Heart valve sealing devices and delivery devices therefor

Abstract

To provide improved devices and methods for treating a regurgitant valve.SOLUTION: An implantable prosthetic device has a coaption element and at least one anchor. The coaption element is configured to be positioned within a native heart valve orifice to help fill a space where a 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.SELECTED DRAWING: Figure 232A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 744,031, filed October 10, 2018, which is incorporated herein by reference for all purposes. [Background technology]

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform important functions in ensuring proper forward flow of blood supply throughout the cardiovascular system. These heart valves can be damaged and therefore less effective due to congenital malformations, inflammatory processes, infectious conditions, disease, etc. Damage to such valves can cause serious cardiovascular problems or death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and can be prone to complications. Transvascular techniques can be used to introduce and implant prosthetic devices in a manner that is much less invasive than open-heart surgery. As an example, a transseptal technique may be used, including inserting a catheter into the right femoral vein, up the inferior vena cava, into the right atrium, puncturing the septum, and threading the catheter into the left atrium.

[0003] A healthy heart has a roughly conical shape that tapers to a lower apex. The heart is divided into four chambers: the left atrium, the right atrium, the left ventricle, and the right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The native mitral valve in the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy from other native heart valves. The mitral valve includes an annulus, a circular portion of native valve tissue surrounding the mitral orifice, and a pair of leaflets or cusps extending downward from the annulus into the left ventricle. The mitral valve annulus can form a "D"-shaped, elliptical, or otherwise non-circular cross-sectional shape with long and short axes. The anterior leaflet is larger than the posterior leaflet, and when they close together, they can form a roughly "C"-shaped boundary between the adjacent leaflets.

[0004] When functioning properly, the anterior and posterior leaflets function together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle expands (also called "ventricular diastole" or "diastole"), oxygenated blood collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricular muscle contracts (also called "ventricular systole" or "systole"), increased blood pressure in the left ventricle closes the one-way mitral valve by drawing the two leaflets together. This prevents blood from flowing back into the left atrium and instead expels blood from the left ventricle through the aortic valve. To prevent the leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, multiple fibrous cords called chordae tendineae connect the leaflets to the papillary muscles of the left ventricle.

[0005] Mitral regurgitation occurs when the native mitral valve fails to close properly during the systolic phase of cardiac contraction, allowing blood to flow from the left ventricle into the left atrium. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral annulus due to left ventricular dilation, or two or more of these. Mitral regurgitation in the central portion of the valve leaflets can be referred to as central-jet mitral regurgitation, while mitral regurgitation closer to one commissure of the leaflets (i.e., where the leaflets meet) 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, thus preventing closure of the valve and resulting in regurgitation.

[0006] Techniques for treating mitral and other valvular regurgitation in patients can involve directly securing the edges of the native valve to one another. For example, catheter-delivered clips can be used to attempt to clip the sides of the leaflets together at the end portions of the leaflets. However, significant challenges exist. For example, multiple clips may be required to eliminate or reduce regurgitation to an acceptable level, but in some situations this can result in longer operating times, excessively restrictive flow, or undesirable stress on the native anatomy. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent No. 8,449,599 [Patent Document 2] US Patent Application Publication No. 2014 / 0222136 [Patent Document 3] US Patent Application Publication No. 2014 / 0067052 [Patent Document 4] US Patent Application Publication No. 2016 / 0331523 [Patent Document 5] U.S. Provisional Patent Application No. 62 / 161,688 [Patent Document 6] US Patent Application Publication No. 2016 / 0155987 [Patent Document 7] U.S. Provisional Patent Application No. 62 / 418,528 Summary of the Invention [Problem to be solved by the invention]

[0008] Despite these conventional techniques, there is a continuing need for improved devices and methods for treating valvular regurgitation. [Means for solving the problem]

[0009] This Summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any features included in an example of this Summary are not required by a claim unless the claim explicitly recites those features. Also, features, components, steps, concepts, etc. described in examples in this Summary and elsewhere in this disclosure may be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples summarized herein.

[0010] An exemplary implantable prosthetic device has a co-option element (the term co-option element is used throughout this application, but it may also be referred to as a co-option element, spacer, etc.) and at least one anchor. The co-option element is configured to be positioned within the native heart valve orifice to help fill the space where the native valve regurgitates and form a more effective seal. The co-option element may have a structure that is impermeable to blood. The co-option element may be connected to the leaflets of the native valve by anchors.

[0011] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a strip of material and a pair of paddles. A co-option element is formed from or includes the strip of material. The pair of paddles is formed from or includes the strip of material and is connected to the co-option element. The pair of paddles is movable between an open position and a closed position.

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

[0013] In one exemplary method of manufacturing a valve repair device, a strip of material is folded to form a co-option element and a pair of paddles connected to the co-option element. The paddles are movable between open and closed positions and are configured for attachment to a patient's native valve. A portion of the strip of material forming the co-option element is attached to a collar. A portion of the strip of material forming the paddles is attached to a cap. Moving the cap toward the collar moves the pair of paddles to the closed position. Moving the cap away from the collar moves the pair of paddles to the open position.

[0014] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a co-option element and a pair of paddles. The co-option element has four layers. The pair of paddles are connected to the co-option element. The paddles are movable between an open position and a closed position and are configured to attach to the patient's native valve.

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

[0016] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a collar, a co-option element, and a pair of paddles. The collar has a plurality of engagement portions configured to releasably engage with a delivery device. The co-option element is attached to the collar. The pair of paddles are connected to the co-option element and are movable between an open position and a closed position. The paddles are circumferentially disposed between the engagement portions. The paddles are configured to attach to the patient's native valve.

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

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

[0019] In one exemplary embodiment, a valve repair device for repairing a patient's native valve is fabricated from a strip of material. The strip of material has first and second edges surrounding a central portion. A co-option 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 co-option element. The paddles are movable between an open position and a closed position.

[0020] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a strip of material, a pair of attachment portions, a pair of extension members, and a cap. The co-option element is formed from the strip of material. The pair of extension members have attachment portions. The pair of paddles are formed from the strip of material. The pair of paddles are connected to the co-option element. The paddles are movable between an open position and a closed position. The paddles are disposed on the extension members. The cap is attached to the paddles. Moving the cap toward the co-option element moves the pair of paddles to the closed position. Moving the cap away from the co-option element moves the pair of paddles to the open position. The cap includes a retention body, a retention nut, and a retention bolt. The retention body has a locking aperture for receiving the attachment portions of the extension members. The retention nut is inserted into the locking aperture. The retention bolt secures the retention nut within the locking aperture.

[0021] In one exemplary method of manufacturing a valve repair device for repairing a patient's native valve, a strip of material is folded to form a co-option element and a pair of paddles connected to the co-option element. The paddles are movable between an open position and a closed position and are configured to attach to the patient's native valve. A portion of the strip of material forming the paddles is attached to a cap. Moving the cap toward the co-option element moves the pair of paddles to the closed position. Moving the cap away from the co-option element moves the pair of paddles to the open position. The cap includes a retaining body, a retaining nut, and a retaining bolt. The retaining body has a locking aperture for receiving an attachment portion of an extension member. The retaining nut is configured to be inserted into the locking aperture. The retaining bolt secures the retaining nut within the locking aperture. The pair of extension members are attached to the retaining body of the cap via the attachment portions of the extension members such that the paddles are disposed on the extension members. The retaining bolt and the retaining nut are assembled to secure the cap to the strip of material.

[0022] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a strip of material, a cap, and a pair of extension members. The co-option element is formed from the strip of material. The pair of paddles is formed from the strip of material and connected to the co-option element. The paddles are movable between an open position and a closed position and are configured to attach to the patient's native valve. The cap is attached to the paddles. Moving the cap toward the co-option element moves the pair of paddles to the closed position. Moving the cap away from the co-option element moves the pair of paddles to the open position. The pair of extension members are connected to the cap and are movable between the open position and the closed position. In the closed position, the extension members are biased in a closing direction.

[0023] In one exemplary method of manufacturing a valve repair device for repairing a patient's native valve, a strip of material formed from a shape memory alloy is folded around a jig to form both a co-option element and a pair of paddles connected to the co-option element. The paddles are movable between open and closed positions and are configured for attachment to the patient's native valve. The strip of shape memory material is heat treated to set the strip of material into the shape of the co-option element and the paddles.

[0024] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a strip of material, a cap, and a pair of extension members. The co-option element is formed from the strip of material. The pair of paddles is formed from the strip of material and connected to the co-option element. The paddles are movable between an open position and a closed position and are configured to attach to the patient's native valve. The cap is attached to the paddles. Moving the cap toward the co-option element moves the pair of paddles to the closed position. Moving the cap away from the co-option element moves the pair of paddles to the open position. The pair of extension members are connected to the cap and the paddles. The extension members extend from an attachment portion for attaching the extension members to the cap to an end portion attached to the strip of material forming the paddles. The end portion of the extension members extends beyond the strip of material.

[0025] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a primary co-option element, at least one auxiliary co-option element, and a pair of paddles. The at least one auxiliary co-option element is connected to the co-option element. The pair of paddles are connected to the primary co-option element. The paddles are movable between an open position and a closed position.

[0026] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a co-option element, a pair of paddles connected to the co-option 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 patient's native valve. The first and second paddle frames have spaced frame portions that are parallel or substantially parallel when the paddles are in the closed position, forming a rectangular leaflet engagement region.

[0027] In one example of a method for repairing a native heart valve, first and second repair devices are placed on a pair of leaflets of the native heart valve. Each repair device has a frame having a rectangular or substantially rectangular shape. The paddle frames of the placed repair devices are adjacent to each other and parallel or substantially parallel to each other.

[0028] The foregoing methods and other treatment methods herein may be performed on live animals or on simulations such as, for example, cadavers, cadaver hearts, simulators (e.g., simulated body parts, tissues, etc.).

[0029] In one exemplary embodiment, a valve repair device for repairing a patient's native valve includes a pair of paddles and a pair of 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 movable arm, and a flexible portion between the barb support portion and the movable arm. The flexible portion is configured to allow the barb support portion to bend away from the movable arm.

[0030] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals and in which:

[0031] To further clarify various aspects of embodiments of the present disclosure, a more particular description of certain embodiments will be made by reference to various aspects of the accompanying drawings. It will be understood that these drawings depict only typical embodiments of the present disclosure and therefore should not be considered as limiting the scope of the present disclosure. Moreover, while the drawings may be to scale for some embodiments, the drawings are not necessarily to scale for all embodiments. Embodiments of the present disclosure and other features and advantages will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0032] [Figure 1]1 shows a cutaway view of a human heart in diastole. [Figure 2] 1 shows a cutaway view of a human heart during systole. [Figure 2A] 1 shows another cutaway view of a human heart during systole. [Figure 2B] FIG. 2B is a cutaway view of FIG. 2A annotated to show the natural shape of the mitral valve leaflet during systole. [Figure 3] A cutaway view of a human heart in diastole is shown, with chordae tendineae shown attaching the leaflets of the mitral and tricuspid valves to the ventricular wall. [Figure 4] A view from the atrial side of the mitral valve shows a healthy mitral valve with the leaflets closed. [Figure 5] Shows a dysfunctional mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 6] 1 shows a mitral valve with a wide gap between the posterior and anterior leaflets. [Figure 6A] 1 shows a coaptation element within the mitral valve gap as viewed from the atrial side of the mitral valve. [Figure 6B] 1 shows a valve repair device attached to the mitral valve leaflets with a coaptation element in the mitral valve gap as viewed from the ventricular side of the mitral valve. [Figure 6C] FIG. 1 is a perspective view of a valve repair device attached to the mitral valve leaflets with a coaptation element in the mitral valve gap shown from the ventricular side of the mitral valve. [Figure 6D] 1A-1C are schematic diagrams illustrating the path of the mitral valve leaflets along each side of the co-option element of an exemplary mitral valve repair device. [Figure 6E] 1 is a top schematic view showing the path of the mitral valve leaflets around the co-option element of an exemplary native valve repair device. [Figure 7] The tricuspid valve is shown as seen from the atrial side. [Figure 8] 1 illustrates an exemplary embodiment of an implantable prosthetic device in a deployment stage. [Figure 9] 1 illustrates an exemplary embodiment of an implantable prosthetic device in a deployment stage. [Figure 10]1 illustrates an exemplary embodiment of an implantable prosthetic device in a deployment stage. [Figure 11] 1 illustrates an exemplary embodiment of an implantable prosthetic device in a deployment stage. [Figure 11A] 12 illustrates an exemplary embodiment of an implantable prosthetic device similar to the device illustrated by FIG. 11, but in which the paddles are independently controllable. [Figure 12] 1 illustrates an exemplary embodiment of an implantable prosthetic device in a deployment stage. [Figure 13] 1 illustrates an exemplary embodiment of an implantable prosthetic device in a deployment stage. [Figure 14] 1 illustrates an exemplary embodiment of an implantable prosthetic device in a deployment stage. [Figure 15] 8-14 shown delivered and implanted within a native valve. [Figure 16] 8-14 shown delivered and implanted within a native valve. [Figure 17] 8-14 shown delivered and implanted within a native valve. [Figure 18] 8-14 shown delivered and implanted within a native valve. [Figure 19] 8-14 shown delivered and implanted within a native valve. [Figure 20] 8-14 shown delivered and implanted within a native valve. [Figure 21] 1 illustrates an exemplary embodiment of an implantable prosthetic device or a frame of an implantable prosthetic device. [Figure 22] 1 illustrates an exemplary embodiment of an implantable prosthetic device or a frame of an implantable prosthetic device. [Figure 23] 1 illustrates an exemplary embodiment of a component of an implantable prosthetic or medical device. [Figure 23A]1 illustrates an exemplary embodiment of a component of an implantable prosthetic or medical device. [Figure 24] 1 illustrates an exemplary embodiment of a component of an implantable prosthetic or medical device. [Figure 25] 1 illustrates an exemplary embodiment of a component of an implantable prosthetic or medical device. [Figure 26] 1 illustrates an exemplary embodiment of a barbed clasp for use in an implantable prosthetic device. [Figure 27] 1 illustrates an exemplary embodiment of a barbed clasp for use in an implantable prosthetic device. [Figure 28] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 29] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 30] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 30A] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 31] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 32] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 32A] FIG. 33 is a perspective view of the insertion of the cap and co-option element of the implantable prosthetic device of FIGS. 28-32 in the sealed position. [Figure 32B] 33 is a perspective view of the insertion of the cap and co-option element of the implantable prosthetic device of FIGS. 28-32 in a spaced apart position. FIG. [Figure 33] 1 shows a barbed clasp for use in an implantable prosthetic device. [Figure 34] 1 shows a portion of native valve tissue grasped by a barbed clasp. [Figure 35] 1 illustrates an exemplary embodiment of an implantable prosthetic device being delivered and implanted within a native valve. [Figure 36]1 illustrates an exemplary embodiment of an implantable prosthetic device being delivered and implanted within a native valve. [Figure 37] 1 illustrates an exemplary embodiment of an implantable prosthetic device being delivered and implanted within a native valve. [Figure 38] 1 illustrates an exemplary embodiment of an implantable prosthetic device being delivered and implanted within a native valve. [Figure 39] 1 illustrates an exemplary embodiment of an implantable prosthetic device being delivered and implanted within a native valve. [Figure 40] 1 illustrates an exemplary embodiment of an implantable prosthetic device being delivered and implanted within a native valve. [Figure 41] 1 illustrates an exemplary embodiment of an implantable prosthetic device being delivered and implanted within a native valve. [Figure 42] 1 illustrates an exemplary embodiment of an implantable prosthetic device being delivered and implanted within a native valve. [Figure 43] 1 illustrates an exemplary embodiment of an implantable prosthetic device being delivered and implanted within a native valve. [Figure 44] 1 illustrates an exemplary embodiment of an implantable prosthetic device being delivered and implanted within a native valve. [Figure 45] 1 illustrates an exemplary embodiment of an implantable prosthetic device being delivered and implanted within a native valve. [Figure 46] 1 illustrates an exemplary embodiment of an implantable prosthetic device being delivered and implanted within a native valve. [Figure 47] 1 illustrates a side view of an exemplary implantable prosthetic device with the barbed clasp not in the closed position. [Figure 47A] 1 illustrates a side view of an exemplary implantable prosthetic device with the barbed clasp not in the closed position. [Figure 48] 1 illustrates a side view of an exemplary implantable prosthetic device with a barbed clasp in a closed position. [Figure 48A]1 illustrates a side view of an exemplary implantable prosthetic device with a barbed clasp in a closed position. [Figure 48B] FIG. 1 shows a side view of an exemplary implantable prosthetic device with the barbed clasp in a closed position and the device attached to a deployment device. [Figure 48C] 48C shows a side view of an exemplary implantable prosthetic device according to FIG. 48B, with a cover provided thereon. [Figure 48D] 48C shows a front view of an exemplary implantable prosthetic device according to FIG. 48B attached to a deployment device. [Figure 48E] 48D shows a front view of an exemplary implantable prosthetic device according to FIG. 48D, with a cover provided. [Figure 48F] 48C shows a side view of an exemplary implantable prosthetic device according to FIG. 48B with the barbed clasp in a closed position. [Figure 48G] 48F shows a front view of an exemplary implantable prosthetic device according to FIG. 48F. [Figure 48H] 48F shows a bottom view of an exemplary implantable prosthetic device according to FIG. 48F. [Figure 49] 1 illustrates a side view of an exemplary implantable prosthetic device with the barbed clasp not in a partially open position. [Figure 50] 1 shows a side view of an exemplary implantable prosthetic device in a partially open position with a barbed clasp in a closed position. [Figure 51] FIG. 1 shows a side view of an exemplary implantable prosthetic device in a partially open position with a barbed clasp in an open position. [Figure 52] 1 illustrates a side view of an exemplary implantable prosthetic device with the barbed clasp not in a half-open position. [Figure 53] 1 shows a side view of an exemplary implantable prosthetic device in a half-open position with a barbed clasp in a closed position. [Figure 53A] 1 shows a side view of an exemplary implantable prosthetic device in a half-open position with a barbed clasp in a closed position. [Figure 53B] 53B shows a front view of an exemplary implantable prosthetic device according to FIG. 53A. [Figure 53C] 53B shows a side view of an exemplary implantable prosthetic device according to FIG. 53A, with a cover provided thereon. [Figure 53D] 53B shows a front view of an exemplary implantable prosthetic device according to FIG. 53A, with a cover provided thereon. [Figure 54] 1 shows a side view of an exemplary implantable prosthetic device in a half-open position with the barbed clasp in an open position. [Figure 54A] 1 shows a side view of an exemplary implantable prosthetic device in a half-open position with the barbed clasp in an open position. [Figure 54B] 54B shows a front view of an exemplary implantable prosthetic device according to FIG. 54A. [Figure 54C] 54B shows a side view of an exemplary implantable prosthetic device according to FIG. 54A, with a cover provided thereon. [Figure 54D] 54B shows a front view of an exemplary implantable prosthetic device according to FIG. 54A, with a cover provided thereon. [Figure 55] 1 illustrates a side view of an exemplary implantable prosthetic device with the barbed clasp not in the three-quarters open position. [Figure 56] 1A-1C show side views of an exemplary implantable prosthetic device in a three-quarters open position with a barbed clasp in a closed position. [Figure 57] FIG. 1 shows a side view of an exemplary implantable prosthetic device in a three-quarters open position with the barbed clasp in the open position. [Figure 58] 1 illustrates a side view of an exemplary implantable prosthetic device with the barbed clasp not near a fully bailed out position or not near a fully open position. [Figure 59] 1A-1C show side views of an exemplary implantable prosthetic device with the barbed clasp in a fully bailed out position or a fully open position. [Figure 60] 1 shows a side view of an exemplary implantable device in a full bail-out position with the barbed clasp in a closed position. [Figure 60A] 1 shows a side view of an exemplary implantable device in a full bail-out position with the barbed clasp in a closed position. [Figure 60B] 60B shows a front view of an exemplary implantable prosthetic device according to FIG. 60A. [Figure 60C] 60B shows a side view of an exemplary implantable prosthetic device according to FIG. 60A, with a cover provided thereon. [Figure 60D] 60B shows a front view of an exemplary implantable prosthetic device according to FIG. 60A, with a cover provided thereon. [Figure 61] 1 shows a side view of an exemplary implantable device in a full bail-out position with the barbed clasp in an open position. [Figure 61A] 1 shows a side view of an exemplary implantable device in a full bail-out position with the barbed clasp in an open position. [Figure 61B] 61B shows a front view of an exemplary implantable prosthetic device according to FIG. 61A. [Figure 61C] 61B shows a side view of an exemplary implantable prosthetic device according to FIG. 61A, with a cover provided thereon. [Figure 61D] 61B shows a front view of an exemplary implantable prosthetic device according to FIG. 61A, with a cover provided thereon. [Figure 62A] 10 illustrates the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 62B] 10 illustrates the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 63A] 10 illustrates the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 63B] 10 illustrates the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 63C] 10 illustrates the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 64A] 10 illustrates the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 64B] 10 illustrates the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 64C] 10 illustrates the movement of paddles of an exemplary embodiment of an implantable prosthetic device. [Figure 65]FIG. 1 illustrates a perspective view of an exemplary implantable prosthetic device in a closed position. [Figure 65A] FIG. 1 illustrates a perspective view of an exemplary implantable prosthetic device in a closed position. [Figure 66] FIG. 66 shows a perspective view of the implantable prosthetic device of FIG. 65. [Figure 66A] 65B shows a perspective view of the implantable prosthetic device of FIG. 65A. [Figure 67] FIG. 66 shows a front view of the implantable prosthetic device of FIG. 65. [Figure 67A] 65B shows a front view of the implantable prosthetic device of FIG. 65A. [Figure 68] FIG. 66 shows a front view of the implantable prosthetic device of FIG. 65 with additional components. [Figure 68A] FIG. 65B shows a front view of the implantable prosthetic device of FIG. 65A with additional components. [Figure 69] FIG. 66 shows a side view of the implantable prosthetic device of FIG. 65. [Figure 70] FIG. 66 shows a top view of the implantable prosthetic device of FIG. 65. [Figure 70A] 65B shows a top view of the implantable prosthetic device of FIG. 65A. [Figure 71] FIG. 66 shows a top view of the implantable prosthetic device of FIG. 65 having a collar component. [Figure 71A] FIG. 65B shows a top view of the implantable prosthetic device of FIG. 65A with a collar component. [Figure 72] FIG. 66 shows a bottom view of the implantable prosthetic device of FIG. 65. [Figure 72A] FIG. 65B shows a bottom view of the implantable prosthetic device of FIG. 65A. [Figure 73] FIG. 66 shows a bottom view of the implantable prosthetic device of FIG. 65 with a cap component. [Figure 73A] FIG. 65B shows a bottom view of the implantable prosthetic device of FIG. 65A with a cap component. [Figure 74] 66 shows a cross-sectional perspective view of the implantable prosthetic device of FIG. 65 cut through section plane 75. FIG. [Figure 74A]65B shows a cross-sectional perspective view of the implantable prosthetic device of FIG. 65A taken through cross-section plane 75A. [Figure 75] 75 shows a top cross-sectional view of the exemplary prosthetic device shown in FIG. 74. [Figure 75A] 74B shows a top cross-sectional view of the exemplary prosthetic device shown in FIG. 74A. [Figure 76] 66 shows a cross-sectional perspective view of the implantable prosthetic device of FIG. 65 taken along cross-sectional plane 77. FIG. [Figure 76A] 65B shows a cross-sectional perspective view of the implantable prosthetic device of FIG. 65A taken through section plane 77A. [Figure 77] 77 shows a top cross-sectional view of the exemplary prosthetic device shown in FIG. 76. [Figure 77A] 76B shows a top cross-sectional view of the exemplary prosthetic device shown in FIG. 76A. [Figure 78] 66 shows a cross-sectional perspective view of the implantable prosthetic device of FIG. 65 taken along cross-sectional plane 77. FIG. [Figure 78A] 65B shows a cross-sectional perspective view of the implantable prosthetic device of FIG. 65A taken through section plane 77A. [Figure 79] 79 shows a top cross-sectional view of the exemplary prosthetic device shown in FIG. 78. [Figure 79A] 78B shows a top cross-sectional view of the exemplary prosthetic device shown in FIG. 78A. [Figure 80] 66 shows a cross-sectional perspective view of the implantable prosthetic device of FIG. 65 cut through section plane 81. FIG. [Figure 80A] 65B shows a cross-sectional perspective view of the implantable prosthetic device of FIG. 65A taken along cross-sectional plane 81A. [Figure 81] 81 shows a top cross-sectional view of the exemplary prosthetic device shown in FIG. 80. [Figure 81A] 80B shows a top cross-sectional view of the exemplary prosthetic device shown in FIG. 80A. [Figure 82] 66 shows a cross-sectional perspective view of the implantable prosthetic device of FIG. 65 cut through section plane 83. FIG. [Figure 82A]65B shows a cross-sectional perspective view of the implantable prosthetic device of FIG. 65A taken through section plane 83A. [Figure 83] 83 shows a top cross-sectional view of the exemplary prosthetic device shown in FIG. 82. [Figure 83A] 82B shows a top cross-sectional view of the exemplary prosthetic device shown in FIG. 82A. [Figure 84] 1 illustrates an exemplary embodiment of an implantable prosthetic device having integral barbs. [Figure 85] 1 illustrates an exemplary embodiment of an implantable prosthetic device having integral barbs. [Figure 86] 1 illustrates an exemplary embodiment of an implantable prosthetic device having integral barbs. [Figure 86A] 1 illustrates an exemplary embodiment of an implantable prosthetic device having integral barbs. [Figure 87] 1 illustrates an exemplary embodiment of an implantable prosthetic device having integral barbs. [Figure 87A] 1 illustrates an exemplary embodiment of an implantable prosthetic device having integral barbs. [Figure 88] 1 illustrates an exemplary embodiment of an implantable prosthetic device having integral barbs. [Figure 88A] 1 illustrates an exemplary embodiment of an implantable prosthetic device having integral barbs. [Figure 89] 66 shows a perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65. [Figure 89A] 65B shows a perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A. [Figure 90] 66 shows a perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65. [Figure 90A] 65B shows a perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A. [Figure 91] FIG. 66 shows a front view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65. [Figure 91A] 65B shows a front view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A. [Figure 92] 66 shows a side view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65. [Figure 92A] 65B shows a side view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A. [Figure 93] 66 shows a top view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65. [Figure 93A] 65B shows a top view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A. [Figure 94] 66 shows a bottom view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65. [Figure 94A] 65B shows a bottom view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A. [Figure 95] 66 shows a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65, with the cross-section taken through plane 96. FIG. [Figure 95A] 65B shows a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A, with the cross-section taken through plane 96A. [Figure 96] 96 shows a cross-sectional view of the interface and paddle portions of FIG. 95. [Figure 96A] 95B shows a cross-sectional view of the interface and paddle portions of FIG. 95A. [Figure 97] 66 shows a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65, with the cross-section taken through plane 98. FIG. [Figure 97A] 65B shows a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A, with the cross-section taken through plane 98A. [Figure 98]98 shows a cross-sectional view of the joint portion and paddle portion of FIG. 97. [Figure 98A] 97B shows a cross-sectional view of the interface and paddle portions of FIG. 97A. [Figure 99] 66 shows a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65, with the cross-section taken through plane 100. FIG. [Figure 99A] 65B shows a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A, with the cross-section taken through plane 100A. [Figure 100] 99A and 99B show cross-sectional views of the interface and paddle portions. [Figure 100A] 99B shows a cross-sectional view of the interface and paddle portions of FIG. 99A. [Figure 101] 66 shows a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65, with the cross-section taken through plane 102. FIG. [Figure 101A] 65B shows a cross-sectional perspective view of the joint and paddle portions of the implantable prosthetic device shown in FIG. 65A, with the cross-section taken through plane 102A. FIG. [Figure 102] 102 shows a cross-sectional view of the joint portion and paddle portion of FIG. 101. [Figure 102A] 101B shows a cross-sectional view of the interface and paddle portions of FIG. 101A. [Figure 103] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 104] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 105] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 106] 1A and 1B show side views of an exemplary embodiment of an expandable co-option element in an unexpanded state. [Figure 106A] 1A and 1B show side views of an exemplary embodiment of an expandable co-option element in an unexpanded state. [Figure 106B] 1A and 1B show side views of an exemplary embodiment of an expandable co-option element in an unexpanded state. [Figure 106C] 1A and 1B show side views of an exemplary embodiment of an expandable co-option element in an unexpanded state. [Figure 106D] 1A and 1B show side views of an exemplary embodiment of an expandable co-option element in an unexpanded state. [Figure 106E] 1A and 1B show side views of an exemplary embodiment of an expandable co-option element in an unexpanded state. [Figure 106F] 1 illustrates an exemplary embodiment of an expandable cooption element. [Figure 106G] 1 illustrates an exemplary embodiment of an expandable cooption element. [Figure 106H] 1 illustrates an exemplary embodiment of an expandable cooption element. [Figure 106I] 1 illustrates an exemplary embodiment of an expandable cooption element. [Figure 107] 107 shows an end view of the expandable cooption element of FIG. 106. [Figure 108] 107 shows the expandable co-option element of FIG. 106 in an expanded state. [Figure 108A] 106B shows the expandable co-option element of FIG. 106A in an expanded state. [Figure 108B] 106C shows the expandable co-option element of FIG. 106B in an expanded state. [Figure 108C] 106D shows the expandable co-option element of FIG. 106C in an expanded state. [Figure 108D] 106D shows the expandable co-option element of FIG. 106D in an expanded state. [Figure 108E] 106F shows the expandable co-option element of FIG. 106E in an expanded state. [Figure 109] 109 shows an end view of the co-option element of FIG. 108. [Figure 110] 1 illustrates a side view of an exemplary embodiment of an implantable prosthetic device. [Figure 111] 111 shows an end view of the co-option element of the exemplary prosthetic device of FIG. 110 taken along line 111. FIG. [Figure 112]66 shows a perspective view of an exemplary embodiment of a paddle frame for the implantable prosthetic device of FIG. 65. [Figure 112A] 65B shows a perspective view of an exemplary embodiment of a paddle frame for the implantable prosthetic device of FIG. 65A. [Figure 113] 66 shows a perspective view of an exemplary embodiment of a paddle frame for the implantable prosthetic device of FIG. 65. [Figure 114] 66 shows a perspective view of an exemplary embodiment of a paddle frame for the implantable prosthetic device of FIG. 65. [Figure 114A] 112B shows a side view of the paddle frame of FIG. 112A. [Figure 115] FIG. 115 shows a front view of the paddle frame of FIGS. 112 to 114. [Figure 115A] 112B shows a top view of the paddle frame of FIG. 112A. [Figure 116] 115 shows a top view of the paddle frame of FIGS. 112 to 114. FIG. [Figure 116A] 112B shows a front view of the paddle frame of FIG. 112A. [Figure 117] 115 shows a side view of the paddle frame of FIGS. 112 to 114. FIG. [Figure 117A] 112B shows a rear view of the paddle frame of FIG. 112A. [Figure 118] 115 shows a bottom view of the paddle frame of FIGS. 112 to 114. FIG. [Figure 118A] 112B shows a bottom view of the paddle frame of FIG. 112A. [Figure 119] FIG. 115 shows a front view of the paddle frame of FIGS. 112 to 114. [Figure 120] 115 shows a front view of the paddle frame of FIGS. 112-114 in a compressed state inside a delivery device. FIG. [Figure 121] FIG. 1 illustrates a side view of an exemplary embodiment of an implantable prosthetic device in a closed state. [Figure 122] 122 shows a front view of a paddle frame of the exemplary prosthetic device of FIG. 121. [Figure 123] 122 shows a side view of the implantable prosthetic device of FIG. 121 in an open state. [Figure 124]FIG. 124 shows a front view of the paddle frame of the open prosthetic device of FIG. 123. [Figure 125] FIG. 1 illustrates a side view of an exemplary embodiment of an implantable prosthetic device in a closed state. [Figure 126] 126 shows a front view of a paddle frame of the exemplary prosthetic device of FIG. 125. [Figure 127] FIG. 126 shows a side view of the implantable prosthetic device of FIG. 125 in a closed state. [Figure 128] 128 shows a front view of the paddle frame of the open prosthetic device of FIG. 127. [Figure 129] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 130] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 131] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 132] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 133] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 134] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 135] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 136] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 137] 1 illustrates an exemplary embodiment of an implantable prosthetic device. [Figure 138] 1 illustrates the use of an exemplary embodiment of an implantable prosthetic device. [Figure 139] 1 illustrates the use of an exemplary embodiment of an implantable prosthetic device. [Figure 140] 1 illustrates the use of an exemplary embodiment of an implantable prosthetic device. [Figure 141] 1 illustrates the use of an exemplary embodiment of an implantable prosthetic device. [Figure 142] 1 illustrates the use of an exemplary embodiment of an implantable prosthetic device. [Figure 143]1 illustrates the use of an exemplary embodiment of an implantable prosthetic device. [Figure 144] 1 illustrates an exemplary embodiment of a delivery assembly including a delivery device and an exemplary prosthetic device. [Figure 145] 1 shows a perspective view of an exemplary embodiment of an implantable prosthetic device removably coupled to a delivery device. [Figure 146] 146 shows the embodiment of FIG. 145 with the implantable prosthetic device released from the delivery device. [Figure 147] 146 shows a cross-sectional view of the coupler of FIG. 145. [Figure 148] 145 shows a perspective view of the delivery assembly of FIG. 144, with the prosthetic device shown in partial cross-section and some components of the delivery apparatus shown schematically. [Figure 149] 145 shows a plan view of the shaft of the delivery device of FIG. 144. [Figure 150] 145 shows a side elevational view of the proximal end portion of the delivery device of FIG. 144. [Figure 151] 151 shows a cross-sectional view of the proximal end portion of the delivery device of FIG. 144 taken along line 151-151 shown in FIG. 150. [Figure 152] 145 shows an exploded view of the proximal end portion of the delivery device of FIG. 144. [Figure 153] 1 shows an example of a procedure used to repair a natural heart valve, which is partially shown. [Fig. 154] 1 shows an example of a procedure used to repair a natural heart valve, which is partially shown. [Figure 155] 1 shows an example of a procedure used to repair a natural heart valve, which is partially shown. [Figure 156] 1 shows an example of a procedure used to repair a natural heart valve, which is partially shown. [Figure 157] 1 shows an example of a procedure used to repair a natural heart valve, which is partially shown. [Figure 158]1 shows an example of a procedure used to repair a natural heart valve, which is partially shown. [Figure 159] 1 shows an example of a procedure used to repair a natural heart valve, which is partially shown. [Figure 160] 1 shows an example of a procedure used to repair a natural heart valve, which is partially shown. [Figure 161] 145 illustrates an exemplary embodiment of a handle for the delivery device of FIG. 144. [Figure 162] FIG. 162 is an exploded view of the handle of FIG. 161. [Figure 163] 145 illustrates an exemplary embodiment of a coupler and proximal collar for the delivery assembly of FIG. 144, showing the coupler releasably coupled to the proximal collar. [Fig. 164] 164 is a perspective view of the coupler and proximal collar of FIG. 163 showing the coupler released from the proximal collar. [Figure 165] 145 illustrates an exemplary embodiment of a cap, actuation element or means, and release wire for the delivery assembly of FIG. 144, showing the cap releasably coupled to the actuation element or means by the release wire. [Figure 166] 164 illustrates an exemplary embodiment of the cap, actuation element or actuation means, and release wire of FIG. 163, showing the cap released from the actuation element or actuation means and release wire. [Figure 167] 145 shows an exemplary embodiment of the coupler, proximal collar, cap, and actuation element or actuation means of the delivery assembly of FIG. 144. [Figure 168] 168 shows a perspective view of the coupler and proximal collar of FIG. 167; [Figure 169] 145 illustrates an exemplary embodiment of a clasp control member of the delivery device of FIG. 144. [Figure 170] 169, taken from the perspective view 170 shown in FIG. 169. [Figure 171] 17 illustrates an exemplary embodiment of a guide rail for the clasp control member of FIG. 169. [Fig. 172] 145 illustrates an exemplary embodiment of the shaft of the delivery device of FIG. 144. [Figure 173] 1 illustrates an exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device. [Fig. 174] 1 illustrates an exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device. [Figure 174A] 1 illustrates an exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device. [Figure 175] 1 illustrates an exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device. [Figure 175A] 1 illustrates an exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device. [Figure 176] 1 illustrates an exemplary embodiment of an implantable prosthetic device and a delivery device for releasing and recapturing the prosthetic device. [Figure 177] 1 illustrates an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 178] 1 illustrates an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 179] 1 illustrates an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 180] 1 illustrates an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 181] 1 illustrates an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 182] 1 illustrates an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 183] 1 illustrates an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 184] 1 illustrates an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 185] 1 illustrates an exemplary embodiment of a coupler for an exemplary implantable prosthetic device. [Figure 186] 1 illustrates an exemplary embodiment of an actuation element or actuation means for an exemplary prosthetic device. [Figure 187] 1 illustrates an actuation mechanism for an exemplary prosthetic device. [Figure 188] 1 illustrates an actuation mechanism for an exemplary prosthetic device. [Figure 188A] 1 illustrates an actuation mechanism for an exemplary prosthetic device. [Figure 189] 1 illustrates an actuation mechanism for an exemplary prosthetic device. [Figure 190] 1 illustrates an actuation mechanism for an exemplary prosthetic device. [Figure 191] FIG. 1 is a perspective view of a blank used to make a paddle frame. [Figure 192] 192 is a perspective view of the blank of FIG. 191 bent to make a paddle frame; [Figure 193] FIG. 16 is a perspective view of a shape-setting paddle frame attached to the cap of a valve repair device. [Figure 194] FIG. 194 is a perspective view of the paddle frame of FIG. 193 bent over and attached to the inner and outer paddles in the closed position. [Figure 195] 112B is two perspective views of the paddle frame of FIG. 112A showing the paddle frame in a shape-setting position. [Figure 196] FIG. 196 is a perspective view of the paddle frame of FIG. 195, showing the paddle frame in a loaded position. [Figure 197] FIG. 60D is an enlarged side view of the device of FIG. 60C showing the cover. [Figure 198] FIG. 60D is an enlarged side view of the device of FIG. 60C showing the cover. [Figure 199] 1 illustrates an exploded view of an exemplary prosthetic device. [Figure 200] 1 illustrates an enlarged perspective view of a collar of an exemplary prosthetic device. [Figure 201] 1 shows an enlarged perspective view of a cap of an exemplary prosthetic device. [Figure 202]207 shows an exploded view of the cap of FIG. 206. [Figure 203] 1 shows a top view of an inner cover for an exemplary prosthetic device. [Figure 204] 1 illustrates a top view of an outer covering for an exemplary prosthetic device. [Figure 205] 1 shows an enlarged view of a strip of material for an exemplary prosthetic device. [Figure 206] 206 shows an end view of the material of FIG. 205. [Figure 207] 206 shows an end view of the material of FIG. 205 arranged in multiple layers. [Figure 208A] 1 shows an exemplary implantable prosthetic device in the gap of a native valve as viewed from the atrial side of the native valve during diastole, with the exemplary expandable spacer in a contracted state. [Figure 208B] 208B shows the device of FIG. 208A during systole, with the exemplary expandable spacer in a deflated state. [Figure 209A] 208A shows the device of FIG. 208A in diastole, with the exemplary expandable spacer in an expanded state. [Figure 209B] 208B shows the device of FIG. 208A during systole, with the exemplary expandable spacer in an expanded state. [Figure 210A] 1 illustrates an exemplary expandable spacer in a compressed state. [Figure 210B] 210B shows the expandable spacer of FIG. 210A in an expanded state. [Figure 211A] 1 illustrates an exemplary implantable prosthetic device with an exemplary expandable spacer in a deflated state. [Figure 211B] 211B shows the device of FIG. 211B with the exemplary expandable spacer in an expanded state. [Figure 212A] FIG. 1 is a side view of an exemplary implantable prosthetic device. [Figure 212B] FIG. 212B is a front / rear view of the device of FIG. 212A. [Figure 213A] FIG. 212B is a top view of an exemplary auxiliary spacer for attachment to the device of FIG. 212A. [Figure 213B] FIG. 213B is a side view of the spacer of FIG. 213A. [Figure 214] 213A and 213B being assembled into the device of FIGS. 212A and 212B. FIG. [Figure 215A] 213A and 213B assembled into the device of FIGS. 212A and 212B. FIG. [Figure 215B] FIG. 215B is a top view of the assembly of FIG. 215A. [Figure 216A] FIG. 1 is a side view of an exemplary implantable prosthetic device. [Figure 216B] FIG. 216B is a front / rear view of the device of FIG. 216A. [Figure 217A] FIG. 216B is a top view of an exemplary auxiliary spacer for attachment to the device of FIG. 216A. [Figure 217B] FIG. 217B is a side view of the spacer of FIG. 217A. [Figure 218] 1 is an exemplary auxiliary spacer. [Figure 219A] FIG. 1 is a top view of an exemplary implantable prosthetic device. [Figure 219B] FIG. 1 is a side view of an exemplary implantable prosthetic device. [Figure 220A] FIG. 10 is a top view of an exemplary auxiliary spacer. [Figure 220B] FIG. 10 is a top view of an exemplary auxiliary spacer. [Figure 220C] FIG. 10 is a top view of an exemplary auxiliary spacer. [Figure 220D] FIG. 10 is a top view of an exemplary auxiliary spacer. [Figure 220E] FIG. 10 is a top view of an exemplary auxiliary spacer. [Figure 221] FIG. 1 is a plan view of an exemplary implantable prosthetic device cut from a planar sheet of material. [Figure 222] FIG. 222 is a perspective view of the device of FIG. [Figure 223] 221-222 show the device of FIGS. 221-222 within the gap of the native valve as viewed from the atrial side of the native valve. [Figure 224] FIG. 1 is a plan view of an exemplary implantable prosthetic device cut from a planar sheet of material. [Figure 225] FIG. 225 is a perspective view of the device of FIG. 224. [Figure 226] 1 illustrates an exemplary embodiment of an implantable prosthetic device having a two-piece cover. [Figure 227] 1 illustrates an exemplary embodiment of an implantable prosthetic device having a two-piece cover. [Figure 228] 1 illustrates an exemplary embodiment of an implantable prosthetic device having a two-piece cover. [Figure 229] 1 illustrates an exemplary embodiment of an implantable prosthetic device having a two-piece cover. [Figure 230] 1 illustrates an exemplary embodiment of an implantable prosthetic device having a two-piece cover. [Figure 231] 1 illustrates an exemplary embodiment of an implantable prosthetic device having a two-piece cover. [Figure 232A] FIG. 1 is a front view of an implantable prosthetic device including a barbed clasp and substantially parallel paddle frame elements according to an exemplary embodiment. [Figure 232B] 232B is a cross-sectional view taken along the plane indicated by line 232B-232B of FIG. 232A. [Figure 233A] FIG. 232B is a view similar to FIG. 232A with annotation of the spaces between substantially parallel sections of the paddle frame elements. [Figure 233B] 233B is a cross-sectional view taken along the plane indicated by line 233B-233B of FIG. 233A. [Figure 234A] FIG. 232B is a view similar to FIG. 232A showing engagement of the native valve leaflets between substantially parallel paddle frame elements. [Figure 234B] 234B is a cross-sectional view taken along the plane indicated by line 234B-234B of FIG. 234A. [Figure 235A] FIG. 234B is a view similar to that of FIG. 234A showing misaligned native valve leaflets. [Figure 235B] 235B is a cross-sectional view taken along the plane indicated by line 235B-235B of FIG. 235A. [Figure 236]FIG. 1 is a side view of an implantable prosthetic device according to an exemplary embodiment. [Figure 237] FIG. 1 is a side view of two adjacent implantable prosthetic devices according to an exemplary embodiment. [Figure 238A] FIG. 1 is a side view of an implantable prosthetic device placed over a native valve, according to an exemplary embodiment. [Figure 238B] 238B is a cross-sectional view taken along the plane indicated by line 238B-238B of FIG. 238A. [Figure 239A] FIG. 1 is a side view of two adjacent implantable prosthetic devices placed on the mitral valve, according to an exemplary embodiment. [Figure 239B] 239B is a cross-sectional view taken along the plane indicated by line 239B-239B of FIG. 239A. [Figure 240A] FIG. 239B is a view similar to that of FIG. 239A showing two adjacent, but misaligned, implantable prosthetic devices. [Figure 240B] 240B is a cross-sectional view taken along the plane indicated by line 240B-240B of FIG. 240A. [Figure 241] FIG. 10 is a perspective view of a portion of a clasp having a flexible barb support, according to an exemplary embodiment. [Figure 242] 242 is a portion of the clasp of FIG. 241 with the barb support bent back to show the flexible nature of the barb support in the illustrated embodiment. [Figure 243A] 243 is a schematic diagram of the clasp of FIG. 242 with the flexible barb support releasing from the leaflets. [Figure 243B] 243 is a schematic diagram of the clasp of FIG. 242 with the flexible barb support releasing from the leaflets. [Figure 243C] 243 is a schematic diagram of the clasp of FIG. 242 with the flexible barb support releasing from the leaflets. [Figure 243D] 243 is a schematic diagram of the clasp of FIG. 242 with the flexible barb support releasing from the leaflets. [Figure 243E] 243 is a schematic diagram of the clasp of FIG. 242 with the flexible barb support releasing from the leaflets. [Figure 243F] 243 is a schematic diagram of the clasp of FIG. 242 with the flexible barb support releasing from the leaflets. [Figure 243G] 243 is a schematic diagram of the clasp of FIG. 242 with the flexible barb support releasing from the leaflets. [Figure 243H] 243 is a schematic diagram of the clasp of FIG. 242 with the flexible barb support releasing from the leaflets. [Figure 244A] FIG. 1 is a schematic diagram of an implantable prosthetic device with the clasps and flexible barb supports disengaged from the valve leaflets. [Figure 244B] FIG. 1 is a schematic diagram of an implantable prosthetic device with the clasps and flexible barb supports disengaged from the valve leaflets. [Figure 244C] FIG. 1 is a schematic diagram of an implantable prosthetic device with the clasps and flexible barb supports disengaged from the valve leaflets. [Figure 244D] FIG. 1 is a schematic diagram of an implantable prosthetic device with the clasps and flexible barb supports disengaged from the valve leaflets. [Figure 244E] FIG. 1 is a schematic diagram of an implantable prosthetic device with the clasps and flexible barb supports disengaged from the valve leaflets. [Figure 245A] FIG. 10 is a diagram of the implantable prosthetic device with the clasps and flexible barb supports disengaged from the valve leaflets. [Figure 245B] FIG. 10 is a diagram of the implantable prosthetic device with the clasps and flexible barb supports disengaged from the valve leaflets. [Figure 245C] FIG. 10 is a diagram of the implantable prosthetic device with the clasps and flexible barb supports disengaged from the valve leaflets. [Figure 245D] FIG. 10 is a diagram of the implantable prosthetic device with the clasps and flexible barb supports disengaged from the valve leaflets. [Figure 245E] FIG. 10 is a diagram of the implantable prosthetic device with the clasps and flexible barb supports disengaged from the valve leaflets. [Figure 246]FIG. 10 is a diagram of an implantable device exerting a force on a single leaflet to illustrate how the clasp can be released from the native valve leaflet. DETAILED DESCRIPTION OF THE INVENTION

[0033] The following description refers to the accompanying drawings that illustrate specific embodiments of the present disclosure. Other embodiments having different structure and operation do not depart from the scope of the present disclosure.

[0034] Exemplary embodiments of the present disclosure relate to devices and methods for repairing defective heart valves. It should be noted that various embodiments of native valve repair devices and systems for delivery are disclosed herein, and unless specifically excluded, any combination of these options may be made. In other words, individual components of the disclosed devices and systems may be combined unless mutually exclusive or otherwise physically impossible.

[0035] 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 between the components or may be indirect, such as through the use of one or more intermediate components. Also, as described herein, references to a "member," "component," or "portion" are not limited to a single structural member, component, or element, but can include a collection of components, members, or elements. Also, as used herein, the terms "substantially" and "about" are defined as at least near (and including) a given value or condition (preferably, within 10%, more preferably, within 1%, and most preferably, within 0.1%).

[0036] Figures 1 and 2 show cutaway views of a human heart H during diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, i.e., atrioventricular valves, respectively. Furthermore, 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 valves (e.g., valve leaflets 20, 22 shown in Figures 4 and 5) that extend inward across individual orifices, which come together or "coapt" in flow to form a one-way fluid-blocking surface. The native valve repair system of the present application is described primarily with reference to the mitral valve MV. Accordingly, the anatomical structures of the left atrium LA and left ventricle LV will be described in more detail. It should be understood that the devices described herein may also be used in the repair of other native valves, for example, the tricuspid valve TV, aortic valve AV, and pulmonary valve PV.

[0037] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, shown in FIG. 1, blood already collected in the left atrium LA (during systole) moves into the left ventricle LV through the mitral valve MV due to the expansion of the left ventricle LV. During the systolic phase, or systole, shown in FIG. 2, the left ventricle LV contracts, pumping blood into the body through the aortic valve AV and the ascending aorta AA. During systole, the leaflets of the mitral valve MV close to prevent blood from returning from the left ventricle LV into the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In one exemplary embodiment, the device described herein is used to restore the function of a defective mitral valve MV. That is, the device is configured to close the leaflets of the mitral valve to help prevent blood from returning from the left ventricle LV into the left atrium LA. Unlike prior art describing the use of sutures or clips, which often require multiple sutures or clips and additional support to treat significant regurgitation, the device described in this application is designed to easily grasp and secure the native valve leaflets around the co-option element, which acts as a filler for the regurgitant orifice.

[0038] Referring now to Figures 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24, a variably dense ring of fibrous tissue surrounding the leaflets 20, 22. Referring to Figure 3, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae 10. The chordae tendineae 10 are cord-like tendons that connect the papillary muscles 12 (i.e., muscles located at the base of the chordae tendineae and within the wall of the left ventricle) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles 12 function to limit the movement of the mitral valve MV and prevent it from returning. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and left ventricle LV. The papillary muscles do not open and close the mitral valve MV. Rather, they support the mitral valve MV against the high pressures required to circulate blood throughout the body. Together, the papillary muscles and chordae tendineae are known as the subvalvular tissue, which function to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed.

[0039] Various disease processes can impair the proper function of one or more of the heart's native valves. These disease processes include degenerative processes (e.g., Barlow's disease, elastic fiber deficiency), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). Furthermore, damage to the left ventricle (LV) or right ventricle (RV) from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other cardiac diseases (e.g., cardiomyopathies) can deform the shape of the native valve, which can lead to native valve dysfunction. However, the majority of patients undergoing valve surgery, such as mitral valve MV surgery, suffer from degenerative disease that causes dysfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), leading to prolapse and regurgitation.

[0040] Generally, native valves can malfunction in two different ways: (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when the native valve does not open completely, thereby causing obstruction to blood flow. Typically, valve stenosis results from the accumulation of calcified material on the valve leaflets, which thickens the leaflets and impairs the valve's ability to open completely and allow forward blood flow.

[0041] The second type of valve dysfunction, valvular regurgitation, occurs when the valve leaflets do not close completely, causing blood to leak back into the previous chamber (e.g., blood leaking from the left ventricle into the left atrium). There are three main mechanisms by which native valves become regurgitant or insufficient, including Carpentier Type I, Type II, and Type III insufficiency. Carpentier Type I insufficiency involves annular dilation, such that normally functioning leaflets are deflected from one another and fail to form a tight seal (i.e., the leaflets do not coapt properly). Malfunctions of Type I mechanism include leaflet perforation, such as occurs in endocarditis. Carpentier Type II insufficiency involves prolapse of one or more leaflets of the native valve above the plane of coaptation. Carpentier Type III insufficiency involves restriction of one or more leaflets of the native valve, such that the leaflets are abnormally constricted below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0042] Referring to FIG. 4, when a healthy mitral valve MV is in a closed position, the anterior leaflet 20 and posterior leaflet 22 coapt, which prevents blood from leaking from the left ventricle LV into the left atrium LA. Referring to FIG. 5, during systole, regurgitation occurs when the anterior leaflet 20 and / or posterior leaflet 22 of the mitral valve MV are translated into the left atrium LA. This failure to coapt causes a gap 26 between the anterior leaflet 20 and posterior leaflet 22, which allows blood to flow back into the left atrium LA from the left ventricle LV during systole. As discussed above, there are several different ways in which a valve leaflet (e.g., the leaflets 20, 22 of the mitral valve MV) may be dysfunctional, thereby causing regurgitation.

[0043] 6 , in certain circumstances, a patient's mitral valve MV may have a wide gap 26 between the anterior leaflet 20 and the posterior leaflet 22 when the mitral valve is in a closed position (i.e., during systole). For example, the gap 26 may have a width W of about 2.5 mm to about 17.5 mm, e.g., about 5 mm to about 15 mm, e.g., about 7.5 mm to about 12.5 mm, e.g., about 10 mm. In some circumstances, the gap 26 may have a width W greater than 15 mm. In any of the above circumstances, a valve repair device capable of engaging the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent backflow of blood through the mitral valve MV is desirable.

[0044] While stenosis or regurgitation can affect any valve, stenosis is known to primarily affect either the aortic valve (AV) or the pulmonary valve (PV), while regurgitation is known to primarily affect either the mitral valve (MV) or the tricuspid valve (TV). Both valve stenosis and regurgitation increase the workload of the heart (H), and if left untreated, can lead to very serious conditions, including endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. The left side of the heart (i.e., the left atrium (LA), left ventricle (LV), mitral valve (MV), and aortic valve (AV)) is primarily responsible for circulating blood throughout the body, and mitral valve (MV) or aortic valve (AV) dysfunction is particularly problematic and often life-threatening. Therefore, mitral valve (MV) or aortic valve (AV) dysfunction is often more problematic because the pressure on the left side of the heart is substantially higher.

[0045] Dysfunction of a native heart valve can be either repaired or replaced. Repair typically involves preserving and correcting the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. The aortic valve (AV) and pulmonary valve (PV) are typically more prone to stenosis. Because the stenotic damage sustained by the valve leaflets is irreversible, the most conventional treatment for a stenotic aortic or pulmonary valve is removal and replacement with a surgically implanted heart valve or a transcatheter heart valve. The mitral valve (MV) and tricuspid valve (TV) are more prone to leaflet deformation, which, as noted above, can prevent the mitral or tricuspid valve from closing properly and allow regurgitation or backflow of blood from the ventricle into the atrium (e.g., a deformed mitral valve (MV) can allow regurgitation or backflow from the left ventricle (LV) into the left atrium (LA). Regurgitation or backflow of blood from the ventricle into the atrium results in valvular insufficiency. Deformities in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. Additionally, regurgitation can occur because the chordae tendineae 10 become incompetent (e.g., the chordae may stretch or rupture), allowing the anterior and posterior leaflets 20, 22 to move back, thus allowing blood to flow back into the left atrium LA. Problems caused by incompetent chordae tendineae 10 can be corrected by repairing the chordae or the structure of the mitral valve (e.g., by fixating the leaflets 20, 22 in the affected portion of the mitral valve).

[0046] The devices and procedures disclosed herein often refer to mitral valve repair for illustrative purposes. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve and any component of a native valve. For example, referring now to FIG. 7 , any of the devices and concepts provided herein can be used to repair a 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 backflow of blood from the right ventricle into the right atrium. Furthermore, any of the devices and concepts provided herein can be used on all three of the leaflets 30, 32, and 34 together to prevent backflow of blood from the right ventricle into the right atrium. That is, the valve repair device provided herein can be centrally positioned between the three leaflets 30, 32, and 34.

[0047] An exemplary implantable prosthetic device includes a co-option element and at least one anchor. The co-option 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 backflow. The co-option element can be impermeable or resistant to blood and have a structure that allows the native valve leaflets to close around the co-option element during ventricular systole, preventing blood from flowing from the left or right ventricle into the left or right atrium, respectively. The prosthetic device can be configured to seal against two or three native valve leaflets; i.e., the device can be used with native mitral (bicuspid) and tricuspid valves. Because the co-option element can fill the space between an improperly functioning native mitral or tricuspid valve that does not close completely, the co-option element is sometimes referred to herein as a spacer.

[0048] Coaptation elements (e.g., spacers, coaptation elements, etc.) can have a variety of shapes. In some embodiments, they can have an elongated cylindrical shape with a circular cross-sectional shape. In other embodiments, they can have an oval, crescent, rectangular cross-sectional shape, or various other non-cylindrical shapes. The coaptation element can have an atrial portion positioned in or adjacent to the left atrium, a ventricular or inferior portion positioned in or adjacent to the left ventricle, and lateral sides extending between the native mitral valve leaflets. In embodiments configured for use with a tricuspid valve, the atrial or superior portion is positioned in or adjacent to the right atrium, the ventricular or inferior portion is positioned in or adjacent to the right ventricle, and the lateral sides extend between the native tricuspid valve.

[0049] The anchor may be configured to secure the device to one or both of the native mitral valve leaflets so that the co-option element is positioned between two native leaflets. In embodiments configured for use with a tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid valve so that the co-option element is positioned between three native leaflets. In some embodiments, the anchor may be attached to the co-option element at a location adjacent to the ventricular portion of the co-option element. In some embodiments, the anchor may be attached to an actuating element, such as a shaft or actuation wire, to which the co-option element is also attached. In some embodiments, the anchor and the co-option element may be positioned independently of each other by separately moving the anchor and the co-option element along the longitudinal axis of the shaft or actuation wire. In some embodiments, the anchor and the co-option element may be positioned simultaneously by moving the anchor and the co-option element together along the longitudinal axis of the shaft or actuation wire. The anchor may be configured to be positioned behind the native valve leaflets when implanted so that the leaflets are gripped by the anchor.

[0050] The prosthetic device may be configured to be implanted via a delivery sheath. The co-option element and anchor may be compressible to a radially compressed state and self-expandable to a radially expanded state when the compressive pressure is released. The device may be configured so that the anchor first expands radially away from the still-compressed co-option element to create a gap between the co-option element and the anchor. The native valve leaflet may then be positioned within the gap. The co-option element may be radially expanded to close the gap between the co-option element and the anchor and capture the leaflet between the co-option element and the anchor. In some embodiments, the anchor and co-option element are optionally configured to self-expand. The implantation methods of various embodiments may vary and are discussed more fully below with respect to each embodiment. Additional information regarding these and other delivery methods can be found in U.S. Patent Nos. 5,929,529; 5,929,529; 5,929,529; and 5,929,529, each of which is incorporated herein by reference in its entirety. These methods may be performed on live animals or on simulations, such as, for example, cadavers, cadaver hearts, simulators (e.g., simulated body parts, tissues, etc.).

[0051] The disclosed prosthetic device can be configured with anchors connected to the valve leaflets and utilizing tension from the natural chordae tendineae to resist high systolic pressures that pull the device toward the left atrium. During diastole, the device can rely on compressive and retaining forces exerted on the leaflets gripped by the anchors.

[0052] 8-14, a schematic illustration of an implantable prosthetic device 100 is shown in various stages of deployment. Device 100 may include any other features of implantable prosthetic devices discussed herein, and device 100 may be positioned to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0053] The device 100 is deployed from a delivery sheath or delivery means 102 and includes a coaptation portion 104 and an anchor portion 106. The coaptation portion 104 of the device 100 is adapted to be implanted between the leaflets of a native valve (e.g., a native mitral valve, a tricuspid valve, etc.) and includes a coaptation element or coaptation means 110 that is slidably attached to an actuation element 112 (e.g., an actuation wire, an actuation shaft, an actuation tube, etc.). The anchor portion 106 is actuable between an open state and a closed state and can take a wide variety of forms, such as, for example, a paddle, a grasping element, etc. Actuation of the actuation element or actuation means 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., a wire, a shaft, a tube, a screw, a line, etc.) can take a wide variety of different forms. For example, the actuating element (e.g., a wire, shaft, tube, screw, etc.) may be threaded such that rotation of the actuating element moves the anchor portion 106 relative to the co-option portion 104. Alternatively, the actuating element may be unthreaded such that pushing or pulling the actuating element 112 moves the anchor portion 106 relative to the co-option portion 104.

[0054] The anchor portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the co-option element or joining means 110 by portions 124, 126, 128. The portions 124, 126, 128 may be articulated and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 120, inner paddle 122, the co-option element or joining means 110, and the cap 114 by portions 124, 126, and 128 can constrain the device to the positions and movements illustrated herein.

[0055] In some implementations, an actuation element or means 112 (e.g., an actuation wire, actuation shaft, etc.) extends through the delivery sheath and co-option element or joint means 110 to a cap 114 at the distal connection of the anchor portion 106. Extension and retraction of the actuation element or means 112 increases and decreases the spacing between the co-option element or joint means 110 and the cap 114, respectively. A collar or other attachment element removably attaches the co-option element or joint means 110 to the delivery sheath or delivery means 102, such that the actuation element or means 112 slides through the collar or other attachment element and the co-option element or joint means 110 during actuation to open and close the paddles 120, 122 of the anchor portion 106.

[0056] Referring now to FIG. 11 , the anchor portion 106 includes an attachment portion or gripping member. The illustrated gripping member includes a barbed clasp 130 including a base or fixed arm 132, a movable arm 134, a barb or securing means 136, and a joint portion 138. The fixed arm 132 is attached to the inner paddle 122, and the joint portion 138 is positioned adjacent to the co-option element or joining means 110. The barbed clasp has a flat surface and does not fit into a recess in the paddle. Rather, the flat portion of the barbed clasp is positioned against the surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixed and movable 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 single piece of flexible material integrally formed with the fixed and movable arms 132, 134. The fixed arm 132 is attached to the inner paddle 122 and remains fixed relative to the inner paddle 122 when the movable arm 134 opens, releasing the barbed clasp 130 and exposing the barb or locking means 136. In some implementations, the barbed clasp 130 is released by applying tension to an actuation line 116 attached to the movable arm 134, thereby allowing the movable arm 134 to articulate, bend, or pivot on a joint portion 138. Other actuation mechanisms are also possible.

[0057] During implantation, the paddles 120, 122 can be opened and closed to grasp the native or mitral valve leaflets, for example, between the paddles 120, 122 and the coaptation element or coaptation means 110. The barbed clasp 130 can be used to clamp and / or further secure the native valve leaflets by engaging the leaflets with the barbs or securement means 136 and clamping the leaflets between the movable arm 134 and the securement arm 132. The barbs or securement means 136 of the barbed clasp 130 may increase friction with the leaflet or partially or fully pierce the leaflet. The actuation wires 116 can be separately actuated so that each barbed clasp 130 can be opened and closed separately. Separate actuation allows for grasping one leaflet at a time or allows for repositioning of the clasp 130 on a poorly grasped leaflet without altering the good grip of the other leaflet. The barbed clasp 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in the open position), thereby allowing the leaflets to be grasped in various positions as the particular situation requires.

[0058] The barbed clasps 130 may be separately opened by pulling on an attached actuation line 116 that extends through the delivery sheath or delivery means 102 to the barbed clasps 130. The actuation line 116 may take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, etc. In the closed position, the barbed clasps 130 may be spring-loaded so that they continue to provide a clamping force on the grasped native valve leaflets. This clamping force remains constant regardless of the position of the inner paddle 122. The barbs or fixation means 136 of the barbed clasps 130 may pierce the native valve leaflets to further secure them.

[0059] Referring now to FIG. 8 , device 100 is shown in an elongated or fully open state for deployment from a delivery sheath. Because the fully open position takes up minimal space, allowing the smallest catheter to be used (or the largest device 100 to be used for a given catheter size), device 100 is loaded into the delivery sheath in the fully open position. In the elongated state, cap 114 is spaced apart from coaptation element or attachment means 110 so that paddles 120, 122 of anchor portion 106 are fully extended. In some embodiments, the angle formed between the interior of outer and inner paddles 120, 122 is approximately 180 degrees. Barbed clasp 130 is held closed during deployment through delivery sheath or delivery means 102, so that barbs or fixation means 136 ( FIG. 11 ) do not catch or damage tissue within the sheath or the patient's heart.

[0060] 9, device 100 is shown in an elongated, uncoiled state similar to that of FIG. 8, but with barbed clasp 130 in a fully open position at an angle ranging from about 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or about 180 degrees between the fixed and movable portions of barbed clasp 130. Allowing paddles 120, 122 and clasp 130 to be fully open has been found to improve the ease of uncoil or detachment of device 100 from the patient's anatomy during implantation.

[0061] Referring now to FIG. 10 , the device 100 is shown in a contracted or fully closed state. The compact size of the device 100 in the contracted state allows for easier manipulation and placement within the heart. To move the device 100 from the elongated state to the contracted state, the actuation element or actuation means 112 is retracted, pulling the cap 114 toward the co-option element or attachment means 110. The joint or flexible connection 126 between the outer paddle 120 and the inner paddle 122 is constrained such that a compressive force acting on the retracted outer paddle 120 from the cap 114 toward the co-option element or attachment means 110 causes the paddles or gripping elements 120, 122 to move radially outward. During movement from the open position to the closed position, the outer paddle 120 maintains an acute angle with the actuation element or actuation means 112. The outer paddle 120 may optionally be biased toward the closed position. During the same operation, the inner paddles 122 move through a significantly larger angle because they are oriented away from the co-option element or joining means 110 in the open state and folded along both sides of the co-option element or joining means 110 in the closed state. In certain embodiments, the inner paddles 122 are thinner and / or narrower than the outer paddle 120, and the joints or flexible portions 126, 128 connected to the inner paddles 122 may be thinner and / or more flexible. For example, this increased flexibility may allow for more movement than the joints or flexible portions 124 connecting the outer paddle 120 to the cap 114. In certain other embodiments, the outer paddle 120 is narrower than the inner paddle 122. The joints or flexible portions 126, 128 connected to the inner paddles 122 may be more flexible, for example, to allow for more movement than the joints or flexible portions 124 connecting the outer paddle 120 to the cap 114. In one embodiment, the inner paddle 122 can be the same or substantially the same width as the outer paddle (see, eg, FIG. 65A).

[0062] 11-13, the device 100 is shown in a partially open, ready-to-grasp state. To transition from the fully closed state to the partially open state, the actuation element or means 112 is extended, pushing the cap 114 away from the coaptation element or means 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, partially expanding the anchor portion 106. The actuation wire 116 is also retracted, opening the clasp 130, which may then grasp the valve leaflets. In the embodiment shown by FIG. 11, the pair of inner and outer paddles 122, 120 are moved in unison, rather than independently, by a single actuation element or means 112. Additionally, the position of the clasp 130 is dependent on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 also closes the clasp.

[0063] Figure 11A shows an example embodiment in which the paddles 120, 122 are independently controllable. The device 100A shown by Figure 11A is similar to the device shown by Figure 11, except that the device 100A includes an actuation element configured as two independent actuation elements 112A, 112B coupled to two independent caps 114A, 114B. To transition the first inner and outer paddles from a fully closed state to a partially open state, the actuation element or actuation means 112A is extended, pushing the cap 114A away from the co-option element or joining means 110, thereby pulling the outer paddle 120, which pulls the inner paddle 122 and causes the first anchor portion 106 to partially unfold. To transition the second inner and second outer paddles from a fully closed state to a partially open state, the actuation element or actuation means 112B is extended to push the cap 114 away from the co-option element or joining means 110, thereby pulling the outer paddle 120, which pulls the inner paddle 122 and causes the second anchor portion 106 to partially unfold. The independent paddle control illustrated by FIG. 11A can be implemented in any of the devices disclosed by the present application.

[0064] 12, one of the actuation lines 116 is extended to allow one of the clasps 130 to close. Now referring to FIG. 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.

[0065] 14, device 100 is shown in a fully closed and deployed state. Delivery sheath or delivery means 102 and actuation element or actuation means 112 are retracted, with paddles 120, 122 and clasp 130 still in the fully closed position. Once deployed, device 100 may be maintained in the fully closed position by a mechanical latch, or may be biased to remain closed by the use of a spring material such as steel, other metals, plastics, composites, or a shape memory alloy such as Nitinol. For example, the articulating or flexible portions 124, 126, 128, 138 and / or the inner and outer paddles 122, 120, and / or additional biasing components (see component 524 in FIG. 28 ) may be formed from a metal such as steel or a shape memory alloy such as Nitinol (manufactured from wire, sheet, tube, or laser-sintered powder) and may bias the outer paddle 120 to close and hold it around the co-option element or coaptation means 110, with the barbed clasp 130 clamping around the native valve leaflets. Similarly, the fixed and movable arms 132, 134 of the barbed clasp 130 are biased to clamp the leaflets. In certain embodiments, the attachment or joint portions 124, 126, 128, 138, and / or the inner and outer paddles 122, and / or additional biasing components (see component 524 in FIG. 28) may be formed from metal or any other suitable resilient material, such as a polymeric material, to maintain the device in a closed state after implantation.

[0066] 226-231, implantable device 100 is shown provided with cover 140. Cover 140 may be a cloth material, such as a fine-mesh polyethylene cloth. The cloth cover may provide a blood seal over the surface of the spacer and / or promote rapid tissue ingrowth. Cover 140 includes a first cover portion 142 and a second cover portion 144, each of which covers a different portion of device 100. In some embodiments, a portion of one of first and second cover portions 142, 144 overlaps a portion of the other of first and second cover portions 142, 144. First and second cover portions 142, 144 may be arranged in various manners and, in some embodiments, may include an overlap portion 146 that overlaps one of first and second cover portions 142, 144.

[0067] 226-229, various arrangements of the first and second cover portions 142, 144 are shown without overlapping portions 146. Referring now to FIG. 226, the first cover portion 142 (represented by thin cross-hatching), which may be made from a single piece of material, extends from the cap 114 and covers the cap 114, the outer paddle 120, the inner paddle 122, and the locking arm 132 of the clasp 130. The second cover 144 (represented by thick cross-hatching), which may be a single piece of material, covers the co-option element or joining means 110.

[0068] 227, a first cover portion 142, which may be made from a single piece of material, extends from the cap 114 to cover the cap 114, the outer paddle 120, the inner paddle 122, the fixed arm 132, and the movable arm 134 of the clasp 130. Similar to the cover 140 of FIG. 226, a second cover 144 covers the co-option element or joining means 110.

[0069] 228, a first cover portion 142, which may be made from a single piece of material, extends from the cap 114 to cover the cap 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 of the clasp 130. A second cover 144, which may be made from a single piece of material, covers the co-option element or joining means 110 and extends from the co-option element or joining means 110 to cover the movable arm 134 of the clasp 130.

[0070] 229, a first cover portion 142, which may be made from a single piece of material, extends from the cap 114 to cover the cap 114 and the outer paddle 120. A second cover 144, which may be made from a single piece of material, covers the co-option element or joining means 110 and extends from the co-option element or joining means 110 to cover the inner paddle 122, the fixed arm 132, and the movable arm 134 of the clasp 130.

[0071] 230-231 , an arrangement of first and second cover portions 142, 144 is shown, including an overlapping portion 146. Referring now to FIG. 230 , first cover portion 142, which may be made from a single piece of material, extends from cap 114 to cover cap 114, outer paddle 120, inner paddle 122, and fixed arm 132, as well as movable arm 134 of clasp 130. Second cover 144, which may be made from a single piece of material, covers co-option element or joining means 110 and includes an overlapping portion 146 that extends from co-option element or joining means 110 and overlaps a portion of movable arm 134 covered by first cover 142.

[0072] 231 , a first cover portion 142, which may be made from a single piece of material, extends from the cap 114 and covers the cap 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 of the clasp 130. A second cover 144, which may be made from a single piece of material, covers the co-option element or joining means 110 and the movable arm 134 of the clasp 130. The first cover 142 also includes an overlapping portion 146 that extends from the fixed arm 132 and the inner paddle 122 and overlaps the portion of the movable arm 134 covered by the second cover 144, and the co-option element or joining means 110.

[0073] 15-20, the implantable device 100 of FIGS. 8-14 is shown delivered and implanted within the native mitral valve MV of a heart H. The methods and steps shown and / or discussed may be performed on a live animal or in a simulation, such as, for example, a cadaver, a cadaver heart, a simulator (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0074] Referring now to FIG. 15 , a delivery sheath is inserted through the septum into the left atrium LA, and device 100 is deployed from the delivery sheath in a fully open state. The actuating element or means 112 is then retracted, moving device 100 to a fully closed state shown in FIG. 16 . As can be seen in FIG. 17 , device 100 moves into position within the mitral valve MV and into the inner chamber LV, partially opening so that leaflets 20, 22 can be grasped. Referring now to FIG. 18 , actuating wire 116 is extended to close one of the clasps 130, capturing leaflet 20. FIG. 19 shows that the other actuating wire 116 is then extended to close the other clasp 130 and capture the remaining leaflet 22. As can be seen in FIG. 20, the delivery sheath or delivery means 102, and the actuating element or actuating means 112, and actuating line 116 are then retracted, causing the device 100 to be fully closed and deployed within the native mitral valve MV.

[0075] Referring now to FIG. 21 , an exemplary implantable prosthetic device 200 or its frame 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 end of each anchor 204 may be coupled to a respective post of the spacer member 202 by a respective sleeve 206, which may be crimped or welded around the connecting portion of the anchor 204 and the post of the spacer member 202. In one exemplary embodiment, a latching mechanism may tie the spacer member 202 to the anchor 204 within the sleeve 206. For example, the sleeve may be machined to have an internal shape that matches or is slightly smaller than the external shape of the ends of the spacer member 202 and anchor 204, allowing the sleeve to frictionally fit over the connecting portion. One or more barbs or protrusions 208 may be mounted on the frame of the spacer member 202. The free ends of the barbs or protrusions 208 may include a variety of shapes, including rounded, pointed, barbed, or the like. The protrusions 208 may exert a retaining force against the native leaflets by virtue of the anchors 204 being shaped to urge the native leaflets inwardly into the spacer member 202.

[0076] 22 , an exemplary 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 may be configured similarly to the prosthetic spacer device 200. One or more barbs or protrusions 306 may be mounted on the frame of the spacer member 302. The ends of the protrusions 306 may include stops 308. The protrusion stops 308 may be configured in a variety of different ways. For example, the stops 308 may be configured to limit the extent to which the protrusions 306 can engage and / or penetrate the native valve leaflets and / or the stops may be configured to prevent removal of the protrusions 306 from the tissue after they have penetrated the tissue.

[0077] The anchors 304 of the prosthetic spacer device 300 may be configured similarly to the anchors 204 of the prosthetic spacer device 200, except that the curve of each anchor 304 includes a larger radius than anchors 204. As such, anchors 304 cover a relatively larger portion of the spacer member 302 than anchors 204. This can, for example, distribute the clamping force of anchors 304 against the native leaflets over a relatively larger surface of the native leaflets to further protect the native leaflet tissue.

[0078] Additional details regarding prosthetic spacer devices can be found, for example, in U.S. Patent Nos. 6,275,999 and 6,275,999, which applications are incorporated herein by reference. Devices 200, 300 can include any other features of implantable prosthetic devices discussed herein, and devices 200, 300 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0079] 23-27, an exemplary embodiment of an implantable prosthetic spacer device 400 and its components is shown. Device 400 may include any other features of implantable prosthetic devices discussed herein, and device 400 may be positioned to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0080] 23, a prosthetic spacer or co-option device 400 can include a co-option portion 404 and an anchor portion 406, with the anchor portion 406 including a plurality of anchors 408. The co-option portion 404 includes a co-option 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 co-option portion 404 and the anchor portion 406 relative to each other.

[0081] 25 , the first connecting portion 425 of the anchor 408 can be coupled to and extend from the first portion 417 of the co-option or spacer member 410, and the second connecting portion 421 of the anchor 408 can be coupled to the second collar 414. The proximal collar 411 can be coupled to the second portion 419 of the co-option member 410.

[0082] The co-option member 410 and the anchor 408 may be coupled together in a variety of ways. For example, as shown in the illustrated embodiment, the co-option member 410 and the anchor 408 may be coupled together by integrally forming the co-option member 410 and the anchor 408 as a single, unitary component. This may be accomplished, for example, by forming the co-option member 410 and the anchor 408 from a braided or woven material, such as braided or woven nitinol wire. In other embodiments, the co-option member 410 and the anchor 408 may be coupled together by welding, fasteners, adhesives, joint connections, sutures, friction fit, swaging, and / or other coupling means.

[0083] 24, anchor 408 can include a first portion or outer paddle 420 and a second portion or inner paddle 422 separated by a joint portion 423. In this manner, anchor 408 is configured similar to a leg in that inner paddle 422 resembles the upper portion of the leg, outer paddle 420 resembles the lower portion of the leg, and joint portion 423 resembles the knee portion of the leg. In some embodiments, inner paddle portion 422, outer paddle portion 420, and joint portion 423 are formed from a continuous strip of material, such as a metal fiber. In some embodiments, the strip of fiber is a composite strip of fiber.

[0084] The anchor 408 can be configured to move between various configurations by axially moving the cap 414 relative to the proximal collar 411, and thus the anchor 408, relative to the co-option member 410, along a longitudinal axis extending between the first or distal portion and the second or proximal portion 417, 419 of the co-option member 410. For example, the anchor 408 can be positioned in a straight configuration by moving the cap 414 away from the co-option 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 portion 423 of the anchor 408 is adjacent to the longitudinal axis of the co-option member 410 (e.g., similar to the configuration shown in FIG. 59). From the straight configuration, the anchor 408 can be moved to a fully collapsed configuration (e.g., FIG. 23) by moving it toward the co-option member 410. 24-25, initially, as the cap 414 moves toward the co-option member 410, the anchor 408 folds at the joint portions 423, 425, 421, and the joint portion 423 moves radially outward relative to the longitudinal axis of the co-option member 410 and axially toward the first portion 417 of the co-option member 410. As the cap 414 continues to move toward the co-option member 410, the joint portion 423 moves radially inward relative to the longitudinal axis of the co-option member 410 and axially toward the proximal portion 419 of the co-option member 410, as shown in FIG.

[0085] In some embodiments, the angle between the inner paddle 422 of the anchor 408 and the co-option member 410 can be approximately 180 degrees when the anchor 408 is in a straight configuration (see, e.g., FIG. 59), and the angle between the inner paddle 422 of the anchor 408 and the co-option member 410 can be approximately 0 degrees when the anchor 408 is in a fully collapsed configuration (see, e.g., FIG. 23). The anchor 408 can be positioned in various partially collapsed configurations such that the angle between the inner paddle 422 of the anchor 408 and the co-option member 410 can be approximately 10 to 170 degrees or approximately 45 to 135 degrees.

[0086] Configuring the prosthetic spacer device 400 so that the anchors 408 can extend to a straight or nearly straight configuration (e.g., approximately 120 degrees to 180 degrees relative to the co-option member 410) can provide several advantages. For example, this can reduce the radial crimping profile of the prosthetic spacer device 400. This can also make it easier to grasp the native valve leaflets by providing larger openings through which to grasp them. Additionally, a relatively narrow straight configuration can prevent or reduce the likelihood of the prosthetic spacer device 400 becoming entangled within the natural anatomy (e.g., chordae tendineae) when positioning and / or removing the prosthetic spacer device 400 within a delivery apparatus.

[0087] 24, clasp 430 can include an attachment or fixation portion 432 and an arm or movable portion 434. Attachment or fixation portion 432 can be coupled to inner paddle 422 of anchor 408 in a variety of ways, such as with sutures, adhesives, fasteners, welding, stitching, swaging, a friction fit, and / or other coupling means or fastening.

[0088] In some embodiments, the movable portion 434 can articulate, bend, or pivot relative to the fixed portion 432 between an open configuration (e.g., FIG. 24 ) and a closed configuration ( FIGS. 23 and 25 ). In some embodiments, the clasp 430 can be biased toward the closed configuration. In some embodiments, in the open configuration, the fixed portion 432 and the movable portion 434 bend or pivot away from each other so that the native valve leaflets can be positioned between the fixed portion 432 and the movable portion 434. In some embodiments, in the closed configuration, the fixed portion 432 and the movable portion 434 bend or pivot toward each other, thereby clamping the native valve leaflets between the fixed portion 432 and the movable portion 434.

[0089] 26-27, a clasp 430 is shown in top and perspective views. The securing portion 432 (only one shown in FIGS. 26-27) can include one or more openings 433 (e.g., three in the illustrated embodiment). At least some of the openings 433 can be used to couple the securing portion 432 to the anchor 408. For example, sutures and / or fasteners can extend through the openings 433 to couple the securing portion 432 to the anchor 408, or other attachments, such as welding, adhesives, etc., can be used.

[0090] The movable portion 434 may include one or more side beams 431. When two side beams are included as shown, the side beams may be spaced apart to form a slot 431A. The slot 431A may be configured to receive the fixed portion 432. The movable portion 434 may also include a spring portion 434A coupled to the fixed portion 432 and a barb support portion 434B disposed opposite the spring portion 434A.

[0091] The barb support portion 434B may include gripper or attachment elements, such as barbs 436 and / or other means for frictionally engaging the native leaflet tissue. The gripper elements may be configured to engage and / or penetrate the native leaflet tissue to help retain the native leaflet between the fixed portion 432 and the movable portion 434 of the clasp 430.

[0092] Barb support portion 434B may also include apertures 435 that may be used to couple barb support portion 434B to an actuation mechanism configured to flex or pivot movable portion 434 relative to fixed portion 432. Additional details regarding coupling clasp 430 to an actuation mechanism are provided below.

[0093] In some embodiments, clasp 430 may be formed from a shape memory material such as nitinol, stainless steel, and / or a shape memory polymer. In certain embodiments, clasp 430 may be formed by laser cutting a section of flat material (e.g., nitinol) or tubing in the configuration shown in FIG. 26, or a tube of a similar or different configuration, and then shape-setting clasp 430 in the configuration shown in FIG. 27.

[0094] Shape-setting the clasp 430 in this manner can provide several advantages. For example, the clasp 430 can be optionally compressed from a shape-set configuration (e.g., FIG. 27) to a planar configuration (e.g., FIG. 26) or another configuration that reduces the radial crimp profile of the clasp 430. For example, the barbs can be optionally compressed into a flat configuration. Reducing the radial crimp profile can improve the trackability and retrievability of the prosthetic spacer device 400 relative to the catheter shaft of a delivery apparatus because the barbs 436 point radially inward toward the anchors 408 when the prosthetic spacer device 400 is advanced through or retrieved within a catheter shaft (see, e.g., FIG. 33). This can prevent or reduce the possibility that the clasp 430 may drag or skip down the catheter shaft.

[0095] Furthermore, shape-setting the clasp 430 in the configuration shown in FIG. 27 can increase the clamping force of the clasp 430 when the clasp 430 is in the closed configuration. This is because the movable portion 434 is shape-set relative to the fixed portion 432 to a first position (e.g., FIG. 27 ) that exceeds the position that the movable portion 434 would achieve when the clasp 430 is attached to the anchor 408 (e.g., FIG. 25 ), and the anchor 408 prevents the movable portion 434 from moving further toward the shape-set configuration. This results in the movable portion 434 having a preload (i.e., a clamping force greater than zero) when the clasp 430 is attached to the anchor 408 and in the closed configuration. Therefore, shape-setting the clasp 430 in the configuration of FIG. 27 can increase the clamping force of the clasp 430 compared to a clasp shape-set in the closed configuration.

[0096] The magnitude of the preload of the clasp 430 can be changed by adjusting the angle at which the movable portion 434 is configured relative to the fixed portion 432. For example, increasing the relative angle between the movable portion 434 and the fixed portion 432 increases the preload, and decreasing the relative angle between the movable portion 434 and the fixed portion 432 decreases the preload. It can also be adjusted in other manners, such as based on the configuration of the joints, hinges, materials, etc.

[0097] In some embodiments, the proximal collar 411 and / or co-option member 410 may include a hemostatic seal 413 configured to reduce or prevent blood from flowing through the proximal collar 411 and / or co-option member 410. For example, in some embodiments, the hemostatic seal 413 may include a plurality of flexible flaps 413A, as shown in FIG. 23 . In some embodiments, the flaps 413A may be configured to pivot from a sealing configuration to an open configuration to allow the shaft of the delivery device to extend through the second collar 414. In one exemplary embodiment, the flaps 413A form a seal around the shaft of the delivery device. The flaps 413A may be configured to return from the open configuration to the sealing configuration when the shaft of the delivery device is removed.

[0098] 23A, an exemplary embodiment of an implantable prosthetic spacer device 400A is shown. Device 400A may include any other features of implantable prosthetic devices discussed herein, and device 400A may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0099] The prosthetic spacer or co-option device 400A can include a co-option portion 404A and an anchor portion 406A, with the anchor portion 406A including multiple anchors 408A. The co-option portion 404A includes a co-option member or spacer 410A. The anchor portion 406A includes multiple paddles 420A (e.g., two in the illustrated embodiment) and multiple 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 co-option portion 404A and anchor portion 406A relative to each other.

[0100] The co-option member 410A extends from a proximal portion 419B, which is assembled to the collar 411A, to a distal portion 417A, which connects to the anchor 408A. The co-option member 410A and the anchor 408A can be coupled together in various manners. For example, as shown in the illustrated embodiment, the co-option member 410A and the anchor 408A can be coupled together by integrally forming the co-option member 410A and the anchor 408A as a single, unitary component. This can be accomplished, for example, by forming the co-option member 410A and the anchor 408A from a continuous strip 401A of a knitted or woven material, such as knitted or woven nitinol wire.

[0101] Anchor 408A is attached to co-option member 410A by hinge portion 425A and to cap 414A by hinge portion 421A. Anchor 408A can include a first portion or outer paddle 420A and a second portion or inner paddle 422A separated by joint portion 423A. Joint portion 423A is attached to a paddle frame 424A that is hinged to cap 414A. In this manner, anchor 408A is configured similar to a leg in that inner paddle 422A is like the top portion of the leg, outer paddle 420A is like the bottom portion of the leg, and joint portion 423A is like the knee portion of the leg. In the illustrated embodiment, inner paddle portion 422A, outer paddle portion 420A, and joint portion 423A are formed from a continuous strip 401A of material, such as metal fiber.

[0102] The anchor 408A can be configured to move between various configurations by axially moving the cap 414A relative to the proximal collar 411A, and thus the anchor 408A relative to the co-option member 410A, along a longitudinal axis extending between the cap 414A and the proximal collar 411A. For example, the anchor 408A can be positioned in a straight configuration (see FIG. 60A ) by moving the cap 414A away from the co-option member 410A. In the straight configuration, the paddle portions 420A, 422A are aligned or linear with the longitudinal axis of the device, and the joint portion 423A of the anchor 408A is adjacent to the longitudinal axis of the co-option member 410A (e.g., similar to the configuration shown in FIG. 60A ). From the straight configuration, the anchor 408 can be moved to a fully collapsed configuration (e.g., FIG. 23A ) by moving it toward the co-option member 410A. Initially, as cap 414A moves toward co-option member 410A, anchor 408A folds at joint portions 421A, 423A, 425A, with joint portion 423A moving radially outward relative to the longitudinal axis of device 400A and axially toward distal portion 417A of co-option member 410A, as shown in Figures 53A and 54A. As cap 414A continues to move toward co-option member 410A, joint portion 423A moves radially inward relative to the longitudinal axis of device 400A and axially toward proximal portion 419A of co-option member 410A, as shown in Figure 23A.

[0103] In some embodiments, the angle between the inner paddle 422A of the anchor 408A and the co-option member 410A can be approximately 180 degrees when the anchor 408A is in a straight configuration (see, e.g., FIG. 60A), and the angle between the inner paddle 422A of the anchor 408A and the co-option member 410A can be approximately 0 degrees when the anchor 408A is in a fully collapsed configuration (see, e.g., FIG. 23A). The anchor 408A can be positioned in various partially collapsed configurations such that the angle between the inner paddle 422A of the anchor 408A and the co-option member 410A can be between approximately 10 degrees and 170 degrees or between approximately 45 degrees and 135 degrees.

[0104] Configuring the prosthetic spacer device 400A so that the anchor 408A can extend to a straight or nearly straight configuration (e.g., approximately 120 to 180 degrees relative to the co-option member 410A) can provide several advantages. For example, this can reduce the radial crimping profile of the prosthetic spacer device 400A. This can also make it easier to grasp the native valve leaflets by providing a larger opening through which to grasp them. Furthermore, a relatively narrow straight configuration can prevent or reduce the likelihood of the prosthetic spacer device 400A becoming entangled within the native anatomy (e.g., chordae tendineae) when positioning and / or removing the prosthetic spacer device 400A within a delivery apparatus.

[0105] Clasp 430A can include an attachment or fixation portion 432C and an arm or movable portion 434C. Attachment or fixation portion 432C can be coupled to inner paddle 422A of anchor 408A in a variety of ways, such as with sutures, adhesives, fasteners, welding, stitching, swaging, a friction fit, and / or other coupling means. Clasp 430A is similar to clasp 430.

[0106] In some embodiments, the movable portion 434C can articulate, bend, or pivot relative to the fixed portion 432C between an open configuration (e.g., FIG. 54A) and a closed configuration ( FIG. 53A). In some embodiments, the clasp 430A can be biased toward the closed configuration. In the open configuration, the fixed portion 432C and the movable portion 434C articulate, pivot, or bend away from each other so that the native valve leaflets can be positioned between the fixed portion 432C and the movable portion 434C. In the closed configuration, the fixed portion 432C and the movable portion 434C articulate, pivot, or bend toward each other, thereby clamping the native valve leaflets between the fixed portion 432C and the movable portion 434C.

[0107] The strip 401A is attached to the collar 411A, cap 414A, paddle frame 424A, and clasp 430A to form both the co-option portion 404A and anchor portion 406A of the device 400A. In the illustrated embodiment, the co-option member 410A, hinge portions 421A, 423A, 425A, outer paddle 420A, and inner paddle 422A are formed from a continuous strip 401A. The continuous strip 401A may be a single layer of material or may include two or more layers. In certain embodiments, some portions of the device 400A have a single layer of the strip of material 401A, while other portions are formed from multiple overlapping or overlapping layers of the strip of material 401A. For example, FIG. 23A shows the co-option member 410A and inner paddle 422A formed from multiple overlapping layers of the strip of material 401A. The single continuous strip of material 401A can start and end at various locations on the device 400A. The ends of the strip of material 401A can be at the same location or at different locations on the device 400A. For example, in the illustrated embodiment of Figure 23A, the strip of material starts and ends at the inner paddle 422A.

[0108] 30A , an exemplary implantable prosthetic device 400A is shown covered with a cover 440A. The cover 440A is disposed over the co-option member 410A, collar 411A, cap 414A, paddles 420A, 422A, paddle frame 424A, and clasp 430A. The cover 440A can be configured to prevent or reduce blood flow through the prosthetic spacer device 400A and / or promote natural tissue ingrowth. In some embodiments, the cover 440A can be a cloth or fabric, such as PET, velour, or other suitable fabric. In other embodiments, instead of or in addition to fabric, the cover 440A can include a coating (e.g., a polymeric material, silicone, etc.) applied to the prosthetic spacer device 400A.

[0109] 28-30 , an exemplary embodiment of an implantable prosthetic device 500 (e.g., a prosthetic spacer device) is shown. The implantable device 500 is one of many different configurations that the device 100, illustrated generally in FIGS. 8-20, can assume. The device 500 can include any other features of implantable prosthetic devices discussed herein, 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 herein).

[0110] The prosthetic spacer device 500 may include a co-option element or spacer member 510 and a plurality of anchors 508, including an outer paddle 520, an inner paddle 522, a clasp 530, a first or proximal collar 511, and a second collar or cap 514. These components of the prosthetic spacer device 500 may be configured the same as or substantially similar to the corresponding components of the prosthetic spacer device 400.

[0111] The prosthetic spacer device 500 may also include multiple paddle extension members or paddle frames 524. The paddle frames 524 may be configured with a rounded, three-dimensional shape with a first connecting portion 526 coupled to and extending from the cap 514 and a second connecting portion 528 disposed on opposite sides of the first connecting portion 526. The paddle frames 524 may be configured to extend circumferentially more widely around the co-option member 510 than the outer paddles 520. For example, in some embodiments, each of the paddle frames 524 extends around approximately half the circumference of the co-option member 510 (as shown in FIG. 29), and the outer paddles 520 extend around less than half the circumference of the co-option member 510 (as shown in FIG. 28). The paddle frames 524 may also be configured to extend laterally (i.e., perpendicular to the longitudinal axis of the co-option member 510) beyond the outer diameter of the co-option member 510. In the illustrated example, the inner paddle portion 522 and the outer paddle portion 520 may be formed from a continuous strip of fabric connected to a paddle frame 524. For example, the inner and outer paddle portions may be connected to a connecting portion of the paddle frame with a flexible connection between the inner and outer paddle portions.

[0112] The paddle frame 524 may be further configured such that a connecting portion 528 of the paddle frame 524 is connected to or axially adjacent to the joint portion 523. The connecting portion of the paddle frame 524 may be positioned between the outer paddle 520 and the inner paddle 522, on the outer side of the paddle portion 520, on the inner side of the inner paddle portion, or on the joint portion 523 when the prosthetic spacer device 500 is in the collapsed configuration (e.g., FIGS. 28-30). The connections between the paddle frame 524, the single strip forming the outer paddle 520 and the inner paddle 522, the cap 514, and the co-option element can limit each of these portions to the movements and positions described herein. In particular, the joint portion 523 is limited by its connection between the outer paddle 520 and the inner paddle 522 and by its connection to the paddle frame. Similarly, the paddle frame 524 is limited by its attachment to the joint portion 523 (and thus the inner and outer paddles) and the cap.

[0113] Configuring the paddle frame 524 in this manner provides an increased surface area compared to the outer paddle 520 alone, which can facilitate, for example, grasping and securing the native valve leaflets. The increased surface area also allows the clamping force of the paddles 520 and paddle frame 524 against the native valve leaflets to be distributed over a larger surface area of ​​the native leaflets to further protect the native leaflet tissue.

[0114] The increased surface area of ​​the paddle frame 524 may also allow the natural valve leaflets to be secured to the prosthetic spacer device 500 such that they are fully coapted around the coaptation member 510. This may, for example, improve the seal of the natural valve leaflets and thus prevent or further reduce mitral regurgitation.

[0115] 30 , the prosthetic spacer device 500 may also include a cover 540. In some embodiments, the cover 540 may be disposed over the co-option member 510, the paddles 520, 522, and / or the paddle frame 524. The cover 540 may be configured to prevent or reduce blood flow through the prosthetic spacer device 500 and / or promote natural tissue ingrowth. In some embodiments, the cover 540 may be a cloth or fabric, such as PET, velour, or other suitable fabric. In other embodiments, instead of or in addition to fabric, the cover 540 may include a coating (e.g., a polymeric fiber, silicone, etc.) applied to the prosthetic device 500.

[0116] 31-32 show the implantable prosthetic device 500 of FIGS. 28 and 29 with the anchor 508 and clasp 530 of the anchor portion 506 in the open position. The device 500 is deployed from a delivery sheath (not shown) and includes a co-option portion 504 and an anchor portion 506. The device 500 is loaded into the delivery sheath in the fully expanded or bailed-out position (see FIG. 35) because this position takes up the least space and allows the smallest catheter to be used. Alternatively, the fully expanded position allows the largest device 500 to be used for a given catheter size. The co-option portion 504 of the device includes a co-option element 510 for implantation between the native leaflets of a native valve (e.g., mitral valve, tricuspid valve, etc.). An insert portion 516A is disposed within the co-option element 510. The insert portion 516A and co-option element 510 are slidably attached to an actuation element 512 (e.g., an actuation wire, rod, shaft, tube, screw, suture, line, etc.). The anchor 508 of the device 500 includes an outer paddle 520 and an inner paddle 522 flexibly connected to the cap 514 and the co-option element 510. Actuation of the actuation element or actuation means 512 opens and closes the anchor 508 of the device 500 to grip the native valve leaflets during implantation.

[0117] Actuation element 512 extends through a delivery sheath (not shown), proximal collar 511, co-option element 510, insert portion 516A, and into cap 514. Extension and retraction of actuation element 512 increases and decreases, respectively, the spacing between co-option element 510 and cap 514. This change in spacing between co-option element 510 and cap 514 moves anchor portion 506 of the device between different positions.

[0118] The proximal collar 511 optionally includes a collar seal 513 that forms a seal around the actuating element or actuating means 512 during implantation of the device 500, which seal closes when the actuating element 512 is removed to close or substantially close the proximal end of the device 500 to allow blood flow through the interior of the co-option element 510 after implantation. In some embodiments, a coupler or means for coupling 2214 (see FIG. 145) removably engages and attaches the proximal collar 511 and co-option element 510 to a delivery sheath. In some embodiments, the coupler or coupling means 2214 is held closed around the proximal collar 511 by the actuating element 512 such that removal of the actuating element 512 allows the fingers (see FIG. 145) of the coupler or coupling means 2214 to open while releasing the proximal collar 511.

[0119] The proximal collar 511 and insert portion 516A in the co-option element 510 slide along the actuation element 512 during actuation to open and close the paddles 520, 522 of the anchor 508. Referring to FIGS. 32A and 32B , in some embodiments, the cap 514 optionally includes a sealing protrusion 516 that sealingly fits within a sealing opening 517 in the insert portion 516A. In one exemplary embodiment, the cap 514 includes a sealing opening and the insert portion 516A includes a sealing protrusion. The insert portion 516A can sealingly fit within a distal opening 515 of the co-option element 510, which has a hollow interior. Referring to FIG. 32A, sealing protrusion 516 of cap 514 sealingly engages opening 517 in insert portion 516A to keep the distal end of co-option element 510 closed or substantially closed to blood flow when device 500 is implanted and / or in the closed position.

[0120] In one exemplary embodiment, instead of a sealing engagement between cap 514 and insert portion 516A, insert portion 516A can optionally include a seal, such as collar seal 513 on the proximal collar portion, that forms a seal around actuation element or actuation means 512 during implantation of device 500 and closes the seal when actuation element 512 is removed. Such a seal can close or substantially close the distal end of co-option element 510 to blood flow after implantation.

[0121] The co-option element 510 and paddles 520, 522 are formed from a flexible material, which may be a metal fiber, such as mesh, woven, knitted, or formed in any other suitable manner, or a laser-cut or otherwise cut flexible material. The material may also be cloth, wire such as Nitinol to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body. The paddle frame 524 provides additional clamping force between the inner paddle 522 and the co-option element 510 and helps wrap the leaflets around the sides of the co-option element 510 for a better seal between the co-option element 510 and the leaflets. In some embodiments, a covering 540, shown by FIG. 30, extends around the paddle frame 524.

[0122] The clasp 530 includes a base or locking arm 532, a movable arm 534, a barb 536, and a joint portion 538. The locking arm 532 is attached to the inner paddle 522, with the joint portion 538 positioned adjacent to the co-option element 510. The barbed clasp has a flat surface and does not fit into a recess in the paddle. Rather, the flat portion of the barbed clasp is positioned against the surface of the inner paddle 522. For example, the locking arm 532 is attached to the inner paddle 522 with a suture (not shown) through a hole or slot 533. The locking arm 532 may be attached to the inner paddle 522 or another portion of the device by any suitable means, such as, for example, a screw or other fastener, a crimp sleeve, a mechanical latch or snap, welding, an adhesive, etc. The locking arm 532 remains stationary or substantially fixed relative to the inner paddle 522 when the movable arm 534 opens, opening the barbed clasp 530 and exposing the barb 536. The barbed clasp 530 is opened by applying tension to an actuation line (not shown) attached to a hole 535 in the movable arm 534 , thereby causing the movable arm 534 to pivot or bend on the joint portion 538 .

[0123] During implantation, the anchor 508 is opened and closed to grasp the native valve leaflet between the paddles 520, 522 and the co-option element 510. The barbed clasp 530 further secures the native valve leaflet by engaging the leaflet with the barbs 536 and sandwiching the leaflet between the movable and fixed arms 534, 532. The barbs 536 of the barbed clasp 530 may increase friction with the leaflet or partially or fully pierce the leaflet. The actuation lines can be separately actuated to allow each barbed clasp 530 to be opened and closed separately. Separate actuation allows for grasping one leaflet at a time or repositioning the clasp 530 on a poorly grasped leaflet without altering the good grip of the other leaflet. The barbed clasp 530 can be opened and closed when the inner paddle 522 is not closed, thereby allowing the leaflet to be grasped in various positions as required by specific situations.

[0124] Referring now to FIG. 33 , an exemplary barbed clasp 600 for use in an implantable prosthetic device such as those 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 this application and any of the applications incorporated by reference herein and / or from which this application claims priority. In the illustrated example, the barbed clasp 600 is formed from an upper layer 602 and a lower layer 604. The two-layer design of the clasp 600 allows for the use of a thinner sheet of material, thereby improving the flexibility of the clasp 600 relative to clasps formed from a single, thicker sheet, while maintaining the strength of the clasp 600 necessary to successfully retain the native valve leaflets.

[0125] The barbed clasp 600 includes a fixation arm 610, a joint portion 620, and a movable arm 630 having a barbed clasp 640. The upper and lower layers 602 and 604 have similar shapes and, in certain embodiments, are attached to one another at the barbed portion 640. However, the upper and lower layers 602 and 604 may be attached to one another at other or additional locations. The joint portion 620 is spring-loaded so that the fixation arm 610 and the movable arm 630 are biased toward one another when the barbed clasp 600 is in a closed state. When assembled into an implantable prosthetic device, the fixation 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 movable arm 630 until the spring force of the joint portion 620 is overcome.

[0126] The fixed arm 610 is formed from a tongue 611 of material extending from a joint 620 between two side beams 631 of the movable arm 630. The tongue 611 is biased between the side beams 631 by the joint 620 such that a 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 to the side beams 631. The tongue 611 is held in the preloaded position by an optional T-shaped crossbar 614 attached to the tongue 611 and extending outward to engage the side beams 631. In one exemplary embodiment, the crossbar is omitted and the tongue 611 is attached to an inner paddle 522, which maintains the clasp in the preloaded position. In a two-layer clasp application, the top layer 602 and bottom layer 604, or just the top layer, can be attached to the inner paddle. In some embodiments, the angle between fixed arm 610 and movable arm 630 when the tongue is in a neutral position is between about 30 degrees and about 100 degrees, between 30 degrees and about 90 degrees, or between about 30 degrees and about 60 degrees, or between about 40 degrees and about 50 degrees, or about 45 degrees.

[0127] Tongue 611 includes a hole 612 for receiving a suture (not shown) that attaches fixation arm 610 to the implantable device. Fixation arm 610 may be attached to the implantable device using a screw or other fastener, a crimp sleeve, a mechanical latch or snap, welding, an adhesive, etc. In certain embodiments, hole 612 is an elongated slot or oval hole to accommodate sliding of layers 602, 604 without damaging the suture that attaches clasp 600 to the implantable device.

[0128] 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 beam 631 of the movable arm 630. In certain embodiments, the beam loops 622 are narrower than the tongue 611 and the side beam 631 to provide additional flexibility. The beam loops 622 each include a central portion 624 that extends from the tongue 611 and an outer portion 626 that extends to the side beam 631. The beam loops 622 are bent in a slight spiral or helical shape by bending the central portion 624 and the outer portion 626 in opposite directions, thereby forming an offset or step distance 628 between the tongue 611 and the side beam 631. The step distance 628 provides space between the arms 610, 630 to accommodate the native leaflets of the native valve after they have been grasped. In certain embodiments, the step distance 628 is about 0.5 millimeters to about 1 millimeter, or about 0.75 millimeters.

[0129] When viewed in a top plan view, the beam loop 622 has an "omega-like" shape. This shape of the beam loop 622 allows the fixed and movable arms 610, 630 to move a significant distance relative to one another without plastically deforming the clasp material. For example, in certain embodiments, the tongue 611 may be bent or pivoted from a neutral position of about 45 degrees beyond the movable arm 630 to a fully open position of about 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or even about 180 degrees from the movable arm 630 without plastically deforming the clasp material. In certain embodiments, the clasp material plastically deforms during opening without reducing or substantially reducing the clamping force exerted between the fixed and movable arms in the closed position.

[0130] Preloading the tongues 611 allows the clasp 600 to maintain a clamping or clipping force on the native valve leaflets when closed. Preloading the tongues 611 provides a significant advantage over prior art clips that provide little or no clamping force when closed. Furthermore, spring-loaded closure of the clasp 600 is a significant improvement over clips that use one-time locking closure mechanisms because the clasp 600 can be repeatedly opened and closed to change position on the leaflets while still maintaining sufficient clamping force when closed. Furthermore, spring-loaded clasps can also facilitate device removal over time compared to devices that lock in a closed position (after tissue ingrowth). In one exemplary embodiment, both the clasp and paddle are spring biased to their closed position (as opposed to being locked in a closed position), which can facilitate removal of the device after tissue ingrowth.

[0131] The barbed portion 640 of the movable arm 630 includes an aperture 642, a barb 644, and a barb support 646. Positioning the barbed portion of the clasp 600 toward the end of the movable arm 630 increases the space between the barb 644 and the fixation arm 610 when the clasp 600 is opened, thereby improving the ability of the clasp 600 to adequately grasp the leaflet during implantation. This distance also allows the barb 644 to more securely disengage from the leaflet for repositioning. In certain embodiments, the barbs of the clasp may be longitudinally staggered to further distribute clamping forces and localized leaflet stresses.

[0132] The barbs 644 are spaced laterally the same distance from the joint portion 620, which provides excellent distribution of clamping forces against the leaflet tissue while making the clasp more robust in grasping the leaflet than barbs arranged in longitudinal rows. In some embodiments, the barbs 644 may be staggered to further distribute the clamping forces and local leaflet stresses.

[0133] 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. By forming the barbs 644 in only one of the two layers 602, 604, the barbs are thinner and therefore more effectively sharp than barbs formed from the same material having twice the thickness. The barb supports 646 extend along the bottom portions of the barbs 644 to stiffen the barbs 644 and further improve penetration and retention of the leaflet tissue. In certain embodiments, the ends of the barbs 644 are further sharpened using any suitable grinding means.

[0134] The barbs 644 are angled away from the movable arm 630 to easily penetrate the tissue of the native valve leaflet with minimal clamping or clipping force. The barbs 644 extend from the movable arm at an angle of about 45 degrees to about 75 degrees, or about 45 degrees to about 60 degrees, or about 48 degrees to about 56 degrees, or about 52 degrees. The angle of the barbs 644 provides an additional benefit in that forces pulling the implant away from the native leaflet encourage the barbs 644 to further engage the tissue, thereby ensuring better retention. Retention of the leaflet to the clasp 600 can be further improved by the location of the T-shaped crossbar 614 near the barbs 644 when the clasp 600 is closed. With this arrangement, tissue pierced by the barbs 644 is clamped against the movable arm 630 at the crossbar 614, thereby forcing the tissue into an S-shaped, tortuous path as it passes through the barbs 644. Thus, the force pulling the leaflet away from the clasp 600 encourages the tissue to further engage the barbs 644 before the leaflet can prolapse. For example, tension on the leaflet during diastole can encourage the barbs to pull toward the end portion of the leaflet. The S-shaped pathway takes advantage of the tension on the leaflet during diastole to allow for tighter engagement between the leaflet and the barbs.

[0135] 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 to the barb portion 640 of the movable arm 630. For example, the layers 602, 604 may be attached only to the barb portion 640 to allow the remaining layers to slide relative to each other. Portions of the bonding layers 602, 604, such as the fixed arm 610, the barb 644 and barb support 646, and the beam loop 622, are bent into the desired position. The layers 602, 604 can be bent and shape-set together, or they can be bent and shape-set separately and then bonded together. The clasp 600 is then subjected to a shape-setting process so that the internal forces of the material tend to return to the set shape after being deformed by an external force. After shape setting, the tongues 611 move to their preloaded positions to allow the crossbar 614 to be attached. In one exemplary embodiment, the clasp 600 can be optionally fully flattened for delivery through a delivery sheath and expanded upon deployment within the heart. The clasp 600 is opened and closed by applying and releasing tension to an actuating line, suture, wire, rod, catheter, or the like (not shown) attached to the movable arm 630. In some embodiments, an actuating line or suture is inserted through a hole 642 near the barb portion 640 of the movable arm 630 and wrapped around the movable arm 630 before returning to the delivery sheath. In certain embodiments, an intermediate suture loop is created through the hole, and the suture is inserted through the intermediate loop. Alternative embodiments of the intermediate loop may be constructed of a fiber or another material attached to the movable arm instead of a suture loop.

[0136] The intermediate loop of suture material reduces the friction experienced by the actuating line / suture compared to the friction between the actuating line / suture and the clasp material. When the suture is looped through the hole 642 or intermediate loop, both ends of the actuating line / suture extend rearwardly into and through the delivery sheath (e.g., FIG. 8). The suture can be removed by pulling one end of the suture proximally and withdrawing the other end of the suture through the hole or intermediate loop until it is back into the delivery sheath.

[0137] Referring now to FIG. 34 , a close-up view of one of the leaflets 20, 22 is shown being grasped by a barbed clasp, such as clasp 430, 530. The leaflets 20, 22 are grasped between the movable arm 434 and the fixation arm 532 of the clasp 430, 530. As shown in FIG. 34 , the tissue of the leaflets 20, 22 is not pierced by the barbs 436, 536, although in some embodiments, the barbs 436, 536 may partially or fully pierce the leaflets 20, 22. The angle and height of the barbs 436, 536 relative to the movable arms 434, 534 help secure the leaflets 20, 22 within the clasp 430, 530. Notably, the force of pulling the implant away from the native leaflets encourages the barbs 436, 536 to further engage the tissue, thereby ensuring a better retention. Retention of the leaflets 20, 22 to the clasps 430, 530 is further improved by the location of the fixation arms 432, 532 near the barbs 436, 536 when the clasps 430, 530 are closed. In this arrangement, the tissue is forced into an S-shaped, curved path by the fixation arms 432, 532 and movable arms 434, 534, and the barbs 436, 536. Thus, forces pulling the leaflets away from the clasps 430, 530 encourage the tissue to further engage with the barbs 436, 536 before the leaflets can prolapse. For example, as described above, tension on the leaflets during diastole can urge the barbs toward the end portions of the leaflets. The S-shaped path utilizes the tension of the leaflets during diastole to allow for tighter engagement between the leaflets and the barbs.

[0138] 35-46, implantable device 500 is shown delivered and implanted within the native mitral valve MV of heart H. The methods and steps shown and / or discussed may be performed on a live animal or in a simulation, such as, for example, a cadaver, a cadaver heart, a simulator (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0139] As described above, device 500 has a cover 540 (see FIG. 30 ) over co-option element 510, clasp 530, inner paddle 522, and / or outer paddle 520. Device 500 is deployed from a delivery sheath 502 and includes a co-option portion 504 including multiple anchors 508 (i.e., two in the illustrated embodiment) and an anchor portion 506. Co-option portion 504 of the device includes a co-option 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 512. Actuation of actuation element or means 512 opens and closes the anchors 508 of device 500 to grip the mitral valve leaflets 20, 22 during implantation.

[0140] The anchor 508 of the device 500 includes an outer paddle 520 and an inner paddle 522 flexibly connected to a cap 514 and a co-option element 510. The actuation element 512 extends through the capture mechanism 503 (see FIG. 41), the delivery sheath 502, and the co-option element 510 to the cap 514, which is connected to the anchor portion 506. Extension and retraction of the actuation element 512 increase and decrease the spacing between the co-option element 510 and the cap 514, respectively. In the embodiment shown in FIGS. 35-46 , the pair of inner and outer paddles 522, 520 are moved in unison, rather than independently, by a single actuation element 512. Additionally, the position of the clasp 530 depends on the positions of the paddles 522, 520. For example, referring to FIG. 45 , closing the paddles 522, 520 also closes the clasp. In one exemplary embodiment, device 500 can be fabricated to allow paddles 520, 522 to be independently controllable in the same manner as the embodiment of FIG. 11A.

[0141] The fingers of capture mechanism 503 removably attach collar 511 to delivery sheath 502. Collar 511 and co-option element 510 slide along actuation element 512 during actuation to open or close anchor 508 of anchor portion 506. In some embodiments, capture mechanism 503 is held closed around collar 511 by actuation element 512 such that removal of actuation element 512 allows the fingers of capture mechanism 503 to release collar 511 and thus open co-option element 510.

[0142] In some embodiments, the co-option element 510 and paddles 520, 522 may be formed from a flexible material, which may be a metal fiber, such as mesh, woven, knitted, or formed in any other suitable manner, or a laser cut or otherwise cut flexible material. The flexible material may also be cloth, a wire such as Nitinol to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body. Other configurations are also possible.

[0143] The barbed clasp 530 includes a base or locking arm 532, a movable arm 534, a barb 536 (see FIG. 41 ), and a joint portion 538. The locking arm 532 is attached to the inner paddle 522, with the joint portion 538 positioned proximate to the co-option element 510. A suture (not shown) attaches the locking arm 532 to the inner paddle 522. The locking arm 532 may be attached to the inner paddle 522 and / or another portion of the device by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, a weld, an adhesive, etc. The locking arm 532 remains locked or substantially locked when the movable arm 534 opens, opening the barbed clasp 530 and exposing the barb 536. The barbed clasp 530 opens by applying tension to a clasp control member or actuation line 537 attached to the movable arm 534 , thereby causing the movable arm 534 to pivot or bend on a joint portion 538 .

[0144] During implantation, the anchor 508 is opened and closed to grip the native valve leaflet between the paddles 520, 522 and the co-option element 510. The outer paddle 520 has a wider curve that fits around the curve of the co-option element 510 to more securely grip the leaflets 20, 22. The curved shape and rounded edges of the outer paddle 520 also prevent tearing of the leaflet tissue. The barbed clasp 530 further secures the native valve leaflet by engaging the leaflet with the barbs 536 and sandwiching the leaflet between the movable and fixation arms 534, 532. The barbs 536 of the barbed clasp 530 may increase friction with the leaflet or partially or completely pierce the leaflet. The actuation wires can be separately actuated to allow each barbed clasp 530 to be opened and closed separately. The separate operation allows for one leaflet to be grasped at a time or for repositioning of the clasp 530 on a poorly grasped leaflet without altering the good grip of the other leaflet. The barbed clasp 530 can be fully opened and closed when the inner paddle 522 is not closed, thereby allowing the leaflets to be grasped in various positions as the particular situation requires.

[0145] The device 500 is loaded into the delivery sheath in the fully open or fully deployed position because the fully open or fully deployed position takes up the least amount of space, allowing the smallest catheter to be used (or the largest device 500 to be used for a given catheter size). Referring now to FIG. 35 , the delivery sheath is inserted through the septum into the left atrium LA, and the device 500 is deployed from the delivery sheath 502 in the fully open position. The actuating element 512 is then retracted to move the device 500 to the fully closed position shown in FIGS. 36-37 and then toward the mitral valve MV as shown in FIG. 38 . Referring now to FIG. 39 , when the device 500 is aligned with the mitral valve MV (or other native valve, if implanted therein), the actuating element 512 is extended to open the paddles 520, 522 to a partially open position, and the clasp control member or actuating line 537 is retracted to open the barbed clasp 530 in preparation for grasping the valve leaflets. Next, as shown in FIGS. 40-41 , the partially opened device 500 is inserted through the mitral valve MV until the leaflets 20, 22 are properly positioned between the inner paddle 522 and the co-option element 510 and inside the open barbed clasps 530. FIG. 42 shows the device 500 with both clasps 530 closed, but the barbs 536 of one clasp 530 have missed one of the leaflets 22. As can be seen in FIGS. 42-44 , the out-of-position clasp 530 is again opened and closed to properly grasp the missed leaflet 22. Once both leaflets 20, 22 are properly grasped, the actuating element 512 is retracted, moving the device 500 to the fully closed position shown in FIG. 45 . Once the device 500 is fully implanted in the native mitral valve MV, the actuating element 512 is withdrawn, releasing the capture mechanism 503 from the proximal collar 511. Once deployed, the device 500 may be maintained in a fully closed position using mechanical means such as a latch, or may remain closed through the use of a spring material such as steel and / or a shape memory alloy such as Nitinol.For example, the paddles 520, 522 may be formed from wire, sheet, tube, or laser-sintered powder-fabricated steel or Nitinol shape memory alloy and are biased to hold the outer paddle 520 closed around the inner paddle 522, the co-option element 510, and the barbed clasp 530 clamped around the native leaflets 20, 22.

[0146] The device 500 can have a wide variety of shapes and sizes. Referring to FIGS. 6 and 6A-6E, in an exemplary embodiment, the co-option element 510 functions as a gap filler within the regurgitant orifice of a valve, such as the gap 26 of a native valve shown by FIG. 6. Referring to FIG. 6A, because the co-option element 510 is deployed between two opposing leaflets 20, 22, the leaflets do not coapt against each other in the region of the co-option element 510, but instead coapt against the co-option element 510. This reduces the distance the leaflets 20, 22 must approximate. Reducing the leaflet approximation distance can provide several advantages. For example, the co-option element and the resulting reduced approximation can facilitate repair of severe mitral valve anatomy, such as large gaps in functional valve disease (see, e.g., FIG. 6). Because the co-option element 510 reduces the distance the native valve must approximate, stresses on the native valve can be reduced or minimized. A shorter approximation distance of the leaflets 20, 22 can require less approximation force, which can result in less tension on the leaflets and a smaller diameter reduction of the annulus. A smaller reduction of the annulus (or no reduction of the annulus) can result in a smaller reduction in valve orifice area compared to a device without a spacer. As a result, the co-option element 510 can reduce the transvalvular gradient.

[0147] In one exemplary embodiment, the paddle frame 524 conforms to the shape of the co-option element 510. In one example, if the co-option element 510 is wider than the paddle frame 524, a distance (gap) between the opposing leaflets 20, 22 can be created by the device 500. With reference to FIGS. 6A-6E , in one exemplary embodiment, the paddles are configured to conform to the shape or geometry of the co-option element 510. As a result, the paddles can mate with both the co-option element 510 and the native valve. With reference to FIGS. 6D and 6E , in one exemplary embodiment, the paddles 524 surround the co-option element 510. Thus, when the leaflets 20, 22 are coapted or depressed against the co-option element 510, the entire leaflets 20, 22 completely surround or "hugge" the co-option element 510, thereby preventing small leaks on the medial and lateral surfaces of the co-option element 510. Figures 6B and 6C show the valve repair device 500 attached to the native valve leaflets 20, 22 from the ventricular side of the mitral valve. Figure 6A shows the valve repair device 500 attached to the mitral valve leaflets 20, 22 from the atrial side of the mitral valve. Referring to Figures 6A and 6B, when the paddles have a geometry that matches the geometry of the co-option element 510, the leaflets 20, 22 can coapt around the co-option element and / or along the length of the spacer. Referring to Figure 6E, a schematic atrial / surgeon view shows the paddle frame (not actually visible in the true atrial view) conforming to the spacer shape. The opposing leaflets 20, 22 (both ends of which are also not visible in the true atrial view) are approximated by the paddles to completely surround or "hug" the co-option element 510.

[0148] 6B-6E, because the paddle frame 524 conforms to the shape of the co-option element 510, the leaflets 20, 22 can be coapted by the paddle frame 524 to completely surround the co-option element, including on the medial and lateral surfaces 601, 603 of the co-option element 510. This co-option of the leaflets 20, 22 against the medial and lateral surfaces of the co-option element 510 seems to contradict the above statement that the presence of the co-option element 510 minimizes the distance the leaflets need to approximate. However, if the co-option element 510 is precisely positioned in the regurgitation gap, and the regurgitation gap is smaller than the width (medial surface minus lateral surface) of the co-option element 510, the distance the leaflets 20, 22 need to approximate is still minimized.

[0149] 6A and 6E, the co-option element 510 can take on a wide variety of different shapes. In one exemplary embodiment, when viewed from the top (and / or cross-sectional views from the top, see FIGS. 95-102), the co-option element has an oval or elliptical shape. The oval or elliptical shape can allow the paddle frame 524 to conform to the shape of the co-option element and / or can reduce lateral leakage (see FIGS. 65-83).

[0150] As described above, the co-option element 510 can reduce tension on the opposing leaflets by reducing the distance the leaflets need to approach the co-option element 510 at locations 601, 603. Reducing the distance of leaflet proximity at locations 601, 603 can result in reduced leaflet stress and gradients. Furthermore, as also described above, the native leaflets 20, 22 can surround or "hug" the co-option element to prevent lateral leakage. In one exemplary embodiment, the geometric features of the co-option element can be designed to preserve and enhance these two features of the device 500. Referring to FIG. 2A , when viewed from the left ventricular outflow tract (LVOT) view, the anatomy of the leaflets 20, 22 is such that the medial sides of the leaflets coapt at their free end portions and the leaflets 20, 22 begin to retract or splay away from each other. The leaflets 20, 22 splay away toward the atrium until each leaflet contacts the mitral annulus.

[0151] In one exemplary embodiment, the valve repair device 500 and its co-option element 510 are designed to match the geometric anatomy of the valve leaflets 20, 22. To achieve valve sealing, the valve repair device 500 can be designed to coapt the native valve to the co-option element, completely surrounding the co-option element, including the inner and outer locations 601, 603 of the co-option element 510. Furthermore, reducing the force required to contact the leaflets with the co-option element 510 at locations 601, 603 can minimize leaflet stresses and gradients. Figure 2B shows how the tapered or triangular shape of the co-option element 510 naturally matches the native valve geometry and its dilated leaflet nature (toward the annulus).

[0152] FIG. 6D shows the geometry of the co-option element 510 and paddle frame 524 from the perspective of the LVOT. As can be seen in this figure, the co-option element 510 has a tapered shape, with smaller dimensions in the region closer to where the inner surfaces of the leaflets 20, 22 need to coapt and increasing dimensions as the co-option element extends toward the atrium. The illustrated geometry of the native valve is accommodated by the tapered co-option element geometry. Further referring to FIG. 6D, the tapered co-option element geometry, in conjunction with the illustrated expanded (toward the annulus) shape of the paddle frame 524, can help achieve co-apposition at the lower ends of the leaflets, reduce stress, and minimize transvalvular gradients.

[0153] Referring to FIG. 6C , in one exemplary embodiment, the remaining shapes of the co-option element 510 and paddle frame 524 can be defined based on a view of the native valve and the medial commissure of the device 500. Two factors contribute to these shapes: leaflet co-aptation relative to the co-option element 510 and reduced stress on the leaflets due to the co-aptation. Referring to FIGS. 6C and 67 , the co-aptation element 510 can have a rounded or curled shape, and the paddle frame 524 can have a full radius extending from one paddle leg to the other, to coapt the leaflets 20, 22 relative to the co-aptation element 510 and reduce the stress applied to the leaflets 20, 22 by the co-aptation element 510 and / or paddle 524. The circular shape of the co-aptation element and / or the fully rounded shape of the paddle frame shown distributes stress on the leaflets 20, 22 over a large, curved engagement area 607. For example, in FIG. 6C, the force on the leaflets 20, 22 by the paddle frame is spread along the entire rounded length of the paddle frame 524 as the leaflets 20 attempt to open during diastole.

[0154] 67, in one exemplary embodiment, the shape of the co-option element 510 in the medial commissure nerve view follows a rounded shape to cooperate with the fully rounded shape of the paddle frame 524 and / or to maximize leaflet co-aptation to the co-option element 510 and leaflet-to-leaflet co-aptation at the sides 601, 603 of the co-option element 510. Referring to FIG. 67, the rounded shape of the co-option element in this view substantially follows or approximates the shape of the paddle frame 524.

[0155] In one exemplary embodiment, the overall shape of the co-option element 510 is an elliptical or oval cross-section when viewed from the surgeon's view (top view - see FIG. 70), a tapered shape or cross-section when viewed from the LVOT view (side view - see FIG. 69), and a substantially rounded or rounded shape when viewed from the medial commissure nerve view (see FIG. 68). In one exemplary embodiment, a blend of these three geometries may result in the three-dimensional shape of the illustrated co-option element 510 that achieves the benefits discussed above.

[0156] In one exemplary embodiment, the dimensions of the co-option element are selected to minimize the number of implants (preferably one) required by a single patient while simultaneously maintaining a low transvalvular gradient. In one exemplary embodiment, the anterior-posterior distance X47B at the top of the spacer is approximately 5 mm, and the medial-lateral distance X67D at its widest point is approximately 10 mm. In one exemplary embodiment, the overall geometry of device 500 may be based on these two dimensions and the overall shape strategy described above. It is readily apparent that using other anterior-posterior distances X47B and medial-lateral distances X67D as a starting point for the device will result in devices with different dimensions. Furthermore, using other dimension and shape strategies described above will also result in devices with different dimensions.

[0157] Tables A, B, and C provide example values ​​and ranges of device dimensions and device components for some example embodiments. However, devices can have a wide variety of different shapes and sizes and need not have all or any of the dimensional values ​​or dimensional ranges provided in Tables A, B, and C. Table A provides example linear dimensions X in millimeters and ranges of linear dimensions in millimeters for devices and device components. Table B provides example radial dimensions R in millimeters and ranges of radial dimensions in millimeters for devices and device components. Table C provides example angular dimensions α (degrees) and ranges of angular dimensions (degrees) for devices and device components. The subscript for each dimension indicates the drawing in which the dimension first appears. [Table 1] [Table 2] [Table 3]

[0158] 47-61 , implantable device 500 is shown in various positions and configurations. Implantable device 500 may include any other features of implantable prosthetic devices discussed herein, and device 500 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0159] The implantable device 500 has a proximal or attachment portion 505, a co-option element (e.g., a spacer, etc.) 510, an inner anchor portion or inner paddle 522, an outer anchor portion or outer paddle 520, an anchor extension member or paddle frame 524, and a distal portion 507. The inner paddle 522 is attached (e.g., articulably attached, etc.) between the co-option element 510 and the outer paddle 520. The outer paddle 520 is attached (e.g., articulably attached, etc.) between the inner paddle 522 and the distal portion 507. The paddle frame 524 is attached to the cap 514 at the distal portion 507 and extends to a joint portion 523 between the inner and outer paddles 522, 520. In some embodiments, the paddle frame 524 is formed of a material that is stiffer and more rigid than the material forming the paddles 522, 520, such that the paddle frame 524 provides support for the paddles 522, 520. In one exemplary embodiment, the inner paddle 522 is hard, relatively stiff, rigid, has rigid portions, and / or is reinforced by a reinforcing member or fixed portion of the clasp 530. The reinforcement of the inner paddle allows the device to move to a variety of different positions as shown and described herein. The inner paddle 522, outer paddle 520, and co-option may all be interconnected as described herein, thereby constraining the device 500 to the movements and positions as shown and described herein.

[0160] 47-48, device 500 is shown in a partially open position. When closed, inner paddle 522 is disposed between outer paddle 520 and co-option element 510. In some embodiments, device 500 includes a clasp or grasping member 530 (FIG. 48) that can be opened and closed to grasp the native leaflets 20, 22 of the mitral valve MV. Clasp 530 is attached to and moves with inner paddle 522, and is disposed between inner paddle 522 and co-option element 510.

[0161] 49-51 , device 500 is shown in a partially open position. Device 500 can be moved to the partially open position by an actuating element or means 512 passing through attachment portion 505 and co-option element 510 to releasably engage distal portion 507. Actuating element 512 is extended through attachment portion 505 such that as actuating element 512 extends, distance D between attachment portion 505 and distal portion 507 increases. In the embodiment shown by FIGS. 49-51 , the pair of inner and outer paddles 522, 520 move in unison, rather than independently, via a single actuating wire 512. Additionally, the position of clasp 530 depends on the position of paddles 522, 520. For example, referring to FIG. 48 , closing of paddles 522, 520 also closes the clasp. In one exemplary embodiment, device 500 can be fabricated to allow paddles 520, 522 to be independently controllable in the same manner as the embodiment of FIG. 11A.

[0162] The extension of the actuation element 512 pulls down the bottom portions of the outer paddle 520 and paddle frame 524. The outer paddle 520 and paddle frame 524 pull down the inner paddle 522, which is connected to the outer paddle 520 and paddle frame 524. Because the attachment portion 505 and co-option element 510 are held in place, the inner paddle 522 is bent or pivoted toward the opening. The inner paddle 522, outer paddle 520, and paddle frame all bend to the position shown in FIG. 49. The opening of the paddles 522, 520, and frame 524 creates a gap 520A between the co-option element 510 and the inner paddle 522 that can receive and grasp the native valve leaflet 20.

[0163] As described above, some embodiments of the device 500 include a clasp or grasping member 530. When the device 500 is partially open, the clasp 530 is exposed. In some embodiments, the closed clasp 530 (FIG. 50) can be opened (FIG. 51), thereby creating a second opening or gap 530A for receiving and capturing the native valve leaflets 20, 22. The extent of the gap 530A in the clasp 530 is limited to the extent that the inner paddle 522 extends away from the co-option element 510.

[0164] 52-54, the device 500 is shown in a laterally extended or open position. The device 500 moves to the laterally extended or open position by continuing to extend the actuating element 512, thereby increasing the distance D between the mounting portion 505 and the distal portion 507. Continuing to extend the actuating element 512 pulls down the outer paddle 520 and paddle frame 524, thereby causing the inner paddle 522 to spread further away from the co-option element 510. In the laterally extended or open position, the inner paddle 522 extends more horizontally than in other positions of the device 500, forming an approximately 90-degree angle with the co-option element 510. Similarly, the paddle frame 524 is in its maximum spread position when the device 500 is in the laterally extended or open position. The increased gap 520A formed in the lateral extension or open position allows the clasp 530 to open further before engaging the co-option element 510 (FIG. 54), thereby increasing the size of the gap 530A.

[0165] 55-57, the device 500 is shown in a three-quarters extended position. The device 500 moves to the three-quarters extended position by continuing to extend the actuation element 512, thereby increasing the distance D between the mounting portion 505 and the distal portion 507. Continuing to extend the actuation element 512 pulls down on the outer paddle 520 and paddle frame 524, thereby causing the inner paddle 522 to spread further away from the co-option element 510. In the three-quarters extended position, the inner paddle 522 opens to an angle of more than 90 degrees to approximately 135 degrees from the co-option element 510. The paddle frame 524 spreads less than in the laterally extended or open position and begins to move inward toward the actuation element 512 as the actuation element 512 extends further. The outer paddle 520 also bends backward 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 the clasp 530 to open further (FIG. 57), thereby increasing the size of the gap 530A.

[0166] Referring now to FIG. 58 , the device 500 is shown in a nearly fully extended position. The device 500 moves to the nearly fully extended position by continuing to extend the actuation element 512, thereby increasing the distance D between the mounting portion 505 and the distal portion 507. Continued extension of the actuation element 512 pulls down on the outer paddle 520 and paddle frame 524, thereby causing the inner paddle 522 to spread further away from the co-option element 510. In the nearly fully extended position, the inner paddle 522 approaches an angle of approximately 180 degrees with the co-option element 510. While the inner paddle moves to this position, the outer paddle 520 and paddle frame 524 do not move or bend to or beyond a 90-degree angle relative to the co-option element 510. In the nearly fully extended position, the inner paddle 522 and outer paddle 520 may have a slightly curved shape.

[0167] 59-61, the device 500 is shown in a fully extended position. The device 500 moves to the fully extended position by continuing to extend the actuation element 512, thereby increasing the distance D between the mounting portion 505 and the distal portion 507 to the maximum distance allowed by the device 500. Continuing to extend the actuation element 512 pulls down the outer paddle 520 and paddle frame 524, thereby causing the inner paddle 522 to spread further away from the co-option element 510. The outer paddle 520 and paddle frame 524 are moved to a position where they are closer to the actuation element. In the fully extended position, the inner paddle 522 opens at approximately a 180-degree angle with the co-option element 510. The inner paddle 522 and outer paddle 520 are straightened out in the fully extended position, forming an approximately 180-degree angle between the paddles 522, 520. The fully extended position of device 500 provides the largest size of gap 520A between the paddles and, in some embodiments, also allows clasp 530 to fully open to approximately 180 degrees between portions of clasp 530 ( FIG. 61 ). The fully extended position of device 500 is in its narrowest configuration. Thus, the fully extended position of device 500 may be the desired position for bailout of device 500 from an attempted implantation, or may be the desired position for placement of the device into a delivery catheter, etc.

[0168] 47A, 48A-48H, 53A-53C, 54A-54D, 60A-60D, and 61A-61D, implantable device 500A is shown in various positions and configurations. Implantable device 500A may include any other features of implantable prosthetic devices discussed herein, and device 500A may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0169] Implantable device 500A has a proximal or attachment portion 505A, a co-option element 510A, an inner anchor portion or inner paddle 522A, an outer anchor portion or outer paddle 520A, an anchor extension member or paddle frame 524A, and a distal portion 507A. The inner paddle 522A is attached (e.g., articulably attached, etc.) between co-option element 510A, for example, by joint portion 525A, and the outer paddle 520A, for example, by joint portion 523A. The outer paddle 520A is attached (e.g., articulably attached, etc.) between the inner paddle 522A, for example, by joint portion 523A, and the distal portion 507A, for example, by joint portion 521A. The paddle frame 524A is attached to the cap 514A at its distal portion 507A (FIG. 48A) and extends to a joint portion 523A between the inner and outer paddles 522A, 520A. In some embodiments, the paddle frame 524A is formed of a material that is stiffer and more rigid than the material forming the paddles 522A, 520A, such that the paddle frame 524A provides support for the paddles 522A, 520A. The paddle frame 524A includes an opening or slot 524B for receiving the joint portion 523A (FIG. 65A). In some embodiments, the inner paddle 522A is hard, relatively rigid, rigid, has a rigid portion, and / or is reinforced by a secure portion of a reinforcing member or clasp 530C. The reinforcement of the inner paddle allows the device to move to the various different positions shown and described herein. The inner paddle 522A, outer paddle 520A, and co-option element may all be interconnected as described herein, thereby constraining the device 500A to the movements and positions shown and described herein.

[0170] The co-option element 510A, inner paddle 522A, and outer paddle 520A may be attached together by integrally forming the co-option element 510A and paddles 520A, 522A as a single, unitary component. This may be accomplished, for example, by forming the co-option element 510A and paddles 520A, 522A from a continuous strip 501A of knitted or woven material, such as knitted or woven nitinol wire.

[0171] The continuous strip 501A is attached to the collar 511D, cap 514A, paddle frame 524A, and clasp 530C. In the illustrated embodiment, the co-option element 510A, hinge portions 521A, 523A, 525A, outer paddle 520A, and inner paddle 522A are formed from the continuous strip 501A. The continuous strip 501A may be a single layer of material or may include two or more layers. In certain embodiments, some portions of the device 500A have a single layer of the strip of material 501A, while other portions are formed from multiple overlapping or overlapping layers of the strip of material 501A. For example, FIG. 47A shows the co-option element 510A and inner paddle 522A formed from multiple overlapping or overlapping layers of the strip of material 501A. As a result, the co-option element 510A and inner paddle 522A have increased stiffness compared to the outer paddle 520A formed from a single layer of material 501A. The single continuous strip of material 501A can start and end at various locations on the device 500A. The ends of the strip of material 501A can be at the same or different locations on the device 500A. For example, in the illustrated embodiment of FIG. 47A , the strip of material starts and ends at the inner paddle 522.

[0172] The clasp 530C can include an attachment or fixation portion 532C, an arm or movable portion 534C, a barb 536C, and a joint portion 538C. The attachment or fixation portion 532C can be coupled to the inner paddle 522A in a variety of manners, such as with sutures, adhesives, fasteners, welding, stitching, swaging, a friction fit, and / or other means for coupling with the joint portion 538C disposed adjacent to the co-option element 510A. The clasp 530C can be similar to the clasp 430.

[0173] The movable portion 534C can pivot or bend relative to the fixed portion 532C between an open configuration (e.g., FIG. 54A) and a closed configuration ( FIG. 48A). In some embodiments, the clasp 530C can be biased toward the closed configuration. In the open configuration, the fixed portion 532C and the movable portion 534C pivot or bend away from each other so that the native valve leaflets can be positioned between the fixed portion 532C and the movable portion 534C. In the closed configuration, the fixed portion 532C and the movable portion 534C pivot or bend toward each other, thereby clamping the native valve leaflets between the fixed portion 532C and the movable portion 534C. The fixed arm 532C remains fixed or substantially fixed when the movable arm 534C opens, opening the barbed clasp 530C and exposing the barb 536C. The barbed clasp 530C opens by applying tension to an actuation line 537A attached to the movable arm 534C, thereby causing the movable arm 534C to pivot or bend on a joint portion 538C.

[0174] 47A and 48A-48H, device 500A is shown in a closed position. Device 500A is shown in side views in FIGS. 48B, 48C, and 48F, front views in FIGS. 48D, 48E, and 48G, and a bottom view in FIG. 48H. Device 500A is narrower when viewed from the front than from the side. From the side, device 500A has a generally inverted trapezoidal shape that is rounded and tapered toward distal portion 507A of device 500A. From the front, device 500A has a generally rounded rectangular shape that tapers slightly toward distal portion 507A. As can be seen from the bottom view of device 500A shown in FIG. 48H, device 500A has a generally rounded rectangular shape when viewed from below (and when viewed from above, for example, as seen in FIG. 70A).

[0175] In the closed configuration of device 500A, inner paddle 522A is positioned between outer paddle 520A and co-option element 510A. In some embodiments, device 500A includes a clasp or grasping member 530C (FIG. 48A) that can be opened and closed to grasp the native leaflets 20, 22 of the mitral valve MV. Clasp 530C is attached to and moves with inner paddle 522A and is positioned between inner paddle 522A and co-option element 510A.

[0176] 48B-48D, device 500A is shown attached to delivery device 502A. Delivery device 502A has an actuable member or finger 503A that releasably engages attachment portion 505A. Actuating element 512A extends from delivery device 502A to cap 514A, through attachment portion 505A and co-option element 510A of prosthetic device 500A. Extending and retracting actuating element 512A opens and closes device 500A, as described below. Actuating line / suture 537A extends from delivery device 502A and is attached to clasp 530C. Tension can be applied to suture 537A to open clasp 530C, releasing it so that clasp 530C can be closed. Device 500A is shown in a deployed state in FIGS. 48F-48G, separated from delivery device 502A.

[0177] Referring now to Figures 48C and 48E, device 500A is shown with cover 540A. Cover 540A may be formed from a single piece of material or from multiple segments adjacent or joined to one another. In the illustrated embodiment, cover 540A has an outer or lower cover 541A and an inner or upper cover 543A. Outer cover 541A covers cap 514A, outer paddle 520A, inner paddle 522A, and clasp 530C. Inner cover 543A covers co-option element 510A, the proximal end of inner paddle 522A, and clasp 530C where co-option element 510A meets inner paddle 522A and clasp 530C. Cover 540A may be a cloth material, such as a fine-mesh polyethylene cloth. The cloth cover can provide a blood seal over the surface of the spacer and / or promote rapid tissue ingrowth.

[0178] 53A-53D and 54A-54D, device 500A is shown in a laterally extended or open position. Device 500A can be moved to the open position by an actuating element or means 512A passing through attachment portion 505A and co-option element 510A to releasably engage distal portion 507A. Actuating element 512A is extended through attachment portion 505A such that distance D2 between attachment portion 505A and distal portion 507A increases as actuating element 512A extends. In the embodiment shown in FIGS. 53A-53D and 54A-54D, the pair of inner and outer paddles 520A, 522A are moved in unison, rather than independently, by a single actuating element 512A. Additionally, the position of clasp 530C depends on the positions of paddles 520A, 522A. For example, referring to Figure 48A, closure of paddles 520A, 522A also closes clasp 530C. In one exemplary embodiment, device 500A can be made to allow paddles 520A, 522A to be independently controllable in the same manner as the embodiment of Figure 11A.

[0179] The extension of the actuation element 512A pulls down the bottom portions of the outer paddle 520A and paddle frame 524A, transitioning the device 500A from the closed position to the partially open position. The outer paddle 520A and paddle frame 524A pull down the inner paddle 522A, which connects to the outer paddle 520A and paddle frame 524A. Because the attachment portion 505A and co-option element 510A are held in place, the inner paddle 522A pivots or bends toward the opening. The inner paddle 522A, outer paddle 520A, and paddle frame all bend to the position shown in FIG. 53A . The release of the paddles 522A, 520A, and frame 524 creates a gap 520D between the co-option element 510A and the inner paddle 522A that can receive and grasp the native valve leaflet 20.

[0180] Continued extension of actuation element 512A pulls outer paddle 520A and paddle frame 524A down, thereby causing inner paddle 522A to spread further away from co-option element 510A. In the laterally extended or open position, inner paddle 522A extends more horizontally than in other positions of device 500A, forming an approximately 90-degree angle with co-option element 510A. Similarly, paddle frames 524A are at their widest position when device 500A is in the laterally extended or open position. The increased gap 520D formed in the laterally extended or open position allows clasp 530C to open further before engaging co-option element 510A ( FIG. 54A ), thereby increasing the size of gap 530D compared to the partially open position.

[0181] As described above, some embodiments of device 500A include a clasp or grasping member 530C. When device 500A is open, clasp 530C is exposed. In some embodiments, closed clasp 530C (FIGS. 53A-53D) can be opened (FIGS. 54A-54D), thereby creating a second opening or gap 530D for receiving and capturing native valve leaflets 20, 22. The extent of gap 530D in clasp 530C is limited to the extent that inner paddle 522A extends away from co-option element 510A.

[0182] 60A-60D and 61A-61D, the device 500A is shown in a fully extended position. The device 500A moves to the fully extended position by continuing to extend the actuation element 512A, thereby increasing the distance D2 between the mounting portion 505A and the distal portion 507A to the maximum distance allowed by the device 500A. Continuing to extend the actuation element 512A pulls down the outer paddle 520A and paddle frame 524A, thereby extending the inner paddle 522A further away from the co-option element 510A. The outer paddle 520A and paddle frame 524A move to a position where they are closer to the actuation element. In the fully extended position, the inner paddle 522A opens approximately 180 degrees from the co-option element 510A. In the fully extended position, the inner paddle 522A and the outer paddle 520A are straight or substantially straight, forming an angle of approximately 180 degrees between the paddles 522A, 520A. The fully extended position of the device 500A provides the largest size of the gap 520D between the paddles and, in some embodiments, also allows the clasp 530C to fully open to approximately 180 degrees between portions of the clasp 530C (FIG. 61A). The position of the device 500A is its narrowest configuration. Thus, the fully extended position of the device 500A may be the desired position for bailout of the device 500A from an attempted implantation or for placement of the device into a delivery catheter, etc.

[0183] 197-198, an enlarged view of a portion of FIG. 60C is shown. Referring now to FIG. 197, an inner cover 543A can be seen covering the co-option element 510A from the proximal portion 519B to the distal portion 517A. In some embodiments, the inner cover 543A is formed from a flat sheet of cloth material (see FIG. 201), such as a fine-mesh polyethylene cloth, which is folded around the co-option element 510A and held in place by stitching 545A. Referring now to FIG. 198, the outer cover 541A can be seen covering the clasp 530C and inner paddle 522A. A collar portion 548A of the inner cover 543A covers the portion of the clasp 530C and inner paddle 522A closest to the co-option element 510A. A transition portion 547A of the inner cover 543A extends from the co-option element 510A to the collar portion 548A to provide a smooth transition between the co-option element 510A and the clasp 530C and inner paddle 522A to prevent natural tissue from catching on the device 500A during implantation.

[0184] Referring now to FIG. 199, an exploded view of device 500A is shown. Coupling element 510A, outer paddle 520A, and inner paddle 522A are formed from a single strip of material 501A, as described above. Collar 511D, cap 514A, paddle frame 524A, and clasp 530C are assembled to strip 501A to form device 500A. Cap 514A includes a retaining body 560A having a locking aperture 561A for receiving a retaining nut 562A having a threaded hole 564A that engages with a threaded portion 568A of a retaining bolt 566A. The threaded portion 568A of retaining bolt 566A is inserted through opening 527B to engage the retaining body and nut 560A, 562A, attaching cap 514A to strip 501A.

[0185] In some embodiments, the reinforcing member 539C is attached to the inner paddle 522A to reinforce the inner paddle 522A and maintain the inner paddle in a straight or substantially straight configuration as the inner paddle is moved between various positions. The cutout 539D of the reinforcing member 539C is shaped to receive the locking arm 532C of the clasp 530C such that the reinforcing member 539C can fit around the locking arm 532C when both the reinforcing member 539C and the clasp 530C are attached to the inner paddle 522A. Similar to the locking arm 532C, the reinforcing member 539C can be connected to the inner paddle 522A in various manners, such as with sutures, adhesives, fasteners, welding, stitching, swaging, a friction fit, and / or other connection means.

[0186] Referring now to FIG. 200, an enlarged view of a collar 511D attached to the proximal portion 519B of the co-option 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 co-option element 510A flares outward to form two loops 519D, which are inserted through arcuate openings 513A in the collar 511D to attach the collar 511D to the proximal portion 519B of the co-option element 510A. The loops 519D are formed by folding a strip of material 501A to form a first layer 581A and a second layer 582A.

[0187] 201-202, which show close-up and exploded views, respectively, of cap 514A. FIG. 201 shows a close-up view of cap 514A attached to distal portion 527A of strip of material 501A. Retaining body 560A, retaining nut 562A, and retaining bolt 566A cooperate to attach paddle frame 524A to distal portion 527A of strip of material 501A. In particular, retaining bolt 566A is inserted through opening 527B in distal portion 527A (FIG. 202) to prevent movement of cap 514A along strip of material 501A. Channel 560B of retaining body 560A and flange 567A of bolt 566A form passageway 514B through cap 514A in distal portion 527A.

[0188] 202, the components of cap 514A are shown in an exploded view to better illustrate the component features of cap 514A and paddle frame 524A and how those features interlock during assembly of cap 514A into distal portion 527A. Forming cap 514A from multiple components that can be assembled around strip of material 501A allows cap 514A to be attached after strip of material 501A is folded to form co-option element 510A and paddles 520A, 522A and woven through collar 511D and paddle frame 524A.

[0189] The retention body 560A includes a locking aperture 561A for receiving a retention nut 562A. The locking aperture 561A has a generally rectangular shape and includes two opposing locking channels 561B that receive the mounting portion 524C of the paddle frame 524A. A lateral locking channel 561C formed in the bottom of the retention body 560A has the same width as the locking channels 561B. The paddle frame 524A includes a notch 524D in the mounting portion 524C that engages with the lateral locking channels 561C to form a hook portion 524E that secures the paddle frame 524A to the cap 514A.

[0190] The retention 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 channel 561B unobstructed. Thus, the locking body 563A can be inserted into the locking aperture 561A to lock the mounting portion 524C of the paddle frame 524A within the locking channel 561B. The notch 563C in the flange 563B accommodates the mounting portion 524C of the paddle frame 524A. A threaded hole 564A is formed through the retention nut 562A to receive the retention bolt 566A.

[0191] Retaining bolt 566A includes a threaded portion 568A extending from flange 567A. Threaded portion 568A is inserted through opening 527B in distal portion 527A for threaded engagement with threaded hole 564A of retaining nut 562A. Flange 567A has a rounded shape that provides a rounded end to distal portion 507A of device 500A. Flange 567A includes opening 567B for receiving a tool (not shown) that engages bolt 566A so that bolt 566A can be turned during assembly to couple the components of cap 514A together.

[0192] To assemble paddle frame 524A and cap 514A to distal portion 527A, paddle frame 524A is compressed to narrow mounting portion 524C so that mounting portion 524C can be inserted into locking channel 561B of locking aperture 561A. When paddle frame 524A is allowed to expand, mounting portion 524C expands outward so that notch 524D engages retention body 560A and hook portion 524E engages lateral locking channel 561C. Retention nut 562A is then inserted into locking aperture 561A with locking portion 563A disposed between the two mounting portions 524C of each paddle frame 524A, thereby locking paddle frame 524A into engagement with retention body 560A. The assembled paddle frame 524A, retention body 560A, and retention nut 562A are placed on distal portion 527A such that threaded hole 564A aligns with opening 527B and threaded portion 568A of bolt 566A is inserted through opening 527B and threadingly engages threaded hole 564A. Bolt 566A is then tightened until flange 567A engages retention body 560A and cap 514A is securely assembled to distal portion 527A.

[0193] 203 and 204, a portion of cover 540A is shown cut from a flat sheet of material. Cover 540A includes an outer cover 541A and an inner cover 543A. Each of covers 541A, 543A includes differently shaped segments or portions for attachment to different portions of device 500A. In particular, covers 541A, 543A are shaped to smooth the transitions between portions of device 500A, reducing catch points and providing a smoother exterior to device 500A.

[0194] The various segments of the covers 541A, 543A extend from a central portion molded to attach to the ends of the device 500A. In other embodiments, the portions of the covers 541A, 543A that attach to the ends of the device 500A can be located at the ends of the covers 541A, 543A, or anywhere between the central and end portions of the covers 541A, 543A. The various portions of the covers 541A, 543A can be molded to encase portions of the device 500A. The cover 540A can be made of any suitable material, such as a fine mesh polyethylene cloth. In certain embodiments, the cover is formed from a single piece of material. In other embodiments, the cover can be formed from any number of pieces of material that are attached to the device and / or joined together by any suitable means, such as stitching, adhesive, welding, etc.

[0195] 60C and 204, outer cover 541A extends outwardly from central portion 580 to end portions 588. Central portion 580 is shaped to attach to cap 514A of device 500A. Outer paddle portion 582 extends from central portion 580 to inner paddle and inner clasp portion 584. Inner paddle and inner clasp portion 584 extend from outer paddle portion 582 to outer movable clasp portion 586. Outer movable clasp portion 586 extends from inner paddle portion 584 to end portion 588.

[0196] The outer paddle portion 582 includes wing portions 583 extending laterally to a width wider than the remainder of the outer cover 541A so that the outer paddle portion 582 can be attached to the outer paddle 520A and paddle frame 524A of the device 500A. The inner paddle portion 584 is attached to the inner paddle 522A, the fixed arm 532C, and the inner surface (barbed side) of the movable arm 534C. The outer clasp portion 586 is attached to the outer surface (non-barbed side) of the movable arm 534C of the clasp 530C. An end 588 of the outer cover 541A terminates near the outer joint portion 538C of the clasp 530C. The inner paddle and inner clasp portion 584 include openings 585 that allow the barbs 536C of the clasp 530C to protrude through the outer cover 541A and engage tissue of the native heart valve.

[0197] Referring to FIG. 60C and FIG. 203 , inner cover 543A extends outward from central portion 590 to end portion 598. Central portion 590 is configured to attach to collar 511D of device 500A. Opening 591 in central portion 590 exposes protrusion 511E from collar 511D when central portion 590 is attached to collar 511D so that protrusion 511E can be engaged by delivery device 502A. Coroption portions 592 extend from central portion 590 to flexible hinge portions 594. Holes 593 along the edges of coroption portions 592 allow each of coroption portions 592 to be joined together after being folded around coroption element 510A, such as by stitches 545A. Flexible hinge portion 594 extends from coroption portion 592 to transition portion 596. Transition portions 596 extend from flexible hinge portions 594 to end portions 598. Holes 597 along the edges of transition portions 596 allow each of transition portions 596 to be wrapped around the ends of inner paddle 522A and clasp 530C and secured to itself by stitching or other suitable fastening means. Flexible hinge portions 594 bridge the gap between co-option element 510A and clasp 530C when device 500A is opened, as seen in FIG. 198.

[0198] 62A-64C, an implantable device 700 is shown. The implantable device 700 has a paddle 702 that opens and closes to grip the valve leaflets 20, 22 against a barbed clasp or grasping device 704. The paddle 702 moves to form an opening 706 between the paddle 702 and the grasping device 704, where the valve leaflets 20, 22 can be grasped. The device 700 can be configured to close the wide gap 26 ( FIG. 6 ) between the native heart valves MV and TV. Additionally, the implantable device 700 can include any other features of the devices discussed herein, and the device 700 can be positioned to engage the valve leaflets 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein). Device 700 may include any other features associated with implantable prosthetic devices discussed herein, and device 700 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein).

[0199] 62A, paddle 702 of device 700 is moved, rotated, or pivoted outward in the X direction to form an opening 706 between paddle 702 and gripping member 704 having a width W. Width W can be, for example, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In alternative embodiments, width W can be less than 5 mm or greater than 15 mm.

[0200] Referring to FIG. 62B , the paddle 702 of the device 700 moves outward in the Z direction such that the opening 706 has a width H. The width H can be, for example, about 10 mm to about 25 mm, such as about 10 mm to about 20 mm, such as about 12.5 mm to about 17.5 mm, or about 15 mm. In some embodiments, the width H can be less than 10 mm or greater than 25 mm. In certain embodiments, the ratio between the width H and the width W can be about 5 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, or about 1 to 1. The device 700 can be configured such that the paddle 702 moves, rotates, or pivots outward in the X direction and then moves outward in the Z direction to create an opening 706 having a width H between the paddle 702 and the gripping member 704. Optionally, device 700 may be configured such that the paddle moves outward in the Z direction and then moves or pivots outward in the X direction to create width H between paddle 702 and gripping member 704. Additionally, device 700 may be configured such that paddle 702 moves or pivots outward in direction X and simultaneously moves outward in direction Z to create width H between paddle 702 and gripping member 704.

[0201] 63A-63C show the implantable device 700 with the paddles 702 moved, rotated, or pivoted outward in the X direction and then moved outward in the Z direction to create a wider opening 706. FIG. 63A shows the implantable device 700 in a closed position such that the paddles 702 engage the gripping members 704. With reference to FIG. 63B, the paddles 702 move or pivot outward in the X direction to create the opening 706 having a width W for receiving the valve tissue. With reference to FIG. 63C, after the paddles 702 move or pivot outward in the X direction, the paddles 702 move outward in the Z direction such that the opening 706 has a width H. After the valve tissue is received in the opening 706 between the paddles 702 and the gripping members 704, the valve repair device is returned to the closed position (as shown in FIG. 63A) to secure the valve repair device 700 to the valve tissue. The implantable device 700 may include any other features of implantable devices discussed in this application, and the implantable device 700 may be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0202] 64A-64C show the implantable device 700 with the paddles 702 moved outward in the Z direction and then moved, extended, or pivoted outward in the X direction to create a wider opening 706. FIG. 64A shows the implantable device 700 in a closed position such that the paddles 702 engage the gripping members 704. With reference to FIG. 64B, the paddles 702 move outward in direction Z to create an opening 706 having a width W for receiving the valve tissue. With reference to FIG. 64C, after the paddles 702 move outward in direction Z, the paddles 702 move or pivot outward in direction X such that the opening 706 has a width H. After the valve tissue is received in the opening 706 between the paddles 702 and the gripping members 704, the implantable device 700 is returned to the closed position (as shown in FIG. 64A ) to secure the implantable device 700 to the valve tissue. The implantable device 700 may include any other features of implantable devices discussed in this application, and the implantable device 700 may be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0203] While Figures 63A-63C show device 700 in which paddles 702 move or pivot and then spread apart, and Figures 64A-64C show device 700 in which paddles 702 spread apart and then move or pivot, in alternative embodiments, device 700 can include paddles 702 that can spread apart and move or pivot simultaneously. Furthermore, in certain embodiments, paddles 702 can spread apart and move or pivot independently of one another. That is, in the embodiments of valve repair device 700 shown in Figures 63A-63C and 64A-64C, as well as in embodiments in which the spreading and movement or pivoting of each paddle 702 is completed simultaneously, paddles 702 can be controlled independently of one another.

[0204] 65-83, an exemplary implantable device 500 is shown in a closed state. Referring now to FIGS. 65-66, device 500 extends from a proximal portion 505 to a distal portion 507 and includes a co-option portion 510, an inner paddle 522, an outer paddle 520, and a paddle frame 524. In some embodiments, outer paddle 520 extends toward and / or around paddle frame 524 and can have multiple layers to surround paddle frame 524. Proximal portion 505 can include a collar 511 for attaching a delivery device (not shown). Distal portion 507 can include a cap 514 that is attached (e.g., articulably attached, etc.) to outer paddle 520 and engaged by an actuation element (not shown) to open and close device 500 to facilitate implantation into a native valve as described herein.

[0205] 67-68, a front view of device 500 is shown. Device 500 is symmetrical or substantially symmetrical about a vertical front-to-back plane 550 and has a generally narrower shape at distal portion 507 than at proximal portion 505. The shapes of co-option element 510 and paddle frame 524 are rounded or generally rounded to prevent device 500 from catching or snagging on cardiac structures, such as chordae tendineae, during implantation. For this reason, proximal collar 511 (FIG. 68) and cap 514 (FIG. 68) also have rounded edges. When viewed from the anterior or posterior, paddle frame 524 can be seen to have a rounded or generally rounded shape extending upward and outward from distal portion 507 to generally match the shape of co-option element 510 when viewed from the anterior or posterior. Thus, the co-option element 510 and the paddle frame 524 generally define the shape of the device 500 when viewed from the front or back. Additionally, the rounded shape of the paddle frame 524 and the corresponding rounded shape of the co-option element can distribute leaflet stress over a larger surface. In some exemplary embodiments, the paddle frame 524 and / or the co-option element 510 may have other shapes.

[0206] 69, a side view of device 500 is shown. Similar to the front and back views (FIGS. 67-68), device 500, when viewed from the side, has a shape that is symmetrical or substantially symmetrical about a perpendicular lateral-to-lateral plane 552. Distal portion 507 is also generally narrower than proximal portion 505 when device 500 is viewed from the side. Co-option element 510 also optionally has a narrow, tapered or generally tapered shape toward distal portion 507 of device 500. However, in some exemplary embodiments, the co-option element is not tapered as it extends from the proximal portion of the device to the distal portion of the device.

[0207] The rounded nature of device 500 is further demonstrated by the rounded shape of paddles 520, 522, which are joined together to form the rounded shape of paddle frame 524. However, paddles 520, 522 and paddle frame 524 can take a wide variety of different forms. For example, paddles 520, 522 and paddle frame 524 can be rounded along their top edges but flat or substantially flat on the sides of paddles 520, 522 and / or paddle frame. By having paddles 520, 522 flat or substantially flat on their sides, the two devices can be implanted side-by-side on the native valve leaflets, with the two devices positioned flush or substantially flush with each other.

[0208] The closed paddles 520, 522 form a gap 542 between the inner paddle 522 and the co-option element 510 that is configured to receive natural tissue. As seen in FIG. 69 , the narrowing of the co-option element 510 gives the gap 542 a somewhat teardrop shape that increases in width as the gap 542 approaches the distal portion 507 of the device. Widening the gap 542 toward the distal portion 507 allows the paddles 520, 522 to contact tissue grasped within the gap 542 closer to the proximal portion 505.

[0209] The paddle frame 524 extends vertically from the distal portion 507 toward the proximal portion 505 approximately down the central third of the device 500 before the frame 524 bends or flares outward so that the connecting portion of the frame 524 passes through the gap 544 formed by the folded inner paddle 522 inside the outer paddle 520. However, in other embodiments, the frame connections are positioned inside the inner paddle 522 or outside the outer paddle 520. The outer paddle 520 has a rounded shape when viewed from the front or back, similar to the shape of the co-option element 510 (FIGS. 67-68). Thus, the device 500 has a rounded or substantially rounded shape. The rounded shape of the device 500 is particularly visible when viewing the device 500 from the top (FIGS. 70-71) or bottom (FIGS. 72-73).

[0210] 70-71, a top view of device 500 is shown. Device 500 has a symmetrical or substantially symmetrical shape about front-to-back surface 550 and, when viewed from the top, is symmetrical or substantially symmetrical about side-to-side plane 552. An opening 519A in co-option element 510 is visible in the proximal portion 505 of device 500. As seen in FIG. 70, co-option element 510 may be hollow internally. A proximal collar 511, shown in FIG. 71, may be secured to co-option element 510 to close it.

[0211] In one exemplary embodiment, the co-option element has all curved surfaces rather than planar surfaces. For example, the co-option element 510 illustrated herein may be formed from a series of blended surfaces with various different radii of curvature. The co-option element 510 has an elliptical or approximately elliptical shape when viewed from above. However, in some exemplary embodiments, the co-option element 510 may have other shapes when viewed from above. For example, the co-option element may have a rectangular, square, diamond, oval, or any other shape. The paddle frames 224 each have an arcuate shape with a smaller radius than the co-option element 510, such that the gaps 542 formed between the inner paddle 522 and paddle frame 524 and the co-option element 510 taper as they approach the left 551 and right 553 sides of the device 500. Thus, natural tissue such as the leaflets 20 , 22 tend to be pinched between the paddle frame 524 and the co-option element 510 toward the left and right sides 551 , 553 of the device 500 .

[0212] 72-73, there is shown a bottom view of device 500. Similar to the top views (FIGS. 70-71), device 500 has a symmetrical or substantially symmetrical shape about front-to-back surface 550, and when viewed from the bottom, is symmetrical or substantially symmetrical about side-to-side plane 552. Cap 514 is shown in FIG. 73 and is articulatably attachable to outer paddle 520 and paddle frame 524.

[0213] The paddle frame 524 extends 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 frame 524 extends further away from the side-to-side plane 552 as the paddle frame 524 extends toward the proximal portion of the device 500 (FIG. 69), ultimately forming the arcuate shape seen in FIGS. 70-71.

[0214] 74-83, perspective and cross-sectional views of device 500 are shown. Referring now to FIG. 74, device 500 is shown cut through cross-sectional plane 75 near the proximal portion of co-option element 510. Referring now to FIG. 75, a cross-sectional view of device 500 as viewed through cross-sectional plane 75 of FIG. 74 is shown. At plane 75, co-option element 510 has a round or nearly round shape with lobes disposed along a front-to-back plane 550. Gap 542 between paddle frame 524 and co-option element 510 forms a crescent-like shape with a central width 543. As noted above, gap 542 narrows as gap 542 approaches left and right sides 551, 553.

[0215] Referring now to FIG. 76, device 500 is shown cut through cross-sectional plane 77 located approximately three-quarters of the distance between distal portion 507 and proximal portion 505 of co-option element 510. Referring now to FIG. 77, a cross-sectional view of device 500 as viewed through cross-sectional plane 77 of FIG. 76 is shown. At plane 75, co-option element 510 has an oval or approximately oval shape oriented along a side-to-side plane 552. Gap 542 between paddle frame 524 and co-option element 510 forms a crescent or crescent-like shape with a central width 543 that is smaller than the central width 543 seen in FIG. 75. At plane 77, width 543 of gap 542 is narrower toward the center of the device and widens slightly as it approaches the left and right sides 551, 553 before narrowing again. Thus, the native tissue is pinched in the center of the gap 542 about three-quarters of the way up the co-option element 510 .

[0216] Referring now to FIG. 78, device 500 is shown cut through cross-sectional plane 79 located approximately halfway between distal portion 507 and proximal portion 505 of co-option element 510. Referring now to FIG. 79, a cross-sectional view of device 500 as viewed through cross-sectional plane 79 of FIG. 78 is shown. At plane 79, co-option element 510 has an elliptical or generally elliptical shape oriented along a side-to-side plane 552. Paddle frame 524 can be seen very close to or touching co-option element 510 near left side 551 and right side 553. Gap 542 is crescent-shaped or generally crescent-shaped and is wider than gap 542 viewed along plane 77 (FIG. 77).

[0217] Referring now to FIG. 80, device 500 is shown cut through cross-sectional plane 81 located approximately one-quarter of the distance between distal portion 507 and proximal portion 505 of co-option element 510. Referring now to FIG. 81, a cross-sectional view of device 500 as viewed through cross-sectional plane 81 of FIG. 80 is shown. At plane 81, co-option element 510 has an elliptical or nearly elliptical shape oriented along side-to-side plane 552 that is narrower than the elliptical shape seen in FIG. 77. Paddle frame 524 can be seen very close to or touching co-option element 510 near left side 551 and right side 553. Gap 542 is crescent-shaped or generally crescent-shaped and is wider than gap 542 viewed along plane 79 (FIG. 79).

[0218] Referring now to FIG. 82, device 500 is shown cut through cross-section plane 83 located near the distal portion 507 of co-option element 510. Referring now to FIG. 83, a cross-section of device 500 as viewed from cross-section plane 83 of FIG. 82 is shown. At plane 83, co-option element 510 has an elliptical or generally elliptical shape oriented along a side-to-side plane 552 that is narrower than the elliptical shape seen in FIG. 79 as co-option element 510 tapers toward the distal portion 507 of device 500. Paddle frame 524 can be seen very close to or touching co-option element 510 near left side 551 and right side 553. While inner paddle 522 is not visible in FIG. 81, gap 542 is crescent-shaped or generally crescent-shaped and is wider than gap 542 viewed along plane 81 (FIG. 81).

[0219] 65A, 66A, 67A, 68A, 70A, 71A, 72A, 73A, 74A, 75A, 76A, 77A, 78A, 79A, 80A, 81A, 82A, and 83A, an exemplary implantable device 500A is shown in a closed state. Referring now to FIGS. 65A-66A, device 500A extends from a proximal portion 505A to a distal portion 507A and includes a co-option portion 510A, an inner paddle 522A, an outer paddle 520A, and a paddle frame 524A. Proximal portion 505A may include a collar 511D for attaching a delivery device (not shown). The distal portion 507A is attached (e.g., articulably attached, etc.) to the outer paddle 520A and may include a cap 514A that is engaged by an actuation element (not shown) to open and close the device 500A to facilitate implantation into the native valve as described herein.

[0220] 67A and 68A, a front view of device 500A is shown. Device 500A is symmetrical or substantially symmetrical about a vertical front-to-back plane 550A and has a generally narrower shape at distal portion 507A than along paddle frame 524A. The shape of co-option element 510A and paddle frame 524A is generally rounded rectangular to prevent device 500A from catching or snagging on cardiac structures, such as chordae tendineae, during implantation. For this reason, proximal collar 511D (FIG. 68A) and cap 514A (FIG. 68A) may also have rounded edges. When viewed from the front or back, the paddle frame 524A can be seen as having a generally rounded rectangular shape that extends upward and outward from the distal portion 507A to a shape that is wider and has generally parallel sides than the co-option element 510A when viewed from the front or back. Thus, the paddle frame 524A generally defines the shape of the device 500A when viewed from the front or back. Furthermore, the rounded rectangular shape of the paddle frame 524A can distribute leaflet stress over a larger surface. In some exemplary embodiments, the paddle frame 524A and / or the co-option element 510A may have other shapes.

[0221] Similar to the front and back views (FIGS. 67A-68A), device 500A has a shape that is symmetrical or substantially symmetrical about a perpendicular lateral-to-lateral plane 552A (FIG. 70A) when viewed from the side (e.g., FIG. 47A). Distal portion 507A is also generally narrower than proximal portion 505A when device 500A is viewed from the side. In the embodiment shown in FIG. 48B, co-option element 510A is not tapered as it extends from proximal portion 505A of device 500A to distal portion 507A of device 500A. However, in some exemplary embodiments, co-option element 510A is tapered as it extends from the proximal portion of the device to the distal portion of the device (e.g., FIG. 47).

[0222] The generally rounded nature of device 500A is further demonstrated by the rounded shape of paddles 520A, 522A, with inner paddle 520A and outer paddle 522A joined together. However, paddles 520A, 522A and paddle frame 524A can take a wide variety of different forms. For example, paddles 520A, 522A and paddle frame 524A can be rounded along their upper edges and flat or substantially flat on their sides (e.g., sides of paddle frame 524A disposed on the anterior and posterior sides of device 500A). By making paddles 520A, 522A flat or substantially flat on their sides, the two devices can be implanted side-by-side on the native valve leaflets, with the two devices positioned flush or substantially flush with each other.

[0223] The closed paddles 520A, 522A form a gap 542A between the inner paddle 522A and the co-option element 510A that is configured to receive natural tissue. As seen in Figures 48B and 48F, the proximal end of the co-option element 510A has a generally dogbone shape such that the gap 542A narrows toward the proximal portion 505A as the gap approaches the distal portion 507A of the device. The narrowing of the gap 542A toward the attachment portion 505A allows the paddles 520A, 522A to contact tissue grasped within the gap 542A closer to the proximal portion 505A.

[0224] The paddle frame 524A extends vertically from the distal portion 507A toward the proximal portion 505A approximately through the central third of the device 500A before the frame 524A bends or unfolds outward so that the connecting portion 524B of the frame 524A passes through the gap 544A formed by the folded inner paddle 522A inside the outer paddle 520A. However, in other embodiments, the frame connections are positioned inside the inner paddle 522A or outside the outer paddle 520A. When viewed from the front or back, the outer paddle 520A has a rounded rectangular shape similar to the shape of the co-option element 510A (FIGS. 67A and 68A). Thus, the device 500A has a rounded rectangular shape. The rounded rectangular shape of device 500A is particularly visible when device 500A is viewed from the top (FIGS. 70A and 71A) or bottom (FIGS. 72A and 73A).

[0225] 70A and 71A, a front view of device 500A is shown. Device 500A has a symmetrical or substantially symmetrical shape about front-to-back surface 550A and, when viewed from the top, is symmetrical or substantially symmetrical about side-to-side plane 552A. A proximal opening 519C in co-option element 510A is visible at a proximal portion 505A of device 500A. Actuating element 512A is received through opening 519C such that co-option element 510A wraps around actuating element 512A. In some embodiments, opening 519C is formed by inserting actuating element 512A between folded and overlapping layers (described in more detail below) of strip of material 501A. In other embodiments, the opening 519C is formed by shaping the folded layers of the strip of material 501A forming the co-option element 510A around a blank or jig to give the co-option element 510A a rounded or nearly rounded shape. The proximal collar 511D shown in FIG. 71A can be secured to the co-option element 510A to close it. The proximal collar 511D includes an attachment portion 513A that engages with the opening 546A formed by the folded layers of the strip of material 501A forming the co-option element 510A. In some embodiments, the attachment portion 513A is a hole in the collar 511D, such 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, attachment portion 513A is an open slot (eg, attachment portion 524B of paddle frame 524A) that receives strip of material 501A either before or after folding strip of material 501A.

[0226] As described above, the co-option element 510A has a generally rectangular shape when viewed from above. In some exemplary embodiments, the co-option element 510A may have other shapes when viewed from above. For example, the co-option element may have a circular, square, diamond, oval, or any other shape. The paddle frames 224A each have a rounded rectangular shape when viewed from above, such that the paddle frames 224A surround the rectangular co-option element 510A. Therefore, natural tissue, such as the valve leaflets 20, 22, tends to be evenly pinched or compressed within the gap 542A formed between the inner paddle 522A, paddle frame 524A, and co-option element 510A.

[0227] 72A and 73A, a bottom view of device 500A is shown. Similar to the top views (FIGS. 70A and 71A), device 500A has a symmetrical or substantially symmetrical shape about front-to-back surface 550A and, when viewed from the bottom, is symmetrical or substantially symmetrical about side-to-side plane 552A. Distal portion 527A of strip of material 501A includes aperture 527B for receiving cap 514A, shown in FIG. 73A.

[0228] The paddle frame 524A extends 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 frame 524A extends further away from the side-to-side plane 552A, maintaining a generally constant distance from the front-to-back plane 550A, as the paddle frame 524A extends toward the proximal portion 505A of the device 500A (FIG. 65A), ultimately forming the rounded rectangular shape seen in FIGS. 70A and 71A.

[0229] In one exemplary embodiment, the dimensions of device 500A are selected to minimize the number of implants required by a single patient (preferably one) while simultaneously maintaining a low transvalvular gradient. In one exemplary embodiment, device 500A's widest anterior-posterior distance Y47I is less than 10 mm, and its widest spacer medial-lateral distance Y67C is less than 6 mm. In one exemplary embodiment, the overall geometry of device 500A may be based on these two dimensions and the overall shape strategy described above. It is readily apparent that using other anterior-posterior distances Y47I and medial-lateral distances Y67C as starting points for device 500A will result in devices with different dimensions. Furthermore, using other dimension and shape strategies described above will also result in devices with different dimensions.

[0230] Tables D and E provide example values ​​and ranges for dimensions of device 500A and components of device 500A for some example embodiments. However, device 500A can have a wide variety of different shapes and sizes and need not have all or any of the dimensional values ​​or dimensional ranges provided in Tables D and E. Table D provides example linear dimension Y in millimeters and ranges of linear dimension in millimeters for device 500A and components of device 500A. Table B provides example radial dimension S in millimeters and ranges of radial dimension in millimeters for device 500A and components of device 500A. The subscript for each dimension indicates the drawing in which the dimension first appears. [Table 4] [Table 5]

[0231] 74A, 75A, 76A, 77A, 78A, 79A, 80A, 81A, 82A, and 83A, perspective and cross-sectional views of device 500A are shown. Referring now to FIG. 74A, device 500A is shown cut through cross-sectional plane 75A near the proximal portion of co-option element 510A. Referring now to FIG. 75A, a cross-sectional view of device 500A as viewed from cross-sectional plane 75A of FIG. 74A is shown. At plane 75A, co-option element 510A has a generally rounded rectangular shape. Gap 542A between inner paddle 522A and co-option element 510A has width 542B. As discussed above, gap 542A has a constant or generally constant width.

[0232] Referring now to FIG. 76A, device 500A is shown cut through cross-sectional plane 77A located approximately three-quarters of the distance between distal portion 507A and proximal portion 505A of co-option element 510A. Referring now to FIG. 77A, a cross-sectional view of device 500A as viewed through cross-sectional plane 77A of FIG. 76A is shown. As seen in FIGS. 76A and 77A, the strips of material 501A forming device 500A overlap to form four layers in the area of ​​co-option element 510A. A single layer of strip of material 501A forms each of inner paddle 522A and outer paddle 520A. At plane 75A, co-option element 510A has a generally rectangular shape oriented along side-to-side plane 552A. A gap 542A between inner paddle 522A and co-option element 510A is visible. The gap 542A between the inner paddle 522A and the co-option element 510A has a width 542B that is larger than the width 542B seen in FIG. 75A. The gap 544A between the outer paddle 520A and the inner paddle 522A has a consistent or generally consistent width 544B for receiving the mounting portion 524B of the paddle frame 524A.

[0233] 78A, device 500A is shown cut through cross-sectional plane 79A located approximately halfway between distal portion 507A and proximal portion 505A of device 500A. Referring now to FIG. 79A, a cross-sectional view of device 500A as viewed through cross-sectional plane 79A of FIG. 78A is shown. As seen in FIGS. 78A and 79A, strips of material 501A forming device 500A overlap to form four layers in the region of co-option element 510A, two layers in the region of inner paddle 522A, and one layer in the region of outer paddle 520A. At plane 79A, co-option element 510A has a generally rectangular shape oriented along a side-to-side plane 552A. The gap 542A between the inner paddle 522A and the co-option element 510A has a width 542B that is the same as or approximately the same as the width 542B seen in FIG. 77A.

[0234] Referring now to FIG. 80A, device 500A is shown cut through cross-sectional plane 81A located approximately one-quarter of the distance between distal portion 507A and proximal portion 505A of device 500A. Referring now to FIG. 81A, a cross-sectional view of device 500A as viewed through cross-sectional plane 81A of FIG. 80A is shown. As seen in FIGS. 80A and 81A, the strips of material 501A forming device 500A overlap to form four layers in the region of co-option element 510A, two layers in the region of inner paddle 522A, and outer paddle 520A formed by a single layer. At plane 81A, co-option element 510A has a generally rectangular shape oriented along side-to-side plane 552A. The gap 542A between the inner paddle 522A and the co-option element 510A has a width 542B that is approximately the same as the central width 542B seen in FIG. 79A.

[0235] Referring now to FIG. 82A, device 500A is shown cut through cross-sectional plane 83A, which is located approximately one-quarter of the distance between distal portion 507A and proximal portion 505A of device 500A. Referring now to FIG. 83A, a cross-sectional view of device 500A as viewed through cross-sectional plane 83A of FIG. 82A is shown. As seen in FIGS. 82A and 83A, strips of material 501A forming device 500A overlap to form four layers in the region of co-option element 510A, two layers in the region of inner paddle 522A, and a single layer forming outer paddle 520A. At the location of plane 83A, co-option element 510A has a generally rectangular shape oriented along a side-to-side plane 552A. The gap 542A between the inner paddle 522A and the co-option element 510A forms an arcuate shape with a width 542B that is approximately the same as the central width 542B seen in FIG. 81A.

[0236] 84-88, 86A, 87A, and 88A, exemplary implantable devices 100, 500, 500A are shown without clasps or articulating gripping members. Rather, the exemplary devices 100, 500, 500A shown in Figures 84-88, 86A, 87A, and 88A have barbs or gripping members 800 / 800A and / or 802 / 802A integrated into the co-option element or paddle portion of the anchor portion of the device to facilitate grasping of the tissue of the native heart valve.

[0237] 84 , an exemplary implantable device 100 is shown that does not include an articulating clasp or grasping element. As described above, device 100 is deployed from a delivery sheath or delivery means 102 and includes a co-option portion 104 and an anchor portion 106. The co-option portion 104 of device 100 is adapted to be implanted between the leaflets 20, 22 of a native valve (such as the mitral valve MV) and includes a co-option element or co-apposition means 110 that is slidably attached to an actuation element or shaft 112 that extends through the co-apposition element or co-apposition means 110 to a distal cap 114.

[0238] The anchor portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 connected between the distal cap 114 and the coaptation element or coaptation means 110. The anchor portion 106 is actuatable between an open state and a closed state and can take a wide variety of forms, such as a paddle, a grasping element, etc. Actuation of the actuation element or means 112 opens and closes the anchor portion 106 of the device 100 to grasp the native valve leaflets 20, 22 during implantation.

[0239] Rather than an articulating clasp or grasping element, the device 100 shown in FIG. 84 includes barbed portions 800 disposed on the co-option element or attachment means 110, with each side of the co-option element or attachment means 110 having at least one barbed portion 800. When the anchor portion 106 of the device 100 is closed, tissue grasped between the inner paddle 122 and the co-option element or attachment means 110 is pressed against the barbed portions 800. The barbed portions 800 may be sharp so that they engage the natural tissue and, in some embodiments, pierce the natural tissue and prevent the tissue from being retracted from the device 100. In some embodiments, the barbed portions 800 are angled downward to increase engagement with the natural tissue.

[0240] 85 , an exemplary implantable device 100 is shown without a separate articulating clasp. As described above, device 100 is deployed from a delivery sheath or delivery means 102 and includes a co-option portion 104 and an anchor portion 106. The co-option portion 104 of device 100 is adapted to be implanted between the leaflets 20, 22 of a native or mitral valve MV and includes a co-option element or co-apposition means 110 that is slidably attached to an actuating element 112 (e.g., an actuating wire, shaft, rod, suture, line, etc.) that extends through the co-apposition element or co-apposition means 110 to a distal cap 114.

[0241] The anchor portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 connected between the distal cap 114 and the coaptation element or coaptation means 110. The anchor portion 106 is actuatable between an open state and a closed state and can take a wide variety of forms, such as a paddle, a grasping element, etc. Actuation of the actuation element or means 112 opens and closes the anchor portion 106 of the device 100 to grasp the native valve leaflets 20, 22 during implantation.

[0242] Rather than a separate articulating clasp or grasping element, the device 100 shown in FIG. 85 includes barbed portions 800 disposed on the inner paddles 122, 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 coaptation element or joining means 110 is pressed against the barbed portions 800. The barbed portions 800 are sharp so that they engage the natural tissue and, in some embodiments, pierce the natural tissue and prevent the tissue from being retracted from the device 100. In some embodiments, the barbed portions 800 are angled downward to increase engagement with the natural tissue.

[0243] 86 , an exemplary implantable device 500 is shown that does not include an articulating clasp or grasping element. As described above, device 500 includes a co-option portion 504 and an anchor portion 506. Co-option portion 504 of device 500 includes a co-option element 510 that is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to an actuation element or means 512 that extends through co-option element 510 to a distal cap 514.

[0244] The anchor portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 connected between the distal cap 514 and the co-option element 510. The anchor portion 506 is actuatable between an open state and a closed state and can take a wide variety of forms, such as a paddle, a grasping element, etc. 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.

[0245] Rather than an articulating clasp or grasping element, device 500 includes barbed portions 800 disposed on inner paddles 522, with each inner paddle 522 optionally having multiple barbed portions 800. When anchor portion 506 of device 500 is closed, tissue grasped between inner paddles 522 and co-option element 510 is pressed against barbed portions 800. Barbed portions 800 are sharp so that they engage natural tissue and, in some embodiments, pierce the tissue and prevent tissue from being retracted from device 500. In some embodiments, barbed portions 800 are angled downward to increase engagement with natural tissue.

[0246] Referring now to FIG. 86A, an exemplary implantable device 500A is shown that does not include an articulating clasp or grasping element. As described above, the device 500A is adapted to be implanted between the leaflets 20, 22 of a native or native mitral valve MV and is slidably attached to an actuation element or actuation means (not shown) that extends through a co-option element 510A to a distal cap 514A. The device 500A also includes an outer paddle 520A and an inner paddle 522A connected between the distal cap 514A and the co-option element 510A. The device 500A is actuable between an open state and a closed state and can take a wide variety of forms, such as paddles, grasping elements, etc. Actuation of the actuation elements opens and closes the paddles 520A, 522A of the device 500A to grasp the native valve leaflets 20, 22 during implantation.

[0247] Rather than an articulating clasp or grasping element, device 500A includes a barbed portion 800A disposed on inner paddle 522A, with each inner paddle 522A optionally having multiple barbed portions 800A. When device 500A is closed, tissue grasped between inner paddle 522A and co-option element 510A is pressed against barbed portions 800A. Barbed portions 800A are sharp so that they engage natural tissue and, in some embodiments, pierce the tissue and prevent tissue from being retracted from device 500A. In some embodiments, barbed portions 800A are angled downward to increase engagement with natural tissue.

[0248] 87 , an exemplary implantable device 500 is shown that does not include a separate articulating clasp or grasping element. As described above, device 500 includes a co-option portion 504 and an anchor portion 506. The co-option portion 502 of device 500 includes a co-option element 510 that is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to an actuation element or means 512 that extends through the co-option element 510 to a distal cap 514.

[0249] The anchor portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 connected between the distal cap 514 and the co-option element 510. The anchor portion 506 is actuatable between an open state and a closed state and can take a wide variety of forms, such as a paddle, a grasping element, etc. 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.

[0250] Rather than a separate articulating clasp or grasping element, device 500 includes a barbed portion 800 disposed on co-option element 510, with each side of co-option element 510 having multiple barbed portions 800. When anchor portion 506 of device 500 is closed, tissue grasped between inner paddle 522 and co-option element 510 is pressed against barbed portions 800. Barbed portions 800 are sharp so that they engage natural tissue and, in some embodiments, pierce the tissue, preventing tissue from being retracted from device 500. In some embodiments, barbed portions 800 are angled downward to increase engagement with natural tissue.

[0251] Referring now to FIG. 87A , an exemplary implantable device 500A is shown that does not include an articulating clasp or grasping element. As described above, the device 500A is adapted to be implanted between the leaflets 20, 22 of a native or native mitral valve MV and can have a co-option element 510A slidably attached to an actuation element or actuation means (not shown) that extends through the co-option element 510A to a distal cap 514A. The device 500A also includes an outer paddle 520A and an inner paddle 522A connected between the distal cap 514A and the co-option element 510A. The device 500A is actuable between an open state and a closed state and can take a wide variety of forms, such as paddles, grasping elements, etc. Actuation of the actuation elements opens and closes the paddles 520A, 522A of the device 500A to grasp the native valve leaflets 20, 22 during implantation.

[0252] Rather than a separate articulating clasp or grasping element, device 500A includes a barbed portion 800A disposed on co-option element 510A, with each side of co-option element 510A having multiple barbed portions 800A. When device 500A is closed, tissue grasped between inner paddle 522A and co-option element 510A is pressed against barbed portions 800A. Barbed portions 800A are sharp so that they engage natural tissue and, in some embodiments, pierce the tissue, preventing tissue from being retracted from device 500A. In some embodiments, barbed portions 800A are angled downward to increase engagement with natural tissue.

[0253] 88 , an exemplary implantable device 500 is shown that does not include a separate articulating clasp or grasping element. As described above, device 500 includes a co-option portion 504 and an anchor portion 506. Co-option portion 504 of device 500 includes a co-option element 510 that is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to an actuation element or means 512 that extends through co-option element 510 to a distal cap 514.

[0254] The anchor portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 connected between the distal cap 514 and the co-option element 510. The anchor portion 506 is actuatable between an open state and a closed state and can take a wide variety of forms, such as a paddle, a grasping element, etc. 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.

[0255] Rather than an articulating clasp or gripping element, device 500 includes barbed portions 800 disposed on co-option element 510, with each side of co-option element 510 including at least one barbed portion 800. Similar to device 1000 described above, device 500 also includes barbed portions 802 disposed on inner paddles 522, with each inner paddle 522 having at least one barbed portion 802.

[0256] When the anchor portion 506 of the device 500 is closed, tissue grasped between the inner paddle 522 and the co-option element 510 is pressed against the barbed portions 800, 802. The barbed portions 800, 802 are sharp so that they engage the natural tissue and, in some embodiments, pierce the natural tissue, preventing the tissue from being retracted from the device 500. In some embodiments, the barbed portions 800, 802 are angled downward to increase engagement with the natural tissue. The combination of the barbed portions 800 on the co-option element 510 and the barbed portions 802 on the inner paddle 522 causes the grasped tissue to form an S-shaped, tortuous path as it passes through the barbed portions 800, 802. Thus, the force pulling the tissue away from the device 500 urges the tissue to further engage the barbed portions 800, 802 before it can escape.

[0257] Referring now to FIG. 88A, an exemplary implantable device 500A is shown that does not include an articulating clasp or grasping element. As described above, the device 500A is adapted to be implanted between the leaflets 20, 22 of a native or native mitral valve MV and can have a co-option element 510A slidably attached to an actuation element or actuation means (not shown) that extends through the co-option element 510A to a distal cap 514A. The device 500A also includes an outer paddle 520A and an inner paddle 522A connected between the distal cap 514A and the co-option element 510A. The device 500A is actuable between an open state and a closed state and can take a wide variety of forms, such as paddles, grasping elements, etc. Actuation of the actuation elements opens and closes the paddles 520A, 522A of the device 500A to grasp the native valve leaflets 20, 22 during implantation.

[0258] Rather than an articulating clasp or grasping element, device 500A includes a barbed portion 800A disposed on co-option element 510A, with each side of co-option element 510A including at least one barbed portion 800A. Device 500A also includes a barbed portion 802A disposed on inner paddle 522A, with each inner paddle 522A having at least one barbed portion 802A.

[0259] When the device 500A is closed, tissue grasped between the inner paddle 522A and the co-option element 510A is pressed against the barbed portions 800A, 802A. The barbed portions 800A, 802A are sharp so that they engage the natural tissue and, in some embodiments, pierce the natural tissue and prevent the tissue from being retracted through the device 500A. In some embodiments, the barbed portions 800A, 802A are angled downward to increase engagement with the natural tissue. The combination of the barbed portions 800A on the co-option element 510A and the barbed portions 802A on the inner paddle 522A causes the grasped tissue to form an S-shaped, serpentine path as it passes through the barbed portions 800A, 802A. Thus, the force pulling the tissue away from the device 500A urges the tissue to further engage the barbed portions 800A, 802A before it can escape.

[0260] 89-102, the co-option element 510 and paddles 520, 522 of an exemplary device 500 are shown. The co-option element 510 and paddles 520, 522 can be made from a wide variety of different materials. The co-option element 510 and paddles 520, 522 can be formed from one or more of a variety of materials, for example, metal fibers, such as mesh, woven, knitted, electrospun, deposited, or formed in any other suitable manner, laser cut or otherwise cut materials, or flexible materials. The material can also be cloth, wire such as Nitinol to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body.

[0261] In one exemplary embodiment, the co-option element is made from a braided mesh of metal wires, such as a braided mesh of nitinol wires. In one exemplary embodiment, the co-option element 510 is made from a braid of 25 to 100 wires, e.g., 40 to 85 wires, e.g., 45 to 60 wires, e.g., about 48 nitinol wires, or 48 nitinol wires.

[0262] The co-option element 510 can be entirely surrounded by a cloth covering, such as a fine mesh polyethylene cloth. The cloth covering can provide a blood seal on the surface of the spacer and / or can promote rapid tissue ingrowth.

[0263] The use of a shape memory material, such as braided nitinol wire mesh, for the construction of the co-option element 510 results in a co-option element that can be self-expandable in all directions, flexible, and / or can provide low strain when the co-option element is crimped and / or bent. The material can be a single piece, two halves joined together, or multiple sections or pieces that are secured or joined together in any suitable manner, such as by welding, adhesive, or the like.

[0264] 89-90, device 500 extends from proximal portion 505 to distal portion 507 and includes a co-option element 510, an inner paddle 522, and an outer paddle 520. Co-option element 510 includes a proximal opening 519A and a distal opening 515 (FIGS. 92 and 94). The proximal opening 519A of co-option element 510 is formed in the proximal portion 519 of co-option element 510. Co-option element 510 is articulably connected to inner paddle 522 by joint portion 525. Inner paddle 522 is articulably connected to outer paddle 520 by joint portion 523. Outer paddle 520 is attached (e.g., articulably attached) to distal portion 527 by joint portion 521. A co-option gap 542 is formed between inner paddle 522 and co-option element 510. A paddle gap 544 is formed between the inner paddle 520 and the outer paddle 522 when the paddles 520, 522 are folded, for example, as shown in FIG.

[0265] 91 , a front view of device 500 is shown (the rear view would be similar). Co-option element 510 includes a proximal portion 519, a central portion 518, and a distal portion 517. Proximal portion 519 includes a proximal opening 519A. Distal portion 517 includes a distal opening 515 and connects to joint portion 525. The shape of co-option element 510 is rounded or generally rounded to prevent device 500 from catching or snagging on cardiac structures, such as chordae tendineae, during implantation.

[0266] 92, a side view of device 500 is shown. Similar to device 500 viewed from the front, distal portion 507 of device 500 is generally narrower than proximal portion 505 of device 500 when device 500 is viewed from the side. Co-option element 510 flares outward within proximal portion 519 from proximal opening 519A to central portion 518. Co-option element 510 then tapers, or narrows, within central portion 518 from proximal portion 519 to distal portion 517. Distal portion 517 remains narrow before splitting into two joint portions 525. The generally rounded nature of device 500 is further demonstrated by the rounded shape of joint portion 523, which articulates inner and outer paddles 520, 522, and the outwardly arcuate shape of outer paddle 520.

[0267] A co-option gap 542 formed between the inner paddle 522 and the co-option element 510 is configured to receive natural tissue. The narrowing of the co-option element 510 gives the gap 542 a somewhat teardrop shape that increases in width as the gap 542 approaches the distal portion 507 of the device 500. Widening the gap 542 toward the distal portion 507 allows the inner paddle 522 to contact tissue grasped within the gap 542 closer to the proximal portion 505, with the clamping force being a result of the greater mechanical advantage provided by the length of the paddles 520, 522 and other fixation or anchor elements such as those described herein.

[0268] 93, a top view of the device 500 is shown. The proximal opening 519A in the co-option element 510 is visible at the proximal portion 505 of the device 500, and the co-option element 510 can be seen as hollow inside. The co-option element 510 has an oval or approximately oval shape when viewed from above. The paddles 520, 522 appear as protruding rectangular shapes, although the paddles 520, 522 extend laterally and can have an arcuate or crescent shape.

[0269] Referring now to FIG. 94, a bottom view of device 500 is shown. A distal opening 515 in co-option element 510 is visible at the distal portion 507 of device 500, and co-option element 510 can be seen as hollow inside. Co-option element 510 has an oval or approximately oval shape when viewed from above. Paddles 520, 522 appear as protruding rectangular shapes, although paddles 520, 522 can extend laterally and have an arcuate or crescent shape. Distal portion 517 of co-option element 510 can be seen split in two to join with joint portion 525.

[0270] 89A, 90A, 91A, 92A, 93A, 94A, 95A, 96A, 97A, 98A, 99A, 100A, 101A, and 102A, there is shown a portion of a device 500A formed by a strip of material 501A (e.g., a single continuous strip of material, a composite strip of material, etc.), i.e., a co-option element 510A and paddles 520A, 522A. The co-option element 510A and paddles 520A, 522A may be made from a wide variety of different materials. The co-option element 510A and paddles 520A, 522A may be formed from a material that may be a mesh, woven, knitted, electrospun, deposited, or other metallic fiber, or may be formed in any other suitable manner, laser cut or otherwise cut, or flexible material. The material may be cloth, wire such as nitinol to provide shape-fixing capabilities, or any other flexible material suitable for implantation in the human body.

[0271] In one exemplary embodiment, the co-option element 510A, inner paddle 522A, and outer paddle 520A are made from a single continuous strip of material 501A. The strip of material 501A may be made from a material that may be a mesh, woven, knitted, electrospun, deposited, or other suitable metallic fiber, or may be formed in any other suitable manner, laser cut, or otherwise cut, or a flexible material. The material may be a cloth, a wire such as Nitinol to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body. In one exemplary embodiment, the strip of material 501A is made from 25-100 strands, e.g., 40-85 strands, e.g., a braid of 45-60 strands, e.g., about 48 Nitinol wire, or 48 Nitinol wire.

[0272] 205-207, an exemplary woven or braided material 4000 that may be used for the strip of material 501A is shown. Referring now to FIG. 205, an enlarged plan view of the material 4000 is shown. The material 4000 extends from a first edge 4002 to a second edge 4004. The edges 4002, 4004 surround a central portion or field 4006. The material 4000 is formed by braiding or weaving together a central strand 4020, such as a nitinol wire. The edge strands 4010 extend longitudinally through the material 4000 along the edges 4002, 4004. The central strand 4020 is woven or braided such that the central strand 4020 is wrapped around the edge strands 4010. Wrapping the central strand 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 when viewed from the end, as shown in FIG. 206, forming a leaf-like or dogbone-like shape. Thus, the edges 4002, 4004 of the material 4000 are less flexible than the central portion 4006. The edge strands 4010 and the central strand 4020 may be similar in diameter, and may have diameters ranging from about 0.06 millimeters to about 0.18 millimeters. In some embodiments, the edge strands 4010 may have a larger diameter than the central strand 4020 to impart more stiffness or rigidity to the edges 4002, 4004 than to the central portion 4006. For example, the edge strands 4010 may have a diameter ranging from 0.07 millimeters to about 0.27 millimeters, or about 0.17 millimeters, and the center strand 4020 may have a diameter ranging from about 0.04 millimeters to about 0.15 millimeters, or about 0.009 millimeters. In some embodiments, the edge portions 4002, 4004 are made less flexible than the center portion 4006 by using different materials for the edge strands 4010 and the center strand 4020, such as, for example, a metallic material (e.g., nitinol) for the edge strands 4010 and a cloth or plastic material (e.g., polyethylene) for the center strand 4020.Alternatively, the edge strands 4010 and the central strands 4020 may be made from the same material that is subjected to different chemical and / or thermal processes that change the flexibility of the material, resulting in the central strands 4020 being more flexible than the edge strands 4010.

[0273] Referring now to FIG. 207, folded portions of material 4000 are stacked on top of each other to form a section having four layers 4000A, 4000B, 4000C, and 4000D. The leaf-like shape of the individual layers, with edge portions 4002, 4004 thicker than the central portion 4006, creates three gaps 4001A, 4001B, and 4001C between layers 4000A, 4000B, 4000C, and 4000D of material 4000 at the central portion 4006. Outer gaps 4001A and 4001C are formed between outer layers 4000A and 4000D and adjacent middle layers 4000B and 4000C.

[0274] As discussed in this disclosure, the co-option element 510A of device 500A can be formed from four layers of material, such as material 4000. When a layer of material 4000 is used to form the co-option element 510A, the actuating element 512A of device 500A can be inserted through a central gap 4001B formed in the center of the four layers of material 4000. The actuating element 512A can have a diameter greater than the width of gap 4001B, such that inserting the actuating element 512A causes the middle gap 4001B to open and stretch the adjacent outer gaps 4001A, 4001C, reducing their size. In some embodiments, inserting the actuating element 512A causes the central body portion 4006 on both sides to bulge outward to a thickness greater than the thickness of the four stacked edge portions 4002, 4004.

[0275] The co-option element 510A and paddles 520A, 522A can be covered with a cloth, such as polyethylene cloth. The co-option element 510A and paddles 520A, 522A can be entirely surrounded by a cloth cover (e.g., cover 540A), such as a fine mesh polyethylene cloth. The cloth cover can provide a blood seal on the surface of the spacer and / or can promote rapid tissue ingrowth.

[0276] The use of a shape memory material, such as braided nitinol wire mesh, for the construction of the co-option element 510A and paddles 520A, 522A results in a co-option element and paddle that can be self-expandable in all directions, flexible, and / or can provide low strain when crimped and / or bent. The material can be a single piece, two halves joined together, or multiple sections or pieces secured or joined together in any suitable manner, such as by welding, adhesive, or the like.

[0277] 89A and 90A, device 500A extends from proximal portion 505A to distal portion 507A and includes co-option element 510A, inner paddle 522A, and outer paddle 520A. A single continuous strip of material 501A extends between two ends 501B and is folded over to form co-option element 510A, inner paddle 522A, and outer paddle 520A. Some portions of device 500A are formed from multiple layers of strip of material 501A. For example, strip of material 501A overlaps to form four layers in the area of ​​co-option element 510A and two layers in the area of ​​inner paddle 522A.

[0278] Co-option element 510A and paddles 520A, 522A are articulably connected together by a joint portion of strip of material 501A. Co-option element 510A is articulably connected to inner paddle 522A by joint portion 525A. Inner paddle 522A is articulably connected to outer paddle 520A by joint portion 523A. Outer paddle 520A is attached (e.g., articulably attached) to distal portion 527A by joint portion 521A. Aperture 527B of distal portion 527A engages with cap 514A.

[0279] When the strip of material 501A is folded into a desired shape, various gaps are formed between portions of the device 500A. A co-option gap 542A is formed between the inner paddle 522A and the co-option element 510A. A paddle gap 544A is formed when the paddles 520A, 522A are folded, for example, between the inner paddle 520A and the outer paddle 522A as shown in FIG. 90A. A collar gap 546A is formed when the strip of material 501A is folded to form the proximal portion 519B of the co-option element 510A.

[0280] Referring now to FIG. 91A, a front view of device 500A is shown (the rear view would be similar). Coroption element 510A includes a proximal portion 519B that extends above joint portions 523A of paddles 520A, 522A. Distal portion 517A of coroption element 510A is hidden by paddles 520A, 522A when viewed from the front or back, giving device 500A a long, narrow, rounded rectangular shape. The shape of coroption element 510A helps prevent device 500A from catching or snagging on cardiac structures, such as chordae tendineae, during implantation.

[0281] Referring now to FIG. 92A, a side view of device 500A is shown. Distal end 507A of device 500A is generally narrower than proximal end 505A of device 500A, forming a generally blunt and rounded shape when device 500A is viewed from the side. Co-option element 510A includes proximal portion 519B, central portion 518A, and distal portion 517A. Proximal portion 519B flares outward from central portion 518A to engage collar 511D (FIG. 48A). Central portion 518A of co-option element 510A is straight or substantially straight when viewed from the side. Distal portion 517A is attached (e.g., articulably attached, etc.) to inner paddle 522A by joint portion 525A. The generally rounded nature of device 500A is further demonstrated by the rounded shape of joint portion 523A that articulately connects paddles 520A, 522A. Joint portion 521A that connects outer paddle 520A to distal portion 527A is also rounded to facilitate the shape transition from strip of material 501A to cap 514A (FIG. 48A) that is assembled to flat or generally flat distal portion 527A.

[0282] Co-option gap 542A formed between inner paddle 522A and co-option element 510A is configured to receive natural tissue. The general linearity of central portion 518A of co-option element 510A and inner paddle 522A gives gap 542A a consistent or generally consistent width with a narrow upper end where proximal portion 519B flares outward to engage collar 511D ( FIG. 48A ). Thus, inner paddle 522A contacts tissue grasped within gap 542A closer to proximal portion 505A, where the clamping force is a result of the greater mechanical advantage provided by the length of paddles 520A, 522A, and other fixation or anchor elements such as those described herein.

[0283] As discussed above, the coroption element 510A and paddles 520A, 522A of the device 500A are formed by folding a 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 frame 524A. The strip of material 501A is shape-set after being formed into the desired shape so that the strip of material 501A returns to the desired shape after assembly with the other components. In some embodiments, a jig is used during the folding and shape-setting of the strip of material 501A to ensure that the strip of material 501A is folded into the proper position at the desired radius.

[0284] Referring again to FIG. 92A , a portion of a jig 570A is shown to aid in the folding and shaping of device 500A. Strip of material 501A is shown folded around jig 570A so that strip of material 501A forms the desired shape. To use jig 570A to fold strip of material 501A into the shape of device 500A, strip of material 501A is disposed at one of ends 501B at the location of inner paddle 522A. Strip 501A extends distally 507B from end 501B to form first layer 581A of inner paddle 522A, around first jig portion 572A to form first layer 581A of hinge portion 525A, and then proximally 507B to form first layer 581A of co-option element 510A. The first layer 581A of material forms the co-option element 510A, surrounding the sides of the inner paddle 522A and the co-option gap 542A. The strip 501A is then wrapped around the second jig portion 574A to form the proximal portion 519B and one of the openings 546A of the co-option element 510A. The strip 501A then extends in the distal direction 507A along the first layer 581A to form the second layer 582A of the co-option element 510A. The strip 501A then wraps around the first jig portion 572A, folding back to form the second layer 582A of the hinge portion 525A, and then wrapping back in the proximal direction 505B to form the second layer 582A of the inner paddle 522A. The strip 501A is then wrapped around the third jig portion 576A to form the joint portion 523A. Strip 501A then extends in a distal direction 507A along inner paddle 522A to form outer paddle 520A before being folded around fourth jig portion 578A to form joint portion 521. Strip 501A then extends laterally to form distal portion 527. The routing of strip 501A through jig 570A is then reversed on the opposite side of jig 570A to form the second half of device 500A. That is, strip 501A is then wrapped around fourth, third, second, and first jig portions 578A, 576A, 574A, 572A to form the second half of device 500A.Once the strip 501A is wrapped around the jig portions as described above, a shape-setting operation is performed. While the jig portions shown have rounded or nearly rounded shapes, the portions may have any shape to aid in folding and shaping the strip of material 501A. The jig 570 may have more or fewer portions for engaging the strip of material 501A.

[0285] Referring now to FIG. 93A, a top view of device 500A is shown. The first and second layers 581A, 582A of each half of device 500A form the four layers of co-option device 510A. A proximal opening 519C of co-option device 510A is formed between the two second layers 582A. In some embodiments, opening 519C is formed by inserting actuation element 512A (not shown) between the folded and overlapping layers of strip of material 501A after shaping strip of material 501A. In other embodiments, opening 519C is formed by shaping folded layers 581A, 582A of strip of material 501A around an additional jig part (not shown), giving co-option element 510A a rounded or generally rounded shape when viewed from the top.

[0286] 94A, a bottom view of device 500A is shown. Distal portion 527A of strip of material 501A is shown, as is aperture 527B for receiving cap 514A. Co-option element 510A and outer paddle 520A have a generally rounded rectangular shape when viewed from below.

[0287] 95-102, perspective and cross-sectional views of device 500 are shown. Referring now to FIG. 95, device 500 is shown cut through cross-sectional plane 96 near the proximal portion of co-option element 510. Referring now to FIG. 96, a cross-sectional view of device 500 is shown as viewed from cross-sectional plane 96 of FIG. 95. At plane 96, co-option element 510 has an oval or approximately oval shape with thicker portions along the sides of co-option element 510. A distal opening 515 is visible from the proximal portion, and co-option element 510 has a hollow interior.

[0288] 97, device 500 is shown cut through a cross-sectional plane 98 located approximately halfway between the distal portion 507 and the proximal portion 505 of co-option element 510. Referring now to FIG. 98, a cross-sectional view of device 500 is shown as viewed through cross-sectional plane 98 of FIG. 97. At plane 98, co-option element 510 has an elliptical or near-elliptical shape that is larger than the elliptical shape of FIG. 96.

[0289] 99, device 500 is shown cut through cross-sectional plane 100 located approximately one-quarter of the distance between distal portion 507 and proximal portion 505 of co-option element 510. Referring now to Fig. 99, a cross-sectional view of device 500 is shown as viewed through cross-sectional plane 100 of Fig. 99. At plane 100, co-option element 510 has an elliptical or near-elliptical shape that is narrower than the elliptical shape seen in Fig. 98.

[0290] 101, device 500 is shown cut through cross-sectional plane 102 located near distal portion 507 of co-option element 510. Referring now to FIG. 102, a cross-sectional view of device 500 is shown as viewed through cross-sectional plane 102 of FIG. 101. At plane 102, co-option element 510 has an elliptical or near-elliptical shape that is smaller than the elliptical shape seen in FIG. 100 and that breaks apart as co-option element 510 joins joint portion 525.

[0291] 95A, 96A, 97A, 98A, 99A, 100A, 101A, and 102A, there are shown perspective and cross-sectional views of a portion of device 500A formed by a single continuous strip of material 501A. Referring now to FIG. 95A, device 500A is shown cut through cross-sectional plane 96A near a proximal portion of co-option element 510A. Referring now to FIG. 96A, there is shown a cross-sectional view of device 500A as viewed through cross-sectional plane 96A of FIG. 95A. At plane 96A, co-option element 510A has a rectangular or approximately rectangular shape. In some embodiments, when an actuation element (not shown) is inserted between layers 582A of co-option element 510A, co-option element 510A remains straight when viewed from the side, but bends outward to form a rounded or nearly rounded shape when viewed from cross-sectional plane 96A.

[0292] 97A, device 500A is shown cut through cross-sectional plane 98A near a proximal portion of co-option element 510A. Referring now to FIG. 98A, a cross-sectional view of device 500A is shown as viewed through cross-sectional plane 98A of FIG. 97A. At plane 98A, co-option element 510A has a rectangular or nearly rectangular shape. In some embodiments, when an actuation element (not shown) is inserted between layers 582A of co-option element 510A, co-option element 510A remains straight when viewed from the side but bends outward to form a rounded or nearly rounded shape when viewed through cross-sectional plane 98A.

[0293] 99A, device 500A is shown cut through cross-sectional plane 100A near a proximal portion of co-option element 510A. Referring now to FIG. 100A, a cross-sectional view of device 500A is shown as viewed through cross-sectional plane 100A of FIG. 99A. At plane 100A, co-option element 510A has a rectangular or nearly rectangular shape. In some embodiments, when an actuation element (not shown) is inserted between layers 582A of co-option element 510A, co-option element 510A remains straight when viewed from the side but bends outward to form a rounded or nearly rounded shape when viewed through cross-sectional plane 100A.

[0294] 101A, device 500A is shown cut through cross-sectional plane 102A near a proximal portion of co-option element 510A. Referring now to FIG. 102A, a cross-sectional view of device 500A is shown as viewed through cross-sectional plane 102A of FIG. 101A. At plane 102A, co-option element 510A has a rectangular or nearly rectangular shape. In some embodiments, when an actuation element (not shown) is inserted between layers 582A of co-option element 510A, co-option element 510A remains straight when viewed from the side but bends outward to form a rounded or nearly rounded shape when viewed through cross-sectional plane 102A.

[0295] 103-105, an exemplary implantable prosthetic device 100 is shown having covered and uncovered portions. The device 100 is shown implanted into the native mitral valve MV and secured to the native leaflets 20, 22. As described above, the device 100 includes the co-option elements or means: the co-option 110, the paddle 120, the clasp 130, and the cap 114. The paddle 120 and the clasp 130 are in a closed position to secure the device 100 to the grasped native leaflets 20, 22 of the mitral valve MV. The proximal portion 105 of the device 100 is exposed to the left atrium LA, and the distal portion 107 of the device 100 is exposed to the left ventricle LV.

[0296] Referring now to FIG. 103 , the device 100 is shown with a cover 900 covering the entire co-option element or co-aptation means 110 and cap 114. In some embodiments, the cover 900 can be a cloth or fabric, or a polymer such as PET, velour, electrospun, deposited, or other suitable material. In other embodiments, instead of or in addition to fabric, the cover can include a coating (e.g., a polymer) applied to the prosthetic spacer device and / or mechanical sealing mechanisms such as silicone and interlocking joints. The cover 900 can be formed from metallic fabric, such as mesh, woven, knitted, or formed in any other suitable manner, or from an otherwise cut flexible material. The cover 900 can also be a cloth, a wire such as Nitinol to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body. The cover 900 prevents blood flow through the co-option element or co-aptation means 110 at the proximal portion 105 and also provides a seal between the device 100 and the valve leaflets 20, 22. Thus, the cover 900 helps to prevent blood flow through the native valve at the location of the device 100. The cover 900 also prevents recirculating blood flow from entering the device 100 from the distal portion 107.

[0297] Referring now to FIG. 104 , the device 100 is shown with a cover 1000 that partially covers the co-option element or co-aptation means 110 from the proximal portion 105 of the device 100 to the portion of the co-option element or co-aptation means 110 that engages the native valve leaflets 20, 22. In some embodiments, the cover can be a cloth or fabric, such as PET, velour, or other suitable fabric. In other embodiments, instead of or in addition to fabric, the cover can include a coating (e.g., a polymer) applied to the prosthetic spacer device. The cover 1000 can be formed from metallic fabric, such as mesh, woven, knitted, or formed in any other suitable manner, or a laser-cut or otherwise cut flexible material. The cover 1000 can also be a cloth, a wire, such as Nitinol, to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body. Thus, the cover 1000 prevents blood flow through the co-option element or co-aptation means 110 at the proximal portion 105.

[0298] Referring now to FIG. 105, device 100 is shown with a cover 1100 partially covering co-option element or co-aptation means 110, extending from the portion of co-option element or co-aptation means 110 that engages with the native valve leaflets 20, 22 toward the distal portion 107. The cover 1100 also covers cap 114. In some embodiments, the cover may be a cloth or fabric, such as PET, velour, or other suitable fabric. In other embodiments, instead of or in addition to fabric, the cover may include a coating (e.g., a polymer) applied to the prosthetic spacer device. Cover 1100 may be formed as a mesh, woven, knitted, or any other suitable manner. Cover 1100 may be a cloth, polymer, silicone, electrospun material, deposited material, and / or shape memory alloy wire such as nitinol to provide shape-fixing capabilities, or any other flexible material suitable for implantation in the human body. Thus, blood flow can enter the coaptation element or joining means 110 but is prevented from passing through the device by the cover 1100 disposed towards the distal portion 107. The cover 1100 also prevents recirculation of blood flow from entering the device 100 from the distal portion 107.

[0299] 106-109, an exemplary co-option element 1200 for an implantable prosthetic device is shown. The co-option element 1200 can be used with any of the implantable prosthetic devices described herein. With reference to FIG. 106, the co-option element 1200 has a cylindrical or approximately cylindrical shape extending between two caps 1201. However, the co-option element 1200 can have any shape, such as any of the shapes disclosed herein. In one exemplary embodiment, the direction of expansion of the co-option element 1200 can be controlled. For example, the width / size of the co-option element in the anterior-to-posterior direction (when implanted), the medial-to-lateral direction (when implanted), or both, can be expanded (or contracted) in a controlled manner. The co-option element can be made from a mesh 1200 of material. With reference to FIG. 107, the mesh walls of the generally cylindrical co-option element 1200 extend outward from the caps 1201 a distance 1204. 108, an axial force 1208 is applied to the cap 1201 of the co-option element 1200, thereby axially compressing the co-option element 1200. Compressing the co-option element 1200 axially causes the co-option element 1200 to expand or bulge in an outward direction 1210 such that the distance 1204 increases.

[0300] The co-option element 1200 can be compressed in a variety of different ways. For example, a threaded connection can be used to pull the two ends of the co-option element together or push the two ends of the co-option element apart. For example, a collar can be provided on each end of the co-option element. One of the collars can be threadably engaged with a threaded shaft, and the other collar is rotatably connected to the shaft. Rotating the shaft in one direction pulls the collars together. Rotating the shaft in the opposite direction moves the collars apart.

[0301] Incorporating the co-option element 1200 into the implantable prosthetic device of the present application allows the co-option element to expand and push outward against tissue grasped between the co-option element and the paddles and / or grasping members.

[0302] 106A , 108A , 106B , and 108B , an exemplary core-option element 1200 for an implantable prosthetic device, similar to the embodiment illustrated by FIGS. 106-109 , is shown. The core-option element 1200 can be used with any of the implantable prosthetic devices described herein. With reference to FIG. 106A , the core-option element 1200 has a cylindrical or generally cylindrical shape extending between two caps 1201. However, the core-option element 1200 can have any shape, such as any of the shapes disclosed herein. In the example illustrated by FIGS. 106A and 108A , the core-option element 1200 includes a tube 1203 having a slot 1205. For example, the tube 1203 can be made of a shape memory alloy, such as Nitinol, and the slot can be cut into the tube, such as by laser cutting. The slot can be cut into the material forming the tube before the material is formed into the tube.

[0303] In one exemplary embodiment, the direction of expansion of the co-option element 1200 can be controlled. For example, the configuration of the slot 1205 and / or the shape setting of the tube can be selected to control the shape of the expanded co-option element 1200. For example, the configuration of the slot 1205 and / or the shape setting can determine the width / size of the co-option element in the anterior-to-posterior direction and / or in the medial-to-lateral direction for expansion (and / or contraction). Referring to FIG. 106A, the tube wall of the generally cylindrical co-option element 1200 extends outward from the cap 1201 by a distance 1204. Now referring to FIG. 108A, an axial force 1208 and / or a rotational force 1209 can be applied to the cap 1201 of the co-option element 1200 to enable the co-option element 1200 to expand from the configuration illustrated by FIG. 106A to the configuration illustrated by FIG. 108A. In the illustrated example, compressing the co-option element 1200 axially and twisting the co-option element 1200 causes it to expand or bulge in an outward direction 1210 such that the distance 1204 increases.

[0304] 106B and 108B, the co-option element 1200 can be compressed in a variety of different ways. For example, the threaded connection 1221 can be used to pull the two ends of the co-option element together and twist the element in a first direction, or to push the two ends of the co-option element apart and twist the element in a second direction. For example, a collar can be provided on each end of the co-option element. One of the collars can threadably engage a threaded shaft, while the other collar is fixedly connected to the shaft. Rotating the shaft in one direction pulls the collars together and rotates them relative to each other in a first direction. Rotating the shaft in the opposite direction moves the collars apart and rotates them relative to each other in a second direction. The pitch of the threaded connection can be selected to set the ratio between the distance the co-option element 1200 is compressed and the angle through which the co-option element is twisted.

[0305] Incorporating the co-option element 1200 illustrated by Figures 106A, 108A, 106B, and 108B into the implantable prosthetic devices of the present application allows the co-option element to expand and push outward against tissue grasped between the co-option element and the paddles and / or grasping members.

[0306] 106C and 108C show an exemplary embodiment of a controllably expandable co-option element 1200 for an implantable prosthetic device. The co-option element 1200 can be used by itself, with a covering, or inside any of the co-option elements described herein (to expand the co-option element). The co-option element 1200 can be used in conjunction with any of the implantable prosthetic devices described herein. Referring to FIG. 106C, the co-option element 1200 has pairs of pivotally connected arms 1231. Each pair of pivotally connected arms 1231 extends between and is pivotally connected to two caps 1201. In the illustrated example, there are two pairs of pivotally connected arms 1231. However, there may be one, three, four, or any number of pairs of pivotally connected arms.

[0307] In one exemplary embodiment, the direction of expansion of the co-option element 1200 can be controlled. For example, two pairs of pivotally connected arms (as shown) can be included to change the width / size of the co-option element in only one of the anterior-to-posterior direction and / or the medial-to-lateral direction. Four pairs of pivotally connected arms 1231 can be included to change the width / size of the co-option element in both the anterior-to-posterior direction and the 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 allow the co-option element 1200 to expand (or contract) separately in different directions. For example, the arm lengths can be selected to expand more in the medial-to-lateral direction than in the anterior-to-posterior direction.

[0308] 108C, an axial force 1208 is applied to the cap 1201 of the co-option element 1200, allowing the co-option element 1200 to expand from the configuration illustrated by FIG. 106C to the configuration illustrated by FIG. 108C. In the illustrated example, axial compression of the pivotally connected arm 1231 causes the pivot connection 1233 or knee to expand in an outward direction 1210 such that the distance 1204 increases.

[0309] 106C and 108C, the co-option element 1200 can be compressed in a variety of different ways. For example, the threaded connection 1221 can be used to pull the two ends of the co-option element together or to push the two ends of the co-option element apart. For example, a collar can be provided on each end of the co-option element. One of the collars can be threadably engaged with a threaded shaft, and the other collar is rotatably connected to the shaft. Rotating the shaft in one direction pulls the collars together. Rotating the shaft in the opposite direction moves the collars apart.

[0310] Incorporating the co-option element 1200 illustrated by Figures 106C and 108C into the implantable prosthetic devices of the present application allows the co-option element to expand and push outward against tissue grasped between the co-option element and the paddles and / or grasping members.

[0311] 106D and 108D show an exemplary embodiment of an expandable core-option element 1200 for an implantable prosthetic device. The core-option element 1200 can be used by itself, with a covering (see FIGS. 106E and 108E), or inside any of the core-option elements described herein (to expand the core-option element). The core-option element 1200 can be used with any of the implantable prosthetic devices described herein. Referring to FIG. 106C, the core-option element 1200 has a central support member 1243, one or more pivotally connected arms 1241, and connecting lines 1245. Each arm 1241 extends from the pivot connection to the central support member 1243. Each connecting line 1245 is connected to the central support member 1243 and the pivotally connected arm 1241. The length of the connecting line 1245 sets the degree to which the connecting arm pivots away from the central support member 1243. In the example shown, there are two pivotally connected arms 1241. However, there may be one, three, four, or any number of pivotally connected arms.

[0312] In one exemplary embodiment, the direction of expansion of the co-option element 1200 can be controlled. For example, two pivotally connected arms can be included to change the width / size of the co-option element in only one of the anterior-to-posterior direction and / or the medial-to-lateral direction. Four pivotally connected arms 1241 can be included to change the width / size of the co-option element in both the anterior-to-posterior direction and the medial-to-lateral direction. When four pivotally connected arms 1241 are included, the arms and / or connecting lines 1245 can have different lengths and / or pivot point locations to allow the co-option element 1200 to expand (or contract) separately in different directions. For example, the lengths of the arms and / or connecting lines can be selected to expand more in the medial-to-lateral direction than in the anterior-to-posterior direction.

[0313] The arms 1241 can be moved from a retracted position (FIG. 106D) to an extended position (FIG. 108D). For example, the arms 1241 can be biased toward the extended position by a spring or other biasing means. In the illustrated example, a restraint 1247, such as a suture, holds the arms 1241 in the retracted position. The restraint 1247 can be removed or broken, thereby allowing the co-option element 1200 to expand from the configuration illustrated by FIG. 106D to the configuration illustrated by FIG. 108D.

[0314] 106E and 108E show an example embodiment similar to the embodiment illustrated by FIGS. 106D and 108D, except that the co-option element includes a cover material 1253. The cover material 1253 can extend from the central support member 1243 to each arm 1241. The cover material 1253 can be used in conjunction with connecting wires 1245, or the cover material can eliminate the need for connecting wires 1245.

[0315] Referring now to FIG. 106F, an exemplary co-option element 1200 for an implantable prosthetic device is shown, similar to the embodiment illustrated by FIGS. 106-109. The co-option element 1200 can be used with any of the implantable prosthetic devices described herein. Referring to FIG. 106F, the co-option element 1200 is defined by a coil 1263 extending between two caps 1201. The co-option element 1200 can have any shape, such as any of the shapes disclosed herein. The coil 1263 can be made of a shape memory alloy, such as Nitinol.

[0316] In one exemplary embodiment, the direction of expansion of the co-option element 1200 can be controlled. For example, the shape setting of the coil 1263 can be selected to control the shape of the expanding co-option element 1200. For example, the shape setting configuration can determine the manner of width / size of the co-option element in the anterior-to-posterior direction and / or medial-to-lateral expansion (and / or contraction). By reference, axial force 1208 and / or rotational force 1209 can be applied to the cap 1201 of the co-option element 1200 to allow the co-option element 1200 to expand or contract from the configuration illustrated by FIG. 106F. In the illustrated example, extending the coil 1263 axially and twisting the coil 1263 contracts the coil in an inward direction 1211, while axially compressing the coil 1263 and twisting the coil in the opposite direction expands or expands the coil in an outward direction.

[0317] Referring to FIG. 106F, the co-option element 1200 can be compressed in a variety of different ways. For example, the threaded connection 1221 can be used to pull the two ends of the co-option element together, twisting the element in a first direction, or to push the two ends of the co-option element apart, twisting the element in a second direction. For example, collars can be fixedly connected to each end of the coil 1263. One of the collars can threadably engage a threaded shaft, and the other collar is fixedly connected to the shaft. Rotating the shaft in one direction pulls the collars together and rotates them relative to each other in a first direction. Rotating the shaft in the opposite direction moves the collars apart and rotates them relative to each other in a second direction. The pitch of the threaded connection can be selected to set the ratio between the distance the co-option element 1200 is compressed and the angle through which the co-option element twists.

[0318] Incorporating the co-option element 1200 illustrated by FIG. 106F into the implantable prosthetic device of the present application allows the co-option element to expand and push outward against tissue grasped between the co-option element and the paddles and / or grasping members.

[0319] 106G-106I show an exemplary embodiment of an expandable co-option element 1200. In the example illustrated by FIGS. 106G-106I, the co-option element is inflated with a fluid medium to expand the co-option element. The fluid medium can take a wide variety of different forms. Examples of fluids that may be used to inflate the co-option element 1200 include, but are not limited to, air, gel, water, blood, foam, and the like. The co-option element 1200 can be used in conjunction with any of the implantable prosthetic devices described herein.

[0320] Referring to FIG. 106G, the co-option element 1200 can have an outer layer 1271 (e.g., any of the co-option elements 110, 510 disclosed herein) and an inner layer 1273, or balloon. The co-option element 1200 can have any shape, such as any of the shapes disclosed herein. In the example illustrated by FIG. 106G and FIG. 1086, the inner layer 1273 is disposed within the outer layer 1271 and can have the same or generally the same shape as the inner surface of the outer layer. The inner layer can be made from an expandable material, such as rubber or other materials conventionally used in the fabrication of balloons and angioplasty devices. The outer layer 1271 can be made from a shape memory alloy, such as Nitinol.

[0321] 106H and 106I, in one exemplary embodiment, the direction of expansion of the co-option element 1200 can be controlled. In the example illustrated by FIG. 106H, the inner layer 1273 includes two balloons that are optionally connected together. However, any number of balloons can be used. For example, the inner layer can include three, four, or any number of balloons. The balloons can be individually inflated to control the shape of the expansion of the co-option element 1200. When the balloons are connected together, the connections can also affect the shape of the 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 direction 1277 is less than expansion in direction 1279 due to the connections 1275. Thus, in this example, expansion upon inflation can be limited, or substantially limited, to expansion from the medial to the lateral direction.

[0322] The use of multiple balloons and the configuration of any connections between the balloons can determine the width / size pattern of the co-option element in the anterior to posterior direction and / or in the medial to lateral direction for expansion (and / or contraction).

[0323] In the embodiment illustrated by FIG. 106I, the inner layer 1273 includes one or more supports 1281 or struts. While one support 1281 is shown, any number can be used. For example, the inner layer can include two, three, four, or any number of supports. The supports 1281 can divide the inner layer into multiple independently inflatable chambers, or the supports do not seal the independent chambers, and inflation fluid applied to some of the chambers fills all of the chambers. With independently inflatable chambers, the chambers can be individually inflated to control the shape of the expansion of the co-option element 1200. The supports also influence the shape of the expansion. In the embodiment illustrated by FIG. 106I, the supports 1281 reduce or eliminate expansion of the inner layer 1273 in direction 1277. Thus, in this embodiment, expansion upon inflation can be limited, or substantially limited, to expansion from the medial to the lateral direction.

[0324] The use of multiple independently inflatable chambers and / or the configuration of the support member 1281 can determine the width / size pattern of the co-option element in expansion (and / or contraction) in the anterior to posterior direction and / or medial to lateral direction.

[0325] Incorporating the co-option element 1200 illustrated by Figures 106G-106I into the implantable prosthetic devices of the present application allows the co-option element to expand and push outward against tissue grasped between the co-option element and the paddles and / or grasping members.

[0326] 110-111 , an exemplary implantable prosthetic device 1300 is shown. The device 1300 is similar to the device 100 described above and includes a cor-option element 1310, a paddle 1320, and a clasp or gripping member 1330. Referring now to FIG. 111 , a top view of the cor-option element 1310 is shown. As seen in FIG. 111 , the cor-option element 1310 has an oval or nearly oval cross-section. The cor-option element 1310 does not include a central opening and may be formed from a solid piece of material, such as foam. Forming the cor-option element 1310 from a solid piece of foam material prevents blood from flowing through the center of the cor-option element 1310, thereby substantially eliminating a location where blood may become trapped. Device 1300 can include any other features of implantable prosthetic devices discussed herein, and device 1300 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed herein). Prosthetic device 1300 can be opened and closed in a variety of different ways. For example, a sleeve can be slidably positioned over a co-option element to engage and release paddles. Alternatively, paddles can be opened by pulling a line or suture that opens a clasp, and movement of the clasp opens the paddles. However, any mechanism for opening and closing device 1300 may be used.

[0327] 112-128 , an exemplary paddle frame 1400 for an implantable prosthetic device is shown. The paddle frame 1400 can be used in conjunction with any of the implantable prosthetic devices described herein. 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 central portion 1424, and a distal portion 1426. In some embodiments, the paddle frame 1400 includes an attachment portion 1440 for securing a cover (see FIG. 30 ), an inner paddle 522, and / or an outer paddle 520 to the paddle frame 1400. In some embodiments, the paddle frame 1400 is thinner at the location of the fifth curve 1438 to facilitate bending the sides of the paddle frame 1400 toward the center plane 1404, for example, during crimping of the device.

[0328] The paddle frame 1400 extends from the first mounting portion 1412 in a rounded, three-dimensional shape through a proximal portion 1422, a central portion 1424, and a distal portion 1426, and back to the second mounting portion 1414. To form the rounded, three-dimensional shape, the paddle frame 1400 is bent or curved in multiple locations as the paddle frame 1400 extends between the first mounting portion 1412 and the second mounting portion 1414. The mounting portions 1412, 1414 include notches 1416, 1418, respectively, for attachment to a cap. The paddle frame 1400 flexes in a region 1419. The region 1419 may include a wider portion 1417 to distribute stress resulting from bending the paddle frame 1400 over a larger area. Notches 1416, 1418 may also include a radiused notch 1415 at each end of the notch. Radiused notch 1415 acts as a strain relief for bend region 1419 and the area where paddle frame 1400 connects to the cap.

[0329] The paddle frame 1400 curves away from the center or central plane 1404 ( FIG. 115 ) at a first curve 1430, causing the paddle frame 1400 to expand in shape. As can be seen in FIG. 117 , the paddle frame 1400 also curves away from the front plane 1406 at 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, forming the sides of the frame 1400. The paddle frame continues to slope away from the front plane 1406 at 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 anterior 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 anterior plane 1406. This curvature at the third curve 1434 results in a gradual deviation of the frame 1400, thus causing the native valve leaflets to deviate from the centerline 1406. This deviation from the centerline results in a spreading of the leaflet tissue toward the 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 anterior plane 1406. The rounded three-dimensional shape of the paddle frame 1400 is closed by a fifth curve 1438, which joins both sides of the paddle frame 1400. 116 and 118, the paddle frame 1400 has an arcuate or generally arcuate shape as the frame 1400 extends away from the attachment portion 1420 and into the closure portion 1424. The central portion 1424 of the frame is closer to the front plane 1406 than the closure portion 1426, thereby giving the sides of the central portion 1424 a rounded, wing-like shape that engages with the curved surfaces of a co-option element (not shown) during grasping of native tissue between the paddles (not shown) and the co-option element of an implantable device of the present invention.

[0330] 191, in an exemplary embodiment, a flat blank 1403 of a paddle frame 1400 can be cut (e.g., laser cut) from a flat sheet of material. Referring to FIG. 192, the cut blank 1403 can then be bent to form the three-dimensional shaped paddle frame 1400.

[0331] 193 and 194, in one exemplary embodiment, the paddle frame 1400 may be shaped to provide an increased clamping force against or toward the co-option element 510 when the paddles 520, 522 are...

Claims

1. 1. A valve repair device for repairing a native valve in a patient, said valve repair device comprising: a strip of material; a co-option element comprising a strip of said material; a collar connected to the cooption element; a pair of paddles formed from the strip of material and connected to the co-option element, the paddles being movable between an open position and a closed position; A valve repair device, wherein the paddles are configured to attach to the patient's native valve.

2. The valve repair device of claim 1 , wherein the collar is spaced from the paddle.

3. The valve repair device of claim 1 or 2, wherein the collar is connected to a proximal end of the co-option element.

4. The valve repair device of claim 2 or 3, wherein the paddle is connected to a distal end of the co-option element.

5. The valve repair device of any one of claims 1 to 4, wherein the strip of material is woven through at least one opening in the collar.

6. The valve repair device of any one of claims 1 to 5, wherein the strip of material is woven through two openings in the collar.

7. The valve repair device of any one of claims 1 to 6, wherein the strip of material is woven through at least one arcuate shaped opening in the collar.

8. The valve repair device of claim 7 , wherein the at least one opening comprises an open slot.

9. The valve repair device of any one of claims 1 to 8, wherein the strip of material comprises metal strands woven together.

10. The valve repair device of any one of claims 1 to 9, wherein the paddle comprises an inner paddle portion and an outer paddle portion.

11. The valve repair device of any one of claims 1 to 10, wherein the paddle is disposed on an extension member.

12. a shaft extending through the collar; a cap attached to the shaft such that the cap can be moved away from the collar by the shaft; Both of the pair of paddles are attached to the cap, 12. The valve repair device of claim 1, wherein movement of the cap toward the collar moves the pair of paddles to the closed position and movement of the cap away from the collar moves the pair of paddles to the open position.

13. The valve repair device of claim 12 , wherein the shaft extends through a central aperture in the collar.

14. The valve repair device of any one of claims 1 to 13, 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 movable arm.

15. 1. A valve repair device for repairing a native valve in a patient, said valve repair device comprising: a strip of material; a co-option element comprising a strip of said material; a pair of paddles formed from the strip of material and connected to the co-option element, the paddles being movable between an open position and a closed position and configured for attachment to the patient's native valve; a cap attached to the paddles, wherein movement of the cap toward the co-option element moves the pair of paddles to the closed position, and movement of the cap away from the co-option element moves the pair of paddles to the open position; and a pair of extension members connected to the cap and movable between an open position and a closed position, wherein in the closed position the extension members are biased in a closing direction.

16. 16. The valve repair device of claim 15, wherein the extension member is configured in a preload position, the extension member being biased in the closing direction to apply a clamping force in the closing direction.

17. The valve repair device of claim 15 or 16, wherein the extension member comprises a hoop.

18. The valve repair device of any one of claims 15 to 17, wherein the paddle comprises an inner paddle portion and an outer paddle portion.

19. The valve repair device of any one of claims 15 to 18, wherein the strip of material comprises metal strands woven together.

Images