the paddle frame 524 and the apposition element 510 toward the left side 551 and the right side 553 of the device 500.

[0523] Reference now Figure 72 to Figure 73 , showing a bottom view of the device 500. and a top view ( Figure 70 to Figure 71 ), when viewed from the bottom, the device 500 is symmetrical or substantially symmetrical about the front-to-back plane 550 and also symmetrical or substantially symmetrical about the side-to-side plane 552. Fig.73 Cover 514 is shown in FIG. 5 and may be engageably attached to outer blade 520 and blade frame 524 .

[0524] The paddle frame 524 extends outwardly from the distal portion 507 of the device 500 to the left side 551 and the right side 553 at a narrow or slight angle to the side-to-side plane 552. When the paddle frame 524 extends toward the proximal portion of the device 500 ( Fig.69 ), the blade frame 524 further extends away from the side-to-side plane 552 to ultimately form Figure 70 to Figure 71 The arc shape seen in .

[0525] Reference now Figures 74 to 83 , which shows a perspective view and a cross-sectional view of the device 500. Now referring to Fig.74 , the device 500 is shown cut through a cross-sectional plane 75 near the proximal portion of the apposition element 510. Referring now to Fig.75 , showing that from Fig.74 75. At the location of plane 75, the engaging element 510 has a circular or substantially circular shape with petal-like protrusions arranged along the front-rear plane 550. The gap 542 between the paddle frame 524 and the engaging element 510 forms a crescent-like 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.

[0526] Reference now Fig.76 , the device 500 is shown cut through a cross-sectional plane 77 positioned approximately three-quarters of the way between the distal portion 507 and the proximal portion 505 of the apposition element 510. Referring now to Fig.77 , showing that from Fig.76 5. A cross-sectional view of the device 500 viewed along the cross-sectional plane 77 in FIG. At the location of the plane 75, the mating element 510 has an oval or substantially oval shape oriented along the side-to-side plane 552. The gap 542 between the blade frame 524 and the mating element 510 forms a central width 543 less than Fig.75 543. At the location of plane 77, the width 543 of gap 542 is narrower toward the center of the device, widening slightly as gap 542 approaches left side 551 and right side 553 before narrowing again. Thus, the native tissue is squeezed in the center of gap 542 to about three quarters of the way up the apposition element 510.

[0527] Reference now Fig.78 , the device 500 is shown cut by cross-sectional plane 79, which is located approximately halfway between the distal portion 507 and the proximal portion 505 of the apposition element 510. Referring now to Fig.79 , showing that from Fig.78 542 is a cross-sectional view of the device 500 as viewed from the cross-sectional plane 79 in FIG. At the location of plane 79, the mate element 510 has an oval or substantially oval shape oriented along the side-to-side plane 552. The blade frame 524 can be seen close to the left side 551 and the right side 553, very close to or in contact with the mate element 510. The gap 542 is crescent-shaped or substantially crescent-shaped and is wider than the gap 542 (see FIG. 54) as viewed from the plane 77. Fig.77 ).

[0528] Reference now Fig.80 , the device 500 is shown cut by a transverse cross-sectional plane 81, which is located approximately one quarter of the way between the distal portion 507 and the proximal portion 505 of the apposition element 510. Referring now to Fig.81 , showing that from Fig.80 81 in the cross-sectional view of the device 500. At the location of plane 81, the juxtaposition element 510 has an oval or substantially oval shape oriented along the side-to-side plane 552, which is larger than Fig.77 The oval shape seen in FIG. 5 is narrow. It can be seen that the blade frame 524 is close to the left side 551 and the right side 553, very close to or in contact with the mating element 510. The gap 542 is crescent-shaped or approximately crescent-shaped and is wider than the gap 542 ( Fig.79 ).

[0529] Reference now Fig.82, the device 500 is shown cut by a cross-sectional plane 83 positioned near the distal portion 507 of the apposition element 510. Referring now to Fig.83 , showing that from Fig.82 83 in the cross-sectional view of the device 500. At the location of plane 83, the juxtaposition element 510 has an oval or substantially oval shape oriented along the side-to-side plane 552, which is larger than the side-to-side plane 552. Fig.79 The oval shape seen in FIG. 5 is narrow because the engaging element 510 tapers toward the distal portion 507 of the device 500. It can be seen that the paddle frame 524 is close to the left side 551 and the right side 553, very close to or in contact with the engaging element 510. Although the inner paddle 522 is Fig.81 , but gap 542 is crescent-shaped or substantially crescent-shaped and is wider than gap 542 when viewed along plane 81 ( Fig.81 ).

[0530] Reference now Fig.65A , 66A , 67A, 68A, 70A, 71A, 72A, 73A, 74A, 75A, 76A, 77A, 78A, 79A, 80A, 81A, 82A and 83A, the example implantable device 500A is shown in a closed state. Referring now to Fig.65A and Fig.66A , device 500A extends from a proximal portion 505A to a distal portion 507A and includes an apposition portion 510A, an inner paddle 522A, an outer paddle 520A, and a paddle frame 524A. Proximal portion 505A may include a collar 511D for connecting a delivery device (not shown). Distal portion 507A may include a cover 514A that is attached (e.g., engageably attached, etc.) to outer paddle 520A and engaged by an actuation element (not shown) to open and close device 500A, thereby facilitating implantation into a native valve as described in the present application.

[0531] Reference now Fig.67A and Fig.68A , showing a front view of device 500A. Device 500A has a symmetrical or substantially symmetrical shape about a vertical anterior-posterior plane 550A and is narrower at distal portion 507A than along paddle frame 524A. The shapes of apposition element 510A and paddle frame 524A are generally rounded rectangular shapes to prevent device 500A from snagging or snagging on cardiac structures, such as chordae tendineae, during implantation. To this end, proximal collar 511D ( Fig.68A ) and 514A( Fig.68A) may also have rounded edges. When viewed from the front or rear, it can be seen that the paddle frame 524A has a generally rounded rectangular shape, extending upward and outward from the distal portion 507A to a plan view having a shape 510A that is wider than the apposing element and substantially parallel to the sides of the apposing element. Therefore, when viewed from the front or rear, the paddle frame 524A generally defines the shape of the device 500A. In addition, the rounded rectangular shape of the paddle frame 524A can distribute the leaflet stresses over a wider surface. In some example embodiments, the paddle frame 524A and / or the apposing element 510A can have other shapes.

[0532] As the front and back views ( Fig.67A and 68A ), when viewed from the side (e.g. Fig.47A ), the device 500A has a vertical side-to-side plane 552A ( Fig.70A ) symmetrical or substantially symmetrical shape. When the device 500A is viewed from the side, the distal portion 507A is also generally narrower than the proximal portion 505A. Fig.48B In the illustrated embodiment, the apposition element 510A is not tapered as it extends from the proximal portion 505A of the device 500A to the distal portion 507A of the device 500A. However, in some example embodiments, the apposition element does taper (e.g., Fig.47 ).

[0533] The generally circular feature of device 500A is further indicated by the circular shape of paddles 520A, 522A where the inner and outer paddles 520A, 522A are joined together. However, paddles 520A, 522A and paddle frames 524A can take a variety of different forms. For example, paddles 520A, 522A and paddle frames 524A can be rounded along the top edges and flat or substantially flat on the sides (e.g., the sides of paddle frames 524A disposed on the front and rear sides of device 500A). By making the sides of paddles 520A, 522A flat or substantially flat, two devices can be implanted side by side on a native valve leaflet so that the two devices are flush or substantially flush with each other.

[0534] The closed paddles 520A, 522A form a gap 542A between the inner paddle 522A and the apposition element 510A, which is configured to receive natural tissue. Fig.48B and Fig.48F505A, the proximal end of the apposition element 510A has a dog-bone-like shape so that the gap 542A narrows toward the proximal portion 505A as the gap 542A approaches the distal portion 507A of the device. The narrowing of the gap 542A toward the attachment portion 505A allows the paddles 520A, 522A to contact tissue grasped in the gap 542A closer to the proximal portion 505A.

[0535] Paddle frame 524A extends vertically from distal portion 507A to proximal portion 505A until approximately the middle third of device 500A, and then bends or flares outwardly so that connection portion 524B of frame 524A passes through gap 544A formed by inner paddle 522A folded inside outer paddle 520A. However, in other embodiments, the connection of the frame is located inside inner paddle 522A or outside outer paddle 520A. When viewed from the front or back ( Fig.67A and 68A ), the outer blade 520A has a rounded rectangular shape similar to the mating element 510A. Therefore, the device 500A has a rounded rectangular shape. When viewed from the top ( Fig.70A and Fig.71A ) or bottom ( Fig.72A and Fig.73A )When observing device 500A, the rounded rectangular shape of device 500A is particularly visible.

[0536] Reference now Fig.70A and Fig.71A , showing a top view of the device 500A. When viewed from the top, the device 500A has a shape that is symmetrical or substantially symmetrical around the front-back plane 550A and also symmetrical or substantially symmetrical around the side-side plane 552A. The proximal opening 519C in the apposition element 510A is visible at the proximal portion 505A of the device 500A. The actuating element 512A is received through the opening 519C so that the apposition element 510A is wrapped around the actuating element 512A. In some embodiments, the opening 519C is formed by inserting the actuating element 512A between the folded and overlapping layers of the material strip 501A (described in detail below). In other embodiments, the opening 519C is formed by shaping the folded layers of the material 501A forming the apposition element 510A around the blank or fixture to give the apposition element 510A a circular or substantially circular shape. Fig.71AThe proximal collar 511D shown in the figure can be fixed to the mate element 510A to close the mate element 510A. The proximal collar 511D includes an attachment portion 513A that engages with the opening 546A formed by the folded layer of material 501A that forms the mate element 510A. In some embodiments, the attachment portion 513A is a hole in the collar 511D, so that during the assembly process of the device 500A, before the material strip 501A is folded, the material strip 501A must be inserted through the collar 511D. In some embodiments, the attachment portion 513A is an open slot (e.g., the attachment portion 524B of the paddle frame 524A) that receives the material strip 501A before or after folding the material strip 501A.

[0537] As described above, when viewed from the top, the apposition element 510A has a generally rectangular shape. In some example embodiments, when viewed from the top, the apposition element 510A may have other shapes. For example, the apposition element may have a circular, square, diamond, oval, or any other shape. When viewed from the top, the paddle frames 224A each have a rounded rectangular shape, such that the paddle frames 224A surround the rectangular apposition element 510A. Therefore, natural tissue, such as the leaflets 20, 22 tend to be uniformly grasped or compressed in the gap 542A formed between the inner paddle 522A and the paddle frame 524A and the apposition element 510A.

[0538] Reference now Fig.72A and Fig.73A , showing a bottom view of the device 500A. Fig.70A and Fig.71A ), when viewed from the bottom, the device 500A has a shape that is symmetrical or substantially symmetrical about the front-to-back plane 550A and also symmetrical or substantially symmetrical about the side-to-side plane 552A. The distal portion 527A of the strip of material 501A includes a Fig.73A Opening 527B of cover 514A is shown.

[0539] The paddle frame 524A extends outwardly from the distal portion 507A of the device 500A to the left side 551A and the right side 553A at a narrow or slight angle to the side-to-side plane 552A. When the paddle frame 524A extends toward the proximal portion 505A of the device 500A ( Fig.65A ), the blade frame 524A further extends away from the side-to-side plane 552A while maintaining a substantially constant distance relative to the front-to-rear plane 550A to ultimately form Fig.70A and 71A The rounded rectangular shape seen in .

[0540] In an exemplary embodiment, the size of device 500A is selected to minimize the number of implants required for a single patient (preferably one) while maintaining a low transvalvular gradient. In an exemplary embodiment, the widest front-to-back distance Y47I of device 500A is less than 10mm, and the widest inside-outside distance Y67C of spacer is less than 6mm. In an exemplary embodiment, the overall geometry of device 500A can be based on these two dimensions and the above-mentioned overall shape strategy. It should be easily understood that using other front-to-back distances Y47I and inside-outside distances Y67C as the starting point of device 500A will result in devices with different sizes. In addition, using other sizes and the above-mentioned shape strategies will also result in devices with different sizes.

[0541] Tables D and E provide examples of values ​​and ranges for dimensions of the device 500A and components of the device 500A for some example embodiments. However, the device 500A can have a variety of different shapes and sizes, and need not have all or any of the dimensional values ​​or dimensional ranges provided in Tables D and E. Table D provides examples of linear dimensions Y in millimeters and linear dimensional ranges in millimeters for the device 500A and components of the device 500A. Table B provides examples of radial dimensions S in millimeters and radial dimensional ranges in millimeters for the device 500A and components of the device 500A. The subscript for each dimension indicates the figure in which the dimension first appears.

[0542]

[0543] Reference now Fig.74A , 75A , 76A, 77A, 78A, 79A, 80A, 81A, 82A and 83A, which show perspective and cross-sectional views of the device 500A. Referring now to Fig.74A , the device 500A is shown cut through a cross-sectional plane 75A near a proximal portion of the apposition element 510A. Referring now to Fig.75A , showing that from Fig.74A 75A. 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 uniform or generally uniform width.

[0544] Reference now Fig.76A , the device 500A is shown cut by a cross-sectional plane 77A positioned approximately three-quarters of the way between the distal portion 507A and the proximal portion 505A of the apposition element 510A. Referring now to Fig.77A , showing that from Fig.76AA cross-sectional view of the device 500A as viewed from the cross-sectional plane 77A in FIG. Fig.76A and Fig.77A As shown, the strips of material 501A forming the device 500A overlap in the region of the mating element 510A to form four layers. A single layer of the strip of material 501A forms each of the inner paddle 522A and the outer paddle 520A. At the location of plane 75A, the mating element 510A has a generally rectangular shape oriented along the side-to-side plane 552A. A 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 Fig.75A The gap 544A between the outer blade 520A and the inner blade 522A has a uniform or substantially uniform width 544B for receiving the attachment portion 524B of the blade frame 524A.

[0545] Reference now Fig.78A , the device 500A is shown cut by cross-sectional plane 79A, which is located approximately halfway between the distal portion 507A and the proximal portion 505A of the device 500A. Fig.79A , showing that from Fig.78A A cross-sectional view of the device 500A as viewed from the cross-sectional plane 79A in FIG. Fig.78A and 79A As shown in FIG. 5 , the strips of material 501A forming the device 500A overlap 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 the location of plane 79A, the mating element 510A has a generally rectangular shape oriented along the side-to-side plane 552A. The gap 542A between the inner paddle 522A and the mating element 510A has a substantially rectangular shape oriented along the side-to-side plane 552A. Fig.77A The width 542B is the same or approximately the same as the width 542B seen in FIG.

[0546] Reference now Fig.80A , the device 500A is cut by the cross-sectional plane 81A, which is located approximately one quarter of the way between the distal portion 507A and the proximal portion 505A of the device 500A. Fig.81A , showing that from Fig.80A A cross-sectional view of the device 500A as viewed from the cross-sectional plane 81A in FIG. Fig.80A and 81AAs shown, the strips of material 501A forming device 500A overlap to form four layers in the area of ​​mate element 510A, two layers in the area of ​​inner paddle 522A, and outer paddle 520A is formed of a single layer. At the location of plane 81A, mate element 510A has a generally rectangular shape oriented along side-to-side plane 552A. Gap 542A between inner paddle 522A and mate element 510A has a substantially rectangular shape oriented along side-to-side plane 552A. Fig.79A The center width 542B seen in is approximately the same width 542B.

[0547] Reference now Fig.82A , the device 500A is cut by cross-sectional plane 83A, which is located approximately one quarter of the way between the distal portion 507A and the proximal portion 505A of the device 500A. Fig.83A , showing that from Fig.82A A cross-sectional view of the device 500A as viewed from the cross-sectional plane 83A in FIG. Fig.82A and 83A As shown in FIG. 83A , the strips of material 501A forming the device 500A overlap to form four layers in the area of ​​the mating element 510A, two layers in the area of ​​the inner paddle 522A, and a single layer forming the outer paddle 520A. At the location of plane 83A, the mating element 510A has a generally 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 arcuate shape having a width 542B that is approximately equal to the width of the outer paddle 522A. Fig.81A The center width 542B seen in is approximately the same.

[0548] Reference now Figures 84 to 88 , 86A, 87A and 88A, show example implantable devices 100, 500, 500A without hooks or hingeable gripping elements. Figures 84-88 The example devices 100, 500, 500A shown in Figures 86A, 87A and 88A have barbs or grasping members 800 / 800A and / or 802 / 802A integrated into the mate elements or paddle portions of the anchoring portion of the device to facilitate grasping tissue of the native heart valve.

[0549] Reference now Fig.84 , an example implantable device 100 is shown that does not include an articulated hook or gripping element. As described above, the device 100 is deployed from a delivery sheath or device for delivery 102, and includes an apposition portion 104 and an anchoring portion 106. The apposition portion 104 of the device 100 includes an apposition element or device for apposition 110 adapted to be implanted between the leaflets 20, 22 of a native valve (e.g., a mitral valve MV, etc.), and is slidably attached to an actuating element or shaft 112 extending through the apposition element or device for apposition 110 to a distal cover 114.

[0550] The anchoring portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 connected between the distal cover 114 and the apposition element or device for apposition 110. The anchoring portion 106 is actuable between an open state and a closed state and can take a variety of forms such as a paddle, a grasping element, etc. Actuation of the actuating element or device for actuation 112 opens and closes the anchoring portion 106 of the device 100 to grasp the native valve leaflets 20, 22 during implantation.

[0551] Fig.84 The device 100 shown in FIG. 1 includes a barbed portion 800 disposed on an apposition element or device for apposition 110 instead of an articulatable hook or grasping element, wherein each side of the apposition element or device for apposition 110 has at least one barbed portion 800. When the anchoring portion 106 of the device 100 is closed, tissue grasped between the inner paddle 122 and the apposition element or device for apposition 110 is pressed against the barbed portion 800. The barbed portion 800 can be sharp so that they engage native tissue, and in some embodiments pierce the native tissue, and prevent the tissue from retracting from the device 100. In some embodiments, the barbed portion 800 is angled downward to increase engagement with the native tissue.

[0552] Reference now Fig.85 , the example implantable device 100 is shown without a separate articulated hook. As described above, the device 100 is deployed from a delivery sheath or an instrument for delivery 102, and includes an apposition portion 104 and an anchoring portion 106. The apposition portion 104 of the device 100 includes an apposition element or an instrument for apposition 110 adapted to be implanted between the leaflets 20, 22 of a native valve or mitral valve MV, and is slidably attached to an actuation element 112 (e.g., an actuation wire, shaft, rod, suture, wire, etc.) extending through the apposition element or the instrument for apposition 110 to a distal cover 114.

[0553] The anchoring portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 connected between the distal cover 114 and the apposition element or device for apposition 110. The anchoring portion 106 is actuable between an open state and a closed state and can take a variety of forms such as a paddle, a grasping element, etc. Actuation of the actuating element or device for actuation 112 opens and closes the anchoring portion 106 of the device 100 to grasp the native valve leaflets 20, 22 during implantation.

[0554] Fig.85The illustrated device 100 includes barbed portions 800 disposed on the inner paddles 122, rather than separate articulatable hooks or gripping elements, wherein each inner paddle 122 has at least one barbed portion 800. When the anchoring portion 106 of the device 100 is closed, tissue captured between the inner paddles 122 and the apposition element or instrument for apposition 110 is pressed against the barbed portions 800. The barbed portions 800 may be sharp so that they engage native tissue, and in some embodiments pierce the native tissue, and prevent the tissue from retracting from the device 100. In some embodiments, the barbed portions 800 are angled downward to increase engagement with the native tissue.

[0555] Reference now Fig.86 , shows an example implantable device 500 that does not include an articulated hook or gripping element. As described above, the device 500 includes an apposition portion 504 and an anchoring portion 506. The apposition portion 504 of the device 500 includes an apposition element 510 that is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to an actuation element or instrument for actuation 512 that extends through the apposition element 510 to a distal cover 514.

[0556] The anchoring portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 connected between the distal cover 514 and the apposition element 510. The anchoring portion 506 is actuable between an open state and a closed state, and can take a variety of forms such as a paddle, a grasping element, etc. Actuation of the actuating element 512 opens and closes the anchoring portion 506 of the device 500 to grasp the native valve leaflets 20, 22 during implantation.

[0557] The device 500 includes barbed portions 800 disposed on the inner paddles 522, rather than articulatable hooks or gripping 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, tissue gripped between the inner paddles 522 and the apposition element 510 is pressed against the barbed portions 800. The barbed portions 800 are sharp so that they engage native tissue, and in some embodiments pierce the native tissue, and prevent the tissue from retracting from the device 500. In some embodiments, the barbed portions 800 are angled downward to increase engagement with the native tissue.

[0558] Reference now Fig.86A, an example implantable device 500A is shown that does not include an articulated hook or gripping element. As described above, the device 500A includes an apposition element 510A, which is suitable for being implanted between the leaflets 20, 22 of a native valve or native mitral valve MV, and is slidably attached to an actuating element or an instrument for actuation (not shown), which extends through the apposition element 510A to a distal cover 514A. The device 500A also includes an outer paddle 520A and an inner paddle 522A connected between the distal cover 514A and the apposition element 510A. The device 500A can be actuated between an open state and a closed state, and can take a variety of forms such as paddles, gripping elements, etc. Actuation of the actuating element opens and closes the paddles 520A, 522A of the device 500A to grip the native valve leaflets 20, 22 during implantation.

[0559] The device 500A includes barbed portions 800A disposed on the inner paddles 522A, rather than articulatable hooks or gripping elements, wherein each inner paddle 522A optionally has more than one barbed portion 800A. When the device 500A is closed, tissue gripped between the inner paddles 522A and the apposition element 510A is pressed against the barbed portions 800A. The barbed portions 800A are sharp so that they engage native tissue, and in some embodiments pierce the native tissue, and prevent the tissue from retracting from the device 500A. In some embodiments, the barbed portions 800A are angled downward to increase engagement with the native tissue.

[0560] Reference now Fig.87 , shows an example implantable device 500 that does not include a separate articulated hook or gripping element. As described above, the device 500 includes an apposition portion 504 and an anchoring portion 506. The apposition portion 502 of the device 500 includes an apposition element 510 that is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to an actuation element or instrument for actuation 512 that extends through the apposition element 510 to a distal cover 514.

[0561] The anchoring portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 connected between the distal cover 514 and the apposition element 510. The anchoring portion 506 is actuable between an open state and a closed state, and can take a variety of forms such as a paddle, a grasping element, etc. Actuation of the actuating element 512 opens and closes the anchoring portion 506 of the device 500 to grasp the native valve leaflets 20, 22 during implantation.

[0562] The device 500 includes barbed portions 800 disposed on the apposition element 510 rather than separate articulatable hooks or gripping elements, with each side of the apposition element 510 having more than one barbed portion 800. When the anchoring portion 506 of the device 500 is closed, tissue gripped between the inner paddle 522 and the apposition element 510 is pressed against the barbed portions 800. The barbed portions 800 are sharp so that they engage native tissue, and in some embodiments pierce the native tissue, and prevent the tissue from retracting from the device 500. In some embodiments, the barbed portions 800 are angled downward to increase engagement with the native tissue.

[0563] Reference now Fig.87A , an example implantable device 500A is shown that does not include an articulated hook or gripping element. As described above, the device 500A may have an apposition element 510A, which is suitable for being implanted between the leaflets 20, 22 of a native valve or native mitral valve MV, and is slidably attached to an actuating element or an instrument for actuation (not shown), which extends through the apposition element 510A to the distal cover 514A. The device 500A also includes an outer paddle 520A and an inner paddle 522A connected between the distal cover 514A and the apposition element 510A. The device 500A can be actuated between an open state and a closed state, and can take a variety of forms such as paddles, gripping elements, etc. Actuation of the actuating element opens and closes the paddles 520A, 522A of the device 500A to grip the native valve leaflets 20, 22 during implantation.

[0564] The device 500A includes a barbed portion 800A disposed on the apposition element 510A, wherein each side of the apposition element 510A has more than one barbed portion 800A, rather than a separate hingeable hook or gripping element. When the device 500A is closed, tissue captured between the inner paddle 522A and the apposition element 510A is pressed against the barbed portion 800A. The barbed portion 800A is sharp so that they engage the native tissue, and in some embodiments pierce the native tissue, and prevent the tissue from retracting from the device 500A. In some embodiments, the barbed portion 800A is angled downward to increase engagement with the native tissue.

[0565] Reference now Fig.88 , an example implantable device 500 is shown that does not include a separate articulated hook or gripping element. As described above, the device 500 includes an apposition portion 504 and an anchoring portion 506. The apposition portion 504 of the device 500 includes an apposition element 510 that is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to an actuation element or instrument for actuation 512 that extends through the apposition element 510 to a distal cover 514.

[0566] The anchoring portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 connected between the distal cover 514 and the apposition element 510. The anchoring portion 506 is actuable between an open state and a closed state, and can take a variety of forms such as a paddle, a grasping element, etc. Actuation of the actuating element 512 opens and closes the anchoring portion 506 of the device 500 to grasp the native valve leaflets 20, 22 during implantation.

[0567] The device 500 includes a barbed portion 800 disposed on the mating element 510 instead of an articulatable hook or gripping element, wherein each side of the mating element 510 includes at least one barbed portion 800. Similar to the device 1000 described above, the device 500 also includes a barbed portion 802 disposed on the inner paddles 522, wherein each inner paddle 522 has at least one barbed portion 802.

[0568] When the anchoring portion 506 of the device 500 is closed, the tissue grasped between the inner paddle 522 and the apposition element 510 is pressed against the barbed portions 800, 802. The barbed portions 800, 802 are sharp so that they engage, and in some embodiments pierce the native tissue and prevent the tissue from retracting from the device 500. In some embodiments, the barbed portions 800, 802 are angled downward to increase engagement with the native tissue. The combination of the barbed portions 800 on the apposition element 510 and the barbed portions 802 on the inner paddle 522 forms the grasped tissue into an S-shaped curved path as the grasped tissue passes through the barbed portions 800, 802. Therefore, the force pulling the tissue away from the device 500 will cause the tissue to further engage the barbed portions 800, 802 before the tissue can disengage.

[0569] Reference now Fig.88A , an example implantable device 500A is shown that does not include an articulated hook or gripping element. As described above, the device 500A may have an apposition element 510A, which is suitable for being implanted between the leaflets 20, 22 of a native valve or native mitral valve MV, and is slidably attached to an actuating element or an instrument for actuation (not shown), which extends through the apposition element 510A to the distal cover 514A. The device 500A also includes an outer paddle 520A and an inner paddle 522A connected between the distal cover 514A and the apposition element 510A. The device 500A can be actuated between an open state and a closed state, and can take a variety of forms such as paddles, gripping elements, etc. Actuation of the actuating element opens and closes the paddles 520A, 522A of the device 500A to grip the native valve leaflets 20, 22 during implantation.

[0570] The device 500A includes a barbed portion 800A disposed on the mating element 510A, instead of an articulatable hook or gripping 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 paddles 522A, wherein each inner paddle 522A has at least one barbed portion 802A.

[0571] When device 500A is closed, the tissue grasped between inner paddle 522A and apposition element 510A is pressed against barbed parts 800A, 802A. Barbed parts 800A, 802A are sharp so that they engage natural tissue and pierce natural tissue in some embodiments and prevent tissue from retracting from device 500A. In some embodiments, barbed parts 800A, 802A are angled downward to increase engagement with natural tissue. The combination of barbed parts 800A on apposition element 510A and barbed parts 802A on inner paddle 522A forms the grasped tissue into an S-shaped curved path when passing through barbed parts 800A, 802A. Therefore, the force of pulling tissue away from device 500A will prompt tissue to further engage barbed parts 800A, 802A before tissue can be disengaged.

[0572] Reference now Figure 89 to Figure 102 , showing the apposition element 510 and paddles 520, 522 of the example device 500. The apposition element 510 and paddles can be made of a variety of different materials. The apposition element 510 and paddles 520, 522 can be formed from one or more of a variety of materials, such as a metal fabric, such as a mesh, woven, braided, electrospun, deposited or formed in any other suitable manner, a material cut by laser or otherwise, or a flexible material. The material is a cloth, a shape memory alloy wire (such as Nitinol) to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body.

[0573] In an exemplary embodiment, the apposition element is made of a braided mesh of metal wires, such as a braided mesh of nickel-titanium alloy wires. In an exemplary embodiment, the apposition element 510 is made of a braided mesh of 25 to 100 wires, such as 40 to 85 wires, such as 45 to 60 wires, such as about 48 nitinol wires or 48 nitinol wires.

[0574] The apposition element can be covered in cloth, such as polyethylene cloth. The apposition element 510 can be entirely surrounded by a cloth cover, such as a fine mesh polyethylene cloth. The cloth cover can provide a blood seal on the surface of the spacer and / or promote rapid tissue ingrowth.

[0575] The use of a shape memory material, such as a braided nitinol wire mesh, to construct the apposition element 510 results in an apposition element that is self-expandable, flexible in all directions, and / or results in low strain when the apposition element is crimped and / or bent. The material can be a single piece, two halves joined together, or multiple sections or pieces fastened or joined together in any suitable manner, such as by welding, using an adhesive, etc.

[0576] Reference now Figures 89 to 90 , the device 500 extends from a proximal portion 505 to a distal portion 507 and includes an apposition element 510, an inner paddle 522, and an outer paddle 520. The apposition element 510 includes a proximal opening 519A and a distal opening 515 ( Fig.92 and 94 ). A proximal opening 519A of the mating element 510 is formed in a proximal portion 519 of the mating element 510. The mating element 510 is engageably connected to the inner paddle 522 via the mating portion 525. The inner paddle 522 is engageably connected to the outer paddle 520 via the mating portion 523. The outer paddle 520 is attached (e.g., engageably attached, etc.) to the distal portion 527 via the mating portion 521. An mating gap 542 is formed between the inner paddle 522 and the mating element 510. When the paddles 520, 522 are folded, a paddle gap 544 is formed between the inner paddle 520 and the outer paddle 522, for example, as Fig.90 shown.

[0577] Reference now Fig.91 , showing a front view of the device 500 (the rear view will be the same). The apposition 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 is connected to the joint portion 525. The shape of the apposition element 510 is circular or substantially circular to prevent the device 500 from catching or snagging on the structure of the heart, such as the chordae tendineae, during implantation.

[0578] Reference now Fig.92 , showing a side view of the device 500. Similar to the device 500 viewed from the front, when the device 500 is viewed from the side, the distal portion 507 of the device 500 is generally narrower than the proximal portion 505 of the device 500. The apposition element 510 flares outward from the proximal opening 519A in the proximal portion 519 to the middle portion 518. The apposition element 510 then tapers or narrows from the proximal portion 519 to the distal portion 517 in the middle portion 518. The distal portion 517 remains narrow and then splits into two joint portions 525. The generally circular feature of the device 500 is also illustrated by the circular shape of the apposition portion 523 that engageably connects the inner paddle 520 and the outer paddle 522, and the outwardly bowed shape of the outer paddle 520.

[0579] The engagement gap 542 formed between the inner paddle 522 and the apposition element 510 is configured to receive native tissue. The narrowing of the apposition element 510 gives the gap 542 a slightly teardrop shape that increases in width as the gap 542 approaches the distal portion 507 of the device 500. The widening of the gap 542 toward the distal portion 507 allows the inner paddle 522 to contact tissue grasped in the gap 542 closer to the proximal portion 505 where the compressive force is greater due to the mechanical advantage provided by the length of the paddles 520, 522 and other fixation or anchoring elements (such as those described in the present application).

[0580] Reference now Fig.93 , showing a top view of the device 500. The proximal opening 519A in the apposition element 510 is visible at the proximal portion 505 of the device 500, and the apposition element 510 can be seen to be hollow inside. The apposition element 510 has an oval or generally oval shape when viewed from the top. Although the paddles 520, 522 appear to be protruding rectangular shapes, the paddles 520, 522 can extend laterally and have an arcuate or crescent-shaped shape.

[0581] Reference now Fig.94 , showing a bottom view of the device 500. The distal opening 515 in the apposition element 510 is visible at the distal portion 507 of the device 500, and it can be seen that the apposition element 510 is hollow inside. The apposition element 510 has an oval or generally oval shape when viewed from the top. Although the paddles 520, 522 appear to be protruding rectangular shapes, the paddles 520, 522 can extend laterally and have an arc or crescent shape. It can be seen that the distal portion 517 of the apposition element 510 is split into two to engage with the joint portion 525.

[0582] Reference now Fig.89A , 90A , 91A, 92A, 93A, 94A, 95A, 96A, 97A, 98A, 99A, 100A, 101A and 102A, showing portions of a device 500A formed from a strip of material 501A (e.g., a single, continuous strip of material, a composite strip, etc.), namely, a mating element 510A and paddles 520A, 522A. The mating element 510A and paddles can be made from a variety of different materials. The mating element 510A and paddles 520A, 522A can be formed from a material that can be a metal fabric, such as a mesh, formed by weaving, braiding, electrospinning, depositing or in any other suitable manner, formed by laser cutting or otherwise cutting a material or a flexible material. The material is cloth, a shape memory alloy wire (such as Nitinol) to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body.

[0583] In an exemplary embodiment, the apposition element 510A, the inner paddle 522A, and the outer paddle 520A are made from a single continuous strip of material 501A. The strip of material 501A may be formed from a material that may be a metal fabric, such as a mesh, woven, braided, electrospun, deposited, or formed in any other suitable manner, a material cut by a laser or otherwise, or a flexible material. The material is a cloth, a shape memory alloy wire (such as Nitinol) to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body. In an exemplary embodiment, the strip of material 501A is made from a braided mesh having 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.

[0584] Reference now Figures 205 to 207 , an example woven or braided material 4000 that may be used for the strip of material 501A is shown. Referring now to Fig.205 , showing an enlarged plan view of material 4000. Material 4000 extends from a first edge 4002 to a second edge 4004. The edges 4002, 4004 surround a central portion or region 4006. Material 4000 is formed by braiding or weaving together a central strand 4020, such as nitinol wire. Edge strands 4010 extend longitudinally through material 4000 along edges 4002, 4004. Central strand 4020 is woven or braided such that central strand 4020 is wrapped around edge strand 4010. Wrapping central strand 4020 around edge strand 4010 causes material 4000 near edges 4002, 4004 to be thicker than material in central portion 4006, forming a flap-like or dog-bone-like shape when material 4000 is viewed from the end, as shown. Fig.2064006. Thus, the edges 4002, 4004 of the material 4000 are less flexible than the central portion 4006. The edge strands 4010 and the central strands 4020 can be similar in diameter and can have a diameter ranging from about 0.06 mm to about 0.18 mm. In some embodiments, the edge strands 4010 can have a larger diameter than the central strands 4020 so that the edges 4002, 4004 have a greater hardness or stiffness than the central portion 4006. For example, the edge strands 4010 can have a diameter ranging from 0.07 mm to about 0.27 mm or about 0.17 mm, and the central strands 4020 can 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 central portion 4006 by using different materials for the edge strands 4010 and the central strand 4020, for example, using a metal material such as nitinol for the edge strands 4010 and a cloth or plastic material such as polyethylene for the central strand 4020. Alternatively, the edge strands 4010 and the central strand 4020 can be made of the same material that is subjected to different chemical and / or thermal treatments that change the flexibility of the material such that the central strand 4020 is more flexible than the edge strands 4010.

[0585] Reference now Fig.207 , the folded portions of the material 4000 are stacked on top of each other to form a portion having four layers 4000A, 4000B, 4000C, 4000D. The petal-like shape of each layer having edges 4002, 4004 thicker than the central portion 4006 creates three gaps 4001A, 4001B, 4001C between the layers 4000A, 4000B, 4000C, 4000D of the material 4000 in the location of the central portion 4006. The outer gaps 4001A, 4001C are formed between the outer layers 4000A, 4000D and the adjacent middle layers 4000B, 4000C.

[0586] As discussed in the present disclosure, the apposition element 510A of the device 500A can be formed from four layers of material, such as material 4000. When the layers of material 4000 are used to form the apposition element 510A, the actuation element 512A of the device 500A can be inserted through the middle gap 4001B formed in the center of the four layers of material 4000. The actuation element 512A can have a diameter greater than the width of the gap 4001B, so that the insertion of the actuation element 512A causes the middle gap 4001B to stretch open and adjacent to the outer gaps 4001A, 4001C to reduce the size. In some embodiments, the insertion of the actuation element 512A causes the central body portion 4006 on either side to bulge outward to a thickness greater than the four stacked edge portions 4002, 4004.

[0587] The apposition element 510A and paddles 520A, 522A can be covered in cloth, such as polyethylene cloth. The apposition element 510A and paddles 520A, 522A can be entirely surrounded by a cloth cover (e.g., cover 540A), such as a fine mesh polyethylene cloth. The cloth cover can provide a blood seal on the surface of the septum and / or promote rapid tissue ingrowth.

[0588] The use of a shape memory material such as a braided nitinol wire mesh to construct the apposition element 510A and paddles 520A, 522A results in an apposition element and paddle that are self-expandable, flexible in all directions, resulting in low strain when the apposition element is crimped and / or bent. The material can be a single piece, two halves joined together, or multiple sections or pieces fastened or joined together in any suitable manner, such as by welding, using an adhesive, etc.

[0589] Reference now Fig.89A and Fig.90A , device 500A extends from proximal portion 505A to distal portion 507A and includes apposition element 510A, inner paddle 522A, and outer paddle 520A. A single continuous strip of material 501A extends between two ends 501B and is folded to form apposition element 510A, inner paddle 522A, and outer paddle 520A. Some portions of device 500A are formed from multiple layers of strips of material 501A. For example, strips of material 501A are overlapped to form four layers in the region of apposition element 510A and two layers in the region of inner paddle 522A.

[0590] The mating element 510A and the paddles 520A, 522A are engageably connected together by the mating portion of the material strip 501A. The mating element 510A is engageably connected to the inner paddle 522A by the mating portion 525A. The inner paddle 522A is engageably connected to the outer paddle 520A by the mating portion 523A. The outer paddle 520A is attached (e.g., engageably attached, etc.) to the distal portion 527A by the mating portion 521A. The opening 527B in the distal portion 527A engages with the cover 514A.

[0591] When the strip of material 501A is folded into a desired shape, a plurality of gaps are formed between the various portions of the device 500A. A plurality of gaps are formed between the inner blade 522A and the folding element 510A. When the blades 520A, 522A are folded, a plurality of gaps are formed between the portions of the device 500A. A plurality of gaps are formed between the inner blade 520A and the outer blade 522A, e.g. Fig.90A When the strip of material 501A is folded to form the proximal portion 519B of the apposition element 510A, a collar gap 546A is formed.

[0592] Reference now Fig.91A , showing a front view of the device 500A (a rear view thereof would be identical). The apposition element 510A includes a proximal portion 519B extending above the joint portion 523A of the paddles 520A, 522A. When viewed from the front or rear, the distal portion 517A of the apposition element 510A is hidden by the paddles 520A, 522A, thereby giving the device 500A a long, narrow, rounded rectangular shape. The shape of the apposition element 510A helps prevent the device 500A from snagging or snagging on cardiac structures, such as chordae tendineae, during implantation.

[0593] Reference now Fig.92A , showing a side view of the device 500A. When the device 500A is viewed from the side, the distal end 507A of the device 500A is generally narrower than the proximal end 505A of the device 500A, thereby forming a generally 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 with 51 ID ( Fig.48A ). When viewed from the side, the middle portion 518A of the mate element 510A is straight or substantially straight. The distal portion 517A is attached (e.g., engageably attached, etc.) to the inner paddle 522A via a joint portion 525A. The generally circular nature of the device 500A is also indicated by the circular shape of the connecting portion 523A that engageably connects the paddles 520A, 522A. The connecting portion 521A connecting the outer paddle 520A to the distal portion 527A is also circular and facilitates assembly from the material strip 501A to the cover 514A ( Fig.48A ) shape transition.

[0594] The apposition gap 542A formed between the inner paddle 522A and the apposition element 510A is configured to receive native tissue. The general straightness of the middle portion 518A of the apposition element 510A and the inner paddle 522A allows the gap 542A to have a uniform or substantially uniform width, with a narrow upper end and a proximal portion 519B that flares outward to engage the collar 511D ( Fig.48A Thus, the inner paddle 522A contacts the tissue grasped in the gap 542A closer to the proximal portion 505A, where the compressive force is greater due to the mechanical advantage provided by the length of the paddles 520A, 522A and other securing or anchoring elements, such as those described herein.

[0595] As described above, the mating element 510A and the paddles 520A, 522A of the device 500A are formed by folding the material strip 501A. The material strip 501A is then unfolded and assembled with other components, such as the collar 511D, the cover 514A, and the paddle frame 524A. The material strip 501A is shaped after being formed into the desired shape so that the material strip 501A returns to the desired shape after being assembled with the other components. In some embodiments, a clamp is used during the folding and shaping of the material strip 501A to ensure that the material strip 501A is folded in the appropriate position with the desired radius.

[0596] Reference again Fig.92A, showing portions of a clamp 570A to assist in folding and shaping the device 500A. The strip of material 501A is shown folded around the clamp 570A so that the strip of material 501A is formed into a desired shape. In order 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 so that one of the ends 501B is located at the location of the inner paddle 522A. The strip 501A extends from the end 501B in a distal direction 507B to form a first layer 581A of the inner paddle 522A, extends around the first clamp portion 572A to form a first layer 581A of the hinge portion 525A, and then extends in a proximal direction 505B to form a first layer 581A of the mate element 510A. The first layer 581A of material forms the sides of the inner paddle 522A and the mate element 510A around the mate gap 542A. The strip 501A is then wrapped around the second clamp portion 574A to form the proximal portion 519B and one of the openings 546A of the apposition element 510A. The strip 501A is then extended along the first layer 581A in the distal direction 507A to form the second layer 582A of the apposition element 510A. The strip 501A is then wrapped back around the first clamp portion 524A to form the second layer 582A of the hinge portion 525A, and is then wrapped back in the proximal direction 505B 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 joint portion 523A. The strip 501A is then extended along the inner paddle 522A in the distal direction 507A to form the outer paddle 520A, and then folded around the fourth clamp portion 578A to form the apposition portion 521. The strip 501A is then extended laterally to form the distal portion 527. The routing of the strip 501A through the jig 570A is then performed in reverse order on the opposite side of the jig 570A to form the second half of the device 500A. That is, the strip 501A is then wrapped around the fourth jig portion 578A, the third jig portion 576A, the second jig portion 574A, and the first jig portion 572A to form the second half of the device 500A. Once the strip 501A is wrapped around the jig portions as described above, a shaping operation is performed. Although the portions of the jig shown have a circular or substantially circular shape, the portions may have any shape to facilitate the folding and shaping of the strip of material 501A. The jig 570 may have more or fewer portions for engaging the strip of material 501A.

[0597] Reference now Fig.93A, showing a top view of the device 500A. The first layer 581A and the second layer 582A of each half of the device 500A form the four layers of the juxtaposition device 510A. The proximal end opening 519C of the juxtaposition device 510A is formed between the two second layers 582A. In some embodiments, after the shaping of the material 501A, the opening 519C is formed by inserting an actuating element 512A (not shown) between the folded and overlapping layers of the material 501A. In other embodiments, the opening 519C is formed by shaping the folded layers 581A, 582A of the material strip 501A around an additional clamp portion (not shown), thereby giving the juxtaposition element 510A a circular or substantially circular shape when viewed from the top.

[0598] Reference now Fig.94A , shows a bottom view of the device 500A. The distal portion 527A of the strip of material 501A is shown, as well as the opening 527B for receiving the cap 514A. When viewed from below, the mate element 510A and the outer paddle 520A have a generally rounded rectangular shape.

[0599] Reference now Figures 95 to 102 , which shows a perspective view and a cross-sectional view of the device 500. Now referring to Fig.95 , the device 500 is shown cut through a cross-sectional plane 96 near the proximal portion of the apposition element 510. Referring now to Fig.96 , showing that from Fig.95 96. At the location of plane 96, the apposition element 510 has an oval or substantially oval shape with thicker portions along the sides of the apposition element 510. The distal opening 515 is visible from the proximal portion, and the apposition element 510 has a hollow interior.

[0600] Reference now Fig.97 , the device 500 is shown cut by cross-sectional plane 98, which is located approximately halfway between the distal portion 507 and the proximal portion 505 of the apposition element 510. Referring now to Fig.98 , showing that from Fig.97 FIG. 5 is a cross-sectional view of the device 500 viewed from the cross-sectional plane 98 in FIG. At the location of the plane 98, the mating element 510 has a Fig.96 Oval shape, large oval or roughly oval shape.

[0601] Reference now Fig.99 , the device 500 is shown cut by a cross-sectional plane 100, which is located approximately one quarter of the way between the distal portion 507 and the proximal portion 505 of the apposition element 510. Referring now to Fig.99 , showing that from Fig.99A cross-sectional view of the device 500 viewed from the cross section 100 in FIG. At the location of the plane 100, the mating element 510 has a Fig.98 A narrow oval or roughly oval shape as seen in the ellipse.

[0602] Reference now Fig.101 , the device 500 is shown cut by a cross-sectional plane 102 positioned near the distal portion 507 of the apposition element 510. Referring now to Fig.102 , showing that from Fig.101 FIG. 5 is a cross-sectional view of the device 500 viewed from the cross-sectional plane 102 in FIG. At the location of the plane 102, the juxtaposition element 510 has an oval or substantially oval shape that is smaller than Fig.100 and are separated when the mate element 510 mates the portion 525.

[0603] Reference now Fig.95A , 96A , 97A, 98A, 99A, 100A, 101A and 102A, which show perspective and cross-sectional views of a portion of a device 500A formed from a single continuous strip of material 501A. Referring now to Fig.95A , the device 500A is shown cut through a cross-sectional plane 96A near the proximal portion of the apposition element 510A. Referring now to Fig.96A , showing that from Fig.95A 96A. At the location of plane 96A, the juxtaposition element 510 has a rectangular or substantially rectangular shape. In some embodiments, when the actuating element (not shown) is inserted between the layers 582A of the juxtaposition element 510A, the juxtaposition element 510A remains straight when viewed from the side, but when viewed from the cross-section 96A, it bends outward to form a circular or substantially circular shape.

[0604] Reference now Fig.97A , the device 500A is shown cut through a cross-sectional plane 98A near a proximal portion of the apposition element 510A. Referring now to Fig.98A , showing that from Fig.97A 98A. At the location of plane 98A, the juxtaposition element 510 has a rectangular or substantially rectangular shape. In some embodiments, when the actuating element (not shown) is inserted between the layers 582A of the juxtaposition element 510A, the juxtaposition element 510A remains straight when viewed from the side, but when viewed from the cross-section 98A, it bends outward to form a circular or substantially circular shape.

[0605] Reference now Fig.99A, the device 500A is shown cut by a cross-sectional plane 100A near the proximal portion of the apposition element 510A. Referring now to Fig.100A , showing that from Fig.99A 10A. At the location of plane 100A, the coupling element 510 has a rectangular or substantially rectangular shape. In some embodiments, when the actuating element (not shown) is inserted between the layers 582A of the coupling element 510A, the coupling element 510A remains straight when viewed from the side, but when viewed from the cross-section 100A, it bends outward to form a circular or substantially circular shape.

[0606] Reference now Fig.101A , the device 500A is shown cut through the cross-sectional plane 102A near the proximal portion of the apposition element 510A. Referring now to Fig.102A , showing that from Fig.101A 102A. At the location of plane 102A, the juxtaposition element 510 has a rectangular or substantially rectangular shape. In some embodiments, when the actuating element (not shown) is inserted between the layers 582A of the juxtaposition element 510A, the juxtaposition element 510A remains straight when viewed from the side, but when viewed from the cross-section 102A, it bends outward to form a circular or substantially circular shape.

[0607] Reference now Figure 103 to Figure 105 , an example implantable prosthetic device 100 having a covered portion and an uncovered portion is shown. The device 100 is shown implanted in a native mitral valve MV and secured to the native leaflets 20, 22. As described above, the device 100 includes an apposition element or instrument for apposition 110, a paddle 120, a hook 130, and a cover 114. The paddle 120 and the hook 130 are in a closed position to secure the device 100 to the captured native 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.

[0608] Reference now Fig.103, the device 100 is shown with a covering 900 covering the entirety of the apposition element or the apparatus 110 for apposition and the cover 114. In some embodiments, the covering 900 can be a cloth or fabric or a polymer, such as PET, velvet, a material formed by electrospinning, deposition, or other suitable material. In other embodiments, instead of or in addition to the fabric, the covering may include a coating (e.g., a polymer) applied to the prosthetic spacer device and / or the mechanical sealing mechanism, such as silicone, and an interlocking joint may be used. The covering 900 may be formed of a metal fabric, such as a mesh, formed by weaving, braiding, or in any other suitable manner, or formed by a flexible material cut by laser or otherwise. The covering 900 may be a cloth, a shape memory alloy wire (such as nitinol) to provide shaping capability, or any other flexible material suitable for implantation in the human body. The covering 900 blocks blood flow through the apposition element or the apparatus 110 for apposition at the proximal portion 105, and also provides a seal between the device 100 and the leaflets 20, 22. Thus, the covering 900 helps prevent blood from flowing through the native valve at the location of the device 100. The covering 900 also prevents recirculating blood flow from entering the device 100 from the distal portion 107.

[0609] Reference now Fig.104 , the device 100 is shown with a covering 1000 that partially covers the apposition element or the device for apposition 110 from the proximal portion 105 of the device 100 to the portion of the apposition element or the device for apposition 110 that engages the natural leaflets 20, 22. In some embodiments, the covering can be a cloth or fabric, such as PET, velvet or other suitable fabrics. In other embodiments, instead of or in addition to the fabric, the covering can include a coating (e.g., a polymer) applied to the prosthetic spacer device. The covering 1000 can be formed of a metal fabric, such as a mesh, woven, braided or formed in any other suitable manner, or formed of a flexible material cut by laser or otherwise. The covering 1000 can be a cloth, a shape memory alloy wire (such as nitinol) to provide shaping ability, or any other flexible material suitable for implantation in the human body. Therefore, the covering 1000 prevents blood from flowing through the apposition element or the device for apposition 110 at the proximal portion 105.

[0610] Reference now Fig.105, the device 100 is shown with a covering 1100, which partially covers the apposition element or the instrument 110 for apposition extending toward the distal portion 107 from the portion of the apposition element or the instrument 110 for apposition that engages the natural leaflets 20, 22. The covering 1100 also covers the cap 114. In some embodiments, the covering can be a cloth or fabric, such as PET, velvet or other suitable fabrics. In other embodiments, instead of or in addition to the fabric, the covering can include a coating (e.g., a polymer) applied to the prosthetic spacer device. The covering 1100 can be formed by a mesh, woven, braided or formed in any other suitable manner. The covering 1100 can be a cloth, a polymer, a silicone, an electrospun material, a deposited material and / or a shape memory alloy wire (such as nitinol) to provide shaping ability, or any other flexible material suitable for implantation in the human body. Therefore, blood flow can enter the apposition element or the instrument 110 for apposition, but is prevented from passing through the device by the covering 1100 arranged toward the distal portion 107. The covering 1100 also prevents recirculating blood flow from entering the device 100 from the distal portion 107 .

[0611] Reference now Figures 106 to 109 , an example apposition element 1200 for an implantable prosthetic device is shown. The apposition element 1200 can be used with any implantable prosthetic device described in this application. Fig.106 , the apposition element 1200 has a cylindrical or substantially cylindrical shape extending between the two covers 1201. However, the apposition element 1200 can have any shape, such as any shape disclosed herein. In an exemplary embodiment, the expansion direction of the apposition element 1200 can be controlled. For example, the width / size of the apposition element in the anterior-posterior direction (when implanted), the lateral-lateral direction (when implanted), or both can be expanded (or contracted) in a controlled manner. The apposition element can be made of a material mesh 1200. Now referring to Fig.107 1, the wall of the generally cylindrical mating element 1200 extends outwardly from the cover 1201 by a distance 1204. Fig.108 , an axial force 1208 is applied to the cap 1201 of the mate element 1200, causing the mate element 1200 to compress in the axial direction. Axially compressing the mate element 1200 causes the mate element 1200 to expand or bulge in an outward direction 1210, causing the distance 1204 to increase.

[0612] The mate element 1200 can be compressed in a variety of different ways. For example, a threaded connector can be used to pull the two ends of the mate element together or push the two ends of the mate element apart. For example, a bushing can be provided on each end of the mate element. One bushing can threadably engage a threaded shaft, while the other bushing can be rotatably connected to the shaft. Rotating the shaft in one direction pulls the bushings together. Rotating the shaft in the opposite direction moves the bushings apart.

[0613] Incorporating apposition element 1200 into the implantable prosthetic device of the present application allows the apposition element to expand to press outwardly against tissue grasped between the apposition element and the paddle and / or grasping member.

[0614] Reference now Fig.106A , 108A , 106B and 108B, showing an example apposition element 1200 for an implantable prosthetic device, which is similar to Figures 106 to 109 The embodiment shown. The apposition element 1200 can be used with any implantable prosthetic device described in this application. Fig.106A , the mating element 1200 has a cylindrical or substantially cylindrical shape extending between the two covers 1201. However, the mating element 1200 can have any shape, such as any shape disclosed herein. Fig.106A and 108A In the example shown, the apposition element 1200 includes a tube 1203 having a slot 1205. For example, the tube 1203 can be made of a shape memory alloy such as Nitinol, and the slot can be cut, such as laser cut, into the tube. The slot can be cut into the material forming the tube before the material is formed into the tube.

[0615] In one example embodiment, the direction of expansion of the apposition element 1200 can be controlled. For example, the configuration of the slot 1205 and / or the shape of the tube can be selected to control the shape of the expanded apposition element 1200. For example, the configuration of the slot 1205 and / or the shape setting can determine the way in which the width / size of the apposition element expands (and / or contracts) in the front-to-back direction and / or the medial-lateral direction. Fig.106A , the wall of the generally cylindrical mating element 1200 may extend outwardly from the cover 1201 a distance 1204. Referring now to Fig.108A , an axial force 1208 and / or a rotational force 1209 may be applied to the cover 1201 of the mating element 1200, thereby causing the mating element 1200 to rotate from Fig.106A The configuration shown extends to Fig.108A In the example shown, the apposition elements 1200 are axially compressed and twisted to expand or bulge in an outward direction 1210 such that the distance 1204 increases.

[0616] refer to Fig.106B and Fig.108B, the mating element 1200 can be compressed in a variety of different ways. For example, the threaded connection 1221 can be used to pull the two ends of the mating element together and twist the mating element in a first direction, or to push the two ends of the mating element apart and twist the mating element in a second direction. For example, a bushing can be set on each end of the mating element. One bushing can be threadedly engaged with a threaded shaft, and the other bushing is fixedly connected to the shaft. Rotating the shaft in one direction pulls the bushings together and causes the bushings to rotate relative to each other in a first direction. Rotating the shaft in the opposite direction moves the bushings apart and causes the bushings to rotate relative to each other in a second direction. The pitch of the threaded connection can be selected to set the ratio between the distance the mating element 1200 is compressed and the angle by which the mating element is twisted.

[0617] Will Fig.106A , 108A Incorporation of the apposition element 1200 shown in FIGS. 106B and 108B into the implantable prosthetic device of the present application allows the apposition element to expand to press outwardly against tissue captured between the apposition element and the paddle and / or grasping member.

[0618] Fig.106C and 108C An example embodiment of a controllably expandable apposition element 1200 for an implantable prosthetic device is shown. The apposition element 1200 can be used alone, with a covering, or within any of the apposition elements described herein (to expand the apposition element). The apposition element 1200 can be used with any implantable prosthetic device described in this application. Fig.106C , the mating element 1200 has a pair of pivotally connected arms 1231. Each of the pair of pivotally connected arms 1231 extends between the two covers 1201 and is pivotally connected to the two covers. In the example shown, there are two pairs of pivotally connected arms 1231. However, there can be one pair, three pairs, four pairs, or any number of pairs of pivotally connected arms.

[0619] In an exemplary embodiment, the expansion direction of the apposition element 1200 can be controlled. For example, two pairs of pivotally connected arms (as shown) can be included to change the width / size of the apposition element in only one of the front-to-back direction and / or the inside-out direction. Four pairs of pivotally connected arms 1231 can be included to change the width / size of the apposition element in the front-to-back direction and the inside-out direction. When four pairs of pivotally connected arms 1231 are included, the arms can have different lengths and / or pivot point locations so that the apposition element 1200 expands (or contracts) differently in different directions. For example, the length of the arm can be selected to expand more in the inside-out direction than in the front-to-back direction.

[0620] Reference now Fig.108C, an axial force 1208 can be applied to the cover 1201 of the mating element 1200, thereby causing the mating element 1200 to move from Fig.106C The configuration shown extends to Fig.108C In the example shown, axial compression of the pivotally connected arm 1231 causes the pivot connection 1233 or knee to expand in an outward direction 1210 such that the distance 1204 increases.

[0621] refer to Fig.106C and Fig.108C , the mate element 1200 can be compressed in a variety of different ways. For example, the threaded connector 1221 can be used to pull the two ends of the mate element together or push the two ends of the mate element apart. For example, a bushing can be provided on each end of the mate element. One bushing can threadably engage a threaded shaft, while the other bushing can be rotatably connected to the shaft. Rotating the shaft in one direction pulls the bushings together. Rotating the shaft in the opposite direction moves the bushings apart.

[0622] Will Fig.106C and 108C Incorporation of the illustrated apposition element 1200 into an implantable prosthetic device of the present application allows the apposition element to expand to press outwardly against tissue captured between the apposition element and the paddle and / or grasping member.

[0623] Fig.106D and 108D An exemplary embodiment of an expandable apposition element 1200 for an implantable prosthetic device is shown. The apposition element 1200 can be used alone, with a covering (see Fig.106E and Fig.108E ), or used within any of the apposition elements described herein (to expand the apposition element). The apposition element 1200 can be used with any implantable prosthetic device described in this application. Fig.106C , the mating element 1200 has a central support member 1243, one or more pivotally connected arms 1241, and connecting wires 1245. Each arm 1241 extends from the pivot connection to the central support member 1243. Each connecting wire 1245 is connected to the central support member 1243 and the pivotally connected arm 1241. The length of the connecting wire 1245 sets the degree to which the connecting arm pivots away from the central support member 1243. In the example shown, there are two pivotally connected arms 1241. However, there can be one, three, four, or any number of pivotally connected arms.

[0624] In an exemplary embodiment, the expansion direction of the apposition element 1200 can be controlled. For example, two pivotally connected arms can be included to change the width / size of the apposition element only in the front-to-back direction and / or the inside-outside direction. Four pivotally connected arms 1241 can be included to change the width / size of the apposition element in the front-to-back direction and the inside-outside direction. When four pivotally connected arms 1241 are included, the arms and / or connecting lines 1245 can have different lengths and / or pivot point locations so that the apposition element 1200 expands (or contracts) differently in different directions. For example, the length of the arms and / or connecting lines can be selected to expand more in the inside-outside direction than in the front-to-back direction.

[0625] The arm 1241 can be moved from a retracted position ( Fig.106D ) to the extended position ( Fig.108D ). For example, the arms 1241 may be biased toward the expanded position by a spring or other biasing device. In the example shown, a restraining member 1247 such as a suture holds the arms 1241 in the retracted position. The restraining member 1247 may be removed or broken to allow the apposition element 1200 to be moved from Fig.106D The configuration shown extends to Fig.108D Configuration shown.

[0626] Fig.106E and Fig.108E Shown with Fig.106D and Fig.108D The illustrated embodiment is similar to the exemplary embodiment except that the mate elements include a covering material 1253. The covering material 1253 can extend from the central support member 1243 to each arm 1241. The covering material 1253 can be used with the connecting wire 1245, or the covering material can eliminate the need for the connecting wire 1245.

[0627] Reference now Fig.106F , showing an example apposition element 1200 for an implantable prosthetic device, which is similar to Figures 106 to 109 The embodiment shown. The apposition element 1200 can be used with any implantable prosthetic device described in this application. Fig.106F , the apposition element 1200 is defined by a coil 1263 extending between two covers 1201. The apposition element 1200 can have any shape, such as any shape disclosed herein. The coil 1263 can be made of a shape memory alloy, such as Nitinol.

[0628] In one example embodiment, the direction of expansion of the apposition element 1200 can be controlled. For example, the shaping of the coil 1263 can be selected to control the shape of the expanded apposition element 1200. For example, the shaping configuration can determine the manner in which the width / size of the apposition element in the anterior-posterior direction and / or the lateral-lateral direction expands (and / or contracts). With reference to the axial force 1208 and / or the rotational force 1209, they can be applied to the cap 1201 of the apposition element 1200 so that the apposition element 1200 is moved from Fig.106F The configuration shown expands or contracts. In the example shown, axially extending the coil 1263 and twisting the coil 1263 contracts the coil in the inward direction 1211, and axially compressing the coil 1263 and twisting the coil in the opposite direction expands or bulges the coil in the outward direction.

[0629] refer to Fig.106F , the coupling element 1200 can be compressed in a variety of different ways. For example, the threaded connection 1221 can be used to pull the two ends of the coupling element together and twist the coupling element in a first direction, or to push the two ends of the coupling element apart and twist the coupling element in a second direction. For example, a bushing can be fixedly connected to each end of the coil 1263. One bushing can be threadedly engaged with a threaded shaft, and the other bushing is fixedly connected to the shaft. Rotating the shaft in one direction pulls the bushings together and causes the bushings to rotate relative to each other in a first direction. Rotating the shaft in the opposite direction moves the bushings apart and causes the bushings to rotate relative to each other in a second direction. The pitch of the threaded connection can be selected to set the ratio between the distance the coupling element 1200 is compressed and the angle by which the coupling element is twisted.

[0630] Will Fig.106F Incorporation of the illustrated apposition element 1200 into an implantable prosthetic device of the present application allows the apposition element to expand to press outwardly against tissue captured between the apposition element and the paddle and / or grasping member.

[0631] Figure 106G to Figure 106I An example embodiment of an expandable integrable element 1200 is shown. Figure 106G to Figure 106I In the example shown, the apposition element is expanded by a fluid medium to expand the apposition element. The fluid medium can take a variety of different forms. Examples of fluids that can be used to expand the apposition element 1200 include, but are not limited to, air, gel, water, blood, foaming materials, etc. The apposition element 1200 can be used with any implantable prosthetic device described in this application.

[0632] refer to Figure 106G, the apposition element 1200 can have an outer layer 1271 (e.g., any of the apposition elements 110, 510 disclosed herein) and an inner layer 1273 or balloon. The apposition element 1200 can have any shape, such as any shape disclosed herein. Figure 106G In the example shown in FIG. 1086 , the inner layer 1273 is disposed within the outer layer 1271 and may have the same or substantially 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 to make balloons and angioplasty devices. The outer layer 1271 may be made of a shape memory alloy, such as Nitinol.

[0633] refer to Fig.106H and Fig.106I In one example embodiment, the expansion direction of the integrable element 1200 can be controlled. Fig.106H In the example shown, the inner layer 1273 includes two balloons that are optionally connected together. However, any number of balloons can be used. For example, the inner layer can include 3, 4 or any number of balloons. The balloons can be expanded individually to control the expanded shape of the apposition element 1200. When the balloons are connected together, the connection also affects the shape of the expansion. In the example shown in 106H, the balloons are connected together along a plane 1275 or area. Due to the connection 1275, the expansion of the inner layer 1273 in the direction 1277 will be less than the expansion in the direction 1279. Thus, in this example, the expansion caused by the expansion can be limited to or substantially limited to the expansion along the inside-out direction.

[0634] The use of multiple balloons and the configuration of any connections between the balloons may determine the manner in which the width / size of the apposition elements expands (and / or contracts) in the anterior-posterior and / or lateral-medial directions.

[0635] exist Fig.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 may be used. For example, the inner layer may include 2, 3, 4, or any number of supports. The supports 1281 may divide the inner layer into multiple independently expandable chambers, or the supports may not seal the independent chambers, and an inflation fluid applied to any chamber will fill all of the chambers. When independently expandable chambers are present, the chambers may be expanded individually to control the expanded shape of the apposition element 1200. The supports also affect the shape of the expansion. In the case of a Fig.106I In the example shown, support member 1281 will reduce or eliminate expansion of inner layer 1273 in direction 1277. Thus, in this example, expansion due to expansion can be limited or substantially limited to expansion along the inner-outer direction.

[0636] The use of multiple independently expandable chambers and / or the configuration of the support members 1281 can determine the manner in which the width / size of the apposition elements expands (and / or contracts) in the anterior-posterior direction and / or the lateral-medial direction.

[0637] Will Figure 106G to Figure 106I Incorporation of the illustrated apposition element 1200 into an implantable prosthetic device of the present application allows the apposition element to expand to press outwardly against tissue captured between the apposition element and the paddle and / or grasping member.

[0638] Reference now Figure 110 to Figure 111 , an exemplary implantable prosthetic device 1300 is shown. Device 1300 is similar to device 100 described above, and includes an apposition element 1310, a paddle 1320, and a hook or grasping member 1330. Referring now to Fig.111 , showing a top view of the mating element 1310. Fig.111 As shown in , the apposition element 1310 has an oval or substantially oval cross-section. The apposition element 1310 does not include a central opening and can be formed by a solid material block such as foam. Forming the apposition element 1310 by a solid block of foam material prevents blood from flowing through the center of the apposition element 1310, thereby substantially eliminating the position where blood can be captured. The device 1300 may include any other feature portion for the implantable prosthetic device discussed in the present application, and the device 1300 may be positioned to engage the valve tissue 20, 22 as a part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). The prosthetic device 1300 can be opened and closed in a variety of different ways. For example, a sleeve can be slidably disposed on the apposition element to engage and open the paddle. Alternatively, the paddle can be opened by pulling a line or suture to open the hook, and the movement of the hook can open the paddle. However, any mechanism for opening and closing the device 1300 can be used.

[0639] Reference now Fig.112 and 128 , an example paddle frame 1400 for an implantable prosthetic device is shown. Paddle frame 1400 can be used with any of the implantable prosthetic devices described in this application. Paddle frame 1400 is formed from a piece of material 1402, such as nitinol or any other suitable material. Paddle frame 1400 extends from a cover 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, paddle frame 1400 includes a cover (see Fig.30), inner blade 522 and / or outer blade 520 are fixed to attachment portion 1440 of blade frame 1400. In some embodiments, blade frame 1400 is thinner at the location of fifth curve 1438 to facilitate bending of both sides of blade frame 1400 toward center plane 1404, for example, during crimping of the device.

[0640] The blade frame 1400 extends from the first attachment portion 1412 in a circular three-dimensional shape 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 circular three-dimensional shape, the blade frame 1400 is bent or flexed in multiple locations when it extends between the first attachment portion 1412 and the second attachment portion 1414. The attachment portions 1412, 1414 include notches 1416, 1418 for attaching to the cover, respectively. The blade frame 1400 flexes at the area 1419. The area 1419 may include a wider portion 1417 to distribute the stress generated by bending the blade frame 1400 over a larger area. Likewise, the notches 1416, 1418 may include a radial notch 1415 at each end of the notch. Radiated notches 1415 act as strain relief for the bend region 1419 and the area where blade frame 1400 connects to the cover.

[0641] The blade frame 1400 is away from the middle or center plane 1404 at the first curve 1430 ( Fig.115 ) is bent to widen the shape of the blade frame 1400. Fig.117 14. As shown, paddle frame 1400 further bends away from frontal plane 1406 at the location of first curve 1430. Paddle frame 1400 bends in an outward direction away from first curve 1430 at second curve 1432 to form the sides of frame 1400. Paddle frame continues to tilt away from frontal plane 1406 at the location of second curve 1432. In some embodiments, second curve 1432 has a larger radius than first curve 1430. When viewed from frontal plane 1406, as paddle frame 1400 continues to bend in the arc of second curve 1432, paddle frame 1400 bends away from frontal plane 1406 at third curve 1434. This curvature at third curve 1434 causes frame 1400, and therefore the native valve leaflets, to gradually deviate from centerline 1406. This deviation from the centerline causes the leaflet tissue to stretch toward the valve annulus, which can result in less stress on the leaflet tissue. As frame 1400 continues to bend away from frontal plane 1406, blade frame 1400 bends toward lateral plane 1404 at fourth curve 1436. The circular three-dimensional shape of blade frame 1400 is closed by fifth curve 1438 connecting the two sides of blade frame 1400. Fig.116 and 118As shown, paddle frame 1400 has an arcuate or substantially arcuate shape as frame 1400 extends from attachment portion 1420 to closure portion 1424. Middle portion 1424 of frame is closer to frontal plane 1406 than closure portion 1426, thereby imparting a rounded wing-like shape to the sides of middle portion 1424 that acts as a curved surface of an apposition element (not shown) during grasping of natural tissue between a paddle (not shown) of an implantable device of the present invention and an apposition element (not shown).

[0642] refer to Fig.191 In an exemplary embodiment, the flat blank 1403 of the blade frame 1400 can be cut from a flat sheet, such as by laser cutting. Fig.192 The cut blank 1403 may then be bent to form a three-dimensionally shaped blade frame 1400 .

[0643] refer to Fig.193 and 194 In one example embodiment, blade frame 1400 may be shaped to provide increased clamping force against or toward mating element 510 when blades 520, 522 are in the closed configuration. This is because blade frame 1400 is shaped relative to the closed position (e.g., Fig.194 ) is shaped to a first position (e.g., Fig.193 ), the first position is beyond the position where the inner blade 522 will engage the mating element, such as beyond the center plane 552 of the device 500, such as beyond the outer blade on the opposite side of the mating element. Fig.194 , blade frame 1400 is bent and connected to inner blade 522 and outer blade 520, for example, by sewing. This results in the blade frame having a preload (i.e., a clamping force against or toward the mating elements greater than zero) when blade frame 1400 is in the closed configuration. Fig.194 ) compared to Fig.193 The configured shaped blade frame 1400 may increase the clamping force of the blade frame 1400 .

[0644] The amount of preload on blade frame 1400 may be varied by adjusting the degree to which blade frame 1400 is shaped relative to mate element 510. The further blade frame 1400 is shaped beyond the closed position, the greater the preload.

[0645] The curves of blade frame 1400 may be independent of one another, ie, one curve is completed before another curve is started, or may be combined, ie, blade frame 1400 curves in multiple directions simultaneously.

[0646] Reference now Fig.112A , 114A, 115A, 116A, 117A, and 118A, show examples of paddle frames 1400A for implantable prosthetic devices. Paddle frames 1400A can be used with any implantable prosthetic device described in the present application. Each paddle frame 1400A is formed from a piece of material 1402A, such as nitinol or any other suitable material. Each paddle frame 1400A extends from a cap attachment portion 1410A to a paddle connection portion 1420A and has a proximal portion 1422A, a middle portion 1424A, and a distal portion 1426A.

[0647] Each blade frame 1400A extends from the first attachment portion 1412A in a circular three-dimensional shape 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 circular three-dimensional shape, each blade frame 1400A is bent or bent in multiple locations when the blade frame 1400A extends between the first attachment portion 1412A and the second attachment portion 1414A. The attachment portions 1...

Claims

1. A valve repair device for repairing a patient's natural valve, the valve repair device comprising: a strip of material, wherein the strip of material is folded to form a plurality of layers; a mating element formed from the strip of material; a collar having a protrusion configured to be engaged by a delivery device; wherein the collar is attached to a proximal end of the apposition element; a pair of paddles formed from the strip of material and connected to the mating element, wherein the paddles are movable between an open position and a closed position, wherein the paddles include an inner paddle portion and an outer paddle portion, and wherein the inner paddle portion is formed from two layers of folded strip of material; a pair of movable hook portions, the pair of movable hook portions being disposed between the mating element and the pair of blades; a first cover portion disposed on and extending from a distal end of the device and covering at least a portion of the paddle; as well as a second cover portion disposed on the collar at a proximal end of the device and extending from the proximal end of the device and covering at least a portion of the apposition element; wherein the second cover portion includes an opening exposing the protrusion of the collar; Wherein the paddle is configured to attach to the native valve of the patient.

2. The valve repair device of claim 1, wherein the strip of material comprises metal strands woven together.

3. A valve repair device as described in any of the preceding claims, wherein the strip of material comprises an electrospun material.

4. The valve repair device of any one of claims 1-2, wherein the strip of material comprises electrospun metal fibers.

5. The valve repair device as described in any one of claims 1-2, wherein the paddle comprises an inner paddle portion and an outer paddle portion.

6. The valve repair device of any one of claims 1-2, wherein the strip of material is folded to form the apposition element and the pair of paddles.

7. The valve repair device of claim 1, wherein the apposition element is formed from four layers of the material strip.

8. The valve repair device according to any one of claims 1 to 2, wherein the paddle is disposed above the extension member.

9. The valve repair device of claim 8, wherein the extension member comprises a hoop and the strip of material is folded around the hoop.

10. The valve repair device of claim 9, wherein the paddle comprises an inner paddle portion and an outer paddle portion, and the fold of the strip of material around the cuff is disposed between the inner paddle portion and the outer paddle portion.

11. The valve repair device of any one of claims 1-2, wherein the strip of material extends from a starting portion in the paddle to an ending portion in the paddle.

12. The valve repair device of claim 11, wherein the beginning portion and the ending portion of the strip of material are located within the paddle.

13. The valve repair device according to any one of claims 1 to 2, further comprising a base component, wherein the base component comprises: axis; wherein the shaft extends through the bushing; as well as a cover attached to the shaft such that the cover is movable through the shaft away from the bushing; wherein the pair of paddles are attached to the cover; and Wherein movement of the cover toward the collar moves the pair of paddles to the closed position, and movement of the cover away from the collar moves the pair of paddles to the open position.

14. The valve repair device of any one of claims 1-2, wherein the apposition element is configured to close a gap in the native valve when the valve repair device is attached to the native valve of the patient.

15. A valve repair device for repairing a natural valve of a patient, the valve repair device comprising: An involute element having four layers; a collar having a protrusion configured to be engaged by a delivery device; wherein the collar is attached to a proximal end of the apposition element; a pair of paddles connected to the coaptation element, wherein the paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient; a pair of movable hook portions, the pair of movable hook portions being disposed between the mating element and the pair of blades; a first cover portion disposed on and extending from a distal end of the device and covering at least a portion of the paddle; as well as a second cover portion disposed on the collar at a proximal end of the device and extending from the proximal end of the device and covering at least a portion of the apposition element; The second cover portion includes an opening exposing the protrusion of the collar.

16. The valve repair device of claim 15, wherein the four layers of the apposition element are formed from a single piece of material.

17. The valve repair device of any one of claims 15-16, wherein each layer of the apposition element comprises metal strands woven together.

18. The valve repair device of any one of claims 15-16, wherein each layer of the apposition element comprises an electrospun material.

19. The valve repair device of any one of claims 15-16, wherein each layer of the apposition element comprises electrospun metal fibers.

20. The valve repair device of any one of claims 15-16, wherein the paddle comprises an inner paddle portion and an outer paddle portion.

21. The valve repair device of claim 20, wherein each of the inner paddle portions is connected to two layers of the apposition element.

22. The valve repair device of any one of claims 15-16, wherein the paddle is disposed above the extension member.

23. The valve repair device of claim 22, wherein the extension member comprises a hoop.

24. The valve repair device of claim 22, wherein the paddle comprises an inner paddle portion and an outer paddle portion.

25. The valve repair device of claim 24, wherein the inner paddle portion is disposed between the extension member and the coaptation element.

26. The valve repair device of any one of claims 15-16, wherein the apposition element has a rectangular cross-section.

27. The valve repair device of any one of claims 15-16, wherein the apposition element has two inner layers and two outer layers.

28. The valve repair device of any one of claims 15-16, wherein each layer has a middle portion extending between two edge portions, and wherein the middle portion is thinner than the two edge portions.

29. The valve repair device according to any one of claims 15 to 16, further comprising a base component, wherein the base component comprises: axis; wherein the shaft extends through the bushing; as well as a cover attached to the shaft such that the cover is movable through the shaft away from the bushing; wherein the pair of paddles are attached to the cover; and Wherein movement of the cover toward the collar moves the pair of paddles to the closed position, and movement of the cover away from the collar moves the pair of paddles to the open position.

30. The valve repair device of claim 29, wherein the shaft extends between the layers of the apposition element.

31. The valve repair device of claim 30, wherein two layers of the apposition elements are disposed on each side of the shaft.

32. The valve repair device of claim 30, wherein the apposition element has two inner layers and two outer layers, and the shaft extends between the two inner layers.

33. The valve repair device of claim 30, wherein each layer has a middle portion extending between two edge portions, and wherein the middle portion is thinner than the two edge portions.

34. The valve repair device of claim 30, wherein the shaft expands the middle portion of each layer outward.

35. The valve repair device of claim 30, wherein the shaft causes the intermediate portion of the layers on one side of the shaft to unfold from the layers on the other side of the shaft.

36. The valve repair device of any one of claims 15-16, wherein the apposition element is configured to close a gap in the native valve when the valve repair device is attached to the native valve of the patient.

37. A valve repair device for repairing a natural valve of a patient, the valve repair device comprising: Strips of material; a mating element formed from the strip of material; a collar connected to the mating element; wherein the collar has a protrusion configured to be engaged by a delivery device; wherein the collar is attached to a proximal end of the apposition element; a pair of paddles formed from the strip of material and connected to the mating element, wherein the paddles are movable between an open position and a closed position; a pair of movable hook portions, the pair of movable hook portions being disposed between the mating element and the pair of blades; a first cover portion disposed on and extending from a distal end of the device and covering at least a portion of the paddle; as well as a second cover portion disposed on the collar at a proximal end of the device and extending from the proximal end of the device and covering at least a portion of the apposition element; wherein the second cover portion includes an opening exposing the protrusion of the collar; wherein the strip of material is woven through at least one opening of the collar; and Wherein the paddle is configured to attach to the native valve of the patient.

38. The valve repair device of claim 37, wherein the collar is spaced apart from the paddle.

39. The valve repair device of any one of claims 37-38, wherein the paddle is connected to the distal end of the coaptation element.

40. The valve repair device of any one of claims 37-38, wherein the strip of material is woven through two openings of the collar.

41. The valve repair device of any one of claims 37-38, wherein the strip of material is woven through at least one arcuate opening of the collar.

42. The valve repair device of claim 41, wherein the at least one arcuate opening comprises an open slot.

43. The valve repair device of any one of claims 37-38, wherein the strip of material comprises metal strands woven together.

44. The valve repair device of any one of claims 37-38, wherein the strip of material comprises an electrospun material.

45. The valve repair device of any one of claims 37-38, wherein the strip of material comprises electrospun metal fibers.

46. ​​The valve repair device of any one of claims 37-38, wherein the paddle comprises an inner paddle portion and an outer paddle portion.

47. The valve repair device of any one of claims 37-38, wherein the paddle is disposed above the extension member.

48. The valve repair device according to any one of claims 37-38, further comprising a base component, wherein the base component comprises: a shaft extending through the bushing; as well as a cover attached to the shaft such that the cover is movable through the shaft away from the bushing; wherein both paddles of the pair of paddles are attached to the cover; and Wherein movement of the cover toward the collar moves the pair of paddles to the closed position, and movement of the cover away from the collar moves the pair of paddles to the open position.

49. The valve repair device of claim 48, wherein the shaft extends through a central opening of the collar.

50. The valve repair device of any one of claims 37-38, wherein the pair of movable hook portions include a hook associated with each of the pair of paddles, each hook having at least one barb, a barb support portion, and a movable arm.

51. The valve repair device of claim 50, wherein the hook comprises a flexible portion disposed between the barb support portion and the movable arm.

52. The valve repair device of claim 51 wherein the paddle and the flexible portion are configured such that pulling on the barbs first causes the paddles to at least partially open and then causes the barb support portions to flex away from the movable arm.

53. The valve repair device of claim 48, wherein the apposition element is configured to close a gap in the native valve when the valve repair device is attached to the native valve of the patient.

54. A valve repair device for repairing a natural valve of a patient, the valve repair device comprising: a strip of material having a first edge and a second edge surrounding a central portion, wherein the central portion is thinner than the first edge and the second edge; a mating element formed from the strip of material; a collar having a protrusion configured to be engaged by a delivery device; wherein the collar is attached to a proximal end of the apposition element; a pair of paddles formed from the strip of material and connected to the mating element, wherein the paddles are movable between an open position and a closed position; a pair of movable hook portions, the pair of movable hook portions being disposed between the mating element and the pair of blades; a first cover portion disposed on and extending from a distal end of the device and covering at least a portion of the paddle; as well as a second cover portion disposed on the collar at a proximal end of the device and extending from the proximal end of the device and covering at least a portion of the apposition element; wherein the second cover portion includes an opening exposing the protrusion of the collar; and Wherein the paddle is configured to attach to the native valve of the patient.

55. The valve repair device of claim 54, wherein the strip of material has a valve-like cross-sectional shape.

56. The valve repair device of claim 54, wherein the strip of material comprises: at least one first edge strand; at least one second edge strand; as well as A plurality of central strands extend between the first edge strands and the second edge strands to form the central portion.

57. A valve repair device for repairing a natural valve of a patient, the valve repair device comprising: a strip of material having a first edge and a second edge surrounding a central portion, a mating element formed from the strip of material; a collar having a protrusion configured to be engaged by a delivery device; wherein the collar is attached to a proximal end of the apposition element; a pair of paddles formed from the strip of material and connected to the mating element, wherein the paddles are movable between an open position and a closed position; a pair of movable hook portions, the pair of movable hook portions being disposed between the mating element and the pair of blades; a first cover portion disposed on and extending from a distal end of the device and covering at least a portion of the paddle; as well as a second cover portion disposed on the collar at a proximal end of the device and extending from the proximal end of the device and covering at least a portion of the apposition element; wherein the second cover portion includes an opening exposing the protrusion of the collar; wherein the paddle is configured to attach to the native valve of the patient; The material strip comprises: at least one first edge strand; at least one second edge strand; and a plurality of central strands extending between the first edge strands and the second edge strands to form the central portion; and Wherein the plurality of central strands are braided around the first edge strands and the second edge strands.

58. The valve repair device of claim 56, wherein the plurality of central strands are woven around the first edge strands and the second edge strands.

59. The valve repair device of claim 56, wherein the first edge strand and the second edge strand have a diameter that is larger than a diameter of the central strand.

60. The valve repair device of claim 56, wherein the first edge strand and the second edge strand have a diameter of approximately 0.017 mm.

61. The valve repair device of claim 56, wherein the central strand has a diameter of approximately 0.009 mm.

62. The valve repair device of claim 56, wherein the central portion is formed by between 25 and 100 central strands.

63. The valve repair device of claim 56, wherein the central portion is formed by between 40 and 85 central strands.

64. The valve repair device of claim 56, wherein the central portion is formed by between 48 and 60 central strands.

65. The valve repair device of claim 56, wherein the central portion is formed from approximately 48 central strands.

66. The valve repair device of claim 56, wherein the central strand, and one or more of the at least one first edge strand and the at least one second edge strand, are formed of the same material.

67. The valve repair device of claim 56, wherein the central strand, and one or more of the at least one first edge strand and the at least one second edge strand, are formed of different materials.

68. The valve repair device of claim 56, wherein the central strand and at least one of the at least one first edge strand or the at least one second edge strand are formed of nitinol wire.

69. The valve repair device of claim 56, wherein the central strand is formed of polyethylene.

70. The valve repair device of claim 54, wherein the first edge and the second edge are more rigid than the central portion.

71. The valve repair device of claim 54, wherein the strip of material comprises an electrospun material.

72. The valve repair device of claim 54, wherein the strip of material comprises electrospun metal fibers.

73. The valve repair device of claim 54, further comprising a base assembly, the base assembly comprising: axis; wherein the shaft extends through the bushing; as well as a cover attached to the shaft such that the cover is movable through the shaft away from the bushing; wherein the pair of paddles are attached to the cover; and Wherein movement of the cover toward the collar moves the pair of paddles to the closed position, and movement of the cover away from the collar moves the pair of paddles to the open position.

74. The valve repair device of claim 54, wherein the apposition element is configured to close a gap in the native valve when the valve repair device is attached to the native valve of the patient.

75. A valve repair device for repairing a natural valve of a patient, the valve repair device comprising: Strips of material; a mating element formed from the strip of material; a collar having a protrusion configured to be engaged by a delivery device; wherein the collar is attached to a proximal end of the apposition element; a pair of paddles formed from the strip of material and connected to the apposition element, wherein the paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient; a pair of movable hook portions, the pair of movable hook portions being disposed between the mating element and the pair of blades; a first cover portion disposed on and extending from a distal end of the device and covering at least a portion of the paddle; a second cover portion disposed on the collar at a proximal end of the device and extending from the proximal end of the device and covering at least a portion of the apposition element; wherein the second cover portion includes an opening exposing the protrusion of the collar; a cover attached to the paddles, wherein movement of the cover toward the mating element moves the pair of paddles to the closed position and movement of the cover away from the mating element moves the pair of paddles to the open position; a pair of extension members connected to the cover and movable between an extension member open position and an extension member closed position wherein the extension members are biased in a closing direction; wherein the extension member is movable in the closing direction beyond the extension member closed position to a preloaded position; as well as At least a portion of each extension member overlaps another extension member in the preloaded position.

76. The valve repair device of claim 75, wherein the extension members do not overlap when in the extension member closed position.

77. The valve repair device of any one of claims 75-76, wherein the extension member is formed in a preloaded position and the extension member moves in the closing direction beyond the extension member closed position to the preloaded position.

78. The valve repair device of claim 75, wherein the ends of the extension members do not overlap.

79. The valve repair device of any one of claims 75-76, wherein the extension member comprises a hoop.

80. The valve repair device of claim 75 wherein the extension member comprises a hoop and wherein the hoop interlocks in the preloaded position.

81. The valve repair device of any one of claims 75-76, wherein the paddle comprises an inner paddle portion and an outer paddle portion.

82. The valve repair device of any one of claims 75-76, wherein the paddle is disposed above the extension member.

83. The valve repair device of any one of claims 75-76, wherein the strip of material comprises metal strands woven together.

84. The valve repair device of any one of claims 75-76, wherein the strip of material comprises electrospun metal fibers.

85. The valve repair device of any one of claims 75-76, further comprising a base component, wherein the base component comprises: a shaft extending through the bushing and attached to the cover so that the cover can be moved away from the bushing by the shaft; Wherein movement of the cover toward the collar moves the pair of paddles to the closed position, and movement of the cover away from the collar moves the pair of paddles to the open position.

86. The valve repair device of any one of claims 75-76, wherein the apposition element is configured to close a gap in the native valve when the valve repair device is attached to the native valve of the patient.

87. A valve repair device for repairing a natural valve of a patient, the valve repair device comprising: Strips of material; a mating element formed from the strip of material; a collar having a protrusion configured to be engaged by a delivery device; wherein the collar is attached to a proximal end of the apposition element; a pair of paddles formed from the strip of material and connected to the apposition element, wherein the paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient; a pair of movable hook portions, the pair of movable hook portions being disposed between the mating element and the pair of blades; a first cover portion disposed on and extending from a distal end of the device and covering at least a portion of the paddle; a second cover portion disposed on the collar at a proximal end of the device and extending from the proximal end of the device and covering at least a portion of the apposition element; wherein the second cover portion includes an opening exposing the protrusion of the collar; a cover attached to the paddles, wherein movement of the cover toward the mating element moves the pair of paddles to the closed position and movement of the cover away from the mating element moves the pair of paddles to the open position; as well as a pair of extension members connected to the cover and the paddle, the extension members extending from attachment portions for attaching the extension members to the cover to end portions attached to the strip of material forming the paddle; Wherein the end portion of the extension member extends beyond the strip of material.

88. The valve repair device of claim 87, wherein the paddle comprises an inner paddle portion and an outer paddle portion.

89. The valve repair device of any one of claims 87 and 88, wherein the paddle is disposed over a portion of the extension member.

90. The valve repair device of any one of claims 87-88, wherein the paddle is disposed above the end portion of the extension member.

91. The valve repair device of any one of claims 87-88, wherein the paddle is disposed within the extension member.

92. The valve repair device of any one of claims 87-88, wherein the paddle is disposed within the end portion of the extension member.

93. The valve repair device of claim 87 wherein the extension member comprises a hoop and the strip of material is folded around a portion of the hoop.

94. A valve repair device as described in claim 93, wherein the paddle includes an inner paddle portion and an outer paddle portion, and the fold of the material strip around the hoop is arranged between the inner paddle portion and the outer paddle portion.

95. The valve repair device of any one of claims 87-88, wherein the end portion includes a groove for receiving the strip of material.

96. The valve repair device of claim 95, wherein the slot includes an opening formed between the slot and an exterior of the extension member.

97. The valve repair device of claim 95, wherein the slot extends between the first end and the second end.

98. The valve repair device of claim 97, wherein the slot comprises an opening disposed between the first end and the second end.

99. The valve repair device of claim 98, wherein the opening is formed between the slot and an exterior of the extension member.

100. The valve repair device according to any one of claims 87-88, further comprising a base component, wherein the base component comprises: axis; wherein the shaft extends through the bushing; a cover attached to the shaft such that the cover is movable through the shaft away from the bushing; wherein the pair of paddles are attached to the cover; Wherein movement of the cover toward the collar moves the pair of paddles to the closed position, and movement of the cover away from the collar moves the pair of paddles to the open position.

101. The valve repair device of any one of claims 87-88, wherein the strip of material comprises metal strands woven together.

102. The valve repair device of any one of claims 87-88, wherein the strip of material comprises an electrospun material.

103. The valve repair device of any one of claims 87-88, wherein the apposition element is configured to close a gap in the native valve when the valve repair device is attached to the native valve of the patient.

104. A valve repair device for repairing a natural valve of a patient, the valve repair device comprising: Integral components; a collar having a protrusion configured to be engaged by a delivery device; wherein the collar is attached to a proximal end of the apposition element; a pair of paddles connected to the engaging element, wherein the paddles are movable between an open position and a closed position; wherein the paddle is configured to attach to the native valve of the patient; a pair of movable hook portions, the pair of movable hook portions being disposed between the mating element and the pair of blades; a first cover portion disposed on and extending from a distal end of the device and covering at least a portion of the paddle; a second cover portion disposed on the collar at a proximal end of the device and extending from the proximal end of the device and covering at least a portion of the apposition element; wherein the second cover portion includes an opening exposing the protrusion of the collar; a first blade frame having two spaced-apart frame portions; as well as A second paddle frame portion, the second paddle frame portion having two spaced apart frame portions, wherein the two spaced apart frame portions of the second paddle frame portion are substantially parallel to the two spaced apart frame portions of the first paddle frame when the paddle is in a closed position to form a rectangular leaflet engagement area.

105. The valve repair device of claim 104, wherein the rectangular leaflet coaptation region is configured to press two native heart valve leaflets on opposite sides of the coaptation element together.

106. A valve repair device as described in any one of claims 104 and 105, wherein the rectangular leaflet coaptation area is configured to press the two natural heart valve leaflets together when the two natural heart valve leaflets are misaligned along the height of the valve repair device.

107. A valve repair device as described in any one of claims 104-105, wherein the rectangular leaflet coaptation area is configured to press the two natural heart valve leaflets together when the two natural heart valve leaflets are misaligned along the height of the valve repair device on both sides of the accompaniment element.

108. The valve repair device of any one of claims 104-105, wherein a strip of material is folded to form the apposition element and the pair of paddles.

109. The valve repair device of any one of claims 104-105, wherein the paddle comprises an inner paddle portion and an outer paddle portion, and the inner paddle portion is formed by two layers of folded material strips.

110. The valve repair device of any one of claims 104-105, wherein the apposition element is configured to close a gap in the native valve when the valve repair device is attached to the native valve of the patient.

111. A valve repair device for repairing a natural valve of a patient, the valve repair device comprising: Strips of material; a mating element formed from the strip of material; a collar having a protrusion configured to be engaged by a delivery device; wherein the collar is attached to a proximal end of the apposition element; as well as a pair of paddles formed from the strip of material and connected to the mating element, wherein the paddles are movable between an open position and a closed position; a pair of movable hook portions, the pair of movable hook portions being disposed between the mating element and the pair of blades; a first cover portion disposed on and extending from a distal end of the device and covering at least a portion of the paddle; a second cover portion disposed on the collar at a proximal end of the device and extending from the proximal end of the device and covering at least a portion of the apposition element; wherein the second cover portion includes an opening exposing the protrusion of the collar; wherein the paddle is configured to attach to the native valve of the patient; A first blade frame and a second blade frame, each having a first frame portion and a second frame portion, the first frame portion being substantially parallel to the second frame portion to form a rectangular leaflet coaptation region.

112. A valve repair device as described in claim 111, wherein the strip of material is folded to form the accommodating element and the pair of paddles.

113. A valve repair device as described in claim 111, wherein the paddle includes an inner paddle portion and an outer paddle portion, and the inner paddle portion is formed by two layers of folded material strips.

114. The valve repair device of any one of claims 111-113, wherein the apposition element is configured to close a gap in the native valve when the valve repair device is attached to the native valve of the patient.

115. A valve repair device as described in any one of claims 111-113, wherein the rectangular leaflet coaptation area is configured to press the two natural heart valve leaflets together when the two natural heart valve leaflets are misaligned along the height of the valve repair device.

116. A valve repair device as described in any one of claims 111-113, wherein the rectangular leaflet coaptation area is configured to press the two mitral valve leaflets together when the two mitral valve leaflets are misaligned along the height of the valve repair device.

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