Patent Publication Number: US-2022233312-A1

Title: Heart valve sealing devices and delivery devices therefor

Description:
RELATED APPLICATIONS 
     The present application is a continuation of PCT/US2020/055482, filed on Oct. 14, 2020, which claims the benefit of U.S. Provisional Patent Application No. 62/915,589, filed on Oct. 15, 2019, titled “Heart Valve Sealing Devices and Delivery Devices Therefor,” which are incorporated herein by reference in their entireties for all purposes. 
    
    
     BACKGROUND OF THE INVENTION 
     The native heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be damaged, and thus rendered less effective, by congenital malformations, inflammatory processes, infectious conditions, disease, etc. Such damage to the valves can result in serious cardiovascular compromise or death. Damaged valves can be surgically repaired or replaced during open heart surgery. However, open heart surgeries are highly invasive and complications may occur. Transvascular techniques can be used to introduce and implant prosthetic devices in a manner that is much less invasive than open heart surgery. As one example, a transseptal technique could be used, e.g., comprising inserting a catheter into the right femoral vein, up the inferior vena cava and into the right atrium, puncturing the septum, and passing the catheter into the left atrium. 
     A healthy heart has a generally conical shape that tapers to a lower apex. The heart is four-chambered and comprises the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair of cusps, or leaflets, extending downward from the annulus into the left ventricle. The mitral valve annulus can form a “D”-shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. The anterior leaflet can be larger than the posterior leaflet, forming a generally “C”-shaped boundary between the abutting sides of the leaflets when they are closed together. 
     When operating properly, the anterior leaflet and the posterior leaflet function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also referred to as “ventricular diastole” or “diastole”), the oxygenated blood that is collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also referred to as “ventricular systole” or “systole”), the increased blood pressure in the left ventricle urges the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle. 
     Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium from the left ventricle during the systolic phase of heart contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral valve annulus resulting from dilation of the left ventricle, more than one of these, etc. Mitral regurgitation at a central portion of the leaflets can be referred to as central jet mitral regurgitation and mitral regurgitation nearer to one commissure (i.e., location where the leaflets meet) of the leaflets can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle and thus the valve does not close, and regurgitation is present. 
     A technique for treating mitral and other valvular regurgitation in patients may include securing edges of the native valve leaflets directly to one another. For example, a catheter delivered clip may be used to attempt to clip the sides of the leaflets together at the end portions of the leaflets. But significant challenges exist. For example, multiple clips may be required to eliminate or reduce regurgitation to an acceptable level, but in some circumstances, this can result in longer operation times and may result in over-restricted flow or undesirable stresses on the native anatomy. 
     Despite these prior techniques, there is a continuing need for improved devices and methods for treating valvular regurgitation. 
     SUMMARY 
     This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here. 
     An example implantable prosthetic device has a coaption element and at least one anchor. The coaption element is configured to be positioned within the native heart valve orifice to help fill a space where the native valve is regurgitant and form a more effective seal. The coaption element can have a structure that is impervious to blood (or otherwise inhibits blood) and that allows the native leaflets to close around the coaption element during ventricular systole to block blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The coaption element can be connected to leaflets of the native valve by the anchor. 
     In one example embodiment, a valve repair device for repairing a native valve of a patient includes a coaption element, and one or more anchor portions. The coaption element can be formed from a solid or hollow piece of material by a variety of different processes, such as molding, three-dimensional printing, casting, etc. The one or more anchor portions are moveable between an open position and a closed position. 
     In one example embodiment, a valve repair device for repairing a native valve of a patient includes a main shaft, a coaption member, at least one paddle, at least one clasp, an actuation shaft, and a cap. An attachment projection extends outward from the main shaft. 
     In some embodiments, the coaption member includes a central opening, a groove along the central opening, and at least one engagement recess. The central opening can be configured to receive the main shaft. The groove along the central opening can be configured to allow the attachment projection of the main shaft to pass through the coaption portion. 
     In some embodiments, the at least one engagement recess receives the attachment projection of the main shaft. 
     In some embodiments, the actuation shaft extends through the main shaft. 
     In some embodiments, the cap is attached to the actuation shaft such that the cap can be moved by the actuation shaft away from the main shaft. 
     The paddle portions are moveable between an open position and a closed position. 
     In some embodiments, the least one clasp is attached to each of the paddle portions. 
     In some embodiments, movement of the cap toward the main shaft causes the paddle portions to move to the closed position, and movement of the cap away from the main shaft causes the paddle portions to move to the open position. 
     In one example embodiment, a valve repair device for repairing a native valve of a patient includes a main shaft, a coaption member, an actuation shaft, a cap, and one or more paddles. In some embodiments, the main shaft has at least one paddle opening. 
     In some embodiments, an attachment projection extends outward from the main shaft. 
     In some embodiments, the actuation shaft extends through the main shaft. 
     In some embodiments, the cap is attached to the actuation shaft such that the cap can be moved by the actuation shaft away from the main shaft. 
     In some embodiments, the cap includes one or more paddle openings. 
     In some embodiments, the plurality of paddle portions are moveable between an open position and a closed position. 
     In some embodiments, a proximal end of each paddle is inserted into one of the plurality of paddle openings in the main shaft. 
     In some embodiments, a distal end of each paddle is inserted into a paddle opening in the cap. 
     In some embodiments, movement of the cap toward the main shaft causes the paddle portions to move to the closed position, and movement of the cap away from the main shaft causes the paddle portions to move to the open position. 
     In one example embodiment, a valve repair device for repairing a native valve of a patient includes a main shaft, a coaption member, one or more paddles, an actuation shaft, and a spreading member. The actuation shaft extends through the main shaft. The spreading member is moveable between an engaged position and a disengaged position. The one or more paddles are moveable between an open position and a closed position. The cam portion is moveable to causes the cam portion to engage the paddles to spread the paddles apart. 
     In one example embodiment, a valve repair device includes a coaption element and an anchor portion. The coaption element including a plurality of cutouts or openings that allow the coaption element to be compressed to fit within a delivery catheter. 
     A further understanding of the nature and advantages of the present invention are set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       To further clarify various aspects of embodiments of the present disclosure, a more particular description of the certain embodiments will be made by reference to various aspects of the appended drawings. It is appreciated that these drawings depict only typical embodiments of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures can be drawn to scale for some embodiments, the figures are not necessarily drawn to scale for all embodiments. Embodiments and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1  illustrates a cutaway view of the human heart in a diastolic phase; 
         FIG. 2  illustrates a cutaway view of the human heart in a systolic phase; 
         FIG. 3  is another cutaway view of the human heart in a systolic phase showing mitral regurgitation; 
         FIG. 4  is the cutaway view of  FIG. 3  annotated to illustrate a natural shape of mitral valve leaflets in the systolic phase; 
         FIG. 5  illustrates a healthy mitral valve with the leaflets closed as viewed from an atrial side of the mitral valve; 
         FIG. 6  illustrates a dysfunctional mitral valve with a visible gap between the leaflets as viewed from an atrial side of the mitral valve; 
         FIG. 7  illustrates a tricuspid valve viewed from an atrial side of the tricuspid valve; 
         FIGS. 8-14  show an example embodiment of an implantable prosthetic device, in various stages of deployment; 
         FIG. 15  shows an example embodiment of an implantable prosthetic device that is similar to the device illustrated by  FIGS. 8-14 , but where the paddles are independently controllable; 
         FIGS. 16-21  show the implantable prosthetic device of  FIGS. 8-14  being delivered and implanted within the native mitral valve; 
         FIG. 22  shows a perspective view of an example implantable prosthetic device in a closed position; 
         FIG. 23  shows a front view of the implantable prosthetic device of  FIG. 22 ; 
         FIG. 24  shows a side view of the implantable prosthetic device of  FIG. 22 ; 
         FIG. 25  shows a front view of the implantable prosthetic device of  FIG. 22  with a cover covering the paddles and coaption element; 
         FIG. 26  shows a top perspective view of the implantable prosthetic device of  FIG. 22  in an open position; 
         FIG. 27  shows a bottom perspective view of the implantable prosthetic device of  FIG. 22  in an open position; 
         FIG. 28  shows a barbed clasp for use in an implantable prosthetic device; 
         FIG. 29  shows a portion of native valve tissue grasped by a barbed clasp; 
         FIG. 30  shows a side view of an example implantable prosthetic device in a partially-open position with barbed clasps in a closed position; 
         FIG. 31  shows a side view of an example implantable prosthetic device in a partially-open position with barbed clasps in an open position; 
         FIG. 32  shows a side view of an example implantable prosthetic device in a half-open position with barbed clasps in a closed position; 
         FIG. 33  shows a side view of an example implantable prosthetic device in a half-open position with barbed clasps in an open position; 
         FIG. 34  shows a side view of an example implantable prosthetic device in a three-quarters-open position with barbed clasps in a closed position; 
         FIG. 35  shows a side view of an example implantable prosthetic device in a three-quarters-open position with barbed clasps in an open position; 
         FIG. 36  shows a side view of an example implantable prosthetic device in a full bailout position with barbed clasps in a closed position; 
         FIG. 37  shows a side view of an example implantable prosthetic device in a full bailout position with barbed clasps in an open position; 
         FIGS. 38-49  show the implantable prosthetic device of  FIGS. 30-38 , including a cover, being delivered and implanted within the native mitral valve; 
         FIG. 50  is a schematic view illustrating a path of native valve leaflets along each side of a coaption element of valve repair device; 
         FIG. 51  is a top schematic view illustrating a path of native valve leaflets around a coaption element of a valve repair device; 
         FIG. 52  illustrates a coaption element in the gap of the mitral valve as viewed from an atrial side of the mitral valve; 
         FIG. 53  illustrates a valve repair device attached to mitral valve leaflets with the coaption element in the gap of the mitral valve as viewed from a ventricular side of the mitral valve; 
         FIG. 54  is a perspective view of a valve repair device attached to mitral valve leaflets with the coaption element in the gap of the mitral valve shown from a ventricular side of the mitral valve; 
         FIG. 55  shows a perspective view of an example implantable prosthetic device in a closed position; 
         FIG. 56  shows a perspective view of an example barbed clasp of an example implantable prosthetic device in a closed position; 
         FIGS. 57-64  illustrate the movement of the paddles of an example implantable prosthetic device; 
         FIG. 65  shows a top perspective view of an example implantable prosthetic device in a closed position; 
         FIG. 66  shows a bottom perspective view of the implantable prosthetic device of  FIG. 65 ; 
         FIG. 67  shows a front view of the implantable prosthetic device of  FIG. 65 ; 
         FIG. 68  shows a side view of the implantable prosthetic device of  FIG. 65 ; 
         FIG. 69  shows a top view of the implantable prosthetic device of  FIG. 65 ; 
         FIG. 70  shows a bottom view of the implantable prosthetic device of  FIG. 65 ; 
         FIG. 71  shows a perspective exploded view of the components of the implantable prosthetic device of  FIG. 65 ; 
         FIG. 71A  shows a perspective view of the components of an example implantable prosthetic device; 
         FIG. 72  shows a top perspective view of the implantable prosthetic device of  FIG. 65  in an open position; 
         FIG. 73  shows a bottom perspective view of the implantable prosthetic device of  FIG. 72 ; 
         FIG. 74  shows a front view of the implantable prosthetic device of  FIG. 72 ; 
         FIG. 75  shows a side view of the implantable prosthetic device of  FIG. 72 ; 
         FIG. 76  shows a top view of the implantable prosthetic device of  FIG. 72 ; 
         FIG. 77  shows a bottom view of the implantable prosthetic device of  FIG. 72 ; 
         FIG. 78  shows a top perspective view of the paddles and actuating components of the implantable prosthetic device of  FIG. 72 ; 
         FIG. 79  shows a bottom perspective view of the implantable prosthetic device of  FIG. 78 ; 
         FIG. 80  shows a front view of the implantable prosthetic device of  FIG. 78 ; 
         FIG. 81  shows a top perspective view of an example implantable prosthetic device attached to a delivery system; 
         FIG. 82  shows a top perspective view of the implantable prosthetic device of  FIG. 81  with the delivery system in an open and retracted position; 
         FIG. 83  shows a bottom perspective view of the example implantable prosthetic device of  FIG. 81 ; 
         FIG. 84  shows a bottom perspective view of the implantable prosthetic device of  FIG. 82 ; 
         FIG. 85  shows a front view of the example implantable prosthetic device of  FIG. 81 ; 
         FIG. 86  shows a front view of the implantable prosthetic device of  FIG. 82 ; 
         FIG. 87  shows a front view of the example implantable prosthetic device of  FIG. 81 ; 
         FIG. 88  shows a front view of the implantable prosthetic device of  FIG. 82 ; 
         FIG. 89  shows a top perspective view of a main shaft of an example implantable device; 
         FIG. 90  shows a bottom perspective view of the main shaft of  FIG. 89 ; 
         FIG. 91  shows a front view of the main shaft of  FIG. 89 ; 
         FIG. 92  shows a side view of the main shaft of  FIG. 89 ; 
         FIG. 93  shows a top view of the main shaft of  FIG. 89 ; 
         FIG. 94  shows a bottom view of the main shaft of  FIG. 89 ; 
         FIG. 95  shows a top perspective view of a coaption element of an example implantable device; 
         FIG. 96  shows a bottom perspective view of the coaption element of  FIG. 95 ; 
         FIG. 97  shows a front view of the coaption element of  FIG. 95 ; 
         FIG. 98  shows a side view of the coaption element of  FIG. 95 ; 
         FIG. 99  shows a top view of the coaption element of  FIG. 95 ; 
         FIG. 100  shows a bottom view of the coaption element of  FIG. 95 ; 
         FIGS. 101-105  show the assembly of an example coaption element and main shaft; 
         FIG. 106  shows a top perspective view of a paddle of an example implantable prosthetic device; 
         FIG. 107  shows a bottom perspective view of the paddle of  FIG. 106 ; 
         FIG. 108  shows a left side view of the paddle of  FIG. 106 ; 
         FIG. 109  shows a front view of the paddle of  FIG. 106 ; 
         FIG. 110  shows a right-side view of the paddle of  FIG. 106 ; 
         FIG. 111  shows a top view of the paddle of  FIG. 106 ; 
         FIG. 112  shows a bottom view of the paddle of  FIG. 106 ; 
         FIGS. 113-114  show the paddle of  FIG. 106  laser cut from a flat sheet of material; 
         FIG. 115  shows a top perspective view of a paddle of an example implantable prosthetic device; 
         FIG. 116  shows a bottom perspective view of the paddle of  FIG. 106 ; 
         FIG. 117  shows a left side view of the paddle of  FIG. 106 ; 
         FIG. 118  shows a front view of the paddle of  FIG. 106 ; 
         FIG. 119  shows a right-side view of the paddle of  FIG. 106 ; 
         FIG. 120  shows a top view of the paddle of  FIG. 106 ; 
         FIG. 121  shows a bottom view of the paddle of  FIG. 106 ; 
         FIG. 122  shows a top perspective view of a spreading member of an example implantable device; 
         FIG. 123  shows a bottom perspective view of the spreading member of  FIG. 122 ; 
         FIG. 124  shows a side view of the spreading member of  FIG. 122 ; 
         FIG. 125  shows a front view of the spreading member of  FIG. 122 ; 
         FIG. 126  shows a top view of the spreading member of  FIG. 122 ; 
         FIG. 127  shows a bottom view of the spreading member of  FIG. 122 ; 
         FIG. 128  shows a top perspective view of the components of a distal nut assembly of an example implantable device in a disassembled condition; 
         FIG. 129  shows the distal nut assembly of  FIG. 128  in an assembled condition; 
         FIG. 130  shows a top perspective view of an actuation element, a spreading member, and a distal nut assembly of an example implantable device in a disassembled condition; 
         FIG. 131  shows a bottom perspective view of the components of  FIG. 130 ; 
         FIG. 132  shows a front view of the components of  FIG. 130 ; 
         FIG. 133  shows a side view of the components of  FIG. 130 ; 
         FIG. 134  shows a top perspective view of an actuation element, a spreading member, and a distal nut assembly of an example implantable device in an assembled condition; 
         FIG. 135  shows a bottom perspective view of the components of  FIG. 134 ; 
         FIG. 136  shows a front view of the components of  FIG. 134 ; 
         FIG. 137  shows a side view of the components of  FIG. 134 ; 
         FIG. 138  shows a top perspective view of an actuation element, a spreading member, and a distal nut assembly of an example implantable device in a disassembled condition; 
         FIG. 139  shows a bottom perspective view of the components of  FIG. 138 ; 
         FIG. 140  shows a front view of the components of  FIG. 138 ; 
         FIG. 141  shows a side view of the components of  FIG. 138 ; 
         FIG. 142  shows a top perspective view of an actuation element, a spreading member, and a distal nut assembly of an example implantable device in an assembled condition; 
         FIG. 143  shows a bottom perspective view of the components of  FIG. 142 ; 
         FIG. 144  shows a front view of the components of  FIG. 142 ; 
         FIG. 145  shows a side view of the components of  FIG. 142 ; 
         FIG. 146  shows a top perspective view of paddle frames and a distal nut assembly of an example implantable device in a disassembled condition; 
         FIG. 147  shows a bottom perspective view of the components of  FIG. 146 ; 
         FIG. 148  shows a side view of the components of  FIG. 146 ; 
         FIG. 149  shows a top perspective view of paddle frames and a distal nut assembly of an example implantable device in an assembled condition; 
         FIG. 150  shows a bottom perspective view of the components of  FIG. 149 ; 
         FIG. 151  shows a side view of the components of  FIG. 149 ; 
         FIG. 152  shows a top perspective view of the components of  FIG. 149  with the paddle frames in a shape setting position; 
         FIG. 153  shows a top perspective view of paddles, paddle frames, and a distal nut assembly in an assembled condition; 
         FIG. 154  shows a bottom perspective view of the components of  FIG. 153 ; 
         FIG. 155  shows a side view of the components of  FIG. 153 ; 
         FIG. 156  shows a top perspective, partially cutaway, view of components of an example implantable device; 
         FIG. 157  shows a bottom perspective, partially cutaway, view of the components of an implantable device of  FIG. 156 ; 
         FIG. 158  shows a side, partially sectioned, view of the components of an implantable device of  FIG. 156 ; 
         FIG. 159  shows an enlarged detail view of the area  159  of  FIG. 156 ; 
         FIG. 160  shows an enlarged detail view of the area  160  of  FIG. 157 ; 
         FIG. 161  shows a top perspective view of paddles of an example implantable device; 
         FIG. 162  shows a bottom perspective view of the paddles of  FIG. 161 ; 
         FIG. 163  shows a top perspective view of a bottom portion of paddles, paddle frames, and a distal nut assembly of an example implantable device in a disassembled condition; 
         FIG. 164  shows a top perspective view of a portion of paddles, paddle frames, and a distal nut assembly of an example implantable device in an assembled condition; 
         FIG. 165  shows a top perspective view of a barbed clasp of an example implantable device; 
         FIG. 166  shows a top perspective view of a laser cut blank for the barbed clasp of  FIG. 165 ; 
         FIG. 167  shows a top view of the barbed clasp blank of  FIG. 166 ; 
         FIGS. 168-171  show a top perspective view of the deployment of a spreading member of an example implantable device; 
         FIGS. 172-175  show a bottom perspective view of the deployment of a spreading member of an example implantable device; 
         FIG. 176  shows a front view of an example implantable device with a spreading member in a stowed condition; 
         FIG. 177  shows a front view of an example implantable device with a spreading member in a deployed condition; 
         FIG. 178  shows a side view of the example implantable device of  FIG. 176 ; 
         FIG. 179  shows a side view of the example implantable device of  FIG. 177 ; 
         FIG. 180  shows a front view of an example implantable device with some of the components removed and with the paddles and barbed claps in a capture-ready condition; 
         FIG. 181  shows a front view of the example implantable device of  FIG. 180  with paddles engaged by a deployed spreading member; 
         FIG. 182  shows a front view of the example implantable device of  FIG. 180  with barbed clasps closed and paddles partially closed to capture the native leaflets; and 
         FIG. 183  shows a front view of the example implantable device of  FIG. 180  in a fully closed condition and with the spreading member in a stowed condition; 
         FIG. 184  shows a top perspective view of an example compressible coaption element; 
         FIG. 185  shows a side view of the compressible coaption element of  FIG. 184 ; 
         FIG. 186  shows a front view of the compressible coaption element of  FIG. 184 ; 
         FIG. 187  shows a top view of the compressible coaption element of  FIG. 184 ; 
         FIG. 188  shows a front schematic view of the compressible coaption element of  FIG. 185  in a compressed state; 
         FIG. 189  shows a top perspective view of an example compressible coaption element; 
         FIG. 190  shows a side view of the compressible coaption element of  FIG. 189 ; 
         FIG. 191  shows a front view of the compressible coaption element of  FIG. 189 ; 
         FIG. 192  shows a top view of the compressible coaption element of  FIG. 189 ; 
         FIG. 193  shows a front schematic view of the compressible coaption element of  FIG. 189  in a compressed state; 
         FIG. 194  shows a top perspective view of an example compressible coaption element; 
         FIG. 195  shows a side view of the compressible coaption element of  FIG. 194 ; 
         FIG. 196  shows a front view of the compressible coaption element of  FIG. 194 ; 
         FIG. 197  shows a top view of the compressible coaption element of  FIG. 194 ; 
         FIG. 198  shows a front schematic view of the compressible coaption element of  FIG. 194  in a compressed state; 
         FIG. 199  shows a top perspective view of an example compressible coaption element; 
         FIG. 200  shows a side view of the compressible coaption element of  FIG. 199 ; 
         FIG. 201  shows a front view of the compressible coaption element of  FIG. 199 ; 
         FIG. 202  shows a top view of the compressible coaption element of  FIG. 199 ; 
         FIG. 203  shows a front schematic view of the compressible coaption element of  FIG. 199  being moved to a compressed state; 
         FIG. 204  shows a top perspective view of an example compressible coaption element; 
         FIG. 205  shows a side view of the compressible coaption element of  FIG. 204 ; 
         FIG. 206  shows a front view of the compressible coaption element of  FIG. 204 ; 
         FIG. 207  shows a top view of the compressible coaption element of  FIG. 204 ; 
         FIG. 208  shows a front schematic view of the compressible coaption element of  FIG. 204  being moved to a compressed state; 
         FIG. 209  shows a top perspective view of an example compressible coaption element; 
         FIG. 210  shows a side view of the compressible coaption element of  FIG. 209 ; 
         FIG. 211  shows a front view of the compressible coaption element of  FIG. 209 ; 
         FIG. 212  shows a top view of the compressible coaption element of  FIG. 209 ; and 
         FIG. 213  shows a top schematic view of the compressible coaption element of  FIG. 209  being moved to a compressed state. 
     
    
    
     DETAILED DESCRIPTION 
     The following description refers to the accompanying drawings, which illustrate specific embodiments of the present disclosure. Other embodiments having different structures and operation do not depart from the scope of the present disclosure. 
     Example embodiments of the present disclosure are directed to devices and methods for repairing a defective heart valve. It should be noted that various embodiments of native valve reparation devices and systems for delivery are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible. 
     As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection may be direct as between the components or may be indirect such as through the use of one or more intermediary components. Also as described herein, reference to a “member,” “component,” or “portion” shall not be limited to a single structural member, component, or element but can include an assembly of components, members, or elements. Also as described herein, the terms “substantially” and “about” are defined as at least close to (and includes) a given value or state (preferably within 10% of, more preferably within 1% of, and most preferably within 0.1% of). 
     The implantable prosthetic devices disclosed herein can take on a wide variety of forms and can incorporate a wide variety of features and methods of operation of implantable prosthetic devices as shown and described in International Application No. PCT/US2018/028171, filed on Apr. 18, 2018, International Application No. PCT/US2019/028041, filed on Apr. 18, 2019, U.S. patent application Ser. No. 16/123,105, filed on Sep. 6, 2018, International Application No. PCT/US2018/031959, filed on May 10, 2018, International Application No. PCT/US2018/028189, Filed on Apr. 18, 2018, International Application No. PCT/US2018/045985, filed on Aug. 9, 2018, U.S. Provisional Patent Application Ser. No. 62/744,031, filed on Oct. 10, 2018, U.S. Provisional Patent Application Ser. No. 62/803,854, filed on Feb. 11, 2019, U.S. Provisional Patent Application Ser. No. 62/809,856, flied on Feb. 25, 2019, U.S. Provisional Patent Application Ser. No. 62/808,377, Filed on Feb. 21, 2019, U.S. Provisional Patent Application Ser. No. 62/805,847, filed on 14 Feb. 2019, and International Application No. PCT/US16/32462, Filed on May 13, 2016, each of which are incorporated herein by reference in its entirety, which are incorporated herein by reference in their entirety. 
       FIGS. 1 and 2  are cutaway views of the human heart H in diastolic and systolic phases, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV; i.e., the atrioventricular valves. Additionally, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets  20 ,  22  shown in  FIGS. 3-7 ) extending inward across the respective orifices that come together or “coapt” in the flow stream to form the one-way, fluid-occluding surfaces. The native valve repair systems of the present application are described primarily with respect to the mitral valve MV. Therefore, anatomical structures of the left atrium LA and left ventricle LV will be explained in greater detail. It should be understood that the devices described herein may also be used in repairing other native valves, e.g., the devices can be used in repairing the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV. 
     The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, seen in  FIG. 1 , the blood that was previously collected in the left atrium LA (during the systolic phase) moves through the mitral valve MV and into the left ventricle LV by expansion of the left ventricle LV. In the systolic phase, or systole, seen in  FIG. 2 , the left ventricle LV contracts to force the blood through the aortic valve AV and ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close to prevent the blood from regurgitating from the left ventricle LV back into the left atrium LA and blood is collected in the left atrium from the pulmonary vein. In one example embodiment, the devices described by the present application are used to repair the function of a defective mitral valve MV. That is, the devices are configured to help close the leaflets of the mitral valve to prevent blood from regurgitating from the left ventricle LV and back into the left atrium LA. The devices described in the present application are designed to easily grasp and secure the native leaflets around an optional coaption element or spacer that acts as a filler in the regurgitant orifice to prevent or inhibit back flow or regurgitation during systole. In this application, the terms coaption element, spacer, spacer element, and coaptation element and refers to a component that fills a portion of a space between a native heart valve, such as a mitral valve or a tricuspid valve. 
     Referring now to  FIGS. 1-7 , the mitral valve MV includes two leaflets, the anterior leaflet  20  and the posterior leaflet  22 . The mitral valve MV also includes an annulus  24 , which is a variably dense fibrous ring of tissues that encircles the leaflets  20 ,  22 . Referring to  FIGS. 3 and 4 , the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., the muscles located at the base of the chordae tendineae CT and within the walls of the left ventricle LV) to the leaflets  20 ,  22  of the mitral valve MV. The papillary muscles PM serve to limit the movements of leaflets  20 ,  22  of the mitral valve MV to prevent the mitral valve MV from being reverted. The mitral valve MV opens and closes in response to relative pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Rather, the papillary muscles PM support or brace the leaflets  20 ,  22  against the high pressure necessary to circulate blood throughout the body. Together the papillary muscles PM and the chordae tendineae CT are known as the subvalvular apparatus, which functions to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As seen from a Left Ventricular Outflow Tract (LVOT) view shown in  FIG. 3 , the anatomy of the leaflets  20 ,  22  is such that the inner sides of the leaflets coapt at the free end portions and the leaflets  20 ,  22  start receding or spreading apart from each other. The leaflets  20 ,  22  spread apart in the atrial direction, until each leaflet meets with the mitral annulus. 
     Various disease processes can impair proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow&#39;s Disease, fibroelastic deficiency), inflammatory processes (e.g., Rheumatic Heart Disease), and infectious processes (e.g., endocarditis). In addition, damage to the left ventricle LV or the right ventricle RV from prior heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy) can distort a native valve&#39;s geometry, which can cause the native valve to dysfunction. However, the vast majority of patients undergoing valve surgery, such as surgery to the mitral valve MV, suffer from a degenerative disease that causes a malfunction in a leaflet (e.g., leaflets  20 ,  22 ) of a native valve (e.g., the mitral valve MV), which results in prolapse and regurgitation. 
     Generally, a native valve may malfunction in two different ways: (1) valve stenosis; and (2) valve regurgitation. Valve stenosis occurs when a native valve does not open completely and thereby causes an obstruction of blood flow. Typically, valve stenosis results from buildup of calcified material on the leaflets of a valve, which causes the leaflets to thicken and impairs the ability of the valve to fully open to permit forward blood flow. The second type of valve malfunction, valve regurgitation, occurs when the leaflets of the valve do not close completely thereby causing blood to leak back into the prior chamber (e.g., causing blood to leak from the left ventricle to the left atrium). 
     There are three main mechanisms by which a native valve becomes regurgitant—or incompetent—which include Carpentier&#39;s type I, type II, and type III malfunctions. A Carpentier&#39;s type I malfunction involves the dilation of the annulus such that normally functioning leaflets are distracted from each other and fail to form a tight seal—i.e., the leaflets do not coapt properly. Included in a type I mechanism malfunction are perforations of the leaflets, as are present in endocarditis. A Carpentier&#39;s type II malfunction involves prolapse of one or more leaflets of a native valve above a plane of coaption. A Carpentier&#39;s type III malfunction involves restriction of the motion of one or more leaflets of a native valve such that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or dilation of a ventricle (Mb). 
     Referring to  FIG. 5 , when a healthy mitral valve MV is in a closed position, the anterior leaflet  20  and the posterior leaflet  22  coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Referring to  FIGS. 3 and 6 , mitral regurgitation MR when the edges of the leaflets  20 ,  22  are not in contact with each other. This failure to coapt causes a gap  26  between the anterior leaflet  20  and the posterior leaflet  22 , which allows blood to flow back into the left atrium LA from the left ventricle LV during systole, as illustrated by the mitral regurgitation MR flow path shown in  FIG. 3 . The gap  26  can have a width W between about 2.5 mm and about 17.5 mm, between about 5 mm and about 15 mm, between about 7.5 mm and about 12.5 mm, or about 10 mm. In some situations, the gap  26  can have a width W greater than 15 mm. As set forth above, there are several different ways that a leaflet (e.g. leaflets  20 ,  22  of mitral valve MV) may malfunction, which can thereby lead to regurgitation. 
     In any of the above-mentioned situations, a valve repair device is desired that is capable of engaging the anterior leaflet  20  and the posterior leaflet  22  to close the gap  26  and prevent regurgitation of blood through the mitral valve MV. As can be seen in  FIG. 4 , an abstract representation of a valve repair device  10  is shown implanted between the leaflets  20 ,  22  such that regurgitation does not occur during systole (compare  FIG. 4  with  FIG. 3 ). In particular, the coaption element of the device  10  has a generally tapered or triangular shape that naturally adapts to the native valve geometry and to its expanding leaflet nature (toward the annulus). 
     Although stenosis or regurgitation can affect any valve, stenosis is predominantly found to affect either the aortic valve AV or the pulmonary valve PV, and regurgitation is predominantly found to affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the workload of the heart H and may lead to very serious conditions if left un-treated; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart is primarily responsible for circulating the flow of blood throughout the body, substantially higher pressures are experienced by the left side heart structures (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV). Accordingly, malfunction of the mitral valve MV or the aortic valve AV can be particularly problematic and often life threatening. 
     Malfunctioning native heart valves may either be repaired or replaced. Repair typically involves the preservation and correction of the patient&#39;s native valve. Replacement typically involves replacing the patient&#39;s native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Because stenotic damage sustained by the leaflets is irreversible, the most conventional treatments for a stenotic aortic valve or stenotic pulmonary valve are removal and replacement of the valve with a surgically implanted heart valve, or displacement of the valve with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV ( FIG. 7 ) are more prone to deformation of leaflets, which, as described above, prevents the mitral valve MV or tricuspid valve TV from closing properly and allows for regurgitation or back flow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow for mitral regurgitation MR or back flow from the left ventricle LV to the left atrium LA as shown in  FIG. 3 ). The regurgitation or back flow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or the tricuspid valve TV are often repairable. In addition, regurgitation can occur due to the chordae tendineae CT becoming dysfunctional (e.g., the chordae tendineae CT may stretch or rupture), which allows the anterior leaflet  20  and the posterior leaflet  22  to be reverted such that blood is regurgitated into the left atrium LA. The problems occurring due to dysfunctional chordae tendineae CT can be repaired by repairing the chordae tendineae CT or the structure of the mitral valve MV (e.g., by securing the leaflets  20 ,  22  at the affected portion of the mitral valve). 
     The devices and procedures disclosed herein often make reference to repairing a mitral valve for illustration. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve, as well as any component of a native valve. For example, such devices can be used between the leaflets  20 ,  22  of the mitral valve MV to prevent or inhibit regurgitation of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV ( FIG. 5 ), such devices can be used between any two of the anterior leaflet  30 , septal leaflet  32 , and posterior leaflet  34  to prevent or inhibit regurgitation of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein can be used on all three of the leaflets  30 ,  32 ,  34  together to prevent or inhibit regurgitation of blood from the right ventricle to the right atrium. That is, the valve repair devices provided herein can be centrally located between the three leaflets  30 ,  32 ,  34 . 
     An example implantable prosthetic device has a coaption element and at least one anchor. The coaption element is configured to be positioned within the native heart valve orifice to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing regurgitation described above. The coaption element can have a structure that is impervious or resistant to blood and that allows the native leaflets to close around the coaption element during ventricular systole to block blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The prosthetic device can be configured to seal against two or three native valve leaflets; that is, the device can be used in the native mitral (bicuspid) and tricuspid valves. The coaption element is sometimes referred to herein as a spacer because the coaption element can fill a space between improperly functioning native mitral leaflets  20 ,  22  or tricuspid leaflets  30 ,  32 ,  34  that do not close completely. 
     The coaption element (e.g., spacer, coaptation element, etc.) can have various shapes. In some embodiments, the coaption element can have an elongated cylindrical shape having a round cross-sectional shape. In some embodiments, the coaption element can have an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. The coaption element can have an atrial portion positioned in or adjacent to the left atrium, a ventricular or lower portion positioned in or adjacent to the left ventricle, and a side surface that extends between the native leaflets. In embodiments configured for use in the tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, and the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the side surface that extends between the native tricuspid leaflets. 
     The anchor can be configured to secure the device to one or both of the native leaflets such that the coaption element is positioned between the two native leaflets. In embodiments configured for use in the tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaption element is positioned between the three native leaflets. In some embodiments, the anchor can attach to the coaption element at a location adjacent the ventricular portion of the coaption element. In some embodiments, the anchor can attach to an actuation element, such as a shaft or actuation wire, to which the coaption element is also attached. In some embodiments, the anchor and the coaption element can be positioned independently with respect to each other by separately moving each of the anchor and the coaption element along the longitudinal axis of the actuation element (e.g., actuation shaft, actuation wire, etc.). In some embodiments, the anchor and the coaption element can be positioned simultaneously by moving the anchor and the coaption element together along the longitudinal axis of the actuation element, e.g., shaft or actuation wire. The anchor can be configured to be positioned behind a native leaflet when implanted such that the leaflet is grasped by the anchor. 
     The prosthetic device can be configured to be implanted via a delivery sheath. The coaption element and the anchor can be compressible to a radially compressed state and can be self-expandable to a radially expanded state when compressive pressure is released. The device can be configured for the anchor to be expanded radially away from the still-compressed coaption element initially in order to create a gap between the coaption element and the anchor. A native leaflet can then be positioned in the gap. The coaption element can be expanded radially, closing the gap between the coaption element and the anchor and capturing the leaflet between the coaption element and the anchor. In some embodiments, the anchor and coaption element are optionally configured to self-expand. The implantation methods for various embodiments can be different and are more fully discussed below with respect to each embodiment. Additional information regarding these and other delivery methods can be found in U.S. Pat. No. 8,449,599 and U.S. Patent Application Publication Nos. 2014/0222136, and 2014/0067052, 2016/0331523 each of which is incorporated herein by reference in its entirety. These methods can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g. with the body parts, tissue, etc. being simulated), etc. 
     The disclosed prosthetic devices can be configured such that the anchor is connected to a leaflet, taking advantage of the tension from native chordae tendineae to resist high systolic pressure urging the device toward the left atrium. During diastole, the devices can rely on the compressive and retention forces exerted on the leaflet that is grasped by the anchor. 
     Referring now to  FIGS. 8-15 , a schematically illustrated implantable prosthetic device  100  (e.g., a prosthetic spacer device, etc.) is shown in various stages of deployment. The device  100  can include any other features for an implantable prosthetic device discussed in the present application, and the device  100  can be positioned to engage valve tissue  20 ,  22  as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). 
     The device  100  is deployed from a delivery sheath or means for delivery  102  and includes a coapting portion or coaptation portion  104  and an anchor portion  106 . The coaptation portion  104  of the device  100  includes a coaption element or means for coapting  110  that is adapted to be implanted between the leaflets of a native valve (e.g., a native mitral valve, tricuspid valve, etc.) and is slidably attached to an actuation element  112  (e.g., actuation wire, actuation shaft, actuation tube, etc.). The anchor portion  106  is actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element or means for actuating  112  opens and closes the anchor portion  106  of the device  100  to grasp the native valve leaflets during implantation. The actuation element  112  (e.g., wire, shaft, tube, screw, line, etc.) can take a wide variety of different forms. For example, the actuation element can be threaded such that rotation of the actuation element (e.g., wire, shaft, tube, screw, etc.) moves the anchor portion  106  relative to the coaption portion  104 . Or, the actuation element can be unthreaded, such that pushing or pulling the actuation element  112  moves the anchor portion  106  relative to the coaption portion  104 . 
     The anchor portion  106  and/or anchors  108  of the device  100  include outer paddles  120  and inner paddles  122  that are connected between a cap  114  and the coaption element or means for coapting  110  by portions  124 ,  126 ,  128 . The connection portions  124 ,  126 ,  128  can be jointed and/or flexible to move between all of the positions described below. The interconnection of the outer paddles  120 , the inner paddles  122 , the coaption element or means for coapting  110 , and the cap  114  by the portions  124 ,  126 , and  128  can constrain the device to the positions and movements illustrated herein. 
     In some implementations, the actuation element or means for actuating  112  (e.g., actuation wire, actuation shaft, etc.) extends through the delivery sheath and the coaption element or means for coapting  110  to the cap  114  at the distal connection of the anchor portion  106 . Extending and retracting the actuation element or means for actuating  112  increases and decreases the spacing between the coaption element or means for coapting  110  and the cap  114 , respectively. A collar or other attachment element removably attaches the coaption element or means for coapting  110  to the delivery sheath or means for delivery  102  so that the actuation element or means for actuating  112  slides through the collar or other attachment element and through the coaption element or means for coapting  110  during actuation to open and close the paddles  120 ,  122 . 
     The anchor portion  106  and/or anchors  108  include attachment portions or gripping members. The illustrated gripping members comprise barbed clasps  130  that include a base or fixed arm  132 , a moveable arm  134 , optional barbs or means for securing  136 , and a joint portion  138 . The fixed arms  132  are attached to the inner paddles  122 , with the joint portion  138  disposed proximate the coaption element or means for coapting  110 . The barbed clasps  130  have flat surfaces and do not fit in a recess of the inner paddle  122 . Rather, the flat portions of the barbed clasps  130  are disposed against the surface of the inner paddle  122 . The joint portion  138  provides a spring force between the fixed and moveable arms  132 ,  134  of the barbed clasp  130 . The joint portion  138  can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some embodiments, the joint portion  138  is a flexible piece of material integrally formed with the fixed and moveable arms  132 ,  134 . The fixed arms  132  are attached to the inner paddles  122  and remain stationary relative to the inner paddles  122  when the moveable arms  134  are opened to open the barbed clasps  130  and expose the barbs or means for securing  136 . 
     The barbed clasps  130  can be opened by applying tension to actuation lines  116  attached to the moveable arms  134 , thereby causing the moveable arms  134  to rotate, flex, or pivot on the joint portions  138 . The actuation lines  116  extend through the delivery sheath or means for delivery  102 . The actuation line  116  can take a wide variety of forms, such as, for example, a line, a suture, a wire, a rod, a catheter, or the like. The barbed clasps  130  can be spring loaded so that in the closed position the barbed clasps  130  continue to provide a pinching force on the grasped native leaflet. This pinching force remains constant regardless of the position of the inner paddles  122 . Barbs or means for securing  136  of the barbed clasps  130  can pierce the native leaflets to further secure the native leaflets. 
     During implantation, the paddles  120 ,  122  can be opened and closed, for example, to grasp the native leaflets or native mitral valve leaflets between the paddles  120 ,  122  and the coaption element or means for coapting  110 . The barbed clasps  130  can be used to grasp and/or further secure the native leaflets by engaging the leaflets with barbs or means for securing  136  and pinching the leaflets between the moveable and fixed arms  134 ,  132 . The barbs or means for securing  136  of the barbed clasps  130  increase friction with the leaflets or may partially or completely puncture the leaflets. The actuation lines  116  can be actuated separately so that each barbed clasp  130  can be opened and closed separately. Separate operation allows one leaflet to be grasped at a time, or for the repositioning of a clasp  130  on a leaflet that was insufficiently grasped, without altering a successful grasp on the other leaflet. The barbed clasps  130  can be opened and closed relative to the position of the inner paddle  122  (as long as the inner paddle is in an open position), thereby allowing leaflets to be grasped in a variety of positions as the particular situation requires. 
     Referring now to  FIG. 8 , the device  100  is shown in an elongated or fully open condition for deployment from the delivery sheath. The device  100  is loaded in the delivery sheath in the fully open position, because the fully open position takes up the least space and allows the smallest catheter to be used (or the largest device  100  to be used for a given catheter size). In the elongated condition the cap  114  is spaced apart from the coaption element or means for coapting  110  such that the paddles  120 ,  122  are fully extended. In some embodiments, an angle formed between the interior of the outer and inner paddles  120 ,  122  is approximately 180 degrees. The barbed clasps  130  are kept in a closed condition during deployment through the delivery sheath or means for delivery  102  so that the barbs or means for securing  136  ( FIG. 9 ) do not catch or damage the sheath or tissue in the patient&#39;s heart. 
     Referring now to  FIG. 9 , the device  100  is shown in an elongated detangling condition, similar to  FIG. 8 , but with the barbed clasps  130  in a fully open position, ranging from about 140 degrees to about 200 degrees, to about 170 degrees to about 190 degrees, or about 180 degrees between fixed and moveable portions  132 ,  134  of the barbed clasps  130 . Fully opening the paddles  120 ,  122  and the clasps  130  has been found to improve ease of detanglement or detachment from anatomy of the patient, such as the chordae tendineae CT, during implantation of the device  100 . 
     Referring now to  FIG. 10 , the device  100  is shown in a shortened or fully closed condition. The compact size of the device  100  in the shortened condition allows for easier maneuvering and placement within the heart H. To move the device  100  from the elongated condition to the shortened condition, the actuation element or means for actuating  112  is retracted to pull the cap  114  towards the coaption element or means for coapting  110 . The connection portion  126  (e.g., joint, flexible connection, etc.) between the outer paddle  120  and inner paddle  122  is constrained in movement such that compression forces acting on the outer paddle  120  from the cap  114  being retracted towards the coaption element or means for coapting  110  causes the paddles  120 ,  122  to move radially outward. During movement from the open to closed position, the outer paddles  120  maintain an acute angle with the actuation element or means for actuating  112 . The outer paddles  120  can optionally be biased toward a closed position. The inner paddles  122  during the same motion move through a considerably larger angle as they are oriented away from the coaption element or means for coapting  110  in the open condition and collapse along the sides of the coaption element or means for coapting  110  in the closed condition. In some embodiments, the inner paddles  122  are thinner and/or narrower than the outer paddles  120 , and the connection portions  126 ,  128  (e.g., joints, flexible connections, etc.) connected to the inner paddles  122  can be thinner and/or more flexible. For example, this increased flexibility can allow more movement than the connection portion  124  connecting the outer paddle  120  to the cap  114 . In some embodiments, the outer paddles  120  are narrower than the inner paddles  122 . The connection portions  126 ,  128  connected to the inner paddles  122  can be more flexible, for example, to allow more movement than the connection portion  124  connecting the outer paddle  120  to the cap  114 . In some embodiments, the inner paddles  122  can be the same or substantially the same width as the outer paddles  120 . 
     Referring now to  FIGS. 11-13 , the device  100  is shown in a partially open, grasp-ready condition. To transition from the fully closed to the partially open condition, the actuation element or means for actuating  112  is extended to push the cap  114  away from the coaption element or means for coapting  110 , thereby pulling on the outer paddles  120 , which in turn pull on the inner paddles  122 , causing the anchors  108  of the anchor portion  106  to partially unfold. The actuation lines  116  are also retracted to open the clasps  130  so that the leaflets can be grasped. Also, the positions of the clasps  130  are dependent on the positions of the paddles  122 ,  120 . For example, referring to  FIG. 10 , closing the paddles  122 ,  120  also closes the clasps  130 . 
     Referring now to  FIG. 12 , one of the actuation lines  116  is extended to allow one of the clasps  130  to close. Referring now 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 . 
     Referring now to  FIG. 14 , the device  100  is shown in a fully closed and deployed condition. The delivery sheath or means for delivery  102  and actuation element or means for actuating  112  are retracted and the paddles  120 ,  122  and clasps  130  remain in a fully closed position. Once deployed, the device  100  can be maintained in the fully closed position with a mechanical latch or may be biased to remain closed through the use of spring materials, such as steel, other metals, plastics, composites, etc. or shape-memory alloys such as Nitinol. For example, the connection portions  124 ,  126 ,  128 , the joint portions  138 , and/or the inner and outer paddles  122 , and/or an additional biasing component (not shown) can be formed of metals such as steel or shape-memory alloy, such as Nitinol—produced in a wire, sheet, tubing, or laser sintered powder—and are biased to hold the outer paddles  120  closed around the coaption element or means for coapting  110  and the barbed clasps  130  pinched around native leaflets. Similarly, the fixed and moveable arms  132 ,  134  of the barbed clasps  130  are biased to pinch the leaflets. In certain embodiments, the connection portions  124 ,  126 ,  128 , joint portions  138 , and/or the inner and outer paddles  122 , and/or an additional biasing component (not shown) can be formed of any other suitably elastic material, such as a metal or polymer material, to maintain the device in the closed condition after implantation. 
       FIG. 15  illustrates an example embodiment where the paddles  120 ,  122  are independently controllable. The device  101  illustrated by  FIG. 15  is similar to the device illustrated by  FIG. 11 , except the device  101  of  FIG. 15  includes two independent actuation elements or actuation wires  111 ,  113  that are coupled to two independent caps  115 ,  117 . To transition a first inner paddle  122  and a first outer paddle  120  from the fully closed to the partially open condition, the actuation element or means for actuating  111  is extended to push the cap  115  away from the coaption element or means for coapting  110 , thereby pulling on the outer paddle  120 , which in turn pulls on the inner paddle  122 , causing the first anchor  108  to partially unfold. To transition a second inner paddle  122  and a second outer paddle  120  from the fully closed to the partially open condition, the actuation element or means for actuating  113  is extended to push the cap  115  away from the coaption element or means for coapting  110 , thereby pulling on the outer paddle  120 , which in turn pulls on the inner paddle  122 , causing the second anchor  108  to partially unfold. The independent paddle control illustrated by  FIG. 15  can be implemented on any of the devices disclosed by the present application. For comparison, in the example illustrated 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 for actuating  112 . 
     Referring now to  FIGS. 16-21 , the implantable device  100  of  FIGS. 8-14  is shown being delivered and implanted within the native mitral valve MV of the heart H, though similar steps can be used on other valves. The methods and steps shown and/or discussed can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g. with the body parts, heart, tissue, etc. being simulated), etc. 
     Referring now to  FIG. 16 , the delivery sheath is inserted into the left atrium LA through the septum and the device  100  is deployed from the delivery sheath in the fully open condition. The actuation element or means for actuating  112  is then retracted to move the device  100  into the fully closed condition shown in  FIG. 17 . As can be seen in  FIG. 18 , the device  100  is moved into position within the mitral valve MV into the ventricle LV and partially opened so that the leaflets  20 , 22  can be grasped. Referring now to  FIG. 19 , an actuation line  116  is extended to close one of the clasps  130 , capturing a leaflet  20 .  FIG. 20  shows the other actuation line  116  being then extended to close the other clasp  130 , capturing the remaining leaflet  22 . As can be seen in  FIG. 21 , the delivery sheath or means for delivery  102  and actuation element or means for actuating  112  and actuation lines  116  are then retracted and the device  100  is fully closed and deployed in the native mitral valve MV. 
     Referring now to  FIGS. 22-27 , an example embodiment of an implantable prosthetic spacer device  200  is shown. The implantable device  200  is one of the many different configurations that the device  100  that is schematically illustrated in  FIGS. 8-14  can take. The device  200  can include any other features for an implantable prosthetic device discussed in the present application, and the device  200  can be positioned to engage valve tissue  20 ,  22  as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). 
     The implantable prosthetic spacer device  200  includes a coaption portion  204 , a proximal or attachment portion  205 , an anchor portion  206 , and a distal portion  207 . The coaption portion  204  of the device includes a coaption element  210  for implantation between the leaflets  20 ,  22  of the native mitral valve MV. The anchor portion  206  includes a plurality of anchors  208 , each anchor  208  including outer paddles  220 , inner paddles  222 , paddle extension members or paddle frames  224 , and clasps  230 . The attachment portion  205  includes a first or proximal collar  211  for engaging with a capture mechanism  213  ( FIGS. 43-49 ) of a delivery sheath or system  202  ( FIGS. 38-42 and 49 ). 
     The coaption element  210  and paddles  220 ,  222  are formed from a flexible material that can be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable way or a laser cut or otherwise cut flexible material. The material can be cloth, shape-memory alloy wire—such as Nitinol—to provide shape-setting capability, or any other flexible material suitable for implantation in the human body. 
     An element  212  (e.g., actuation wire, shaft, etc.) extends from the delivery sheath or system  202  to engage and enable actuation of the implantable prosthetic device  200 . The actuation element  212  extends through the capture mechanism  213 , proximal collar  211 , and coaption element  210  to engage a cap  214  of the distal portion  207 . The actuation element  212  can be configured to removably engage the cap  214  with a threaded connection, or the like, so that the actuation element  212  can be disengaged and removed from the device  200  after implantation. 
     The coaption element  210  extends from the proximal collar  211  to the inner paddles  222 . The coaption element  210  has a generally elongated and round shape. In particular, the coaption element  210  has an elliptical shape or cross-section when viewed from above ( FIG. 51 ) and has a tapered shape or cross-section when seen from a front view (e.g.,  FIG. 23 ) and a round shape or cross-section when seen from a side view (e.g.,  FIG. 24 ). A blend of these three geometries can result in the three-dimensional shape of the illustrated coaption element  210  that achieves the benefits described herein. The round shape of the coaption element  210  can also be seen, when viewed from above, to substantially follow or be close to the shape of the paddle frames  570 . 
     The size of the coaption element  210  can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In one example embodiment, the anterior-posterior distance at the top of the spacer is about 5 mm, and the medial-lateral distance of the spacer at its widest is about 10 mm. In one example embodiment, the overall geometry of the device  200  can be based on these two dimensions and the overall shape strategy described above. It should be readily apparent that the use of other anterior-posterior distance anterior-posterior distance and medial-lateral distance as starting points for the device will result in a device having different dimensions. Further, using other dimensions and the shape strategy described above will also result in a device having different dimensions. 
     The outer paddles  220  are jointably attached to the cap  214  of the distal portion  207  by connection portions  221  and to the inner paddles  222  by connection portions  223 . The inner paddles  222  are jointably attached to the coaption element by connection portions  225 . In this manner, the anchors  208  are configured similar to legs in that the inner paddles  222  are like upper portions of the legs, the outer paddles  220  are like lower portions of the legs, and the connection portions  223  are like knee portions of the legs. 
     The inner paddles  222  are stiff, relatively stiff, rigid, have rigid portions and/or are stiffened by a stiffening member or a fixed portion  232  of the clasps  230 . The stiffening of the inner paddle allows the device to move to the various different positions shown and described herein. The inner paddle  222 , the outer paddle  220 , and the coaption element can all be interconnected as described herein, such that the device  200  is constrained to the movements and positions shown and described herein. 
     The paddle frames  224  are attached to the cap  214  at the distal portion  207  and extend to the connection portions  223  between the inner and outer paddles  222 ,  220 . In some embodiments, the paddle frames  224  are formed of a material that is more rigid and stiff than the material forming the paddles  222 ,  220  so that the paddle frames  224  provide support for the paddles  222 ,  220 . 
     The paddle frames  224  provide additional pinching force between the inner paddles  222  and the coaption element  210  and assist in wrapping the leaflets around the sides of the coaption element  210  for a better seal between the coaption element  210  and the leaflets, as can be seen in  FIG. 51 . That is, the paddle frames  224  can be configured with a round three-dimensional shape extending from the cap  214  to the connection portions  223  of the anchors  208 . The connections between the paddle frames  224 , the outer and inner paddles  220 ,  222 , the cap  214 , and the coaption element  210  can constrain each of these parts to the movements and positions described herein. In particular the connection portion  223  is constrained by its connection between the outer and inner paddles  220 ,  222  and by its connection to the paddle frame  224 . Similarly, the paddle frame  224  is constrained by its attachment to the connection portion  223  (and thus the inner and outer paddles  222 ,  220 ) and to the cap  214 . 
     Configuring the paddle frames  224  in this manner provides increased surface area compared to the outer paddles  220  alone. This can, for example, make it easier to grasp and secure the native leaflets. The increased surface area can also distribute the clamping force of the paddles  220  and paddle frames  224  against the native leaflets over a relatively larger surface of the native leaflets in order to further protect the native leaflet tissue. Referring again to  FIG. 51 , the increased surface area of the paddle frames  224  can also allow the native leaflets  20 ,  22  to be clamped to the implantable prosthetic spacer device  200 , such that the native leaflets  20 ,  22  coapt entirely around the coaption member  210 . This can, for example, improve sealing of the native leaflets  20 ,  22  and thus prevent or further reduce valvular regurgitation. 
     The barbed clasps  230  include a base or fixed arm  232 , a moveable arm  234 , barbs  236 , and a joint portion  238 . The fixed arms  232  are attached to the inner paddles  222 , with the joint portion  238  disposed proximate the coaption element  210 . The joint portion  238  is spring-loaded so that the fixed and moveable arms  232 ,  234  are biased toward each other when the barbed clasp  230  is in a closed condition. 
     The fixed arms  232  are attached to the inner paddles  222  through holes or slots  231  with sutures (not shown). The fixed arms  232  can be attached to the inner paddles  222  with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, or the like. The fixed arms  232  remain substantially stationary relative to the inner paddles  222  when the moveable arms  234  are opened to open the barbed clasps  230  and expose the barbs  236 . The barbed clasps  230  are opened by applying tension to actuation lines  216  ( FIGS. 43-48 ) attached to holes  235  in the moveable arms  234 , thereby causing the moveable arms  234  to move, pivot, flex, etc. on the joint portions  238 . 
     Referring now to  FIG. 29 , a close-up view of one of the leaflets  20 ,  22  grasped by a barbed clasp such as clasp  230  is shown. The leaflet  20 ,  22  is grasped between the moveable and fixed arms  234 ,  232  of the clasp  230 . The tissue of the leaflet  20 ,  22  is not pierced by the barbs  236 , though in some embodiments the barbs  236  may partially or fully pierce through the leaflet  20 ,  22 . The angle and height of the barbs  236  relative to the moveable arm  234  helps to secure the leaflet  20 ,  22  within the clasp  230 . In particular, a force pulling the implant off of the native leaflet  20 ,  22  will encourage the barbs  236  to further engage the tissue, thereby ensuring better retention. Retention of the leaflet  20 ,  22  in the clasp  230  is further improved by the position of fixed arm  232  near the barbs  236  when the clasp  230  is closed. In this arrangement, the tissue is formed by the fixed arms  232  and the moveable arms  234  and the barbs  236  into an S-shaped torturous path. Thus, forces pulling the leaflet  20 ,  22  away from the clasp  230  will encourage the tissue to further engage the barbs  236  before the leaflets  20 ,  22  can escape. For example, leaflet tension during diastole can encourage the barbs  236  to pull toward the end portion of the leaflet  20 ,  22 . Thus, the S-shaped path can utilize the leaflet tension during diastole to more tightly engage the leaflets  20 ,  22  with the barbs  236 . 
     Referring to  FIG. 25 , the prosthetic spacer device  200  can also include a cover  240 . In some embodiments, the cover  240  can be disposed on the coaption member  210 , the outer and inner paddles  220 ,  222 , and/or the paddle frames  224 . The cover  240  can be configured to prevent or reduce blood-flow through the prosthetic spacer device  200  and/or to promote native tissue ingrowth. In some embodiments, the cover  240  can be a cloth or fabric such as PET, velour, or other suitable fabric. In some embodiments, in lieu of or in addition to a fabric, the cover  240  can include a coating (e.g., polymeric, silicone, etc.) that is applied to the implantable prosthetic spacer device  200 . 
     During implantation, the paddles  220 ,  222  of the anchors  208  are opened and closed to grasp the native valve leaflets  20 ,  22  between the paddles  220 ,  222  and the coaption element  210 . The anchors  208  are moved between a closed position ( FIGS. 22-25 ) to various open positions ( FIGS. 26-37 ) by extending and retracting the actuation element, wire, or shaft  212 . Extending and retracting the actuation element  212  increases and decreases the spacing between the coaption element  210  and the cap  214 , respectively. The proximal collar  211  and the coaption element  210  slide along the actuation element  212  during actuation so that changing of the spacing between the coaption element  210  and the cap  214  causes the paddles  220 ,  220  to move between different positions to grasp the native valve leaflets  20 ,  22  during implantation. 
     As the device  200  is opened and closed, the pair of inner and outer paddles  222 ,  220  are moved in unison, rather than independently, by a single actuation element  212 . Also, the positions of the clasps  230  are dependent on the positions of the paddles  222 ,  220 . For example, the clasps  230  are arranged such that closure of the anchors  208  simultaneously closes the clasps  230 . In one example embodiment, the device  200  can be made to have the paddles  220 ,  222  be independently controllable in the same manner as the device  100  illustrated in  FIG. 15 . 
     The barbed clasps  230  further secure the native leaflets  20 ,  22  by engaging the leaflets  20 ,  22  with barbs  236  and pinching the leaflets  20 ,  22  between the moveable and fixed arms  234 ,  232 . The barbs  236  of the barbed clasps  230  increase friction with or may partially or completely puncture the leaflets  20 ,  22 . The actuation lines  216  ( FIGS. 43-48 ) can be actuated separately so that each barbed clasp  230  can be opened and closed separately. Separate operation allows one leaflet  20 ,  22  to be grasped at a time, or for the repositioning of a clasp  230  on a leaflet  20 ,  22  that was insufficiently grasped, without altering a successful grasp on the other leaflet  20 ,  22 . The barbed clasps  230  can be fully opened and closed when the inner paddle  222  is not closed, thereby allowing leaflets  20 ,  22  to be grasped in a variety of positions as the particular situation requires. 
     Referring now to  FIGS. 22-25 , the device  200  is shown in a closed position. When closed, the inner paddles  222  are disposed between the outer paddles  220  and the coaption element  210 . The clasps  230  are disposed between the inner paddles  222  and the coaption element  210 . Upon successful capture of native leaflets  20 ,  22  the device  200  is moved to and retained in the closed position so that the leaflets  20 ,  22  are secured within the device  200  by the clasps  230  and are pressed against the coaption element  210  by the paddles  220 ,  222 . The outer paddles  220  have a wide curved shape that fits around the curved shape of the coaption element  210  to more securely grip the leaflets  20 ,  22  when the device  200  is closed, as can be seen in  FIG. 51 . The curved shape and rounded edges of the outer paddle  220  also prohibits tearing of the leaflet tissue. 
     Referring now to  FIGS. 30-37 , the implantable prosthetic device  200  described above is shown in various positions and configurations ranging from partially open to fully open. The paddles  220 ,  222  of the device  200  transition between each of the positions shown in  FIGS. 30-37  from the closed position shown in  FIGS. 22-25  through to the fully open position upon extension of the actuation element  212  (e.g., wire, shaft, etc.) from a fully retracted position to a fully extended position of the actuation element. 
     Referring now to  FIGS. 30-31 , the device  200  is shown in a partially open position. The device  200  is moved into the partially open position by extending the actuation element  212 . Extending the actuation element  212  pulls down on the bottom portions of the outer paddles  220  and paddle frames  224 . The outer paddles  220  and paddle frames  224  pull down on the inner paddles  222 , where the inner paddles  222  are connected to the outer paddles  220  and the paddle frames  224 . Because the proximal collar  212  and coaption element  210  are held in place by the capture mechanism  213 , the inner paddles  222  are caused to move, pivot, flex, etc. in an opening direction. The inner paddles  222 , the outer paddles  220 , and the paddle frames all flex to the position shown in  FIGS. 30-31 . Opening the paddles  222 ,  220  and frames  224  forms a gap between the coaption element  210  and the inner paddle  222  that can receive and grasp the native leaflets  20 ,  22 . This movement also exposes the barbed clasps  230  that can be moved between closed ( FIG. 30 ) and open ( FIG. 31 ) positions to form a second gap for grasping the native leaflets  20 ,  22 . The extent of the gap between the fixed and moveable arms  232 ,  234  of the clasp  230  is limited to the extent that the inner paddle  222  has spread away from the coaption element  210 . 
     Referring now to  FIGS. 32-33 , the device  200  is shown in a laterally extended or open position. The device  200  is moved into the laterally extended or open position by continuing to extend the actuation element  212  described above, thereby increasing the distance between the coaption element  210  and the cap  214  of the distal portion  207 . Continuing to extend the actuation element  212  pulls down on the outer paddles  220  and paddle frames  224 , thereby causing the inner paddles  222  to spread apart further from the coaption element  210 . In the laterally extended or open position, the inner paddles  222  extend horizontally more than in other positions of the device  200  and form an approximately 90-degree angle with the coaption element  210 . Similarly, the paddle frames  224  are at their maximum spread position when the device  200  is in the laterally extended or open position. The increased gap between the coaption element  210  and inner paddle  222  formed in the laterally extended or open position allows clasps  230  to open further ( FIG. 33 ) before engaging the coaption element  210 , thereby increasing the size of the gap between the fixed and moveable arms  232 ,  234 . 
     Referring now to  FIGS. 34-35 , the device  200  is shown in a three-quarters extended position. The device  200  is moved into the three-quarters extended position by continuing to extend the actuation element  212  described above, thereby increasing the distance between the coaption element  210  and the cap  214  of the distal portion  207 . Continuing to extend the actuation element  212  pulls down on the outer paddles  220  and paddle frames  224 , thereby causing the inner paddles  222  to spread apart further from the coaption element  210 . In the three-quarters extended position, the inner paddles  222  are open beyond 90 degrees to an approximately 135-degree angle with the coaption element  210 . The paddle frames  224  are less spread than in the laterally extended or open position and begin to move inward toward the actuation element  212  as the actuation element  212  extends further. The outer paddles  220  also flex back toward the actuation element  212 . As with the laterally extended or open position, the increased gap between the coaption element  210  and inner paddle  222  formed in the laterally extended or open position allows clasps  230  to open even further ( FIG. 35 ), thereby increasing the size of the gap between the fixed and moveable arms  232 ,  234 . 
     Referring now to  FIGS. 36-37 , the device  200  is shown in a fully extended position. The device  200  is moved into the fully extended position by continuing to extend the actuation element  212  described above, thereby increasing the distance between the coaption element  210  and the cap  214  of the distal portion  207  to a maximum distance allowable by the device  200 . Continuing to extend the actuation element  212  pulls down on the outer paddles  220  and paddle frames  224 , thereby causing the inner paddles  222  to spread apart further from the coaption element  210 . The outer paddles  220  and paddle frames  224  move to a position where they are close to the actuation element. In the fully extended position, the inner paddles  222  are open to an approximately 180-degree angle with the coaption element  210 . The inner and outer paddles  222 ,  220  are stretched straight in the fully extended position to form an approximately 180-degree angle between the paddles  222 ,  220 . The fully extended position of the device  200  provides the maximum size of the gap between the coaption element  210  and inner paddle  222 , and, in some embodiments, allows clasps  230  to also open fully to approximately 180 degrees ( FIG. 37 ) between the fixed and moveable arms  232 ,  234  of the clasp  230 . The position of the device  200  is the longest and the narrowest configuration. Thus, the fully extended position of the device  200  may be a desirable position for bailout of the device  200  from an attempted implantation or may be a desired position for placement of the device in a delivery catheter, or the like. 
     Configuring the prosthetic spacer device  200  such that the anchors  208  can extend to a straight or approximately straight configuration (e.g. approximately 120-180 degrees relative to the coaption element  210 ) can provide several advantages. For example, this configuration can reduce the radial crimp profile of the prosthetic spacer device  200 . It can also make it easier to grasp the native leaflets  20 ,  22  by providing a larger opening between the coaption element  210  and the inner paddles  222  in which to grasp the native leaflets  20 ,  22 . Additionally, the relatively narrow, straight configuration can prevent or reduce the likelihood that the prosthetic spacer device  200  will become entangled in native anatomy (e.g., chordae tendineae CT shown in  FIGS. 3 and 4 ) when positioning and/or retrieving the prosthetic spacer device  200  into the delivery apparatus  202 . 
     Referring now to  FIGS. 38-49 , the implantable device  200  is shown being delivered and implanted within the native mitral valve MV of the heart H, though similar steps can be used on other valves. The methods and steps shown and/or discussed can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g. with the body parts, heart, tissue, etc. being simulated), etc. 
     As described above, the device  200  shown in  FIGS. 38-49  includes the optional covering  240  (e.g.,  FIG. 25 ) over the coaption element  210 , clasps  230 , inner paddles  222  and/or the outer paddles  220 . The device  200  is deployed from a delivery sheath  202 , is retained by a capture mechanism  213  (See  FIGS. 43-49 ) and is actuated by extending or retracting the actuation element, wire, or shaft  212 . Fingers of the capture mechanism  213  removably attach the collar  211  to the delivery sheath  202 . In some embodiments, the capture mechanism  213  is held closed around the collar  211  by the actuation element  212 , such that removal of the actuation element  212  allows the fingers of the capture mechanism  213  to open and release the collar  211  to decouple the capture mechanism  213  from the device  200  after the device  200  has been successfully implanted. 
     Referring now to  FIG. 38 , the delivery sheath  202  is inserted into the left atrium LA through the septum and the device  200  is deployed from the delivery sheath  202  in the fully open condition for the reasons discussed above with respect to the device  100 . The actuation element  212  is then retracted to move the device  200  through the partially closed condition ( FIG. 39 ) and to the fully closed condition shown in  FIGS. 40-41  and then maneuvered towards the mitral valve MV as shown in  FIG. 41 . Referring now to  FIG. 42 , when the device  200  is aligned with the mitral valve MV, the actuation element  212  is extended to open the paddles  220 , 222  into the partially opened position and the actuation lines  216  ( FIGS. 43-48 ) are retracted to open the barbed clasps  230  to prepare for leaflet grasp. Next, as shown in  FIGS. 43-44 , the partially open device  200  is inserted through the mitral valve MV until leaflets  20 , 22  are properly positioned in between the inner paddles  222  and the coaption element  210  and inside the open barbed clasps  230 .  FIG. 45  shows the device  200  with both clasps  230  closed, though the barbs  236  of one clasp  230  missed one leaflet  22 . As can be seen in  FIGS. 45-47 , the out of position clasp  230  is opened and closed again to properly grasp the missed leaflet  22 . When both leaflets  20 , 22  are grasped properly, the actuation element  212  is retracted to move the device  200  into the fully closed position shown in  FIG. 48 . With the device  200  fully closed and implanted in the native mitral valve MV, the actuation element  212  is disengaged from the cap  214  and is withdrawn to release the capture mechanism  213  from the proximal collar  211  so that the capture mechanism  213  can be withdrawn into the delivery sheath  202 , as shown in  FIG. 49 . Once deployed, the device  200  can be maintained in the fully closed position with a mechanical means such as a latch or can be biased to remain closed through the use of spring material, such as steel, and/or shape-memory alloys such as Nitinol. For example, the paddles  220 ,  222  can be formed of steel or Nitinol shape-memory alloy—produced in a wire, sheet, tubing, or laser sintered powder—and are biased to hold the outer paddles  220  closed around the inner paddles  222 , coaption element  210 , and the barbed clasps  230  pinched around native leaflets  20 ,  22 . 
     Referring to  FIGS. 50-54 , once the device  200  is implanted in the native mitral valve MV, the coaption element  210  functions as a gap filler in the valve regurgitant orifice, such as the gap  26  in the mitral valve MV illustrated by  FIG. 6 . When the device  200  has been deployed between the two opposing valve leaflets  20 ,  22 , the leaflets  20 ,  22  no longer coapt against each other in the area of the coaption element  210 , but instead coapt against the coaption element  210 . This reduces the distance the leaflets  20 ,  22  need to be approximated to close the mitral valve MV during systole, thereby facilitating repair of functional valve disease that may be causing mitral regurgitation. A reduction in leaflet approximation distance can result in several other advantages as well. For example, the reduced approximation distance required of the leaflets  20 ,  22  reduces or minimizes the stress experienced by the native valve. Shorter approximation distance of the valve leaflets  20 ,  22  can also require less approximation forces which can result in less tension experienced by the leaflets  20 ,  22  and less diameter reduction of the valve annulus. The smaller reduction of the valve annulus—or none at all—can result in less reduction in valve orifice area as compared to a device without a spacer. In this way, the coaption element  210  can reduce the transvalvular gradients. 
     To adequately fill the gap  26  between the leaflets  20 ,  22 , the device  200  and the components thereof can have a wide variety of different shapes and sizes. For example, the outer paddles  220  and paddle frames  224  can be configured to conform to the shape or geometry of the coaption element  210  as is shown in  FIGS. 50-54 . As a result, the outer paddles  220  and paddle frames  224  can mate with both the coaption element  210  and the native valve leaflets  20 ,  22 . That is, when the leaflets  20 ,  22  are coapted against the coaption element  210 , the leaflets  20 ,  22  fully surround or “hug” the coaption element  210  in its entirety, thus small leaks at lateral and medial aspects  201 ,  203  of the coaption element  210  can be prevented or inhibited. The interaction of the leaflets  20 ,  22  and the device  200  is made clear in  FIG. 51 , which shows a schematic atrial or surgeon&#39;s view that shows the paddle frame  224  (which would not actually be visible from a true atrial view, e.g.,  FIG. 52 ), conforming to the coaption element  210  geometry. The opposing leaflets  20 ,  22  (the ends of which would also not be visible in the true atrial view, e.g.,  FIG. 52 ) being approximated by the paddle frames  224 , to fully surround or “hug” the coaption element  210 . 
     This coaption of the leaflets  20 ,  22  against the lateral and medial aspects  201 ,  203  of the coaption element  210  (shown from the atrial side in  FIG. 52 , and the ventricular side in  FIG. 53 ) would seem to contradict the statement above that the presence of a coaption element  210  minimizes the distance the leaflets need to be approximated. However, the distance the leaflets  20 ,  22  need to be approximated is still minimized if the coaption element  210  is placed precisely at a regurgitant gap  26  and the regurgitant gap  26  is less than the width (medial-lateral) of the coaption element  210 . 
       FIG. 50  illustrates the geometry of the coaption element  210  and the paddle frame  224  from an LVOT perspective. As can be seen in this view, the coaption element  210  has a tapered shape being smaller in dimension in the area closer to where the inside surfaces of the leaflets  20 ,  22  are required to coapt and increase in dimension as the coaption element  210  extends toward the atrium. Thus, the depicted native valve geometry is accommodated by a tapered coaption element geometry. Still referring to  FIG. 50 , the tapered coaption element geometry, in conjunction with the illustrated expanding paddle frame  224  shape (toward the valve annulus) can help to achieve coaption on the lower end of the leaflets, reduce stress, and minimize transvalvular gradients. 
     Referring to  FIG. 54 , the shape of the coaption element  210  and the paddle frames  224  can be defined based on an Intra-Commissural view of the native valve and the device  200 . Two factors of these shapes are leaflet coaption against the coaption element  210  and reduction of stress on the leaflets due to the coaption. Referring to  FIGS. 54 and 24 , to both coapt the valve leaflets  20 ,  22  against the coaption element  210  and reduce the stress applied to the valve leaflets  20 ,  22  by the coaption element  210  and/or the paddle frames  224 , the coaption element  210  can have a round or rounded shape and the paddle frames  224  can have a full radius that spans nearly the entirety of the paddle frame  224 . The round shape of the coaption element  210  and/or the illustrated fully rounded shape of the paddle frames  224  distributes the stresses on the leaflets  20 ,  22  across a large, curved engagement area  205 ′. For example, in  FIG. 54 , the force on the leaflets  20 ,  22  by the paddle frames is spread along the entire rounded length of the paddle frame  224 , as the leaflets  20  try to open during the diastole cycle. 
     Referring now to  FIG. 55 , an example embodiment of an implantable prosthetic spacer device  300  is shown. The implantable device  300  is one of the many different configurations that the device  100  that is schematically illustrated in  FIGS. 8-14  can take. The device  300  can include any other features for an implantable prosthetic device discussed in the present application, and the device  300  can be positioned to engage valve tissue  20 , 22  as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). 
     The implantable prosthetic spacer device  300  includes a coaption portion  304 , a proximal or attachment portion  305 , an anchor portion  306 , and a distal portion  307 . The coaption portion  304  of the device includes a coaption element  310  for implantation between the leaflets  20 , 22  of the native valve. The anchor portion  306  includes a plurality of anchors  308 , each anchor  308  including outer paddles  320 , inner paddles  322 , paddle extension members or paddle frames  324 , and clasps  330 . The attachment portion  305  includes a first or proximal collar  311  for engaging with a capture mechanism (e.g., a capture mechanism such as the capture mechanism  213  shown in  FIGS. 43-49 ) of a delivery sheath or system (e.g., a delivery sheath or system such as the delivery sheath or system  202  shown in  FIGS. 38-42 and 49 ). 
     The anchors  308  are attached to the coaption member  310  by connection portions  325  and to the cap  314  by connection portions  321 . The anchors  308  can comprise first portions or outer paddles  320  and second portions or inner paddles  322  separated by connection portions  323 . The connection portions  323  can be attached to paddle frames  324  that are hingeably attached to the cap  314 . In this manner, the anchors  308  are configured similar to legs in that the inner paddles  322  are like upper portions of the legs, the outer paddles  320  are like lower portions of the legs, and the connection portions  323  are like knee portions of the legs. 
     The coaption member  310  and the anchors  308  can be coupled together in various ways. For example, as shown in the illustrated embodiment, the coaption member  310  and the anchors  308  can be coupled together by integrally forming the coaption member  310  and the anchors  308  as a single, unitary component. This can be accomplished, for example, by forming the coaption member  310  and the anchors  308  from a continuous strip  301  of a braided or woven material, such as braided or woven nitinol wire. In some embodiments, such as in the illustrated example, the coaption member  310 , the outer paddle portions  320 , the inner paddle portions  322 , and the connection portions  321 ,  323 ,  325  are formed from the continuous strip of material  301 . 
     Like the anchors  208  of the implantable prosthetic device  200  described above, the anchors  308  can be configured to move between various configurations by axially moving the cap  314  relative to the proximal collar  311  and thus the anchors  308  relative to the coaption member  310  along a longitudinal axis extending between the cap  314  and the proximal collar  311 . For example, the anchors  308  can be positioned in a fully extended or straight configuration (e.g., similar to the configuration of device  200  shown in  FIG. 36 ) by moving the cap  314  away from the coaption member  310 . In the straight configuration, the paddle portions  320 ,  322  are aligned or straight in the direction of the longitudinal axis of the device and the connection portions  323  of the anchors  308  are adjacent the longitudinal axis of the coaption member  310  (e.g., similar to the configuration of device  200  shown in  FIG. 36 ). From the straight configuration, the anchors  308  can be moved to a fully folded configuration (e.g.,  FIG. 55 ) by moving the toward the coaption member  310 . Initially, as the cap  314  moves toward the coaption member  310 , the anchors  308  bend at connection portions  321 ,  323 ,  325 , and the connection portions  323  move radially outwardly relative to the longitudinal axis of the device  300  and axially toward the coaption member  310  (e.g., similar to the configuration of device  200  shown in  FIG. 34 ). As the cap  314  continues to move toward the coaption member  310 , the connection portions  323  move radially inwardly relative to the longitudinal axis of the device  300  and axially toward the proximal end of the coaption member  310  (e.g., similar to the configuration of device  200  shown in  FIG. 30 ). 
     The barbed clasps  330  (shown in detail in  FIG. 56 ) include a base or fixed arm  332 , a moveable arm  334 , barbs  336 , and a joint portion  338 . The fixed arms  332  are attached to the inner paddles  322 , with the joint portion  338  disposed proximate the coaption element  310 . The joint portion  338  is spring-loaded so that the fixed and moveable arms  332 ,  334  are biased toward each other when the barbed clasp  330  is in a closed condition. 
     The fixed arms  332  are attached to the inner paddles  322  through holes or slots  331  with sutures (not shown). The fixed arms  332  can be attached to the inner paddles  322  with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, or the like. The fixed arms  332  remain substantially stationary relative to the inner paddles  322  when the moveable arms  334  are opened to open the barbed clasps  330  and expose the barbs  336 . The barbed clasps  330  are opened by applying tension to actuation lines (e.g., the actuation lines  216  shown in  FIGS. 43-48 ) attached to holes  335  in the moveable arms  334 , thereby causing the moveable arms  334  to move, pivot, flex, etc. on the joint portions  338 . 
     In short, the implantable prosthetic device  300  is similar in configuration and operation to the implantable prosthetic device  200  described above, except that the coaption element  310 , outer paddles  320 , inner paddles  322 , and connection portions  321 ,  323 ,  325  are formed from the single strip of material  301 . The strip of material  301  is attached to the proximal collar  311 , cap  314 , and paddle frames  324  by being woven or inserted through openings in the proximal collar  311 , cap  314 , and paddle frames  324  that are configured to receive the continuous strip of material  301 . The continuous strip  301  can be a single layer of material or can include two or more layers. In certain embodiments, portions of the device  300  have a single layer of the strip of material  301  and other portions are formed from multiple overlapping or overlying layers of the strip of material  301 . For example,  FIG. 55  shows the coaption member  310  and inner paddles  322  formed from multiple overlapping layers of the strip of material  301 . The single continuous strip of material  301  can start and end in various locations of the device  300 . The ends of the strip of material  301  can be in the same location or different locations of the device  300 . For example, in the illustrated embodiment of  FIG. 55 , the strip of material  301  begins and ends in the location of the inner paddles  322 . 
     As with the implantable prosthetic device  200  described above, the size of the coaption element  310  can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In particular, forming many components of the device  300  from the strip of material  301  allows the device  300  to be made smaller than the device  200 . For example, in one example embodiment, the anterior-posterior distance at the top of the coaption element  310  is less than 2 mm, and the medial-lateral distance of the device  300  (i.e., the width of the paddle frames  324  which are wider than the coaption element  310 ) at its widest is about 5 mm. 
     Referring now to  FIGS. 57-64 , an implantable device  400  is shown. The implantable device  400  has paddles  402  that open and close to grasp leaflets  20 ,  22  against barbed clasps or gripping devices  404 . The paddles  402  move to create an opening  406  between the paddles  402  and gripping devices  404  in which the leaflets  20 ,  22  can be grasped. The device  400  can be configured to close a gap  26  ( FIG. 6 ) in the native heart valve MV, TV. In addition, the implantable device  400  can include any other features for a device discussed in the present application, and the device  400  can be positioned to engage valve leaflets  20 ,  22  as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). The device  400  can include any other features for an implantable prosthetic device discussed in the present application, and the device  400  can be positioned to engage valve tissue  20 ,  22  as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). 
     Referring to  FIG. 57 , the paddles  402  of the device  400  are moved, flexed, rotated, or pivoted outward in the rotational or pivot direction  410  to create the opening  406  between the paddles  402  and the gripping members  404  having a first width  420 . The first width  420  can be, for example, between about 5 mm and about 15 mm, such as between 7.5 mm and about 12.5 mm, such as about 10 mm. In some embodiments, the first width  420  can be less than 5 mm or greater than 15 mm. 
     Referring to  FIG. 58 , the paddles  402  of the device  400  are moved outward in the translation direction  412  so that the opening  406  reaches the first width  420 , instead of being rotated as shown in  FIG. 57 . As with the rotated paddles  402  described above, the first width  420  can be, for example, between about 5 mm and about 15 mm, such as between 7.5 mm and about 12.5 mm, such as about 10 mm. In some embodiments, the first width  420  can be less than 5 mm or greater than 15 mm. In this example, the translated paddles can then be moved, flexed, rotated, or pivoted outward to a width that is wider than the width  420 . 
     Referring to  FIGS. 59-61 , in one example embodiment the device  400  can be configured such that the paddles  402  are moved, flexed, rotated, or pivoted outward in the rotational or pivot direction  410  and then moved outward in the translation direction  412  to create the opening  406  having a second width  422  between the paddles  402  and the gripping members  404 . The second width  422  can be, for example, between about 10 mm and about 25 mm, such as between about 10 mm and about 20 mm, such as between about 12.5 mm and about 17.5 mm, such as about 15 mm. In some embodiments, the second width  422  can be less than 10 mm or more than 25 mm. In certain embodiments, the ratio between the second width  422  and the first width  420  can be about 5 to 1 or less, such as about 4 to 1 or less such as about 3 to 1 or less, such as about 2 to 1 or less, such as about 1.5 to 1 or less, such as about 1.25 to 1 or less, such as about 1 to 1. Optionally, the device  400  can be configured such that the paddles are moved outward in the translation direction  412  and then rotated or pivoted outward in the rotational or pivot direction  410  to create the opening  406  with the second width  420  between the paddles  402  and gripping members  404 . In addition, the device  400  can be configured such that the paddles  402  are moved, flexed, rotated, or pivoted outward in the rotational or pivot direction  410  and moved outward in the translation direction  412  simultaneously to create the second width  422  between the paddles  402  and the gripping members  404 . 
       FIGS. 59-61  illustrate an implantable device  400  in which the paddles  402  are moved, flexed, rotated, or pivoted outward in the rotational or pivot direction  410 , and, subsequently, moved outward in the translation direction  412  to create a wider opening  406 .  FIG. 59  illustrates the implantable device  400  in a closed position, such that the paddles  402  are engaging the gripping members  404 . Referring to  FIG. 60 , the paddles  402  are moved, flexed, rotated, or pivoted outward in the rotational or pivot direction  410  to create an opening  406  having a first width  420  for receiving valve tissue. Referring to  FIG. 61 , after the paddles  402  are moved, flexed, rotated, or pivoted outward in the rotational or pivot direction  410 , the paddles  402  are moved outward in the translation direction  412  such that the opening  406  has a second width  422 . After valve tissue is received in the openings  406  between the paddles  402  and the gripping members  404 , the valve repair device is moved back to the closed position (as shown in  FIG. 59 ) to secure the valve repair device  400  to the valve tissue. The implantable device  400  can include any other features for an implantable device discussed in the present application, and the implantable device  400  can be positioned to engage valve tissue  20 , 22  as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). 
       FIGS. 62-64  illustrate an implantable device  400  in which the paddles  402  are moved outward in the translation direction  412 , and, subsequently, moved, flexed, rotated, or pivoted outward in the rotational or pivot direction  410  to create a wider opening  406 .  FIG. 62  illustrates the implantable device  400  in a closed position, such that the paddles  402  are engaging the gripping members  404 . Referring to  FIG. 63 , the paddles  402  are moved outward in the translation direction  412  to create an opening  406  having a first width  420  for receiving valve tissue. Referring to  FIG. 64 , after the paddles  402  are moved outward in the translation direction  412 , the paddles  402  are moved, flexed, rotated, or pivoted outward in the rotational or pivot direction  410  such that the opening  406  has a second width  422 . After valve tissue is received in the openings  406  between the paddles  402  and the gripping members  404 , the implantable device  400  is moved back to the closed position (as shown in  FIG. 62 ) to secure the implantable device  400  to the valve tissue. The implantable device  400  can include any other features for an implantable device discussed in the present application, and the implantable device  400  can be positioned to engage valve tissue  20 , 22  as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). 
     While  FIGS. 59-61  illustrate a device  400  in which the paddles  402  are rotated or pivoted and then spread apart (e.g., moved translationally away from each other), and  FIGS. 62-64  illustrate a device  400  in which the paddles  402  are spread apart and then rotated or pivoted. In some embodiments, a device  400  can include paddles  402  that can be spread apart and rotated or pivoted simultaneously. In addition, in certain embodiments, the paddles  402  can be spread apart and rotated or pivoted independently of each other. That is, in the embodiments for the valve repair device  400  shown in  FIGS. 59-61 and 62-64 , as well as the embodiment in which the spreading apart and rotating or pivoting of each paddle  402  is completed simultaneously, the paddles  402  can be controlled independently of each other. 
     Referring now to  FIGS. 65-183 , an example embodiment of an implantable prosthetic spacer device  500  is shown. The implantable prosthetic spacer device  500  is one of the many different configurations that the device  100  that is schematically illustrated in  FIGS. 8-15  can take. The device  500  can include any other features for an implantable prosthetic device discussed in the present application or any of the applications that are incorporated herein by reference, and the device  500  can be positioned to engage valve tissue  20 , 22  as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application or any of the applications that are incorporated herein by reference). The various components of the implantable prosthetic spacer device  500  can be made at any suitable size to accommodate different size patient anatomy. 
     The implantable prosthetic spacer device  500  extends from a proximal portion  501  to a distal portion  502  and includes a coaption portion  504  and an anchor portion  506 . The coaption portion  504  of the device  500  includes a central or main shaft  510  and a coaption element  520  for implantation between the leaflets  20 , 22  of the native valve. The anchor portion  506  includes a plurality of anchors  508 , each anchor  508  including a paddle  530 , paddle extension members or paddle frames  570 , and clasps  580 . The anchor portion  506  can also include an optional spreading member  550  that can be actuated to adjust the position of portions of the paddles  530  and clasps  580 . 
     The implantable prosthetic spacer device  500  is implanted into the native valve in a similar fashion to the implantable prosthetic spacer device  200  described above. That is, during implantation the paddles  530  of the anchors  508  are opened and closed to grasp the native valve leaflets  20 ,  22  between the paddles  530  and the coaption element  520 . The anchors  508  are moved between a closed position ( FIGS. 65-70 ) to various open positions ( FIGS. 72-80 ) by extending and retracting an actuation element  591  (e.g., wire, shaft, rod, line, etc.) extending from a delivery system  590 , through the main shaft  510  and to the spreading member  550  that is connected to a distal cap assembly  560 . Referring to  FIG. 72 , the actuation element  591  removably engages the spreading member  550  with a threaded connection, or the like, so that the actuation element  591  can be disengaged and removed from the device  500  after implantation. In embodiments without the spreading member  550 , the actuation element extends to and is removably attached to the distal cap assembly  560 . In these embodiments, the device illustrated by  FIGS. 65-183  can be operated in substantially the same manner as any of the non-spreading devices described herein. 
     Extending and retracting the actuation element  591  attached to the spreading member  550  increases and decreases the spacing between the main shaft  510  and the distal cap assembly  560 , respectively. The main shaft  510  slides along the spreading member  550  and actuation element  591  during actuation so that changing of the spacing between the main shaft  510  and the distal cap assembly  560  causes the paddles  530  to move between different positions to grasp the native valve leaflets  20 ,  22  during implantation. 
     In one example embodiment, as the device  500  is opened and closed, the paddles  530  are moved in unison, rather than independently, by the single actuation element or actuation wire  591 . Also, the positions of the clasps  580  are dependent on the positions of the paddles  530 . For example, the clasps  580  are arranged such that closure of the anchors  508  simultaneously closes the clasps  580 . In any of the embodiments disclosed herein, the clasps  580  can be omitted and the native valve leaflets are captured directly between the paddles  530  and the coaption element. 
     In one example embodiment, the device  500  can be made to have the paddles  530  be independently controllable in the same manner as the device  100  illustrated in  FIG. 15 . 
     The barbed clasps  580  further secure the native leaflets  20 ,  22  by engaging the leaflets  20 ,  22  with barbs  586  and pinching the leaflets  20 ,  22  between the fixed and moveable arms  582 ,  584 . The barbs  586  of the barbed clasps  580  increase friction with or may partially or completely puncture the leaflets  20 ,  22 . Actuation lines  596  ( FIGS. 72-75 ) can be actuated separately so that each barbed clasp  580  can be opened and closed separately. Separate operation of the barbed clasps  580  allows one leaflet  20 ,  22  to be grasped at a time, or for the repositioning of a clasp  580  on a leaflet  20 ,  22  that was insufficiently grasped, without altering a successful grasp on the other leaflet  20 ,  22 . The barbed clasps  580  can be fully opened and closed when the paddle  530  is not closed, thereby allowing leaflets  20 ,  22  to be grasped in a variety of positions as the particular situation requires. 
     Referring now to  FIGS. 65-70 , the implantable prosthetic device  500  is shown in a closed position. When closed, inner portions  538  of the paddles  530  are disposed between the outer portions  540  of the paddles  530  and the coaption element  520 . The clasps  580  are disposed between the inner portions  538  and the coaption element  520 . Upon successful capture of native leaflets  20 ,  22  the device  500  is moved to and retained in the closed position so that the leaflets  20 ,  22  are secured within the device  500  by the clasps  580  and are pressed against the coaption element  520  by the paddles  530  and/or paddle frames  570 . In the illustrated example, the outer portions  540  of the paddles have a wide curved shape that fits around the curved shape of the coaption element  520  to more securely grip the leaflets  20 ,  22  when the device  500  is closed, similar to what is shown in  FIG. 51  with respect to the device  200 . The curved shape and rounded edges of the outer portions  540  also inhibits tearing of the leaflet tissue. The various components of the implantable prosthetic device  500  in closed positions are shown in an exploded view in  FIG. 71 . 
     In the illustrated embodiment of  FIG. 71 , the implantable prosthetic device  500  includes the optional spreading member  550 , as described above. However, the implantable prosthetic device  500  may have other configurations. For example, as shown in  FIG. 71A , the implantable prosthetic device does not include the optional spreading member  500 . 
     Referring now to  FIGS. 72-77 , the implantable prosthetic device  500  is shown in a partially or approximately three-quarters extended position. Like the device  200  described above, the device  500  is capable of being actuated from closed, to partially open, to fully open, and any position in between, as the circumstance requires. The paddles  530  of the device  500  transition between the closed position shown in  FIGS. 65-70  to the open position shown in  FIGS. 72-80  upon extension of the actuation element  591  from a fully retracted or closed position to the three-quarter extended position. The implantable prosthetic device  500  is shown in  FIGS. 78-80  with various components removed and the main shaft  510  and distal cap assembly  560  cutaway to better show how the paddles  530  connect to the other components to facilitate opening and closing the device  500 . 
     Extending the actuation element  591  pulls down on distal ends  532  of the paddles  530  that are attached to the distal cap assembly  560 . The paddles  530  include inner and outer paddle portions  538 ,  540 . The paddle frames  570  are connected by a connector  579  (as shown schematically in the  FIGS. 72-74 ) to the paddles  530  between the inner and outer paddle portions  538 ,  540  and also to the distal cap assembly  560 . The connection  579  can take a wide variety of different forms. For example, the connection  579  can be to the inner paddle portion  538 , to the outer paddle portion  540 , or on a transition between the inner paddle portion and the outer paddle portion. Pulling down on the distal ends  532  pulls down on the outer paddle portions  540  and paddle frames  570 . In turn, the outer paddle portions  540  and paddle frames  570  pull down on the inner paddle portions  538  that are connected to proximal attachment interfaces  533  that are fixedly attached to the main shaft  510 . Because the main shaft  510  is held in place by the capture mechanism  592 , the inner paddle portions  538  are caused to move, pivot, flex, etc. in an opening direction. When the actuation element  591  is extended sufficiently, the inner paddle portions  538 , outer paddle portions  540 , and paddle frames  570  all flex to the position shown in  FIGS. 72-77 . That is, opening the paddles  530  and frames  570  forms a gap  505  between the coaption element  520  and the inner paddle portions  538  that can receive the native leaflets  20 ,  22 . This movement also exposes the barbed clasps  580  that can be moved between closed ( FIG. 65 ) and open ( FIG. 72 ) positions to form another gap  507  for grasping the native leaflets  20 ,  22 . The extent of the gap  507  of the clasp  580  is limited to the extent that the inner paddle portion  538  has spread away from the coaption element  520 . 
     Continuing to extend the actuation element  591  pulls down on the paddles  530  and paddle frames  570 , thereby causing the inner paddle portions  538  to spread apart further from the coaption element  520 . When fully extended, the outer paddle portions  540  and paddle frames  570  move to a position where they are close to the actuation element  591 . In the fully extended position, the inner paddle portions  538  are open to an approximately 180-degree angle with the coaption element  520  (See  FIGS. 36 and 37 ). The inner and outer paddle portions  538 ,  540  are stretched straight in the fully extended position to form an approximately 180-degree angle between the paddle portions  538 ,  540  (See  FIGS. 36 and 37 ). The fully extended position of the device  500  provides the maximum size of the gap between the coaption element  520  and inner paddle portions  530 , and, in some embodiments, allows clasps  580  to also open fully to approximately 180 degrees (e.g.,  FIG. 37 ) between the fixed and moveable arms  582 ,  584  of the clasp  580 . The position of the device  500  is the longest and the narrowest configuration. Thus, the fully extended position of the implantable prosthetic device  500  can be the position for placement of the device in a delivery catheter, or the like, can be the position for initial deployment of the device in the atrium (See  FIG. 38 ), and/or can be the position for bailout of the device  500  from an attempted implantation. 
     Configuring the implantable prosthetic spacer device  500  such that the anchors  508  can extend to a straight or approximately straight configuration (e.g. approximately 120-180 degrees relative to the coaption element  520 ) can provide several advantages. For example, this configuration can reduce the radial crimp profile of the prosthetic spacer device  500 . It can also make it easier to grasp the native leaflets  20 ,  22  by providing a larger opening between the coaption element  520  and the inner paddle portions  538  in which to grasp the native leaflets  20 ,  22 . Additionally, the relatively narrow, straight configuration can prevent or reduce the likelihood that the prosthetic spacer device  500  will become entangled in native anatomy (e.g., chordae tendineae CT shown in  FIGS. 3 and 4 ) when positioning and/or retrieving the prosthetic spacer device  500  into the delivery system  590 . The clasps can be fully open while the prosthetic spacer device is in the fully elongated position the facilitate disentanglement from the native anatomy. 
     The implantable prosthetic spacer device  500  is similar in many ways to the devices  200 ,  300  described above. Like the implantable prosthetic spacer device  200 , the implantable prosthetic spacer device  500  can include a cover (not shown). In some embodiments, the cover can be disposed on the coaption member  520 , the paddles  530 , and/or the paddle frames  570 . The cover can be configured to prevent or reduce blood-flow through the prosthetic spacer device  500  and/or to promote native tissue ingrowth. In some embodiments, the cover can be a cloth or fabric such as PET, velour, or other suitable fabric. In some embodiments, in lieu of or in addition to a fabric, the cover can include a coating (e.g., polymeric) that is applied to the implantable prosthetic spacer device  500 . In some embodiments, in lieu of or in addition to a fabric, the coaption member cam be made from any of the cover materials described herein. 
     Referring to  FIGS. 81-88 , the implantable prosthetic device  500  is retained by a capture mechanism  592  of a delivery system  590 . The capture mechanism  592  can be opened and/or closed in a variety of different ways. In one example embodiment, the capture mechanism is opened by retracting the actuation element, wire, or shaft  591 . Moveable portions  594  of the capture mechanism  592  removably attach the main shaft  510  to the delivery system  590 . Referring to  FIGS. 81, 83, 85, and 87 , in the illustrated embodiment, the capture mechanism  592  is held closed around the main shaft  510  by the actuation element  591 . For example, the actuation element can engage eyelets or other structures that are attached to the insides of the moveable portions  594  to hold the moveable portions closed. Referring to  FIGS. 82, 84, 86, and 88 , removal of the actuation element  591  in a removal direction  593  allows the moveable portions  594  of the capture mechanism  592  to spring open in an opening direction  597  and release the main shaft  510  to decouple the capture mechanism  592  from the implantable prosthetic device  500  after the device  500  has been successfully implanted. The movable portions  594  include openings  595  that receive portions of attachment projections  515  near the proximal end  512  of the main shaft  510 . 
     Referring now to  FIGS. 89-94 , various views of the central or main shaft  510  are shown with the main shaft  510  separate from other components of the implantable prosthetic device  500 . The main shaft  510  extends from a first or proximal end  511  to a second or distal end  512 . A central opening  513  extends through the main shaft  510  from the proximal end  511  to the distal end  512 . The central opening  513  has a round shape for receiving and sliding along the optional spreading member  550  and the actuation element  591 . Parallel paddle slots  514  extend opposite each other from the proximal end  511  to the distal end  512  for receiving the ribbon paddles  530 . The paddle slots  514  can be open to the central opening  513  to form a larger and irregularly shaped central opening  513  that can be formed in a single manufacturing operation. Pairs of spacer connection projections  503  and delivery attachment projections  515  extend outward from opposite sides of the main shaft  510  near the proximal end  511 . A gap  516  between each pair of spacer connection projections  503  and attachment projections  515  can be shaped to receive at least part of the moveable portion  594  of the attachment mechanism  592 . The gap is sized so that at least a portion of the attachment projections  515  protrude into openings  595  of the moveable portion  594 . 
     A first cam slot  517  extends from the front to back of the main shaft  510  between the paddle slots  514  and has a width that is about the same or slightly larger than a width of cam portions  556  of the spreading member  550 . The first slot  517  receives cam portions  556  of the spreading member  550  when the spreading member  550  is in a stowed position and orientation. A second cam slot  518  extends from the distal end  512  on each side of the main shaft  510  to intersect with the paddle slots  514 . The second cam slot  518  is orthogonal to the first cam slot  517  and is narrower in near the middle of the main shaft  510 —having a width approximately the same as the first cam slot  517 —and spreads out to the width of the paddle slots  514  to provide room for the paddles  530  to open and spread apart. The second cam slot  518  receives the cam portions  556  of the spreading member  550  when the spreading member  550  is in a deployed position and orientation. The first and second cam slots  517 , 518  receive the cam portions  556  of the spreading member  550  when the spreading member  550  is retracted into the main shaft  510  to fully close the implantable prosthetic device  500 . Distal projections  519  extend between the first and second cam slots  517 , 518  to engage the cam portions  556  and to restrict the rotation of the spreading member  550  between the active and inactive rotational positions. 
     Still referring to  FIGS. 89-94 , the optional cutouts  610  form optional flanges  612  at the proximal end  511  of the central shaft. Optional recapture tether passages  614  extend through the flanges  612 . Optional recapture tethers can be routed through the passages  614  to allow the device to be recaptured after an initially unsuccessful deployment. 
     Still referring to  FIGS. 89-94 , the main shaft  510  can be made from a wide variety of different materials. For example, the main shaft can be made of plastic, such as PET, PTFE, ePTFE, metal, foam, fabric, braided material, etc. 
     Referring now to  FIGS. 95-100 , various views of the coaption member or element  520  are shown with the coaption element  520  separate from other components of the implantable prosthetic device  500 . The coaption element  520  extends from a proximal end  521  to a distal end  522  and has a generally elongated and round shape. In particular, the coaption element  520  has an elliptical shape or cross-section when viewed from above ( FIG. 99 ) and has a tapered shape or cross-section when seen from a front view (e.g.,  FIG. 97 ) and a round shape or cross-section when seen from a side view (e.g.,  FIG. 98 ). A blend of these three geometries can result in the three-dimensional shape of the illustrated coaption element  520  that achieves the benefits described herein. To adequately fill the gap  26  between the leaflets  20 , 22 , the device  500  and the components thereof can have a wide variety of different shapes and sizes. For example, the paddles  530  and paddle frames  570  can be configured to conform to the shape or geometry of the coaption element  520  as is shown in  FIGS. 50-54 . With regards to the device  500 , the round shape of the coaption element  520  can be seen, when viewed from above, to substantially follow or be close to the shape of the paddle frames  570 . 
     The size of the coaption element  520  can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In one example embodiment, the anterior-posterior distance at the top of the spacer is about 5 mm, and the medial-lateral distance of the spacer at its widest is about 10 mm. In one example embodiment, the overall geometry of the separate coaption element  520  can be based on these two dimensions and the overall shape strategy described above. It should be readily apparent that the use of other anterior-posterior distance anterior-posterior distance and medial-lateral distance as starting points for the device will result in a coaption element  520  having different dimensions. Further, using other dimensions and the shape strategy described above will also result in a coaption element  520  having different dimensions. 
     A central opening  523  extends through the coaption member  520  from the proximal end  521  to the distal end  522 . The central opening  523  has a diameter that is about the same or is slightly larger than a diameter of the main shaft  510  so that the main shaft  510  can be received within the central opening  523  of the coaption element  520 . The central opening  523  includes assembly slots or grooves  524  that run along the full length of the central opening  523 . The assembly grooves  524  allow the coaption element  520  to slide over the projections  503 , 515  during assembly to the main shaft  510  from the proximal end  511 , as shown in  FIGS. 101-105 , which are described below. The assembly grooves  524  are also wide and long enough to receive the cam portions  556  of the spreading member  550  so that the spreading member  550  can be fully retracted in the proximal direction without interfering with the coaption element  520 . Engagement or locking recesses  525  are arranged in the proximal end  521  of the coaption element  520  at about a 90-degree offset from the assembly grooves  524 . The locking recesses  525  receive the distal end of the projections  503  of the main shaft  510  to complete assembly of the coaption element  520  to the main shaft  510  to “lock” the two components together by prohibiting rotation of the coaption element  520 . The distal end  522  of the coaption element  520  includes tapered cuts  526  that intersect the central opening  523  to form a rounded slot or clearance opening  527  that is orthogonal to the assembly grooves  524  and runs through the coaption element from side-to-side. The tapered cuts  526  provide the coaption element  520  with the tapered shape described above, and the clearance opening  527  provides room for the paddles  530  and the spreading member  550 , as shown in  FIGS. 155-168 , which are described below. 
     In some embodiments, the coaption element  520  is a solid or hollow body instead of being formed from a braided material. Forming the coaption element  520  as a or hollow or solid body also enables the coaption element  520  to be formed by injection molding, casting, machining, additive manufacturing, such as 3D printing, or the like rather than being braided out of strands of material. The coaption element  520  can be formed from any suitable material for use in the human body, such as, for example, various plastics, rubber, foam, and/or metal materials. Forming the coaption element  520  with a molding process also facilitates the creation of custom shaped coaption elements  520  based on the heart anatomy of a particular patient. In some cases, the coaption element  520  can also be removed and replaced with a different coaption element  520  having a different size or shape. In one example embodiment, additive manufacturing techniques are used to form a custom-shaped coaption element that is shaped according to scans of the native anatomy of the patient that will receive the implant. The additive manufacturing techniques, such as 3D printing, allow a custom-shaped coaption element to be produced quickly, even intraoperatively, based on images of the patient. The coaption element  520  can also be made, shaped, or otherwise configured to be compressible. The coaption element  520  can be made to be compressible in a wide variety of ways, such as the ways described below. 
     Referring now to  FIGS. 101-105 , the steps to assemble the coaption element  520  to the main shaft  510  of the implantable prosthetic device  500  are shown. When the implantable prosthetic device  500  is fully assembled, the paddles  530  will extend from the distal end  512  of the main shaft  510  thereby preventing the coaption element  520  from being assembled from the distal end  512  of the main shaft. Thus, assembly of the coaption element  520  to the main shaft  510  is accomplished by placing the distal end of the coaption element  520  over the proximal end  511  of the shaft  510 . 
     In some embodiments, as can be seen in  FIGS. 101 and 102 , prior to assembly the coaption element  520  is arranged at the proximal end  511  of the main shaft  510  and is oriented so that the assembly grooves  524  of the coaption element  520  align with the attachment projections  515  of the main shaft  510 . The coaption element  520  is then moved downward onto the main shaft  510  until the proximal end  521  of the coaption element  520  is below the distal end of the attachment projections  515  as can be seen in  FIG. 103 . Now looking to  FIG. 104 , the coaption element  520  is then rotated 90 degrees until the engagement recesses  525  are aligned with the attachment projections  503 . Finally, the coaption element  520  is moved in a proximal direction so that the distal ends of the attachment projections  503  are inserted into the engagement recesses  525  of the coaption element  520 . Optionally, the attachment projections  503  can latch into or otherwise be secured or locked in the engagement recesses to prevent disassembly of the main shaft  510  from the coaption element. 
     Assembly of the coaption element  520  to the main shaft  510  can be performed prior to implantation or during the implantation process. Such as, for example, once the native leaflets  20 ,  22  have been captured by the clasps  580  but the paddles  530  are not yet closed. In some embodiments, the coaption element  520  can be removed after implantation and replaced with a new coaption element  520 . A re-capture system (not shown) could be used to re-capture an already implanted device  500  which could then be opened, the coaption element removed while the implanted device remains attached to the native valve leaflets, a new coaption element would be installed, and then the device would be closed around the new coaption element. 
     A wide variety of different connection arrangements can be used to connect the coaption element  520  to the main shaft  510 . The illustrated quarter turn connection mechanism is just one of the many connection arrangements that can be used. The illustrated quarter-turn locking mechanism used to join the coaption element  520  to the main shaft  510  allows different coaption elements  520  to be interchanged rapidly. Quick changeover between different coaption elements  520  can enable the physician to adapt to new information learned during the implantation procedure. For example, it may turn out that the size or shape of the gap  26  in the native valve, e.g., native mitral valve, is different than expected or has changed and now requires a different size spacer device than initially planned. Providing the physician with a package or kit containing different size and shape coaption elements  520  along with the implantable prosthetic device  500  allows the physician to choose which size or shape coaption element  520  is needed based on all available information. Or, one or more custom molded coaption elements  520  can also be planned for in advance and provided along with the device  500  so that the fit of each can be tested. Rather than making entire devices having different sized coaption portions, a single implantable prosthetic device  500  can be configured with any number of coaption elements  520  having a wide variety of sizes and shapes thereby improving the fit of the implanted device and reducing manufacturing costs. 
     Referring now to  FIGS. 106-121 , various views of one of the pair of paddles  530  are shown with the paddle  530  separate from other components of the implantable prosthetic device  500 . The paddles  530  have a ribbon-like form that extends from a proximal end  531  to a distal end  532  and includes three primary segments: a connection portion  534 , an inner paddle portion  538 , and an outer paddle portion  540 . The inner and outer paddle portions  538 ,  540  of the paddles  530  are configured similar to legs in that the inner paddle portions  538  are like upper portions of the legs, the outer paddle portions  540  are like lower portions of the legs, and a middle connection portion  539  between the inner and outer paddle portions  538 ,  540  are like knee portions of the legs. The inner paddle portions  538  are stiff, relatively stiff, rigid, have rigid portions and/or are stiffened by a stiffening member or a fixed portion  582  of the clasps  580 . As shown, the inner paddle portion  538  can include more material than the other portions of the paddle  530  and can therefore be stiffer. The stiffening of the inner paddle portions  538  allows the device  500  to move to the various different positions shown and described herein. 
     The proximal end  531  includes the proximal attachment interface  533  that engages with the main shaft  510  to secure the proximal end  531  of the paddle  530  near the proximal end  511  of the main shaft  510 . The fixed or connection portion  534  extends from the proximal end  531  to a flexible or spreading portion  535  that is engaged by the cam portions  556  of the spreading member  550 . In embodiments where the spreading member  550  is not included, the portion  535  can be rigid or substantially rigid. A hinge or connection portion  536  connects the spreading portion  535  to the inner paddle portion  538 . The inner paddle portion  538  can include an optional opening  537  for securing the barbed clasps  580  via sutures or some other attachment means. A hinge or connection portion  539  connects the inner paddle portion  538  to the outer paddle portion  540  that is connected to the distal end  532  via a lower hinge or connection portion  546 . Like the proximal end  531 , the distal end  532  includes an attachment interface  547  that engages with the distal cap assembly  560 . 
     The paddles  530  can be made from a wide variety of different materials and can be made in a wide variety of different ways. In one example embodiment illustrated by  FIGS. 113 and 114 , the paddles  530  are laser cut from a flat layer of shape-memory, material such as Nitinol. The various portions of the paddles  530  lay flat in the same plane when cutout of the layer of material. Referring to  FIGS. 106-112 , the flat paddle  530  is bent into a desired shape in a shape-setting jig and then subjected to a shape-setting process. After shape-setting, deforming the paddle  530  by bending or stretching the various components thereof will generate a spring force that tends to return the components of the paddle  530  to their shape-set position. Because the paddles  530  are shape-set in a roughly closed condition, the various connection portions act as spring-loaded hinges that tend to close the paddles  530 . 
     The outer paddle portion  540  includes upper and lower flexible members  542 ,  544  that enable the outer paddle portion  540  to stretch to a longer and narrower stretched condition, shown in  FIGS. 115-121 . The upper and lower flexible members  542 ,  544  are connected by various hinge or connection portions: first connection portions  541  connect the upper flexible members  542  to the middle connection portion  539 ; second connection portions  543  connect the upper flexible members  542  to the lower flexible members  544 ; and third connection portions  545  connect the lower flexible members  544  to the lower connection portion  546 . During stretching of the outer paddle portions  540  the upper flexible members  542  move, pivot, or flex toward each other and the lower flexible members  544  also move, pivot, or flex toward each other so that the outer paddle portion  540  lengthens and narrows. This lengthening and narrowing occurs when the device is moved from the closed condition to the open position and/or to the fully elongated position. In particular, pulling down on the attachment interface  547  to open and/or elongate the device  500  applies a tensile force to the outer paddle portions  540  and the illustrated configuration of the outer paddle portions allows the outer paddle portions to elongate and narrow. 
     When force is applied to the implantable prosthetic device  500  to stretch the outer paddle portion  540 , the angles between the various components connected by each of the first, second, and third connection portions  541 ,  543 ,  545  increases. This increase in angle is resisted by a restorative spring force caused by the shape-memory nature of the material of the paddles  530  that resists the expanding of the connection portions  541 ,  543 ,  545 . Thus, when stretching forces are removed, the outer paddle portion  540  contracts to an original length and widens to an original width. 
     In some embodiments, the connection portions  536 ,  539 ,  546  are formed by a plurality of spring or connecting segments arranged in a repeating pattern of cutouts that are formed when the paddle  530  is laser cut from a flat sheet of material. The thinner sections of the segments provide flexibility along a mid-plane of the paddle  530  and the symmetrical shape of each segment resists bending moments that may twist the paddle  530  outside of the mid-plane during bending. These connecting segments allow the connection portions  536 ,  539 ,  546  to bend a considerable amount while avoiding plastic deformation of the material as the individual connecting segments are bent. 
     Referring now to  FIGS. 122-127 , various views of embodiments of the optional spreading member  550  are shown with the spreading member  550  separate from other components of the implantable prosthetic device  500 . The spreading member  550  extends from a proximal end  551  that attaches to the actuation element  591  to a distal end  552  that attaches to the distal cap  560 . A central rod  553  of the spreading member  550  includes a threaded opening  554  at the proximal end  551  of the spreading member  550 . The central rod  553  extends from the proximal end  551  to the distal end  552  that includes an attachment portion  555 . Cam portions  556  extend laterally in the bottom half of the spreading member  550 . The cam portions  556  have a rounded triangular shape and include an external rounded cam surface  558  that engages with the paddles  530 . Though the spreading member  550  is shown as an elongated body with ramp-like portions extending laterally, the spreading member  550  can be any device or mechanism that spreads the paddles  530  laterally. 
     The cam portions  556  can take on a wide variety of shapes and sizes. Also, the cam portions  556  can be formed from a solid piece of material or can be expandable by inflation or other suitable means so that the cam portions  556  can change size, shape, and/or position. In certain embodiments, the cam portions  556  are expandable or inflatable such that no rotation of the spreading member  550  is necessary to engage the paddles  530  with the cam surfaces  558 . That is, inflating the cam portions  556  engages the paddles  530  and deflating the cam portions  556  disengages the paddles  530 . 
     Referring now to  FIGS. 128-129 , an example distal cap assembly  560  is shown in an exploded view ( FIG. 128 ) and an assembled view ( FIG. 129 ). The distal cap assembly  560  holds the distal end  502  of the device  500  and enables the device  500  to be opened and closed, e.g., by extending and retracting the actuation element  591 . The base of the distal cap assembly  560  is a threaded bolt  561  that extends from a rounded head. Washers  562  fit over the bolt  561  and include a square-shaped central opening  563  for receiving a distal retaining nut  566  and rectangular side openings  564  for receiving the paddle frames  570 . The washers  562  also include paddle slots  565  for receiving the distal ends  532  of the paddles  530 . The retaining nut  566  includes a square or locking end  567  that fits within the central opening  563  and closes off the side openings  564  to retain the paddle frames  570 . A threaded opening  568  extends through the length (threads can be included on all or a portion of the length of the opening) of the retaining nut  566  and is engaged by the bolt  561 , thereby holding the distal cap assembly  560  together. Side slots  569  align with the side openings  564  of the washers  562  to provide further engagement with the paddle frames  570 . 
     Referring now to  FIGS. 130-137 , various views of an example assembly of the spreading member  550 , distal cap assembly  560 , and actuation element  591  in an exploded condition ( FIGS. 130-133 ) and an assembled condition ( FIGS. 134-137 ) are shown. The two connections of the assembly—between the spreading member  550  and the distal cap assembly  560  and between the spreading member  550  and the actuation element  591 —are different in their nature and purpose. That is, the connection between the distal cap assembly  560  and the spreading member  550  allows the two components to rotate relative to each other without coming undone, as would be the case with a typical threaded connection. A wide variety of different rotatable couplings between the distal cap assembly  560  and the spreading member  550  can be used. In contrast, the connection between the spreading member  550  and the actuation element  591  is a fixed connection, such as a threaded connection that fixes the spreading member  550  to the actuation element but disassembles when the actuation element  591  is rotated in a counter-tightening direction while the spreading member  550  is retained in a fixed position. However, any fixed, but releasable, connection can be used between the actuation element  591  and the spreading member  550 . 
     In the illustrated example, the rotatable coupling between the spreading member  550  and the distal cap assembly  560  is made by inserting the attachment portion  555  of the spreading member  550  into the opening  568  of the distal nut  566 . The opening  568  includes a radially inwardly extending projection that engages the radially outwardly extending end of the attachment portion. The attachment portion  555  engages internal projection in the opening  568  to join the spreading member  550  to the distal nut  566  so that the spreading member  550  is free to rotate relative to the distal nut  566 . The attachment portion  555  engages the opening  568  by snapping the two components together with cam surfaces at the end of the attachment portion  555  engaging the protrusion on the interior of the opening  568 . The connection between the spreading member  550  and distal nut  566  allows the spreading member  550  to rotate freely relative to the distal nut  566  without coming apart, in contrast to a fixed threaded connection. Thus, the spreading member  550  can be rotated between the resting and engaged positions by the wire  591 , as described below. 
     In one example embodiment, the connection between the spreading member  550  and the actuation element  591  is made by threading the actuation element  591  into the threaded opening  568  of the distal cap assembly  560 . When fully attached, the connection between the spreading member  550  and the actuation  591  is rotationally fixed so that rotation of the actuation element  591  also rotates the spreading member  550 . The connection between the spreading member  550  and the actuation element  591  can be unscrewed when the spreading member  550  is fully retracted into the main shaft  510  and prevented from rotating by the projections  519 . For example, once implantation of the device  500  is completed, the actuation element  591  can be unscrewed from the spreading member  550  and retracted into the delivery system  590 . 
     Referring now to  FIGS. 138-145 , various views of an example assembly of a spreading member  650 , the distal cap assembly  560 , the actuation element  591 , and an actuation tube  691  in an exploded condition ( FIGS. 138-141 ) and an assembled condition ( FIGS. 142-145 ) are shown. The spreading member  650  is similar in shape and function to the spreading member  550  but can be actuated independently from the distal cap assembly  560  to provide additional control over the lateral position of the paddles  530  that is independent from the open condition of the paddles  530 . That is, the spreading member  650  can be actuated when the implantable prosthetic device  500  is partially opened, half opened, three-quarters open, fully open, or opened any other amount. 
     In some embodiments, the spreading member  650  extends from a proximal end  651  that attaches to the actuation tube  691  to a distal end  652 . The actuation element  591  extends through the actuation tube  691  to attach to the opening  568  of the distal cap assembly  560 . A central rod  653  of the spreading member  650  includes a central opening  654  that extends through the spreading member  650 . The actuation element  591  extends through the central opening  654  so that the spreading member  650  can slide along the actuation element  591 . The central rod  653  extends from the proximal end  651  to the distal end  652 . Cam portions  656  extend laterally in the bottom half of the spreading member  650 . The cam portions  656  have a rounded triangular shape and include an external rounded cam surface  658  that engages with the paddles  530 . 
     The two connections of the assembly—between the actuation element  591  and the distal cap assembly  560  and between the spreading member  650  and the actuation tube  691 —are similar in their nature and purpose. That is, both connections are fixed connections that enable the actuation element  591  and tube  691  to extend and retract the connected component—i.e., the distal cap assembly  560  and the spreading member  650 , respectively. For example, a threaded connection can be used between the actuation element  591  and distal cap assembly  560  and between the spreading member  650  and the actuation tube  691  so that the connections can be released by rotating the actuation element  591  or tube  691  in a counter-tightening direction while the distal cap assembly  560  or spreading member  650  are retained in a fixed position. However, any fixed, but releasable, connection can be used between the actuation element  591  and the distal cap assembly  560  and between the actuation tube  691  and the spreading member  650 . 
     Referring now to  FIGS. 146-152 , various views of the example distal cap assembly  560  and paddle frames  570  are shown separate from other components of the implantable prosthetic device  500 . The paddle frames  570  extend from a cap attachment portion  571  to a paddle connection portion  572 . The paddle frames  570  are formed from a piece of material such as nitinol, or any other suitable material, that extends from a first end  573  at the cap attachment portion  571 , through a middle or loop portion  574  at the paddle connection portion  572  and returns to a second end  575  at the cap attachment portion  571 . The first and second ends  573 ,  575  of the paddle frame  570  each include an attachment notch or recess  576  that helps to secure the paddle frames  570  to the distal cap assembly  560 . The paddle frames  570  also include attachment holes  577  in the loop portion  574  for securing the paddles  530  to the paddle frame  570 . In some embodiments, the paddle frames  224  are formed of a material that is more rigid and stiff than the material forming the paddles  222 ,  220  so that the paddle frames  224  provide support for the paddles  222 ,  220 . The paddle frames  570  can be formed from a flat blank that is cut from a flat sheet of material, for example, by laser cutting. The cut blank can then be bent to form the three-dimensional shape of the paddle frames  570 . 
     The paddle frames  570  provide additional pinching force between the paddles  530  and the coaption element  520  and assist in wrapping the leaflets  20 ,  22  around the sides of the coaption element  520  for a better seal between the coaption element  520  and the leaflets  20 ,  22 , as can be seen in  FIG. 51 . That is, the paddle frames  570  can be configured with a round three-dimensional shape extending from the distal cap assembly  560  to the middle hinge portion  539  between the inner and outer paddle portions  538 ,  540 . The connections between the main shaft  510 , paddles  530 , the distal cap assembly  560 , paddle frames  570  can constrain each of these parts to the movements and positions described herein. In particular the middle hinge portion  539  is constrained by its connection between the inner and outer paddle portions  538 ,  540  and by its connection to the paddle frame  570 . Similarly, the paddle frame  570  is constrained by its attachment to the paddles  530  (by way of the middle hinge portion  539 ) and to the distal cap assembly  560 . 
     In some embodiments, the loop portions  574  of the paddle frames  570  form a generally rounded, three-dimensional shape that—as discussed above and as can be seen in  FIGS. 65 and 69 —generally conforms to the shape of the coaption element  520 . The sides of the paddle frames  570  between the cap attachment portion  571  and the paddle connection portion  572  have a rounded, wing-like shape that engages the curved surface of the coaption element  520  during grasping of native leaflets  20 ,  22  between the paddle  530  and coaption element  520  of an implantable device of the present invention, as can be seen in  FIGS. 50 and 51 . Configuring the paddle frames  570  in this manner provides increased surface area compared to the paddles  530  alone. This can, for example, make it easier to grasp and secure the native leaflets  20 ,  22 . The increased surface area can also distribute the clamping force of the paddles  530  and paddle frames  570  against the native leaflets  20 ,  22  over a relatively larger surface of the native leaflets  20 ,  22  in order to further protect the native leaflet tissue. Similar to the frames  224  shown in  FIG. 51 , the increased surface area of the paddle frames  570  can also allow the native leaflets  20 ,  22  to be clamped to the implantable prosthetic spacer device  500 , such that the native leaflets  20 ,  22  coapt entirely around the coaption member  520 . This can, for example, improve sealing of the native leaflets  20 ,  22  and thus prevent or further reduce valvular regurgitation. 
     Referring again to  FIGS. 146-148 , the example distal cap assembly  560  and paddle frames  570  are shown in an exploded condition prior to being joined together. To assemble the paddle frames  570  to the distal cap assembly  560  the first and second ends  573 ,  575  are squeezed together to narrow the width of the cap attachment portion  571  so that the first and second ends  573 ,  575  can be inserted into the side openings  564  of the washers  562 . When the paddle frames  570  are allowed to expand, the first and second ends  573 ,  575  expand outwards so that the attachment recesses  576  receive and hook around a portion of the washers  562 . The retaining nut  566  is then inserted into the opening  563  so that the locking end  567  fits between the ends  573 ,  575  of the paddle frames  570 , thereby locking the paddle frames  570  in engagement with the washers  562 . The bolt  561  is then threaded into the retaining nut  566  and tightened until the flange or cap of the bolt  561  engages the washers  562 , as is shown in  FIGS. 149-151 . 
     Referring to  FIG. 152 , the paddle frames  570  are shown assembled to the distal cap assembly  560 . The paddle frames  570  can be shape set to provide increased clamping force against or toward the coaption element  520  when the paddles  530  are in the closed configuration. This is because the paddle frames  570  are shape-set relative to the closed position (e.g.,  FIG. 149 ) to a first position (e.g.,  FIG. 152 ) which is beyond the position where the paddle  530  would engage the coaption element  520 , such as beyond a central plane of the device  500 , such as beyond the opposite side of the coaption element  520 , such as beyond the outer paddle  570  on the opposite side of the coaption element  520 . In the first position the loop portions  574  of the paddle frames  570  are intertwined in that the sides of one paddle frame  570  are moved slightly laterally to allow movement past the sides of the other paddle frame  570  until the paddle connection portions  572  of each frame  570  contact each other and the sides and prevent further movement. 
     Referring now to  FIGS. 153-155 , the paddles  530  are shown spaced apart from the connected distal nut assembly that forms the distal cap  560  and paddle frames  570 . To attach the paddles  530  to the distal cap assembly  560 , the distal ends  532  of the paddles  530  are aligned with the paddle slots  565  in the washers  562 . The distal attachment interface  547  of the paddles  530  is squeezed laterally to fit within the paddle slot  565  and is then inserted into the paddle slot  565  until the attachment interface  547  bottoms out on the washer  562 . Then the attachment interface  547  is allowed to expand to secure the distal end  532  of the paddle  530  within the paddle slot  565 , as is shown in  FIGS. 156-158 and 160 . 
     Referring to  FIGS. 156-159 , the paddles  530  and the main shaft  510  are assembled by inserting the proximal attachment interfaces  533  through the slots  514  at the distal end  512  of the main shaft. The attachment interfaces  533  are advanced through the slots  514 , until the attachment interfaces reach the proximal end  511  of the main shaft  510 . The proximal attachment interfaces  533  expand laterally to secure the proximal ends  531  of the paddles  530  to the proximal end  511  of the main shaft  510 . Though the proximal attachment interfaces  533  are shown slightly protruding from the proximal end  511  of the main shaft  510 , the proximal attachment interfaces  533  can be flush with the proximal end of the main shaft  510  or recessed within the proximal end of the main shaft  510 . 
     Referring to  FIGS. 156-159 , the proximal end  551  of the shaft  553  of the spreading member  550  is inserted through the passage  513  at the distal end  512  of the main shaft  510 . The shaft  553  of the spreading member  550  is advanced through the passage  513  toward the proximal end  511  of the main shaft  510 . 
     Referring now to  FIGS. 161-164 , another example embodiment of paddles  630  for an example implantable are shown. The paddles  630  are formed by joining distal ends  532  of the two of the paddles  530  (described above) together with a connecting portion  632 . The connecting portion  632  includes an opening  634  for receiving the distal retaining nut  566  ( FIG. 163 ) so that the paddles  630  are sandwiched between the bolt  561  and the washers  562  ( FIG. 163 ). Optionally, the paddles  530  can be joined by a connecting portion (not shown) at their proximal ends  532 . Attaching the paddles  630  in this way enables both paddles  530  to be formed in a single operation. 
     Referring now to  FIGS. 165-167 , various views of one of the barbed clasps  580  are shown with the barbed clasp  580  separate from other components of the implantable prosthetic device  500 . The barbed clasp  580  can be substantially the same as the barbed clasp  330  shown in  FIG. 56 , but the size of the clasp  580  can be different than the size of the clasp  330 , since the device  300  shown in  FIG. 55  can be a different size than the device  500 . However, a wide variety of different barbed clasps can be used in the devices disclosed herein. Examples of barbed clasps that can be used include but are not limited the barbed clasp illustrated by  FIG. 29  and/or any of the barbed clasps disclosed in the present application and any of the applications that are incorporated herein by reference and/or that the present application claims priority to. The barbed clasps  580  grasp the native leaflets  20 , 22  in a similar manner to that shown in  FIG. 29  and described above. 
     The barbed clasps  580  include a base or fixed arm  582 , a moveable arm  584 , barbs  586 , and a joint or hinge portion  588 . The fixed arms  582  are attached to the paddles  530 , with the joint portion  588  disposed proximate the coaption element  520 . The joint portion  588  is spring-loaded so that the fixed and moveable arms  582 , 584  are biased toward each other when the barbed clasp  580  is in a closed condition, as well as the open portion. The hinge portion  588  is formed from a plurality of spring segments arranged in a repeating pattern extending between the fixed arm  582  and the movable arm  584 . Joining multiple segments together allows the hinge portion  588  to bend a considerable amount while avoiding plastic deformation of the material as the individual spring segments are twisted. For example, in certain embodiments, the fixed arm  582  can be moved, flexed, rotated, or pivoted from a neutral position that is approximately 125 degrees beyond the moveable arm  584  to a fully open position that is approximately 180 degrees from the moveable arm  584  without plastically deforming the clasp material. In certain embodiments, the clasp material plastically deforms during opening without reducing or without substantially reducing the pinch force exerted between the fixed and moveable arms in the closed position. 
     The fixed arms  582  are attached to the openings  537  of the paddles  530  through holes or slots  581  with sutures (not shown). The fixed arms  582  can be attached to the paddles  530  with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, or the like. The fixed arms  582  remain substantially stationary relative to the paddles  530  when the moveable arms  584  are opened to open the barbed clasps  580  and expose the barbs  586 . The barbed clasps  580  are opened by applying tension to actuation lines  596  ( FIGS. 72-75 ) attached to holes  585  in the moveable arms  584 , thereby causing the moveable arms  584  to move, pivot, flex, etc. on the joint portions  588 . 
     In some embodiments, the barbed clasps  580  are laser cut from a layer of shape-memory alloy, such as Nitinol. As is shown in  FIGS. 166-167 , the barbs  586  lay flat in the same plane as the rest of the clasp  580  when cut out of the layer of material. The moveable arms  584  and barbs  586  are then bent and/or twisted and are then subjected to a shape setting process. These can be formed in other ways as well. 
     Referring again to  FIGS. 115-121 , the outer paddle portion  540  of the paddles  530  can be stretched to extend the length and decrease the width of the implantable prosthetic device  500 . The paddle frames  570  can also be lengthened and narrowed by stretching. In some embodiments, the width of the paddle frames  570  can decrease from about 10 millimeters to about 8 millimeters during stretching. Stretching of the paddles  530  and paddle frames  570  can be achieved by applying force to the actuation element  591  to push the distal cap assembly  560  away from the main shaft  510  while simultaneously maintaining tension on the actuation lines  596 . Movement of the distal cap assembly  560  away from the main shaft  510  pulls down on the distal ends  532  of the paddles  530  which in turn apply a tensile force to the outer paddle portions  540 . The force applied to the actuation lines can be less than the force required to open the clasps  580  while still being sufficient to maintain the position of the clasps  580  as the actuation element  591  is extended. Consequently, the inner paddle portion  538  attached to the clasp  580  and the paddle connection portions  572  of the paddle frames  570  are also restrained from moving. Thus, the outer paddle portions  540  and the paddle frames  570  are stretched between the distal cap assembly  560  and the paddle connection portions  572  so that the outer paddle portions  540  are extended from the resting position shown in  FIGS. 106-112  to the extended position shown in  FIGS. 115-121  and the paddle frames  570  are similarly extended (not shown). In embodiments of the implantable prosthetic device  500  that include a spreading member  650  ( FIGS. 138-145 ) that can be actuated independently from the movement of the distal cap assembly  560 , the paddles  530  and paddle frames  570  can be spread apart while they are maintained in an open position. That is, the position of the distal cap assembly  560  (which controls the opening and closing of the paddles) can be maintained by the control wire, while the spreading member  650  is moved to engage the paddles  530 . The engagement of the paddles  530  with the spreading member  650 , while the position of the cap  560  is maintained, can also increase tension along the outer paddle portions  540  and paddle frames  570 . This tension can stretch the outer paddle portions  540  and paddle frames  570  to allow the outer paddle portions and paddle frames to fit between small gaps in the patient&#39;s anatomy, such as between chordae tendinea. 
     As described above, the upper and lower flexible members  542 , 544  move together to reduce the overall width of the outer paddle portions  540  as the length of the outer paddle portions  540  is increased. The paddle frames  570  similarly narrow as they are stretched. Accordingly, the width of the outer paddle portions  540  and the paddle frames  570  can be adjusted by stretching the outer paddle portions  540  and the paddle frames  570 . In some embodiments, the outer paddle portions  540  are more flexible than the paddle frames  570  such that the outer paddle portions  540  narrow before the paddle frames  570  and, consequently, the paddle frames  570  carry more of the load exerted on the device  500  from stretching. Conversely, in some embodiments, the paddle frames  570  are more flexible than the outer paddle portions  540  so that the paddle frames  570  narrow before the outer paddle portions  540  and, consequently, the outer paddle portions  540  carry more of the load exerted on the device  500  from stretching. 
     During the implantation procedure, native heart structures (e.g., numerous and/or densely packed chordae) can interfere with capture of the leaflets. That is, portions of the implantable prosthetic device  500  may contact the chordae such that the connected leaflet is pushed away as the surgeon attempts to move the implantable prosthetic device  500  toward the leaflet for capture. Enabling the adjustment of the width of the implantable prosthetic device  500  improves maneuverability of the implantable prosthetic device  500  when configured in a “capture ready” configuration during the implantation procedure. When such native structures are encountered, the implantable prosthetic device  500  can be partially extended to stretch the outer paddle portions  540  and paddle frames  570  to reduce the width of the paddles  530  and the paddle frames  570 , thereby avoiding the native heart structures and enabling capture of the leaflet. The paddles  530  widen when the implantable prosthetic device  500  is closed to capture the leaflet which provides an increased pinching surface to better secure the leaflet within the implantable prosthetic device  500 . 
     Referring now to  FIGS. 168-183 , various views of the deployment of the optional spreading member  550  are shown. The spreading member  550  can be selectively deployed to engage and spread apart the paddles  530  to enable the translational movement of the paddles  530  shown in  FIGS. 57-64  and described above. That is, deployment and actuation of the spreading member  550  causes the paddles  530  to translate outward to better position the clasps  580  to grasp leaflets  20 ,  22  of a native valve with a larger gap  26 . As is discussed above, the translation of the paddles  530  can occur prior to, during, or after the paddles are rotated or pivoted in an opening direction to prepare to capture the leaflets  20 ,  22 . When the gap  26  is not large enough to require spreading, the device can be used as described above, without using the paddle spreading feature. That is, the paddles  530  are simply opened and closed, by translating the spreading member  550 , without rotating the spreading member  550  to enable the paddle spreading feature. 
     Referring now to  FIGS. 168, 172, 176, and 178 , when not needed to spread apart the paddles  530 , the spreading member  550  is stowed at the distal end  512  of the main shaft  510  such that the cam portions  556  are arranged between and rotationally restricted by the distal projections  519  of the main shaft  510 . In the stowed position, the spreading member  550  is also partially located within the central opening  523  and assembly grooves  524  at the distal end  522  of the coaption element  520 . The actuation element  591  is extended to deploy the spreading member  550  by first moving the spreading member  550  distally such that the cam portions  556  are free from the distal projections  519  of the main shaft, as shown in  FIGS. 169 and 173 . This extension of the actuation element  591  can partially open the paddles  530 . Optionally, this partial opening can be limited or prevented altogether by applying tension to the actuation lines  596  during extension of the actuation element  591  as described above. That is, the force exerted by extension of the actuation element  591  can be directed to stretching the outer paddle portions  540  and paddle frames  570  rather than opening the paddles  530 . In some embodiments, the outer paddle portions  540  and paddle frames  570  are stretched and the paddles  530  are partially opened by extension of the actuation element  591  to deploy the spreading member  550 . 
     Referring now to  FIGS. 170 and 174 , the extended actuation element  591  is rotated to rotate the spreading member  550  to a deployed orientation that is 90 degrees from the stowed orientation. This rotation aligns the cam portions  556  of the spreading member  550  with the second cam slot  518  of the main shaft  510  so that the spreading member  550  can be retracted to engage and spread apart the paddles  530  (see  FIG. 181 ). The actuation element  591  and spreading member  550  can be retracted into the second cam slot  518  between the distal projections  519  to engage the paddles  530 . The spreading member  550  can be actuated to any position between the extended position shown in  FIGS. 170 and 174  and the retracted position shown in  FIGS. 171, 175, 177, and 179  to achieve translation of the paddles  530 . 
     In one use, the cam spreader  550  can be configured to remain in the cam spreading position after the leaflets are captured, the clasps  580  are closed, and the paddles  530  are closed around the coaption member  520  by retraction of the cam spreader. In another example embodiment, the cam spreader  550  can be used to widen the spacing between the clasps  580  by rotating the cam spreader  550  to capture the spaced apart leaflets. Once the spaced apart leaflets are grasped by the clasps  580 , the cam spreader  550  can be used to return the spacing between the clasps  580  (and the captured leaflets) to the original, narrower spacing by rotating the cam spreader  550  back to the illustrated position. The paddles  530  can then be closed around the captured leaflets by retracting the cam spreader. 
     Referring now to  FIGS. 180-183 , portions of the paddles  530  and clasps  580  are shown in addition to the components of the device  500  shown in  FIGS. 168-179  to illustrate how the spreading member  550  engages the paddles  530  to facilitate the above described translation movement that spreads apart the paddles  530  to capture leaflets  20 ,  22 . To begin leaflet capture, the device  500  is opened to a capture-ready condition, shown in  FIG. 180 , with the paddles  530  and clasps  580  opened about half-way (though any amount of opening can be used). The spreading member  550  is in a stowed or disengaged position so that the spreading member  550  fits between and does not engage the paddles  530 . In this position, the leaflets  20 ,  22  are spread apart and would likely not be captured by closing the clasps  580 . 
     To move the clasps  580  into a more desirable capture position, the spreading member  550  can be used to widen the spacing between the clasps  580  by rotating the spreading member  550  to the position illustrated by  FIG. 181  to capture the spaced apart leaflets  20 ,  22 . The spreading member  550  is extended (See  FIG. 180 ), rotated, and retracted to move from the stowed position shown in  FIG. 179  to the deployed position shown in  FIG. 181 . During retraction, the optional distal projections  519  of the main shaft  510  can prohibit the rotation of the spreading member  550  out of either the disengaged position or the engaged position during retraction of the spreading member  550  into the main shaft  510  and coaption element  520 . This retracting movement causes the cam surfaces  558  of the cam portions  556  engage the spreading portions  535  of the paddles  530  to spread the spreading portions  535  apart. Outward movement of the spreading portions  535  also moves the connection portions  536  and inner paddle portions  538  outward so that the clasps  580  attached to the inner paddle portions  538  also translate in an outward direction. The illustrated ramp-like shape of the cam portions  556  enables the magnitude of the lateral translation of the paddles  530  and clasps  580  to be controlled by controlling the magnitude of the extension and retraction of the actuation element  591  and/or spreading portions. That is, the maximum outward movement of the paddles  530  is reached when the spreading member  550  is retracted to the fullest extent possible. The cam portions  556  are shown with a triangular shape, but and can have a wide variety of shapes to increase or decrease the magnitude and rate at which the paddles  530  are spread during retraction of the spreading member  550  to aid in the capture of the native leaflets  20 ,  22 . 
     Once the paddles  530  and clasps  580  have been spread apart, the leaflets  20 ,  22  are captured by closing the clasps  580  and paddles  530 . Closing the clasps  580  pinches the leaflets  20 ,  22  between the fixed and moveable arms  582 ,  584 , as can be seen in  FIG. 182 . The paddles  530  can also be closed partially to move the leaflets  20 ,  22  toward the coaption element  520 . Once the leaflets  20 ,  22  are captured, the spreading member  550  can be used to return the spacing between the clasps  580  (and the captured leaflets  20 ,  22 ) to the original, narrower spacing by rotating the spreading member  550  back to the stowed or disengaged position illustrated by  FIG. 183 . The paddles  530  are then closed fully to secure the leaflets  20 ,  22  against the coaption element  520 , as illustrated in  FIG. 183 . In another use, the spreading member  550  can remain in the spread-out position shown in  FIGS. 181 and 182  after the leaflets  20 ,  22  are captured, the clasps  580  are closed, and the paddles  530  are closed around the coaption member  520  by retraction of the spreading member  550 . 
     Referring now to  FIGS. 184-213 , a coaption element can be configured in a variety of ways to be compressible. For example, the coaption element  520  described above can be compressible such that it fits within, can be moved through, and/or can be deployed from a delivery catheter or the like. Each of the coaption elements can incorporate any of the features previously described herein, such as the coaption element  520  described in  FIGS. 95-100 . Additionally, each of the coaption elements can be used with any of the implantable prosthetic spacer devices  100 ,  200 ,  300 ,  400 ,  500  previously described herein. Each of the coaption elements can be made of a flexible and/or compressible material such as, for example, rubber, foam, plastic, or other suitable material. 
     Referring to  FIGS. 184-188 , a coaption element  1520  is depicted according to one embodiment. The coaption element  1520  extends from a proximal end  1521  to a distal end  1522  and has a generally elongated and rounded shape. In particular, the coaption element  1520  has an elliptical shape or cross-section when viewed from above ( FIG. 187 ) and has a tapered shape or cross-section when seen from a front view ( FIG. 186 ) and a rounded shape or cross-section when seen from a side view ( FIG. 185 ). A central opening  1523  extends through a body portion  1528  of the coaption member  1520  from the proximal end  1521  to the distal end  1522 . The central opening  1523  has a diameter that is about the same or is slightly larger than a diameter of the main shaft  510  so that the main shaft  510  can be received within the central opening  1523  of the coaption element  1520 . 
     The coaption element  1520  has one or more arm portions  1530  extending outwardly (to the front and rear) from the body portion  1528 . The one or more arm portions  1530  connect to the body portion  1528  near the proximal end  1521  and the distal end  1522  of the body portion  1528 , thereby defining one or more openings  1531  between the arm portion  1530  and the body portion  1528 . The one or more arm portions  1530  can be made from a flexible and/or compressible material such as, for example, foam, rubber, plastic, or other suitable material. 
     Optionally, the coaption element  1520  can also include a distal arm  1532  defining a distal opening  1533  between the body portion  1528  and the distal arm  1532 . The distal arm  1532  can be made from a flexible and/or compressible material such as, for example, foam, rubber, plastic, or other suitable material. In one example embodiment, the entire coaption element  1520  is a single molded component. 
     As shown in  FIG. 188 , a force can be applied to the one or more arm portions  1530  such that the arm portions  1530  bend, move, or are otherwise flexed medially or inwardly toward the body portion  1528 , thereby decreasing the size of the one or more openings  1531  or eliminating the one or more openings. As such, the arm portions  1530  are compressed toward the body portion  1528  and the overall size of the coaption element  1520  is decreased. In the illustrated embodiment, a force is applied downwardly (distally) such that the arm portions  1530  are compressed toward the body portion  1528 . However, it will be appreciated that the arm portions  1530  can be compressed toward the body portion  1528  in a variety of ways. For example, a medial inward force can be applied to the arm portions  1530  such that the arm portions  1530  are compressed toward the body portion  1528 . 
     Referring to  FIGS. 189-193 , a coaption element  2520  is depicted according to one embodiment. The coaption element  2520  extends from a proximal end  2521  to a distal end  2522  and has a generally elongated and rounded shape. In particular, the coaption element  2520  has an elliptical shape or cross-section when viewed from above ( FIG. 192 ) and has a tapered shape or cross-section when seen from a front view ( FIG. 191 ) and a rounded shape or cross-section when seen from a side view ( FIG. 190 ). A central opening  2523  extends through a body portion  2528  of the coaption member  2520  from the proximal end  2521  to the distal end  2522 . The central opening  2523  has a diameter or size that is about the same or is slightly larger than a diameter of the main shaft  510  so that the main shaft  510  can be received within the central opening  2523  of the coaption element  2520 . 
     The coaption element  2520  has a plurality of protrusions or wing portions  2530  extending outwardly (to the front and rear) from the body portion  2528 . The protrusions or wing portions  2530  are generally oriented perpendicularly to the central opening  2523 . The one or more protrusions or wing portions  2530  connect to the body portion  2528  at two points thereby defining longitudinal openings  2531  between the body portion  2528  and each of the wing portions  2530 . The longitudinal openings  2531  on each side of the body portion  2528  can be at least partially aligned. In some embodiments, there are 2-20 protrusions/wing portions, and the protrusions/wing portions are spaced apart anywhere from 0.1 mm to 3 mm. The one or more protrusions/wing portions  2530  can be made from a flexible and/or compressible material such as, for example, foam, rubber, plastic, silicone, or other suitable material. 
     As shown in  FIG. 193 , the coaption element  2520  can be compressed. A force can be applied to the protrusions/wing portions  2530  such that the protrusions/wing portions  2530  angle downwardly or distally in the direction of the distal portion  2522 . The outer portion of each protrusion/wing portion  2530  can be moved downwardly or distally such that the outer portion of each protrusion/wing portion  2530  nests or fits within the longitudinal opening  2531  defined by the protrusion/wing portion  2530  distally below. As such, the overall size of the coaption element  2520  is decreased. In the illustrated embodiment, a force is applied downwardly (distally) and inwardly (medially) to each wing portion  2530  such that the protrusions/wing portions  2530  are compressed toward the body portion  2528 . However, it will be appreciated that the protrusions/wing portions  2530  can be compressed toward the body portion  2528  in a variety of ways. For example, a downward or an inward force can be applied to the protrusions/wing portions  2530  such that the protrusions/wing portions  2530  are compressed toward the body portion  2528 . 
     Referring to  FIGS. 194-198 , a coaption element  3520  is depicted according to one embodiment. The coaption element  3520  extends from a proximal end  3521  to a distal end  3522  and has a generally elongated and rounded shape. In particular, the coaption element  3520  has an elliptical shape or cross-section when viewed from above ( FIG. 197 ) and has a tapered shape or cross-section when seen from a front view ( FIG. 196 ) and a rounded shape or cross-section when seen from a side view ( FIG. 195 ). A central opening  3523  extends through a body portion  3528  of the coaption member  3520  from the proximal end  3521  to the distal end  3522 . The central opening  3523  has a diameter or shape that is about the same or is slightly larger than a diameter of the main shaft  510  so that the main shaft  510  can be received within the central opening  3523  of the coaption element  3520 . 
     The coaption element  3520  has a plurality of protrusions or wing portions  3530  extending outwardly (to the front and rear) from the body portion  3528 . Similarly to the coaption element  2520  of  FIGS. 189-193 , the protrusions or wing portions  3530  are generally oriented perpendicularly to the central opening  3523  and the one or more wing portions  3530  connect to the body portion  3528  at two points thereby defining longitudinal openings  3531  between the body portion  3528  and each of the protrusions/wing portions  3530 . However, the protrusions/wing portions  3530  are thinner and spaced farther apart (e.g., 1-3 times farther apart) than the protrusions/wing portions  2530  of the coaption element  2520  shown in  FIGS. 189-193 . The one or more wing portions  3530  can be made from a flexible and/or compressible material such as, for example, foam, rubber, plastic, or other suitable material. In some embodiments, there are 2-20 protrusions/wing portions, and the protrusions/wing portions are spaced apart anywhere from 0.1 mm to 5 mm. 
     As shown in  FIG. 198 , the coaption element  3520  can be compressed. A force can be applied to the protrusions/wing portions  3530  such that the protrusions/wing portions  3530  angle downwardly or distally. The outer portion of each protrusion/wing portion  3530  can be moved downwardly or distally such that the outer portion of each protrusion/wing portion  3530  nests or fits within the opening  3531  defined by the protrusion/wing portion  3530  below. Due to the configuration and spacing of the protrusions/wing portions  3530 , each protrusion/wing portion  3530  can extend farther outwardly (toward the front and rear) than the protrusion/wing portion  3530  proximally above. As such, the protrusions/wing portions  3530  can nest more easily which can facilitate the overall compression of the coaption element  3520 . In the illustrated embodiment, a force is applied downwardly (distally) and inwardly (medially) to each protrusion/wing portion  3530  such that the protrusions/wing portions  2530  are compressed toward the body portion  3528 . However, it will be appreciated that the protrusions/wing portions  3530  can be compressed toward the body portion  3528  in a variety of ways. For example, a downward or an inward force can be applied to the protrusions/wing portions  3530  such that the protrusions/wing portions  3530  are compressed toward the body portion  3528 . 
     Referring to  FIGS. 199-203 , a coaption element  4520  is depicted according to one embodiment. The coaption element  4520  extends from a proximal end  4521  to a distal end  4522  and is depicted with a generally elongated and rounded shape. In particular, the coaption element  4520  is depicted with an elliptical shape or cross-section when viewed from above ( FIG. 202 ) and has a tapered shape or cross-section when seen from a front view ( FIG. 201 ) and a rounded shape or cross-section when seen from a side view ( FIG. 200 ), though variations and other shapes are possible. A central opening  4523  extends through a body portion  4528  of the coaption member  4520  from the proximal end  4521  to the distal end  4522 . The central opening  4523  has a diameter or shape that is about the same or is slightly larger than a diameter of the main shaft  510  so that the main shaft  510  can be received within the central opening  4523  of the coaption element  4520 . 
     The coaption element  4520  has a plurality of protrusions or wing portions  4530  extending outwardly (to the front and rear) from the body portion  4528 . The protrusions/wing portions  4530  are angled distally and outwardly from the body portion  4528 , with the distal protrusions/wing portions  4530  being oriented more downwardly (i.e., toward the distal end  4522  of the coaption element  4520 ). Optionally, the one or more protrusions/wing portions  4530  connect to the body portion  4528  at two points thereby defining openings  4531  between the body portion  4528  and each of the protrusions/wing portions  4530 . The coaption element  4520  also includes grooves  4533  between that the protrusions/wing portions  4530  that are narrowly tapered toward the body portion  4528 . The distal grooves  4533  can be wider than the proximal grooves  4533 . The one or more protrusions/wing portions  4530  can be made from a flexible and/or compressible material such as, for example, foam, rubber, plastic, or other suitable material. 
     As shown in  FIG. 203 , a force can be applied to the protrusions/wing portions  4530  such that the outer portion of the wing protrusions/portions  4530  are moved downwardly (distally) and inwardly (toward the body portion  4528 ). The grooves  4533  can be configured such that the longer protrusions/wing portions  4530  move farther downward than the other protrusions/wing portions  4530 . Optionally, portions of the protrusions/wing portions  4530  can fit or nest in the longitudinal opening  4531  defined by the protrusion/wing portion  4530  distally below. As such, the overall size of the coaption element  4520  can be compressed or otherwise decreased. In the illustrated embodiment, a force is applied downwardly (distally) and inwardly (medially) to each protrusion/wing portion  4530  such that the protrusions/wing portions  4530  are compressed toward the body portion  4528 . However, it will be appreciated that the protrusions/wing portions  4530  can be compressed toward the body portion  4528  in a variety of ways. For example, a downward or an inward force can be applied to the protrusions/wing portions  4530  such that the protrusions/wing portions  4530  are compressed toward the body portion  4528 . 
     Referring to  FIGS. 204-208 , a coaption element  5520  is depicted according to one embodiment. The coaption element  5520  extends from a proximal end  5521  to a distal end  5522  and has a generally elongated and rounded shape. In particular, the coaption element  5520  has an elliptical shape or cross-section when viewed from above ( FIG. 207 ) and has a tapered shape or cross-section when seen from a front view ( FIG. 206 ) and a rounded shape or cross-section when seen from a side view ( FIG. 205 ). A central opening  5523  extends through a body portion  5528  of the coaption member  5520  from the proximal end  5521  to the distal end  5522 . The central opening  5523  has a diameter or size that is about the same or is slightly larger than a diameter of the main shaft  510  so that the main shaft  510  can be received within the central opening  5523  of the coaption element  5520 . 
     The coaption element  5520  has a plurality of protrusions or wing portions  5530  extending outwardly (to the front and rear) from the body portion  5528 . The protrusions/wing portions  5530  are angled or generally angled distally and outwardly from a point substantially in the middle of the body portion  5528 . The protrusions/wing portions  5530  closer to the proximal end  5521  can be angled upwardly away from the body portion  5528  and the protrusions/wing portions  5530  closer to the distal end  5522  can be angled downwardly away from the body portion  5528 . Optionally, the one or more protrusions/wing portions  5530  connect to the body portion  5528  at two points thereby defining openings  5531  between the body portion  5528  and each of the protrusions/wing portions  5530 . The coaption element  4520  also includes grooves  5533  between that the protrusions/wing portions  5530  that are narrowly tapered toward the body portion  5528 . The grooves  5533  extend medially toward a center of the body portion  5528 . The one or more protrusions/wing portions  5530  can be made from a flexible and/or compressible material such as, for example, foam, rubber, plastic, or other suitable material. 
     As shown in  FIG. 208 , forces can be applied to the protrusions/wing portions  5530  to compress the coaption element  5520 . An upward (proximal) and inward (toward the body portion  5528 ) force can be applied to the protrusions/wing portions  5530  that are closer to the proximal end  5521  and a downward (distal) and inward (toward the body portion  5528 ) force can be applied to the protrusions/wing portions  5530  that are closer to the distal end  5522 . The grooves  5533  can be configured such that the protrusions/wing portions  5530  can move toward the body portion  5528  as much as possible. Optionally, portions of the protrusions/wing portions  5530  can fit or nest in the longitudinal opening  5531  defined by the protrusion/wing portion  5530  toward which the protrusion/wing portion  5530  is moved. As such, the overall size of the coaption element  5520  can be compressed. In the illustrated embodiment, a force is applied upwardly (proximally) and inwardly to the protrusions/wing portions  5530  that are closer to the proximal end  5521  and a force is applied downwardly (distally) and inwardly to the protrusions/wing portions  5530  closer to the distal end  5522  such that the protrusions/wing portions  5530  are compressed toward the body portion  5528 . However, the protrusions/wing portions  5530  can be compressed toward the body portion  5528  in a variety of ways. For example, the protrusions/wing portions  5530  can be oriented, shaped, and/or configured such that a medially inward force can be applied to all the protrusions/wing portions  5530  to compress the protrusions/wing portions  5530  toward the body portion  5528 . 
     Referring to  FIGS. 209-213 , a coaption element  6520  is depicted according to one embodiment. The coaption element  6520  extends from a proximal end  6521  to a distal end  6522  and has a generally elongated and rounded shape. In particular, the coaption element  6520  has an elliptical shape or cross-section when viewed from above ( FIG. 212 ) and has a tapered shape or cross-section when seen from a front view ( FIG. 211 ) and a rounded shape or cross-section when seen from a side view ( FIG. 210 ). A central opening  6523  extends through a body portion  6528  of the coaption member  5520  from the proximal end  6521  to the distal end  6522 . The central opening  6523  has a diameter or size that is about the same or is slightly larger than a diameter of the main shaft  510  so that the main shaft  510  can be received within the central opening  6523  of the coaption element  6520 . 
     The coaption element  6520  has a plurality of protrusions or wing portions  6530  extending radially outwardly (to the front and rear) from the body portion  6528 . The protrusions or wing portions  6530  are separated by one or more longitudinal grooves  6531  which extends radially inwardly toward the body portion  6528 . The longitudinal grooves  6531  can be tapered inwardly toward the body portion  6528 . The protrusions/wing portions  6530  and the longitudinal grooves  6531  can be configured such that the protrusions/wing portions  6530  are thicker at the radial outer portions. The one or more protrusions/wing portions  6530  can be made from a flexible and/or compressible material such as, for example, foam, rubber, plastic, or other suitable material. 
     As shown in  FIG. 213 , forces can be applied to the protrusions/wing portions  6530  to compress the coaption element  6520 . Radially inward forces can be applied to the protrusions/wing portions  6530  to radially compress the protrusions/wing portions  6530  and thereby decrease the overall size of the coaption element  6520 . The longitudinal grooves  6531  can be configured such that the protrusions/wing portions  6530  can move toward the body portion  6528  as much as possible. As such, the overall size of the coaption element  6520  can be compressed. 
     In the illustrated embodiment, inward radial forces are applied to the protrusions/wing portions  6530  such that the protrusions/wing portions  6530  are compressed toward the body portion  6528 . However, it will be appreciated that the protrusions/wing portions  6530  can be compressed toward the body portion  6528  in a variety of ways. For example, a lateral force, either forward or backward, can be applied to the protrusions/wing portions  6530  such that the protrusions/wing portions are compressed toward the body portion  6528 . 
     While the coaption elements have been described according to specific embodiments, the various features of any of the coaption elements  520 ,  1520 ,  2520 ,  3520 ,  4520 ,  5520 ,  6620  can be used in many alternative embodiments, either individually or in various combinations and sub-combinations thereof. 
     The coaption element  7020  can be sized, shaped, and configured to fit in the native anatomy of the patient that will receive the implant. For example, any of the coaption elements  520 ,  1520 ,  2520 ,  3520 ,  4520 ,  5520 ,  6620 , or a coaption element incorporating any of the various features of any of the coaption elements  520 ,  1520 ,  2520 ,  3520 ,  4520 ,  5520 ,  6620  can be employed. The coaption element  520  can be sized, shaped, and configured specifically for the native anatomy of the patient that will receive the implant. Optionally, the person performing the procedure can have a variety of coaption elements available to him or her during the procedure, e.g., in a kit, which can include any of the associated tools and other elements. The person performing the procedure can select the coaption element with the desired size, shape, and configuration corresponding to the native anatomy of the patient that will receive the implant. 
     While various inventive aspects, concepts and features of the disclosures may be described and illustrated herein as embodied in combination in the example embodiments, these various aspects, concepts, and features can be used in many alternative embodiments, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the present application. Still further, while various alternative embodiments as to the various aspects, concepts, and features of the disclosures—such as alternative materials, structures, configurations, methods, devices, and components, alternatives as to form, fit, and function, and so on—may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether presently known or later developed. Those skilled in the art may readily adopt one or more of the inventive aspects, concepts, or features into additional embodiments and uses within the scope of the present application even if such embodiments are not expressly disclosed herein. 
     Additionally, even though some features, concepts, or aspects of the disclosures may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, example or representative values and ranges may be included to assist in understanding the present application, however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated. 
     Moreover, while various aspects, features and concepts may be expressly identified herein as being inventive or forming part of a disclosure, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a specific disclosure, the disclosures instead being set forth in the appended claims. Descriptions of example methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated. Further, the treatment techniques, methods, operations, steps, etc. described or suggested herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, simulator (e.g. with the body parts, tissue, etc. being simulated), etc. The words used in the claims have their full ordinary meanings and are not limited in any way by the description of the embodiments in the specification.