Heart valve sealing devices and delivery devices therefor

Abstract

An implantable prosthetic device has a coaption ele- ment and at least one anchor. The coaption element is configured to be positioned within the native heart valve orifice to help fill a space where the native valve is regurgitant and form a more effective seal. The coaption element can have a structure that is impervious to blood. The coaption element can be connected to leaflets of the native valve by the anchor.

Description

DEMANDE OU BREVET VOLUMINEUX LA PRÉSENTE PARTIE DE CETTE DEMANDE OU CE BREVET COMPREND PLUS D'UN TOME. CECI EST LE TOME 1 DE 2 CONTENANT LES PAGES 1 À 143 NOTE: Pour les tomes additionels, veuillez contacter le Bureau canadien des brevets JUMBO APPLICATIONS / PATENTS THIS SECTION OF THE APPLICATION / PATENT CONTAINS MORE THAN ONE VOLUME THIS IS VOLUME 1 OF 2 CONTAINING PAGES 1 TO 143 NOTE: For additional volumes, please contact the Canadian Patent Office NOM DU FICHIER / FILE NAME : NOTE POUR LE TOME / VOLUME NOTE: HEART VALVE SEALING DEVICES AND DELIVERY DEVICES THEREFOR CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Patent Application No. 62 / 744031, filed October 10, 2018. BACKGROUND OF THE INVENTION

[0002] The native heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be damaged, and thus rendered less effective, by congenital malformations, inflammatory processes, infectious conditions, disease, etc. Such damage to the valves can result in serious cardiovascular compromise or death. Damaged valves can be surgically repaired or replaced during open heart surgery. However, open heart surgeries are highly invasive and complications may occur. Transvascular techniques can be used to introduce and implant prosthetic devices in a manner that is much less invasive than open heart surgery. As one example, a transseptal technique could be used, e.g., comprising inserting a catheter into the right femoral vein, up the inferior vena cava and into the right atrium, puncturing the septum, and passing the catheter into the left atrium.

[0003] A healthy heart has a generally conical shape that tapers to a lower apex. The heart is four- chambered and comprises the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair of cusps, or leaflets, extending downward from the annulus into the left ventricle. The mitral valve annulus can form a "D"-shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. The anterior leaflet can be larger than the posterior leaflet, forming a generally "C"-shaped boundary between the abutting sides of the leaflets when they are closed together.

[0004] When operating properly, the anterior leaflet and the posterior leaflet function 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 dilates (also referred to as "ventricular diastole" or "diastole"), the oxygenated blood that is 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 referred to as "ventricular systole" or "systole"), the increased blood pressure in the left ventricle urges the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle.

[0005] Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium from the left ventricle during the systolic phase of heart contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral valve annulus resulting from dilation of the left ventricle, more than one of these, etc. Mitral regurgitation at a central portion of the leaflets can be referred to as central jet mitral regurgitation and mitral regurgitation nearer to one commissure (i.e., location where the leaflets meet) of the leaflets can 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 thus the valve does not close, and regurgitation is present.

[0006] A technique for treating mitral and other valvular regurgitation in patients may include securing edges of the native valve leaflets directly to one another. For example, a catheter delivered clip may be used to attempt to clip the sides of the leaflets together at the end portions of the leaflets. But significant challenges exist. For example, multiple clips may be required to eliminate or reduce regurgitation to an acceptable level, but in some circumstances, this can result in longer operation times and may result in over-restricted flow or undesirable stresses on the native anatomy.

[0007] Despite these prior techniques, there is a continuing need for improved devices and methods for treating valvular regurgitation. SUMMARY

[0008] This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary 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 summarized here.

[0009] An example implantable prosthetic device has a coaption element (while the term coaption element is used throughout this application, this can also be referred to as a coaptation element, a spacer, etc.) and at least one anchor. The coaption element is configured to be positioned within the native heart valve orifice to help fill a space where the native valve is regurgitant and form a more effective seal. The coaption element can have a structure that is impervious to blood. The coaption element can be connected to leaflets of the native valve by the anchor.

[0010] In one example embodiment, a valve repair device for repairing a native valve of a patient includes a strip of material, and a pair of paddles. A coaption element is formed from or comprises the strip of material. The pair of paddles is formed from or comprises the strip of material and are connected to the coaption element. The pair of paddles are movable between an open position and a closed position.

[0011] The "strip of material" in the various embodiments described throughout this disclosure can be a single unitary strip or piece of a material. However, in some embodiments, the "strip of material" can be formed of multiple smaller discreet pieces of one or more materials that combine into a larger composite strip of material.

[0012] In one example method of manufacturing a valve repair device, a strip of material is folded to form a coaption element and a pair of paddles connected to the coaption element. 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 portion of the strip of material forming the coaption element is attached to a collar. A portion of the strip of material forming the paddles is attached to a cap. Movement of the cap toward the collar causes the pair of paddles to move to the closed position. Movement of the cap away from the collar causes the pair of paddles to move to the open position.

[0013] In one example embodiment, a valve repair device for repairing a native valve of a patient has a coaption element and a pair of paddles. The coaption element has four layers. The pair of paddles is connected to the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient.

[0014] In one example embodiment, a valve repair device for repairing a native valve of a patient includes a strip of material and a collar. A coaption element is formed from the strip of material. A collar is connected to the coaption element. A pair of paddles is formed from the strip of material and connected to the coaption element. The paddles are movable between an open position and a closed position by moving the collar toward and away from the paddles.

[0015] In one example embodiment, a valve repair device for repairing a native valve of a patient includes a collar, a coaption element, and a pair of paddles. The collar has a plurality of engagement portions configured to releasably engage a delivery apparatus. The coaption element is attached to the collar. The pair of paddles are connected to the coaption element 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 native valve of the patient.

[0016] In one example embodiment, a valve repair device for repairing a native valve of a patient includes a coaption element, a pair of paddles, and a covering. The pair of paddles is connected to the coaption element. The paddles are movable between an open position and a closed position. A catch point (e.g., a point that might snag or catch on a portion of the delivery system and interfere with deployment and / or recapture of the device) is formed by or between a portion of at least one of the coaption element and the pair of paddles when the paddles are in the open position. A cover connected to the coaption element and the paddles covers the catch point.

[0017] In one example embodiment, a valve repair device for repairing a native valve of a patient includes a coaption element, a pair of paddles, a first cover, and a second cover. The pair of paddles is connected to the coaption element and are movable between an open position and a closed position. A first cover extends from a distal end of the device and covers at least a portion of the paddles. A second cover extends from a proximal end of the device and covers at least a portion of the coaption element.

[0018] In one example embodiment, a valve repair device for repairing a native valve of a patient is made from a strip of material. The strip of material has first and second edges surrounding a central portion. A coaption element is formed from the strip of material. A pair of paddles is formed from the strip of material. The pair of paddles are connected to the coaption element. The paddles are movable between an open position and a closed position.

[0019] In one example embodiment, a valve repair device for repairing a native valve of a patient includes a strip of material, a pair of attachment portions, a pair of extension members, and a cap. A coaption element is formed from the strip of material. The pair of extension members have attachment portions. A pair of paddles are formed from the strip of material. The pair of paddles are connected to the coaption element. The paddles are movable between an open position and a closed position. The paddles are disposed over the extension members. The cap is attached to the paddles. Movement of the cap toward the coaption element causes the pair of paddles to move to the closed position. Movement of the cap away from the coaption element causes the pair of paddles to move to the open position. The cap includes a retention body, a retaining nut, and a retaining bolt. The retention body has a locking aperture for receiving the attachment portions of the extension members. The retaining nut is inserted into the locking aperture. The retaining bolt secures the retaining nut within the locking aperture.

[0020] In one example method of manufacturing a valve repair device for repairing a native valve of a patient a strip of material is folded to form a coaption element and a pair of paddles connected to the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient. The portion of the strip of material forming the paddles is attached to a cap. Movement of the cap toward the coaption element causes the pair of paddles to move to the closed position. Movement of the cap away from the coaption element causes the pair of paddles to move to the open position. The cap includes a retention body, a retaining nut, and a retaining bolt. The retention body has a locking aperture for receiving attachment portions of extension members. The retaining nut is configured to insert into the locking aperture. The retaining bolt secures the retaining nut within the locking aperture. A pair of extension members are attached to the retention body of the cap via the attachment portions of the extension members such that the paddles are disposed over the extension members. The retaining bolt and the retaining nut are assembled to secure the cap to the strip of material.

[0021] In one example embodiment, a valve repair device for repairing a native valve of a patient includes a strip of material, a cap, and a pair of extension members. A coaption element is formed from the strip of material. A pair of paddles are formed from the strip of material and are connected to the coaption element. 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 cap is attached to the paddles. Movement of the cap toward the coaption element causes the pair of paddles to move to the closed position. Movement of the cap away from the coaption element causes the pair of paddles to move to the open position. The pair of extension members are connected to the cap and are moveable between an open position and a closed position. In the closed position the extension members are biased in a closing direction.

[0022] In one example method of manufacturing a valve repair device for repairing a native valve of a patient a strip of material formed from shape-memory alloy is folded around a jig to form both a coaption element and a pair of paddles connected to the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient. The strip of shape memory material is heat treated to shape-set the strip of material in the shape of the coaption element and paddles.

[0023] In one example embodiment, a valve repair device for repairing a native valve of a patient includes a strip of material, a cap, and a pair of extension members. A coaption element is formed from the strip of material. A pair of paddles is formed from the strip of material and is connected to the coaption element. The paddles are movable between an open position and a closed position and are configured to attach to the native valve of the patient. The cap is attached to the paddles. Movement of the cap toward the coaption element causes the pair of paddles to move to the closed position. Movement of the cap away from the coaption element causes the pair of paddles to move to the open position. The pair of extension members is connected to the cap and the paddles. The extension members extend from attachment portions for attaching the extension members to the cap to end portions that are attached to the strip material forming the paddles. The end portions of the extension members extend beyond the strip of material.

[0024] In one example embodiment, a valve repair device for repairing a native valve of a patient includes a main coaption element, at least one auxiliary coaption element, and a pair of paddles. The at least one auxiliary coaption element is connected to the coaption element. The pair of paddles is connected to the main coaption element. The paddles are movable between an open position and a closed position.

[0025] In one example embodiment, a valve repair device for repairing a native valve of a patient includes a coaption element, a pair of paddles connected to the coaption element, and a pair of paddle frames. The paddles are movable between an open position and a closed position. The paddles are configured to attach to the native valve of the patient. The first and second paddle frames have spaced apart frame portions that are parallel or substantially parallel when the paddles are in a closed position to form rectangular shaped leaflet engagement areas.

[0026] In one example method of repairing a native heart valve, first and second repair devices are installed on a pair of leaflets of the native heart valve. The repair devices each have a frame with a rectangular or substantially rectangular shape. The paddle frames of the installed repair devices are adjacent to one another and are parallel or substantially parallel to one another.

[0027] The foregoing method and other treatment methods herein can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g. with the body parts, tissue, etc. being simulated), etc.

[0028] In one example embodiment, a valve repair device for repairing a native valve of a patient includes a pair of paddles and a pair of clasps. The paddles are movable between an open position and a closed position. Each clasp has at least one barb, a barb support portion, a moveable arm, and a flexible portion between the barb support portion and the moveable arm. The flexible portion is configured to allow the barb support portion to flex away from the moveable arm.

[0029] A further understanding of the nature and advantages of the present invention are set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] To further clarify various aspects of embodiments of the present disclosure, a more particular description of the certain embodiments will be made by reference to various aspects of the appended drawings. It is appreciated that these drawings depict only typical embodiments of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures can be drawn to scale for some embodiments, the figures are not necessarily drawn to scale for all embodiments. Embodiments and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0031] Figure 1 illustrates a cutaway view of the human heart in a diastolic phase;

[0032] Figure 2 illustrates a cutaway view of the human heart in a systolic phase;

[0033] Figure 2A is another cutaway view of the human heart in a systolic phase;

[0034] Figure 2B is the cutaway view of Figure 2A annotated to illustrate a natural shape of mitral valve leaflets in the systolic phase;

[0035] Figure 3 illustrates a cutaway view of the human heart in a diastolic phase, in which the chordae tendineae are shown attaching the leaflets of the mitral and tricuspid valves to ventricle walls;

[0036] Figure 4 illustrates a healthy mitral valve with the leaflets closed as viewed from an atrial side of the mitral valve;

[0037] Figure 5 illustrates a dysfunctional mitral valve with a visible gap between the leaflets as viewed from an atrial side of the mitral valve;

[0038] Figure 6 illustrates a mitral valve having a wide gap between the posterior leaflet and the anterior leaflet;

[0039] Figure 6A illustrates a coaption element in the gap of the mitral valve as viewed from an atrial side of the mitral valve;

[0040] Figure 6B illustrates a valve repair device attached to mitral valve leaflets with the coaption element in the gap of the mitral valve as viewed from a ventricular side of the mitral valve;

[0041] Figure 6C is a perspective view of a valve repair device attached to mitral valve leaflets with the coaption element in the gap of the mitral valve shown from a ventricular side of the mitral valve;

[0042] Figure 6D is a schematic view illustrating a path of mitral valve leaflets along each side of a coaption element of an example mitral valve repair device;

[0043] Figure 6E is a top schematic view illustrating a path of mitral valve leaflets around a coaption element of an example native valve repair device;

[0044] Figure 7 illustrates a tricuspid valve viewed from an atrial side of the tricuspid valve;

[0045] Figures 8–14 show an example embodiment of an implantable prosthetic device, in various stages of deployment;

[0046] Figure 11A shows an example embodiment of an implantable prosthetic device that is similar to the device illustrated by Figure 11, but where the paddles are independently controllable;

[0047] Figures 15–20 show the implantable prosthetic device of Figures 8–14 being delivered and implanted within the native valve;

[0048] Figure 21 shows an example embodiment of an implantable prosthetic device or frame of an implantable prosthetic device;

[0049] Figure 22 shows an example embodiment of an implantable prosthetic device or frame of an implantable prosthetic device;

[0050] Figures 23–25 show example embodiments of an implantable prosthetic device or component of an implantable medical device;

[0051] Figures 26 and 27 show an example embodiment of a barbed clasp for use in an implantable prosthetic device;

[0052] Figures 28–32 show example embodiments of an implantable prosthetic device;

[0053] Figures 32A and 32B are perspective views of a cap and a coaption element insert of the implantable prosthetic device of Figures 28-32 in sealed and spaced apart positions, respectively;

[0054] Figure 33 shows a barbed clasp for use in an implantable prosthetic device;

[0055] Figure 34 shows a portion of native valve tissue grasped by a barbed clasp;

[0056] Figures 35-46 show an example embodiment of an implantable prosthetic device being delivered and implanted within the native valve;

[0057] Figure 47 shows a side view of an example implantable prosthetic device without barbed clasps in a closed position;

[0058] Figure 47A shows a side view of an example implantable prosthetic device without barbed clasps in a closed position;

[0059] Figure 48 shows a side view of an example implantable prosthetic device with barbed clasps in a closed position;

[0060] Figure 48A shows a side view of an example implantable prosthetic device with barbed clasps in a closed position;

[0061] Figure 48B shows a side view of an example implantable prosthetic device with barbed clasps in a closed position, the device being attached to a deployment device;

[0062] Figure 48C shows a side view of the example implantable prosthetic device according to Figure 48B, the device being provided with a cover;

[0063] Figure 48D shows a front view of the example implantable prosthetic device according to Figure 48B, the device being attached to a deployment device;

[0064] Figure 48E shows a front view of the example implantable prosthetic device according to Figure 48D, the device being provided with a cover;

[0065] Figure 48F shows a side view of the example implantable prosthetic device according to Figure 48B with barbed clasps in the closed position;

[0066] Figure 48G shows a front view of the example implantable prosthetic device according to Figure 48F;

[0067] Figure 48H shows a bottom view of the example implantable prosthetic device according to Figure 48F;

[0068] Figure 49 shows a side view of an example implantable prosthetic device without barbed clasps in a partially-open position;

[0069] Figure 50 shows a side view of an example implantable prosthetic device in a partially-open position with barbed clasps in a closed position;

[0070] Figure 51 shows a side view of an example implantable prosthetic device in a partially -open position with barbed clasps in an open position;

[0071] Figure 52 shows a side view of an example implantable prosthetic device without barbed clasps in a half-open position;

[0072] Figure 53 shows a side view of an example implantable prosthetic device in a half-open position with barbed clasps in a closed position;

[0073] Figure 53 A shows a side view of an example implantable prosthetic device in a half-open position with barbed clasps in a closed position;

[0074] Figure 53B shows a front view of the example implantable prosthetic device according to Figure 53A;

[0075] Figure 53C shows a side view of the example implantable prosthetic device according to Figure 53A, the device being provided with a cover;

[0076] Figure 53D shows a front view of the example implantable prosthetic device according to Figure 53A, the device being provided with a cover;

[0077] Figure 54 shows a side view of an example implantable prosthetic device in a half-open position with barbed clasps in an open position;

[0078] Figure 54A shows a side view of an example implantable prosthetic device in a half-open position with barbed clasps in an open position;

[0079] Figure 54B shows a front view of the example implantable prosthetic device according to Figure 54A;

[0080] Figure 54C shows a side view of the example implantable prosthetic device according to Figure 54A, the device being provided with a cover;

[0081] Figure 54D shows a front view of the example implantable prosthetic device according to Figure 54A, the device being provided with a cover;

[0082] Figure 55 shows a side view of an example implantable prosthetic device without barbed clasps in a three-quarters-open position;

[0083] Figure 56 shows a side view of an example implantable prosthetic device in a three-quarters- open position with barbed clasps in a closed position;

[0084] Figure 57 shows a side view of an example implantable prosthetic device in a three-quarters- open position with barbed clasps in an open position;

[0085] Figure 58 shows a side view of an example implantable prosthetic device without barbed clasps near a full bailout position or near a fully-open position;

[0086] Figure 59 shows a side view of an example implantable prosthetic device without barbed clasps in a full bailout position or a fully-open position;

[0087] Figure 60 shows a side view of an example implantable device in a full bailout position with barbed clasps in a closed position;

[0088] Figure 60A shows a side view of an example implantable device in a full bailout position with barbed clasps in a closed position;

[0089] Figure 60B shows a front view of the example implantable prosthetic device according to Figure 60A;

[0090] Figure 60C shows a side view the example implantable prosthetic device according to Figure 60A, the device being provided with a cover;

[0091] Figure 60D shows a front view of the example implantable prosthetic device according to Figure 60A, the device being provided with a cover;

[0092] Figure 61 shows a side view of an example implantable device in a full bailout position with barbed clasps in an open position;

[0093] Figure 61 A shows a side view of an example implantable device in a full bailout position with barbed clasps in an open position;

[0094] Figure 61B shows a front view of the example implantable prosthetic device according to Figure 61A;

[0095] Figure 61C shows a side view the example implantable prosthetic device according to Figure 61 A, the device being provided with a cover;

[0096] Figure 61D shows a front view of the example implantable prosthetic device according to Figure 61A, the device being provided with a cover;

[0097] Figures 62A-62B illustrate the movement of the paddles of an example embodiment of an implantable prosthetic device;

[0098] Figures 63A-63C illustrate the movement of the paddles of an example embodiment of an implantable prosthetic device;

[0099] Figures 64A-64C illustrate the movement of the paddles of an example embodiment of an implantable prosthetic device;

[00100] Figure 65 shows a perspective view of an example implantable prosthetic device in a closed position;

[00101] Figure 65A shows a perspective view of an example implantable prosthetic device in a closed position;

[00102] Figure 66 shows a perspective view of the implantable prosthetic device of Figure 65;

[00103] Figure 66A shows a perspective view of the implantable prosthetic device of Figure 65A;

[00104] Figure 67 shows a front view of the implantable prosthetic device of Figure 65;

[00105] Figure 67A shows a front view of the implantable prosthetic device of Figure 65A;

[00106] Figure 68 shows a front view of the implantable prosthetic device of Figure 65 with additional components;

[00107] Figure 68A shows a front view of the implantable prosthetic device of Figure 65A with additional components;

[00108] Figure 69 shows a side view of the implantable prosthetic device of Figure 65;

[00109] Figure 70 shows a top view of the implantable prosthetic device of Figure 65;

[00110] Figure 70A shows a top view of the implantable prosthetic device of Figure 65A;

[00111] Figure 71 shows a top view of the implantable prosthetic device of Figure 65 with a collar component;

[00112] Figure 71A shows a top view of the implantable prosthetic device of Figure 65A with a collar component;

[00113] Figure 72 shows a bottom view of the implantable prosthetic device of Figure 65;

[00114] Figure 72A shows a bottom view of the implantable prosthetic device of Figure 65A;

[00115] Figure 73 shows a bottom view of the implantable prosthetic device of Figure 65 with a cap component;

[00116] Figure 73A shows a bottom view of the implantable prosthetic device of Figure 65A with a cap component;

[00117] Figure 74 shows a sectioned perspective view of the implantable prosthetic device of Figure 65 sectioned by cross-section plane 75;

[00118] Figure 74A shows a sectioned perspective view of the implantable prosthetic device of Figure 65A sectioned by cross-section plane 75A;

[00119] Figure 75 shows a top cross-section view of the example prosthetic device illustrated by Figure 74;

[00120] Figure 75A shows a top cross-section view of the example prosthetic device illustrated by Figure 74A;

[00121] Figure 76 shows a sectioned perspective view of the implantable prosthetic device of Figure 65 sectioned by cross-section plane 77;

[00122] Figure 76A shows a sectioned perspective view of the implantable prosthetic device of Figure 65A sectioned by cross-section plane 77A;

[00123] Figure 77 shows a top cross-section view of the example prosthetic device illustrated by Figure 76;

[00124] Figure 77A shows a top cross-section view of the example prosthetic device illustrated by Figure 76A;

[00125] Figure 78 shows a sectioned perspective view of the implantable prosthetic device of Figure 65 sectioned by cross-section plane 77;

[00126] Figure 78A shows a sectioned perspective view of the implantable prosthetic device of Figure 65A sectioned by cross-section plane 77A;

[00127] Figure 79 shows a top cross-section view of the example prosthetic device illustrated by Figure 78;

[00128] Figure 79A shows a top cross-section view of the example prosthetic device illustrated by Figure 78A;

[00129] Figure 80 shows a sectioned perspective view of the implantable prosthetic device of Figure 65 sectioned by cross-section plane 81;

[00130] Figure 80A shows a sectioned perspective view of the implantable prosthetic device of Figure 65A sectioned by cross-section plane 81A;

[00131] Figure 81 shows a top cross-section view of the example prosthetic device illustrated by Figure 80;

[00132] Figure 81A shows a top cross-section view of the example prosthetic device illustrated by Figure 80A;

[00133] Figure 82 shows a sectioned perspective view of the implantable prosthetic device of Figure 65 sectioned by cross-section plane 83;

[00134] Figure 82A shows a sectioned perspective view of the implantable prosthetic device of Figure 65A sectioned by cross-section plane 83A;

[00135] Figure 83 shows a top cross-section view of the example prosthetic device illustrated by Figure 82;

[00136] Figure 83A shows a top cross-section view of the example prosthetic device illustrated by Figure 82A;

[00137] Figure 84 shows an example embodiment of an implantable prosthetic device with integral barbs;

[00138] Figure 85 shows an example embodiment of an implantable prosthetic device with integral barbs;

[00139] Figure 86 shows an example embodiment of an implantable prosthetic device with integral barbs;

[00140] Figure 86A shows an example embodiment of an implantable prosthetic device with integral barbs;

[00141] Figure 87 shows an example embodiment of an implantable prosthetic device with integral barbs;

[00142] Figure 87A shows an example embodiment of an implantable prosthetic device with integral barbs;

[00143] Figure 88 shows an example embodiment of an implantable prosthetic device with integral barbs;

[00144] Figure 88A shows an example embodiment of an implantable prosthetic device with integral barbs;

[00145] Figure 89 shows a perspective view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65;

[00146] Figure 89A shows a perspective view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65A;

[00147] Figure 90 shows a perspective view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65;

[00148] Figure 90A shows a perspective view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65A;

[00149] Figure 91 shows a front view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65;

[00150] Figure 91A shows a front view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65A;

[00151] Figure 92 shows a side view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65;

[00152] Figure 92A shows a side view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65A;

[00153] Figure 93 shows a top view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65;

[00154] Figure 93A shows a top view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65A;

[00155] Figure 94 shows a bottom view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65;

[00156] Figure 94A shows a bottom view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65A;

[00157] Figure 95 shows a sectioned perspective view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65 with the section taken across plane 96;

[00158] Figure 95A shows a sectioned perspective view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65A with the section taken across plane 96A;

[00159] Figure 96 shows a cross-section view of the coapting portion and paddle portions of Figure 95;

[00160] Figure 96A shows a cross-section view of the coapting portion and paddle portions of Figure 95A;

[00161] Figure 97 shows a sectioned perspective view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65 with the section taken across plane 98;

[00162] Figure 97A shows a sectioned perspective view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65A with the section taken across plane 98A;

[00163] Figure 98 shows a cross-section view of the coapting portion and paddle portions of Figure 97;

[00164] Figure 98A shows a cross-section view of the coapting portion and paddle portions of Figure 97A;

[00165] Figure 99 shows a sectioned perspective view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65 with the section taken across plane 100;

[00166] Figure 99A shows a sectioned perspective view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65A with the section taken across plane 100A;

[00167] Figure 100 shows a cross-section view of the coapting portion and paddle portions of Figure 99;

[00168] Figure 100A shows a cross-section view of the coapting portion and paddle portions of Figure 99A;

[00169] Figure 101 shows a sectioned perspective view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65 with the section taken across plane 102;

[00170] Figure 101A shows a sectioned perspective view of a coapting portion and paddle portions of the implantable prosthetic device illustrated by Figure 65A with the section taken across plane 102A;

[00171] Figure 102 shows a cross-section view of the coapting portion and paddle portions of Figure 101;

[00172] Figure 102 A shows a cross-section view of the coapting portion and paddle portions of Figure 101A;

[00173] Figure 103 shows an example embodiment of an implantable prosthetic device;

[00174] Figure 104 shows an example embodiment of an implantable prosthetic device;

[00175] Figure 105 shows an example embodiment of an implantable prosthetic device;

[00176] Figure 106 shows a side view of an example embodiment of an expandable coaption element in an unexpanded condition;

[00177] Figure 106A shows a side view of an example embodiment of an expandable coaption element in an unexpanded condition;

[00178] Figure 106B shows a side view of an example embodiment of an expandable coaption element in an unexpanded condition;

[00179] Figure 106C shows a side view of an example embodiment of an expandable coaption element in an unexpanded condition;

[00180] Figure 106D shows a side view of an example embodiment of an expandable coaption element in an unexpanded condition;

[00181] Figure 106E shows a side view of an example embodiment of an expandable coaption element in an unexpanded condition;

[00182] Figure 106F shows an example embodiment of an expandable coaption element;

[00183] Figure 106G shows an example embodiment of an expandable coaption element;

[00184] Figure 106H shows an example embodiment of an expandable coaption element;

[00185] Figure 106I shows an example embodiment of an expandable coaption element;

[00186] Figure 107 shows an end view of the expandable coaption element of Figure 106;

[00187] Figure 108 shows the expandable coaption element of Figure 106 in an expanded condition;

[00188] Figure 108A shows the expandable coaption element of Figure 106A in an expanded condition;

[00189] Figure 108B shows the expandable coaption element of Figure 106B in an expanded condition;

[00190] Figure 108C shows the expandable coaption element of Figure 106C in an expanded condition;

[00191] Figure 108D shows the expandable coaption element of Figure 106D in an expanded condition;

[00192] Figure 108E shows the expandable coaption element of Figure 106E in an expanded condition;

[00193] Figure 109 shows an end view of the coaption element of Figure 108;

[00194] Figure 110 shows a side view of an example embodiment of an implantable prosthetic device;

[00195] Figure 111 shows an end view of a coaption element of the example prosthetic device of Figure 110, taken along lines 111.

[00196] Figures 112–114 show perspective views of an example embodiment of a paddle frame for the implantable prosthetic device of Figure 65;

[00197] Figure 112A shows a perspective view of an example embodiment of a paddle frame for the implantable prosthetic device of Figure 65A;

[00198] Figure 114A shows a side view of the paddle frame of Figure 112A;

[00199] Figure 115 shows a front view of the paddle frame of Figures 112–114;

[00200] Figure 115A shows a top view of the paddle frame of Figure 112A;

[00201] Figure 116 shows a top view of the paddle frame of Figures 112–114;

[00202] Figure 116A shows a front view of the paddle frame of Figure 112A;

[00203] Figure 117 shows a side view of the paddle frame of Figures 112–114;

[00204] Figure 117A shows a rear view of the paddle frame of Figure 112A;

[00205] Figure 118 shows a bottom view of the paddle frame of Figures 112–114;

[00206] Figure 118A shows a bottom view of the paddle frame of Figure 112A;

[00207] Figure 119 shows a front view of the paddle frame of Figures 112–114;

[00208] Figure 120 shows a front view of the paddle frame of Figures 112–114 in a compressed condition inside a delivery device;

[00209] Figure 121 shows a side view of an example embodiment of an implantable prosthetic device in a closed condition;

[00210] Figure 122 shows a front view of a paddle frame of the example prosthetic device of Figure 121;

[00211] Figure 123 shows a side view of the implantable prosthetic device of Figure 121 in an open condition;

[00212] Figure 124 shows a front view of the paddle frame of the open prosthetic device of Figure 123;

[00213] Figure 125 shows a side view of an example embodiment of an implantable prosthetic device in a closed condition;

[00214] Figure 126 shows a front view of a paddle frame of the example prosthetic device of Figure 125;

[00215] Figure 127 shows a side view of the implantable prosthetic device of Figure 125 in a closed condition;

[00216] Figure 128 shows a front view of the paddle frame of the open prosthetic device of Figure 127;

[00217] Figure 129 shows an example embodiment of an implantable prosthetic device;

[00218] Figures 130–131 show an example embodiment of an implantable prosthetic device;

[00219] Figure 132 shows an example embodiment of an implantable prosthetic device;

[00220] Figures 133–134 show an example embodiment of an implantable prosthetic device;

[00221] Figures 135–136 show an example embodiment of an implantable prosthetic device;

[00222] Figure 137 shows an example embodiment of an implantable prosthetic device;

[00223] Figures 138–143 show use of an example embodiment of an implantable prosthetic device;

[00224] Figure 144 shows an example embodiment of a delivery assembly including a delivery device and an example prosthetic device;

[00225] Figure 145 shows a perspective view of an example embodiment of an implantable prosthetic device releasably coupled to a delivery device;

[00226] Figure 146 shows the embodiment of Figure 145 with the implantable prosthetic device released from the delivery device;

[00227] Figure 147 shows a cross-sectional view of the coupler of Figure 145;

[00228] Figure 148 shows a perspective view of the delivery assembly of Figure 144 with the prosthetic device shown in partial cross-section and some components of the delivery apparatus shown schematically;

[00229] Figure 149 shows a plan view of a shaft of the delivery device of Figure 144;

[00230] Figure 150 shows a side elevation view of a proximal end portion of the delivery device of Figure 144;

[00231] Figure 151 shows a cross-sectional view of the proximal end portion of the delivery device of Figure 144, taken along the line 151–151 shown in Figure 150;

[00232] Figure 152 shows an exploded view of the proximal end portion of the delivery device of Figure 144;

[00233] Figures 153–160 show an example procedure used to repair a native valve of a heart, which is partially shown;

[00234] Figure 161 shows an example embodiment of a handle for the delivery apparatus of Figure 144;

[00235] Figure 162 is an exploded view of the handle of Figure 161;

[00236] Figure 163 shows an example embodiment of a coupler and a proximal collar for the delivery assembly of Figure 144, showing the coupler releasably coupled to the proximal collar;

[00237] Figure 164 shows a perspective view of the coupler and proximal collar of Figure 163, showing the coupler released from the proximal collar;

[00238] Figure 165 shows example embodiments of a cap, actuation element or means of actuating, and release wire for the delivery assembly of Figure 144, showing the cap releasably coupled to the actuation element or means of actuating by the release wire.

[00239] Figure 166 shows a perspective view of the cap, actuation element or means of actuating, and the release wire of Figure 163, showing the cap released from the actuation element or means of actuating and the release wire;

[00240] Figure 167 shows example embodiments of a coupler, a proximal collar, a cap, and an actuation element or means of actuating of the delivery assembly of Figure 144;

[00241] Figure 168 shows a perspective view of the coupler and proximal collar of Figure 167;

[00242] Figure 169 shows an example embodiment of a clasp control member of the delivery apparatus of Figure 144;

[00243] Figure 170 shows a detail view of the clasp control member of Figure 169, taken from the perspective 170 shown in Figure 169;

[00244] Figure 171 shows an example embodiment of a guide rail for the clasp control member of Figure 169;

[00245] Figure 172 shows an example embodiment of a shaft of the delivery device of Figure 144;

[00246] Figure 173 shows an example embodiment of an implantable prosthetic device and delivery device for releasing and recapturing the prosthetic device;

[00247] Figure 174 shows an example embodiment of an implantable prosthetic device and delivery device for releasing and recapturing the prosthetic device;

[00248] Figure 174A shows an example embodiment of an implantable prosthetic device and delivery device for releasing and recapturing the prosthetic device;

[00249] Figure 175 shows an example embodiment of an implantable prosthetic device and delivery device for releasing and recapturing the prosthetic device;

[00250] Figure 175A shows an example embodiment of an implantable prosthetic device and delivery device for releasing and recapturing the prosthetic device;

[00251] Figure 176 shows an example embodiment of an implantable prosthetic device and delivery device for releasing and recapturing the prosthetic device;

[00252] Figures 177–178 show an example embodiment of a coupler for an example implantable prosthetic device;

[00253] Figures 179–181 show an example embodiment of a coupler for an example implantable prosthetic device;

[00254] Figures 182–183 show an example embodiment of a coupler for an example implantable prosthetic device;

[00255] Figures 184–185 show an example embodiment of a coupler for an example implantable prosthetic device;

[00256] Figure 186 shows an example embodiment of an actuation element or means of actuating for an example prosthetic device;

[00257] Figure 187 shows an actuation mechanism for an example prosthetic device;

[00258] Figure 188 shows an actuation mechanism for an example prosthetic device;

[00259] Figure 188A shows an actuation mechanism for an example prosthetic device;

[00260] Figure 189 shows an actuation mechanism for an example prosthetic device;

[00261] Figure 190 shows an actuation mechanism for an example prosthetic device;

[00262] Figure 191 is a perspective view of a blank used to make a paddle frame;

[00263] Figure 192 is a perspective view of the blank of Figure 191 bent to make a paddle frame;

[00264] Figure 193 is a perspective view of a shape-set paddle frame attached to a cap of a valve repair device;

[00265] Figure 194 is a perspective view of the paddle frame of Figure 193 flexed and attached to inner and outer paddles at a closed position;

[00266] Figure 195 is a perspective view of two of the paddle frames of Figure 112A showing the paddle frames in a shape-set position;

[00267] Figure 196 is a perspective view of the paddle frames of Figure 195 showing the paddle frames in a loaded position;

[00268] Figure 197 is an enlarged side view of device of Figure 60C showing the cover;

[00269] Figure 198 is an enlarged side view of the device of Figure 60C showing the cover;

[00270] Figure 199 shows an exploded view of an example prosthetic device;

[00271] Figure 200 shows an enlarged perspective view of the collar of an example prosthetic device;

[00272] Figure 201 shows an enlarged perspective view of the cap of an example prosthetic device;

[00273] Figure 202 shows an exploded view of the cap of Figure 206;

[00274] Figure 203 shows a plan view of an inner cover for an example prosthetic device;

[00275] Figure 204 shows a plan view of an outer cover for an example prosthetic device;

[00276] Figure 205 shows an enlarged view of a strip of material for an example prosthetic device;

[00277] Figure 206 shows an end view of the material of Figure 205;

[00278] Figure 207 shows an end view of the material of Figure 205 arranged in a plurality of layers;

[00279] Figure 208A shows an example implantable prosthetic device in the gap of the native valve as viewed from an atrial side of the native valve during diastole, with example inflatable spacers in a deflated condition;

[00280] Figure 208B shows the device of Figure 208A during systole, with example inflatable spacers in a deflated condition;

[00281] Figure 209A shows the device of Figure 208A during diastole, with example inflatable spacers in an inflated condition;

[00282] Figure 209B shows the device of Figure 208A during systole, with example inflatable spacers in an inflated condition;

[00283] Figure 210A shows an example expandable spacer in a compressed condition;

[00284] Figure 210B shows the expandable spacer of Figure 210A in an expanded condition;

[00285] Figure 211A shows an example implantable prosthetic device, with example inflatable spacers in a deflated condition;

[00286] Figure 211B shows the device of Figure 211B, with example inflatable spacers in an inflated condition;

[00287] Figure 212A is a side view of an example implantable prosthetic device;

[00288] Figure 212B is a front / back view of the device of Figure 212A;

[00289] Figure 213A is a top view of an example auxiliary spacer for attaching to the device of Figure 212A;

[00290] Figure 213B is a side view of the spacer of Figure 213A;

[00291] Figure 214 is a side view of the spacer of Figures 213A, 213B being assembled to the device of Figures 212A, 212B;

[00292] Figure 215A is a side view of the spacer of Figures 213A, 213B assembled to the device of Figures 212A, 212B;

[00293] Figure 215B is a top view of the assembly of Figure 215A;

[00294] Figure 216A is a side view of an example implantable prosthetic device;

[00295] Figure 216B is a front / back view of the device of Figure 216A;

[00296] Figure 217A is a top view of an example auxiliary spacer for attaching to the device of Figure 216A;

[00297] Figure 217B is a side view of the spacer of Figure 217A;

[00298] Figure 218 is an example auxiliary spacer;

[00299] Figure 219A is a top view of an example implantable prosthetic device;

[00300] Figure 219B is a side view of an example implantable prosthetic device;

[00301] Figure 220A is a top view of example auxiliary spacers;

[00302] Figure 220B is a top view of example auxiliary spacers;

[00303] Figure 220C is a top view of example auxiliary spacers;

[00304] Figure 220D is a top view of example auxiliary spacers;

[00305] Figure 220E is a top view of example auxiliary spacers;

[00306] Figure 221 is a plan view of an example implantable prosthetic device cut from a flat sheet of material;

[00307] Figure 222 is a perspective view of the device of Figure 221;

[00308] Figure 223 shows the device of Figures 221–222 in the gap of the native valve as viewed from an atrial side of the native valve;

[00309] Figure 224 is a plan view of an example implantable prosthetic device cut from a flat sheet of material;

[00310] Figure 225 is a perspective view of the device of Figure 224;

[00311] Figure 226 shows an example embodiment of an implantable prosthetic device with a two- piece cover;

[00312] Figure 227 shows an example embodiment of an implantable prosthetic device with a two- piece cover;

[00313] Figure 228 shows an example embodiment of an implantable prosthetic device with a two- piece cover;

[00314] Figure 229 shows an example embodiment of an implantable prosthetic device with a two- piece cover;

[00315] Figure 230 shows an example embodiment of an implantable prosthetic device with a two- piece cover;

[00316] Figure 231 shows an example embodiment of an implantable prosthetic device with a two- piece cover;

[00317] Figure 232A is a front view of an implantable prosthetic device including barbed clasps and substantially parallel paddle frame elements according to an example embodiment;

[00318] Figure 232B is a cross section view taken along the plane indicated by lines 232B-232B in Figure 232A;

[00319] Figure 233A is a view similar to Figure 232A with an annotation of the space between substantially parallel sections of the paddle frame elements;

[00320] Figure 233B is a cross section view taken along the plane indicated by lines 233B-233B in Figure 233A;

[00321] Figure 234A is a view similar to Figure 232A illustrating engagement of a portion of native valve leaflets between the substantially parallel paddle frame elements;

[00322] Figure 234B is a cross section view taken along the plane indicated by lines 234B-234B in Figure 234A;

[00323] Figure 235A is a view similar to the view of Figure 234A illustrating misaligned native valve leaflets;

[00324] Figure 235B is a cross section view taken along the plane indicated by lines 235B-235B in Figure 235A;

[00325] Figure 236 is a side view of an implantable prosthetic device according to an example embodiment;

[00326] Figure 237 is a side view of two adjacent implantable prosthetic devices according to an example embodiment;

[00327] Figure 238A is a side view of an implantable prosthetic device installed on a native valve according to an example embodiment;

[00328] Figure 238B is a cross section view taken along the plane indicated by lines 238B-238B in Figure 238A;

[00329] Figure 239A is a side view of two adjacent implantable prosthetic devices installed on a mitral valve according to an example embodiment;

[00330] Figure 239B is a cross section view taken along the plane indicated by lines 239B-239B in Figure 239A;

[00331] Figure 240A is a view similar to the view of Figure 239A illustrating two adjacent but misaligned implantable prosthetic devices;

[00332] Figure 240B is a cross section view taken along the plane indicated by lines 240B-240B in Figure 240A;

[00333] Figure 241 is a perspective view of a portion of a clasp with a flexible barb support according to an example embodiment;

[00334] Figure 242 is the portion of a clasp of Figure 241 where the barb support is bent back to illustrate the flexible nature of the barb support in an example embodiment;

[00335] Figures 243A-243H are schematic illustrations of the clasp with a flexible barb support of Figure 242 releasing from a valve leaflet;

[00336] Figures 244A-244E are schematic illustrations of an implantable prosthetic device with a clasp and flexible barb support releasing from a valve leaflet;

[00337] Figures 245A-245E are illustrations of an implantable prosthetic device with a clasp and flexible barb support releasing from a valve leaflet; and

[00338] Figure 246 is an illustration of an implantable device exerting force on a single leaflet to illustrate a circumstance in which a clasp may be released from a native valve leaflet.

[00339] detailed description

[00340] The following description refers to the accompanying drawings, which illustrate specific embodiments of the present disclosure. Other embodiments having different structures and operation do not depart from the scope of the present disclosure.

[00341] Example embodiments of the present disclosure are directed to devices and methods for repairing a defective heart valve. It should be noted that various embodiments of native valve reparation devices and systems for delivery are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible.

[00342] As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection may be direct as between the components or may be indirect such as through the use of one or more intermediary components. Also as described herein, reference to a "member," "component," or "portion" shall not be limited to a single structural member, component, or element but can include an assembly of components, members, or elements. Also as described herein, the terms "substantially" and "about" are defined as at least close to (and includes) a given value or state (preferably within 10% of, more preferably within 1% of, and most preferably within 0.1% of).

[00343] Figures 1 and 2 are cutaway views of the human heart H in diastolic and systolic phases, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV; i.e., the atrioventricular valves. Additionally, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in Figures 4 and 5) extending inward across the respective orifices that come together or "coapt" in the flow stream to form the one-way, fluid- occluding surfaces. The native valve repair systems of the present application are described primarily with respect to the mitral valve MV. Therefore, anatomical structures of the left atrium LA and left ventricle LV will be explained in greater detail. It should be understood that the devices described herein may also be used in repairing other native valves, e.g., the devices can be used in repairing the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[00344] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, seen in Figure 1, the blood that was previously collected in the left atrium LA (during the systolic phase) moves through the mitral valve MV and into the left ventricle LV by expansion of the left ventricle LV. In the systolic phase, or systole, seen in Figure 2, the left ventricle LV contracts to force the blood through the aortic valve AV and ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close to prevent the blood from regurgitating from the left ventricle LV and back into the left atrium LA, and blood is collected in the left atrium from the pulmonary vein. In one example embodiment, the devices described by the present application are used to repair the function of a defective mitral valve MV. That is, the devices are configured to help close the leaflets of the mitral valve to prevent blood from regurgitating from the left ventricle LV and back into the left atrium LA. Unlike the prior art that describes using sutures or clips often require multiple sutures or clips and additional supports to treat large regurgitation, the devices described in the present application are designed to easily grasp and secure the native leaflets around a coaption element that acts as a filler in the regurgitant orifice.

[00345] Referring now to Figures 1–7, the mitral valve MV includes two leaflets, the anterior leaflet 20 and the posterior leaflet 22. The mitral valve MV also includes an annulus 24, which is a variably dense fibrous ring of tissues that encircles the leaflets 20, 22. Referring to Figure 3, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae 10. The chordae tendineae 10 are cord-like tendons that connect the papillary muscles 12 (i.e., the muscles located at the base of the chordae tendineae and within the walls of the left ventricle) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles 12 serve to limit the movements of the mitral valve MV and prevent the mitral valve from being reverted. 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 do not open or close the mitral valve MV. Rather, the papillary muscles brace the mitral valve MV against the high pressure needed to circulate blood throughout the body. Together the papillary muscles and the chordae tendineae are known as the subvalvular apparatus, which functions to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes.

[00346] Various disease processes can impair proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's Disease, fibroelastic deficiency), inflammatory processes (e.g., Rheumatic Heart Disease), and infectious processes (e.g., endocarditis). In addition, damage to the left ventricle LV or the right ventricle RV from prior heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy) can distort a native valve's geometry, which can cause the native valve to dysfunction. However, the vast majority of patients undergoing valve surgery, such as surgery to the mitral valve MV, suffer from a degenerative disease that causes a malfunction in a leaflet (e.g., leaflets 20, 22) of a native valve (e.g., the mitral valve MV), which results in prolapse and regurgitation.

[00347] Generally, a native valve may malfunction in two different ways: (1) valve stenosis; and (2) valve regurgitation. Valve stenosis occurs when a native valve does not open completely and thereby causes an obstruction of blood flow. Typically, valve stenosis results from buildup of calcified material on the leaflets of a valve, which causes the leaflets to thicken and impairs the ability of the valve to fully open to permit forward blood flow.

[00348] The second type of valve malfunction, valve regurgitation, occurs when the leaflets of the valve do not close completely thereby causing blood to leak back into the prior chamber (e.g., causing blood to leak from the left ventricle to the left atrium). There are three main mechanisms by which a native valve becomes regurgitant—or incompetent—which include Carpentier's type I, type II, and type III malfunctions. A Carpentier type I malfunction involves the dilation of the annulus such that normally functioning leaflets are distracted from each other and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in a type I mechanism malfunction are perforations of the leaflets, as are present in endocarditis. A Carpentier's type II malfunction involves prolapse of one or more leaflets of a native valve above a plane of coaption. A Carpentier's type III malfunction involves restriction of the motion of one or more leaflets of a native valve such that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or dilation of a ventricle (IIIb).

[00349] Referring to Figure 4, when a healthy mitral valve MV is in a 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. Referring to Figure 5, regurgitation occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV is 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, which allows blood to flow back into the left atrium LA from the left ventricle LV during systole. As set forth above, there are several different ways that a leaflet (e.g. leaflets 20, 22 of mitral valve MV) may malfunction, which can thereby lead to regurgitation.

[00350] Referring to Figure 6, in certain situations, the mitral valve MV of a patient can have a wide gap 26 between the anterior leaflet 20 and the posterior leaflet 22 when the mitral valve is in a closed position (i.e., during the systolic phase). For example, the gap 26 can 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 situations, the gap 26 can have a width W greater than 15 mm. In any of the above-mentioned situations, a valve repair device is desired that is capable of engaging the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent regurgitation of blood through the mitral valve MV.

[00351] Although stenosis or regurgitation can affect any valve, stenosis is predominantly found to affect either the aortic valve AV or the pulmonary valve PV, and regurgitation is predominantly found to affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the workload of the heart H and may lead to very serious conditions if left un- treated; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) is primarily responsible for circulating the flow of blood throughout the body, malfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life threatening. Accordingly, because of the substantially higher pressures on the left side of the heart, dysfunction of the mitral valve MV or the aortic valve AV is often more problematic.

[00352] Malfunctioning native heart valves may either be repaired or replaced. Repair typically involves the preservation and correction of the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Because stenotic damage sustained by the leaflets is irreversible, the most conventional treatments for a stenotic aortic valve or stenotic pulmonary valve are removal and replacement of the valve with a surgically implanted heart valve, or displacement of the valve with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more prone to deformation of leaflets, which, as described above, prevents the mitral valve or tricuspid valve from closing properly and allows for regurgitation or back flow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow for regurgitation or back flow from the left ventricle LV to the left atrium LA). The regurgitation or back flow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or the tricuspid valve TV are often repairable. In addition, regurgitation can occur due to the chordae tendineae 10 becoming dysfunctional (e.g., the chordae tendineae may stretch or rupture), which allows the anterior leaflet 20 and the posterior leaflet 22 to be reverted such that blood is regurgitated into the left atrium LA. The problems occurring due to dysfunctional chordae tendineae 10 can be repaired by repairing the chordae tendineae or the structure of the mitral valve (e.g., by securing the leaflets 20, 22 at the affected portion of the mitral valve).

[00353] The devices and procedures disclosed herein often make reference to repairing a mitral valve for illustration. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve, as well as any component of a native valve. For example, referring now to Figure 7, any of the devices and concepts provided herein can be used to repair the tricuspid valve TV. For example, any of the devices and concepts provided herein can be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent regurgitation of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein can be used on all three of the leaflets 30, 32, 34 together to prevent regurgitation of blood from the right ventricle to the right atrium. That is, the valve repair devices provided herein can be centrally located between the three leaflets 30, 32, 34.

[00354] An example implantable prosthetic device has a coaption element and at least one anchor. The coaption element is configured to be positioned within the native heart valve orifice to help fill the space and form a more effective seal, thereby reducing or preventing regurgitation described above. The coaption element can have a structure that is impervious or resistant to blood and that allows the native leaflets to close around the coaption element during ventricular systole to block blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The prosthetic device can be configured to seal against two or three native valve leaflets; that is, the device may be used in the native mitral (bicuspid) and tricuspid valves. The coaption element is sometimes referred to herein as a spacer because the coaption element can fill a space between improperly functioning native mitral or tricuspid leaflets that do not close completely.

[00355] The coaption element (e.g., spacer, coaptation element, etc.) can have various shapes. In some embodiments, the coaption element can have an elongated cylindrical shape having a round cross- sectional shape. In other embodiments, the coaption 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 coaption element can have an atrial portion positioned in or adjacent to the left atrium, a ventricular or lower portion positioned in or adjacent to the left ventricle, and a side surface that extends between the native mitral leaflets. In embodiments configured for use in the tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, and the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the side surface that extends between the native tricuspid leaflets.

[00356] The anchor can be configured to secure the device to one or both of the native mitral leaflets such that the coaption element is positioned between the two native leaflets. In embodiments configured for use in the tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaption element is positioned between the three native leaflets. In some embodiments, the anchor can attach to the coaption element at a location adjacent the ventricular portion of the coaption element. In some embodiments, the anchor can attach to an actuation element, such as a shaft or actuation wire, to which the coaption element is also attached. In some embodiments, the anchor and the coaption element can be positioned independently with respect to each other by separately moving each of the anchor and the coaption element along the longitudinal axis of the shaft or actuation wire. In some embodiments, the anchor and the coaption element can be positioned simultaneously by moving the anchor and the coaption element together along the longitudinal axis of the shaft or actuation wire. The anchor can be configured to be positioned behind a native leaflet when implanted such that the leaflet is grasped by the anchor.

[00357] The prosthetic device can be configured to be implanted via a delivery sheath. The coaption element and the anchor can be compressible to a radially compressed state and can be self-expandable to a radially expanded state when compressive pressure is released. The device can be configured for the anchor to be expanded radially away from the still-compressed coaption element initially in order to create a gap between the coaption element and the anchor. A native leaflet can then be positioned in the gap. The coaption element can be expanded radially, closing the gap between the coaption element and the anchor and capturing the leaflet between the coaption element and the anchor. In some embodiments, the anchor and coaption element are optionally configured to self-expand. The implantation methods for various embodiments can be different and are more fully discussed below with respect to each embodiment. Additional information regarding these and other delivery methods can be found in U.S. Pat. No. 8,449,599 and U.S. Patent Application Publication Nos. 2014 / 0222136, 2014 / 0067052 and 2016 / 0331523. These methods can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g. with the body parts, tissue, etc. being simulated), etc.

[00358] The disclosed prosthetic devices can be configured such that the anchor is connected to a leaflet, taking advantage of the tension from native chordae tendineae to resist high systolic pressure urging the device toward the left atrium. During diastole, the devices can rely on the compressive and retention forces exerted on the leaflet that is grasped by the anchor.

[00359] Referring now to Figures 8–14, a schematically illustrated implantable prosthetic device 100 is shown in various stages of deployment. The device 100 can include any other features for an implantable prosthetic device discussed in the present application, and the device 100 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 the present application).

[00360] The device 100 is deployed from a delivery sheath or means for delivery 102 and includes a coaptation portion 104 and an anchor portion 106. The coaptation portion 104 of the device 100 includes a coaption element or means for coapting 110 that is adapted to be implanted between the leaflets of a native valve (e.g., a native mitral valve, tricuspid valve, etc.) and is slidably attached to an actuation element 112 (e.g., actuation wire, actuation shaft, actuation tube, etc.). The anchor portion 106 is actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element or means for actuating 112 opens and closes the anchor portion 106 of the device 100 to grasp the native valve leaflets during implantation. The actuation element 112 (e.g., wire, shaft, tube, screw, line, etc.) can take a wide variety of different forms. For example, the actuation element can be threaded such that rotation of the actuation element (e.g., wire, shaft, tube, screw, etc.) moves the anchor portion 106 relative to the coaption portion 104. Or, the actuation element can be unthreaded, such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the coaption portion 104.

[00361] The anchor portion 106 of the device 100 includes outer paddles 120 and inner paddles 122 that are connected between a cap 114 and the coaption element or means for coapting 110 by portions 124, 126, 128. The portions 124, 126, 128 can be jointed and / or flexible to move between all of the positions described below. The interconnection of the outer paddles 120, the inner paddles 122, the coaption element or means for coapting 110, and the cap 114 by the portions 124, 126, and 128 can constrain the device to the positions and movements illustrated herein.

[00362] In some implementations, the actuation element or means for actuating 112 (e.g., actuation wire, actuation shaft, etc.) extends through the delivery sheath and the coaption element or means for coapting 110 to the cap 114 at the distal connection of the anchor portion 106. Extending and retracting the actuation element or means for actuating 112 increases and decreases the spacing between the coaption element or means for coapting 110 and the cap 114, respectively. A collar or other attachment element removably attaches the coaption element or means for coapting 110 to the delivery sheath or means for delivery 102 so that the actuation element or means for actuating 112 slides through the collar or other attachment element and through the coaption element or means for coapting 110 during actuation to open and close the paddles 120, 122 of the anchor portion 106.

[00363] Referring now to Figure 11, the anchor portion 106 includes attachment portions or gripping members. The illustrated gripping members comprise barbed clasps 130 that include a base or fixed arm 132, a moveable arm 134, barbs or means for securing 136, and a joint portion 138. The fixed arms 132 are attached to the inner paddles 122, with the joint portion 138 disposed proximate the coaption element or means for coapting 110. The barbed clasps have flat surfaces and do not fit in a recess of the paddle. Rather, the flat portions of the barbed clasps are disposed against the surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixed and moveable arms 132, 134 of the barbed clasp 130. The joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In certain embodiments, the joint portion 138 is a flexible piece of material integrally formed with the fixed and moveable arms 132, 134. The fixed arms 132 are attached to the inner paddles 122 and remain stationary relative to the inner paddles 122 when the moveable arms 134 are opened to open the barbed clasps 130 and expose the barbs or means for securing 136. In some implementations, the barbed clasps 130 are opened by applying tension to actuation lines 116 attached to the moveable arms 134, thereby causing the moveable arms 134 to articulate, flex, or pivot on the joint portions 138. Other actuation mechanisms are also possible.

[00364] During implantation, the paddles 120, 122 can be opened and closed, for example, to grasp the native leaflets or native mitral valve leaflets between the paddles 120, 122 and the coaption element or means for coapting 110. The barbed clasps 130 can be used to grasp and / or further secure the native leaflets by engaging the leaflets with barbs or means for securing 136 and pinching the leaflets between the moveable and fixed arms 134, 132. The barbs or means for securing 136 of the barbed clasps 130 increase friction with the leaflets or may partially or completely puncture the leaflets. The actuation lines 116 can be actuated separately so that each barbed clasp 130 can be opened and closed separately. Separate operation allows one leaflet to be grasped at a time, or for the repositioning of a clasp 130 on a leaflet that was insufficiently grasped, without altering a successful grasp on the other leaflet. The barbed clasps 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open position), thereby allowing leaflets to be grasped in a variety of positions as the particular situation requires.

[00365] The barbed clasps 130 can be opened separately by pulling on an attached actuation line 116 that extends through the delivery sheath or means for delivery 102 to the barbed clasp 130. The actuation line 116 can take a wide variety of forms, such as, for example, a line, a suture, a wire, a rod, a catheter, or the like. The barbed clasps 130 can be spring loaded so that in the closed position the barbed clasps 130 continue to provide a pinching force on the grasped native leaflet. This pinching force remains constant regardless of the position of the inner paddles 122. Barbs or means for securing 136 of the barbed clasps 130 can pierce the native leaflets to further secure the native leaflets.

[00366] Referring now to Figure 8, the device 100 is shown in an elongated or fully open condition for deployment from the delivery sheath. The device 100 is loaded in 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 condition the cap 114 is spaced apart from the coaption element or means for coapting 110 such that the paddles 120, 122 of the anchor portion 106 are fully extended. In some embodiments, an angle formed between the interior of the outer and inner paddles 120, 122 is approximately 180 degrees. The barbed clasps 130 are kept in a closed condition during deployment through the delivery sheath or means for delivery 102 so that the barbs or means for securing 136 (Fig. 11) do not catch or damage the sheath or tissue in the patient's heart.

[00367] Referring now to Figure 9, the device 100 is shown in an elongated detangling condition, similar to Figure 8, but with the barbed clasps 130 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 fixed and moveable portions of the barbed clasps 130. Fully opening the paddles 120, 122 and the clasps 130 has been found to improve ease of detanglement or detachment from anatomy of the patient during implantation of the device 100.

[00368] Referring now to Figure 10, the device 100 is shown in a shortened or fully closed condition. The compact size of the device 100 in the shortened condition allows for easier maneuvering and placement within the heart. To move the device 100 from the elongated condition to the shortened condition, the actuation element or means for actuating 112 is retracted to pull the cap 114 towards the coaption element or means for coapting 110. The joints or flexible connections 126 between the outer paddle 120 and inner paddle 122 are constrained in movement such that compression forces acting on the outer paddle 120 from the cap 114 being retracted towards the coaption element or means for coapting 110 cause the paddles or gripping elements 120, 122 to move radially outward. During movement from the open to closed position, the outer paddles 120 maintain an acute angle with the actuation element or means for actuating 112. The outer paddles 120 can optionally be biased toward a closed position. The inner paddles 122 during the same motion move through a considerably larger angle as they are oriented away from the coaption element or means for coapting 110 in the open condition and collapse along the sides of the coaption element or means for coapting 110 in the closed condition. In certain embodiments, the inner paddles 122 are thinner and / or narrower than the outer paddles 120, and the joint 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 joint or flexible portion 124 connecting the outer paddle 120 to the cap 114. In certain other embodiments, the outer paddles 120 are narrower than the inner paddles 122. The joint or flexible portions 126, 128 connected to the inner paddles 122 can be more flexible, for example, to allow more movement than the joint or flexible portion 124 connecting the outer paddle 120 to the cap 114. In one embodiment, the inner paddles 122 can be the same or substantially the same width as the outer paddles (See for example, Figure 65A).

[00369] Referring now to Figures 11–13, the device 100 is shown in a partially open, grasp-ready condition. To transition from the fully closed to the partially open condition, the actuation element or means for actuating 112 is extended to push the cap 114 away from the coaption element or means for coapting 110, thereby pulling on the outer paddles 120, which in turn pulls on the inner paddles 122, causing the anchor portion 106 to partially unfold. The actuation lines 116 are also retracted to open the clasps 130 so that the leaflets can be grasped. In the example illustrated by Figure 11, the pair of inner and outer paddles 122, 120 are moved in unison, rather than independently, by a single actuation element or means for actuating 112. Also, the positions of the clasps 130 are dependent on the positions of the paddles 122, 120. For example, referring to Figure 10 closing the paddles 122, 120 also closes the clasps.

[00370] Figure 11A illustrates an example embodiment where the paddles 120, 122 are independently controllable. The device 100A illustrated by Figure 11A is similar to the device illustrated by Figure 11, except the device 100A includes an actuation element that is configured as two independent actuation elements 112A, 112B, which are coupled to two independent caps 114A, 114B. To transition a first inner paddle and a first outer paddle from the fully closed to the partially open condition, the actuation element or means for actuating 112A is extended to push the cap 114A away from the coaption element or means for coapting 110, thereby pulling on the outer paddle 120, which in turn pulls on the inner paddle 122, causing the first anchor portion 106 to partially unfold. To transition a second inner paddle and a second outer paddle from the fully closed to the partially open condition, the actuation element or means for actuating 112B is extended to push the cap 114 away from the coaption element or means for coapting 110, thereby pulling on the outer paddle 120, which in turn pulls on the inner paddle 122, causing the second anchor portion 106 to partially unfold. The independent paddle control illustrated by Figure 11A can be implemented on any of the devices disclosed by the present application.

[00371] Referring now to Figure 12, one of the actuation lines 116 is extended to allow one of the clasps 130 to close. Referring now to Figure 13, the other actuation line 116 is extended to allow the other clasp 130 to close. Either or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the barbed clasps 130.

[00372] Referring now to Figure 14, the device 100 is shown in a fully closed and deployed condition. The delivery sheath or means for delivery 102 and actuation element or means for actuating 112 is / are retracted and the paddles 120, 122 and clasps 130 remain in a 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 through the use of spring materials, such as steel, other metals, plastics, composites, etc. or shape-memory alloys such as Nitinol. For example, the jointed or flexible portions 124, 126, 128, 138, and / or the inner and outer paddles 122, 120 and / or an additional biasing component (see component 524 in Figure 28) can be formed of metals such as steel or shape-memory alloy, such as Nitinol—produced in a wire, sheet, tubing, or laser sintered powder—and are biased to hold the outer paddles 120 closed around the coaption element or means for coapting 110 and the barbed clasps 130 pinched around native leaflets. Similarly, the fixed and moveable arms 132, 134 of the barbed clasps 130 are biased to pinch the leaflets. In certain embodiments, the attachment or joint portions 124, 126, 128, 138, and / or the inner and outer paddles 122, and / or an additional biasing component (see component 524 in Figure 28) can be formed of any other suitably elastic material, such as a metal or polymer material, to maintain the device in the closed condition after implantation.

[00373] Referring now to Figures 226–231, the implantable device 100 is shown provided with a cover 140. The cover 140 can be a cloth material such as polyethylene cloth of a fine mesh. The cloth cover can provide a blood seal on the surface of the spacer, and / or promote rapid tissue ingrowth. The cover 140 includes first and second cover portions 142, 144 that each cover different portions of the device 100. In some embodiments, a portion of one of the first and second cover portions 142, 144 overlaps a portion of the other of the first and second cover portion 142, 144. The first and second cover portions 142, 144 can be arranged in various ways, and in some embodiments, can include an overlapping portion 146 that overlaps one of the first and second cover portions 142, 144.

[00374] Referring now to Figures 226–229, various arrangements of the first and second cover portions 142, 144 are shown without overlapping portions 146. Referring now to Figure 226, the first cover portion 142 (represented by thin line cross-hatching), which can be made from a single piece of material, extends from the cap 114 to cover the cap 114, outer paddles 120, inner paddles 122, and the fixed arms 132 of the clasps 130. The second cover 144 (represented by thick line cross-hatching), which can be a single piece of material, covers the coaption element or means for coapting 110.

[00375] Referring now to Figure 227, the first cover portion 142, which can be made from a single piece of material, extends from the cap 114 to cover the cap 114, outer paddles 120, inner paddles 122, the fixed arms 132 and moveable arms 134 of the clasps 130. As with the cover 140 of Figure 226, the second cover 144 covers the coaption element or means for coapting 110.

[00376] Referring now to Figure 228, the first cover portion 142, which can be made from a single piece of material, extends from the cap 114 to cover the cap 114, outer paddles 120, inner paddles 122, and the fixed arms 132 of the clasps 130. The second cover 144, which can be made from a single piece of material, covers the coaption element or means for coapting 110 and extends from the coaption element or means for coapting 110 to cover the moveable arms 134 of the clasps 130.

[00377] Referring now to Figure 229, the first cover portion 142, which can be made from a single piece of material, extends from the cap 114 to cover the cap 114 and outer paddles 120. The second cover 144, which can be made from a single piece of material, covers the coaption element or means for coapting 110 and extends from the coaption element or means for coapting 110 to cover the inner paddles 122, and the fixed arms 132 and moveable arms 134 of the clasps 130.

[00378] Referring now to Figures 230–231, arrangements of the first and second cover portions 142, 144 are shown that include an overlapping portion 146. Referring now to Figure 230, the first cover portion 142, which can be made from a single piece of material, extends from the cap 114 to cover the cap 114, outer paddles 120, inner paddles 122, and the fixed arms 132 and moveable arms 134 of the clasps 130. The second cover 144, which can be made from a single piece of material, covers the coaption element or means for coapting 110 and includes overlapping portions 146 that extend from the coaption element or means for coapting 110 to overlap a portion of the moveable arms 134 that are covered by the first cover 142.

[00379] Referring now to Figure 231, the first cover portion 142, which can be made from a single piece of material, extends from the cap 114 to cover the cap 114, outer paddles 120, inner paddles 122, and the fixed arms 132 of the clasps 130. The second cover 144, which can be made from a single piece of material, covers the coaption element or means for coapting 110 and moveable arms 134 of the clasps 130. The first cover 142 also includes overlapping portions 146 that extend from the fixed arms 132 and inner paddles 122 to overlap a portion of the moveable arms 134 and coaption element or means for coapting 110 that are covered by the second cover 144.

[00380] Referring now to Figures 15–20, the implantable device 100 of Figures 8–14 is shown being delivered and implanted within the native mitral valve MV of the heart H. The methods and steps shown and / or discussed can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g. with the body parts, heart, tissue, etc. being simulated), etc.

[00381] Referring now to Figure 15, the delivery sheath is inserted into the left atrium LA through the septum and the device 100 is deployed from the delivery sheath in the fully open condition. The actuation element or means for actuating 112 is then retracted to move the device 100 into the fully closed condition shown in Figure 16. As can be seen in Figure 17, the device 100 is moved into position within the mitral valve MV into the ventricle LV and partially opened so that the leaflets 20, 22 can be grasped. Referring now to Figure 18, an actuation line 116 is extended to close one of the clasps 130, capturing a leaflet 20. Figure 19 shows the other actuation line 116 being then extended to close the other clasp 130, capturing the remaining leaflet 22. As can be seen in Figure 20, the delivery sheath or means for delivery 102 and actuation element or means for actuating 112 and actuation lines 116 are then retracted and the device 100 is fully closed and deployed in the native mitral valve MV.

[00382] Referring now to Figure 21, an example implantable prosthetic device 200 or frame thereof is shown. In certain embodiments, the device 200 includes an annular spacer member 202, a fabric cover (not shown), and anchors 204 extending from the spacer member 202. The ends of each anchor 204 can be coupled to respective struts of the spacer member 202 by respective sleeves 206 that can be crimped or welded around the connection portions of the anchors 204 and the struts of the spacer member 202. In one example embodiment, a latching mechanism can bind the spacer member 202 to the anchor 204 within the sleeve 206. For example, the sleeve can be machined to have an interior shape that matches or is slightly smaller than the exterior shape of the ends of the spacer member 202 and the anchor 204, so that the sleeve can be friction fit on the connection portions. One or more barbs or projections 208 can be mounted on the frame of the spacer member 202. The free ends of the barbs or projections 208 can comprise various shapes including rounded, pointed, barbed, or the like. The projections 208 can exert a retaining force against native leaflets by virtue of the anchors 204, which are shaped to force the native leaflets inwardly into the spacer member 202.

[00383] Referring now to Figure 22, an example implantable prosthetic device 300 or frame thereof is shown. In certain embodiments, the prosthetic spacer device 300 includes an annular spacer member 302, a fabric cover (not shown), and anchors 304 extending from the spacer member 302 and can be configured similar to the prosthetic spacer device 200. One or more barbs or projections 306 can be mounted on the frame of the spacer member 302. The ends of the projections 306 can comprise stoppers 308. The stoppers 308 of the projections can be configured in a wide variety of different ways. For example, the stoppers 308 can be configured to limit the extent of the projections 306 that can engage and / or penetrate the native leaflets and / or the stoppers can be configured to prevent removal of the projections 306 from the tissue after the projections 306 have penetrated the tissue.

[00384] The anchors 304 of the prosthetic spacer device 300 can be configured similar to the anchors 204 of the prosthetic spacer device 200 except that the curve of each anchor 304 comprises a larger radius than the anchors 204. As such, the anchors 304 cover a relatively larger portion of the spacer member 302 than the anchors 204. This can, for example, distribute the clamping force of the anchors 304 against the native leaflets over a relatively larger surface of the native leaflets in order to further protect the native leaflet tissue.

[00385] Additional details regarding the prosthetic spacer devices can be found, for example, in U.S. Patent Application Publication No. 2016 / 0331523. The devices 200, 300 can include any other features for an implantable prosthetic device discussed in the present application, and the device 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 the present application).

[00386] Referring now to Figures 23–27, an example embodiment of an implantable prosthetic spacer device 400 and components thereof are shown. The device 400 can include any other features for an implantable prosthetic device discussed in the present application, and the device 400 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 the present application).

[00387] Referring now to Figure 23, the prosthetic spacer or coaption device 400 can include a coaption portion 404 and an anchor portion 406, the anchor portion 406 including a plurality of anchors 408. The coaption portion 404 includes a coaption or spacer member 410. The anchor portion 406 includes a plurality of paddles 420 (e.g., two in the illustrated embodiment), and a plurality of clasps 430 (e.g., two in the illustrated embodiment). A first or proximal collar 411, and a second collar or cap 414 are used to move the coaption portion 404 and the anchor portion 406 relative to one another.

[00388] As shown in Figure 25, first connection portions 425 of the anchors 408 can be coupled to and extend from a first portion 417 of the coaption or spacer member 410, and second connection portions 421 of the anchors 408 can be coupled to the first collar 414. The proximal collar 411 can be coupled to a second portion 419 of the coaption member 410.

[00389] The coaption member 410 and the anchors 408 can be coupled together in various ways. For example, as shown in the illustrated embodiment, the coaption member 410 and the anchors 408 can be coupled together by integrally forming the coaption member 410 and the anchors 408 as a single, unitary component. This can be accomplished, for example, by forming the coaption member 410 and the anchors 408 from a braided or woven material, such as braided or woven nitinol wire. In other embodiments, the coaption member 410 and the anchors 408 can be coupled together by welding, fasteners, adhesive, joint connections, sutures, friction fittings, swaging, and / or other means for coupling.

[00390] Referring now to Figure 24, the anchors 408 can comprise first portions or outer paddles 420 and second portions or inner paddles 422 separated by joint portions 423. In this manner, the anchors 408 are configured similar to legs in that the inner paddles 422 are like upper portions of the legs, the outer paddles 420 are like lower portions of the legs, and the joint portions 423 are like knee portions of the legs. In some embodiments, the inner paddle portion 422, the outer paddle portion 420, and the joint portion 423 are formed from a continuous strip of a fabric, such as a metal fabric. In some embodiments, the strip of fabric is a composite strip of fabric.

[00391] The anchors 408 can be configured to move between various configurations by axially moving the cap 414 relative to the proximal collar 411 and thus the anchors 408 relative to the coaption member 410 along a longitudinal axis extending between the first or distal and second or proximal portions 417, 419 of the coaption member 410. For example, the anchors 408 can be positioned in a straight configuration by moving the cap 414 away from the coaption member 410. In the straight configuration, the paddle portions are aligned or straight in the direction of the longitudinal axis of the device and the joint portions 423 of the anchors 408 are adjacent the longitudinal axis of the coaption member 410 (e.g., similar to the configuration shown in Figure 59). From the straight configuration, the anchors 408 can be moved to a fully folded configuration (e.g., Figure 23) by moving the toward the coaption member 410. Initially as the cap 414 moves toward the coaption member 410, the anchors 408 bend at the joint portions 423, 425, 421 and the joint portions 423 move radially outwardly relative to the longitudinal axis of the coaption member 410 and axially toward the first portion 417 of the coaption member 410, as shown in Figures 24–25. As the cap 414 continues to move toward the coaption member 410, the joint portions 423 move radially inwardly relative to the longitudinal axis of the coaption member 410 and axially toward the proximal portion 419 of the coaption member 410, as shown in Figure 23.

[00392] In some embodiments, an angle between the inner paddles 422 of the anchors 408 and the coaption member 410 can be approximately 180 degrees when the anchors 408 are in the straight configuration (see, e.g., Figure 59), and the angle between the inner paddles 422 of the anchors 408 and the coaption member 410 can be approximately 0 degrees when the anchors 408 are in the fully folded configuration (See Figure 23). The anchors 408 can be positioned in various partially folded configurations such that the angle between the inner paddles 422 of the anchors 408 and the coaption member 410 can be approximately 10–170 degrees or approximately 45–135 degrees.

[00393] Configuring the prosthetic spacer device 400 such that the anchors 408 can extend to a straight or approximately straight configuration (e.g. approximately 120–180 degrees relative to the coaption member 410) can provide several advantages. For example, this can reduce the radial crimp profile of the prosthetic spacer device 400. It can also make it easier to grasp the native leaflets by providing a larger opening in which to grasp the native leaflets. Additionally, the relatively narrow, straight configuration can prevent or reduce the likelihood that the prosthetic spacer device 400 will become entangled in native anatomy (e.g., chordae tendineae) when positioning and / or retrieving the prosthetic spacer device 400 into the delivery apparatus.

[00394] Referring again to Figure 24, the clasps 430 can comprise attachment or fixed portions 432 and arm or moveable portions 434. The attachment or fixed portions 432 can be coupled to the inner paddles 422 of the anchors 408 in various ways such as with sutures, adhesive, fasteners, welding, stitching, swaging, friction fit and / or other means for coupling or fastening.

[00395] In some embodiments, the moveable portions 434 can articulate, flex, or pivot relative to the fixed portions 432 between an open configuration (e.g., Figure 24) and a closed configuration (Figures 23 and 25). In some embodiments, the clasps 430 can be biased to the closed configuration. In some embodiments, in the open configuration, the fixed portions 432 and the moveable portions 434 flex or pivot away from each other such that native leaflets can be positioned between the fixed portions 432 and the moveable portions 434. In some embodiments, in the closed configuration, the fixed portions 432 and the moveable portions 434 flex or pivot toward each other, thereby clamping the native leaflets between the fixed portions 432 and the moveable portions 434.

[00396] Referring to Figures 26–27, clasps 430 are shown in top and perspective views. The fixed portions 432 (only one shown in Figures 26–27) can comprise one or more openings 433 (e.g., three in the illustrated embodiment). At least some of the openings 433 can be used to couple the fixed portions 432 to the anchors 408. For example, sutures and / or fasteners can extend through the openings 433 to couple the fixed portions 432 to the anchors 408 or other attachments, such as welding, adhesives, etc. can be used.

[00397] The moveable portions 434 can comprise one or more side beams 431. When two side beams are included as illustrated, the side beams can be spaced apart to form slots 431A. The slots 431A can be configured to receive the fixed portions 432. The moveable portions 434 can also include spring portions 434A that are coupled to the fixed portions 432 and barb support portions 434B disposed opposite the spring portions 434A.

[00398] The barb support portions 434B can comprise gripper or attachment elements such as barbs 436 and / or other means for frictionally engaging native leaflet tissue. The gripper elements can be configured to engage and / or penetrate the native leaflet tissue to help retain the native leaflets between the fixed portions 432 and moveable portions 434 of the clasps 430.

[00399] The barb support portions 434B can also comprise eyelets 435, which can be used to couple the barb support portions 434B to an actuation mechanism configured to flex or pivot the moveable portions 434 relative to the fixed portions 432. Additional details regarding coupling the clasps 430 to the actuation mechanism are provided below.

[00400] In some embodiments, the clasps 430 can be formed from a shape memory material such as nitinol, stainless steel, and / or shape memory polymers. In certain embodiments, the clasps 430 can be formed by laser-cutting a piece of flat sheet material (e.g., nitinol) or a tube in the configuration shown in Figure 26 or a similar or different configuration and then shape-setting the clasp 430 in the configuration shown in Figure 27.

[00401] Shape-setting the clasps 430 in this manner can provide several advantages. For example, the clasps 430 can optionally be compressed from the shape-set configuration (e.g., Figure 27) to the flat configuration (e.g., Figure 26), or another configuration which reduces the radial crimp profile of the clasps 430. For example, the barbs can optionally be compressed to a flat configuration. Reducing the radial crimp profile can improve trackability and retrievability of the prosthetic spacer device 400 relative to a catheter shaft of a delivery apparatus because barbs 436 are pointing radially inwardly toward the anchors 408 when the prosthetic spacer device 400 is advanced through or retrieved into the catheter shaft (see, e.g., Figure 33). This can prevent or reduce the likelihood that the clasps 430 may snag or skive the catheter shaft.

[00402] In addition, shape-setting the clasps 430 in the configuration shown in Figure 27 can increase the clamping force of the clasps 430 when the clasps 430 are in the closed configuration. This is because the moveable portions 434 are shape-set relative to the fixed portions 432 to a first position (e.g., Figure 27) which is beyond the position the moveable portions 434 can achieve when the clasps 430 are attached to the anchors 408 (e.g., Figure 25) because the anchors 408 prevent the moveable portions 434 from further movement toward the shape-set configuration. This results in moveable portions 434 having a preload (i.e., the clamping force is greater than zero) when the clasps 430 are attached to the anchors 408 and in the closed configuration. Thus, shape-setting the clasps 430 in the Figure 27 configuration can increase the clamping force of the clasps 430 compared to clasps that are shape-set in the closed configuration.

[00403] The magnitude of the preload of the clasps 430 can be altered by adjusting the angle in which the moveable portions 434 are shape-set relative to the fixed portions 432. For example, increasing the relative angle between the moveable portions 434 and the fixed portions 432 increases the preload, and decreasing the relative angle between the moveable portions 434 and the fixed portions 432 decreases the preload. It can also be adjusted in other ways, such as based on the configuration of the joint, hinge, materials, etc.

[00404] In some embodiments, the proximal collar 411 and / or the coaption member 410 can comprise a hemostatic seal 413 configured to reduce or prevent blood from flowing through the proximal collar 411 and / or the coaption member 410. For example, in some embodiments, the hemostatic seal 413 can comprise a plurality of flexible flaps 413A, as shown in Figure 23. In some embodiments, the flaps 413A can be configured to pivot from a sealed configuration to an open configuration to allow a shaft of a delivery apparatus to extend through the second collar 414. In one example embodiment, the flaps 413A form a seal around the shaft of the delivery apparatus. When the shaft of the delivery apparatus is removed, the flaps 413A can be configured to return to the sealed configuration from the open configuration.

[00405] Referring now to Figure 23A, an example embodiment of an implantable prosthetic spacer device 400A is shown. The device 400A can include any other features for an implantable prosthetic device discussed in the present application, and the device 400A 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 the present application).

[00406] The prosthetic spacer or coaption device 400A can include a coaption portion 404A and an anchor portion 406A, the anchor portion 406A including a plurality of anchors 408A. The coaption portion 404A includes a coaption member or spacer 410A. The anchor portion 406A includes a plurality of paddles 420A (e.g., two in the illustrated embodiment), and a plurality of clasps 430A (e.g., two in the illustrated embodiment). A first or proximal collar 411A, and a second collar or cap 414A are used to move the coaption portion 404A and the anchor portion 406A relative to one another.

[00407] The coaption member 410A extends from a proximal portion 419B assembled to the collar 411A to a distal portion 417A that connects to the anchors 408A. The coaption member 410A and the anchors 408A can be coupled together in various ways. For example, as shown in the illustrated embodiment, the coaption member 410A and the anchors 408A can be coupled together by integrally forming the coaption member 410A and the anchors 408A as a single, unitary component. This can be accomplished, for example, by forming the coaption member 410A and the anchors 408A from a continuous strip 401 A of a braided or woven material, such as braided or woven nitinol wire.

[00408] The anchors 408A are attached to the coaption member 410A by hinge portions 425A and to the cap 414A by hinge portions 421 A. The anchors 408A can comprise first portions or outer paddles 420A and second portions or inner paddles 422A separated by joint portions 423A. The joint portions 423A are attached to paddle frames 424A that are hingably attached to the cap 414A. In this manner, the anchors 408A are configured similar to legs in that the inner paddles 422A are like upper portions of the legs, the outer paddles 420A are like lower portions of the legs, and the joint portions 423A are like knee portions of the legs. In the illustrated example, the inner paddle portion 422A, the outer paddle portion 420A, and the joint portion 423A are formed from the continuous strip of fabric 401A, such as a metal fabric.

[00409] The anchors 408A can be configured to move between various configurations by axially moving the cap 414A relative to the proximal collar 411A and thus the anchors 408A relative to the coaption member 410A along a longitudinal axis extending between the cap 414A and the proximal collar 411A. For example, the anchors 408 can be positioned in a straight configuration (see Fig. 60A) by moving the cap 414A away from the coaption member 410A. 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 portions 423A of the anchors 408A are adjacent the longitudinal axis of the coaption member 410A (e.g., similar to the configuration shown in Figure 60A). From the straight configuration, the anchors 408 can be moved to a fully folded configuration (e.g., Figure 23A) by moving the toward the coaption member 410A. Initially, as the cap 414A moves toward the coaption member 410A, the anchors 408A bend at joint portions 421A, 423A, 425A, and the joint portions 423A move radially outwardly relative to the longitudinal axis of the device 400A and axially toward the distal portion 417A of the coaption member 410A, as shown in Figures 53A and 54A. As the cap 414A continues to move toward the coaption member 410A, the joint portions 423A move radially inwardly relative to the longitudinal axis of the device 400A and axially toward the proximal portion 419A of the coaption member 410A, as shown in Figure 23A.

[00410] In some embodiments, an angle between the inner paddles 422A of the anchors 408A and the coaption member 410A can be approximately 180 degrees when the anchors 408A are in the straight configuration (see, e.g., Figure 60A), and the angle between the inner paddles 422A of the anchors 408A and the coaption member 410A can be approximately 0 degrees when the anchors 408A are in the fully folded configuration (see Figure 23A). The anchors 408A can be positioned in various partially folded configurations such that the angle between the inner paddles 422A of the anchors 408A and the coaption member 410A can be approximately 10–170 degrees or approximately 45–135 degrees.

[00411] Configuring the prosthetic spacer device 400A such that the anchors 408A can extend to a straight or approximately straight configuration (e.g. approximately 120–180 degrees relative to the coaption member 410A) can provide several advantages. For example, this can reduce the radial crimp profile of the prosthetic spacer device 400A. It can also make it easier to grasp the native leaflets by providing a larger opening in which to grasp the native leaflets. Additionally, the relatively narrow, straight configuration can prevent or reduce the likelihood that the prosthetic spacer device 400A will become entangled in native anatomy (e.g., chordae tendineae) when positioning and / or retrieving the prosthetic spacer device 400A into the delivery apparatus.

[00412] The clasps 430A can comprise attachment or fixed portions 432C and arm or moveable portions 434C. The attachment or fixed portions 432C can be coupled to the inner paddles 422A of the anchors 408A in various ways such as with sutures, adhesive, fasteners, welding, stitching, swaging, friction fit, and / or other means for coupling. The clasps 430A are similar to the clasps 430.

[00413] In some embodiments, the moveable portions 434C can articulate, flex, or pivot relative to the fixed portions 432C between an open configuration (e.g., Figure 54A) and a closed configuration (Figure 53A). In some embodiments, the clasps 430A can be biased to the closed configuration. In the open configuration, the fixed portions 432C and the moveable portions 434C articulate, pivot, or flex away from each other such that native leaflets can be positioned between the fixed portions 432C and the moveable portions 434C. In the closed configuration, the fixed portions 432C and the moveable portions 434C articulate, pivot, or flex toward each other, thereby clamping the native leaflets between the fixed portions 432C and the moveable portions 434C.

[00414] The strip 401A is attached to the collar 411A, cap 414A, paddle frames 424A, clasps 430A to form both the coaption portion 404A and the anchor portion 406A of the device 400A. In the illustrated embodiment, the coaption member 410A, hinge portions 421A, 423A, 425A, outer paddles 420A, and inner paddles 422A are formed from the continuous strip 401A. The continuous strip 401A can be a single layer of material or can include two or more layers. In certain embodiments, portions of the device 400A have a single layer of the strip of material 401A and other portions are formed from multiple overlapping or overlying layers of the strip of material 401 A. For example, Figure 23 A shows the coaption member 410A and inner paddles 422A formed from multiple overlapping layers of the strip of material 401A. The single continuous strip of material 401A can start and end in various locations of the device 400A. The ends of the strip of material 401A can be in the same location or different locations of the device 400A. For example, in the illustrated embodiment of Figure 23A, the strip of material begins and ends in the location of the inner paddles 422A.

[00415] Referring now to Figure 30A, the example implantable prosthetic device 400A is shown covered with a cover 440A. The cover 440A is disposed on the coaption member 410A, the collar 411A, the cap 414A, the paddles 420A, 422A, the paddle frames 424A, and the clasps 430A. The cover 440A can be configured to prevent or reduce blood-flow through the prosthetic spacer device 400A and / or to promote native tissue ingrowth. In some embodiments, the cover 440A can be a cloth or fabric such as PET, velour, or other suitable fabric. In other embodiments, in lieu of or in addition to a fabric, the cover 440A can include a coating (e.g., polymeric material, silicone, etc.) that is applied to the prosthetic spacer device 400A.

[00416] Referring now to Figures 28–30, an example embodiment of an implantable prosthetic device 500 (e.g., a prosthetic spacer device) is shown. The implantable device 500 is one of the many different configurations that the device 100 that is schematically illustrated in Figures 8–20 can take. The device 500 can include any other features for an implantable prosthetic device discussed in the present application, and the device 500 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 the present application).

[00417] The prosthetic spacer device 500 can comprise a coaption element or spacer member 510, a plurality of anchors 508 that include outer paddles 520, inner paddles 522, clasps 530, a first or proximal collar 511, and a second collar or cap 514. These components of the prosthetic spacer device 500 can be configured the same or substantially similar to the corresponding components of the prosthetic spacer device 400.

[00418] The prosthetic spacer device 500 can also include a plurality of paddle extension members or paddle frames 524. The paddle frames 524 can be configured with a round three-dimensional shape with first connection portions 526 coupled to and extending from the cap 514 and second connection portions 528 disposed opposite the first connection portions 526. The paddle frames 524 can be configured to extend circumferentially farther around the coaption member 510 than the outer paddles 520. For example, in some embodiments, each of the paddle frames 524 extend around approximately half of the circumference of the coaption member 510 (as shown in Figure 29), and the outer paddles 520 extend around less than half of the circumference of the coaption member 510 (as shown in Figure 28). The paddle frames 524 can also be configured to extend laterally (i.e., perpendicular to a longitudinal axis of the coaption member 510) beyond an outer diameter of the coaption member 510. In the illustrated example, the inner paddle portions 522 and the outer paddle portions 520 can formed from a continuous strip of fabric that are connected to the paddle frames 524. For example, the inner paddle portions and the outer paddle portions can be connected to the connection portion of the paddle frame at the flexible connection between the inner paddle portion and the outer paddle portion.

[00419] The paddle frames 524 can further be configured such that connection portions 528 of the paddle frames 524 are connected to or axially adjacent a joint portion 523. The connection portions of the paddle frames 524 can be positioned between outer and inner paddles 520, 522, on the outside of the paddle portion 520, on the inside of the inner paddle portion, or on top of the joint portion 523 when the prosthetic spacer device 500 is in a folded configuration (e.g., Figures 28–30). The connections between the paddle frames 524, the single strip that forms the outer and inner paddles 520, 522, the cap 514, and the coaption element can constrain each of these parts to the movements and positions described herein. In particular the joint portion 523 is constrained by its connection between the outer and inner paddles 520, 522 and by its connection to the paddle frame. Similarly, the paddle frame 524 is constrained by its attachment to the joint portion 523 (and thus the inner and outer paddles) and to the cap.

[00420] Configuring the paddle frames 524 in this manner provides increased surface area compared to the outer paddles 520 alone. This can, for example, make it easier to grasp and secure the native leaflets. The increased surface area can also distribute the clamping force of the paddles 520 and paddle frames 524 against the native leaflets over a relatively larger surface of the native leaflets in order to further protect the native leaflet tissue.

[00421] The increased surface area of the paddle frames 524 can also allow the native leaflets to be clamped to the prosthetic spacer device 500, such that the native leaflets coapt entirely around the coaption member 510. This can, for example, improve sealing of the native leaflet and thus prevent or further reduce mitral regurgitation.

[00422] Referring to Figure 30, the prosthetic spacer device 500 can also include a cover 540. In some embodiments, the cover 540 can be disposed on the coaption member 510, the paddles 520, 522, and / or the paddle frames 524. The cover 540 can be configured to prevent or reduce blood-flow through the prosthetic spacer device 500 and / or to promote native tissue ingrowth. In some embodiments, the cover 540 can be a cloth or fabric such as PET, velour, or other suitable fabric. In other embodiments, in lieu of or in addition to a fabric, the cover 540 can include a coating (e.g., polymeric, silicone, etc.) that is applied to the prosthetic device 500.

[00423] Figures 31–32 illustrate the implantable prosthetic device 500 of Figures 28 and 29 with anchors 508 of an anchor portion 506 and clasps 530 in open positions. The device 500 is deployed from a delivery sheath (not shown) and includes a coaption portion 504 and the anchor portion 506. The device 500 is loaded in the delivery sheath in the fully extended or bailout position, because the fully extended or bailout position takes up the least space and allows the smallest catheter to be used (See Figure 35). Or, the fully extended position allows the largest device 500 to be used for a given catheter size. The coaption portion 504 of the device includes a coaption element 510 for implantation between the native leaflets of a native valve (e.g., mitral valve, tricuspid valve, etc.). An insert 516A is disposed inside the coaption element 510. The insert 516A and the coaption element 510 are slidably attached to an actuation element 512 (e.g., actuation wire, rod, shaft, tube, screw, suture, line, etc.). The anchors 508 of the device 500 include outer paddles 520 and inner paddles 522 that are flexibly connected to the cap 514 and the coaption element 510. Actuation of the actuation element or means for actuation 512 opens and closes the anchors 508 of the device 500 to grasp the native valve leaflets during implantation.

[00424] The actuation element 512 extends through the delivery sheath (not shown), the proximal collar 511, the coaption element 510, the insert 516A, and extends to the cap 514. Extending and retracting the actuation element 512 increases and decreases the spacing between the coaption element 510 and the cap 514, respectively. This changing of the spacing between the coaption element 510 and the cap 514 causes the anchor portion 506 of the device to move between different positions.

[00425] The proximal collar 511 optionally includes a collar seal 513 that forms a seal around the actuation element or means for actuation 512 during implantation of the device 500, and that seals shut when the actuation element 512 is removed to close or substantially close the proximal end of the device 500 to blood flow through the interior of the coaption element 510 after implantation. In some embodiments, a coupler or means for coupling 2214 (see Figure 145) removably engages and attaches the proximal collar 511 and the coaption element 510 to the delivery sheath. In some embodiments, coupler or means 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 fingers (see Figure 145) of the coupler or means for coupling 2214 to open, releasing the proximal collar 511.

[00426] The proximal collar 511 and the insert 516A in the coaption element 510 slide along the actuation element 512 during actuation to open and close the paddles 520, 522 of the anchors 508. Referring to Figures 32A and 32B, in some embodiments the cap 514 optionally includes a sealing projection 516 that sealingly fits within a sealing opening 517 of the insert 516A. In one example embodiment, the cap 514 includes a sealing opening and the insert 516A includes a sealing projection. The insert 516A can sealingly fit inside a distal opening 515 of the coaption element 510, the coaption element 510 having a hollow interior. Referring to Figure 32A, the sealing projection 516 of the cap sealingly engages the opening 517 in the insert 516A to maintain the distal end of the coaption element 510 closed or substantially closed to blood flow when the device 500 is implanted and / or in the closed position.

[00427] In one example embodiment, instead of the sealing engagement between the cap 514 and the insert 516A, the insert 516A can optionally include a seal, like the collar seal 513 of the proximal collar, that forms a seal around the actuation element or means for actuation 512 during implantation of the device 500, and that seals shut when the actuation element 512 is removed. Such a seal can close or substantially close the distal end of the coaption element 510 to blood flow after implantation.

[00428] The coaption element 510 and paddles 520, 522 are formed from a flexible material that can be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable way or a laser cut or otherwise cut flexible material. The material can be cloth, shape-memory alloy wire—such as Nitinol—to provide shape-setting capability, or any other flexible material suitable for implantation in the human body. Paddle frames 524 provide additional pinching force between the inner paddles 522 and the coaption element 510 and assist in wrapping the leaflets around the sides of the coaption element 510 for a better seal between the coaption element 510 and the leaflets. In some embodiments, the covering 540 illustrated by Figure 30 extends around the paddle frames 524.

[00429] The clasps 530 include a base or fixed arm 532, a moveable arm 534, barbs 536, and a joint portion 538. The fixed arms 532 are attached to the inner paddles 522, with the joint portion 538 disposed proximate the coaption element 510. The barbed clasps have flat surfaces and do not fit in a recess of the paddle. Rather, the flat portion of the barbed clasps are disposed against the surface of the inner paddle 522. For example, the fixed arms 532 are attached to the inner paddles 522 through holes or slots 533 with sutures (not shown). The fixed arms 532 can be attached to the inner paddles 522 or another portion of the device with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, or the like. The fixed arms 532 remain stationary or substantially stationary relative to the inner paddles 522 when the moveable arms 534 are opened to open the barbed clasps 530 and expose the barbs 536. The barbed clasps 530 are opened by applying tension to actuation lines (not shown) attached to holes 535 in the moveable arms 534, thereby causing the moveable arms 534 to pivot or flex on the joint portions 538.

[00430] During implantation, the anchors 508 are opened and closed to grasp the native valve leaflets between the paddles 520, 522 and the coaption element 510. The barbed clasps 530 further secure the native leaflets by engaging the leaflets with barbs 536 and pinching the leaflets between the moveable and fixed arms 534, 532. The barbs 536 of the barbed clasps 530 increase friction with the leaflets or may partially or completely puncture the leaflets. The actuation lines can be actuated separately so that each barbed clasp 530 can be opened and closed separately. Separate operation allows one leaflet to be grasped at a time, or for the repositioning of a clasp 530 on a leaflet that was insufficiently grasped, without altering a successful grasp on the other leaflet. The barbed clasps 530 can open and close when the inner paddle 522 is not closed, thereby allowing leaflets to be grasped in a variety of positions as the particular situation requires.

[00431] Referring now to Figure 33, an example barbed clasp 600 for use in implantable prosthetic devices, such as the devices described above, is shown. However, a wide variety of different barbed clasps can be used. Examples of barbed clasps that can be used include but are not limited to any of the barbed clasps disclosed in the present application and any of the applications that the present application claims priority to. In the illustrated example, the barbed clasp 600 is formed from a top layer 602 and a bottom layer 604. The two-layer design of the clasp 600 allow thinner sheets of material to be used, thereby improving the flexibility of the clasp 600 over a clasp formed from a single thicker sheet, while maintaining the strength of the clasp 600 needed to successfully retain a native valve leaflet.

[00432] The barbed clasp 600 includes a fixed arm 610, a jointed portion 620, and a movable arm 630 having a barbed portion 640. The top and bottom layers 602, 604 have a similar shape and in certain embodiments are attached to each other at the barbed portion 640. However, the top and bottom layers 602, 604 can be attached to one another at other or additional locations. The jointed portion 620 is spring-loaded so that the fixed and moveable arms 610, 630 are biased toward each other when the barbed clasp 600 is in a closed condition. When assembled to an implantable prosthetic device, the fixed arm 610 is attached to a portion of the prosthetic device. The clasp 600 is opened by pulling on an actuation line attached to the moveable arm 630 until the spring force of the joint portion 620 is overcome.

[00433] The fixed arm 610 is formed from a tongue 611 of material extending from the jointed portion 620 between two side beams 631 of the moveable arm 630. The tongue 611 is biased between the side beams 631 by the joint portion 620 such that force must be applied to move the tongue 611 from a neutral position located beyond the side beams 631 to a preloaded position parallel or substantially parallel with the side beams 631. The tongue 611 is held in the preloaded position by an optional T- shaped cross-bar 614 that is attached to the tongue 611 and extends outward to engage the side beams 631. In one example embodiment, the cross-bar is omitted and the tongue 611 is attached to the inner paddle 522, and the inner paddle 522 maintains the clasp in the preloaded position. In the two-layer clasp application, the top and bottom layers 602, 604 or just the top layer can be attached to the inner paddle. In some embodiments, the angle between the fixed and moveable arms 610, 630 when the tongue is in the neutral position is about 30 to about 100 degrees, 30 to about 90 degrees, or about 30 to about 60 degrees, or about 40 to about 50 degrees, or about 45 degrees.

[00434] The tongue 611 includes holes 612 for receiving sutures (not shown) that attach the fixed arm 610 to an implantable device. The fixed arm 610 can be attached to an implantable device, such as with screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, or the like. In certain embodiments, the holes 612 are elongated slots or oval-shaped holes to accommodate sliding of the layers 602, 604 without damaging the sutures attaching the clasp 600 to an implantable device.

[00435] The joint portion 620 is formed by two beam loops 622 that extend from the tongue 611 of the fixed arm 610 to the side beams 631 of the moveable arm 630. In certain embodiments, the beam loops 622 are narrower than the tongue 611 and side beam 631 to provide additional flexibility. The beam loops 622 each include a center portion 624 extending from the tongue 611 and an outer portion 626 extending to the side beams 631. The beam loops 622 are bent into a somewhat spiral or helical shape by bending the center and outer portions 624, 626 in opposite directions, thereby forming an offset or step distance 628 between the tongue 611 and side beams 631. The step distance 628 provides space between the arms 610, 630 to accommodate the native leaflet of the native valve after it is grasped. In certain embodiments, the step distance 628 is about 0.5 millimeter to about 1 millimeter, or about 0.75 millimeters.

[00436] When viewed in a top plan view, the beam loops have an "omega-like" shape. This shape of the beam loops 622 allows the fixed and moveable arms 610, 630 to move considerably relative to each other without plastically deforming the clasp material. For example, in certain embodiments, the tongue 611 can be flexed or pivoted from a neutral position that is approximately 45 degrees beyond the moveable arm 630 to a fully open position that ranges from about 140 degrees to about 200 degrees, from about 170 degrees to about 190 degrees, or about 180 degrees from the moveable arm 630 without plastically deforming the clasp material. In certain embodiments, the clasp material plastically deforms during opening without reducing or without substantially reducing the pinch force exerted between the fixed and moveable arms in the closed position.

[00437] Preloading the tongue 611 enables the clasp 600 to maintain a pinching or clipping force on the native leaflet when closed. The preloading of the tongue 611 provides a significant advantage over prior art clips that provide little or no pinching force when closed. Additionally, closing the clasp 600 with spring force is a significant improvement over clips that use a one-time locking closure mechanism, as the clasp 600 can be repeatedly opened and closed for repositioning on the leaflet while still maintaining sufficient pinching force when closed. In addition, the spring-loaded clasps also allow for easier removal of the device over time as compared to a device that locks in a closed position (after tissue ingrowth). In one example embodiment, both the clasps and the paddles are spring biased to their closed positions (as opposed to being locked in the closed position), which can allow for easier removal of the device after tissue ingrowth.

[00438] The barbed portion 640 of the moveable arm 630 includes an eyelet 642, barbs 644, and barb supports 646. Positioning the barbed portion of the clasp 600 toward an end of the moveable arm 630 increases the space between the barbs 644 and the fixed arm 610 when the clasp 600 is opened, thereby improving the ability of the clasp 600 to successfully grasp a leaflet during implantation. This distance also allows the barbs 644 to more reliably disengage from the leaflet for repositioning. In certain embodiments, the barbs of the clasps can be staggered longitudinally to further distribute pinch forces and local leaflet stress.

[00439] The barbs 644 are laterally spaced apart at the same distance from the joint portion 620, providing a superior distribution of pinching forces on the leaflet tissue while also making the clasp more robust to leaflet grasp than barbs arranged in a longitudinal row. In some embodiments, the barbs 644 can be staggered to further distribute pinch forces and local leaflet stress.

[00440] The barbs 644 are formed from the bottom layer 604 and the 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 the barbs 644 only in one of the two layers 602, 604 allows the barbs to be thinner and therefore effectively sharper than a barb formed from the same material that is twice as thick. The barb supports 646 extend along a lower portion of the barbs 644 to stiffen the barbs 644, further improving penetration and retention of the leaflet tissue. In certain embodiments, the ends of the barbs 644 are further sharpened using any suitable sharpening means.

[00441] The barbs 644 are angled away from the moveable arm 630 such that they easily penetrate tissue of the native leaflets with minimal pinching or clipping force. The barbs 644 extend from the moveable 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 further benefits, in that force pulling the implant off the native leaflet will encourage the barbs 644 to further engage the tissue, thereby ensuring better retention. Retention of the leaflet in the clasp 600 can be further improved by the position of the T-shaped cross bar 614 near the barbs 644 when the clasp 600 is closed. In this arrangement, the tissue pierced by the barbs 644 is pinched against the moveable arm 630 at the cross bar 614 location, thereby forming the tissue into an S-shaped torturous path as it passes over the barbs 644. Thus, forces pulling the leaflet away from the clasp 600 will encourage the tissue to further engage the barbs 644 before the leaflets can escape. For example, leaflet tension during diastole can encourage the barbs to pull toward the end portion of the leaflet. The S- shaped path can utilize the leaflet tension during diastole to more tightly engage the leaflets with the barbs.

[00442] Each layer 602, 604 of the clasp 600 is laser cut from a sheet of shape-memory alloy, such as Nitinol. The top layer 602 is aligned and attached to the bottom layer 604. In certain embodiments, the layers 602, 604 are attached at the barbed portion 640 of the moveable arm 630. For example, the layers 602, 604 can be attached only at the barbed portion 640, to allow the remainder of the layers to slide relative to one another. Portions of the combined layers 602, 604, such as a fixed arm 610, barbs 644 and barb supports 646, and beam loops 622 are bent into a desired position. The layers 602, 604 can be bent and shape-set together or can be bent and shape-set separately and then joined together. The clasp 600 is then subjected to a shape-setting process so that internal forces of the material will tend to return to the set shape after being subjected to deformation by external forces. After shape- setting, the tongue 611 is moved to its preloaded position so that the cross-bar 614 can be attached. In one example embodiment, the clasp 600 can optionally be completely flattened for delivery through a delivery sheath and allowed to expand once deployed within the heart. The clasp 600 is opened and closed by applying and releasing tension on an actuation line, suture, wire, rod, catheter, or the like (not shown) attached to the moveable arm 630. In some embodiments, the actuation line or suture is inserted through an eyelet 642 near the barbed portion 640 of the moveable arm 630 and wraps around the moveable 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 loop. An alternate embodiment of the intermediate loop can be composed of fabric or another material attached to the movable arm, instead of a suture loop.

[00443] An intermediate loop of suture material reduces friction experienced by the actuation line / suture relative to the friction between the actuation line / suture and the clasp material. When the suture is looped through the eyelet 642 or intermediate loop, both ends of the actuation line / suture extend back into and through a 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 pulls through the eyelet or intermediate loop and back into the delivery sheath.

[00444] Referring now to Figure 34, a close-up view of one of the leaflets 20, 22 grasped by a barbed clasp such as clasps 430, 530 is shown. The leaflet 20, 22 is grasped between the moveable and fixed arms 434, 532 of the clasp 430, 530. As shown in Figure 34, the tissue of the leaflet 20, 22 is not pierced by the barbs 436, 536, though in some embodiments the barbs 436, 536 may partially or fully pierce through the leaflet 20, 22. The angle and height of the barbs 436, 536 relative to the moveable arm 434, 534 helps to secure the leaflet 20, 22 within the clasp 430, 530. In particular, a force pulling the implant off of the native leaflet will encourage the barbs 436, 536 to further engage the tissue, thereby ensuring better retention. Retention of the leaflet 20, 22 in the clasp 430, 530 is further improved by the position of fixed arm 432, 532 near the barbs 436, 536 when the clasp 430, 530 is closed. In this arrangement, the tissue is formed by the fixed arms 432, 532 and the moveable arms 434, 534 and the barbs 436, 536 into an S-shaped torturous path. Thus, forces pulling the leaflet away from the clasp 430, 530 will encourage the tissue to further engage the barbs 436, 536 before the leaflets can escape. For example, as mentioned above, leaflet tension during diastole can encourage the barbs to pull toward the end portion of the leaflet. The S-shaped path can utilize the leaflet tension during diastole to more tightly engage the leaflets with the barbs.

[00445] Referring now to Figures 35-46, the implantable device 500 is shown being delivered and implanted within the native mitral valve MV of the heart H. The methods and steps shown and / or discussed can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g. with the body parts, heart, tissue, etc. being simulated), etc.

[00446] As described above, the device 500 has a covering 540 (see Figure 30) over the coaption element 510, clasps 530, inner paddles 522 and / or the outer paddles 520. The device 500 is deployed from a delivery sheath 502 and includes a coaption portion 504 and an anchor portion 506 including a plurality of anchors 508 (i.e., two in the illustrated embodiment). The coaption portion 504 of the device includes a coaption element 510 for implantation between the leaflets 20, 22 of the native mitral valve MV that is slidably attached to an actuation element or means for actuation 512. Actuation of the actuation element or means for actuation 512 opens and closes the anchors 508 of the device 500 to grasp the mitral valve leaflets 20, 22 during implantation.

[00447] The anchors 508 of the device 500 include outer paddles 520 and inner paddles 522 that are flexibly connected to the cap 514 and the coaption element 510. The actuation element 512 extends through a capture mechanism 503 (see Figure 41), delivery sheath 502, and the coaption element 510 to the cap 514 connected to the anchor portion 506. Extending and retracting the actuation element 512 increases and decreases the spacing between the coaption element 510 and the cap 514, respectively. In the example illustrated by Figures 35-46, the pair of inner and outer paddles 522, 520 are moved in unison, rather than independently, by a single actuation element 512. Also, the positions of the clasps 530 are dependent on the positions of the paddles 522, 520. For example, referring to Figure 45 closing the paddles 522, 520 also closes the clasps. In one example embodiment, the device 500 can be made to have the paddles 520, 522 be independently controllable in the same manner as the Figure 11A embodiment.

[00448] Fingers of the capture mechanism 503 removably attach the collar 511 to the delivery sheath 502. The collar 511 and the coaption 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, such that removal of the actuation element 512 allows the fingers of the capture mechanism 503 to open, releasing the collar 511, and thus the coaption element 510.

[00449] In some embodiments, the coaption element 510 and paddles 520, 522 are formed from a flexible material that can be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable way or a laser cut or otherwise cut flexible material. The flexible material can be cloth, shape- memory alloy wire—such as Nitinol—to provide shape-setting capability, or any other flexible material suitable for implantation in the human body. Other configurations are also possible.

[00450] The barbed clasps 530 include a base or fixed arm 532, a moveable arm 534, barbs 536 (see Figure 41), and a joint portion 538. The fixed arms 532 are attached to the inner paddles 522, with the joint portions 538 disposed proximate the coaption element 510. Sutures (not shown) attach the fixed arms 532 to the inner paddles 522. The fixed arms 532 can be attached to the inner paddles 522 and / or another portion of the device with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, or the like. The fixed arms 532 remain stationary or substantially stationary when the moveable arms 534 are opened to open the barbed clasps 530 and expose the barbs 536. The barbed clasps 530 are opened by applying tension to clasp control members or actuation lines 537 attached to the moveable arms 534, thereby causing the moveable arms 534 to pivot or flex on the joint portions 538.

[00451] During implantation, the anchors 508 are opened and closed to grasp the native valve leaflets between the paddles 520, 522 and the coaption element 510. The outer paddles 520 have a wide curved shape that fits around the curved shape of the coaption element 510 to more securely grip the leaflets 20, 22. The curved shape and rounded edges of the outer paddle 520 also prohibits tearing of the leaflet tissue. The barbed clasps 530 further secure the native leaflets by engaging the leaflets with barbs 536 and pinching the leaflets between the moveable and fixed arms 534, 532. The barbs 536 of the barbed clasps 530 increase friction with the leaflets or may partially or completely puncture the leaflets. The actuation lines can be actuated separately so that each barbed clasp 530 can be opened and closed separately. Separate operation allows one leaflet to be grasped at a time, or for the repositioning of a clasp 530 on a leaflet that was insufficiently grasped, without altering a successful grasp on the other leaflet. The barbed clasps 530 can be fully opened and closed when the inner paddle 522 is not closed, thereby allowing leaflets to be grasped in a variety of positions as the particular situation requires.

[00452] The device 500 is loaded in the delivery sheath in the 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). Referring now to Figure 35, the delivery sheath is inserted into the left atrium LA through the septum and the device 500 is deployed from the delivery sheath 502 in the fully open condition. The actuation element 512 is then retracted to move the device 500 into the fully closed condition shown in Figures 36–37 and then maneuvered towards the mitral valve MV as shown in Figure 38. Referring now to Figure 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 extended to open the paddles 520, 522 into the partially opened position and the clasp control members or actuation lines 537 are retracted to open the barbed clasps 530 to prepare for leaflet grasp. Next, as shown in Figures 40–41, the partially open device 500 is inserted through the mitral valve MV until leaflets 20, 22 are properly positioned in between the inner paddles 522 and the coaption element 510 and inside the open barbed clasps 530. Figure 42 shows the device 500 with both clasps 530 closed, though the barbs 536 of one clasp 530 missed one of the leaflets 22. As can be seen in Figures 42–44, the out of position clasp 530 is opened and closed again to properly grasp the missed leaflet 22. When both leaflets 20, 22 are grasped properly, the actuation element 512 is retracted to move the device 500 into the fully closed position shown in Figure 45. With the device 500 fully implanted in the native mitral valve MV, the actuation 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 with a mechanical means such as a latch or can be biased to remain closed through the use of spring material, such as steel, and / or shape-memory alloys such as Nitinol. For example, the paddles 520, 522 can be formed of steel or Nitinol shape-memory alloy— produced in a wire, sheet, tubing, or laser sintered powder-and are biased to hold the outer paddles 520 closed around the inner paddles 522, coaption element 510, and the barbed clasps 530 pinched around native leaflets 20,22.

[00453] The device 500 can have a wide variety of different shapes and sizes. Referring to Figures 6 and 6A-6E, in an example embodiment, the coaption element 510 functions as a gap filler in the valve regurgitant orifice, such as the gap 26 in the native valve illustrated by Figure 6. Referring to Figure 6A, since the coaption element 510 is deployed between two opposing valve leaflets 20, 22, the leaflets will not coapt against each other in the area of the coaption element 510, but coapt against the coaption element 510 instead. This reduces the distance the leaflets 20, 22 need to be approximated. A reduction in leaflet approximation distance can result in several advantages. For example, the coaption element and resulting reduced approximation can facilitate repair of severe mitral valve anatomies, such as large gaps in functional valve disease (See for example, Figure 6). Since the coaption element 510 reduces the distance the native valves have to be approximated, the stress in the native valves can be reduced or minimized. Shorter approximation distance of the valve leaflets 20,22 can require less approximation forces which can result in less tension of the leaflets and less diameter reduction of the valve annulus. The smaller reduction of the valve annulus (or no reduction of the valve annulus) can result in less reduction in valve orifice area as compared to a device without a spacer. As a result, the coaption element 510 can reduce the transvalvular gradients.

[00454] In one example embodiment, the paddle frames 524 conform to the shape of the coaption element 510. In one example, if the coaption element 510 is wider than the paddle frames 524, a distance (gap) between the opposing leaflets 20, 22 can be created by the device 500. Referring to Figures 6A-6E, in one example embodiment the paddles are configured to conform to the shape or geometry of the coaption element 510. As a result, the paddles can mate with both the coaption element 510 and the native valve. Referring to Figures 6D and 6E, in one example embodiment the paddles 524 surround the coaption element 510. Thus, when the leaflets 20, 22 are coapted or pressed against the coaption element 510, the leaflets 20, 22 fully surround or "hug" the coaption element 510 in its entirety, thus small leaks on the medial and lateral aspects of the coaption element 510 can be prevented. Figures 6B and 6C illustrate the valve repair device 500 attached to native valve leaflets 20, 22 from the ventricular side of the mitral valve. Figure 6A illustrates the valve repair device 500 attached to mitral valve leaflets 20, 22 from the atrial side of the mitral valve. Referring to Figures 6A and 6B, when the paddles have a geometry that conforms to the geometry of the coaption element 510, the leaflets 20, 22 can coapt around the coaption element and / or along the length of the spacer. Referring to Figure 6E, a schematic atrial view / surgeons view depicts the paddle frames (which would not actually be visible from a true atrial view), conforming to the spacer geometry. The opposing leaflets 20, 22 (the ends of which would also not be visible in the true atrial view) being approximated by the paddles, to fully surround or "hug" the coaption element 510.

[00455] Referring to Figures 6B-6E, because the paddle frames 524 conform to the shape of the coaption element 510, the valve leaflets 20, 22 can be coapted completely around the coaption element by the paddle frames 524, including on the lateral and medial aspects 601, 603 of the coaption element 510. This coaption of the leaflets 20, 22 against the lateral and medial aspects of the coaption element 510 would seem to contradict the statement above that the presence of a coaption element 510 minimizes the distance the leaflets need to be approximated. However, the distance the leaflets 20, 22 need to be approximated is still minimized if the coaption element 510 is placed precisely at a regurgitant gap and the regurgitant gap is less than the width (medial – lateral) of the coaption element 510.

[00456] Referring to Figures 6 A and 6E, the coaption element 510 can take a wide variety of different shapes. In one example embodiment, when viewed from the top (and / or sectional views from the top; see Figures 95-102), the coaption element has an oval shape or an elliptical shape. The oval or elliptical shape can allow the paddle frames 524 conform to the shape of the coaption element and / or can reduce lateral leaks (See Figures 65–83).

[00457] As mentioned above, the coaption element 510 can reduce tension of the opposing leaflets by reducing the distance the leaflets need to be approximated to the coaption element 510 at the positions 601, 603. The reduction of the distance of leaflet approximation at the positions 601, 603 can result in the reduction of leaflet stresses and gradients. In addition, as is also explained above, the native valve leaflets 20, 22 can surround or "hug" the coaption element in order to prevent lateral leaks. In one example embodiment, the geometrical characteristics of the coaption element can be designed to preserve and augment these two characteristics of the device 500. Referring to Figure 2A, as seen from a 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 start receding or spreading apart from each other. The leaflets 20, 22 spread apart in the atrial direction, until each leaflet meets with the mitral annulus.

[00458] In one example embodiment, the valve repair device 500 and its coaption element 510 are designed to conform to the geometrical anatomy of the valve leaflets 20, 22. To achieve valve sealing, the valve repair device 500 can be designed to coapt the native leaflets to the coaption element, completely around the coaption element, including at the medial 601 and lateral 603 positions of the coaption element 510. Additionally, a reduction on forces required to bring the leaflets into contact with the coaption element 510 at the positions 601, 603 can minimize leaflet stress and gradients. Figure 2B shows how a tapered or triangular shape of a coaption element 510 will naturally adapt to the native valve geometry and to its expanding leaflet nature (toward the annulus).

[00459] Figure 6D illustrates the geometry of the coaption element 510 and the paddle frame 524 from an LVOT perspective. As can be seen in this view, the coaption element 510 has a tapered shape being smaller in dimension in the area closer to where the inside surfaces of the leaflets 20, 22 are required to coapt and increase in dimension as the coaption element extends toward the atrium. The depicted native valve geometry is accommodated by a tapered coaption element geometry. Still referring to Figure 6D, the tapered coaption element geometry, in conjunction with the illustrated expanding paddle frame 524 shape (toward the valve annulus) can help to achieve coaptation on the lower end of the leaflets, reduce stress, and minimize transvalvular gradients.

[00460] Referring to Figure 6C, in one example embodiment remaining shapes of the coaption element 510 and the paddle frames 524 can be defined based on an Intra-Commissural view of the native valve and the device 500. Two factors of these shapes are leaflet coaptation against the coaption element 510 and reduction of stress on the leaflets due to the coaption. Referring to Figures 6C and 67, to both coapt the valve leaflets 20, 22 against the coaption element 510 and reduce the stress applied to the valve leaflets 20, 22 by the coaption element 510 and / or the paddles 524, the coaption element 510 can have a round or rounded shape and the paddle frame 524 can have a full radius that spans from one leg of the paddles to the other leg of the paddles. The round shape of the coaption element and / or the illustrated fully rounded shape of the paddle frame will distribute the stresses on the leaflets 20, 22 across a large, curved engagement area 607. For example, in Figure 6C, the force on the leaflets 20, 22 by the paddle frames is spread along the entire rounded length of the paddle frame 524, as the leaflets 20 try to open during the diastole cycle.

[00461] Referring to Figure 67, in one example embodiment, to cooperate with the full rounded shape of the paddle frames 524, and / or in order to maximize leaflet coaptation against the coaption element 510 and leaflet-to-leaflet coaptation at the sides 601, 603 of the coaption element 510, the shape of the coaption element in the intra-commissural view follows a round shape. Referring to Figure 67, the round shape of the coaption element in this view substantially follows or is close to the shape of the paddle frames 524.

[00462] In one example embodiment, the overall shape of the coaption element 510 is an elliptical or oval cross section when seen from the surgeon's view (top view - See Figure 70), a tapered shape or cross section when seen from an LVOT view (side view - See Figure 69), and a substantially round shape or rounded shape when seen from an intra-commissural view (See Figure 68). In one example embodiment, a blend of these three geometries can result in the three-dimensional shape of the illustrated coaption element 510 that achieves the benefits described above.

[00463] In one example embodiment, the dimensions of the coaption element are selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In one example embodiment, the anterior-posterior distance X47B at the top of the spacer is about 5 mm, and the medial-lateral distance X67D of the spacer at its widest is about 10 mm. In one example embodiment, the overall geometry of the device 500 can be based on these two dimensions and the overall shape strategy described above. It should be readily apparent that the use of other anterior-posterior distance anterior-posterior distance X47B and medial- lateral distance X67D as starting points for the device will result in a device having different dimensions. Further, using other dimensions and the shape strategy described above will also result in a device having different dimensions.

[00464] Tables A, B, and C provide examples of values and ranges for dimensions of the device and components of the device for some example embodiments. However, the device can have a wide variety of different shapes and sizes and need not have all or any of the dimensional values or dimensional ranges provided in Tables A, B, and C. Table A provides examples of linear dimensions X in millimeters and ranges of linear dimensions in millimeters for the device and components of the device. Table B provides examples of radius dimensions R in millimeters and ranges of radius dimensions in millimeters for the device and components of the device. Table C provides examples of angular dimensions <semantics>α<annotation encoding="application / x-tex">\alpha< / annotation>< / semantics> in degrees and ranges of angular dimensions in degrees for the device and components of the device. The subscripts for each of the dimensions indicates the drawing in which the dimension first appears. [Image disponible dans le document PDF, Image available in the PDF document]

[0465] [Image disponible dans le document PDF, Image available in the PDF document]

[00468] Referring now to Figures 47–61, an implantable device 500 is shown in various positions and configurations. The implantable device 500 can include any other features for an implantable prosthetic device discussed in the present application, and the device 500 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 the present application).

[00469] The implantable device 500 has a proximal or attachment portion 505, a coaption element 510 (e.g., spacer, etc.), inner anchor portions or inner paddles 522, outer anchor portions or outer paddles 520, anchor extension members or paddle frames 524, and a distal portion 507. The inner paddles 522 are attached (e.g., jointably attached, etc.) between the coaption element 510 and the outer paddles 520. The outer paddles 520 are attached (e.g., jointably attached, etc.) between the inner paddles 522 and the distal portion 507. The paddle frames 524 are attached to the cap 514 at the distal portion 507 and extend to the joint portion 523 between the inner and outer paddles 522, 520. In some embodiments, the paddle frames 524 are formed of a material that is more rigid and stiff than the material forming the paddles 522, 520 so that the paddle frames 524 provide support for the paddles 522, 520. In one example embodiment, the inner paddles 522 are stiff, relatively stiff, rigid, have rigid portions and / or are stiffened by a stiffening member or the fixed portion of the clasps 530. The stiffening of the inner paddle allows the device to move to the various different positions shown and described herein. The inner paddle 522, the outer paddle 520, the coaption can all be interconnected as described herein, such that the device 500 is constrained to the movements and positions shown and described herein.

[00470] Referring now to Figures 47–48, the device 500 is shown in a closed position. When closed, the inner paddles 522 are disposed between the outer paddles 520 and the coaption element 510. In some embodiments, the device 500 includes clasps or gripping members 530 (Figure 48) that can be opened and closed to grasp the native leaflets 20, 22 of the mitral valve MV. The clasps 530 are attached to and move with the inner paddles 522 and are disposed between the inner paddles 522 and the coaption element 510.

[00471] Referring now to Figures 49–51, the device 500 is shown in a partially open position. The device 500 is moved into the partially open position by an actuation element or means for actuation 512 that passes through the attachment portion 505 and coaption element 510 and can removably engage the distal portion 507. The actuation element 512 is extended through the attachment portion 505 such that a distance D between the attachment portion 505 and distal portion 507 increases as the actuation element 512 is extended. In the example illustrated by Figures 49-51, the pair of inner and outer paddles 522, 520 are moved in unison, rather than independently, by a single actuation element 512. Also, the positions of the clasps 530 are dependent on the positions of the paddles 522, 520. For example, referring to Figure 48 closing the paddles 522, 520 also closes the clasps. In one example embodiment, the device 500 can be made to have the paddles 520, 522 be independently controllable in the same manner as the Figure 11A embodiment.

[00472] Extending the actuation element 512 pulls down on the bottom portions of the outer paddles 520 and paddle frames 524. The outer paddles 520 and paddle frames 524 pull down on the inner paddles 522, where the inner paddles 522 are connected to the outer paddles 520 and the paddle frames 524. Because the attachment portion 505 and coaption element 510 are held in place, the inner paddles 522 are caused to flex or pivot in an opening direction. The inner paddles 522, the outer paddles 520, and the paddle frames all flex to the position shown in Figure 49. Opening the paddles 522, 520 and frames 524 forms a gap 520A between the coaption element 510 and the inner paddle 522 that can receive and grasp the native leaflets 20.

[00473] As is described above, some embodiments of the device 500 include clasps or gripping members 530. When the device 500 is partially opened the clasps 530 are exposed. In some embodiments, the closed clasps 530 (Figure 50) can be opened (Figure 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 clasps 530 is limited to the extent that the inner paddle 522 has spread away from the coaption element 510.

[00474] Referring now to Figures 52–54, the device 500 is shown in a laterally extended or open position. The device 500 is moved into the laterally extended or open position by continuing to extend the actuation element 512 described above, thereby increasing the distance D between the attachment portion 505 and distal portion 507. Continuing to extend the actuation element 512 pulls down on the outer paddles 520 and paddle frames 524, thereby causing the inner paddles 522 to spread apart further from the coaption element 510. In the laterally extended or open position, the inner paddles 522 extend horizontally more than in other positions of the device 500 and form an approximately 90-degree angle with the coaption element 510. Similarly, the paddle frames 524 are at their maximum spread position when the device 500 is in the laterally extended or open position. The increased gap 520A formed in the laterally extended or open position allows clasps 530 to open further (Figure 54) before engaging the coaption element 510, thereby increasing the size of the gap 530A.

[00475] Referring now to Figures 55–57, the device 500 is shown in a three-quarters extended position. The device 500 is moved into the three-quarters extended position by continuing to extend the actuation element 512 described above, thereby increasing the distance D between the attachment portion 505 and distal portion 507. Continuing to extend the actuation element 512 pulls down on the outer paddles 520 and paddle frames 524, thereby causing the inner paddles 522 to spread apart further from the coaption element 510. In the three-quarters extended position, the inner paddles 522 are open beyond 90 degrees to an approximately 135-degree angle with the coaption element 510. The paddle frames 524 are less spread than in the laterally extended or open position and begin to move inward toward the actuation element 512 as the actuation element 512 extends further. The outer paddles 520 also flex back toward the actuation element 512. As with the laterally extended or open position, the increased gap 520A formed in the laterally extended or open position allows clasps 530 to open even further (Figure 57), thereby increasing the size of the gap 530A.

[00476] Referring now to Figure 58, the device 500 is shown in an almost fully extended position. The device 500 is moved into the almost fully extended position by continuing to extend the actuation element 512 described above, thereby increasing the distance D between the attachment portion 505 and distal portion 507. Continuing to extend the actuation element 512 pulls down on the outer paddles 520 and paddle frames 524, thereby causing the inner paddles 522 to spread apart further from the coaption element 510. In the almost fully extended position the inner paddles 522 begin to approach an approximately 180-degree angle with the coaption element 510. Although the inner paddles move to this position, the outer paddles 520 and the paddle frames 524 never move or flex to or past a ninety- degree angle with respect to the coaption element 510. In the almost fully extended position the inner and outer paddles 522, 520 can have a somewhat curved shape.

[00477] Referring now to Figures 59–61, the device 500 is shown in a fully extended position. The device 500 is moved into the fully extended position by continuing to extend the actuation element 512 described above, thereby increasing the distance D between the attachment portion 505 and distal portion 507 to a maximum distance allowable by the device 500. Continuing to extend the actuation element 512 pulls down on the outer paddles 520 and paddle frames 524, thereby causing the inner paddles 522 to spread apart further from the coaption element 510. The outer paddles 520 and paddle frames 524 move to a position where they are close to the actuation element. In the fully extended position, the inner paddles 522 are open to an approximately 180-degree angle with the coaption element 510. The inner and outer paddles 522, 520 are stretched straight in the fully extended position to form an approximately 180-degree angle between the paddles 522, 520. The fully extended position of the device 500 provides the maximum size of the gap 520A between the paddles, and, in some embodiments, allows clasps 530 to also open fully to approximately 180 degrees (Figure 61) between portions of the clasp 530. The position of the device 500 is the narrowest configuration. Thus, the fully extended position of the device 500 may be a desirable position for bailout of the device 500 from an attempted implantation or may be a desired position for placement of the device in a delivery catheter, or the like.

[00478] Referring now to Figures 47A, 48A-48H, 53A-53C, 54A-54D, 60A-60D, and 61A-61D, an implantable device 500A is shown in various positions and configurations. The implantable device 500A can include any other features for an implantable prosthetic device discussed in the present application, and the device 500A 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 the present application).

[00479] The implantable device 500A has a proximal or attachment portion 505A, a coaption element 510A, inner anchor portions or inner paddles 522A, outer anchor portions or outer paddles 520A, anchor extension members or paddle frames 524A, and a distal portion 507A. The inner paddles 522A are attached (e.g., jointably attached, etc.) between the coaption element 510A, e.g., by joint portions 525A and the outer paddles 520A by joint portions 523A. The outer paddles 520A are attached (e.g., jointably attached, etc.) between the inner paddles 522A, e.g., by joint portions 523A and the distal portion 507 A by joint portions 521 A. The paddle frames 524 A are attached to the cap 514 A (Figure 48A) at the distal portion 507A and extend to the joint portion 523A between the inner and outer paddles 522A, 520A. In some embodiments, the paddle frames 524A are formed of a material that is more rigid and stiff than the material forming the paddles 522A, 520A so that the paddle frames 524A provide support for the paddles 522A, 520A. The paddle frames 524A include an opening or slot 524B for receiving the joint portions 523A (Figure 65A). In some embodiments, the inner paddles 522A are stiff, relatively stiff, rigid, have rigid portions and / or are stiffened by a stiffening member or the fixed portion of the clasps 530C. The stiffening of the inner paddle allows the device to move to the various different positions shown and described herein. The inner paddle 522A, the outer paddle 520A, and the coaption element can all be interconnected as described herein, such that the device 500A is constrained to the movements and positions shown and described herein.

[00480] The coaption element 510A, inner paddles 522A, outer paddles 520A can be attached together by integrally forming the coaption element 510A and the paddles 520A, 522A as a single, unitary component. This can be accomplished, for example, by forming the coaption element 510A and the paddles 520A, 522A from a continuous strip 501A of a braided or woven material, such as braided or woven nitinol wire.

[00481] The continuous strip 501A is attached to a collar 511D, a cap 514A, paddle frames 524A, clasps 530C. In the illustrated embodiment, the coaption element 510A, hinge portions 521A, 523A, 525A, outer paddles 520A, and inner paddles 522A are formed from the continuous strip 501A. The continuous strip 501A can be a single layer of material or can include two or more layers. In certain embodiments, portions of the device 500A have a single layer of the strip of material 501A and other portions are formed from multiple overlapping or overlying layers of the strip of material 501 A. For example, Figure 47A shows the coaption element 510A and inner paddles 522A formed from multiple overlapping or overlying layers of the strip of material 501A. Consequently, the coaption element 510A and inner paddle 522A have an increased stiffness relative to the outer paddles 520A that are formed from a single layer of material 501A. The single continuous strip of material 501A can start and end in various locations of the device 500A. The ends of the strip of material 501A can be in the same location or different locations of the device 500A. For example, in the illustrated embodiment of Figure 47A, the strip of material begins and ends in the location of the inner paddles 522.

[00482] The clasps 530C can comprise attachment or fixed portions 532C, arm or moveable portions 534C, barbs 536C, and joint portions 538C. The attachment or fixed portions 532C can be coupled to the inner paddles 522A in various ways such as with sutures, adhesive, fasteners, welding, stitching, swaging, friction fit and / or other means for coupling with the joint portions 538C disposed proximate the coaption element 510A. The clasps 530C can be similar to clasps 430.

[00483] The moveable portions 534C can pivot or flex relative to the fixed portions 532C between an open configuration (e.g., Figure 54A) and a closed configuration (Figure 48A). In some embodiments, the clasps 530C can be biased to the closed configuration. In the open configuration, the fixed portions 532C and the moveable portions 534C pivot or flex away from each other such that native leaflets can be positioned between the fixed portions 532C and the moveable portions 534C. In the closed configuration, the fixed portions 532C and the moveable portions 534C pivot or flex toward each other, thereby clamping the native leaflets between the fixed portions 532C and the moveable portions 534C. The fixed arms 532C remain stationary or substantially stationary when the moveable arms 534C are opened to open the barbed clasps 530C and expose the barbs 536C. The barbed clasps 530C are opened by applying tension to actuation lines 537A attached to the moveable arms 534C, thereby causing the moveable arms 534C to pivot or flex on the joint portions 538C.

[00484] Referring now to Figures 47A, and 48A–48H, the device 500A is shown in a closed position. A side view of the device 500A is shown in Figures 48B, 48C, and 48F, from a front view in Figures Figure 48D, 48E, and 48G, and from a bottom view in Figure 48H. The device 500A is narrower when viewed from the front than 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 rectangle shape that tapers somewhat toward the distal portion 507 A. As can be seen from the bottom view of the device 500 A shown in Figure 48H, the device 500 A has a generally rounded rectangle shape when viewed from below (and when viewed from above as can be seen in, for example, Figure 70A).

[00485] In the closed configuration of the device 500A, the inner paddles 522A are disposed between the outer paddles 520A and the coaption element 510A. In some embodiments, the device 500A includes clasps or gripping members 530C (Figure 48A) that can be opened and closed to grasp the native leaflets 20, 22 of the mitral valve MV. The clasps 530C are attached to and move with the inner paddles 522A and are disposed between the inner paddles 522A and the coaption element 510A.

[00486] Referring now to Figures 48B-48D, the device 500A is shown attached to a delivery device 502A. The delivery device 502A has actuatable members or fingers 503A that releasably engage the attachment portion 505A. An actuation element 512A extends from the delivery device 502A to the cap 514A through the attachment portion 505A and coaption element 510A of the prosthetic device 500A. Extending and retracting the actuation element 512A causes the device 500A to open and close, as is described below. Actuation lines / sutures 537A extend from the delivery device 502A to attach to the clasps 530C. Tension can be applied to the sutures 537A to open the clasps 530C and released to allow the clasps 530C to close. The device 500A is shown separated from the delivery device 502A in a deployed condition in Figures 48F–48G.

[00487] Referring now to Figures 48C and 48E, the device 500A is shown with a cover 540A. The cover 540A can be formed from a single piece of material, or from multiple segments abutting or joined to each other. In the illustrated embodiment, the cover 540A has an outer or lower cover 541A and an inner or upper cover 543A. The outer cover 541A covers the cap 514A, outer paddles 520A, inner paddles 522A, and clasps 530C. The inner cover 543A covers the coaption element 510A and the proximal ends of the inner paddles 522A and clasps 530C where the coaption element 510A meets the inner paddles 522A and clasps 530C. The cover 540A can be a cloth material such as polyethylene cloth of a fine mesh. The cloth cover can provide a blood seal on the surface of the spacer, and / or promote rapid tissue ingrowth.

[00488] Referring now to Figures 53A-53D and 54A-54D, the device 500A is shown in a laterally extended or open position. The device 500A is moved into the open position by the actuation element or means for actuation 512A that passes through the attachment portion 505A and coaption element 510A and can removably engage the distal portion 507A. The actuation element 512A is extended through the attachment portion 505A such that a distance D2 between the attachment portion 505A and distal portion 507A increases as the actuation element 512A is extended. In the example illustrated by Figures 53A–53D and 54A–54D, the pair of inner and outer paddles 520A, 522A are moved in unison, rather than independently, by a single actuation element 512A. Also, the positions of the clasps 530C are dependent on the positions of the paddles 520A, 522A. For example, referring to Figure 48A closing the paddles 520A, 522A also closes the clasps 530C. In one example embodiment, the device 500A can be made to have the paddles 520A, 522A be independently controllable in the same manner as the Figure 11A embodiment.

[00489] Extending the actuation element 512A pulls down on the bottom portions of the outer paddles 520A and paddle frames 524A to transition the device 500A from a closed to partially open position. The outer paddles 520A and paddle frames 524A pull down on the inner paddles 522A where the inner paddles 522A are connected to the outer paddles 520A and the paddle frames 524A. Because the attachment portion 505A and coaption element 510A are held in place, the inner paddles 522A are caused to pivot or flex in an opening direction. The inner paddles 522A, the outer paddles 520A, and the paddle frames all flex to the position shown in Figure 53A. Opening the paddles 522A, 520A and frames 524 forms a gap 520D between the coaption element 510A and the inner paddle 522A that can receive and grasp the native leaflets 20.

[00490] Continuing to extend the actuation element 512A pulls down on the outer paddles 520A and paddle frames 524A, thereby causing the inner paddles 522A to spread apart further from the coaption element 510A. In the laterally extended or open position, the inner paddles 522A extend horizontally more than in other positions of the device 500A and form an approximately 90-degree angle with the coaption element 510A. Similarly, the paddle frames 524A are at their maximum spread position when the device 500A is in the laterally extended or open position. The increased gap 520D formed in the laterally extended or open position allows clasps 530C to open further (Figure 54A) before engaging the coaption element 510A, thereby increasing the size of the gap 530D as compared to the partially open position.

[00491] As is described above, some embodiments of the device 500A include clasps or gripping members 530C. When the device 500A is opened the clasps 530C are exposed. In some embodiments, the closed clasps 530C (Figures 53A-53D) can be opened (Figures 54A-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 clasps 530C is limited to the extent that the inner paddle 522A has spread away from the coaption element 510A.

[00492] Referring now to Figures 60A-60D and 61A-61D, the device 500A is shown in a fully extended position. The device 500A is moved into the fully extended position by continuing to extend the actuation element 512A described above, thereby increasing the distance D2 between the attachment portion 505A and distal portion 507A to a maximum distance allowable by the device 500A. Continuing to extend the actuation element 512A pulls down on the outer paddles 520A and paddle frames 524A, thereby causing the inner paddles 522A to extend further away from the coaption element 510A. The outer paddles 520A and paddle frames 524A move to a position where they are close to the actuation element. In the fully extended position, the inner paddles 522A are open to an approximately 180-degree angle with the coaption element 510A. The inner and outer paddles 522A, 520A are stretched straight or substantially straight in the fully extended position to form an approximately 180-degree angle between the paddles 522A, 520A. The fully extended position of the device 500A provides the maximum size of the gap 520D between the paddles, and, in some embodiments, allows clasps 530C to also open fully to approximately 180 degrees (Figure 61A) between portions of the clasp 530C. The position of the device 500A is the narrowest configuration. Thus, the fully extended position of the device 500A may be a desirable position for bailout of the device 500A from an attempted implantation or may be a desired position for placement of the device in a delivery catheter, or the like.

[00493] Referring now to Figures 197–198, enlarged views of portions of Figure 60C are shown. Referring now to Figure 197, the inner cover 543A can be seen covering the coaption element 510A from the proximal portion 519B to the distal portion 517A. In some embodiments, the inner cover 543A is formed from a flat sheet (see Figure 201) of a cloth material such as polyethylene cloth of a fine mesh and is folded around the coaption element 510A and held in place by stitches 545A. Referring now to Figure 198, the outer cover 541A can be seen covering the clasps 530C and inner paddles 522A. Collar portions 548A of inner cover 543A cover the portion of the clasps 530C and inner paddles 522A closest to the coaption element 510A. Transition portions 547A of the inner cover 543 Aextend from the coaption element 510 A to the collar portions 548 A to provide a smooth transition between the coaption element 510A and the clasps 530C and inner paddles 522A so that native tissue is not caught on the device 500A during implantation.

[00494] Referring now to Figure 199, an exploded view of the device 500A is shown. The coaption element 510A, outer paddles 520A, and inner paddles 522A are formed from a single strip of material 501 A, as described above. The collar 511D, cap 514A, paddle frames 524A, and clasps 530C are assembled to the strip of material 501A to form the device 500A. The cap 514A includes a retention body 560A with a locking aperture 561A for receiving a retaining nut 562A having a threaded bore 564A that engages 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 retention body and nut 560A, 562A to attach the cap 514A to the strip of material 501A.

[00495] In some embodiments, a stiffening member 539C is attached to the inner paddle 522A to stiffen the inner paddle 522 A to maintain the inner paddle in a straight or substantially straight configuration as the inner paddle is moved between the various positions. A cutout 539D in the stiffening member 539C is shaped to receive the fixed arm 532C of the clasp 530C so that the stiffening member 539C can fit around the fixed arm 532C when both the stiffening member 539C and clasp 530C are attached to the inner paddle 522A. Like the fixed arm 532C, the stiffening member 539C can be coupled to the inner paddles 522A in various ways such as with sutures, adhesive, fasteners, welding, stitching, swaging, friction fit and / or other means for coupling.

[00496] Referring now to Figure 200, an enlarged view of the collar 511D attached to the proximal portion 519B of the coaption element 510A is shown. The collar 511D includes protrusions 511B for releasably engaging the fingers 503A of the delivery device 502A. An aperture 515A in the collar 511D receives the actuation element 512A. The proximal portion 519B of the coaption element 510A flares outward to form two loops 519D that are inserted through the arcuate openings 513A of the collar 511D to attach the collar 511D to the proximal portion 519B of the coaption element 510A. The loops 519D are formed by folding the strip of material 501A to form first and second layers 581A, 582A.

[00497] Referring now to Figures 201–202, enlarged and exploded views of the cap 514A are shown, respectively. Figure 201 shows an enlarged view of the cap 514A attached to the distal portion 527A of the strip of material 501A. The retention body 560A, retaining nut 562A, and retaining bolt 566 A cooperate to attach the paddle frames 524 A to the distal portion 527 A of the strip of material 501 A. In particular, the retaining bolt 566 A is inserted through the opening 527B of the distal portion 527A (Figure 202) to prohibit movement of the cap 514A along the strip of material 501A. A channel 560B in the retention body 560A and a flange 567A of the bolt 566A form a passageway 514B through the cap 514A for the distal portion 527A.

[00498] Referring now to Figure 202, the components of the cap 514A are shown in an exploded view to better illustrate the features of the components of the cap 514A and paddle frames 524A and to show how those features interlock during assembly of the cap 514A to the distal portion 527 A. Forming the cap 514A from multiple components that can be assembled around the strip of material 501A allows the cap 514A to be attached after the strip of material 501A has been folded to form the coaption element 510A and paddles 520A, 522A and been woven through the collar 511D and paddle frames 524A.

[00499] The retention body 560A includes a locking aperture 561A for receiving the retaining nut 562A. The locking aperture 561A has a generally rectangular shape and includes two opposing locking channels 561B that receive the attachment portions 524C of the paddle frames 524A. A transverse locking channel 561C formed in the bottom of the retention body 560A has the same width as the locking channels 561B. The paddle frames 524A include notches 524D in the attachment portions 524C that form hook portions 524E that engage the transverse locking channel 561C to secure the paddle frames 524A to the cap 514A.

[00500] The retaining nut 562A includes a rectangular locking body 563A extending distally from a flange 563B. The locking body 563A is configured to slidably engage the locking aperture 561A of the retention body 560A while leaving the locking channels 561B unobstructed. Thus, the locking body 563A can be inserted into the locking aperture 561A to lock the attachment portions 524C of the paddle frames 524A within the locking channels 561B. Notches 563C in the flange 563B accommodate the attachment portions 524C of the paddle frames 524A. The threaded bore 564A is formed through the retaining nut 562A to receive the retaining bolt 566A.

[00501] The retaining bolt 566 A includes a threaded portion 568 A extending from the flange 567 A. The threaded portion 568A is inserted through the opening 527B in the distal portion 527A to threadedly engage the threaded bore 564A of the retaining nut 562A. The flange 567A has a rounded shape that provides a rounded end to the distal portion 507A of the device 500A. The flange 567A includes openings 567B for receiving a tool (not shown) that engages the bolt 566A so that the bolt 566A can be turned during assembly to couple the components of the cap 514A together.

[00502] To assemble the paddle frames 524A and cap 514A to the distal portion 527A, the paddle frames 524A are squeezed to narrow the width of the attachment portion 524C so that the attachment portions 524C can be inserted into the locking channels 561B of the locking aperture 561A. When the paddle frames 524A are allowed to expand, the attachment portions 524C expand outward so that the notches 524D engage the retention body 560A and the hook portions 524E engage the transverse locking channel 561C. The retaining nut 562A is then inserted into the locking aperture 561A with the locking portion 563A arranged between the two attachment portions 524C of each paddle frame 524A, thereby locking the paddle frames 524A in engagement with the retention body 560A. The assembled paddle frames 524A, retention body 560A, and retaining nut 562A are placed on the distal portion 527A so that the threaded bore 564A aligns with the opening 527B and the threaded portion 568A of the bolt 566A is inserted through the opening 527B to threadedly engage the threaded bore 564A. The bolt 566A is then tightened until the flange 567A engages the retention body 560A and the cap 514A is securely assembled to the distal portion 527A.

[00503] Referring now to Figures 203 and 204, portions of the cover 540A are shown cut from flat sheets of material. The cover 540A includes the outer cover 541A and the inner cover 543A. Each of the covers 541A, 543A include different 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 catch points and provide a smoother exterior to the device 500.

[00504] The various segments of the covers 541A, 543A extend from a middle portion that is shaped to attach to an end of the device 500A. In other embodiments, the portion of the cover 541A, 543A that attaches to an end of the device 500A is located at an end of the covers 541A, 543A or can be located anywhere between the middle and ends of the covers 541A, 543A. Various portions of the covers 541A, 543A can be shaped to wrap around portions of the device 500A. The cover 540A can be made of any suitable material, such as a polyethylene cloth of a fine mesh. In certain embodiments, the cover is formed out of a single piece of material. In other embodiments, the cover can be formed of any number of pieces of material that are attached to the device and / or joined together by any suitable means, such as by stitching, adhesives, welding, or the like.

[00505] Referring to Figures 60C and 204, the outer cover 541A extends outward from a middle portion 580 to end portions 588. The middle portion 580 is shaped to be attached to the cap 514A of the device 500A. Outer paddle portions 582 extend from the middle portion 580 to inner paddle and inside clasp portions 584. The inner paddle and inside clasp portions 584 extend from the outer paddle portions 582 to outside moveable clasp portions 586. The outside moveable clasp portions 586 extend from the inner paddle portions 584 to the end portions 588.

[00506] The outer paddle portions 582 include wing portions 583 that extend laterally to a width that is wider than the other portions of the outer cover 541A so that the outer paddle portions 582 can attach to the outer paddles 520A and paddle frames 524A of the device 500A. The inner paddle portions 584 attach to the inner paddles 522A, stationary arms 532C, and the inside surface (the side with the barbs) of the moveable arms 534C. The outside clasp portions 586 attach to the outside surface (the side without the barbs) of the moveable arms 534C of the clasps 530C. The ends 588 of the outer cover 541 A terminate near the joint portion 538C of the clasp 530C on the outside of the clasps 530C. The inner paddle and inside clasp portions 584 include openings 585 that allow the barbs 536C of the clasps 530C to protrude through the outer cover 541A to engage tissue of the native heart valve.

[00507] Referring to Figures 60C and 203, the inner cover 543 A extends outward from a middle portion 590 to end portions 598. The middle portion 590 is configured to be attached to the collar 511D of the device 500A. Openings 591 in the middle portion 590 expose the protrusions 511E from the collar 511D when the middle portion 590 is attached to the collar 511D so that the protrusions 511E can be engaged by the delivery device 502A. Coaption portions 592 extend from the middle portion 590 to flexible hinge portions 594. Holes 593 along the edges of the coaption portions 592 allow each of the coaption portions 592 to be joined together after being folded around the coaption element 510A, such as, for example, by stitches 545A. The flexible hinge portions 594 extend from the coaption portions 592 to transition portions 596. The transition portions 596 extend from the flexible hinge portions 594 to the end portions 598. Holes 597 along the edges of the transition portions 596 allow each of the transition portions 596 to be wrapped around the inner paddle 522A and ends of the clasp 530C and secured to itself by stitches or other suitable securing means. The flexible hinge portions 594 bridge the gaps between the coaption element 510A and the clasps 530C when the device 500A is opened, as can be seen in Figure 198.

[00508] Referring now to Figures 62A–64C, an implantable device 700 is shown. The implantable device 700 has paddles 702 that open and close to grasp leaflets 20, 22 against barbed clasps or gripping devices 704. The paddles 702 move to create an opening 706 between the paddles 702 and gripping devices 704 in which the leaflets 20, 22 can be grasped. The device 700 can be configured to close a wide gap 26 (Figure 6) in the native heart valve MV, TV. In addition, the implantable device 700 can include any other features for a device discussed in the present application, and the device 700 can be positioned to engage 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 can include any other features for an implantable prosthetic device discussed in the present application, and the device 700 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 the present application).

[00509] Referring to Figure 62A, the paddles 702 of the device 700 are moved, rotated, or pivoted outward in the direction X to create an opening 706 between the paddles 702 and the gripping members 704 having a width W. The width W can be, for example, between about 5 mm and about 15 mm, such as between 7.5 mm and about 12.5 mm, such as about 10 mm. In alternative embodiments, the width W can be less than 5 mm or greater than 15 mm.

[00510] Referring to Figure 62B, the paddles 702 of the device 700 are moved outward in the direction Z such that the opening 706 has a width H. The width H can be, for example, between about 10 mm and about 25 mm, such as between about 10 mm and about 20 mm, such as between about 12.5 mm and about 17.5 mm, such as about 15 mm. In some embodiments, the width H can be less than 10 mm or more than 25 mm. In certain embodiments, the ratio between the width H and the width W can be about 5 to 1 or less, such as about 4 to 1 or less such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1 or less, such as about 1.25 to 1 or less, such as about 1 to 1. The device 700 can be configured such that the paddles 702 are moved, rotated, or pivoted outward in the direction X and then moved outward in the direction Z to create the opening 706 having a width H between the paddles 702 and the gripping members 704. Optionally, the device 700 can be configured such that the paddles are moved outward in the direction Z and then moved or pivoted outward in the direction X to create width H between the paddles 702 and gripping members 704. In addition, the device 700 can be configured such that the paddles 702 are moved or pivoted outward in the direction X and moved outward in the direction Z simultaneously to create the width H between the paddles 702 and the gripping members 704.

[00511] Figures 63A–63C illustrate an implantable device 700 in which the paddles 702 are moved, rotated, or pivoted outward in the direction X, and, subsequently, moved outward in the direction Z to create a wider opening 706. Figure 63A illustrates the implantable device 700 in a closed position, such that the paddles 702 are engaging the gripping members 704. Referring to Figure 63B, the paddles 702 are moved or pivoted outward in the direction X to create an opening 706 having a width W for receiving valve tissue. Referring to Figure 63C, after the paddles 702 are moved or pivoted outward in the direction X, the paddles 702 are moved outward in the direction Z such that the opening 706 has a width H. After valve tissue is received in the openings 706 between the paddles 702 and the gripping members 704, the valve repair device is moved back to the closed position (as shown in Figure 63A) to secure the valve repair device 700 to the valve tissue. The implantable device 700 can include any other features for an implantable device discussed in the present application, and the implantable device 700 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 the present application).

[00512] Figures 64A–64C illustrate an implantable device 700 in which the paddles 702 are moved outward in the direction Z, and, subsequently, moved, extended, or pivoted outward in the direction X to create a wider opening 706. Figure 64A illustrates the implantable device 700 in a closed position, such that the paddles 702 are engaging the gripping members 704. Referring to Figure 64B, the paddles 702 are moved outward in the direction Z to create an opening 706 having a width W for receiving valve tissue. Referring to Figure 64C, after the paddles 702 are moved outward in the direction Z, the paddles 702 are moved or pivoted outward in the direction X such that the opening 706 has a width H. After valve tissue is received in the openings 706 between the paddles 702 and the gripping members 704, the implantable device 700 is moved back to the closed position (as shown in Figure 64A) to secure the implantable device 700 to the valve tissue. The implantable device 700 can include any other features for an implantable device discussed in the present application, and the implantable device 700 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 the present application).

[00513] While Figures 63A–63C illustrate a device 700 in which the paddles 702 are moved or pivoted and then spread apart, and Figures 64A–64C illustrate a device 700 in which the paddles 702 are spread apart and then moved or pivoted, in alternative embodiments, a device 700 can include paddles 702 that can be spread apart and moved or pivoted simultaneously. In addition, in certain embodiments, the paddles 702 can be spread apart and moved or pivoted independently of each other. That is, in the embodiments for the valve repair device 700 shown in Figures 63A–63C and 64A–64C, as well as the embodiment in which the spreading apart and moving or pivoting of each paddle 702 is completed simultaneously, the paddles 702 can be controlled independently of each other.

[00514] Referring now to Figures 65–83, the example implantable device 500 is shown in the closed condition. Referring now to Figures 65–66, the device 500 extends from a proximal portion 505 to a distal portion 507 and includes a coaption portion 510, inner paddles 522, outer paddles 520, and paddle frames 524. In some embodiments, the outer paddles 520 extend to and / or around the paddle frames 524 and can have more than one layer to surround the paddle frames 524. The proximal portion 505 can include a collar 511 for attaching a delivery device (not shown). The distal portion 507 can include a cap 514 that is attached (e.g., jointably attached, etc.) to the outer paddles 520 and is engaged by an actuation element (not shown) to open and close the device 500 to facilitate implantation in the native valve as described in the present application.

[00515] Referring now to Figures 67–68, a front view of the device 500 is shown. The device 500 has a shape that is symmetrical or substantially symmetrical around a vertical front-to-back plane 550 and is generally narrower at the distal portion 507 than the proximal portion 505. The shape of the coaption element 510 and paddle frames 524 is rounded or generally rounded to prevent the device 500 from catching or snagging on structures of the heart, such as the chordae tendineae, during implantation. For this reason, the proximal collar 511 (Figure 68) and cap 514 (Figure 68) also have round edges. When viewed from the front or back, the paddle frames 524 can be seen to have a rounded or generally rounded shape, extending upwards and outwards from the distal portion 507 to approximately coincide with the shape of the coaption element 510 when viewed from the front or back. Thus, the coaption element 510 and paddle frames 524 generally define the shape of the device 500 when viewed from the front or back. In addition, the rounded shape of the paddle frames 524 and the corresponding rounded shape of the coaption element can distribute leaflet stress across a wider surface. In some example embodiments, the paddle frames 524 and / or the coaption element 510 can have other shapes.

[00516] Referring now to Figure 69, a side view of the device 500 is shown. As with the front and back views (Figures 67–68), the device 500 has a shape that is symmetrical or substantially symmetrical around a vertical side-to-side plane 552 when viewed from the side. The distal portion 507 is also generally narrower than the proximal portion 505 when the device 500 is viewed from the side. The coaption element 510 optionally also has a tapering or generally tapering shape that narrows toward the distal portion 507 of the device 500. However, in some example embodiments, the coaption element does not taper as it extends from the proximal portion of the device to the distal portion of the device.

[00517] The rounded features of the device 500 are further demonstrated by the round shape of the paddles 520, 522 where the inner and outer paddles 520, 522 are joined together and the round shape of the paddle frames 524. However, the paddles 520, 522 and paddle frames 524 can take a wide variety of different forms. For example, the paddles 520, 522 and the paddle frames 524 can be rounded along the top edges but be flat or substantially flat on the sides of the paddles 520, 522 and / or the paddle frames. 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 leaflet, with the two devices sitting flush or substantially flush against each other.

[00518] The closed paddles 520, 522 form gaps 542 between the inner paddles 522 and the coaption element 510 that are configured to receive native tissue. As can be seen in Figure 69, the narrowing of the coaption element 510 gives the gaps 542 a somewhat teardrop shape that increases in width as the gaps 542 approach the distal portion 507 of the device. The widening of the gaps 542 toward the distal portion 507 allows the paddles 520, 522 to contact tissue grasped in the gaps 542 nearer to the proximal portion 505.

[00519] The paddle frames 524 extend vertically from the distal portion 507 toward the proximal portion 505 until approximately a middle third of the device 500 before bending or flaring outward so that the connection portion of the frames 524 passes through gaps 544 formed by the inner paddles 522 folded inside of the outer paddles 520. However, in other embodiments the connection of the frames are positioned inside the inner paddles 522 or outside the outer paddles 520. The outer paddles 520 have a rounded shape that is similar to that of the coaption element 510 when viewed from the front or back (Figures 67–68). Thus, the device 500 has a rounded shape or substantially round shape. The round shape of the device 500 is particularly visible when the device 500 is viewed from the top (Figures 70–71) or bottom (Figures 72–73).

[00520] Referring now to Figures 70–71, top views of the device 500 are shown. The device 500 has a shape that is symmetrical or substantially symmetrical around a front-to-back plane 550 and is also symmetrical or substantially symmetrical around a side-to-side plane 552 when viewed from the top. An opening 519A in the coaption element 510 is visible at the proximal portion 505 of the device 500. As can be seen in Figure 70, the coaption element 510 can be hollow inside. The proximal collar 511 shown in Figure 71 can be secured to the coaption element 510 to close off the coaption element 510.

[00521] In one example embodiment, the coaption element is not planar and has all curved surfaces. For example, the coaption elements 510 illustrated herein can be formed of a series of blended surfaces have a variety of different radii of curvature. The coaption element 510 has an oval or generally oval- shape when viewed from the top. However, in some example embodiments, the coaption element 510 can have other shapes when viewed from the top. For example, the coaption element can have a rectangular, square, diamond, elliptical, or any other shape. The paddle frames 224 each have an arcuate shape with a smaller radius than the coaption element 510 so that the gaps 542 formed between the inner paddles 522 and paddle frames 524 and the coaption element 510 taper as they approach left 551 and right 553 sides of the device 500. Thus, native tissue, such as the leaflets 20, 22 tend to be pinched between the paddle frames 524 and the coaption element 510 towards the left and right sides 551, 553 of the device 500.

[00522] Referring now to Figures 72–73, bottom views of the device 500 are shown. As with the top views (Figures 70–71), the device 500 has a shape that is symmetrical or substantially symmetrical around the front-to-back plane 550 and is also symmetrical or substantially symmetrical around the side-to-side plane 552 when viewed from the bottom. The cap 514 is shown in Figure 73 and can jointably attach to the outer paddles 520 and the paddle frames 524.

[00523] The paddle frames 524 extend outward from the distal portion 507 of the device 500 to the left and right sides 551, 553 at a narrow or slight angle from the side-to-side plane 552. The paddle frames 524 extend further away from the side-to-side plane 552 as the paddle frames 524 extend toward the proximal portion of the device 500 (Figure 69) to ultimately form the arcuate shape seen in Figures 70–71.

[00524] Referring now to Figures 74–83, perspective and cross-sectional views of the device 500 are shown. Referring now to Figure 74, the device 500 is shown sliced by cross-section plane 75 near the proximal portion of the coaption element 510. Referring now to Figure 75, a cross-sectional view of the device 500 is shown as viewed from cross-section plane 75 in Figure 74. At the location of the plane 75, the coaption element 510 has a round or generally round shape with lobes arranged along the front-to-back plane 550. The gaps 542 between the paddle frames 524 and coaption element 510 form a crescent-like shape with a central width 543. As noted above, the gaps 542 narrow as the gaps 542 approach the left and right sides 551, 553.

[00525] Referring now to Figure 76, the device 500 is shown sliced by cross-section plane 77 positioned about three-quarters of the way between the distal portion 507 and the proximal portion 505 of the coaption element 510. Referring now to Figure 77, a cross-sectional view of the device 500 is shown as viewed from cross-section plane 77 in Figure 76. At the location of the plane 75, the coaption element 510 has an oval or generally oval shape oriented along the side-to-side plane 552. The gaps 542 between the paddle frames 524 and coaption element 510 form a crescent or crescent-like shape with a central width 543 that is less than the central width 543 seen in Figure 75. At the location of the plane 77, the width 543 of the gaps 542 is narrower towards the center of the device, widens somewhat as the gaps 542 approach the left and right sides 551, 553 before narrowing again. Thus, the native tissue is pinched in the center of the gaps 542 about three-quarters of the way up the coaption element 510.

[00526] Referring now to Figure 78, the device 500 is shown sliced by cross-section plane 79 positioned about half of the way between the distal portion 507 and the proximal portion 505 of the coaption element 510. Referring now to Figure 79, a cross-sectional view of the device 500 is shown as viewed from cross-section plane 79 in Figure 78. At the location of the plane 79, the coaption element 510 has an oval or generally oval shape oriented along the side-to-side plane 552. The paddle frames 524 can be seen near the left and right sides 551, 553 very close to or in contact with the coaption element 510. The gaps 542 are crescent or generally crescent shaped and are wider than the gaps 542 viewed along the plane 77 (Figure 77.)

[00527] Referring now to Figure 80, the device 500 is shown sliced by cross-section plane 81 positioned about one-quarter of the way between the distal portion 507 and the proximal portion 505 of the coaption element 510. Referring now to Figure 81, a cross-sectional view of the device 500 is shown as viewed from cross-section plane 81 in Figure 80. At the location of the plane 81, the coaption element 510 has an oval or generally oval shape oriented along the side-to-side plane 552 that is narrower than the oval shape seen in Figure 77. The paddle frames 524 can be seen near the left and right sides 551, 553 very close to or in contact with the coaption element 510. The gaps 542 are crescent or generally crescent shaped and are wider than the gaps 542 viewed along the plane 79 (Figure 79.)

[00528] Referring now to Figure 82, the device 500 is shown sliced by cross-section plane 83 positioned near the distal portion 507 of the coaption element 510. Referring now to Figure 83, a cross-sectional view of the device 500 is shown as viewed from cross-section plane 83 in Figure 82. At the location of the plane 83, the coaption element 510 has an oval or generally oval shape oriented along the side- to-side plane 552 that is narrower than the oval shape seen in Figure 79 as the coaption element 510 tapers toward the distal portion 507 of the device 500. The paddle frames 524 can be seen near the left and right sides 551, 553 very close to or in contact with the coaption element 510. While the inner paddles 522 are not visible in Figure 81, the gaps 542 are crescent or generally crescent shaped and are wider than the gaps 542 viewed along the plane 81 (Figure 81.)

[00529] Referring now to Figures 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 the closed condition. Referring now to Figures 65A and 66A, the device 500A extends from a proximal portion 505A to a distal portion 507A and includes a coaption portion 510A, inner paddles 522A, outer paddles 520A, and paddle frames 524A. The proximal portion 505A can include a collar 511D for attaching a delivery device (not shown). The distal portion 507A can include a cap 514A that is attached (e.g., jointably attached, etc.) to the outer paddles 520A and is engaged by an actuation element (not shown) to open and close the device 500A to facilitate implantation in the native valve as described in the present application.

[00530] Referring now to Figures 67A and 68A, front views of the device 500A are shown. The device 500A has a shape that is symmetrical or substantially symmetrical around a vertical front-to-back plane 550A and is generally narrower at the distal portion 507A than along the paddle frames 524A. The shape of the coaption element 510A and paddle frames 524A is a generally rounded rectangular shape to prevent the device 500A from catching or snagging on structures of the heart, such as the chordae tendineae, during implantation. For this reason, the proximal collar 511D (Figure 68A) and cap 514A (Figure 68A) can also have round edges. When viewed from the front or back, the paddle frames 524A can be seen to have a generally rounded rectangular shape, extending upwards and outwards from the distal portion 507A to a shape that has sides that are wider than and approximately parallel to the coaption element 510A when viewed from the front or back. Thus, the paddle frames 524A generally define the shape of the device 500A when viewed from the front or back. In addition, the rounded rectangular shape of the paddle frames 524A can distribute leaflet stress across a wider surface. In some example embodiments, the paddle frames 524A and / or the coaption element 510A can have other shapes.

[00531] As with the front and back views (Figures 67A and 68A), the device 500A has a shape that is symmetrical or substantially symmetrical around a vertical side-to-side plane 552A (Figure 70A) when viewed from the side (e.g., Figure 47A). The distal portion 507A is also generally narrower than the proximal portion 505A when the device 500A is viewed from the side. In the embodiment illustrated in Figure 48B, the coaption element 510A does not taper 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 coaption element does taper as it extends from the proximal portion of the device to the distal portion of the device (e.g., Figure 47).

[00532] The generally rounded features of the device 500A are further demonstrated by the rounded shape of the paddles 520A, 522A where the inner and outer paddles 520A, 522A are joined together. However, the paddles 520A, 522A and paddle frames 524A can take a wide variety of different forms. For example, the paddles 520A, 522A and the paddle frames 524A can be rounded along the top edges and be flat or substantially flat on the sides (e.g., the sides of the paddle frames 524A arranged at the front and back sides of the device 500A). By making the paddles 520A, 522A flat or substantially flat on the sides, two devices can be implanted side-by-side on the native valve leaflet, with the two devices sitting flush or substantially flush against each other.

[00533] The closed paddles 520A, 522A form gaps 542A between the inner paddles 522A and the coaption element 5 lOA that are configured to receive native tissue. As can be seen in Figures 48B and 48F, the proximal end of the coaption element 510A has an approximately dog-bone shape so that the gaps 542A are narrower toward the proximal portion 505A as the gaps 542A approach the distal portion 507A of the device. The narrowing of the gaps 542A toward the attachment portion 505A allows the paddles 520A, 522A to contact tissue grasped in the gaps 542A nearer to the proximal portion 505A.

[00534] The paddle frames 524A extend vertically from the distal portion 507A toward the proximal portion 505A until approximately a middle third of the device 500A before bending or flaring outward so that a connection portion 524B of the frames 524A passes through gaps 544A formed by the inner paddles 522A folded inside of the outer paddles 520A. However, in other embodiments the connections of the frames are positioned inside the inner paddles 522A or outside the outer paddles 520A. The outer paddles 520A have a rounded rectangular shape that is similar to that of the coaption element 510A when viewed from the front or back (Figures 67A and 68A). Thus, the device 500A has a rounded rectangular shape. The rounded rectangular shape of the device 500A is particularly visible when the device 500A is viewed from the top (Figures 70A and 71A) or bottom (Figures 72A and 73A).

[00535] Referring now to Figures 70A and 71A, top views of the device 500A are shown. The device 500A has a shape that is symmetrical or substantially symmetrical around a front-to-back plane 550A and is also symmetrical or substantially symmetrical around a side-to-side plane 552A when viewed from the top. A proximal opening 519C in the coaption element 510A is visible at the proximal portion 505A of the device 500A. The actuation element 512A is received through the opening 519C so that the coaption element 510A wraps around the actuation element 512A. In some embodiments, the opening 519C is formed by inserting the actuation element 512A between the folded and overlapping layers of the strip of material 501A (described in detail below). In other embodiments, the opening 519C is formed by shape-setting the folded layers of the strip of material 501A forming the coaption element 510A around a blank or jig to give the coaption element 510A a rounded or generally rounded shape. The proximal collar 511D shown in Figure 71A can be secured to the coaption element 510A to close off the coaption element 510A. The proximal collar 511D includes attachment portions 513A that engage with openings 546A formed by the folded layers of the strip of material 501A that form the coaption element 510A. In some embodiments, the attachment portions 513A are holes in the collar 511D so that the strip of material 501A must be inserted through the collar 511D before folding the strip of material 501A during assembly of the device 500A. In some embodiments, the attachment portions 513A are open slots (e.g., the attachment portions 524B of the paddle frames 524A) that receive the strip of material 501A before or after folding the strip of material 501A.

[00536] As is noted above, the coaption element 510A has a generally rectangular shape when viewed from the top. In some example embodiments, the coaption element 510A can have other shapes when viewed from the top. For example, the coaption element can have a round, square, diamond, elliptical, or any other shape. The paddle frames 224A each have a rounded rectangular shape when viewed from the top so that the paddle frames 224A surround the rectangular coaption element 510A. Thus, native tissue, such as the leaflets 20, 22 tend to be pinched or compressed evenly in the gaps 542A formed between the inner paddles 522A and paddle frames 524A and the coaption element 510A.

[00537] Referring now to Figures 72A and 73A, bottom views of the device 500A are shown. As with the top views (Figures 70A and 71A), the device 500A has a shape that is symmetrical or substantially symmetrical around the front-to-back plane 550A and is also symmetrical or substantially symmetrical around the side-to-side plane 552A when viewed from the bottom. A distal portion 527A of the strip of material 501A includes an aperture 527B for receiving the cap 514A shown in Figure 73A.

[00538] The paddle frames 524A extend outward from the distal portion 507A of the device 500A to the left and right sides 551A, 553A at a narrow or slight angle from the side-to-side plane 552A. The paddle frames 524A extend further away from the side-to-side plane 552A while maintaining a generally constant distance relative to the front-to-back plane 550A as the paddle frames 524A extend toward the proximal portion 505A of the device 500A (Figure 65A) to ultimately form the rounded rectangle shape seen in Figures 70A and 71A.

[00539] In one example embodiment, the dimensions of the device 500A are selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In one example embodiment, the anterior-posterior distance Y47I of the device 500A at the widest is less than 10 mm, and the medial-lateral distance Y67C of the spacer at its widest is less than 6 mm. In one example embodiment, the overall geometry of the device 500A can be based on these two dimensions and the overall shape strategy described above. It should be readily apparent that the use of other anterior-posterior distance Y47I and medial-lateral distance Y67C as starting points for the device 500A will result in a device having different dimensions. Further, using other dimensions and the shape strategy described above will also result in a device having different dimensions.

[00540] 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 wide 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 ranges of linear dimensions in millimeters for the device 500A and components of the device 500A. Table B provides examples of radius dimensions S in millimeters and ranges of radius dimensions in millimeters for the device 500A and components of the device 500A. The subscripts for each of the dimensions indicates the drawing in which the dimension first appears. [Image disponible dans le document PDF, Image available in the PDF document]

[00541] [Image disponible dans le document PDF, Image available in the PDF document]

[0542]

[00543] Referring now to Figures 74A, 75A, 76A, 77A, 78A, 79A, 80A, 81A, 82A, and 83A, perspective and cross-sectional views of the device 500A are shown. Referring now to Figure 74A, the device 500A is shown sliced by cross-section plane 75A near the proximal portion of the coaption element 510A. Referring now to Figure 75A, a cross-sectional view of the device 500A is shown as viewed from cross-section plane 75A in Figure 74A. At the location of the plane 75A, the coaption element 510A has a generally rounded rectangular shape. The gaps 542A between the inner paddles 522A and coaption element 510A have a width 542B. As noted above, the gaps 542A have a consistent or generally consistent width.

[00544] Referring now to Figure 76A, the device 500A is shown sliced by cross-section plane 77A positioned about three-quarters of the way between the distal portion 507A and the proximal portion 505A of the coaption element 510A. Referring now to Figure 77A, a cross-sectional view of the device 500A is shown as viewed from cross-section plane 77A in Figure 76A. As can be seen in Figures 76A and 77A, the strip of material 501A forming the device 500A is overlapped to form four layers in the area of the coaption element 510A. 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 the plane 75A, the coaption element 510A has a generally rectangular shape oriented along the side-to-side plane 552A. The gaps 542A between the inner paddle 522A and the coaption element 510A are visible. The gaps 542A between the inner paddles 522A and coaption element 510A have a width 542B that is greater than the width 542B seen in Figure 75A. The gaps 544A between the outer and inner paddles 520A, 522A have a consistent or generally consistent width 544B for receiving the attachment portion 524B of the paddle frames 524A.

[00545] Referring now to Figure 78A, the device 500A is shown sliced by cross-section plane 79A positioned about half of the way between the distal portion 507A and the proximal portion 505A of the device 500A. Referring now to Figure 79A, a cross-sectional view of the device 500A is shown as viewed from cross-section plane 79A in Figure 78A. As can be seen in Figures 78A and 79A, the strip of material 501A forming the device 500A is overlapped to form four layers in the area of the coaption element 510A, two layers in the area of the inner paddle 522A, and one layer in the area of the outer paddle 520A. At the location of the plane 79A, the coaption element 510A has a generally rectangular shape oriented along the side-to-side plane 552A. The gaps 542A between the inner paddles 522A and the coaption element 510A have a width 542B that is the same or about the same as the width 542B seen in Figure 77A.

[00546] Referring now to Figure 80A, the device 500A is shown sliced by cross-section plane 81A positioned about one-quarter of the way between the distal portion 507A and the proximal portion 505A of the device 500A. Referring now to Figure 81A, a cross-sectional view of the device 500A is shown as viewed from cross-section plane 81A in Figure 80A. As can be seen in Figures 80A and 81A, the strip of material 501A forming the device 500A is overlapped to form four layers in the area of the coaption element 510A, two layers in the area of the inner paddle 522A, and the outer paddle 520A is formed by a single layer. At the location of the plane 81A, the coaption element 510A has a generally rectangular shape oriented along the side-to-side plane 552A. The gaps 542A between the inner paddle 522A and coaption element 510A have a width 542B that is about the same as the central width 542B seen in Figure 79A.

[00547] Referring now to Figure 82A, the device 500A is shown sliced by cross-section plane 83A positioned about one-quarter of the way between the distal portion 507A and the proximal portion 505A of the device 500A. Referring now to Figure 83A, a cross-sectional view of the device 500A is shown as viewed from cross-section plane 83A in Figure 82A. As can be seen in Figures 82A and 83A, the strip of material 501A forming the device 500A is overlapped to form four layers in the area of the coaption element 510A, two layers in the area of the inner paddle 522A, and a single layer forms the outer paddle 520A. At the location of the plane 83A, the coaption element 510A has a generally rectangular shape oriented along the side-to-side plane 552A. The gaps 542A between the inner paddles 522A and coaption element 510A form an arcuate shape with a width 542B that is about the same as the central width 542B seen in Figure 81A.

[00548] Referring now to Figures 84–88, 86A, 87A, and 88A, example implantable devices 100, 500, 500A are shown without clasps or articulable gripping members. Rather, the example devices 100, 500, 500A shown in Figures 84–88, 86A, 87A, and 88A, have barbs or gripping members 800 / 800A and / or 802 / 802A integrated into portions of the coaption element or paddles of the anchor portion of the devices to facilitate grasping of the tissue of the native heart valve.

[00549] Referring now to Figure 84, an example implantable device 100 is shown that does not include articulable clasps or gripping elements. As described above, the device 100 is deployed from a delivery sheath or means for delivery 102 and includes a coaption portion 104 and an anchor portion 106. The coaption portion 104 of the device 100 includes a coaption element or means for coapting 110 that is adapted to be implanted between the leaflets 20, 22 of a native valve (e.g., mitral valve MV, etc.) and is slidably attached to an actuation element or shaft 112 that extends through the coaption element or means for coapting 110 to a distal cap 114.

[00550] The anchor portion 106 of the device 100 includes outer paddles 120 and inner paddles 122 that are connected between the distal cap 114 and the coaption element or means for coapting 110. The anchor portion 106 is actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element or means for actuating 112 opens and closes the anchor portion 106 of the device 100 to grasp the native valve leaflets 20, 22 during implantation.

[00551] Rather than articulable clasps or gripping elements, the device 100 shown in Figure 84 includes barbed portions 800 arranged on the coaption element or means for coapting 110, with each side of the coaption element or means for coapting 110 having at least one barbed portion 800. When the anchor portion 106 of the device 100 is closed, tissue grasped between the inner paddles 122 and the coaption element or means for coapting 110 is pressed against the barbed portions 800. The barbed portions 800 can be sharp so that they engage—and in some embodiments, pierce—the native tissue and prohibit 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.

[00552] Referring now to Figure 85, the example implantable device 100 is shown without separate articulable clasps. As described above, the device 100 is deployed from a delivery sheath or means for delivery 102 and includes a coaption portion 104 and an anchor portion 106. The coaption portion 104 of the device 100 includes a coaption element or means for coapting 110 that is adapted to be implanted between the leaflets 20, 22 of the native valve or mitral valve MV and is slidably attached to an actuation element 112 (e.g., actuation wire, shaft, rod, suture, line, etc.) that extends through the coaption element or means for coapting 110 to a distal cap 114.

[00553] The anchor portion 106 of the device 100 includes outer paddles 120 and inner paddles 122 that are connected between the distal cap 114 and the coaption element or means for coapting 110. The anchor portion 106 is actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element or means for actuating 112 opens and closes the anchor portion 106 of the device 100 to grasp the native valve leaflets 20, 22 during implantation.

[00554] Rather than separate articulable clasps or gripping elements, the device 100 shown in Figure 85 includes barbed portions 800 arranged on the inner paddles 122, with each inner paddle 122 having at least one barbed portion 800. When the anchor portion 106 of the device 100 is closed, tissue grasped between the inner paddles 122 and the coaption element or means for coapting 110 is pressed against the barbed portions 800. The barbed portions 800 are sharp so that they engage—and in some embodiments, pierce—the native tissue and prohibit 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.

[00555] Referring now to Figure 86, the example implantable device 500 is shown that does not include articulable clasps or gripping elements. As described above, the device 500 includes a coaption portion 504 and an anchor portion 506. The coaption portion 504 of the device 500 includes a coaption element 510 that is adapted to be implanted between the leaflets 20, 22 of the native valve or native mitral valve MV and is slidably attached to an actuation element or means for actuation 512 that extends through the coaption element 510 to a distal cap 514.

[00556] The anchor portion 506 of the device 500 includes outer paddles 520 and inner paddles 522 that are connected between the distal cap 514 and the coaption element 510. The anchor portion 506 is actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element 512 opens and closes the anchor portion 506 of the device 500 to grasp the native valve leaflets 20, 22 during implantation.

[00557] Rather than articulable clasps or gripping elements, the device 500 includes barbed portions 800 arranged on the inner paddles 522, with each inner paddle 522 optionally having more than one barbed portion 800. When the anchor portion 506 of the device 500 is closed, tissue grasped between the inner paddles 522 and the coaption element 510 is pressed against the barbed portions 800. The barbed portions 800 are sharp so that they engage—and in some embodiments, pierce—the native tissue and prohibit 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.

[00558] Referring now to Figure 86A, the example implantable device 500A is shown that does not include articulable clasps or gripping elements. As described above, the device 500A includes a coaption element 510A that is adapted to be implanted between the leaflets 20,22 of the native valve or native mitral valve MV and is slidably attached to an actuation element or means for actuation (not shown) that extends through the coaption element 510A to a distal cap 514A. The device 500A also includes outer paddles 520A and inner paddles 522A that are connected between the distal cap 514A and the coaption element 510A. The device 500A is actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element opens and closes the paddles 520A, 522A of the device 500A to grasp the native valve leaflets 20, 22 during implantation.

[00559] Rather than articulable clasps or gripping elements, the device 500A includes barbed portions 800A arranged on the inner paddles 522A, with each inner paddle 522A optionally having more than one barbed portion 800A. When the device 500A is closed, tissue grasped between the inner paddles 522A and the coaption element 510A is pressed against the barbed portions 800A. The barbed portions 800A are sharp so that they engage—and in some embodiments, pierce—the native tissue and prohibit 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.

[00560] Referring now to Figure 87, the example implantable device 500 is shown that does not include separate articulable clasps or gripping elements. As described above, the device 500 includes a coaption portion 504 and an anchor portion 506. The coaption portion 502 of the device 500 includes a coaption element 510 that is adapted to be implanted between the leaflets 20, 22 of the native valve or native mitral valve MV and is slidably attached to an actuation element or means for actuation 512 that extends through the coaption element 510 to a distal cap 514.

[00561] The anchor portion 506 of the device 500 includes outer paddles 520 and inner paddles 522 that are connected between the distal cap 514 and the coaption element 510. The anchor portion 506 is actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element 512 opens and closes the anchor portion 506 of the device 500 to grasp the native valve leaflets 20, 22 during implantation.

[00562] Rather than separate articulable clasps or gripping elements, the device 500 includes barbed portions 800 arranged on the coaption element 510, with each side of the coaption element 510 having more than one barbed portion 800. When the anchor portion 506 of the device 500 is closed, tissue grasped between the inner paddles 522 and the coaption element 510 is pressed against the barbed portions 800. The barbed portions 800 are sharp so that they engage—and in some embodiments, pierce—the native tissue and prohibit 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.

[00563] Referring now to Figure 87A, the example implantable device 500A is shown that does not include articulable clasps or gripping elements. As described above, the device 500A can have a coaption element 510A that is adapted to be implanted between the leaflets 20, 22 of the native valve or native mitral valve MV and is slidably attached to an actuation element or means for actuation (not shown) that extends through the coaption element 510A to a distal cap 514A. The device 500A also includes outer paddles 520A and inner paddles 522A that are connected between the distal cap 514A and the coaption element 510A. The device 500A is actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element opens and closes the paddles 520A, 522A of the device 500A to grasp the native valve leaflets 20, 22 during implantation.

[00564] Rather than separate articulable clasps or gripping elements, the device 500A includes barbed portions 800A arranged on the coaption element 510A, with each side of the coaption element 510A having more than one barbed portion 800A. When the device 500A is closed, tissue grasped between the inner paddles 522A and the coaption element 510A is pressed against the barbed portions 800A. The barbed portions 800A are sharp so that they engage—and in some embodiments, pierce—the native tissue and prohibit 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.

[00565] Referring now to Figure 88, the example implantable device 500 is shown that does not include separate articulable clasps or gripping elements. As described above, the device 500 includes a coaption portion 504 and an anchor portion 506. The coaption portion 504 of the device 500 includes a coaption element 510 that is adapted to be implanted between the leaflets 20, 22 of the native valve or native mitral valve MV and is slidably attached to an actuation element or means for actuation 512 that extends through the coaption element 510 to a distal cap 514.

[00566] The anchor portion 506 of the device 500 includes outer paddles 520 and inner paddles 522 that are connected between the distal cap 514 and the coaption element 510. The anchor portion 506 is actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element 512 opens and closes the anchor portion 506 of the device 500 to grasp the native valve leaflets 20, 22 during implantation.

[00567] Rather than articulable clasps or gripping elements, the device 500 includes barbed portions 800 arranged on the coaption element 510, with each side of the coaption element 510 including at least one barbed portion 800. Similar to device 1000 described above, the device 500 also includes barbed portions 802 arranged on the inner paddles 522, with each inner paddle 522 having at least one barbed portion 802.

[00568] When the anchor portion 506 of the device 500 is closed, tissue grasped between the inner paddles 522 and the coaption 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 prohibit 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 barbed portions 800 on the coaption element 510 and barbed portions 802 on the inner paddles 522 forms the grasped tissue into an S-shaped tortuous path as it passes over the barbed portions 800, 802. Thus, forces pulling the tissue away from the device 500 will encourage the tissue to further engage the barbed portions 800, 802 before the tissue can escape.

[00569] Referring now to Figure 88A, the example implantable device 500A is shown that does not include articulable clasps or gripping elements. As described above, the device 500A can have a coaption element 510A that is adapted to be implanted between the leaflets 20, 22 of the native valve or native mitral valve MV and is slidably attached to an actuation element or means for actuation (not shown) that extends through the coaption element 510A to a distal cap 514A. The device 500A also includes outer paddles 520A and inner paddles 522A that are connected between the distal cap 514A and the coaption element 510A. The device 500A is actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element opens and closes the paddles 520A, 522A of the device 500A to grasp the native valve leaflets 20, 22 during implantation.

[00570] Rather than articulable clasps or gripping elements, the device 500A includes barbed portions 800A arranged on the coaption element 510A, with each side of the coaption element 510A including at least one barbed portion 800A. The device 500A also includes barbed portions 802A arranged on the inner paddles 522A, with each inner paddle 522A having at least one barbed portion 802A.

[00571] When the device 500A is closed, tissue grasped between the inner paddles 522A and the coaption element 510A is pressed against the barbed portions 800A, 802A. The barbed portions 800A, 802A are sharp so that they engage—and in some embodiments, pierce—the native tissue and prohibit the tissue from retracting from the device 500A. In some embodiments, the barbed portions 800A, 802A are angled downward to increase engagement with the native tissue. The combination of barbed portions 800A on the coaption element 510A and barbed portions 802A on the inner paddles 522A forms the grasped tissue into an S-shaped tortuous path as it passes over the barbed portions 800A, 802A. Thus, forces pulling the tissue away from the device 500A will encourage the tissue to further engage the barbed portions 800A, 802A before the tissue can escape.

[00572] Referring now to Figures 89–102, the coaption element 510 and paddles 520, 522 of the example device 500 are shown. The coaption element 510 and the paddles can be made from a wide variety of different materials. The coaption element 510 and paddles 520, 522 can be formed from one or more of a variety of materials, for example, a metal fabric, such as a mesh, woven, braided, electrospun, deposited or formed in any other suitable way, laser cut, or otherwise cut material or flexible material. The material can be cloth, shape-memory alloy wire—such as Nitinol—to provide shape-setting capability, or any other flexible material suitable for implantation in the human body.

[00573] In one example embodiment, the coaption element is made from a braided mesh of metal wires, such as a braided mesh of nitinol wires. In one example embodiment, the coaption element 510 is made of a braided mesh of between 25 and 100 wires, such as between 40 and 85 wires, such as between 45 and 60 wires, such as about 48 Nitinol wires or 48 Nitinol wires.

[00574] The coaption element can be covered in a cloth, such as a polyethylene cloth. The coaption element 510, can be surrounded in its entirety with a cloth cover, such as a polyethylene cloth of a fine mesh. The cloth cover can provide a blood seal on the surface of the spacer, and / or promote rapid tissue ingrowth.

[00575] The use of a shape memory material, such as braided Nitinol wire mesh, for the construction of the coaption element 510 results in a coaption element that can self-expandable, flexible in all directions, and / or results in low strains when the coaption element is crimped and / or bent. The material can be a single piece, two halves joined together, or a plurality of sections or pieces that are fastened or joined together in any suitable manner, such as, by welding, with adhesives, or the like.

[00576] Referring now to Figures 89–90, the device 500 extends from a proximal portion 505 to a distal portion 507 and includes a coaption element 510, inner paddles 522, and outer paddles 520. The coaption element 510 includes a proximal opening 519A and a distal opening 515 (Figures 92 and 94). The proximal opening 519A of the coaption element 510 is formed in a proximal portion 519 of the coaption element 510. The coaption element 510 is jointably connected to the inner paddles 522 by joint portions 525. The inner paddles 522 are jointably connected to the outer paddles 520 by joint portions 523. The outer paddles 520 are attached (e.g., jointably attached, etc.) to distal portions 527 by joint portions 521. Coaption gaps 542 are formed between the inner paddles 522 and the coaption element 510. Paddle gaps 544 are formed between the inner and outer paddles 520, 522 when the paddles 520, 522 are folded, for example, as shown in Figure 90.

[00577] Referring now to Figure 91, a front view of the device 500 is shown (a back view of which would be identical). The coaption element 510 includes the proximal portion 519, a middle portion 518, and a distal portion 517. The proximal portion 519 includes the proximal opening 519A. The distal portion 517 includes the distal opening 515 and is connected to the joint portions 525. The shape of the coaption element 510 is rounded or generally rounded to prevent the device 500 from catching or snagging on structures of the heart, such as the chordae tendineae, during implantation.

[00578] Referring now to Figure 92, a side view of the device 500 is shown. Similar to the device 500 viewed from the front, the distal portion 507 of the device 500 is generally narrower than the proximal portion 505 of the device 500 when the device 500 is viewed from the side. The coaption element 510 flares outwards in the proximal portion 519 from the proximal opening 519A to the middle portion 518. The coaption element 510 then tapers or narrows in the middle portion 518 from the proximal portion 519 to the distal portion 517. The distal portion 517 remains narrow and then splits into the two joint portions 525. The generally rounded features of the device 500 are further demonstrated by the round shape of the joint portions 523 that jointably connect the inner and outer paddles 520, 522 and the outwardly bowed shape of the outer paddles 520.

[00579] The coaption gaps 542 formed between the inner paddles 522 and the coaption element 510 are configured to receive native tissue. The narrowing of the coaption element 510 gives the gaps 542 a somewhat teardrop shape that increases in width as the gaps 542 approach the distal portion 507 of the device 500. The widening of the gaps 542 toward the distal portion 507 allows the inner paddles 522 to contact tissue grasped in the gaps 542 nearer to the proximal portion 505 where pinching forces are greater as a result of the mechanical advantage provided by the length of the paddles 520, 522 and other securing or anchoring elements, such as those described in the present application.

[00580] Referring now to Figure 93, a top view of the device 500 is shown. The proximal opening 519A in the coaption element 510 is visible at the proximal portion 505 of the device 500 and the coaption element 510 can be seen to be hollow inside. The coaption element 510 has an oval or generally oval- shape when viewed from the top. While the paddles 520, 522 appear as protruding rectangular shapes, the paddles 520, 522 can extend laterally and have an arcuate or crescent-like shape.

[00581] Referring now to Figure 94, a bottom view of the device 500 is shown. The distal opening 515 in the coaption element 510 is visible at the distal portion 507 of the device 500 and the coaption element 510 can be seen to be hollow inside. The coaption element 510 has an oval or generally oval- shape when viewed from the top. While the paddles 520, 522 appear as protruding rectangular shapes, the paddles 520, 522 can extend laterally and have an arcuate or crescent-like shape. The distal portion 517 of the coaption element 510 can be seen splitting in two to join with the joint portions 525.

[00582] Referring now to Figures 89A, 90A, 91A, 92A, 93A, 94A, 95A, 96A, 97A, 98A, 99A, 100A, 101A, and 102A, the portions of the device 500A formed by the strip of material 501A (e.g., a single, continuous strip of material, a composite strip of material, etc.), that is, the coaption element 510A and paddles 520A, 522A, are shown. The coaption element 510A and the paddles can be made from a wide variety of different materials. The coaption element 510A, and paddles 520A, 522A can be formed from a material that can be a metal fabric, such as a mesh, woven, braided, electrospun, deposited or formed in any other suitable way, laser cut, or otherwise cut material or flexible material. The material can be cloth, shape-memory alloy wire—such as Nitinol—to provide shape-setting capability, or any other flexible material suitable for implantation in the human body.

[00583] In one example embodiment, the coaption element 510A, inner paddle 522A, and outer paddle 520A are made from a single, continuous strip of material 501A. The strip of material 501A can be formed from a material that can be a metal fabric, such as a mesh, woven, braided, electrospun, deposited or formed in any other suitable way, laser cut, or otherwise cut material or flexible material. The material can be cloth, shape-memory alloy wire—such as Nitinol—to provide shape-setting capability, or any other flexible material suitable for implantation in the human body. In one example embodiment, the strip of material 501 A is made of a braided mesh of between 25 and 100 strands, such as between 40 and 85 strands, such as between 45 and 60 strands, such as about 48 Nitinol wires or 48 Nitinol wires.

[00584] Referring now to Figures 205–207, an example woven or braided material 4000 that can be used for the strip of material 501A is shown. Referring now to Figure 205, an enlarged plan view of the material 4000 is shown. The material 4000 extends from a first edge 4002 to a second edge 4004. The edges 4002, 4004 surround a central portion or field 4006. The material 4000 is formed by braiding or weaving together central strands 4020, such as Nitinol wires. Edge strands 4010 extend longitudinally through the material 4000 along the edges 4002, 4004. The central strands 4020 are woven or braided such that the central strands 4020 wrap around the edge strands 4010. Wrapping the central strands 4020 around the edge strands 4010 causes the material 4000 near the edges 4002, 4004 to be thicker than the material in the central portion 4006, forming a lobed or dog-bone-like shape when the material 4000 is viewed from the end, as is shown in Figure 206. Thus, the edges 4002, 4004 of the material 4000 are less flexible than the central portion 4006. The edge strands 4010 and central strands 4020 can be similar in diameter and can have a diameter ranging from about 0.06 millimeters to about 0.18 millimeters. In some embodiments, the edge strands 4010 can have a larger diameter than the central strands 4020 to impart more stiffness or rigidity to the edges 4002, 4004 than the central portion 4006. For example, the edge strands 4010 can have a diameter ranging from 0.07 millimeters to about 0.27 millimeters, or about 0.17 millimeters, and the central strands 4020 can have a diameter ranging from about 0.04 millimeters to about 0.15 millimeters, or about 0.009 millimeters. In some embodiments, the edges 4002, 4004 are made less flexible than the central portion 4006 by using different materials for the edge strands 4010 and central strands 4020, such as, for example, a metal material—e.g., Nitinol—for the edge strands 4010 and a cloth or plastic material—e.g., polyethylene—for the central strands 4020. Alternatively, the edge strands 4010 and central strands 4020 can be made from the same material that is subjected to different chemical and / or thermal processes that alter the flexibility of the materials so that the central strands 4020 are more flexible than the edge strands 4010.

[00585] Referring now to Figure 207, folded portions of material 4000 are layered on top of each other to form a section that has four layers 4000A, 4000B, 4000C, 4000D. The lobed shape of the individual layers, with thicker edges 4002, 4004 than the central portion 4006, creates three gaps 4001 A, 4001 B, 4001C between the layers 4000A, 4000B, 4000C, 4000D of material 4000 in the location of the central portion 4006. Outer gaps 4001A, 4001C are formed between outer layers 4000A, 4000D and the adjacent middle layers 4000B, 4000C.

[00586] As is discussed in the present disclosure, the coaption element 510A of the device 500A can be formed from four layers of material, such as the material 4000. When layers of the material 4000 are used to form the coaption 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 larger diameter than the width of the gap 4001B, so that inserting the actuation element 512A causes the middle gap 4001B to stretch open and adjacent outer gaps 4001A, 4001C to reduce in size. In some embodiments, inserting the actuation element 512A causes the center body portions 4006 on either side to bulge outward to a thickness that is greater than the thickness of the four stacked edge portions 4002, 4004.

[00587] The coaption element 510A and paddles 520A, 522A can be covered in a cloth, such as a polyethylene cloth. The coaption element 510A and paddles 520A, 522A can be surrounded in their entirety with a cloth cover (e.g., cover 540A), such as a polyethylene cloth of a fine mesh. The cloth cover can provide a blood seal on the surface of the spacer, and / or promote rapid tissue ingrowth.

[00588] The use of a shape memory material, such as braided Nitinol wire mesh, for the construction of the coaption element 510A and paddles 520A, 522A results in a coaption element and paddles that can be self-expandable, flexible in all directions, and / or results in low strains when crimped and / or bent. The material can be a single piece, two halves joined together, or a plurality of sections or pieces that are fastened or joined together in any suitable manner, such as, by welding, with adhesives, or the like.

[00589] Referring now to Figures 89A and 90A, the device 500A extends from a proximal portion 505A to a distal portion 507A and includes a coaption element 510A, inner paddles 522A, and outer paddles 520A. The single, continuous strip of material 501A extends between two ends 501B and is folded to form the coaption element 510A, inner paddles 522A, and outer paddles 520A. Some portions of the device 500A are formed from multiple layers of the strip of material 501A. For example, the strip of material 501A is overlapped to form four layers in the area of the coaption element 510A and two layers in the area of the inner paddle 522A.

[00590] The coaption element 510A and paddles 520A, 522A are jointably connected together by joint portions of the strip of material 501A. The coaption element 510A is jointably connected to the inner paddles 522A by joint portions 525A. The inner paddles 522A are jointably connected to the outer paddles 520A by joint portions 523A. The outer paddles 520A are attached (e.g., jointably attached, etc.) to the distal portion 527A by joint portions 521A. The aperture 527B in the distal portion 527A engages the cap 514A.

[00591] Various gaps are formed between portions of the device 500A when the strip of material 501A is folded into the desired shape. Coaption gaps 542A are formed between the inner paddles 522A and the coaption element 510A. Paddle gaps 544A are formed between the inner and outer paddles 520A, 522A when the paddles 520A, 522A are folded, for example, as shown in Figure 90A. Collar gaps 546A are formed when the strip of material 501A is folded to form the proximal portions 519B of the coaption element 510A.

[00592] Referring now to Figure 91A, a front view of the device 500A is shown (a back view of which would be identical). The coaption element 510A includes the proximal portion 519B extending above the joint portions 523A of the paddles 520A, 522A. The distal portion 517A of the coaption element 510A is concealed by the paddles 520A, 522A when viewed from the front or back, giving the device 500A a long and narrow rounded rectangular shape. The shape of the coaption element 510A helps prevent the device 500A from catching or snagging on structures of the heart, such as the chordae tendineae, during implantation.

[00593] Referring now to Figure 92A, a side view of the device 500A is shown. The distal end 507A of the device 500A is generally narrower than the proximal end 505A of the device 500A when the device 500A is viewed from the side, forming a generally blunt and rounded shape. The coaption element 510A includes the proximal portion 519B, a middle portion 518A, and the distal portion 517A. The proximal portion 519B flares outward from the middle portion 518A to engage the collar 511D (Figure 48A). The middle portion 518A of the coaption element 510A is straight or generally straight when viewed from the side. The distal portion 517A is attached (e.g., jointably attached, etc.) to the inner paddles 522A by the joint portions 525A. The generally rounded features of the device 500A are further demonstrated by the round shape of the joint portions 523A that jointably connect the paddles 520A, 522A. The joint portions 521A connecting the outer paddles 520A to the distal portion 527A are also rounded and ease the transition in shape from the strip of material 501A to the cap 514A (Figure 48A) that is assembled to the flat or generally flat distal portion 527A.

[00594] The coaption gaps 542A formed between the inner paddles 522A and the coaption element 510A are configured to receive native tissue. The general straightness of the middle portion 518A of the coaption element 510A and the inner paddles 522A gives the gaps 542A a consistent or generally consistent width with a narrow upper end where the proximal portion 519B flares outward to engage the collar 511D (Figure 48A). Thus, the inner paddles 522A contact the tissue grasped in the gaps 542A nearer to the proximal portion 505A where pinching forces are greater as a result of the mechanical advantage provided by the length of the paddles 520A, 522A and other securing or anchoring elements, such as those described in the present application.

[00595] As discussed above, the coaption element 510A and paddles 520A, 522A of the device 500A are formed by folding the strip of material 501A. The strip of material 501A is then unfolded and assembled with other components, such as the collar 511D, cap 514A, and paddle frames 524A. The strip of material 501 A is shape-set after being formed into a desired shape so that the strip of material 501A returns to the desired shape after assembly with other components. In some embodiments, a jig is used during folding and shape-setting of the strip of material 501 A to ensure that the strip of material 501A is folded in the proper location with the desired radius.

[00596] Referring again to Figure 92A, portions of a jig 570A to aid in folding and shape-setting the device 500A are shown. The strip of material 501A is shown folded around the jig 570A so that the strip of material 501 A forms a desired shape. To fold the strip of material 501 A into the shape of the device 500A using the jig 570A, the strip of material 501A is arranged with one of the ends 501B at the location of the inner paddle 522A. The strip 501A is extended from the end 501B in a distal direction 507B to form a first layer 581A of the inner paddle 522A, around a first jig portion 572A to form a first layer 581A of the hinge portion 525A, and then in a proximal direction 505B to form the first layer 581A of the coaption element 510A. The first layer 581A of material forms the sides of the inner paddle 522A and coaption element 510A that surround the coaption gap 542A. The strip 501A is then wrapped around a second jig portion 574A to form one of the proximal portions 519B and openings 546A of the coaption element 510A. The strip 501A is then extended in a distal direction 507A along the first layer 581A to form a second layer 582A of the coaption element 510A. The strip 501A is then wrapped back round the first jig portion 572A, forming the second layer 582A of the hinge portion 525A and back in the proximal direction 505B to form the second layer 582A of the inner paddle 522A. The strip 501 A is then wrapped around a third jig portion 576 A to form the joint portion 523A. The strip 501A then extends in the distal direction 507A along the inner paddle 522A to form the outer paddle 520A before being folded around a fourth jig portion 578A to form the joint 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, third, second, and first jig portions 578A, 576A, 574A, 572A to form the second half of the device 500A. Once the strip 501A has been wrapped around the jig portions as described above, a shape-setting operation is performed. While the portions of the illustrated jig have a rounded or generally round shape, the portions can have any shape to aid in the folding and shaping of the strip of material 501A. The jig 570 can have more or fewer portions for engaging the strip of material 501A.

[00597] Referring now to Figure 93A, a top view of the device 500A is shown. The first and second layers 581A, 582A of each half of the device 500A form the four layers of the coaption device 510A. The proximal opening 519C of the coaption device 510A is formed between the two second layers 582A. In some embodiments, the opening 519C is formed by inserting the actuation element 512A (not shown) between the folded and overlapping layers of the strip of material 501A after shape-setting of the strip of material 501A. In other embodiments, the opening 519C is formed by shape-setting the folded layers 581A, 582A of the strip of material 501A around an additional jig portion (not shown) to give the coaption element 510A a rounded or generally rounded shape when viewed from the top.

[00598] Referring now to Figure 94A, a bottom view of the device 500A is shown. The distal portion 527A of the strip of material 501A is shown, as is the aperture 527B for receiving the cap 514A. The coaption element 510A and outer paddles 520A have a generally rounded rectangle shape when viewed from below.

[00599] Referring now to Figures 95–102, perspective and cross-sectional views of the device 500 are shown. Referring now to Figure 95, the device 500 is shown sliced by cross-section plane 96 near the proximal portion of the coaption element 510. Referring now to Figure 96, a cross-sectional view of the device 500 is shown as viewed from cross-section plane 96 in Figure 95. At the location of the plane 96, the coaption element 510 has an oval or generally oval shape with thicker portions along the sides of the coaption element 510. The distal opening 515 is visible from the proximal portion and the coaption element 510 has a hollow interior.

[00600] Referring now to Figure 97, the device 500 is shown sliced by cross-section plane 98 positioned about half of the way between the distal portion 507 and the proximal portion 505 of the coaption element 510. Referring now to Figure 98, a cross-sectional view of the device 500 is shown as viewed from cross-section plane 98 in Figure 97. At the location of the plane 98, the coaption element 510 has an oval or generally oval shape that is larger than the oval shape of Figure 96.

[00601] Referring now to Figure 99, the device 500 is shown sliced by cross-section plane 100 positioned about one-quarter of the way between the distal portion 507 and the proximal portion 505 of the coaption element 510. Referring now to Figure 99, a cross-sectional view of the device 500 is shown as viewed from cross-section plane 100 in Figure 99. At the location of the plane 100, the coaption element 510 has an oval or generally oval shape that is narrower than the oval shape seen in Figure 98.

[00602] Referring now to Figure 101, the device 500 is shown sliced by cross-section plane 102 positioned near the distal portion 507 of the coaption element 510. Referring now to Figure 102, a cross-sectional view of the device 500 is shown as viewed from cross-section plane 102 in Figure 101. At the location of the plane 102, the coaption element 510 has an oval or generally oval shape that is smaller than the oval shape seen in Figure 100 and that is split as the coaption element 510 joins the joint portions 525.

[00603] Referring now to Figures 95A, 96A, 97A, 98A, 99A, 100A, 101A, and 102A, perspective and cross-sectional views of the portions of the device 500A formed by the single, continuous strip of material 501A are shown. Referring now to Figure 95A, the device 500A is shown sliced by cross- section plane 96A near the proximal portion of the coaption element 510A. Referring now to Figure 96A, a cross-sectional view of the device 500A is shown as viewed from cross-section plane 96A in Figure 95A. At the location of the plane 96A, the coaption element 510 has a rectangular or generally rectangular shape. In some embodiments, when the actuation element (not shown) is inserted between the layers 582A of the coaption element 510A, the coaption element 510A remains straight when viewed from the side but bows outward to form a rounded or generally round shape when viewed from cross-section plane 96A.

[00604] Referring now to Figure 97A, the device 500A is shown sliced by cross-section plane 98A near the proximal portion of the coaption element 510A. Referring now to Figure 98A, a cross-sectional view of the device 500A is shown as viewed from cross-section plane 98A in Figure 97A. At the location of the plane 98A, the coaption element 510 has a rectangular or generally rectangular shape. In some embodiments, when the actuation element (not shown) is inserted between the layers 582A of the coaption element 510A, the coaption element 510A remains straight when viewed from the side but bows outward to form a rounded or generally round shape when viewed from cross-section plane 98A.

[00605] Referring now to Figure 99A, the device 500A is shown sliced by cross-section plane 100A near the proximal portion of the coaption element 510A. Referring now to Figure 100A, a cross- sectional view of the device 500A is shown as viewed from cross-section plane 100A in Figure 99A. At the location of the plane 100A, the coaption element 510 has a rectangular or generally rectangular shape. In some embodiments, when the actuation element (not shown) is inserted between the layers 582A of the coaption element 510A, the coaption element 510A remains straight when viewed from the side but bows outward to form a rounded or generally round shape when viewed from cross-section plane 100A.

[00606] Referring now to Figure 101A, the device 500A is shown sliced by cross-section plane 102A near the proximal portion of the coaption element 510A. Referring now to Figure 102A, a cross- sectional view of the device 500A is shown as viewed from cross-section plane 102A in Figure 101A. At the location of the plane 102A, the coaption element 510 has a rectangular or generally rectangular shape. In some embodiments, when the actuation element (not shown) is inserted between the layers 582A of the coaption element 510A, the coaption element 510A remains straight when viewed from the side but bows outward to form a rounded or generally round shape when viewed from cross-section plane 102A.

[00607] Referring now to Figures 103–105, the example implantable prosthetic device 100 is shown having covered and uncovered portions. The device 100 is shown implanted in the native mitral valve MV and secured to the native leaflets 20, 22. As described above, the device 100 includes a coaption element or means for coapting 110, paddles 120, clasps 130, and a cap 114. The paddles 120 and clasps 130 are in a closed position to secure the device 100 to the grasped native leaflets 20, 22 of the mitral valve MV. A proximal portion 105 of the device 100 is exposed to the left atrium LA and a distal portion 107 of the device 100 is exposed to the left ventricle LV.

[00608] Referring now to Figure 103, the device 100 is shown with a covering 900 that covers the entirety of the coaption element or means for coapting 110 and the cap 114. In some embodiments, the covering 900 can be a cloth or fabric or polymer such as PET, velour, electrospun, deposited, or other suitable material. In other embodiments, in lieu of or in addition to a fabric, the cover can include a coating (e.g., polymeric) that is applied to the prosthetic spacer device and / or mechanical sealing mechanisms, such as silicone and interlocking joints can be used. The covering 900 can be formed from a metal fabric, such as a mesh, woven, braided, or formed in any other suitable way or a laser cut or otherwise cut flexible material. The covering 900 can be cloth, shape-memory alloy wire—such as Nitinol—to provide shape-setting capability, or any other flexible material suitable for implantation in the human body. The covering 900 prohibits blood flow through coaption element or means for coapting 110 at the proximal portion 105, and also provides a seal between the device 100 and the leaflets 20, 22. Thus, the covering 900 aids in the prohibition of blood flow through the native valve at the location of the device 100. The covering 900 also prohibits recirculating blood flow from entering the device 100 from the distal portion 107.

[00609] Referring now to Figure 104, the device 100 is shown with a covering 1000 that partially covers the coaption element or means for coapting 110 from the proximal portion 105 of the device 100 to the portion of the coaption element or means for coapting 110 that engages the native leaflets 20, 22. In some embodiments, the cover can be a cloth or fabric such as PET, velour, or other suitable fabric. In other embodiments, in lieu of or in addition to a fabric, the cover can include a coating (e.g., polymeric) that is applied to the prosthetic spacer device. The covering 1000 can be formed from a metal fabric, such as a mesh, woven, braided, or formed in any other suitable way or a laser cut or otherwise cut flexible material. The covering 1000 can be cloth, shape-memory alloy wire—such as Nitinol—to provide shape-setting capability, or any other flexible material suitable for implantation in the human body. Thus, the covering 1000 prohibits blood flow through the coaption element or means for coapting 110 at the proximal portion 105.

[00610] Referring now to Figure 105, the device 100 is shown with a covering 1100 that partially covers the coaption element or means for coapting 110 extending from the portion of the coaption element or means for coapting 110 that engages the native leaflets 20, 22 toward the distal portion 107. The covering 1100 also covers the cap 114. In some embodiments, the cover can be a cloth or fabric such as PET, velour, or other suitable fabric. In other embodiments, in lieu of or in addition to a fabric, the cover can include a coating (e.g., polymeric) that is applied to the prosthetic spacer device. The covering 1100 can be formed from a mesh, woven, braided, or formed in any other suitable way. The covering 1100 can be cloth, polymer, silicone, electrospun material, deposited material, and / or shape- memory alloy wire—such as Nitinol—to provide shape-setting capability, or any other flexible material suitable for implantation in the human body. Thus, blood flow can enter the coaption element or means for coapting 110 but is prohibited from passing through the device by the covering 1100 arranged toward the distal portion 107. The covering 1100 also prohibits recirculating blood flow from entering the device 100 from the distal portion 107.

[00611] Referring now to Figures 106–109, an example coaption element 1200 for an implantable prosthetic device is shown. The coaption element 1200 can be used with any of the implantable prosthetic devices described in the present application. Referring to Figure 106, the coaption element 1200 has a cylindrical or generally cylindrical shape extending between two caps 1201. However, the coaption element 1200 can have any shape, such as any of the shapes disclosed herein. In one example embodiment, the direction of expansion of the coaption element 1200 can be controlled. For example, the width / size of the coaption element in the Anterior to Posterior direction (when implanted), Medial to Lateral direction (when implanted), or both can be expanded (or contracted) in a controlled manner. The coaption element can be made from a mesh 1200 of material. Referring now to Figure 107, the mesh wall of the generally cylindrical coaption element 1200 extends outward from the caps 1201 by a distance 1204. Referring now to Figure 108, axial forces 1208 are applied to the caps 1201 of the coaption element 1200 causing the coaption element 1200 to compress in an axial direction. Compressing the coaption element 1200 axially causes the coaption element 1200 to expand or bulge in an outward direction 1210, such that the distance 1204 increases.

[00612] The coaption element 1200 can be compressed in a wide variety of different ways. For example, a threaded connection can be used to draw the two ends of the coaption element together or push the two ends of the coaption element apart. For example, a collar can be provided on each end of the coaption element. One of the collars can threadedly engage a threaded shaft, while the other collar is rotatably connected to the shaft. Rotating the shaft in one direction draws the collars together. Rotating the shaft in the opposite direction moves the collars apart.

[00613] Incorporating the coaption element 1200 into an implantable prosthetic device of the present application allows the coaption element to be expanded to press outward against tissue grasped between the coaption element and the paddles and / or gripping members.

[00614] Referring now to Figures 106A, 108A, 106B, and 108B, example coaption elements 1200, similar to the embodiment illustrated by Figures 106–109, for an implantable prosthetic device is shown. The coaption element 1200 can be used with any of the implantable prosthetic devices described in the present application. Referring to Figure 106A, the coaption element 1200 has a cylindrical or generally cylindrical shape extending between two caps 1201. However, the coaption element 1200 can have any shape, such as any of the shapes disclosed herein. In the example illustrated by Figures 106A and 108A, the coaption element 1200 comprises a tube 1203 with slots 1205. For example, the tube 1203 can be made from a shape memory alloy, such as nitinol, and the slots can be cut, such as laser cut, into the tube. The slots can be cut into the material that forms the tube, before the material is formed into a tube.

[00615] In one example embodiment, the direction of expansion of the coaption element 1200 can be controlled. For example, the configuration of the slots 1205 and / or a shape-set of the tube can be selected to control the shape of the expanded coaption element 1200. For example, the configuration of the slots 1205 and / or a shape-set can determine the way the width / size of the coaption element in the Anterior to Posterior direction, and / or Medial to Lateral direction expanded (and / or contract). Referring to Figure 106A, the tube wall of the generally cylindrical coaption element 1200 can extend outward from caps 1201 by a distance 1204. Referring now to Figure 108A, axial forces 1208 and / or rotational forces 1209 can be applied to the caps 1201 of the coaption element 1200 causing the coaption element 1200 to expand from the configuration illustrated by Figure 106A to the configuration illustrated by Figure 108A. In the illustrated example, compressing the coaption element 1200 axially and twisting the coaption element 1200 to expand or bulge in an outward direction 1210, such that the distance 1204 increases.

[00616] Referring to Figures 106B and 108B, the coaption element 1200 can be compressed in a wide variety of different ways. For example, a threaded connection 1221 can be used to draw the two ends of the coaption element together and twist the coaption element in a first direction or push the two ends of the coaption element apart and twist the coaption element in a second direction. For example, a collar can be provided on each end of the coaption element. One of the collars can threadedly engage a threaded shaft, while the other collar is fixedly connected to the shaft. Rotating the shaft in one direction draws the collars together and rotates the collars relative to one another in a first direction. Rotating the shaft in the opposite direction moves the collars apart and rotates the collars relative to one another in a second direction. The pitch of the threaded connection can be selected to set a ratio between the distance the coaption element 1200 is compressed and the angle that the coaption element is twisted.

[00617] Incorporating the coaption elements 1200 illustrated by Figures 106A, 108A, 106B, and 108B into an implantable prosthetic device of the present application allows the coaption element to be expanded to press outward against tissue grasped between the coaption element and the paddles and / or gripping members.

[00618] Figures 106C and 108C illustrate an example embodiment of a controllably expandable coaption element 1200 for an implantable prosthetic device. The coaption element 1200 can be used on its own, with a covering, or inside any of the coaption elements described herein (to expand the coaption element). The coaption element 1200 can be used with any of the implantable prosthetic devices described in the present application. Referring to Figure 106C, the coaption element 1200 has pairs of pivotally connected arms 1231. The pairs of pivotally connected arms 1231 each extending between and pivotally connected to two caps 1201. In the illustrated example, there are two pairs of pivotally connected arms 1231. However, there can be one, three, four, or any number of pairs of pivotally connected arms.

[00619] In one example embodiment, the direction of expansion of the coaption element 1200 can be controlled. For example, two pairs (as illustrated) of pivotally connected arms can be included to change the width / size of the coaption element in only one of the Anterior to Posterior direction, and / or Medial to Lateral direction. Four pairs of pivotally connected arms 1231 can be included to change the width / size of the coaption element in both the Anterior to Posterior direction and Medial to Lateral direction. When four pairs of pivotally connected arms 1231 are included, the arms can have different lengths and / or pivot point locations to make the coaption element 1200 expand (or contract) differently in different dictions. For example, the lengths of the arms can be selected to expand more in the Medial to Lateral direction than the Anterior to Posterior direction.

[00620] Referring now to Figure 108C, axial forces 1208 can be applied to the caps 1201 of the coaption element 1200 causing the coaption element 1200 to expand from the configuration illustrated by Figure 106C to the configuration illustrated by Figure 108C. In the illustrated example, compressing the pivotally connected arms 1231 axially causes the pivotal connections 1233 or knees to spread apart in an outward direction 1210, such that the distance 1204 increases.

[00621] Referring to Figures 106C and 108C, the coaption element 1200 can be compressed in a wide variety of different ways. For example, a threaded connection 1221 can be used to draw the two ends of the coaption element together or push the two ends of the coaption element apart. For example, a collar can be provided on each end of the coaption element. One of the collars can threadedly engage a threaded shaft, while the other collar is rotatably connected to the shaft. Rotating the shaft in one direction draws the collars together. Rotating the shaft in the opposite direction moves the collars apart.

[00622] Incorporating the coaption element 1200 illustrated by Figures 106C, and 108C into an implantable prosthetic device of the present application allows the coaption element to be expanded to press outward against tissue grasped between the coaption element and the paddles and / or gripping members.

[00623] Figures 106D and 108D illustrate an example embodiment of an expandable coaption element 1200 for an implantable prosthetic device. The coaption element 1200 can be used on its own, with a covering (See Figures 106E and 108E), or inside any of the coaption elements described herein (to expand the coaption element). The coaption element 1200 can be used with any of the implantable prosthetic devices described in the present application. Referring to Figure 106C, the coaption element 1200 has, a central support member 1243, one or more pivotally connected arms 1241, and connection lines 1245. Each arm 1241 extends from a pivotal connection to the central support member 1243. Each connection line 1245 is connected to the central support member 1243 and a pivotally connected arm 1241. The length of the connection line 1245 sets the degree to which the connection arms pivot away from the central support member 1243. In the illustrated example, there are two pivotally connected arms 1241. However, there can be one, three, four, or any number of pivotally connected arms.

[00624] In one example embodiment, the direction of expansion of the coaption element 1200 can be controlled. For example, two pivotally connected arms can be included to change the width / size of the coaption element in only one of the Anterior to Posterior direction, and / or Medial to Lateral direction. Four pivotally connected arms 1241 can be included to change the width / size of the coaption element in both the Anterior to Posterior direction and Medial to Lateral direction. When four pivotally connected arms 1241 are included, the arms and / or the connection lines 1245 can have different lengths and / or pivot point locations to make the coaption element 1200 expand (or contract) differently in different directions. For example, the lengths of the arms and / or the connection lines can be selected to expand more in the Medial to Lateral direction than the Anterior to Posterior direction.

[00625] The arms 1241 can be moved from the contracted position (Figure 106D) to the expanded position (Figure 108D). For example, the arms 1241 can be biased toward the expanded position by a spring or other biasing means. In the illustrated example, restraints 1247, such as sutures hold the arms 1241 in the contracted position. The restraints 1247 can be removed or broken to cause the coaption element 1200 to expand from the configuration illustrated by Figure 106D to the configuration illustrated by Figure 108D.

[00626] Figures 106E and 108E illustrate an example embodiment that is similar to the embodiment illustrated by Figures 106D and 108D, except that the coaption element includes 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 connection lines 1245 or the covering material can eliminate the need for the connection lines 1245.

[00627] Referring now to Figure 106F, an example coaption element 1200, similar to the embodiment illustrated by Figures 106-109, for an implantable prosthetic device is shown. The coaption element 1200 can be used with any of the implantable prosthetic devices described in the present application. Referring to Figure 106F, the coaption element 1200 is defined by a coil 1263 extending between two caps 1201. The coaption element 1200 can have any shape, such as any of the shapes disclosed herein. The coil 1263 can be made from a shape memory alloy, such as nitinol.

[00628] In one example embodiment, the direction of expansion of the coaption element 1200 can be controlled. For example, the shape-set of the coil 1263 can be selected to control the shape of the expanded coaption element 1200. For example, the configuration of the shape-set can determine the way the width / size of the coaption element in the Anterior to Posterior direction, and / or Medial to Lateral direction expand (and / or contract). Referring to Axial forces 1208 and / or rotational forces 1209 can be applied to caps 1201 of the coaption element 1200 causing the coaption element 1200 to expand or retract from the configuration illustrated by Figure 106F. In the illustrated example, extending the coil 1263 axially and twisting the coil 1263 contracts the coil in an inward direction 1211 and compressing the coil 1263 axially and twisting the coil in the opposite direction expands or bulge the coil in an outward direction.

[00629] Referring to Figure 106F, the coaption element 1200 can be compressed in a wide variety of different ways. For example, a threaded connection 1221 can be used to draw the two ends of the coaption element together and twist the coaption element in a first direction or push the two ends of the coaption element apart and twist the coaption element in a second direction. For example, a collar can be fixedly connected to each end of the coil 1263. One of the collars can threadedly engage a threaded shaft, while the other collar is fixedly connected to the shaft. Rotating the shaft in one direction draws the collars together and rotates the collars relative to one another in a first direction. Rotating the shaft in the opposite direction moves the collars apart and rotates the collars relative to one another in a second direction. The pitch of the threaded connection can be selected to set a ratio between the distance the coaption element 1200 is compressed and the angle that the coaption element is twisted.

[00630] Incorporating the coaption elements 1200 illustrated by Figure 106F into an implantable prosthetic device of the present application allows the coaption element to be expanded to press outward against tissue grasped between the coaption element and the paddles and / or gripping members.

[00631] Figures 106G–106I illustrate example embodiments of expandable coaption elements 1200. In the examples illustrated by Figures 106G-106I, the coaption elements are inflated by a fluid medium to expand the coaption element. The fluid medium can take a wide variety of different forms. Examples of fluids that can be used to inflate the coaption element 1200 include, but are not limited to, air, gel, water, blood, foaming materials, etc. The coaption element 1200 can be used with any of the implantable prosthetic devices described in the present application.

[00632] Referring to Figure 106G, the coaption element 1200 can have an outer layer 1271 (For example, any of the coaption elements 110, 510 disclosed herein) and an inner layer 1273 or balloon. The coaption element 1200 can have any shape, such as any of the shapes disclosed herein. In the example illustrated by Figures 106G and 1086, the inner layer 1273 is disposed in the outer layer 1271 and can have the same or generally the same shape as the inner surface of the outer layer. The inner layer can be made from an expandable material, such as a rubber or other material traditionally used for making balloons and angioplasty devices. The outer layer 1271 can be made from a shape memory alloy, such as nitinol.

[00633] Referring to Figures 106H and 106I, in one example embodiment, the direction of expansion of the coaption element 1200 can be controlled. In the example illustrated by Figure 106H, the inner layer 1273 comprises two balloons that are optionally connected together. However, any number of balloons can be used. For example, the inner layer can comprise 3, 4, or any number of balloons. The balloons can be individually inflated to control the shape of expansion of the coaption element 1200. When the balloons are connected together, the connection can also affect the shape of expansion. In the example illustrated by Fig. 106H, the balloons are connected together along a plane 1275 or area. Expansion of the inner layer 1273 in the direction 1277 will be less than the expansion in the direction 1279 due to the connection 1275. As such, in this example, the expansion due to inflation can be limited to or substantially limited to expansion in the Medial to Lateral direction.

[00634] The use of multiple balloons and the configuration of any connections between the balloons can determine the way the width / size of the coaption element in the Anterior to Posterior direction, and / or Medial to Lateral direction expand (and / or contract).

[00635] In the example illustrated by Figure 106I, the inner layer 1273 comprises one or more supports 1281 or struts. One support 1281 is illustrated, but any number can be used. For example, the inner layer can comprise 2, 3, 4, or any number of supports. The supports 1281 can divide the inner layer into multiple independently inflatable chambers or the supports may not seal off independent chambers and inflation fluid applied to any chamber will fill all of the chambers. When there are independently inflatable chambers, the chambers can be individually inflated to control the shape of expansion of the coaption element 1200. The supports also affect the shape of expansion. In the example illustrated by FIG. 106I, the support 1281 will reduce or eliminate expansion of the inner layer 1273 in the direction 1277. As such, in this example, the expansion due to inflation can be limited to or substantially limited to expansion in the Medial to Lateral direction.

[00636] The use of multiple independently inflatable chambers and / or the configuration of the support members 1281 can determine the way the width / size of the coaption element in the Anterior to Posterior direction, and / or Medial to Lateral direction expand (and / or contract).

[00637] Incorporating the coaption elements 1200 illustrated by Figures 106G-106I into an implantable prosthetic device of the present application allows the coaption element to be expanded to press outward against tissue grasped between the coaption element and the paddles and / or gripping members.

[00638] Referring now to Figures 110–111, an example implantable prosthetic device 1300 is shown. The device 1300 is similar to the device 100, described above, and includes a coaption element 1310, paddles 1320, and clasps or gripping members 1330. Referring now to Figure 111, a top view of the coaption element 1310 is shown. As can be seen in Figure 111, the coaption element 1310 has an oval or generally oval-shaped cross-section. The coaption element 1310 does not include a central opening and can be formed from a solid piece of material, such as foam. Forming the coaption element 1310 from a solid piece of foam material prohibits blood from flowing through the center of the coaption element 1310, thereby substantially eliminating a location where blood can be captured. The device 1300 can include any other features for an implantable prosthetic device discussed in the present application, and the device 1300 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). The prosthetic device 1300 can be opened and closed in a wide variety of different ways. For example, a sleeve can be slidably disposed over the coaption element to engage and open the paddles. Or, the paddles can be opened by pulling a line or suture that opens the clasps and the movement of the clasps can open the paddles. However, any mechanism for opening and closing the device 1300 can be used.

[00639] Referring now to Figures 112–128, an example paddle frame 1400 for an implantable prosthetic device is shown. The paddle frame 1400 can be used with any of the implantable prosthetic devices described in the present application. The paddle frame 1400 is formed from a piece of material 1402, such as nitinol, or any other suitable material. The paddle frame 1400 extends from a cap attachment portion 1410 to a paddle connection portion 1420 and has a proximal portion 1422, a middle portion 1424, and a distal portion 1426. In some embodiments, the paddle frame 1400 includes attachment portions 1440 for securing a cover (see Figure 30), the inner paddle 522, and / or the outer paddle 520 to the paddle frame 1400. In some embodiments, the paddle frame 1400 is thinner in the location of the fifth curve 1438 to facilitate bending of both sides of the paddle frame 1400 toward the center plane 1404 during, for example, crimping of the device.

[00640] The paddle frame 1400 extends from a first attachment portion 1412 in a rounded, three- dimensional shape through the proximal, middle, and distal portions 1422, 1424, 1426 and returns to a second attachment portion 1414. To form a rounded three-dimensional shape, the paddle frame 1400 is bent or curved in multiple locations as the paddle frame 1400 extends between the first and second attachment portions 1412, 1414. The attachment portions 1412, 1414 include notches 1416, 1418 respectively for attachment to the cap. The paddle frame 1400 flexes at the area 1419. The area 1419 can include a wider portion 1417 to distribute the stress that results from flexing the paddle frame 1400 over a greater area. Also, notches 1416, 1418 can include radiused notches 1415 at each end of the notches. The radiused notches 1415 serve as strain reliefs for the bending area 1419 and the area where the paddle frame 1400 connects to the cap.

[00641] The paddle frame 1400 curves away from a median or central plane 1404 (Figure 115) at a first curve 1430 to widen the shape of the paddle frame 1400. As can be seen in Figure 117, the paddle frame 1400 also curves away from a frontal plane 1406 in the location of the first curve 1430. The paddle frame 1400 curves away from the outward direction of the first curve 1430 at a second curve 1432 to form sides of the frame 1400. The paddle frame continues to slope away from the frontal plane 1406 in the location of the second curve 1432. In some embodiments, the second curve 1432 has a larger radius than the first curve 1430. The paddle frame 1400 curves away from the frontal plane 1406 at a third curve 1434 as the paddle frame 1400 continues to curve in the arc of the second curve 1432 when viewed from the frontal plane 1406. This curvature at the third curve 1434 results in a gradual departure of the frame 1400, and thus the native valve leaflet from the centerline 1406. This departure from the centerline results in spreading of the leaflet tissue toward the valve annulus, which can result in less stress on the leaflet tissue. The paddle frame 1400 curves toward the lateral plane 1404 at a fourth curve 1436 as the frame 1400 continues to curve away from the frontal plane 1406. The rounded three-dimensional shape of the paddle frame 1400 is closed with a fifth curve 1438 that joins both sides of the paddle frame 1400. As can be seen in Figures 116 and 118, the paddle frame 1400 has an arcuate or generally arcuate shape as the frame 1400 extends away from the attachment portion 1420 and to the closed portion 1424. The middle portion 1424 of the frame is closer to the frontal plane 1406 than the closed portion 1426, giving the sides of the middle portion 1424 a rounded, wing-like shape that engages the curved surface of coaption element (not shown) during grasping of native tissue between a paddle (not shown) and coaption element of an implantable device of the present invention.

[00642] Referring to Figure 191, in an example embodiment, a flat blank 1403 of paddle frame 1400 can be cut, for example laser cut, from a flat sheet of material. Referring to Figure 192, the cut blank 1403 can then be bent to form the three-dimensional shaped paddle frame 1400.

[00643] Referring to Figures 193 and 194, in one example embodiment, the paddle frames 1400 can be shape-set to provide increased clamping force against or toward the coaption element 510 when the paddles 520, 522 are in the closed configuration. This is because the paddle frames are shape-set relative to the closed position (e.g. Figure 194) to a first position (e.g., Figure 193) which is beyond the position where the inner paddle 522 would engage the coaption element, such as beyond the central plane 552 of the device 500, such as beyond the opposite side of the coaption element, such as beyond the outer paddle on the opposite side of the coaption element. Ref...

Claims

1. A valve repair device for repairing a native valve of a patient, the valve repair device comprising: a strip of material; a coaptation element formed from the strip of material; and a pair of paddles formed from the strip of material and connected to the coaptation element, wherein the paddles are movable between an open position and a closed position; wherein the paddles are 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 that are woven together.

3. The valve repair device of any one of claims 1-2, wherein the strip of material comprises an electrospun material.

4. The valve repair device of any one of claims 1-3, wherein the strip of material comprises electrospun metal fibers.

5. The valve repair device of any one of claims 1-4, wherein the paddles comprise an inner paddle portion and an outer paddle portion.

6. The valve repair device of any one of claims 1-5, wherein the strip of material is folded to form the coaptation element and the pair of paddles.

7. The valve repair device of any one of claims 1-6, wherein the strip of material is folded to form a plurality of layers.

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

9. The valve repair device of claim 7, wherein the paddles comprise an inner paddle portion and an outer paddle portion, and the inner paddle portion is formed from two layers of the folded strip of material.

10. The valve repair device of any one of claims 1-9, wherein the paddles are disposed over an extension member.

11. The valve repair device of claim 10, wherein the extension member comprises a hoop and the strip of material is folded around the hoop.

12. The valve repair device of claim 11, wherein the paddles comprise an inner paddle portion and an outer paddle portion and the fold of the strip of material around the hoop is arranged between the inner and outer paddle portions.

13. The valve repair device of any one of claims 1-12, wherein the strip of material extends from a beginning in the paddle portion to an end in the paddle portion.

14. The valve repair device of claim 13, wherein the paddles comprise an inner paddle portion and an outer paddle portion, and wherein the beginning and end of the strip of material are located in the paddle portions.

15. The valve repair device of any one of claims 1-14, further comprising a base assembly that comprises: a shaft; a collar that the shaft extends through; and a cap attached to the shaft such that the cap can be moved by the shaft away from the collar; wherein the pair of paddles are attached to the cap; and wherein movement of the cap toward the collar causes the pair of paddles to move to the closed position, and movement of the cap away from the collar causes the pair of paddles to move to the open position.

16. The valve repair device of any one of claims 1-15, wherein the coaptation element is configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

17. A method of manufacturing a valve repair device for repairing a native valve of a patient, the method comprising: folding a strip of material to form a coaptation element and 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; attaching a portion of the strip of material forming the coaptation element to a collar; and attaching the portion of the strip of material forming the paddles to a cap, wherein movement of the cap toward the collar causes the pair of paddles to move to the closed position, and movement of the cap away from the collar causes the pair of paddles to move to the open position.

18. The method of claim 17, wherein the strip of material comprises metal strands that are woven together.

19. The method of any one of claims 17 and 18, wherein the strip of material comprises an electrospun material.

20. The method of any one of claims 17–19, wherein the strip of material comprises electrospun metal fibers.

21. The method of any one of claims 17–20, wherein the paddles comprise an inner paddle portion and an outer paddle portion.

22. The method of any one of claims 17–21, wherein the strip of material is folded to form the coaptation element and the pair of paddles.

23. The method of any one of claims 17–22, wherein the strip of material is folded to form a plurality of layers.

24. The method of claim 23, wherein the coaptation element is formed from four layers of the strip of material.

25. The method of claim 23, wherein the paddles comprise an inner paddle portion and an outer paddle portion, and the inner paddle portion is formed from two layers of the folded strip of material.

26. The method of any one of claims 17–25, wherein the paddles are disposed over an extension member.

27. The method of claim 26, wherein the extension member comprises a hoop and the strip of material is folded around the hoop.

28. The method of claim 27, wherein the paddles comprise an inner paddle portion and an outer paddle portion and the fold of the strip of material around the hoop is arranged between the inner and outer paddle portions.

29. The method of any one of claims 17–28, wherein the strip of material extends from a beginning in the paddle portion to an end in the paddle portion.

30. The method of claim 29, wherein the paddles comprise an inner paddle portion and an outer paddle portion, and wherein the beginning and end of the strip of material are located in the inner paddle portions.

31. The method of any one of claims 17–30, further comprising a base assembly that comprises: a shaft; a collar that the shaft extends through; and a cap attached to the shaft such that the cap can be moved by the shaft away from the collar; wherein the pair of paddles are attached to the cap; and wherein movement of the cap toward the collar causes the pair of paddles to move to the closed position, and movement of the cap away from the collar causes the pair of paddles to move to the open position.

32. The method of any one of claims 17–31, wherein the coaptation element is configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

33. A valve repair device for repairing a native valve of a patient, the valve repair device comprising: a strip of material; a coaptation element formed from the strip of material; a collar connected to the coaptation element; and a pair of paddles formed from the strip of material and connected to the coaptation element, wherein the paddles are movable between an open position and a closed position; and wherein the paddles are configured to attach to the native valve of the patient.

34. The valve repair device of claim 33, wherein the collar is spaced apart from the paddles.

35. The valve repair device of any one of claims 33-34, wherein the collar is connected to a proximal end of the coaptation element.

36. The valve repair device of any one of claims 33-35, wherein the paddles are connected to a distal end of the coaptation element.

37. The valve repair device of any one of claims 33-36, wherein the strip of material is woven through at least one opening of the collar.

38. The valve repair device of any one of claims 33-37, wherein the strip of material is woven through two openings of the collar.

39. The valve repair device of any one of claims 33-38, wherein the strip of material is woven through at least one arcuate shaped opening of the collar.

40. The valve repair device of claim 39, wherein the at least one opening comprises an open slot.

41. The valve repair device of any one of claims 33-40, wherein the strip of material comprises metal strands that are woven together.

42. The valve repair device of any one of claims 33-41, wherein the strip of material comprises an electrospun material.

43. The valve repair device of any one of claims 33-42, wherein the strip of material comprises electrospun metal fibers.

44. The valve repair device of any one of claims 33-43, wherein the paddles comprise an inner paddle portion and an outer paddle portion.

45. The valve repair device of any one of claims 33-44, wherein the paddles are disposed over an extension member.

46. The valve repair device of any one of claims 33-45, further comprising a base assembly that comprises: a shaft that extends through the collar; and a cap attached to the shaft such that the cap can be moved by the shaft away from the collar; wherein both of the pair of paddles are attached to the cap; and wherein movement of the cap toward the collar causes the pair of paddles to move to the closed position, and movement of the cap away from the collar causes the pair of paddles to move to the open position.

47. The valve repair device of claim 46, wherein the shaft extends through a central aperture of the collar.

48. The valve repair device of any one of claims 33-47, further comprising a clasp associated with each paddle of the pair of paddles, each clasp having at least one barb, a barb support portion, and a moveable arm49. The valve repair device of claim 48, wherein the clasp includes a flexible portion disposed between the barb support portion and the moveable arm.

50. The valve repair device of claim 49, wherein the paddles and the flexible portions are configured such that pulling on the at least one barb first causes the paddles to at least partially open and then causes the barb support portion to flex away from the moveable arm.

51. The valve repair device of any one of claims 46-50, wherein the coaptation element is configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

52. A valve repair device for repairing a native valve of a patient, the valve repair device comprising: a strip of material having first and second edges surrounding a central portion; a coaptation element formed from the strip of material; and a pair of paddles formed from the strip of material and connected to the coaptation element, wherein the paddles are movable between an open position and a closed position; and wherein the paddles are configured to attach to the native valve of the patient.

53. The valve repair device of claim 52, wherein the central portion is thinner than the first and second edges.

54. The valve repair device of any one of claims 52-53, wherein the strip of material has a lobed cross-sectional shape.

55. The valve repair device of any one of claims 52-54, wherein the strip of material comprises: at least one first edge strand; at least one second edge strand; and a plurality of central strands extending between the first and second edge strands to form the central portion.

56. The valve repair device of claim 55, wherein the plurality of central strands are braided around the first and second edge strands.

57. The valve repair device of claim 55, wherein the plurality of central strands are woven around the first and second edge strands.

58. The valve repair device of any one of claims 55–57, wherein the first and second edge strands have a diameter that is larger than a diameter of the central strands.

59. The valve repair device of any one of claims 55–58, wherein the first and second edge strands have a diameter of about 0.017 millimeters.

60. The valve repair device of any one of claims 55–59, wherein the central strands have a diameter of about 0.009 millimeters.

61. The valve repair device of any one of claims 55–60, wherein the central portion is formed from between about 25 and about 100 central strands.

62. The valve repair device of any one of claims 55–61, wherein the central portion is formed from between about 40 and about 85 central strands.

63. The valve repair device of any one of claims 55–62, wherein the central portion is formed from between about 48 and about 60 central strands.

64. The valve repair device of any one of claims 55–63, wherein the central portion is formed from about 48 central strands.

65. The valve repair device of any one of claims 55–64, wherein the central strands and the edge strands are formed from the same material.

66. The valve repair device of any one of claims 55–64, wherein the central strands and the edge strands are formed from different materials.

67. The valve repair device of any one of claims 55–66, wherein at least one of the central strands and the edge strands are formed from Nitinol wire.

68. The valve repair device of any one of claims 55–67, wherein the central strands are formed from polyethylene.

69. The valve repair device of any one of claims 52-68, wherein the first and second edge portions are more rigid than the central portion.

70. The valve repair device of any one of claims 52-69, wherein the strip of material comprises an electrospun material.

71. The valve repair device of any one of claims 52-70, wherein the strip of material comprises electrospun metal fibers.

72. The valve repair device of any one of claims 52-71, further comprising a base assembly that comprises: a shaft; a collar that the shaft extends through; and a cap attached to the shaft such that the cap can be moved by the shaft away from the collar; wherein the pair of paddles are attached to the cap; and wherein movement of the cap toward the collar causes the pair of paddles to move to the closed position, and movement of the cap away from the collar causes the pair of paddles to move to the open position.

73. The valve repair device of any one of claims 52-72, wherein the coaptation element is configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

74. A valve repair device for repairing a native valve of a patient, the valve repair device comprising: a strip of material; a coaptation element formed from the strip of material; a pair of extension members extending from attachment portions; a pair of paddles formed from the strip of material and connected to the coaptation element, wherein the paddles are movable between an open position and a closed position, are disposed over the extension member, and are configured to attach to the native valve of the patient; and a cap attached to the paddles, wherein movement of the cap toward the coaptation element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaptation element causes the pair of paddles to move to the open position, the cap comprising: a retention body having a locking aperture for receiving the attachment portions of the extension members; a retaining nut configured to insert into the locking aperture; and a retaining bolt for securing the retaining nut within the locking aperture.

75. The valve repair device of claim 74, further comprising: a collar attached to the coaptation element; a shaft extending through the collar to attach to the cap such that the cap can be moved by the shaft away from the collar; and wherein movement of the cap toward the collar causes the pair of paddles to move to the closed position, and movement of the cap away from the collar causes the pair of paddles to move to the open position.

76. The valve repair device of claim 75, wherein the shaft is attached to the retaining nut of the cap.

77. The valve repair device of any one of claims 74-76, wherein the locking aperture extends through the retention body.

78. The valve repair device of any one of claims 74-77, wherein the locking aperture is rectangular.

79. The valve repair device of any one of claims 74-78, wherein the locking aperture includes opposing locking channels for receiving the attachment portions of the extension members.

80. The valve repair device of claim 79, wherein the opposing locking channels have a rectangular shape.

81. The valve repair device of claims 79 or 80, wherein each locking channel receives two attachment portions of extension members.

82. The valve repair device of any one of claims 74-81, wherein the extension members have a rectangular cross-section.

83. The valve repair device of any one of claims 74-82, wherein the attachment portions of the extension members include hook portions for engaging the locking aperture.

84. The valve repair device of claim 83, wherein the hook portions engage opposing locking channels of the locking aperture.

85. The valve repair device of any one of claims 74-84, wherein the attachment portions of the extension members include notches for engaging the locking aperture.

86. The valve repair device of claim 85, wherein the notches engage opposing locking channels of the locking aperture.

87. The valve repair device of any one of claims 74-86, wherein the retaining bolt has a threaded portion extending from a flange.

88. The valve repair device of claim 87, wherein the flange includes at least one recess for receiving a tool.

89. The valve repair device of any one of claims 74-88, wherein each extension member comprises a hoop.

90. The valve repair device of claim 89, wherein the hoop extends between two attachment portions.

91. The valve repair device of claim 90, wherein the two attachment portions are biased to spread apart from each other.

92. The valve repair device of any one of claims 74-91, wherein: the locking aperture includes opposing locking channels for receiving the attachment portions of the extension members each extension member comprises a hoop extending between two attachment portions; the extension members are formed from a shape-memory alloy; and the attachment portions are shape-set in a spaced apart relationship that is wider than a distance between the two locking channels.

93. The valve repair device of any one of claims 74-92, wherein the strip of material is attached to the cap such that the strip of material is prohibited from moving relative to the cap.

94. The valve repair device of any one of claims 74-93, wherein the strip of material includes an opening for receiving the retaining bolt.

95. The valve repair device of any one of claims 74-94, wherein the retention body includes a channel for receiving the strip of material.

96. The valve repair device of claim 95, wherein the channel is enclosed by a flange of the retaining bolt.

97. The valve repair device of any one of claims 95 and 96, wherein the channel is narrower than a distance between the locking channels.

98. The valve repair device of any one of claims 95-97, wherein the channel is narrower than a width of the locking aperture.

99. The valve repair device of any one of claims 74-98, wherein the strip of material comprises metal strands that are woven together.

100. The valve repair device of any one of claims 74-99, wherein the strip of material comprises an electrospun material.

101. The valve repair device of any one of claims 74-100, wherein the coaptation element is configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

102. A method of manufacturing a valve repair device for repairing a native valve of a patient, the method comprising: folding a strip of material to form a coaptation element and 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; and attaching a portion of the strip of material forming the paddles to a cap, wherein movement of the cap toward the coaptation element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaptation element causes the pair of paddles to move to the open position, the cap comprising: a retention body having a locking aperture for receiving attachment portions of extension members; a retaining nut configured to insert into the locking aperture; and a retaining bolt for securing the retaining nut within the locking aperture; attaching a pair of extension members to the retention body of the cap via the attachment portions of the extension members such that the paddles are disposed over the extension members; and assembling the retaining bolt and retaining nut to secure the cap to the strip of material.

103. The method of claim 102, further comprising: a collar attached to the coaptation element; a shaft extending through the collar to attach to the cap such that the cap can be moved by the shaft away from the collar; and wherein movement of the cap toward the collar causes the pair of paddles to move to the closed position, and movement of the cap away from the collar causes the pair of paddles to move to the open position.

104. The method of claim 103, wherein attaching the pair of extension members to the cap further comprises: inserting the attachment portions of the extension members into the locking aperture of the retention body; and inserting the retaining nut into the locking aperture of the retention body after inserting the extension members.

105. The method of any one of claims 103–104, wherein the shaft is attached to the retaining nut of the cap.

106. The method of any one of claims 102-105, wherein the locking aperture extends through the retention body.

107. The method of any one of claims 102-106, wherein the locking aperture includes opposing locking channels for receiving the attachment portions of the extension members.

108. The method of any one of claims 102-107, wherein each locking channel receives two attachment portions of extension members.

109. The method of any one of claims 102-108, wherein the attachment portions of the extension members include hook portions for engaging the locking aperture.

110. The method of claim 109, wherein the hook portions engage opposing locking channels of the locking aperture.

111. The method of any one of claims 102-110, wherein the attachment portions of the extension members include notches for engaging the locking aperture.

112. The method of any one of claims 102–111, wherein the retaining bolt has a threaded portion extending from a flange.

113. The method of claim 112, wherein the flange includes at least one recess for receiving a tool.

114. The method of any one of claims 102-113, wherein each extension member comprises a hoop.

115. The method of claim 114, wherein the hoop extends between two attachment portions.

116. The method of claim 115, wherein the two attachment portions are biased to spread apart from each other.

117. The method of any one of claims 102–116, wherein: the locking aperture includes opposing locking channels for receiving the attachment portions of the extension members each extension member comprises a hoop extending between two attachment portions; the extension members are formed from a shape-memory alloy; and the attachment portions are shape-set in a spaced apart relationship that is wider than a distance between the two locking channels.

118. The method of any one of claims 102–117, wherein the strip of material is attached to the cap such that the strip of material is prohibited from moving relative to the cap.

119. The method of any one of claims 102–118, wherein the retention body includes a channel for receiving the strip of material.

120. The method of claim 119, wherein the channel is narrower than a distance between the locking channels.

121. The method of any one of claims 119–120, wherein the channel is narrower than a width of the locking aperture.

122. The method of any one of claims 102–121, wherein the strip of material comprises metal strands that are woven together.

123. The method of any one of claims 102-122, wherein the strip of material comprises an electrospun material.

124. The method of any one of claims 102–123, wherein the coaptation element is configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

125. A valve repair device for repairing a native valve of a patient, the valve repair device comprising: a strip of material; a coaptation element formed from the strip of material; a pair of paddles formed from the strip of material and 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 cap attached to the paddles, wherein movement of the cap toward the coaptation element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaptation element causes the pair of paddles to move to the open position; and a pair of extension members connected to the cap and moveable between an open position and a closed position, wherein in the closed position the extension members are biased in a closing direction.

126. The valve repair device of claim 125, wherein the extension members do not overlap while in the closed position.

127. The valve repair device of any one of claims 125 and 126, wherein the extension members are moveable in the closing direction beyond the closed position to a pre-loading position.

128. The valve repair device of any one of claims 125-127, wherein the extension members are shape-set in a pre-loading position and the extension members are moved in the closing direction beyond the closed position to the pre-loading position.

129. The valve repair-device of any one of claims 127 and 128, wherein at least a portion of each extension member overlaps the other extension member in the pre-loading position.

130. The valve repair device of any one of claims 127–129, wherein ends of the extension members do not overlap.

131. The valve repair device of any one of claims 125-130, wherein the extension members comprise hoops.

132. The valve repair device of claim 131, wherein the hoops interlock in a pre-loading position.

133. The valve repair device of any one of claims 125-132, wherein the paddles comprise an inner paddle portion and an outer paddle portion.

134. The valve repair device of any one of claims 125-133, wherein the paddles are disposed over the extension members.

135. The valve repair device of any one of claims 125-134, wherein the strip of material comprises metal strands that are woven together.

136. The valve repair device of any one of claims 125-135, wherein the strip of material comprises electrospun metal fibers.

137. The valve repair device of any one of claims 125-136, further comprising a base assembly that comprises: a collar; and a shaft that extends through the collar and is attached to the cap such that the cap can be moved by the shaft away from the collar; wherein movement of the cap toward the collar causes the pair of paddles to move to the closed position, and movement of the cap away from the collar causes the pair of paddles to move to the open position.

138. The valve repair device of any one of claims 125-137, wherein the coaptation element is configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

139. A method of manufacturing a valve repair device for repairing a native valve of a patient, the method comprising: folding a strip of material formed from shape-memory alloy around a jig to form a coaptation element and 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; and heat treating the strip of material to shape-set the strip of material in the shape of the coaptation element and paddles.

140. The method of claim 139, wherein the jig further comprises plurality of jig portions.

141. The method of claim 140, wherein the strip of material is folded around each of the plurality of jig portions.

142. The method of any one of claims 140 and 141, wherein the strip of material is folded more than once around one of the plurality of jig portions.

143. The method of any one of claims 139-142, wherein the jig further comprises first, second, third, and fourth jig portions.

144. The method of claim 143, wherein folding the strip of material around the jig comprises: folding the strip of material around the first jig portion; folding the strip of material around the second jig portion; folding the strip of material around the first jig portion a second time; folding the strip of material around the third jig portion; and folding the strip of material around the fourth jig portion.

145. The method of any one of claims 143 and 144, wherein the first jig portion is larger than the second, third, and fourth jig portions.

146. The method of any one of claims 143–145, wherein the jig portions are cylindrical, and the first jig portion has a larger diameter than a diameter of the second, third, and fourth jig portions.

147. The method of any one of claims 143–146, wherein the second jig portion is closer to a proximal end of the valve repair device than the first, third, and fourth jig portions.

148. The method of any one of claims 143–147, wherein the fourth jig portion is closer to a distal end of the valve repair device than the first, second, and third jig portions.

149. The method of any one of claims 143–148, wherein the first and third jig portions are arranged closer to a proximal end of the valve repair device than the fourth jig portion.

150. The method of any one of claims 143–149, wherein: the second jig portion is a closest jig portion to a proximal end of the valve repair device; the fourth jig portion is a closest jig portion to a distal end of the valve repair device; and the first and third jig portions are arranged between the second and fourth jig portions.

151. The method of any one of claims 143–150, wherein the first jig portion is arranged between the fourth jig portion and the third jig portion.

152. The method of any one of claims 143–151, wherein each jig portion comprises a pair of jig portions.

153. The method of claim 152, wherein folding the strip of material around the jig comprises: folding the strip of material around one of the first jig portions; folding the strip of material around one of the second jig portions; folding the strip of material around one of the first jig portions a second time; folding the strip of material around one of the third jig portions; folding the strip of material around one of the fourth jig portions; folding the strip of material around the other of the fourth jig portions; folding the strip of material around the other of the third jig portions; folding the strip of material around the other of the first jig portions; folding the strip of material around the other of the second jig portions; and folding the strip of material around the other of the first jig portions a second time.

154. The method of any one of claims 143–153, wherein a proximal end of the coaptation element is formed by folding the strip of material around the second jig portion.

155. The method of any one of claims 143–154, wherein a distal end of the paddles is formed by folding the strip of material around the fourth jig portion.

156. The method of any one of claims 143–155, wherein the paddles comprise an inner paddle portion and an outer paddle portion and a hinge between the inner and outer paddle portions is formed by folding the strip of material around the third jig portion.

157. The method of any one of claims 143–156, wherein the first jig portion is cylindrical and has a diameter of about 1.0 mm.

158. A valve repair device for repairing a native valve of a patient, the valve repair device comprising: a strip of material; a coaptation element formed from the strip of material; a pair of paddles formed from the strip of material and 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 cap attached to the paddles, wherein movement of the cap toward the coaptation element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaptation element causes the pair of paddles to move to the open position; and a pair of extension members connected to the cap and the paddles, the extension members extending from attachment portions for attaching the extension members to the cap to end portions that are attached to the strip material forming the paddles; wherein the end portions of the extension members extend beyond the strip of material.

159. The valve repair device of claim 158, wherein the paddles comprise an inner paddle portion and an outer paddle portion.

160. The valve repair device of any one of claims 158 and 159, wherein the paddles are disposed over a portion of the extension members.

161. The valve repair device of any one of claims 158-160, wherein the paddles are disposed over the end portions of the extension members.

162. The valve repair device of any one of claims 158-161, wherein the paddles are disposed within the extension members.

163. The valve repair device of any one of claims 158-162, wherein the paddles are disposed within the end portions of the extension members.

164. The valve repair device of any one of claims 158-163, wherein the extension members comprise a hoop and the strip of material is folded around a portion of the hoop.

165. The valve repair device of claim 164, wherein the paddles comprise an inner paddle portion and an outer paddle portion and the fold of the strip of material around the hoop is arranged between the inner and outer paddle portions.

166. The valve repair device of any one of claims 158-165, wherein the end portions include a slot for receiving the strip of material.

167. The valve repair device of claim 166, wherein the slot includes an opening formed between the slot and an exterior of the extension members.

168. The valve repair device of any one of claims 166-167, wherein the slot extends between first and second ends.

169. The valve repair device of claim 168, wherein the slot includes an opening arranged between the first and second ends.

170. The valve repair device of claim 169, wherein the opening is formed between the slot and an exterior of the extension member.

171. The valve repair device of any one of claims 158-170, wherein the end portions include at least one attachment hole for securing a cover to the extension member.

172. The valve repair device of any one of claims 158-171, further comprising a base assembly that comprises: a shaft; a collar that the shaft extends through; a cap attached to the shaft such that the cap can be moved by the shaft away from the collar; wherein the pair of paddles are attached to the cap; wherein movement of the cap toward the collar causes the pair of paddles to move to the closed position, and movement of the cap away from the collar causes the pair of paddles to move to the open position.

173. The valve repair device of any one of claims 158-172, wherein the strip of material comprises metal strands that are woven together.

174. The valve repair device of any one of claims 158-173, wherein the strip of material comprises an electrospun material.

175. The valve repair device of any claims 158-174, wherein the coaptation element is configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

176. A valve repair device for repairing a native valve of a patient, the valve repair device comprising: a strip of material; a coaptation element formed from the strip of material; and a pair of paddles formed from the strip of material and connected to the coaptation element, wherein the paddles are movable between an open position and a closed position; wherein the paddles are configured to attach to the native valve of the patient; a first and second paddle frame each having a first frame portion that is substantially parallel to a second frame portion to form a rectangular shaped leaflet engagement area.

177. The valve repair device of claim 176, wherein the strip of material is folded to form the coaptation element and the pair of paddles.

178. The valve repair device of claim 177, wherein the paddles comprise an inner paddle portion and an outer paddle portion, and the inner paddle portion is formed from two layers of the folded strip of material.

179. The valve repair device of any one of claims 176-178, wherein the coaptation element is configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

180. The valve repair device of any one of claims 176-179, wherein the rectangular leaflet engagement area is configured to press two native heart valve leaflets together when the two leaflets are misaligned along a height of the valve repair device.

181. The valve repair device of any one of claims 176-179, wherein the rectangular leaflet engagement area is configured to press two mitral valve leaflets together when the two leaflets are misaligned along a height of the valve repair device.

182. A valve repair device for repairing a native valve of a patient, the valve repair device comprising: a single strip of woven material having a plurality of central strands woven together to form a central portion and woven around first and second edge strands to form first and second edges surrounding the central portion; a coaptation element formed by folding the single strip of woven material; and a pair of paddles formed from the strip of woven material and connected to the coaptation element, wherein the paddles are movable between an open position and a closed position; wherein the paddles are configured to attach to the native valve of the patient.

183. The valve repair device of claim 182, wherein the central portion is thinner than the first and second edges.

184. The valve repair device of claim 182 or claim 183, wherein the strip of material has a lobed cross-sectional shape.

185. The valve repair device of any one of claims 182-184, wherein the first and second edge strands have a diameter that is larger than a diameter of the central strands.

186. The valve repair device of any one of claims 182-185, wherein the first and second edge strands have a diameter of about 0.017 millimeters.

187. The valve repair device of any one of claims 182-186, wherein the central strands have a diameter of about 0.009 millimeters.

188. The valve repair device of any one of claims 182-187, wherein the central portion is formed from between about 25 and about 100 central strands.

189. The valve repair device of any one of claims 182-188, wherein the central portion is formed from between about 40 and about 85 central strands.

190. The valve repair device of any one of claims 182-189, wherein the central portion is formed from between about 48 and about 60 central strands.

191. The valve repair device of any one of claims 182-190, wherein the central portion is formed from about 48 central strands.

192. The valve repair device of any one of claims 182-191, wherein the central portion is formed from 48 central strands.

193. The valve repair device of any one of claims 182-192, wherein the central strands and the edge strands are formed from the same material.

194. The valve repair device of any one of claims 182-192, wherein the central strands and the edge strands are formed from different materials.

195. The valve repair device of any one of claims 182-194, wherein at least one of the central strands and the edge strands are formed from Nitinol wire.

196. The valve repair device of any one of claims 182-194, wherein the central strands are formed from polyethylene.

197. The valve repair device of any one of claims 182-196, wherein the first and second edge portions are more rigid than the central portion.

198. The valve repair device of any one of claims 182-197, wherein the strip of material comprises an electrospun material.

199. The valve repair device of any one of claims 182-198, wherein the strip of material comprises electrospun metal fibers.

200. The valve repair device of any one of claims 182-199, further comprising a base assembly that comprises: a shaft; a collar that the shaft extends through; and a cap attached to the shaft such that the cap can be moved by the shaft away from the collar; wherein the pair of paddles are attached to the cap; and wherein movement of the cap toward the collar causes the pair of paddles to move to the closed position, and movement of the cap away from the collar causes the pair of paddles to move to the open position.

201. A valve repair device for repairing a native valve of a patient, the valve repair device comprising: a strip of material; a coaptation element comprising two or more folded layers of the strip of material; and a pair of paddles formed from the strip of material and connected to the coaptation element, wherein the paddles are movable between an open position and a closed position; wherein the paddles are configured to attach to the native valve of the patient.

202. The valve repair device of claim 201, wherein the strip of material comprises metal strands that are woven together.

203. The valve repair device of claim 201 or claim 202, wherein the strip of material comprises an electrospun material.

204. The valve repair device of any one of claims 201-203, wherein the strip of material comprises electrospun metal fibers.

205. The valve repair device of any one of claims 201-204, wherein the paddles comprise an inner paddle portion and an outer paddle portion.

206. The valve repair device of any one of claims 201-205, wherein the strip of material is folded to form the coaptation element and the pair of paddles.

207. The valve repair device of any one of claims 201-206, wherein the coaptation element is formed from four layers of the strip of material.

208. The valve repair device of any one of claims 201-207, wherein the paddles comprise an inner paddle portion and an outer paddle portion, and the inner paddle portion is formed from two layers of the strip of material.

209. The valve repair device of any one of claims 201-208, wherein the paddles are disposed over an extension member.

210. The valve repair device of claim 209, wherein the extension member comprises a hoop and the strip of material is folded around the hoop.

211. The valve repair device of claim 210, wherein the paddles comprise an inner paddle portion and an outer paddle portion and the fold of the strip of material around the hoop is arranged between the inner and outer paddle portions.

212. The valve repair device of any one of claims 201-211, wherein the strip of material extends from a beginning in the paddle portion to an end in the paddle portion.

213. The valve repair device of claim 212, wherein the paddles comprise an inner paddle portion and an outer paddle portion, and wherein the beginning and end of the strip of material are located in the inner paddle portions.

214. The valve repair device of claims 201-213, comprising a base assembly that comprises: a shaft; a collar that the shaft extends through; and a cap attached to the shaft such that the cap can be moved by the shaft away from the collar; wherein the pair of paddles are attached to the cap; and wherein movement of the cap toward the collar causes the pair of paddles to move to the closed position, and movement of the cap away from the collar causes the pair of paddles to move to the open position.

215. The valve repair device of any one of claims 201-214, wherein the coaptation element is configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

216. A method of manufacturing a valve repair device for repairing a native valve of a patient, the method comprising: folding a strip of material into a plurality of layers to form a coaptation element and a pair of paddles connected to the coaptation element, wherein the coaptation element includes two or more layers of the plurality of layers; 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; attaching a portion of the strip of material forming the coaptation element to a collar; and attaching the portion of the strip of material forming the paddles to a cap, wherein movement of the cap toward the collar causes the pair of paddles to move to the closed position, and movement of the cap away from the collar causes the pair of paddles to move to the open position.

217. The method of claim 216, wherein the strip of material comprises metal strands that are woven together.

218. The method of any one of claims 216 and 217, wherein the strip of material comprises an electrospun material.

219. The method of any one of claims 216-218, wherein the strip of material comprises electrospun metal fibers.

220. The method of any one of claims 216-219, wherein the paddles comprise an inner paddle portion and an outer paddle portion.

221. The method of any one of claims 216-220, wherein the coaptation element is formed from four layers of the plurality of layers of the strip of material.

222. The method of any one of claims 216-221, wherein the paddles comprise an inner paddle portion and an outer paddle portion, and the inner paddle portion is formed from two layers of the plurality of layers.

223. The method of any one of claims 216-222, wherein the paddles are disposed over an extension member.

224. The method of claim 223, wherein the extension member comprises a hoop and the strip of material is folded around the hoop.

225. The method of claim 224, wherein the paddles comprise an inner paddle portion and an outer paddle portion and the fold of the strip of material around the hoop is arranged between the inner and outer paddle portions.

226. The method of any one of claims 216-225, wherein the strip of material extends from a beginning in the paddle portion to an end in the paddle portion.

227. The method of claim 226, wherein the paddles comprise an inner paddle portion and an outer paddle portion, and wherein the beginning and end of the strip of material are located in the inner paddle portions.

228. The method of any one of claims 216-227, comprising a base assembly that comprises: a shaft; a collar that the shaft extends through; and a cap attached to the shaft such that the cap can be moved by the shaft away from the collar; wherein the pair of paddles are attached to the cap; and wherein movement of the cap toward the collar causes the pair of paddles to move to the closed position, and movement of the cap away from the collar causes the pair of paddles to move to the open position.

229. The method of any one of claims 216-228, wherein the coaptation element is configured to close a gap in the native valve of the patient when the valve repair device is attached to the native valve.

230. The valve repair device of claim 201, wherein the valve repair device comprises a collar connected to the coaptation element.

231. The valve repair device of claim 230, wherein the collar is spaced apart from the paddles.

232. The valve repair device of any one of claims 230 and 231, wherein the collar is connected to a proximal end of the coaptation element.

233. The valve repair device of any one of claims 230-232, wherein the paddles are connected to a distal end of the coaptation element.

234. The valve repair device of any one of claims 230-233, wherein the strip of material is woven through at least one opening of the collar.

235. The valve repair device of any one of claims 230-234, wherein the strip of material is woven through two openings of the collar.

236. The valve repair device of any one of claims 230-235, wherein the strip of material is woven through at least one arcuate shaped opening of the collar.

237. The valve repair device of claim of claim 236, wherein the at least one opening comprises an open slot.

238. The valve repair device of any one of claims 230-237, comprising a clasp associated with each paddle of the pair of paddles, each clasp having at least one barb, a barb support portion, and a moveable arm.

239. The valve repair device of claim 238, wherein the clasp includes a flexible portion disposed between the barb support portion and the moveable arm.

240. The valve repair device of claim 239, wherein the paddles and the flexible portions are configured such that pulling on the at least one barb first causes the paddles to at least partially open and then causes the barb support portion to flex away from the moveable arm.

241. The valve repair device of claim 201, wherein the strip of material has first and second edges surrounding a central portion.

242. The valve repair device of claim 241, wherein the central portion is thinner than the first and second edges.

243. The valve repair device of any one of claims 241 and 242, wherein the strip of material has a lobed cross-sectional shape.

244. The valve repair device of any one of claims 241-243, wherein the strip of material comprises: at least one first edge strand; at least one second edge strand; and a plurality of central strands extending between the first and second edge strands to form the central portion.

245. The valve repair device of claim 244, wherein the plurality of central strands are braided around the first and second edge strands.

246. The valve repair device of claim 244, wherein the plurality of central strands are woven around the first and second edge strands.

247. The valve repair device of any one of claims 244-246, wherein the first and second edge strands have a diameter that is larger than a diameter of the central strands.

248. The valve repair device of any one of claims 244-247, wherein the first and second edge strands have a diameter of 0.017 millimeters.

249. The valve repair device of any one of claims 244-248, wherein the central strands have a diameter of 0.009 millimeters.

250. The valve repair device of any one of claims 244-249, wherein the central portion is formed from between 25 and 100 central strands.

251. The valve repair device of any one of claims 244-250, wherein the central portion is formed from between 40 and 85 central strands.

252. The valve repair device of any one of claims 244-251, wherein the central portion is formed from between 48 and 60 central strands.

253. The valve repair device of any one of claims 244-252, wherein the central portion is formed from 48 central strands.

254. The valve repair device of any one of claims 244-253, wherein the central strands and the edge strands are formed from the same material.

255. The valve repair device of any one of claims 244-254, wherein the central strands and the edge strands are formed from different materials.

256. The valve repair device of any one of claims 244-255, wherein at least one of the central strands and the edge strands are formed from Nitinol wire.

257. The valve repair device of any one of claims 244-256, wherein the central strands are formed from polyethylene.

258. The valve repair device of any one of claims 241-257, wherein the first and second edge portions are more rigid than the central portion.

259. The valve repair device of claim 202, wherein the valve repair device comprises: a pair of extension members extending from attachment portions; a cap attached to the paddles, wherein movement of the cap toward the coaptation element causes the pair of paddles to move to the closed position, and movement of the cap away from the coaptation element causes the pair of paddles to move to the open position, the cap comprising: a retention body having a locking aperture for receiving the attachment portions of the extension members; a retaining nut configured to insert into the locking aperture; and a retaining bolt for securing the retaining nut within the locking aperture.

260. The valve repair device of claim 259, further comprising: a collar attached to the coaptation element; a shaft extending through the collar to attach to the cap such that the cap can be moved by the shaft away from the collar; wherein movement of the cap toward the collar causes the pair of paddles to move to the closed position, and movement of the cap away from the collar causes the pair of paddles to move to the open position.

261. The valve repair device of claim 260, wherein the shaft is attached to the retaining nut of the cap.

262. The valve repair device of any one of claims 259-261, wherein the locking aperture extends through the retention body.

263. The valve repair device of any one of claims 259-262, wherein the locking aperture is rectangular.

264. The valve repair device of any one of claims 259-263, wherein the locking aperture includes opposing locking channels for receiving the attachment portions of the extension members.

265. The valve repair device of claim 264, wherein the opposing locking channels have a rectangular shape.

266. The valve repair device of any one of claims 264 and 265, wherein each locking channel receives two attachment portions of extension members.

267. The valve repair device of any one of claims 259-266, wherein the extension members have a rectangular cross-section.

268. The valve repair device of any one of claims 259-267, wherein the attachment portions of the extension members include hook portions for engaging the locking aperture.

269. The valve repair device of claim 268, wherein the hook portions engage opposing locking channels of the locking aperture.

270. The valve repair device of any one of claims 259-269, wherein the attachment portions of the extension members include notches for engaging the locking aperture.

271. The valve repair device of claim 270, wherein the notches engage opposing locking channels of the locking aperture.

272. The valve repair device of any one of claims 259-271, wherein the retaining bolt has a threaded portion extending from a flange.

273. The valve repair device of claim 272, wherein the flange includes at least one recess for receiving a tool.

274. The valve repair device of any one of claims 259-273, wherein each extension member comprises a hoop.

275. The valve repair device of claim 274, wherein the hoop extends between two attachment portions.

276. The valve repair device of claim 275, wherein the two attachment portions are biased to spread apart from each other.

277. The valve repair device of any one of claims 259-276, wherein: the locking aperture includes opposing locking channels for receiving the attachment portions of the extension members; each extension member comprises a hoop extending between two attachment portions; the extension members are formed from a shape-memory alloy; and the attachment portions are shape-set in a spaced apart relationship that is wider than a distance between the two locking channels.

278. The valve repair device of any one of claims 259-277, wherein the strip of material is attached to the cap such that the strip of material is prohibited from moving relative to the cap.

279. The valve repair device of any one of claims 259-278, wherein the strip of material includes an opening for receiving the retaining bolt.

280. The valve repair device of any one of claims 259-279, wherein the retention body includes a channel for receiving the strip of material.

281. The valve repair device of claim 280, wherein the channel is enclosed by a flange of the retaining bolt.

282. The valve repair device of any one of claims 280 and 281, wherein the channel is narrower than a distance between the locking channels.

283. The valve repair device of any one of claims 280-282, wherein the channel is narrower than a width of the locking aperture.