Heart valve sealing device and delivery device therefor - Patent application

Abstract

The implantable device is configured to be positioned within the native heart valve and to enable the native heart valve to form a more effective seal. The implantable device includes a first cover portion and a second cover portion. The second cover portion has a lower coefficient of friction than the first cover portion.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 138,309, filed January 15, 2021, the contents of which are incorporated by reference in their entirety. [Background technology]

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) play a critical function in ensuring proper forward flow of blood throughout the cardiovascular system. These heart valves can be damaged and therefore less effective due to, for example, congenital malformations, inflammatory processes, infectious conditions, disease, etc. Damage to such valves can result in serious cardiovascular problems or death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and can result in complications. Transvascular techniques can be used to introduce and implant prosthetic devices in a much less invasive manner than open-heart surgery. As an example, a transvascular technique that can be used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., threading the catheter into the right femoral vein, ascending the inferior vena cava, and into the right atrium). The septum is then punctured, and the catheter is advanced into the left atrium. When implanting a prosthetic device within the tricuspid valve, a similar transvascular technique can be used, beginning similarly to the transseptal technique, but without puncturing the septum, and directing the delivery catheter toward the tricuspid valve in the right atrium.

[0003] A healthy heart has a generally conical shape that tapers to a lower apex. The heart is divided into four chambers, including the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The native mitral valve in the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy from other native heart valves. The mitral valve includes an annulus, a circular portion of native valve tissue surrounding the mitral orifice, and a pair of leaflets or cusps extending downward from the annulus into the left ventricle. The mitral valve annulus can form a "D"-shaped, elliptical, or other cross-sectional shape that is not a perfect circle with long and short axes. The anterior leaflet is larger than the posterior leaflet, and when they close together, they can form a generally "C"-shaped boundary between the abutting leaflets.

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

[0005] Valve regurgitation involves a valve improperly allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the native mitral valve fails to close properly during the systolic phase of cardiac contraction, causing blood to flow from the left ventricle into the left atrium. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral annulus due to left ventricular dilation, or two or more of these. Mitral regurgitation in the central portion of the valve leaflets can be referred to as central-jet mitral regurgitation, while mitral regurgitation closer to one commissure of the leaflets (i.e., where the leaflets meet) can be referred to as eccentric-jet mitral regurgitation. Central-jet regurgitation occurs when the edges of the leaflets do not meet in the middle, thus preventing the valve from closing and resulting in regurgitation. Tricuspid regurgitation is similar but can occur on the right side of the heart. Summary of the Invention

[0006] This Summary is intended to provide some examples and is not intended to limit the scope of the present invention in any way. For example, any features included in the examples of this Summary are not required by the claims unless the claims explicitly recite those features. Also, features, components, steps, concepts, etc. described in the examples of this Summary and elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples summarized herein.

[0007] An implantable device or implant (such as an implantable prosthetic device) is configured to be positioned within a native heart valve so that the native heart valve forms a more effective seal. The device includes a first cover portion and a second cover portion. The second cover portion has a lower coefficient of friction than the first cover portion.

[0008] In some implementations, the implantable device or implant includes at least one anchor configured to attach the device to at least one leaflet of the native heart valve, the device including a first cover portion and a second cover portion, the second cover portion having a lower coefficient of friction than the first cover portion.

[0009] In some implementations, the implantable device or implant includes a plurality of paddles, a first cover portion, and a second cover portion, the first and second cover portions attached to the plurality of paddles, and the second cover portion having a lower coefficient of friction than the first cover portion.

[0010] In some implementations, the implantable device or implant includes an interface portion, an anchor portion, and first and second cover portions. The anchor portion includes a plurality of paddles movably connected to the interface portion. The first and second cover portions cover one or more of the interface portion and the anchor portion. The second cover portion has a lower coefficient of friction than the first cover portion.

[0011] An exemplary implantable device or implant includes a coaptation element and at least one anchor. The coaptation element is configured to be positioned within the opening of the native heart valve and help fill the space through which the native valve regurgitates, forming a more effective seal. The coaptation element is impermeable to blood and can have a structure that allows the native valve leaflets to close around the coaptation element during ventricular systole, preventing blood from flowing from the left or right ventricle into the left or right atrium, respectively. The coaptation element can be connected to the leaflets of the native valve by the anchor. The implantable device or implant also includes first and second cover portions. The second cover portion has a lower coefficient of friction than the first cover portion.

[0012] In some implementations, an implantable device or implant includes an anchor portion and one or more sleeves. The anchor portion is configured to attach to one or more leaflets of a native heart valve and includes one or more anchors. Each anchor has a paddle frame. The one or more sleeves are attached to the paddle frame, and each sleeve is lubricious to facilitate movement of the device through the native anatomy of the patient's heart.

[0013] In some implementations, the implantable device or implant includes an anchor portion, one or more sleeves, and a cover. The anchor portion is configured to attach to one or more leaflets of the native heart valve and includes one or more anchors. Each anchor has a paddle frame. The one or more sleeves are attached to the paddle frame, and the cover is attached to the one or more sleeves and covers at least a portion of the paddle frame.

[0014] An exemplary implantable device or implant includes a coaptation portion, an anchor portion, and a cover assembly. The coaptation portion has a coaptation element. The anchor portion is configured to attach to one or more leaflets of the native heart valve and includes first and second anchors. Each of the first and second anchors has a paddle frame, an inner paddle, an outer paddle, and a clasp. The cover assembly includes a first cover for covering at least a portion of the paddle frames of both the first and second anchors, a pair of second covers, one second cover covering at least a portion of the inner paddle of the first anchor and the other second cover covering at least a portion of the inner paddle of the second anchor, and a third cover for covering at least a portion of the coaptation element and the clasps of the first and second anchors.

[0015] A further understanding of the nature and advantages of the present invention can be found in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals and in which:

[0016] To further clarify various aspects of implementations of the present disclosure, a more particular description of specific examples and implementations will be made by reference to various aspects of the accompanying drawings. It will be understood that these drawings depict only exemplary implementations of the present disclosure and therefore should not be considered to limit the scope of the present disclosure. Moreover, while the figures may be to scale for some examples, the figures are not necessarily to scale for all examples. Examples 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. [Brief explanation of the drawings]

[0017] [Figure 1] FIG. 1 shows a cutaway view of a human heart in diastole. [Figure 2] FIG. 2 shows a cutaway view of a human heart during systole. [Figure 3] FIG. 3 is another cutaway view of a human heart during systole showing mitral regurgitation. [Figure 4] FIG. 4 is a cutaway view of FIG. 3 annotated to show the natural shape of the mitral valve leaflets during systole. [Figure 5] FIG. 5 shows a healthy mitral valve with the leaflets closed as viewed from the atrial side of the mitral valve. [Figure 6] FIG. 6 shows a dysfunctional mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 7] FIG. 7 shows the tricuspid valve as seen from the atrial side of the tricuspid valve. [Figure 8] FIG. 8 shows an embodiment of an implantable device or implant in one stage of deployment. [Figure 9] FIG. 9 shows an embodiment of an implantable device or implant in another stage of deployment. [Figure 10] FIG. 10 shows an embodiment of an implantable device or implant in another stage of deployment. [Figure 11] FIG. 11 shows an embodiment of an implantable device or implant in another stage of deployment. [Figure 12] FIG. 12 shows an embodiment of an implantable device or implant in another stage of deployment. [Figure 13] FIG. 13 shows an embodiment of an implantable device or implant in another stage of deployment. [Figure 14] FIG. 14 shows an embodiment of an implantable device or implant in another stage of deployment. [Figure 15] FIG. 15 shows an embodiment of an implantable device or implant similar to the devices illustrated by FIGS. 8-14, but in which the paddles are independently controllable. [Figure 16] FIG. 16 shows an example of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 17] FIG. 17 shows an example of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 18] FIG. 18 shows an example of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 19] FIG. 19 shows an example of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 20] FIG. 20 shows an example of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 21] FIG. 21 shows an example of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 22] FIG. 22 shows a perspective view of an exemplary implantable device or implant in a closed position. [Figure 23] FIG. 23 shows a front view of the implantable device or implant of FIG. [Figure 24] FIG. 24 shows a side view of the implantable device or implant of FIG. [Figure 25]FIG. 25 shows a front view of the implantable device or implant of FIG. 22 with a cover over the paddle and coaptation element or spacer. [Figure 26] FIG. 26 shows a top perspective view of the implantable device or implant of FIG. 22 in an open position. [Figure 27] FIG. 27 shows a bottom perspective view of the implantable device or implant of FIG. 22 in the open position. [Figure 28] FIG. 28 shows a clasp for use with an implantable device or implant. [Figure 29] FIG. 29 shows a portion of native valve tissue grasped by a clasp. [Figure 30] FIG. 30 shows a side view of an exemplary implantable device or implant in a partially open position with the clasp in a closed position. [Figure 31] FIG. 31 shows a side view of an exemplary implantable device or implant in a partially open position with the clasp in an open position. [Figure 32] FIG. 32 shows a side view of an exemplary implantable device or implant in a semi-open position with the clasp in a closed position. [Figure 33] FIG. 33 shows a side view of an exemplary implantable device or implant in a semi-open position with the clasp in the open position. [Figure 34] FIG. 34 shows a side view of an exemplary implantable device or implant in a three-quarters open position with the clasp in a closed position. [Figure 35] FIG. 35 shows a side view of an exemplary implantable device or implant in a three-quarters open position with the clasp in the open position. [Figure 36] FIG. 36 shows a side view of an exemplary implantable device in a fully open or fully bailed out position with the clasp in a closed position. [Figure 37] FIG. 37 shows a side view of an exemplary implantable device in a fully open or fully bailed out position with the clasp in the open position. [Figure 38] FIG. 38 shows the exemplary implantable device or implant of FIGS. 30-38, including the cover, delivered and implanted within a native valve. [Figure 39] FIG. 39 shows the exemplary implantable device or implant of FIGS. 30-38, including the cover, delivered and implanted within a native valve. [Figure 40] FIG. 40 shows the exemplary implantable device or implant of FIGS. 30-38, including the cover, delivered and implanted within a native valve. [Figure 41] FIG. 41 shows the exemplary implantable device or implant of FIGS. 30-38, including the cover, delivered and implanted within a native valve. [Figure 42] FIG. 42 shows the exemplary implantable device or implant of FIGS. 30-38, including the cover, delivered and implanted within a native valve. [Figure 43] FIG. 43 shows the exemplary implantable device or implant of FIGS. 30-38, including the cover, delivered and implanted within a native valve. [Figure 44] FIG. 44 shows the exemplary implantable device or implant of FIGS. 30-38, including the cover, delivered and implanted within a native valve. [Figure 45] FIG. 45 shows the exemplary implantable device or implant of FIGS. 30-38, including the cover, delivered and implanted within a native valve. [Figure 46] FIG. 46 shows the exemplary implantable device or implant of FIGS. 30-38, including the cover, delivered and implanted within a native valve. [Figure 47] FIG. 47 shows the exemplary implantable device or implant of FIGS. 30-38, including the cover, delivered and implanted within a native valve. [Figure 48] FIG. 48 shows the exemplary implantable device or implant of FIGS. 30-38, including the cover, delivered and implanted within a native valve. [Figure 49]FIG. 49 shows the exemplary implantable device or implant of FIGS. 30-38, including the cover, delivered and implanted within a native valve. [Figure 50] FIG. 50 is a schematic diagram illustrating the path of the leaflets of a native valve along each side of a coaptation element or spacer of an exemplary valve repair device or implant. [Figure 51] FIG. 51 is a top schematic view illustrating the routing of the leaflets of a native valve around a coaptation element or spacer of an exemplary valve repair device or implant. [Figure 52] FIG. 52 illustrates a coaptation element or spacer in the gap of the native valve as viewed from the atrial side of the native valve. [Figure 53] FIG. 53 illustrates a valve repair device or implant attached to the leaflets of a native valve with coaptation elements or spacers in the gaps between the native valve when viewed from the ventricular side of the native valve. [Figure 54] FIG. 54 is a perspective view of a valve repair device or implant attached to the leaflets of a native valve, with coaptation elements or spacers in the gaps of the native valve as viewed from the ventricular side of the native valve. [Figure 55] FIG. 55 shows a perspective view of an exemplary implantable device or implant in a closed position. [Figure 56] FIG. 56 shows a perspective view of an exemplary clasp of an exemplary implantable device or implant in a closed position. [Figure 57] FIG. 57 shows a front view of an exemplary implantable device or implant in a closed state, including a cover shown in dashed lines. [Figure 58] FIG. 58 shows a front view of the exemplary implantable device or implant of FIG. 57 with the cover shown in solid lines. [Figure 59] FIG. 59 shows a side view of the exemplary implantable device or implant of FIG. [Figure 60] FIG. 60 shows a top view of the exemplary implantable device or implant of FIG. [Figure 61]FIG. 61 shows a bottom view of the exemplary implantable device or implant of FIG. [Figure 62] FIG. 62 shows a front view of the exemplary implantable device or implant of FIG. 58 in an open state. [Figure 63] FIG. 63 shows a side view of the exemplary implantable device or implant of FIG. [Figure 64] FIG. 64 shows a top view of the exemplary implantable device or implant of FIG. [Figure 65] FIG. 65 shows a bottom view of the exemplary implantable device or implant of FIG. [Figure 66] FIG. 66 shows a top view of an exemplary implantable device or implant in an open state. [Figure 67] FIG. 67 shows a bottom view of the exemplary implantable device or implant of FIG. [Figure 68] FIG. 68 shows a top view of an exemplary implantable device or implant in an open state. [Figure 69] FIG. 69 shows a bottom view of the exemplary implantable device or implant of FIG. [Figure 70] FIG. 70 shows a top view of an exemplary implantable device or implant in an open state. [Figure 71] FIG. 71 shows a bottom view of the exemplary implantable device or implant of FIG. [Figure 72] FIG. 72 shows a front view of an exemplary implantable device or implant in a closed state, including a cover shown in dashed lines. [Figure 73] FIG. 73 shows a front view of the exemplary implantable device or implant of FIG. 72 with the cover shown in solid lines. [Figure 74] FIG. 74 shows a side view of the exemplary implantable device or implant of FIG. [Figure 75] FIG. 75 shows a top view of the exemplary implantable device or implant of FIG. [Figure 76] FIG. 76 shows a bottom view of the exemplary implantable device or implant of FIG. [Figure 77] FIG. 77 shows a front view of the exemplary implantable device or implant of FIG. 73 in an open state. [Figure 78] FIG. 78 shows a side view of the exemplary implantable device or implant of FIG. [Figure 79] FIG. 79 shows a top view of the exemplary implantable device or implant of FIG. [Figure 80] FIG. 80 shows a bottom view of the exemplary implantable device or implant of FIG. [Figure 81] FIG. 81 shows a top view of an exemplary implantable device or implant in an open state. [Figure 82] FIG. 82 shows a bottom view of the exemplary implantable device or implant of FIG. [Figure 83] FIG. 83 shows a top view of an exemplary implantable device or implant in an open state. [Figure 84] FIG. 84 shows a bottom view of the exemplary implantable device or implant of FIG. [Figure 85] FIG. 85 shows a top view of an exemplary implantable device or implant in an open state. [Figure 86] FIG. 86 shows a bottom view of the exemplary implantable device or implant of FIG. [Figure 87] FIG. 87 shows a side view of an exemplary cover for an implantable device or implant. [Figure 88] FIG. 88 is a cross-sectional view taken along the plane indicated by line 88-88 in FIG. [Figure 89] FIG. 89 is a cross-sectional view taken along the plane indicated by line 89-89 in FIG. [Figure 90] FIG. 90 shows a side view of an exemplary cover for an implantable device or implant. [Figure 91] FIG. 91 is a cross-sectional view taken along the plane indicated by line 91-91 in FIG. [Figure 92] FIG. 92 is a cross-sectional view taken along the plane indicated by line 91-91 in FIG. 90 with the cover turned inside out. [Figure 93] FIG. 93 illustrates a first side of a first knitted material for covering an exemplary implantable device or implant. [Figure 94] FIG. 94 shows a second side of the first knit material of FIG. [Figure 95] FIG. 95 shows a first side of a second knitted material for covering an exemplary implantable device or implant. [Figure 96] FIG. 96 shows a second side of the second knit material of FIG. [Figure 97] FIG. 97 shows a diagram comparing the forces experienced by a probe covered with the cover shown in FIGS. 93-96 with a first surface of knitted material disposed on the exterior. [Figure 98] FIG. 98 shows a diagram comparing the forces experienced by a probe covered with the cover shown in FIGS. 93-96 with a second surface of knitted material disposed on the exterior. [Figure 99] FIG. 99 shows a first side of a first woven material for covering an exemplary implantable device or implant, the second side of which would be similar in appearance. [Figure 100] FIG. 100 shows a first side of a second woven material for covering an exemplary implantable device or implant, the second side of which may be similar in appearance. [Figure 101] FIG. 101 shows a diagram comparing the forces experienced by a probe covered with the cover shown in FIGS. 99-100 and a first surface of a woven material disposed on the exterior. [Figure 102] FIG. 102 shows a diagram comparing the forces experienced by a probe covered with the cover shown in FIGS. 99-100 and a second surface of woven material disposed on the exterior. [Figure 103]FIG. 103 shows a perspective view of an exemplary implantable device having paddles with adjustable widths. [Figure 104] FIG. 104 is a cross-section of the implantable device of FIG. 103, with the implantable device bisected. [Figure 105] FIG. 105 is another cross-section of the implantable device of FIG. 103, where the implantable device is bisected along a plane perpendicular to the plane shown in FIG. [Figure 106] FIG. 106 is a schematic diagram of an exemplary implant catheter assembly coupled to the implantable device of FIG. 103, where an actuating element, such as a tube, is coupled to a paddle actuation control and a driver head of the implantable device. [Figure 107] FIG. 107 is a view of the assembly of FIG. 106 with the implantable device rotated 90 degrees to show a paddle width adjustment element coupled to a movable member of the implantable device and connected to a paddle width control. [Figure 108] FIG. 108 shows a perspective view of an exemplary sleeve for attachment to a paddle frame of an implantable device. [Figure 109] FIG. 109 shows a perspective view of an exemplary implantable device including a plurality of the exemplary sleeves of FIG. 108 and an exemplary cover. [Figure 110] FIG. 110 shows another perspective view of the exemplary implantable device of FIG. [Figure 111] FIG. 111 shows a front view of the exemplary implantable device of FIG. [Figure 112] FIG. 112 shows a side view of the exemplary implantable device of FIG. [Figure 113] FIG. 113 illustrates an exemplary inner paddle cover of the exemplary cover of FIG. [Figure 114] FIG. 114 illustrates an exemplary interface element cover of the exemplary cover of FIG. [Figure 115] FIG. 115 illustrates an exemplary paddle frame cover of the exemplary cover of FIG. [Figure 116]FIG. 116 illustrates the exemplary implantable device of FIG. 109, where the cover includes a clasp cover. [Figure 117] FIG. 117 shows a partial view of the clasp and clasp cover of FIG. [Figure 117A] FIG. 117A shows an exemplary clasp cover for covering the clasp of FIG. [Figure 118] FIG. 118 shows an example connection between a tether frame and a paddle frame of a pair of paddles for the implantable device of FIG. [Figure 119] FIG. 119 shows a schematic diagram of an example connection between the tether frame and paddle frame of FIG. 116, shown in area A of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0018] The following description refers to the accompanying drawings that illustrate example implementations of the present disclosure. Other implementations having different structure and operation do not depart from the scope of the present disclosure.

[0019] Exemplary implementations of the present disclosure are directed to systems, devices, methods, and the like for repairing defective heart valves. For example, various implementations of implantable devices, valve repair devices, implants, and systems (including systems for their delivery) are disclosed herein, and any combination of these options may be made unless specifically excluded. In other words, individual components of the disclosed devices and systems may be combined unless mutually exclusive or otherwise physically impossible. Furthermore, the techniques and methods herein may be performed on live animals or simulations, such as, for example, cadavers, cadaver hearts, simulators (e.g., simulated body parts, hearts, tissues, etc.).

[0020] As used herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection may be direct between the components or may be indirect, such as through the use of one or more intermediate components. Also, as used herein, references to a "member," "component," or "portion" are not limited to a single structural member, component, or element, but can include a collection of components, members, or elements. Also, as used herein, the terms "substantially" and "about" are defined as at least near (and including) a given value or condition (preferably, within 10%, more preferably, within 1%, and most preferably, within 0.1%).

[0021] Figures 1 and 2 show cutaway views of a human heart H during diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, i.e., atrioventricular valves, respectively. Furthermore, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in Figures 3-6 and leaflets 30, 32, 34 shown in Figure 7) that extend inward across their respective valve orifices, which come together or "coapt" in flow to form a one-way fluid-blocking surface. The autologous valve repair system of the present application is frequently described and / or illustrated with respect to the mitral valve MV. Accordingly, the anatomical structures of the left atrium LA and left ventricle LV will be described in more detail. However, the devices described herein may also be used in the repair of other native valves, for example, the devices may be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0022] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, shown in FIG. 1, blood already collected in the left atrium LA (during systole) moves to the left ventricle LV through the mitral valve MV due to the expansion of the left ventricle LV. During the systolic phase, or systole, shown in FIG. 2, the left ventricle LV contracts to pump blood into the body through the aortic valve AV and the ascending aorta AA. During systole, the leaflets of the mitral valve MV close to prevent blood from returning from the left ventricle LV to the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In some implementations, the device described herein is used to restore the function of a defective mitral valve MV. That is, the device is configured to close the leaflets of the mitral valve to help prevent blood from returning from the left ventricle LV to the left atrium LA. Many of the devices described in this application are designed to easily grasp and secure the native valve leaflets around a coaptation element or spacer, which beneficially acts as a filler for the regurgitant opening to prevent or inhibit backflow or regurgitation during systole, although this is not required.

[0023] Referring now to FIGS. 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24, a variably dense ring of fibrous tissue surrounding the leaflets 20, 22. Referring to 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., muscles located at the base of the chordae tendineae CT and within the wall of the left ventricle LV) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM limit the movement of the leaflets 20, 22 of the mitral valve MV and prevent the mitral valve MV from retracting. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Rather, the papillary muscles PM support or brace the valve leaflets 20, 22 against the high pressures required to circulate blood throughout the body. Together, the papillary muscles PM and chordae tendineae CT are known as the subvalvular tissue, which functions to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed. When viewed from the left ventricular outflow tract (LVOT) view shown in FIG. 3, the anatomy of the valve leaflets 20, 22 is such that the medial sides of the leaflets coapt at their free ends and the leaflets 20, 22 begin to retract or splay away from each other. The leaflets 20, 22 splay apart toward the atrium until each leaflet contacts the mitral annulus.

[0024] Various disease processes can impair the proper function of one or more of the heart's native valves. These disease processes include degenerative processes (e.g., Barlow's disease, elastic fiber deficiency, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). Furthermore, damage to the left ventricle (LV) or right ventricle (RV) from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other cardiac diseases (e.g., cardiomyopathies, etc.) can deform the shape of the native valve, which can lead to valve dysfunction. However, the majority of patients undergoing valve surgery, such as mitral valve MV surgery, suffer from degenerative disease that causes dysfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), resulting in prolapse and regurgitation.

[0025] Generally, native valves can malfunction in different ways, including (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when the native valve does not open completely, thereby causing obstruction to blood flow. Typically, valve stenosis results from the accumulation of calcified material on the valve leaflets, which thickens the leaflets and impairs the valve's ability to open completely and allow forward blood flow. Valve regurgitation occurs when the valve leaflets do not close completely, causing blood to leak back into the previous ventricle (e.g., blood leaking from the left ventricle into the left atrium).

[0026] There are three main mechanisms by which native valves become regurgitant or incompetent, including Carpentier Type I, Type II, and Type III insufficiency. Carpentier Type I insufficiency involves annular dilation, such that the normally functioning leaflets are deflected from one another and fail to form a tight seal (i.e., the leaflets do not coapt properly). Type I mechanism dysfunction includes leaflet perforation, such as occurs in endocarditis. Carpentier Type II insufficiency involves prolapse of one or more native valve leaflets above the plane of coaptation. Carpentier Type III insufficiency involves restriction of one or more native valve leaflets, such that the leaflets are abnormally constricted below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (MA) or ventricular dilation (IIIb).

[0027] Referring to FIG. 5, when a healthy mitral valve MV is in the closed position, the anterior leaflet 20 and the posterior leaflet 22 coapt, which prevents blood from leaking from the left ventricle LV into the left atrium LA. Referring to FIGS. 3 and 6, during systole, mitral regurgitation MR occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV are displaced into the left atrium LA, so that the edges of the leaflets 20, 22 do not contact each other. This lack of coaptation causes a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow regurgitantly from the left ventricle LV into the left atrium LA during systole, as exemplified by the mitral regurgitation MR flow path shown in FIG. 3. Referring to FIG. 6, the gap 26 can have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some circumstances, the gap 26 can have a width W greater than 15 mm. As noted above, there are several different ways in which a valve leaflet (eg, the leaflets 20, 22 of the mitral valve MV) can be dysfunctional, thereby causing valve regurgitation.

[0028] In any of the above situations, a valve repair device or implant capable of engaging the anterior and posterior leaflets 20, 22 to close the gap 26 and prevent backflow of blood through the mitral valve MV is desirable. As seen in FIG. 4, an abstract representation of an implantable device, valve repair device, or implant 10 is shown implanted between the valve leaflets 20, 22 to prevent backflow during systole (compare FIG. 3 with FIG. 4). In some implementations, the coaptation elements (e.g., spacers, coaptation elements, coaptation members, gap fillers, etc.) of the device 10 have a generally tapered or triangular shape that naturally conforms to the geometry of the native valve and its propensity to expand (toward the annulus). In this application, the terms spacer, coaptation element, coaptation element, and gap filler are used interchangeably to refer to an element that is configured to fill a portion of the space between the leaflets of the native valve and / or to engage or "coapt" the leaflets of the native valve (e.g., so that the native valve leaflets coapt against the coaptation element, coaptation element, spacer, etc. instead of only against each other).

[0029] While stenosis or regurgitation can affect any valve, stenosis is known to primarily affect either the aortic valve (AV) or the pulmonary valve (PV), while regurgitation is known to primarily affect either the mitral valve (MV) or the tricuspid valve (TV). Both valve stenosis and regurgitation increase the workload of the heart (H), and if left untreated, can lead to very serious conditions, including endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. The left side of the heart (i.e., the left atrium (LA), left ventricle (LV), mitral valve (MV), and aortic valve (AV)) is primarily responsible for circulating blood throughout the body. Therefore, because pressures on the left side of the heart are substantially higher, insufficiency of the mitral valve (MV) or aortic valve (AV) is particularly problematic and often life-threatening.

[0030] Dysfunction of native heart valves can be either repaired or replaced. Repair typically involves preserving and correcting the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve (AV) and pulmonary valve (PV) are more prone to stenosis. Because stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic or pulmonary valve can involve removal of the valve and replacement with a surgically implanted heart valve or a transcatheter heart valve. The mitral valve (MV) and tricuspid valve (TV) are more prone to deformation of the leaflets and / or surrounding tissue, which, as described above, can prevent the mitral valve (MV) or tricuspid valve (TV) from closing properly and allow regurgitation or backflow of blood from the ventricle into the atrium (e.g., a deformed mitral valve (MV) can allow regurgitation or backflow from the left ventricle (LV) into the left atrium (LA), as shown in Figure 3). Regurgitation or backflow of blood from the ventricle into the atrium results in valvular insufficiency. Deformities in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. Additionally, regurgitation can occur because the chordae tendineae CT become dysfunctional (e.g., the chordae tendineae CT may stretch or rupture), allowing the anterior and posterior leaflets 20, 22 to back out, thus allowing blood to flow back into the left atrium LA. Problems caused by dysfunctional chordae tendineae CT can be corrected by repairing the structure of the chordae tendineae CT or mitral valve MV (e.g., by fixating the leaflets 20, 22 in the affected portion of the mitral valve).

[0031] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve and any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit the backflow of blood from the left ventricle to the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts provided herein can be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or inhibit the backflow of blood from the right ventricle into the right atrium. Furthermore, any of the devices and concepts provided herein can be used on all three of the leaflets 30, 32, and 34 together to prevent or inhibit the backflow of blood from the right ventricle to the right atrium. That is, the valve repair device or implant provided herein can be centrally positioned between the three leaflets 30, 32, and 34.

[0032] Exemplary implantable devices (e.g., implantable prosthetic devices, etc.) or implants may optionally include a coaptation element (e.g., a spacer, coaptation element, void filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, the implantable device or implant may include any combination or subcombination of the features disclosed herein without a coaptation element. When included, the coaptation element (e.g., a coaptation element, spacer, etc.) is configured to be positioned within the native heart valve orifice to help fill the space between the valve leaflets and form a more effective seal, thereby reducing or preventing regurgitation. The coaptation element may be impermeable to blood (or resist blood flow therethrough) and may have a structure that allows the native valve leaflets to close around the coaptation element during ventricular systole, preventing blood from flowing from the left or right ventricle into the left or right atrium, respectively. The device or implant can be configured to seal against two or three native valve leaflets, i.e., the device can be used with native mitral (bicuspid) and tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because it can fill the space between non-functioning native valve leaflets (e.g., mitral valve leaflets 20, 22 or tricuspid valve leaflets 30, 32, 34) that do not close completely.

[0033] The optional coaptation element (e.g., spacer, coaption element, etc.) can have a variety of shapes. In some implementations, the coaptation element can have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the coaptation element can have an elliptical, oval, crescent, rectangular, or various other non-cylindrical cross-sectional shapes. In some implementations, the coaptation element can have an atrial portion positioned in or adjacent to the atrium, a ventricular or inferior portion positioned in or adjacent to the ventricle, and lateral sides extending between the native valve leaflets. In some implementations configured for use with a tricuspid valve, the atrial or superior portion is positioned in or adjacent to the right atrium, and the ventricular or inferior portion is positioned in or adjacent to the right ventricle, with lateral sides extending between the native tricuspid valve leaflets.

[0034] In some implementations, the anchors can be configured to secure the device to one or both of the native valve leaflets so that the coaptation element is positioned between two native leaflets. In some implementations configured for use with a tricuspid valve, the anchors can be configured to secure the device to one, two, or three of the tricuspid valve so that the coaptation element is positioned between three native leaflets. In some implementations, the anchors can be attached to the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some implementations, the anchors can be attached to an actuating element, such as a shaft or actuation wire, to which the coaptation element is also attached. In some implementations, the anchors and coaptation element can be independently positioned relative to each other by separately moving each of the anchors and coaptation element along the longitudinal axis of the actuating element (e.g., actuating shaft, actuating rod, actuating tube, actuating wire, etc.). In some implementations, the anchors and coaptation element can be simultaneously positioned by moving the anchors and coaptation element together along the longitudinal axis of the actuating element (e.g., shaft, actuation wire, etc.). The anchors may be configured to be positioned behind the native valve leaflets when implanted such that the leaflets are gripped by the anchors.

[0035] The device or implant may be configured to be implanted via a delivery system or other delivery means. The delivery system may include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, or the like. The coaptation elements and anchors may be compressible to a radially compressed state and self-expandable to a radially expanded state when the compressive pressure is released. The device may be configured so that the anchors first expand radially away from the still-compressed coaptation elements to create a gap between the coaptation elements and the anchors. The native leaflets may then be positioned within the gap. The coaptation elements may be radially expanded to close the gap between the coaptation elements and the anchors and capture the leaflets between them. In some implementations, the anchors and coaptation elements are optionally configured to self-expand. The implantation methods for various implementations may vary and are discussed more fully below for each implementation. Additional information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599 and U.S. Patent Application Publication Nos. 2014 / 0222136, 2014 / 0067052, 2016 / 0331523, and PCT Patent Application Publication No. WO2020 / 076898, each of which is incorporated herein by reference in its entirety for all purposes. These methods can, mutatis mutandis, be performed on live animals or on simulations such as, for example, cadavers, cadaver hearts, simulators (e.g., simulated body parts, hearts, tissues), etc.

[0036] The disclosed device or implant can be configured with anchors connected to the valve leaflets and utilizing tension from the natural chordae tendineae to resist high systolic pressures that pull the device toward the left atrium. During diastole, the device can rely on compressive and retaining forces exerted on the leaflets that are gripped by the anchors.

[0037] 8-15, a schematically illustrated implantable device or implant 100 (e.g., a prosthetic spacer device, a valve repair device, etc.) is shown in various stages of deployment. Device or implant 100 and other similar devices / implants are described in more detail in PCT Patent Application Publication Nos. WO2018 / 195215, WO2020 / 076898, and WO2019 / 139904, which are incorporated by reference in their entireties for all purposes. Device 100 can include any other features of implantable devices or implants discussed in this or the above-listed applications, and device 100 can be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this or the above-listed applications).

[0038] The device or implant 100 is deployed from a delivery system or other delivery means 102. The delivery system 102 may include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a passageway, combinations thereof, etc. The device or implant 100 includes a joint portion 104 and an anchor portion 106.

[0039] In some implementations, the coaptation portion 104 of the device or implant 100 includes a coaptation element 110 (e.g., a spacer, plug, filter, foam, sheet, membrane, coaptation element, etc.) adapted to be implanted between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and slidably attached to an actuation element 112 (e.g., an actuation wire, an actuation shaft, an actuation tube, etc.). The anchor portion 106 includes one or more anchors 108 that are actuable between an open state and a closed state and can take a wide variety of forms, such as, for example, paddles, grasping elements, etc. Actuation of the actuation means or actuation means 112 opens and closes the anchor portion 106 of the device 100 to grasp the leaflets of the native valve during implantation. The actuation means or actuation element 112 (as well as other actuation means and elements herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), be made from a variety of different materials, and have a variety of configurations. As an example, the actuation element may be threaded such that rotation of the actuation element moves the anchor portion 106 relative to the interface portion 104. Alternatively, the actuation element may be non-threaded such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the interface portion 104.

[0040] The anchor portion 106 and / or anchor of the device 100, in some implementations, includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the mating means or mating element 110 by portions 124, 126, and 128. The portions 124, 126, and 128 may be coupled and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 120, inner paddle 122, mating element 110, and cap 114 by portions 124, 126, and 128 can constrain the device to the positions and movements illustrated herein.

[0041] In some implementations, the delivery system 102 includes a steerable catheter, an implant catheter, and an actuation means or element 112 (e.g., an actuation wire, an actuation shaft, etc.), which may be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuation means or element 112 extends through the delivery catheter and the joint means or element 110 to a distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuation element 112 increases and decreases the spacing between the joint element 110 and the distal end (e.g., the cap 114 or other attachment portion) of the device, respectively. In some implementations, a collar or other attachment element removably attaches, either directly or indirectly, the joint element 110 to the delivery system 102, such that the actuation means or element 112 slides through the collar or other attachment element, and in some implementations, through the joint means or element 110 during actuation, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0042] In some implementations, the anchor portion 106 and / or the anchor 108 may include an attachment portion or gripping member. The illustrated gripping member may include a clasp 130 including a base or fixed arm 132, a movable arm 134, optional barbs, friction-enhancing elements, or other fastening means 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesive, etc.), and a joint portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 using the joint portion 138 located proximate to the joining means or joining element 110. In some implementations, the clasp (e.g., a barbed clasp) has a flat surface and does not fit into a recess in the inner paddle. Rather, the flat portion of the clasp is positioned against the surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixed and movable arms 132, 134 of the clasp 130. Joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, etc. In some implementations, joint portion 138 is a single piece of flexible material integrally formed with fixed and movable arms 132, 134. Fixed arm 132 is attached to inner paddle 122 and remains fixed or substantially fixed relative to inner paddle 122 when movable arm 134 is released to open clasp 130 and expose retractable, friction-enhancing element, or securing means 136.

[0043] In some implementations, the clasp 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, bend, or pivot on a joint portion 138. The actuation line 116 extends through the delivery system 102 (e.g., through a steerable catheter and / or an implant catheter). Other actuation mechanisms are also possible.

[0044] The actuation line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, etc. The clasp 130 can be spring-loaded so that in the closed position, the clasp 130 continues to provide a clamping force against the grasped native valve leaflet. This clamping force remains constant regardless of the position of the inner paddle 122. Optional barbs, friction-enhancing elements, or other fixation means 136 of the clasp 130 can grasp, pinch, and / or pierce the native valve leaflet to further secure the native leaflet.

[0045] During implantation, the paddles 120, 122 can be opened and closed to grasp native valve leaflets (e.g., native mitral valve leaflets) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation means or coaptation element 110, for example. The clasp 130 can be used to grasp and / or further secure the native valve leaflets by engaging the leaflets with barbs, friction-enhancing elements, or fixation means 136 and clamping the leaflets between the movable arm 134 and the fixation arm 132. The barbs, friction-enhancing elements, or other fixation means 136 (e.g., barbs, projections, ridges, grooves, textured surfaces, adhesives, etc.) of the clasp or barbed clasp 130 can increase friction with the leaflets or partially or fully pierce the leaflets. The actuation wire 116 can be separately actuated to allow each clasp 130 to be opened and closed separately. The separate operation allows one leaflet to be grasped at a time or allows repositioning of the clasp 130 on a poorly grasped leaflet without altering the good grip of the other leaflet. The clasp 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 or at least partially open position), thereby allowing for grasping of the leaflets in various positions as a particular situation requires.

[0046] Referring now to FIG. 8 , the device 100 is shown in an elongated or fully open state for deployment from an implant delivery catheter of a delivery system 102. The device 100 is positioned at the end of the catheter 102 in the fully open position because the fully open position takes up minimal space, allowing the smallest catheter to be used (or the largest device 100 to be used for a given catheter size). In the elongated state, the cap 114 is spaced from the attachment means or attachment element 110 so that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the interiors of the outer and inner paddles 120, 122 is approximately 180 degrees. The clasp 130 is held closed during deployment through the delivery system 102 so that the barbs, friction-enhancing elements, or other securing means 136 ( FIG. 9 ) do not catch or damage tissue within the delivery system 102 or the patient's heart. The actuation wire 116 extends through a coupler 117, around a collar 115, and may be attached to a movable arm 134.

[0047] 9, device 100 is shown in an elongated, uncoiled state similar to FIG. 8, but with clasp 130 in a fully open position at an angle ranging from about 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or about 180 degrees between fixed portion 132 and movable portion 134 of clasp 130. Allowing paddles 120, 122 and clasp 130 to be fully open has been found to improve the ease of uncoil or detachment of device 100 from patient anatomy, such as chordae tendineae CT, during implantation.

[0048] Referring now to FIG. 10 , the device 100 is shown in a contracted or fully closed state. The compact size of the device 100 in the contracted state allows for easier manipulation and placement within the heart. To move the device 100 from the elongated state to the contracted state, the actuation means or element 112 is retracted, pulling the cap 114 toward the attachment means or element 110. The connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained such that a compressive force acting on the retracted outer paddle 120 from the cap 114 toward the attachment means or element 110 moves the paddle or gripping element radially outward. During movement from the open position to the closed position, the outer paddle 120 maintains an acute angle with the actuation means or element 112. The outer paddle 120 may optionally be biased toward the closed position. During the same operation, the inner paddles 122 move through a significantly larger angle because they are oriented away from the connecting means or element 110 in the open state and folded along both sides of the connecting means or element 110 in the closed state. In some implementations, the inner paddle 122 is thinner and / or narrower than the outer paddle 120, and the connecting portions 126, 128 (e.g., joints, flexible connections, etc.) connected to the inner paddle 122 may be thinner and / or more flexible. For example, this increased flexibility may allow for more movement than the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some implementations, the outer paddle 120 is narrower than the inner paddle 122. The connecting portions 126, 128 connected to the inner paddle 122 may be more flexible, for example, to allow for more movement than the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some implementations, the inner paddle 122 may be the same or substantially the same width as the outer paddle.

[0049] 11-13, the device 100 is shown in a partially open, ready-to-grasp state. To transition from the fully closed state to the partially open state, an actuation means or element (e.g., an actuation wire, actuation shaft, etc.) is extended to push the cap 114 away from the coaptation means or element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor or anchor portion 106 to partially unfold. The actuation wire 116 is also retracted to open the clasp 130, which may then grasp the valve leaflets. In some implementations, the pair of inner and outer paddles 122, 120 are moved in unison, rather than independently, by a single actuation means or element 112. Additionally, the position of the clasp 130 depends on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 also closes the clasp. In some implementations, the paddles 120, 122 may be independently controllable. For example, the device 100 may have two actuation elements and two independent caps (or other mounting portions), whereby one independent actuation element (e.g., a wire, shaft, etc.) and cap (or other mounting portion) is used to control one paddle, and the other independent actuation element and cap (or other mounting portion) is used to control the other paddle.

[0050] 12, one of the actuation lines 116 is extended to allow one of the clasps 130 to close. Now referring to FIG. 13, the other actuation line 116 is extended to allow the other clasp 130 to close. Either or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0051] 14 , device 100 is shown in a fully closed and deployed state. Delivery system or delivery means 102 and actuation means or element 112 are retracted, with paddles 120, 122 and clasp 130 still in the fully closed position. Once deployed, device 100 may be maintained in the fully closed position by a mechanical latch or may be biased to remain closed through the use of a spring material, such as steel, other metals, plastics, composites, or a shape-memory alloy, such as Nitinol. For example, connecting portions 124, 126, 128, joint portion 138, and / or inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from a metal, such as steel, or a shape-memory alloy, such as Nitinol, fabricated from a wire, sheet, tube, or laser-sintered powder, and biased to hold outer paddle 120 closed around coaptation means or element 110, with clasp 130 clamped around the native valve leaflets. Similarly, the fixed and movable arms 132, 134 of the clasp 130 are biased to clamp the valve leaflets. In some implementations, the attachment or connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from metal or any other suitable resilient material, such as a polymeric material, to maintain the device 100 in a closed state after implantation.

[0052] Figure 15 illustrates an embodiment in which the paddles 120, 122 are independently controllable. The device 100 illustrated by Figure 15 is similar to the device illustrated by Figure 11, except that the device 100 of Figure 15 includes actuation elements configured as two independent actuation elements 111, 113 coupled to two independent caps 115, 117. To transition the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, the actuation means or element 111 extends to push the cap 115 away from the joining means or element 110, thereby pulling the outer paddle 120, which pulls the inner paddle 122 and causes the first anchor 108 to partially unfold. To transition the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, the actuation means or element 113 extends to push the cap 115 away from the mating means or element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchor 108 to partially unfold. The independent paddle control illustrated by FIG. 15 can be implemented in any of the devices disclosed herein. For comparison, in the embodiment illustrated by FIG. 11, the pair of inner and outer paddles 122, 120 move in unison, rather than independently, by a single actuation means or element 112.

[0053] 16-21, the implantable device 100 of Figures 8-14 is shown delivered and implanted within the native mitral valve MV of the heart H. Referring now to Figure 16, a delivery sheath / catheter is inserted through the septum into the left atrium LA, and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state as illustrated in Figure 16. The actuation means or element 112 is then retracted to move the implant / device to a fully closed state shown in Figure 17.

[0054] As can be seen in Figure 18, the implant / device is moved into position within the ventricle LV and into the mitral valve MV and partially opened so that the leaflets 20, 22 can be grasped. For example, the steerable catheter can be advanced and steered or bent to position the steerable catheter as illustrated by Figure 18. An implant catheter connected to the implant / device can be advanced from inside the steerable catheter to position the implant as illustrated by Figure 18.

[0055] 19, the implant catheter may be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 within the clasps 130. The actuating wire 116 is extended to close one of the clasps 130 and capture the leaflet 20. FIG. 20 shows that the other actuating wire 116 is then extended to close the other clasp 130 and capture the remaining leaflet 22. Finally, as seen in FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), actuating means or element 112, and actuating wire 116 are then retracted, and the device or implant 100 is fully closed and deployed within the native mitral valve MV.

[0056] 22-27, an example of an implantable device or implant or implants 200 is shown. The implantable device 200 is one of many different configurations that the device 100, illustrated generally in FIGS. 8-14, can assume. The device 200 can include any other features of an implantable device or implant discussed herein, and the device 200 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein). The device / implant 200 can be a prosthetic spacer device, a valve repair device, or another type of implant that attaches to the leaflets of a native valve.

[0057] In some embodiments, the implantable device or implant 200 includes a coaptation portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some embodiments, the coaptation portion 204 of the device optionally includes a coaptation element 210 (e.g., a spacer, coaptation element, plug, membrane, sheet, etc.) for implantation between the leaflets of a native valve. In some embodiments, the anchor portion 206 includes multiple anchors 208. The anchors may be configured in various manners. In some embodiments, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clasp 230. In some embodiments, the attachment portion 205 includes a first or proximal collar 211 (or other attachment element) for engaging a capture mechanism 213 ( FIGS. 43-49 ) of the delivery system 202 ( FIGS. 38-42 and 49 ). Delivery system 202 may be the same as or similar to delivery system 102 described elsewhere and may include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, and the like.

[0058] In some implementations, the coaptation element 210 and paddles 220, 222 may be formed from a flexible material, which may be a metallic fabric such as a mesh, woven fabric, braided fabric, or formed in any other suitable manner, or a laser cut or otherwise cut flexible material. The material may also be cloth, wire such as Nitinol to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body.

[0059] An actuation element 212 (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) extends from the delivery system 202 to engage and enable actuation of the implantable device or implant 200. In some implementations, the actuation element 212 extends through the capture mechanism 213, the proximal collar 211, and the interface element 210 to engage with a cap 214 of the distal portion 207. The actuation element 212 may be configured to releasably engage the cap 214, such as with a threaded connection, so that the actuation element 212 can be disengaged and removed from the device 200 after implantation.

[0060] The coaptation element 210 extends from the proximal collar 211 (or other attachment element) to the inner paddle 222. In some implementations, the coaptation element 210 has a generally elongated, round shape, although other shapes and configurations are possible. In some implementations, the coaptation element 210 has an oval shape or cross-section when viewed from above (e.g., FIG. 51), a tapered shape or cross-section when viewed from the front (e.g., FIG. 23), or a round shape or cross-section when viewed from the side (e.g., FIG. 24). A blend of these three geometries can result in the three-dimensional shape of the illustrated coaptation element 210 that achieves the benefits described herein. The round shape of the coaptation element 210 can also be seen to substantially follow or approximate the shape of the paddle frame 224 when viewed from above.

[0061] The size and / or shape of the coaptation element 210 can be selected to minimize the number of implants (preferably one) required by a single patient while simultaneously maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the top of the coaptation element is approximately 5 mm, and the medial-lateral distance of the coaptation element at its widest portion is approximately 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and the overall shape strategy described above. It is readily apparent that using other anterior-posterior and medial-lateral distances as a starting point for the device will result in a device with different dimensions. Furthermore, using other size and shape strategies described above will also result in a device with different dimensions.

[0062] In some implementations, outer paddle 220 is articulably attached to cap 214 of distal portion 207 by connecting portion 221 and to inner paddle 222 by connecting portion 223. Inner paddle 222 is articulably attached to the articulating element by connecting portion 225. In this manner, anchor 208 is configured similar to a leg in that inner paddle 222 is like the upper part of the leg, outer paddle 220 is like the lower part of the leg, and connecting portion 223 is like the knee part of the leg.

[0063] In some implementations, the inner paddle 222 is hard, relatively hard, rigid, has a rigid portion, and / or is reinforced by a reinforcing member or fixed portion 232 of the clasp 230. The reinforcement of the inner paddle allows the device to move to a variety of different positions as shown and described herein. The inner paddle 222, outer paddle 220, and joints may all be interconnected as described herein, thereby restraining the device 200 to the movements and positions as shown and described herein.

[0064] In some implementations, the paddle frame 224 is attached to the cap 214 at the distal portion 207 and extends to a connection portion 223 between the inner and outer paddles 222, 220. In some implementations, the paddle frame 224 is formed of a material that is stiffer and harder than the material forming the paddles 222, 220, such that the paddle frame 224 provides support for the paddles 222, 220.

[0065] The paddle frame 224, as can be seen in FIG. 51 , provides additional clamping force between the inner paddle 222 and the coaptation element 210 and helps wrap the leaflets around the sides of the coaptation element 210 for a better seal between the coaptation element 210 and the leaflets. That is, the paddle frame 224 may be configured with a rounded, three-dimensional shape extending from the cap 214 to the connecting portion 223 of the anchor 208. The connections between the paddle frame 224, the outer and inner paddles 220, 222, the cap 214, and the coaptation element 210 can limit each of these portions to the movements and positions described herein. In particular, the connecting portion 223 is limited 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 limited by its attachment to the connecting portion 223 (and thus the inner and outer paddles 222, 220) and the cap 214.

[0066] Configuring the paddle frame 224 in this manner provides an increased surface area compared to the outer paddle 220 alone, which can facilitate, for example, grasping and securing the native valve leaflets. The increased surface area can also distribute the clamping force of the paddles 220 and paddle frame 224 against the native valve leaflets over a larger surface area of ​​the native valve leaflets to further protect the native valve leaflet tissue. Referring again to FIG. 51 , the increased surface area of ​​the paddle frame 224 can also enable the native valve leaflets to be secured to the implantable device or implant 200 such that the native valve leaflets are fully coapted around the coaptation member or element 210. This can, for example, improve the sealing of the native valve leaflets 20, 22 and thus prevent or further reduce mitral regurgitation.

[0067] In some implementations, the clasp includes a movable arm coupled to the anchor. In some implementations, the clasp 230 includes a base or fixed arm 232, a movable arm 234, a barb 236, and a joint portion 238. The fixed arm 232 is attached to the inner paddle 222, and the joint portion 238 is positioned proximate to the joining element 210. The joint portion 238 is spring-loaded so that the fixed and movable arms 232, 234 are biased toward each other when the clasp 230 is in the closed state. In some implementations, the clasp 230 includes friction-enhancing elements or means for securing, such as barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.

[0068] In some implementations, the fixed arm 232 is attached to the inner paddle 222 with a suture (not shown) through a hole or slot 231. The fixed arm 232 may be attached to the inner paddle 222 by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, welding, an adhesive, etc. The fixed arm 232 remains substantially fixed relative to the inner paddle 222 when the movable arm 234 opens, releasing the clasp 230 and exposing the barb or other friction-enhancing element 236. The clasp 230 is opened by applying tension to an actuation line 216 (shown, for example, in FIGS. 43-48 ) attached to a hole 235 in the movable arm 234, thereby causing the movable arm 234 to articulate, pivot, and / or bend on a joint portion 238.

[0069] 29 , a close-up view of one of the leaflets 20, 22 grasped by a clasp, such as clasp 230, is shown. The leaflets 20, 22 are grasped between the movable and fixation arms 234 of the clasp 230. The tissue of the leaflets 20, 22 is not pierced by the barbs or friction-enhancing elements 236, although in some implementations, the barbs 236 may partially or completely pierce the leaflets 20, 22. The angle and height of the barbs or friction-enhancing elements 236 relative to the movable arms 234 help secure the leaflets 20, 22 within the clasp 230. In particular, the force pulling the implant away from the native leaflets 20, 22 encourages the barbs or friction-enhancing elements 236 to further engage the tissue, thereby ensuring better retention. Retention of the leaflets 20, 22 in the clasp 230 is further improved by the location of the fixation arms 232 near the barbs / friction-enhancing elements 236 when the clasp 230 is closed. In this arrangement, the tissue is formed into an S-shaped, tortuous path by the fixed and movable arms 232, 234 and the barbs / friction-enhancing elements 236. Thus, forces pulling the leaflets 20, 22 away from the clasp 230 will encourage the tissue to further engage the barbs / friction-enhancing elements 236 before the leaflets 20, 22 can prolapse. For example, tension on the leaflets during diastole can urge the barbs 236 to pull toward the end portions of the leaflets 20, 22. Thus, the S-shaped path can take advantage of leaflet tension during diastole to more tightly engage the leaflets 20, 22 with the barbs / friction-enhancing elements 236.

[0070] 25 , the device or implant 200 may also include a cover 240. In some implementations, the cover 240 may be disposed on the joint element 210, the outer and inner paddles 220, 222, and / or the paddle frame 224. The cover 240 may be configured to prevent or reduce blood flow through the device or implant 200 and / or promote autologous tissue ingrowth. In some implementations, the cover 240 may be a cloth or fabric, such as PET, velour, or other suitable fabric. In some implementations, instead of or in addition to a fabric, the cover 240 may include a coating (e.g., a polymer) applied to the implantable device or implant 200.

[0071] During implantation, the paddles 220, 222 of the anchor 208 are opened and closed to grip the native valve leaflets 20, 22 between the paddles 220, 222 and the coaptation element 210. The anchor 208 is moved between a closed position ( FIGS. 22-25 ) and various open positions ( FIGS. 26-37 ) by extending and retracting the actuation element 212. Extending and retracting the actuation element 212 increases and decreases the spacing between the coaptation element 210 and the cap 214, respectively. The proximal collar 211 (or other attachment element) and the coaptation element 210 slide along the actuation element 212 during actuation, and as a result, changing the spacing between the coaptation element 210 and the cap 214 moves the paddles 220, 220 between different positions to grip the mitral valve leaflets 20, 22 during implantation.

[0072] As device 200 opens and closes, the pair of inner and outer paddles 222, 220 are moved in unison by a single actuation element 212, rather than independently. Also, the position of clasp 230 depends on the position of paddles 222, 220. For example, clasp 230 is positioned such that closure of anchor 208 simultaneously closes clasp 230. In some implementations, device 200 can be fabricated with paddles 220, 222 that are independently controllable in the same manner (e.g., device 100 illustrated in FIG. 15).

[0073] In some implementations, the clasps 230 further secure the native leaflets 20, 22 by engaging the leaflets 20, 22 with barbs and / or other friction-enhancing elements 236 and sandwiching the leaflets 20, 22 between the movable and fixed arms 234, 232. In some implementations, the clasps 230 are barbed clasps that include barbs that increase friction with the leaflets 20, 22 and / or can partially or fully pierce the leaflets 20, 22. The actuation lines 216 ( FIGS. 43-48 ) can be separately actuated so that each clasp 230 can be opened and closed separately. Separate actuation allows for gripping one leaflet 20, 22 at a time or allows for repositioning of the clasp 230 on a poorly gripped leaflet 20, 22 without altering the good grip of the other leaflet 20, 22. The clasps 230 can be fully opened and closed when the inner paddles 222 are not closed, thereby allowing the leaflets 20, 22 to be grasped in various positions as the particular situation requires.

[0074] 22-25, the device 200 is shown in a partially closed position. When closed, the inner paddle 222 is positioned between the outer paddle 220 and the coaptation element 210. The clasp 230 is positioned between the inner paddle 222 and the coaptation element 210. Upon successful capture of the native leaflets 20, 22, the device 200 is moved to and held in the closed position such that the leaflets 20, 22 are secured within the device 200 by the clasp 230 and pressed against the coaptation element 210 by the paddles 220, 222. The outer paddle 220 may have a wider curved shape that fits around the curved shape of the coaptation element 210 to more firmly grip the leaflets 20, 22 when the device 200 is closed (e.g., as seen in FIG. 51). The curved shape and rounded edges of the outer paddle 220 also prevent or inhibit tearing of the leaflet tissue.

[0075] 30-37, the implantable device or implant 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 of the actuating element 212 to a fully retracted position to a fully extended position.

[0076] 30-31 , device 200 is shown in a partially open position. Device 200 is moved to the partially open position by extending actuation element 212. The extension of actuation element 212 pulls down the bottom portions of outer paddle 220 and paddle frame 224. Outer paddle 220 and paddle frame 224 pull down inner paddle 222, which is connected to outer paddle 220 and paddle frame 224. Because proximal collar 211 (or other attachment element) and interface element 210 are held in place by capture mechanism 213, inner paddle 222 is forced to articulate, pivot, and / or bend toward the opening. Inner paddle 222, outer paddle 220, and paddle frame all bend to the positions shown in FIGS. 30 and 31 . The opening of the paddles 222, 220 and frame 224 creates a gap between the coaptation element 210 and the inner paddle 222 that can receive and grasp the native leaflets 20, 22. This movement also exposes the clasp 230, which can move 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 movable arms 232, 234 of the clasp 230 is limited to the extent that the inner paddle 222 extends away from the coaptation element 210.

[0077] 32-33, the device 200 is shown in a laterally extended or open position. The device 200 moves to the laterally extended or open position by continuing to extend the actuation element 212, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207. Continuing to extend the actuation element 212 pulls down the outer paddle 220 and the paddle frame 224, thereby causing the inner paddle 222 to spread further away from the coaptation element 210. In the laterally extended or open position, the inner paddle 222 extends more horizontally than in other positions of the device 200, forming an approximately 90-degree angle with the coaptation element 210. Similarly, the paddle frame 224 is in its most spread position when the device 200 is in the laterally extended or open position. The increased gap between the joining element 210 and the inner paddle 222 formed in the laterally extended or open position allows the clasp 230 to open further (FIG. 33) before engaging the joining element 210, thereby increasing the size of the gap between the fixed and movable arms 232, 234.

[0078] 34 and 35, the exemplary device 200 is shown in a three-quarters extended position. The device 200 moves to the three-quarters extended position by continuing to extend the actuation element 212, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207. Continuing to extend the actuation element 212 pulls down on the outer paddle 220 and paddle frame 224, thereby causing the inner paddle 222 to spread further away from the coaptation element 210. In the three-quarters extended position, the inner paddle 222 opens to an angle of more than 90 degrees to approximately 135 degrees from the coaptation element 210. The paddle frame 224 spreads less than in the laterally extended or open position and begins to move inward toward the actuation element 212 as the actuation element 212 extends further. The outer paddle 220 also bends backward toward the actuation element 212. Similar to the laterally extended or open position, the increased gap between the joint element 210 and the inner paddle 222 formed in the laterally extended or open position allows the clasp 230 to open even further (FIG. 35), thereby increasing the size of the gap between the fixed and movable arms 232, 234.

[0079] 36 and 37 , the exemplary device 200 is shown in a fully extended position. The device 200 moves to the fully extended position by continuing to extend the actuation element 212, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207 to the maximum distance allowable by the device 200. Continuing to extend the actuation element 212 pulls down the outer paddle 220 and paddle frame 224, thereby causing the inner paddle 222 to spread further away from the coaptation element 210. The outer paddle 220 and paddle frame 224 are moved to a position where they are closer to the actuation element. In the fully extended position, the inner paddle 222 opens approximately 180 degrees from the coaptation element 210. The inner and outer paddles 222, 220 are straightened in the fully extended position, forming an approximately 180-degree angle between the paddles 222, 220. The fully extended position of the device 200 provides the largest gap size between the coaptation element 210 and the inner paddle 222 and, in some implementations, also allows the clasp 230 to fully open to approximately 180 degrees between the fixed and movable arms 232, 234 of the clasp 230 ( FIG. 37 ). The position of the device 200 is its longest and narrowest configuration. Thus, the fully extended position of the device 200 may be a desired position for bailout of the device 200 from an attempted implantation or for placement of the device into a delivery catheter, etc.

[0080] Configuring the device or implant 200 so that the anchor 208 can extend to a straight or nearly straight configuration (e.g., approximately 120 to 180 degrees relative to the coaptation element 210) can provide several advantages. For example, this configuration can reduce the radial wave profile of the device or implant 200. This can also make it easier to grasp the native leaflets 20, 22 by providing a larger opening between the coaptation element 210 and the inner paddle 222 for grasping the native leaflets 20, 22. Furthermore, the relatively narrow straight configuration can prevent or reduce the likelihood of the device or implant 200 becoming entangled within native anatomical structures (e.g., the chordae tendineae CT shown in FIGS. 3 and 4 ) when positioning and / or removing the device or implant 200 from the delivery system 202.

[0081] 38-49, an exemplary implantable device 200 is shown delivered and implanted within a native mitral valve MV of a heart H. As described above, the device 200 shown in FIGS. 38-49 includes a coaptation element 210, a clasp 230, an inner paddle 222, and / or an optional cover 240 (e.g., FIG. 25) over the outer paddle 220. The device 200 is deployed from a delivery system 202 (which may comprise, e.g., a steerable catheter and / or an implant catheter extendable from a guide sheath), held by a capture mechanism 213 (see, e.g., FIGS. 43 and 48), and actuated by extending or retracting an actuation element 212. Fingers of the capture mechanism 213 removably attach a collar 211 to the delivery sheath 202. In some implementations, the capture mechanism 213 is held closed around the collar 211 by the actuating element 212 such that removal of the actuating 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 is successfully implanted.

[0082] 38, a delivery system 202 (e.g., its delivery catheter / sheath) is inserted through the septum into the left atrium LA, and the device / implant 200 is deployed from the delivery system 202 in a fully open state for the reasons described above for device 100 (e.g., an implant catheter holding the device / implant can be extended to deploy the device / implant out of the steerable catheter). The actuating element 212 is then retracted to move the device 200 through a partially closed state (FIG. 39) to the fully closed state shown in FIGS. 40 and 41. The delivery system or catheter then steers the device / implant 200 toward the mitral valve MV as shown in FIG. 41. 42, when the device 200 is aligned with the mitral valve MV, the actuating element 212 is extended to open the paddles 220, 222 to a partially open position, and the actuating line 216 (FIGS. 43-48) is retracted to open the clasp 230 and prepare to grasp the valve leaflets. Next, as shown in FIGS. 43 and 44, the partial opening device 200 is inserted through the native valve (e.g., by advancing an implant catheter from the steerable catheter) until the leaflets 20, 22 are properly positioned between the inner paddle 222 and the coaptation element 210 and inside the open clasp 230.

[0083] FIG. 45 shows the device 200 with both clasps 230 closed, but the barb 236 of one clasp 230 has missed one leaflet 22. As can be seen in FIGS. 45-47, the out-of-position clasp 230 is again opened and closed to properly grasp the missed leaflet 22. Once both leaflets 20, 22 are properly grasped, the actuating element 212 is retracted to move the device 200 to the fully closed position shown in FIG. 48. Once the device 200 is fully occluded and implanted within the native valve, the actuating element 212 is disengaged from the cap 214 and withdrawn to release the capture mechanism 213 from the proximal collar 211 (or other attachment element) so that the capture mechanism 213 can be retracted into the delivery system 202 (e.g., into a catheter / sheath), as shown in FIG. Once deployed, the device 200 may be maintained in a fully closed position using mechanical means such as a latch, or may remain closed through the use of a spring material such as steel and / or a shape memory alloy such as Nitinol. For example, the paddles 220, 222 may be formed from wire, sheet, tube, or laser-sintered powder-produced steel or Nitinol shape memory alloy and are biased to hold the outer paddle 220 closed around the inner paddle 222, the coaptation element 210, and / or the clasp 230 clamped around the native leaflets 20, 22.

[0084] 50-54, when the device 200 is implanted in a native valve, the coaptation element 210 functions as a gap filler for a valve regurgitation opening, such as the gap 26 in the mitral valve MV illustrated by FIG. 6 or a gap in another native valve. In some implementations, when the device 200 is deployed between two opposing valve leaflets 20, 22, the leaflets 20, 22 no longer coapt against each other in the region of the coaptation element 210 but instead coapt against the coaptation element 210. This reduces the distance the leaflets 20, 22 must be brought close to close the mitral valve MV, thereby facilitating repair of functional valve disease that can cause mitral regurgitation. The reduction in leaflet coaptation distance may result in several other benefits as well. For example, the reduced coaptation distance required for the leaflets 20, 22 reduces or minimizes stress experienced by the native valve. The shorter approximation distance of the leaflets 20, 22 can also require less approximation force, which can result in less tension experienced by the leaflets 20, 22 and a smaller diameter reduction of the annulus. The smaller, or no, reduction of the annulus can result in a smaller reduction in valve orifice area compared to a device without a coaptation element or spacer. In this way, the coaptation element 210 can reduce transvalvular gradients.

[0085] To adequately fill the gap 26 between the leaflets 20, 22, the device 200 and its components can have a wide variety of different shapes and sizes. For example, the outer paddle 220 and paddle frame 224 can be configured to fit the shape or geometry of the coaptation element 210, as shown in FIGS. 50-54 . As a result, the outer paddle 220 and paddle frame 224 can mate with both the coaptation element 210 and the leaflets 20, 22 of the native valve. In some implementations, when the leaflets 20, 22 are coapted against the coaptation element 210, the entire leaflets 20, 22 completely surround or "hugge" the coaptation element 210, thereby preventing small leaks at the lateral and medial surfaces 201, 203 of the coaptation element 210. The interaction of the leaflets 20, 22 and device 200 is made clear in FIG. 51, which shows a schematic atrial view or surgeon's perspective showing a paddle frame 224 (not actually visible from a true atrial view, e.g., FIG. 52) that conforms to the geometry of the coaptation element 210. The opposing leaflets 20, 22 (both ends of which are also not visible in a true atrial view, e.g., FIG. 52) are approximated by the paddle frame 224 to completely surround or "hug" the coaptation element 210.

[0086] This coaptation of the leaflets 20, 22 against the lateral and medial surfaces 201, 203 of the coaptation element 210 (shown from the atrial side in FIG. 52 and the ventricular side in FIG. 53) seems to contradict the statement above that the presence of the coaptation element 210 minimizes the distance the leaflets need to be approximated. However, if the coaptation element 210 is precisely positioned in the regurgitation gap 26, and the regurgitation gap 26 is smaller than the width (medial surface minus lateral surface) of the coaptation element 210, the distance the leaflets 20, 22 need to approximate is still minimized.

[0087] Figure 50 illustrates the geometry of the coaptation element 210 and paddle frame 224 from the perspective of the LVOT. As can be seen in this figure, the coaptation element 210 has a tapered shape, with smaller dimensions in regions closer to where the inner surfaces of the leaflets 20, 22 need to coapt and increasing dimensions as the coaptation element 210 extends toward the atrium. Thus, the illustrated geometry of the native valve is accommodated by the tapered coaptation element geometry. With further reference to Figure 50, the tapered coaptation element geometry, in conjunction with the illustrated expanded (toward the annulus) shape of the paddle frame 224, can help achieve coaptation at the lower ends of the leaflets, reduce stress, and minimize transvalvular gradients.

[0088] 54, the shapes of the coaptation elements 210 and paddle frame 224 can be defined based on a view of the native valve and the inner commissure of the device 200. Two factors contribute to these shapes: leaflet coaptation against the coaptation elements 210 and reducing stress on the leaflets due to coaptation. Referring to FIGS. 54 and 24, the coaptation elements 210 can have a round or rounded shape, and the paddle frame 224 can have a full radius that spans nearly the entire length of the paddle frame 224, both to coapt the leaflets 20, 22 against the coaptation elements 210 and to reduce stress applied to the valve leaflets 20, 22 by the coaptation elements 210 and / or paddles 224. The round shape of the coaptation elements 210 and / or the illustrated fully rounded shape of the paddle frame 224 distributes stress on the leaflets 20, 22 over a large, curved engagement region 255. For example, in FIG. 54, the force on the leaflets 20, 22 by the paddle frame is spread along the entire rounded length of the paddle frame 224 as the leaflets 20 attempt to open during diastole.

[0089] 55, an example of an implantable device or implant 300 is shown. The implantable device 300 is one of many different configurations that the device 100, illustrated generally in FIGS. 8-14, can assume. The device 300 can include any other features of an implantable device or implant discussed herein, and the device 300 can be positioned to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0090] The implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 includes a coaptation portion 304, which may optionally include a coaptation element 310 (e.g., a spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes multiple anchors 308. In some implementations, each anchor 308 may include one or more paddles, such as an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchors may also include and / or be coupled to a clasp 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging with a capture mechanism (such as capture mechanism 213 shown in Figures 43-49) of a delivery system (such as the systems shown in Figures 38-42 and 49).

[0091] The anchors 308 may be attached to other portions of the device and / or to each other in a variety of different ways (e.g., directly, indirectly, by welding, stitching, adhesive, linking, latching, integrally formed, some or all combinations thereof, etc.) In some implementations, the anchors 308 are attached to the joining member or joining element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0092] Anchor 308 can include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a joint portion 323. Connecting portion 323 can be attached to a paddle frame 324 that is hingedly attached to cap 314 or other mounting portion. In this manner, anchor 308 is configured similar to a leg in that inner paddle 322 is like the upper portion of a leg, outer paddle 320 is like the lower portion of a leg, and connecting portion 323 is like the knee portion of the leg.

[0093] In implementations using a joining member or element 310, the joining member or element 310 and the anchor 308 can be coupled together in a variety of ways. For example, as shown in the illustrated implementation, the joining element 310 and the anchor 308 can be coupled together by integrally forming the joining element 310 and the anchor 308 as a single, unitary component. This can be accomplished, for example, by forming the joining element 310 and the anchor 308 from a continuous strip 301 of braided or woven material, such as braided or woven nitinol wire. In the illustrated example, the joining element 310, outer paddle portion 320, inner paddle portion 322, and connecting portions 321, 323, 325 are formed from a continuous strip 301 of fabric.

[0094] Similar to the anchor 208 of the implantable device or implant 200 described above, the anchor 308 can be configured to move between various configurations by axially moving the distal end of the device (e.g., cap 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.), such that the anchor 308 moves relative to the midpoint of the device. This movement can occur along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device. For example, the anchor 308 can be positioned in a fully extended or straight configuration (e.g., similar to the configuration of the device 200 shown in FIG. 36 ) by moving the distal end (e.g., cap 314, etc.) away from the proximal end of the device.

[0095] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or linear with respect to the longitudinal axis of the device. In some implementations, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the coaptation element 310 (e.g., similar to the configuration of device 200 shown in FIG. 36 ). From the straight configuration, the anchor 308 can be moved to a fully collapsed configuration (e.g., FIG. 55 ), for example, by moving the proximal and distal ends toward each other and / or toward the midpoint or center of the device. Initially, as the distal end (e.g., cap 314, etc.) moves toward the proximal end and / or midpoint or center of the device, the anchor 308 bends at the connecting portions 321, 323, 325, and the connecting portion 323 moves radially outward relative to the longitudinal axis of the device 300 and axially toward the midpoint and / or proximal end of the device (e.g., similar to the configuration of device 200 shown in FIG. 34 ). As cap 314 continues to move toward the midpoint and / or toward the proximal end of the device, connecting portion 323 moves radially inward relative to the longitudinal axis of device 300 and axially toward the proximal end of the device (e.g., similar to the configuration of device 200 shown in FIG. 30).

[0096] In some implementations, the clasp includes a movable arm coupled to the anchor. In some implementations, the clasp 330 (shown in detail in FIG. 56 ) includes a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancing element 336, and a joint portion 338. The fixed arm 332 is attached to the inner paddle 322, and the joint portion 338 is positioned proximate to the joining element 310. The joint portion 338 is spring loaded such that the fixed and movable arms 332, 334 are biased toward each other when the clasp 330 is in the closed state.

[0097] The locking arm 332 is attached to the inner paddle 322 with sutures (not shown) through holes or slots 331. The locking arm 332 may be attached to the inner paddle 322 by any suitable means, such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, etc. The locking arm 332 remains substantially fixed relative to the inner paddle 322 when the movable arm 334 opens, releasing the barbed clasp 330 and exposing the barbs 336. The clasp 330 is opened by applying tension to an actuation line (e.g., actuation line 216 shown in FIGS. 43-48 ) attached to the hole 335 in the movable arm 334, thereby causing the movable arm 334 to articulate, pivot, and / or bend on the joint portion 338.

[0098] In summary, the implantable device or implant 300 is similar in construction and operation to the implantable device or implant 200 described above, except that the joint element 310, outer paddle 320, inner paddle 322, and connecting portions 321, 323, 325 are formed from a single strip of material 301. In some implementations, the strip of material 301 is attached to the proximal collar 311, cap 314, and paddle frame 324 by weaving or inserting it through openings in the proximal collar 311, cap 314, and paddle frame 324 that are configured to receive the continuous strip of material 301. The continuous strip 301 may be a single layer of material or may include two or more layers. In some implementations, some portions of the device 300 have a single layer of the strip of material 301, while other portions are formed from multiple overlapping or overlapping layers of the strip of material 301.

[0099] For example, Figure 55 shows a joining element 310 and inner paddle 322 formed from multiple overlapping layers of strip of material 301. The single continuous strip of material 301 can start and end at various locations on the device 300. The ends of the strip of material 301 can be at the same location or at different locations on the device 300. For example, in the illustrated embodiment of Figure 55, the strip of material 301 starts and ends at the location of the inner paddle 322.

[0100] According to the implantable device or implant 200 described above, the size of the coaptation element 310 can be selected to minimize the number of implants (preferably one) required for a single patient while simultaneously maintaining a low transvalvular gradient. In particular, forming many components of device 300 from strips of material 301 allows device 300 to be made smaller than device 200. For example, in some implementations, the anterior-posterior distance at the top of coaptation element 310 is less than 2 mm, and the medial-lateral distance of device 300 at its widest portion (i.e., the width of paddle frame 324, which is wider than coaptation element 310) is approximately 5 mm.

[0101] During implantation of an implantable device or implant into a native heart valve, movement of the device into the implanted position may be impeded or obstructed by native heart structures. For example, the articulating portion of the implantable device or implant (such as the paddle portion of the anchor used to secure the device to the native heart valve tissue) may rub against, temporarily catch on, or become temporarily blocked by the chordae tendineae CT (shown in FIGS. 3 and 4 ) extending to the valve leaflets. Exemplary implantable devices or implants may be configured to reduce the likelihood of the device or implant becoming temporarily trapped or blocked by the CT. For example, the implantable device or implant may assume a variety of different configurations that are actively or passively narrowed to reduce the width of the paddle frame of the anchor portion of the device and, as a result, reduce the surface area of ​​the device, thereby facilitating movement of the device / implant through and / or past the CT.

[0102] 57-67, an exemplary implementation of an implantable device or implant 400 is shown. The device 400 includes a material and / or coating that creates a more lubricious, slippery, or smooth exterior surface to reduce friction due to engagement between the device 400 and the heart's natural structures, such as the chordae tendineae. This reduced friction allows the device 400 to be more easily manipulated into position for implantation into the heart. The device 400 can include any other features related to implantable devices or implants discussed in this application or in the applications and patents incorporated herein by reference, and the device 400 can be positioned to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed in this application or any currently known valve repair system). Additionally, any of the devices described herein can incorporate the features of the device 400.

[0103] 57, an implantable device or implant 400 may be deployed from a delivery sheath or delivery means 402 by a pusher 413, such as a rod or tube as described above. The device 400 may include a joint portion 404 and an anchor portion 406. The anchor portion 406 may include two or more anchors 408.

[0104] Interface portion 404 may optionally include interface elements or spacers 410. Anchor portion 406 includes a plurality of paddles 420 (e.g., two in the illustrated implementation) and a plurality of clasps 430 (e.g., two in the illustrated implementation).

[0105] A first or proximal collar 411 and a second collar or cap 414 are used to move the interface portion 404 and the anchor portion 406 relative to one another. Actuation of the actuator, actuation element, or actuation means 412 opens and closes the anchor portion 406 of the device 400 to grip the native valve leaflets during implantation in the manner described above. The actuator or actuation element 412 can take a wide variety of different forms. For example, the actuation element may be threaded such that rotation of the actuation element moves the anchor portion 406 relative to the interface portion 404. Alternatively, the actuation element may be unthreaded such that pushing or pulling on the actuation element 412 moves the anchor portion 406 relative to the interface portion 404.

[0106] The joint element 410 extends from a proximal portion 419 assembled to the collar 411 to a distal portion 417 that connects to the anchor 408. The joint element 410 and the anchor 408 can be coupled together in a variety of ways. For example, as shown in the illustrated implementation, the joint element 410 and the anchor 408 can optionally be coupled together by integrally forming the joint element 410 and the anchor 408 as a single, unitary component. This can be accomplished, for example, by forming the joint element 410 and the anchor 408 from a continuous strip of braided or woven material, such as braided or woven nitinol wire. In another implementation, the components are formed separately and attached together.

[0107] The anchor 408 is attached to the joint element 410 by an inner flexible portion 422 and to the cap 414 by an outer flexible portion 421. The anchor 408 may include a pair of paddle portions 420. In some implementations, the anchor 408 may include an inner paddle and an outer paddle joined by a flexible portion (e.g., paddles 220, 222 of device 200 joined by hinge portion 223). The paddle portions 420 are attached to a paddle frame 424 that is flexibly attached to the cap 414.

[0108] 22-37, the anchor 408 can be configured to move between various configurations by axially moving the cap 414 relative to the proximal collar 411, and thus the anchor 408, relative to the coaptation element 410, along a longitudinal axis extending between the cap 414 and the proximal collar 411. For example, the anchor 408 can be positioned in a straight configuration by moving the cap 414 away from the coaptation element 410. The anchor 408 can also be positioned in a closed configuration (e.g., FIG. 57) by moving the cap 414 toward the coaptation element 410. When the cap 414 is pulled all the way toward the coaptation element 410 by the actuation element 412, the paddle portion 420 closes against the coaptation element 410, and any self-tissue (e.g., valve leaflets, not shown) captured between the coaptation element 410 and the paddle portion 420 is pinched to secure the device 400 to the self-tissue.

[0109] Clasp 430 may include an attachment or fixation portion 432 hingedly connected to an arm or movable portion 434 by a hinge portion 438. Movable portion 434 may include barbs or fixation means 436 capable of piercing the native leaflet to further secure the native leaflet captured between fixed portion 432 and movable portion 434 of clasp 430. Attachment or fixation portion 432 may be coupled or connected to paddle portion 420 of anchor 408 in a variety of ways, such as by sutures, adhesives, fasteners, welding, stitching, swaging, friction fit, and / or other coupling means. Clasp 430 may be similar to or identical to clasp 430.

[0110] The movable portion 434 can articulate, pivot, and / or flex relative to the fixed portion 432 between an open configuration (e.g., the device 200 shown in FIGS. 30-37) and a closed configuration ( FIGS. 57-58). In some implementations, the clasp 430 can be biased toward the closed configuration. In the open configuration, the fixed portion 432 and the movable portion 434 articulate, pivot, and / or flex away from each other so that the native valve leaflets (see, e.g., FIGS. 38-49) can be positioned between the fixed portion 432 and the movable portion 434. In the closed configuration, the fixed portion 432 and the movable portion 434 articulate, pivot, and / or flex toward each other, thereby clamping the native valve leaflets between the fixed portion 432 and the movable portion 434 (e.g., FIG. 47). The clasp 430 can be spring-loaded so that it continues to provide a clamping force to the grasped native valve leaflets in the closed position. This clamping force remains constant regardless of the position of the paddle portion 420.

[0111] Tension can be applied to the actuation line 416 connected to the clasp 430 to retract or retract the movable portion 434 of the clasp 430 in a retracting or proximal direction while the paddle portion 420 remains open as described above. The clasp 430 is opened against the biasing force of the hinge portion 438 described above. Once the clasp 430 is opened, the device 400 is moved in a capturing direction by retracting the pusher tube or rod 413 into the catheter 402 and / or moving the catheter 402 to position the valve leaflets 20, 22 between the fixed portion 432 and the movable portion 434 of the open clasp 430. Once the device 400 is in a position to capture the leaflets 20, 22, tension in the actuation line 416 is released, thereby allowing the actuation line 416 to move in the release direction, causing the spring-loaded hinge portion 438 to close the clasp 430 as described above, capturing and clamping the leaflets 20, 22 between the fixed portion 432 and the movable portion 434 of the clasp 430.

[0112] 58-71 , an implantable device or implant 400 is shown with a portion of the device 400 covered by a first cover portion 440 and a second cover portion 450. The first cover portion 440 provides for native cardiac tissue ingrowth and improves the connection between the native cardiac tissue and the device 400, while the second cover portion 450 provides a more lubricious or slippery surface, improving maneuverability of the device 400 during the implantation procedure. That is, the second cover portion 450 provides the device 400 with a surface having a lower coefficient of friction than the first cover portion 440, so that the device 400 can more easily move against and / or over native cardiac structures, such as chordae tendineae. The second cover portion 450 may also be made from a material that promotes tissue ingrowth and provides a low-friction surface, for example, depending on the thickness of the material and the size of the openings.

[0113] The first cover portion 440 is formed from a flexible material that promotes tissue ingrowth over time to further secure the implantable device / implant 400 between the native valve leaflets. The first cover portion 440 may be formed from a fabric, cloth, or any other flexible material suitable for implantation in the human body.

[0114] 57-60, 62-64, 66, 68, and 70, first cover portion 440 is formed around coaptation element 410 and paddle portion 420. First cover portion 440 may also extend to cover portions of clasps 430. Thus, when a native leaflet is captured by device 400, the area of ​​the leaflet in contact with first cover portion 440 can grow into the material of first cover portion 440 to enhance the grip of anchor 408 on the leaflet.

[0115] The second cover portion 450 may be a portion of the first cover portion 440 that has been treated to provide a lower coefficient of friction, or may be formed from a different material that is joined to the first cover portion 450 with a stitch or by overlapping the piece of material forming the second cover portion 450 over the first cover portion 440. The first cover portion 440 and the second cover portion 450 may be joined in any suitable manner, such as, for example, sewing, adhesive, a coating, a thermally bonded layer, etc.

[0116] The first cover portion 440 and the second cover portion 450 can take a wide variety of different forms. In various different exemplary implementations, the second, lower coefficient of friction portion can be provided in a portion of the device 400 that is likely to engage with the heart's own internal structures during advancement, positioning, and / or implantation of the device within the heart. The second, lower coefficient of friction portion can be included in an anchor portion, such as the illustrated paddles and / or clasps. In some implementations, the anchor portion can take other forms that may or may not include paddles and clasps. The second, lower coefficient of friction portion can be included in an interface portion of the device. In some implementations, the second, lower coefficient of friction portion is not included in an interface portion, or the device includes an interface portion.

[0117] The second cover portion 450 can cover some or all of the edges of the paddle portion 420, as shown in Figures 58-71. For example, the second cover portion 450 illustrated by Figures 64-65 covers all of the edges, while the second cover portion 450 does not cover the ends of the paddle portion 420 in Figures 66-67. Providing increased friction areas at the ends of the paddle portion 420 promotes increased friction or gripping force against the native leaflets during capture, while maintaining lower friction areas on the sides of the paddle portion 420 helps avoid entanglement with the chordae tendineae during implantation.

[0118] In some implementations, the second cover portion 450 illustrated by Figures 58-71 can extend to cover some or all of the outer surface of the paddle portion 420. For example, the second cover portion 450 can extend to cover all of the first cover portion 440 shown in Figure 65. Figures 68-71 show an exemplary implementation similar to the configuration of Figures 64-67, in which the proximal side of the paddle has the first cover portion 440 and the distal side of the paddle has the second cover portion 450. Figures 70-71 are similar to the configuration of Figures 66-67, in which the second cover portion 450 does not extend to cover the end of the upper paddle portion 420 of the device 400.

[0119] The second cover portion 450 can take a variety of forms to provide a lower coefficient of friction between the device 400 and the native tissue within the heart. The second cover portion 450 can be formed from a woven material having a lower coefficient of friction than the coefficient of friction of the first cover portion 440. That is, the second cover portion 450 can be formed from a fabric woven from threads of a different material than the first cover portion 440. The second cover portion 450 can also be formed by embedding a material such as plastic particles within a region of the first cover portion 440 or by applying a coating to a region of the first cover portion 440.

[0120] The coating applied to second cover portion 450 may be a permanent coating or a temporary coating that dissolves in the blood after one hour or more, such as one hour to one year, one hour to six months, one hour to three months, one hour to one month, one hour to two weeks, or one hour to one week. The temporary coating can provide the desired reduction in friction during the implantation procedure and then dissolve to expose more of first cover portion 440, which can contact the native tissue and provide additional gripping surface area. The coating that forms second cover portion 450 can be applied during manufacturing of device 400 or by the person performing the implantation procedure.

[0121] In exemplary implementations, the second cover portion 450 is formed from, includes, or incorporates a hydrophilic material, or is coated with a hydrophilic coating. Hydrophilic materials and coatings reduce surface friction of the medical device and increase the lubricity or slipperiness of the device surface to which the material is added. Hydrophilic materials, like a fine sponge, readily absorb liquids and provide a low-friction surface as long as the material is wet.

[0122] 72-86, an exemplary implementation of an implantable device or implant 500 is shown. The device 500 includes a material and / or coating that includes surface features that create an exterior surface that reduces friction due to engagement between the device 500 and the heart's natural structures, e.g., chordae tendineae. This reduced friction allows the device 500 to be more easily manipulated into position for implantation into the heart. The device 500 can include any other features related to implantable devices / implants discussed in this application or in the applications and patents incorporated herein by reference, and the device 500 can be positioned to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed in this application or any currently known valve repair system). Additionally, any of the devices described herein can incorporate the features of the device 500.

[0123] 72, a spacer or joining device 500 may be deployed from a delivery sheath or delivery means 502 by a pusher 513, such as a rod or tube as described above. The device 500 may include a joining portion 504 and an anchor portion 506. The anchor portion 506 may include two or more anchors 508.

[0124] In some applications, interface portion 504 may include an optional interface element or spacer 510. Anchor portion 506 includes a plurality of paddles 520 (e.g., two in the illustrated implementation) and a plurality of clasps 530 (e.g., two in the illustrated implementation).

[0125] A first or proximal collar 511 and a second collar or cap 514 are used to move the interface portion 504 and the anchor portion 506 relative to one another. Actuation of the actuator, actuation element, or actuation means 512 opens and closes the anchor portion 506 of the device 500 to grip the native valve leaflets during implantation in the manner described above. The actuator or actuation element 512 can take a wide variety of different forms. For example, the actuation element may be threaded such that rotation of the actuation element moves the anchor portion 506 relative to the interface portion 504. Alternatively, the actuation element may be unthreaded such that pushing or pulling on the actuation element 512 moves the anchor portion 506 relative to the interface portion 504.

[0126] The joint element 510 extends from a proximal portion 519, which is assembled to the collar 511, to a distal portion 517, which connects to the anchor 508. The joint element 510 and the anchor 508 can be coupled together in a variety of ways. For example, as shown in the illustrated implementation, the joint element 510 and the anchor 508 can optionally be coupled together by integrally forming the joint element 510 and the anchor 508 as a single, unitary component. This can be accomplished, for example, by forming the joint element 510 and the anchor 508 from a continuous strip of braided or woven material, such as braided or woven nitinol wire. In some implementations, the components are formed separately and attached together.

[0127] The anchor 508 is attached to the joint element 510 by an inner flexible portion 522 and to the cap 514 by an outer flexible portion 521. The anchor 508 may include a pair of paddle portions 520. In some implementations, the anchor 508 may include an inner paddle and an outer paddle joined by a flexible portion (e.g., paddles 220, 222 of device 200 joined by hinge portion 223). The paddle portions 520 are attached to a paddle frame 524 that is flexibly attached to the cap 514.

[0128] 22-37, the anchor 508 can be configured to move between various configurations by axially moving the cap 514 relative to the proximal collar 511, and thus the anchor 508, relative to the coaptation element 510, along a longitudinal axis extending between the cap 514 and the proximal collar 511. For example, the anchor 508 can be positioned in a straight configuration by moving the cap 514 away from the coaptation element 510. The anchor 508 can also be positioned in a closed configuration (e.g., FIG. 72) by moving the cap 514 toward the coaptation element 510. When the cap 514 is pulled all the way toward the coaptation element 510 by the actuation element 512, the paddle portion 520 closes against the coaptation element 510, and any self-tissue (e.g., valve leaflets, not shown) captured between the coaptation element 510 and the paddle portion 520 is pinched to secure the device 500 to the self-tissue.

[0129] Clasp 530 may include an attachment or fixation portion 532 hingedly connected to an arm or movable portion 534 by a hinge portion 538. Movable portion 534 may include barbs or fixation means 536 that can pierce the native leaflet to further secure the native leaflet captured between fixed portion 532 and movable portion 534 of clasp 530. Attachment or fixation portion 532 may be coupled or connected to paddle portion 520 of anchor 508 in a variety of ways, such as by sutures, adhesives, fasteners, welding, stitching, swaging, friction fit, and / or other coupling means.

[0130] The movable portion 534 can articulate, pivot, and / or flex relative to the fixed portion 532 between an open configuration (e.g., the device 200 shown in FIGS. 30-37) and a closed configuration ( FIGS. 72-73). In some implementations, the clasp 530 can be biased toward the closed configuration. In the open configuration, the fixed portion 532 and the movable portion 534 articulate, pivot, and / or flex away from each other so that the native valve leaflets (see, e.g., FIGS. 38-49) can be positioned between the fixed portion 532 and the movable portion 534. In the closed configuration, the fixed portion 532 and the movable portion 534 articulate, pivot, and / or flex toward each other, thereby clamping the native valve leaflets between the fixed portion 532 and the movable portion 534 (e.g., FIG. 47). The clasp 530 can be spring-loaded so that in the closed position, the clasp 530 continues to provide a clamping force to the grasped native valve leaflets. This clamping force remains constant regardless of the position of the paddle portion 520.

[0131] Tension can be applied to the actuation line 516 connected to the clasp 530 to retract or retract the movable portion 534 of the clasp 530 in a retracting or proximal direction while the paddle portion 520 remains open as described above. The clasp 530 is opened against the biasing force of the hinge portion 538 described above. Once the clasp 530 is opened, the device 500 is moved in a capturing direction by retracting the pusher tube or rod 513 into the catheter 502 and / or moving the catheter 502 to position the valve leaflets 20, 22 between the fixed portion 532 and the movable portion 534 of the open clasp 530. Once the device 500 is in a position to capture the valve leaflets 20, 22, tension in the actuation line 516 is released, thereby allowing the actuation line 516 to move in the release direction, causing the spring-loaded hinge portion 538 to close the clasp 530 as described above, capturing and clamping the valve leaflets 20, 22 between the fixed portion 532 and the movable portion 534 of the clasp 530.

[0132] 72-86, an implantable device or implant 500 is shown with a portion of the device 500 covered by a first cover portion 540 and a second cover portion 550. The first cover portion 540 provides for native cardiac tissue ingrowth and improves the connection between the native cardiac tissue and the device 500, while the second cover portion 550 provides a more lubricious or slippery surface, improving maneuverability of the device 500 during the implantation procedure. That is, the second cover portion 550 provides the device 500 with a surface having a lower coefficient of friction than the first cover portion 540, so that the device 500 can more easily move against and / or over native cardiac structures, such as chordae tendineae. The second cover portion 550 may also be made from a material that promotes tissue ingrowth and provides a low-friction surface, for example, depending on the thickness of the material and the size of the openings.

[0133] The first cover portion 540 is formed from a flexible material that promotes tissue ingrowth over time to further secure the implantable device / implant 500 between the native valve leaflets. The first cover portion 540 may be formed from a fabric, cloth, or any other flexible material suitable for implantation in the human body.

[0134] 72-75, 77-79, 81, 83, and 85, first cover portion 540 is formed around coaptation element 510 and paddle portion 520. First cover portion 540 may also extend to cover portions of clasps 530. Thus, when a native leaflet is captured by device 500, the area of ​​the leaflet in contact with first cover portion 540 can grow into the material of first cover portion 540 to enhance the grip of anchor 508 on the leaflet.

[0135] The second cover portion 550 may be part of the first cover portion 540 formed with surface features that provide a lower coefficient of friction, or may be formed from a different, low-friction material that is bonded to the first cover portion 550 with stitching or by overlapping the piece of material that forms the second cover portion 550 over the first cover portion 540. The first cover portion 540 and the second cover portion 550 may be joined in any suitable manner, such as, for example, sewing, adhesive, a coating, a thermally bonded layer, etc.

[0136] The first cover portion 540 and the second cover portion 550 can take a wide variety of different forms. In some implementations, the second, lower coefficient of friction portion can be provided in a portion of the device 500 that is likely to engage with the heart's own internal structures during advancement, positioning, and / or implantation of the device within the heart. The second, lower coefficient of friction portion can be included in an anchor portion, such as the illustrated paddles and / or clasps. In some implementations, the anchor portion can take other forms that may or may not include paddles and clasps. The second, lower coefficient of friction portion can be included in an interface portion of the device. In some implementations, the second, lower coefficient of friction portion is not included in an interface portion, or the device does not include an interface portion.

[0137] The second cover portion 550 can cover some or all of the edge of the paddle portion 520, as shown in Figures 73-86. For example, the second cover portion 550 illustrated in Figures 79-80 covers all of the edge portion, while the second cover portion 550 does not cover the end of the paddle portion 520 in Figures 81-82. Providing increased friction areas at the end of the paddle portion 520 promotes increased friction or gripping force against the native leaflets during capture, while maintaining lower friction areas on the sides of the paddle portion 520 helps avoid entanglement with the chordae tendineae during implantation. Also, note that the second cover portion 550 shown in Figures 79-80 provides surface features that change orientation with respect to the leaflets as they move along the edge of the paddle portion 520, with raised portions oriented along the edge on the sides of the paddle portion 520 and across the edge on the end portion of the paddle portion 520. The arrangement shown in Figures 81-82 provides surface features that more closely align with the edge contour to allow leaflets and other tissue to slide past the paddle portion 520 except when in the ready-to-capture position.

[0138] In some implementations, the second cover portion 550 illustrated by Figures 73-86 can extend to cover some or all of the outer surface or outer portion of the paddle portion 520. For example, the second cover portion 550 can extend to cover all of the first cover portion 540 shown in Figure 80. Figures 83-86 show exemplary implementations similar to the configurations of Figures 79-82 in which the proximal side of the paddle has the first cover portion 540 and the distal side of the paddle has the second cover portion 550. Figures 85-86 are similar to the configurations of Figures 81-82 in which the second cover portion 550 does not extend to cover the end of the upper paddle portion 520 of the device 500.

[0139] Second cover portion 550 can take a variety of forms to create a lower coefficient of friction between device 500 and the native tissue within the heart. Second cover portion 550 may be formed from the same material as first cover portion 540, but with a different treatment, and / or may be oriented differently to create a lower coefficient of friction between second cover portion 550 and the native tissue than between first cover portion 540 and the native tissue.

[0140] In some implementations, the second cover portion 550 includes surface features that reduce friction between the device 500 and the native heart tissue. For example, the second cover portion 550 may be formed with elongated ridges oriented in the direction of movement (see, e.g., FIG. 89 ), thereby reducing friction with the native tissue and reducing the likelihood that portions of the device 500 will become trapped on or otherwise obstructed by the native tissue. The elongated ridges may be formed during or after the formation of the second cover portion 550. In some implementations, the ridges are formed as a result of the second cover portion 550 being knitted from strands of material. For example, a knit stitch may be used to form the second cover portion 550 in which the wales of the knit material are longitudinally oriented.

[0141] For example, the second cover portion 550 may be formed by knitting or weaving the same strands of material used to form the first cover portion 540, but with a different knit or weave pattern or orientation to provide the second cover portion 550 with different surface properties than the first cover portion 540. In some implementations, the first cover portion 540 may have wales of knit material or longitudinal strands of woven material oriented circumferentially, and the second cover portion 550 may have wales or longitudinal strands oriented orthogonal to the wales or longitudinal strands of the first cover portion 540, i.e., oriented longitudinally or along the direction of movement of the device 500 during implantation. Exemplary cover materials and their interaction with native cardiac tissue are discussed in more detail below.

[0142] 87-92, abstract representations of implantable devices having circumferentially or laterally oriented covers with longitudinally oriented surface features are shown to interact with chordae tendineae CT. As used herein, the orientation terms "circumferential" or "lateral" refer to directions generally or substantially across the width of exemplary implantable devices described herein, such as device 500 of FIG. 73 or FIG. 77, when these devices are viewed from the front or side. Additionally, the "circumferential" or "lateral" orientation may be perpendicular or oblique to the direction of movement of the device.

[0143] FIG. 87 is a side view of a portion of a cover 610 on a portion of an implantable device or implant 600, which may be any of the valve repair devices shown and described herein or any other known valve repair device. The device 600 is positioned between two chordae tendineae CT. In FIG. 87, the device 600 can be moved in the direction indicated by the double arrow 601, with the chordae tendineae extending into or out of the page. FIGS. 88 and 89 are cross-sectional views taken along the planes indicated by lines 88-88 and 89-89 in FIG. 87, respectively. Thus, the view shown in FIG. 88 is a cross-sectional view of the device 600 through one of the raised portions 612 of the cover material, and FIG. 89 is a cross-sectional view of the device 600 through one of the valley portions 614 of the cover material. In FIGS. 88 and 89, the direction of movement 601 of the device 600 is in or out of the plane of the page, such that the device 600 moves in a direction 601 perpendicular to the length of the chordae tendineae CT.

[0144] The device 600 includes a device body 602 covered by a cover 610. The cover 610 includes raised portions 612 having larger outer diameters spaced apart by valley portions 614 having smaller outer diameters. One of the chordae CT contacts the raised portion 612 at a first contact area 620, while the other chordae CT is disposed within the valley portion 614 and overlaps the adjacent raised portion 612 at a second contact area 622. As the device 600 moves relative to the chordae CT, the first contact area 620 tends to increase in size because the raised portion 612 is oriented in the same direction as the chordae CT and the pressure exerted by the raised portion 612 against the chordae CT tends to wrap the chordae around the raised portion 612. Further movement can cause the chordae CT to move into one of the valley portions 614 and overlap the raised portion 612, as shown at the second contact area 622. It has been found that in some circumstances, chordae CT with lower tension are more likely to become trapped within the valley portion 614. As the chordae CT move into the valley portion 614, the force required to move the device 600 increases significantly because the chordae CT are trapped in one place on the adjacent ridge portion 612. In this manner, both the first and second contact regions 620, 622 provide increased friction between the chordae CT and the device 600.

[0145] Referring now to FIG. 90, there is shown a cross-sectional view of a portion of a cover 710 on a portion of an implantable device 700, which may be any of the valve repair devices shown and described herein or any other known valve repair device. The device 700 is positioned between two chordae tendineae CT. In FIG. 90, the device 700 can be moved in the direction indicated by the double arrow 701, with the chordae tendineae extending into or out of the plane of the page. FIG. 91 is a cross-sectional view taken along the plane indicated by line 91-91 in FIG. 90. In FIG. 91, the device 700 is positioned between two chordae tendineae CT such that the direction of movement 601 of the device 700 is either in or out of the plane of the page. In this manner, the device 700 is moved in a direction 701 perpendicular to the length of the chordae tendineae CT.

[0146] The device 700 includes a device body 702 covered by a cover 710. The cover 710 includes raised portions 712 with larger outer diameters spaced apart by valley portions 714 with smaller outer diameters. The chordae CT contact the raised portions 712 at contact areas 720. As the device 700 moves relative to the chordae CT, the contact areas 720 tend to maintain a substantially constant size because the raised portions 712 are oriented perpendicular to the length of the chordae CT and the pressure applied by the raised portions 712 against the chordae CT causes the chordae CT to contact adjacent raised portions 712 but does not move into the valley portions 714 or change the size of the contact areas 720 with each raised portion 712. Further movement allows the chordae CT to slide along the raised portions 712 so that the force required to move the device 700 remains stable. In this manner, friction between the chordae CT and the device 700 is reduced.

[0147] The cover 710 of the device 700 can also be inverted, as shown in FIG. 92, so that the ridges 712 and valleys 714 face inward and the underside of the cover 710 faces outward. In this configuration, the thickness of the material of the cover 710 remains the same, but a smooth exterior is presented. This allows for the same tissue ingrowth capabilities and can alter the frictional performance of the cover 710. Notably, when the cover 710 is inverted, friction is significantly reduced because the ridges 612 and valleys 614 are no longer exposed to the chordae tendineae CT.

[0148] In some implementations, cover material 610 shown in Figures 87-89 can be used for first cover portion 540 of the embodiment shown in Figures 72-86, and cover material 710 shown in Figures 90-92 can be used for second cover portion 550 of the embodiment shown in Figures 72-86. In some implementations, cover materials 610 and 710 are the same material oriented differently. For example, cover material 710 can be the same as cover material 610, but rotated 90 degrees.

[0149] 93-100, exemplary materials and data illustrating the friction of various materials are shown. These materials, such as the knitted materials shown in FIGS. 93-96 and the woven materials shown in FIGS. 99-100, can be used to coat any of the devices disclosed herein. Similar surface features shown for the knitted and woven materials can also be formed by molding or otherwise forming grooves in the outer surface of the outer layer or coating of an exemplary cover for an implantable device / implant (e.g., the coating described above with respect to device 400).

[0150] Referring now to Figures 93-96, examples of knitted covers for implantable devices / implants are shown. Knitted materials can be formed from one or more threads or strands of material that are sewn together by forming a series of loops. The threads or strands of material follow a serpentine path, or course, through the material as the stitch loops are formed. A series of stitches that hang from one another is called a wale. For weft knitted materials, the courses are perpendicular to the wales, and courses are created by adding stitches to each wale until the knitted material reaches the desired size.

[0151] 93-94, first knit cover 800 is shown with an outward-facing first side 810 in FIG. 93 and an outward-facing second side 820 in FIG. 94. That is, cover 800 of FIG. 93 is inverted to produce cover 800 of FIG. 94. Courses 802 of first knit cover 800 are circumferentially oriented such that courses 802 encase the tubular shape of first knit cover 800. Wales 804 of first knit cover 800 are longitudinally oriented such that wales 804 extend along the tubular length of first knit cover 800. Circumferentially oriented ridges 812 spaced apart by circumferentially oriented valleys 814 are formed on first side 810 of first knit cover 800 by courses 802. Longitudinally oriented raised portions 822 spaced apart by longitudinally oriented valley portions 824 are formed on the second surface 820 of the first knit cover 800 by the wales 804. The raised portions 822 formed by the wales 804 protrude beyond the raised portions 812 formed by the courses 802 such that the valley portions 824 on the second surface 820 are deeper than the valley portions 814 on the first surface 810.

[0152] 95-96, a second knit cover 900 is shown with a first side 910 facing outward in FIG. 95 and a second side 920 facing outward in FIG. 96. That is, the cover 900 of FIG. 95 is turned inside out to produce the cover 900 of FIG. 96. The second knit cover 900 is knitted in a manner similar to the first knit cover 800, but the knit pattern is rotated 90 degrees so that the surface features of the second knit cover 900 are orthogonal to the surface features of the first knit cover 800. For example, the courses 902 of the second knit cover 900 are oriented longitudinally such that the courses 902 extend along the length of the tubular shape of the second knit cover 900. The wales 904 of the second knit cover 900 are oriented circumferentially such that the wales 904 encase the tubular shape of the second knit cover 900. Longitudinally oriented raised portions 912 spaced apart by longitudinally oriented valley portions 914 are formed on the first surface 910 of the second knit cover 900 by the courses 902. Circumferentially oriented raised portions 922 spaced apart by circumferentially oriented valley portions 924 are formed on the second surface 920 of the second knit cover 900 by the wales 904. The raised portions 922 formed by the wales 904 protrude beyond the raised portions 912 formed by the courses 902 such that the valley portions 924 on the second surface 920 are deeper than the valley portions 914 on the first surface 910.

[0153] 97-98 are graphs of data showing the different forces required to displace probes with different covers along a tissue sample. In these examples, probes covered with first and second knit covers 800, 900 having outwardly facing first and second surfaces 810, 910 and 820, 920 for engaging the tissue sample were tested.

[0154] Data comparing first surfaces 810, 910 is shown in Figure 95. The force data for first surfaces 810, 910 is plotted as data series 811, 911, respectively. Comparing data series 811, 911 shows that first surface 910 of second knit cover 900 requires less force to move while engaging with the self-tissue, and therefore has a lower coefficient of friction than first surface 810 of first knit cover 800.

[0155] As seen in FIG. 97 , the force data 811 rises to a first peak, then rises again to successive smaller peaks, while the force data 911 remains generally lower. The large peak in the force data 811 may be due to the self-tissue engaging and becoming trapped in the valley portion 814 relative to one of the raised portions 812. The trapped raised portion 812 may then move with the self-tissue, colliding with successive raised portions 812 and bunching the material of the first knitted cover 800, creating a larger obstacle for the self-tissue to overcome. At some point, the tension in the self-tissue causes it to stretch around the bunched raised portion 812, thereby quickly relieving the force experienced by the probe, as shown by a large peak followed by a sudden drop in the force data 811. Similar sticking and slippage may be observed during implantation of a device covered with a fabric material. The later smaller peak in the data 811 may again be caused by the self-tissue becoming trapped on one or more raised portions 812. The force data 911 recorded against the first surface 910 of the second knit cover 900 does not exhibit as many large peaks as the force data 811. When comparing data sets, the frictional forces of a particular cover material can be compared based on steady-state values, i.e., the small peaks and valleys in the data, rather than the large peaks that may result from bunching.

[0156] The data in Figure 98 illustrates a similar scenario to that in Figure 97. That is, a comparison of force data 821 from first knitted cover 800 and force data 921 from second knitted cover 900 indicates that less force is required to displace longitudinally oriented surface features, i.e., the surface having raised portions 822 of first knitted cover 800, than a surface having circumferentially oriented features, i.e., the raised portions 922 of second knitted cover 900. The reduced friction of longitudinally oriented raised portions 822, 912 results from a reduced contact area between the raised portions 822, 912 and the autogenous tissue, and because the autogenous tissue cannot be trapped in valley portions 824, 914 that are oriented diagonally or perpendicular to the autogenous tissue.

[0157] Comparing the two data sets for surfaces with longitudinally oriented features, i.e., the second surface 820 of the first knit cover 800 and the first surface 910 of the second knit cover 900, further reveals that the raised portions 822 formed by the wales 804 of the first knit cover 800 provide a lower friction surface than the raised portions 912 formed by the courses 902 of the second knit cover 900. As can be seen in FIG. 96 , the wales 904 (and similarly the wales 804 of the first knit cover 800) form larger raised portions 822, 922, resulting in deeper valley portions 824, 924 than the raised portions 812, 912 and valley portions 814, 914 formed by the courses 802, 902. There are also fewer wales 804 than courses 902, resulting in a smaller total contact patch between the self-organization and the raised portions 822 than between the self-organization and the raised portions 912.

[0158] Referring now to Figures 99-100, the first and second woven covers 1000, 1100 are shown with their first faces 1010, 1110 oriented outward. The second faces of the first and second woven covers 1000, 1100 are not shown and have the same appearance as Figures 99-100, respectively. Woven materials can be formed by weaving one or more weft yarns or strands of material in and out of multiple warp yarns or strands. The weft strands follow a somewhat straight path that is perpendicular to the warp strands. The relatively straight paths of the weft and warp strands, as opposed to the tortuous paths of the strands in knitted materials, result in less stretch than knitted materials. Woven materials can be stronger than knitted materials and also tend to have smaller openings in the material because the warp and weft strands are more densely packed than the courses and wales of knitted materials. The first and second woven fabric covers 1000, 1100 may be formed of any suitable material, such as, for example, polyethylene terephthalate (PET).

[0159] 99, the first woven cover 1000 is shown with the first side 1010 oriented outward. The second side of the first woven cover 1000 is not shown but has a similar appearance to the first side 1010. The warp strands 1002 of the first woven cover 1000 are oriented circumferentially such that the warp strands 1002 are wrapped around the tubular shape of the first woven cover 1000. The weft strands 1004 of the first woven cover 1000 are oriented longitudinally such that the weft strands 1004 extend along the length of the tubular shape of the first woven cover 1000. Circumferentially oriented ridges 1012 spaced apart by circumferentially oriented valleys 1014 are formed on the first side 1010 of the first knit cover 1000 by the warp strands 1002. Note that the raised portions 1012 and the valley portions 1014 are smaller in height and width than the raised portions 812 and the valley portions 814 of the first knit cover 800, for example.

[0160] Referring now to FIG. 100, the second woven fabric cover 1100 is shown with the first side 1110 oriented outward. The second side of the second woven fabric cover 1100 is not shown but has a similar appearance to the first side 1110. The warp strands 1102 of the second woven fabric cover 1100 are longitudinally oriented such that the warp strands 1102 extend along the length of the tubular shape of the second woven fabric cover 1100. The weft strands 1104 of the second woven fabric cover 1100 are circumferentially oriented such that the weft strands 1104 are wrapped around the tubular shape of the second woven fabric cover 1100. Longitudinally oriented ridges 1112 spaced apart by longitudinally oriented valleys 1114 are formed on the first side 1110 of the second knitted fabric cover 1100 by the warp strands 1102. Note that the raised portions 1112 and the valley portions 1114 are smaller in height and width than the raised portions 812 and the valley portions 814 of the first knit cover 800, for example.

[0161] Referring now to FIGS. 101-102, data are shown illustrating the force required to displace a probe covered by first and second woven fabric covers 1000, 1100 having a first surface 1010, 1110 and a second surface (not shown) facing outward for engaging a tissue sample. Data comparing the first surfaces 1010, 1110 are shown in FIG. 101. The force data for the first surfaces 1010, 1110 are plotted as data series 1011, 1111, respectively. Comparing the data series 1011, 1111 indicates that the first surface 1110 of the second knitted cover 1100 requires less force to move while engaging with the tissue and therefore has a lower coefficient of friction than the first surface 1010 of the first knitted cover 1000. Data for the second surfaces (not shown) of the first and second woven fabric covers 1000, 1100 are shown in data series 1021, 1121 of FIG. 102.

[0162] Data from testing of the first and second woven covers 1000, 1100, as well as the first and second knit covers 800, 900, indicate that longitudinally oriented surface features reduce friction with the self-tissue. The data also indicate that the self-tissue tends to become trapped in circumferentially oriented surface features, such as the longitudinal strands 1002, sharply increasing the force required to pass through the self-tissue.

[0163] Comparing the knitted covers 800, 900 to the woven covers 1000, 1100, it can also be seen that the orientation of the material forming the knitted covers 800, 900 has a more pronounced effect on the friction between the cover material and the self-organizing tissue. In other words, the woven covers 1000, 1100 are less sensitive to changes in orientation. This is likely due to the smaller overall surface features of the woven covers 1000, 1100. Therefore, an advantage of woven materials such as the woven covers 1000, 1100 is that the orientation of the fabric does not need to be strictly controlled during manufacturing. Knitted materials, such as those used to make the knitted covers 800, 900, are more stretchable than woven materials due to the tortuous path of the yarns or strands used to form the knitted materials. Therefore, an advantage of knitted materials, such as those used to make the knitted covers 800, 900, is that the resulting cover can more easily conform to different shapes, flexing and stretching as the underlying device moves and changes size, shape, or position.

[0164] 103-107 show an example of a valve repair system for repairing a patient's native valve. The valve repair system may include a delivery device 11010 (FIGS. 106-107) and an implantable valve repair device 11000. Referring to FIGS. 103-105, the implantable device 11000 includes a proximal or attachment portion 11050, a paddle frame 11240, and a distal portion 11070. The proximal portion 11050, the distal portion 11070, and the paddle frame 11240 can be configured in a variety of ways.

[0165] 103, the paddle frame 11240 may be symmetrical along the longitudinal axis YY. However, in some implementations, the paddle frame 11240 is not symmetrical about the axis YY. Further, referring to FIG. 103, the paddle frame 11240 may include an outer frame portion 11560 and an inner frame portion 11600.

[0166] In the illustrated implementation, the outer frame portion 11560 is flexibly attached to the outer end portion of a w-shaped connector 11660 (e.g., a molded metal part, molded plastic part, tether, wire, strut, line, cord, suture, etc.). Between the connector 11660 and the proximal portion 11050, the outer frame portion 11560 forms a curved shape. For example, in the illustrated embodiment, the shape of the outer frame portion 11560 resembles an apple, with the outer frame portion 11560 being wider toward the proximal portion 11050 and narrower toward the distal portion 11070. However, in some implementations, the outer frame portion 11560 may be shaped in other ways.

[0167] The inner frame portion 11600 extends from the proximal portion 11050 toward the distal portion 11070. The inner frame portion 11600 then extends inward to form a retaining portion 11720 that is attached to the actuation cap 11140. The retaining portion 11720 and the actuation cap 11140 can be configured to attach in any suitable manner.

[0168] In some implementations, the inner frame portion 11600 is a rigid frame portion and the outer frame portion 11560 is a flexible frame portion. As shown in FIG. 103 , the proximal end of the outer frame portion 11560 connects to the proximal end of the inner frame portion 11600.

[0169] The width adjustment element 11110 is configured to move the outer frame portion 11560 from the expanded position to the narrow position by pulling the inner end 11680 of the connector 11660 ( FIGS. 105 and 107 ) proximally relative to the actuation cap 11140. In some implementations, when the outer frame portion 11560 is moved to the narrow position, a portion of the connector 11660 moves through the actuation cap 11140 and into the receiver 11120 (e.g., an internally threaded element, a notched receiving portion, a column, a lumen, a tube, a shaft, a post, etc.). The actuation element 11020 can be configured to engage the receiver 11120 and / or the cap 11140 to move the inner paddle frame portion 11600 to open or close the paddle.

[0170] As shown in FIGS. 104 and 105 , the connector 11660 has an inner end 11680 that engages with the width adjustment element 11110, allowing a user to move the inner end 11680 relatively within the receiver 11120 to move the outer frame portion 11560 between a narrow position and an expanded position. In the illustrated embodiment, the inner end 11680 of the connector 11660 includes a post 11700 that attaches to the outer frame portion 11560 and a coupler 11130 extending from the post 11700. The coupler 11130 is configured to attach to and detach from both the width adjustment element 11110 and the receiver 11120. When the coupler 11130 is attached to the width adjustment element 11110, the coupler 11130 disengages from the receiver 11120. When the coupler 11130 is detached from the width adjustment element 11110, the coupler is secured to the receiver 11120. However, the inner end 11680 of the connector 11660 can be configured in a variety of ways. Any configuration can be used that properly attaches the connector 11660 to the coupler and enables the width adjustment element 11110 to move the outer frame portion 11560 between the narrow and expanded positions.

[0171] The width adjustment element 11110 allows a user to expand or contract the outer frame portion 11560 of the implantable device 11000. In the example shown in FIGS. 104 and 105 , the width adjustment element 11110 includes an externally threaded end that threads into a coupler 11130. The width adjustment element 11110 moves the coupler within the receiver 11120 to adjust the width of the outer frame portion 11560. When the width adjustment element 11110 is unscrewed from the coupler 11130, the coupler 11130 engages the inner surface of the receiver 11120 to set the width of the outer frame portion 11560.

[0172] In some implementations, the receiver 11120 can be integrally formed with the cap 11140. Moving the cap 11140 relative to the interface element connected to the mounting portion 11050 opens and closes the paddle. In the example shown, the receiver 11120 slides within the interface element. When the coupler 11130 is removed from the width adjustment element 11110, the width of the outer frame portion 11560 is fixed and the actuation element 11020 moves the receiver 11120 and cap 11140 relative to the interface element. Moving the cap 11140 can open and close the device in the same manner as other implementations disclosed above.

[0173] In the illustrated embodiment, the driver head 11160 is disposed at the proximal end of the actuation element 11020. The driver head 11160 releasably couples the opening / closing actuation element 11020 to the receiver 11120. In the illustrated embodiment, the width adjustment element 11110 extends through the receiver 11120. The receiver 11120 advances axially in a direction opposite to direction Y to move the cap 11140. As shown by the arrows in FIG. 104 , movement of the cap 11140 relative to the mounting portion 11050 is effective to open and close the paddle. That is, movement of the cap 11140 in the Y direction closes the device, and movement of the cap in a direction opposite to the Y direction opens the device.

[0174] 104 and 105 , the width adjustment element 11110 extends through the actuation element 11020, the driver head 11160, and the receiver 11120 and engages with a coupler 11130 attached to the inner end 11680 of the connector 11660. Moving the outer frame portion 11560 to the narrow position can allow the device or implant 11000 to be more easily manipulated into position for implantation into the heart by reducing contact and / or friction between the heart's native structures (e.g., chordae tendineae) and the device 11000. Moving the outer frame portion 11560 to the expanded position provides a larger surface area for the anchor portions of the device or implant 11000 to engage and capture the leaflets of the native heart valve.

[0175] 106 and 107 show an implementation of an implant catheter assembly 11010 in which the clasp actuation line 11510 extends through the handle 11530, the actuation element 11020 is coupled to the paddle actuation control 11260, and the width adjustment element 11110 is coupled to the paddle width control 11280. A proximal end portion 11550 of the shaft or catheter of the catheter assembly 11010 may be coupled to the handle 11530, and a distal end portion 11570 of the shaft or catheter may be coupled to the implantable device 11000. The actuation element 11020 may extend distally from the paddle actuation control 11260, through the handle 11530, through the delivery shaft or catheter of the delivery device 11010, and through the proximal end of the device 11000 where it couples with the driver head 11160. The actuation element 11020 is axially movable relative to the outer shaft of the catheter assembly 11010 and the handle 11530 to open and close the device.

[0176] The width adjustment element 11110 can extend distally from the paddle width control 11280, through the paddle actuation control 11260, through the actuation element 11020 (and thus through the handle 11530, the outer shaft of the implant catheter assembly 11010, and the device 11000), where it couples with a movable coupler 11130. The width adjustment element 11110 is axially movable relative to the actuation element 11020, the outer shaft of the catheter assembly 11010, and the handle 11530. The clasp actuation line 11510 extends through and can be axially movable relative to the handle 11530 and the outer shaft of the catheter assembly 11010. The clasp actuation line 11510 can also be axially movable relative to the actuation element 11020.

[0177] 106 and 107, the width adjustment element 11110 can be removably coupled to the coupler 11130 of the device 11000. Advancing and retracting the width adjustment element 11110 with the control 11280 increases or decreases the width of the paddle. Advancing and retracting the actuation element 11020 with the control 11260 opens and closes the paddle of the device.

[0178] 106 and 107, the catheter or shaft of the implant catheter assembly 11010 is an elongate shaft extending axially between a proximal end portion 11550 coupled to the handle 11530 and a distal end portion 11570 coupled to the device 11000. The outer shaft of the catheter assembly 11010 may also include an intermediate portion 11590 disposed between the proximal end portion 11550 and the distal end portion 11570.

[0179] 108-119, an exemplary sleeve 12010 (FIG. 108) and cover assembly 12030 (FIGS. 109-117) are shown for attachment to an exemplary implantable device 12000. The sleeve 12010 and / or cover assembly 12030 may be used with any suitable type of implantable device, such as, for example, the device or implant 100 shown in FIGS. 8-15, the implantable device 11000 shown in FIGS. 103-108, the devices / implants described in detail in PCT Patent Application Publications WO2018 / 195215, WO2020 / 076898, and WO2019 / 139904 (which are incorporated by reference in their entireties for all purposes), or any combination thereof. The implantable device 12000 may include any other features of an implantable device or implant discussed in this application or the applications listed above, and the device 12000 may be positioned to engage valve tissue as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the applications listed above).

[0180] In the illustrated implementation, with reference to Figures 109-112 and 116-118, an implantable device 12000 includes a proximal or attachment portion 12050, a joint portion 12040 having a joint element 12100, an anchor portion 12060, and a distal portion 12070. The proximal portion 12050, the joint portion 12040, the anchor portion 12060, and the distal portion 12070 can be configured in a variety of ways, such as, for example, any of the ways described in this application or the above-cited applications.

[0181] The device or implant 12000 is deployed from a delivery system 12020 (FIG. 116) or other delivery means. The delivery system 12020 may include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, an actuating element, combinations thereof, etc. The delivery system 12020 may be configured in a variety of ways, such as, for example, any of the ways described in this or the above-mentioned applications.

[0182] In some implementations, the coaptation portion 12040 of the device or implant 12000 includes a coaptation element 12100 (e.g., a spacer, plug, filter, foam, sheet, membrane, coaption element, etc.) adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and slidably attached to an actuation element (e.g., actuation wire, actuation shaft, actuation tube, etc.) of the delivery system 12020. The coaptation element 12100 can be configured in a variety of ways, such as, for example, any of the ways described in this or the above-mentioned applications.

[0183] The anchor portion 12060 can include one or more anchors 12080 actuable between an open position and a closed position. The anchors 12080 can take a variety of forms, such as, for example, any of the methods described in this or the above-referenced applications. In the illustrated implementation, each of the anchors 12080 includes an inner paddle 12220, an outer paddle 12200, and a gripping element or clasp 12300. The anchors 12080 can also include a paddle frame 12240. The paddle frame 12240 can be configured in a variety of ways, such as, for example, the paddle frame 11240 configuration shown in FIGS. 103-107 or any of the other methods described in this or the above-referenced applications. In the illustrated implementation, the paddle frame 12240 includes an outer frame portion 12560 and an inner frame portion 12600.

[0184] Actuation of the actuating element (FIG. 106) opens and closes the anchor portion 12060 of the device 12000 to grip the leaflets of the native valve during implantation. The actuating element can take a variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), be made from a variety of different materials, and have a variety of configurations. In certain implementations, the actuating element can take the form of the actuating element 11020 shown in FIGS. 103-107.

[0185] 108, the sleeve 12010 may be a cylindrical tube having a first end 12310, a second end 12330, and a lumen 12350 extending therebetween. In certain implementations, one or more sleeves 12010 are disposed over portions of the paddle frame 12240. For example, with reference to FIG. 111, a sleeve 12010 may be disposed over each of the struts or elongated wire-like portions of both the inner frame portion 12600 and the outer frame portion 12560 of the paddle frame 12240 for each of the anchors 12080 (the paddle frame 12240 may be the same or substantially the same as the paddle frame 11240, with the inner frame portion 11600 and the outer frame portion 11560 uncovered; see also FIG. 103). As a result, there are four sleeves on each side of the illustrated device (i.e., one sleeve on each of the two struts or elongated wire-like portions of the inner frame portion 12600, and one sleeve on each of the two struts or elongated wire-like portions of the outer frame portion 12560). With a paddle frame 12240 on each side of the device, there are a total of eight sleeves in the illustrated embodiment.

[0186] However, the sleeve 12010 may be disposed on any portion of the paddle frame 12240. With reference to FIG. 108 , while the illustrated implementation shows the sleeve 12010 as a cylindrical tube, it should be understood that the sleeve 12010 may take any suitable form that at least partially covers or surrounds a member of the paddle frame 12240. The sleeve 12010 may be made from any suitable material, such as, for example, polyethylene. In certain implementations, the sleeve 12010 may be made from braided polyethylene terephthalate (PET) with a spin finish. In some implementations, the sleeve 12010 is made from a material that promotes tissue ingrowth and / or provides reduced friction benefits of any of the embodiments disclosed herein. The sleeve 12010 may be stretchable such that compressing the sleeve 12010 increases the diameter of the lumen and stretching the sleeve 12010 decreases the diameter of the lumen.

[0187] In certain implementations, the sleeve 12010 can allow a cover (e.g., a portion of the cover assembly 12030 described herein) to easily attach to the device 12000 and / or provide low-friction device edges to allow easy passage through cardiac structures such as chordae tendineae. The cover can be attached to the sleeve 12010 by one or more connectors (e.g., stitches, adhesives, mechanical fasteners, ultrasonic welding, etc.). The sleeve 12010 can prevent or inhibit protrusions extending from the one or more connectors from extending past the outer surface of the device. For example, stitches can extend into the sleeve 12010 rather than around a portion of the paddle frame 12240. The sleeve 12010 can be made from a material strong enough to receive and retain connectors, such as stitches, to connect the cover to the sleeve 12010.

[0188] In some implementations, the sleeve 12010 may be lubricious to reduce friction between the heart's natural structures, such as the chordae tendineae, and the edges of the sleeve-covered device 11000, thereby allowing the device 12000 to be more easily manipulated into position for implantation into the heart. For example, in implementations in which the sleeve 12010 is made of braided PET with a spin finish, the spin finish acts as a lubricant. In some implementations, the sleeve 12010 may be coated with a lubricious substance. In certain implementations, the sleeve 12010 may be made of an inherently lubricious material. The sleeve 12010 may have a lower coefficient of friction than other components of the device 12000. For example, the sleeve 12010 may have a lower coefficient of friction than the paddle frame, the cover of the cover assembly 12030, and / or any other component of the device 12000. Any of the friction-reducing features of any implementation disclosed herein may be applied to the sleeve.

[0189] 109-117, the device 12010 may include a cover assembly 12030 having one or more covers for attachment to various components of the device. The covers of the cover assembly 12030 may be configured to act as a barrier to prevent or inhibit the movement of blood through the native valve, to assist in leaflet coaptation by providing further engagement with the valve leaflets, and / or to promote tissue ingrowth. Each cover may include a sheet, material, fabric, layer, and / or membrane attached to one or more components of the device 12000 by one or more connectors (e.g., stitches, adhesives, mechanical fasteners, ultrasonic welding, etc.). The sheet, material, fabric, layer, and / or membrane may be made from any suitable material, such as, for example, polyethylene. For example, the sheet, material, fabric, layer, and / or membrane may be made from a fine-mesh polyethylene cloth, knitted PET, woven PET, or any other suitable type of polyethylene material. In some implementations, the sheets, materials, fabrics, layers, and / or membranes can be made from flexible materials, porous or non-porous materials, and / or materials that are impermeable to (or that inhibit or hinder) blood flow. In some implementations, the sheets, materials, fabrics, layers, and / or membranes are made from or include biocompatible materials, such as woven biocompatible fabrics configured to promote tissue ingrowth.

[0190] In the illustrated implementation, the cover assembly 12030 includes a first cover 12400 for attaching to the paddle frame 12240, a second cover 12420 for attaching to the inner paddle 12220, and a third cover 12440 for attaching to the interface element 12100 and clasp 12300. Referring to FIGS. 113-115 , these portions of the cover assembly 12030 are shown cut from a flat sheet of material. Each of the covers 12400, 12420, 12440 includes differently shaped segments or portions for attachment to different portions of the device 12000. The covers 12400, 12420, 12440 can be shaped to smooth the transitions between portions of the device 12000, reducing catch points and providing a smoother exterior to the device.

[0191] 113, the second cover 12420 is configured to be disposed over the inner paddle 11220 (see FIGS. 109 and 110 where the inner paddle 12220 is covered, and FIG. 103 where the inner paddle 11220 is uncovered). The second cover 12420 may have a first portion 12410 and a second portion 12430. The first portion 12410 may be configured to be disposed over the inner paddle 12220 proximate a central portion of the device 12000 (e.g., proximate the interface element 12100—see also the exposed interface element 11100 in FIG. 103), and the second portion 12430 may be configured to be disposed over a portion of the inner paddle 12220 that extends furthest from the central portion of the device 12000 when the anchor 12080 is in the open position. In certain implementations, the second cover 12420 is attached to the inner paddle 12220 by placing the cover 12420 on a top or proximal surface of the inner paddle 12220, wrapping the side edges 12450, 12470 of both the first portion 12410 and the second portion 12430 around the inner paddle, and attaching the cover 12420 to the inner paddle with one or more connectors. In the illustrated implementation, the cover 12420 includes an end portion 12490 configured to attach to another cover of the cover assembly 12030 (e.g., the paddle frame and cover 12400 disposed over the outer paddle) or another component of the device 12000 (e.g., the paddle frame 12240) to further secure the cover 12420 to the device 12000.

[0192] The cover 12420 may include one or more cutout portions 12510 that allow the cover 12420 to wrap smoothly around the inner paddle 12220. In some implementations, the second cover 12420 also covers the securing arms (not shown) of the clasp 12300 that secure to the inner paddle 12220. In certain implementations, the second cover 12420 includes a window or opening 12530 that allows an indicator (not shown) to be visible to the user during implantation of the device 12000. For example, the device 12000 may have an indicator, such as the indicator shown in U.S. Provisional Patent Application No. 63 / 225,387, filed July 23, 2021, the entirety of which is incorporated herein by reference, and the window 12530 allows the indicator to be visible to the user.

[0193] The second cover 12420 may have threads 12419 extending in a horizontal direction H1 from a first side edge 12421 to a second side edge 12423 of the cover 12420 (e.g., by laser cutting the cover 12420). The horizontal orientation of the threads 12419 may allow for easy attachment of a connector to the cover 12420 and may also allow for the cover to extend in a vertical direction V1. While the second cover 12420 is shown with horizontally extending threads 12419, it should be understood that other configurations are contemplated.

[0194] 114 , the third cover 12440 can have a central portion 12550 for attachment to the proximal end of the device 12000. In the illustrated implementation, the cover 12440 has an opening 12570 for attachment to the collar of the proximal or attachment portion 12050 of the device 12000 (see FIGS. 109, 110, and 112) and the uncovered collar of the attachment portion 11050 of FIG. 103. The cover 12440 can also have an interface portion 12590 extending from the central portion 12550 and configured to cover the interface element 12100 of the device 12000 (see FIGS. 109, 110, and 112) and the uncovered interface element 11100 of FIG. 103. In the illustrated implementation, the interface portions have holes 12610 along their edges, allowing the interface portions 12590 to be joined together, for example, by stitches or any other suitable connector, after being folded around the interface element 12100.

[0195] The cover 12440 can also have end portions 12630 extending from the interface portion 12590 and configured to cover a portion of the movable arm of the clasp 12300 (see FIGS. 109, 110, and 116). The end portions 12630 can have holes 12650 along their edges that allow the end portions to be secured to the clasp 12300. The cover 12440 can include one or more cutout portions 12670 that allow the cover 12440 to be smoothly wrapped around the proximal portion 12050, the interface element 12100, and the clasp 12300.

[0196] The third cover 12440 can have threads 12439 extending at an angle α (e.g., by laser cutting the cover 12440). The angle α can be from about 30 degrees to about 60 degrees, for example, about 45 degrees. The angled orientation of the threads 12419 can allow for easy attachment of a connector to the cover 12440 (e.g., via holes 12610, 12650) and can also allow the cover to be stretched in various directions. While the third cover 12440 is shown with threads 12439 extending at an angle α, it should be understood that other configurations are contemplated.

[0197] 115 , the first cover 12400 can have a central portion 12690 for attachment to the distal end 12070 of the device 12000. In the illustrated implementation, the central portion 12690 has an opening 12710 for receiving and attaching the cap 12140 of the device 12000. The cover 12400 also includes a paddle frame portion 12730 extending from the central portion 12690 and configured to cover each paddle frame 12240 of the anchor 12080. In the illustrated implementation, the paddle frame 12240 takes the form of the paddle frame 11240 shown in FIGS. 103-107 , and the cover 12400 is molded to fit over the outer frame member 12560 of the paddle frame 12240. In certain implementations, the cover 12400 may be configured to attach to both the inner frame portion 12560 and the outer frame portion 12600 of the paddle frame 12240. However, it should be appreciated that the cover 12400 may be shaped to correspond to the shape of any suitable type of paddle frame. In implementations including one or more sleeves 12010 ( FIG. 108 ) attached to the paddle frame 12240, the cover 12400 may be configured to attach to the sleeves 12010. In the illustrated implementation, the first cover 12400 has holes 12732 along their edges that allow the cover 12400 to be connected to the paddle frame and / or sleeves, for example, by stitching or any other suitable connector. The first cover 12400 may also have one or more distal holes 12734 for attachment to a distal portion of the paddle frame and / or one or more proximal holes 12736 for attachment to a proximal portion of the paddle frame.

[0198] The second cover 12420 may have threads 12409 that extend in a vertical direction V2 from a first end 12411 (e.g., by laser cutting the cover 12400) to a second end 12413 of the cover 12400. The horizontal orientation of the threads 12409 may allow for easy attachment of a connector to the cover 12400 (e.g., via holes 12732) and may also allow for the cover to extend in a horizontal direction H2. While the second cover 12420 is shown with horizontally extending threads 12409, it should be understood that other configurations are contemplated.

[0199] 116 and 117 , in some implementations, the cover assembly 12030 can include a clasp cover 12750 configured to attach to the clasp 12300 proximate the barbs 12360. The clasp cover 12750 can be configured to promote tissue ingrowth and provide a shield or cushion over the clasp 12300 as the device 12000 moves through the delivery device 12020. Locating the clasp cover 12750 proximal to or over the barbs 12360 is advantageous because the barbs 12360 can engage the valve tissue, allowing the clasp cover 12750, configured to promote tissue ingrowth, to connect the clasp cover 12750 to the valve tissue. A clasp actuation line 12770 can extend from the delivery device 12020 and be attached to the clasp 12300 to allow a user to move the clasp 12300 between an open position and a closed position. In the illustrated implementation, the connection between the clasp 12300 and the clasp actuation line 12770 may be covered by a clasp cover 12750, which may help secure the actuation line 12770 to the clasp 12300. For example, the clasp 12300 may have one or more holes (e.g., holes 235 shown in Figures 26-28 of the present application) for receiving one or more clasp actuation lines 12770, and the one or more holes may be covered by the clasp cover 12750.

[0200] 117A , in some implementations, the clasp cover 12750 has a first portion 12752 for covering the barb 12360 ( FIGS. 116-117 ) and a second portion 12754 for folding over the free end of the movable arm of the clasp 12300 and covering the other side of the clasp 12300. The clasp cover 12750 may have one or more cutout portions 12756 that allow the cover 12750 to wrap smoothly around the clasp 12300. In certain implementations, the second portion 12754 includes an opening 12758 for aligning with one or more holes in the clasp 12300 so that the clasp 12300 can receive the clasp actuation line 12770. The clasp cover 12750 may have a thread 12751 extending in the horizontal direction H3 (e.g., by laser cutting the cover 12750). The horizontal orientation of the threads 12751 may allow for easy attachment of a connector to the cover 12750 and may also allow for extension of the cover in the vertical direction V3. While the clasp cover 12750 is shown with horizontally extending threads 12751, it should be understood that other configurations are contemplated.

[0201] 118 and 119, in some implementations, the device 12000 has a connector 12660 that attaches the paddle frame 12240 to an actuation element of a delivery device such that a user can move the actuation element to move an inner end of the connector 12660 relative to the cap 12140, thereby moving the paddle frame 12240 between a narrow position and an extended position. The connector 12660 can take the form of the connector 11660 shown in FIGS. 103-107 or any other form described in this application or the references incorporated herein.

[0202] In the illustrated implementation, the connector 12660 is attached to the outer frame portion 12560 of the paddle frame 12240 (see the exposed outer paddle frame portion 11560 in FIG. 103 ). However, other configurations are contemplated. A connecting element 12830 (e.g., one or more sutures, one or more mechanical fasteners, etc.) can extend through the opening 12790 in the connector 12660 and the opening 12810 in the paddle frame to secure the paddle frame 12240 of each anchor 12080 to the connector 12660. With reference to FIG. 119 , in an implementation in which each outer frame portion 12560 of each paddle frame 12240 includes a sleeve 12010, the connector 12660 and outer frame portion 12560 of one anchor 12080 can both be disposed in one sleeve 12010, and the outer frame portion 12560 of the other anchor 12080 can be disposed in a different sleeve. In these implementations, the connecting element 12830 can extend through the sleeve 12790 and the opening 12810 to secure the connector 12660 to the paddle frame 12240 of each anchor 12080.

[0203] Although various inventive aspects, concepts, and features of the present disclosure may be described and illustrated herein as embodied in combination in some implementations, these various aspects, concepts, and features may be used individually or in various combinations and subcombinations thereof in many different implementations. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of this application. Furthermore, although various alternative implementations of various aspects, concepts, and features of the present disclosure, such as alternative materials, structures, configurations, methods, devices, and components, form, fit, and function alternatives, may be described herein, such descriptions are not intended to be a complete or comprehensive listing of available alternative implementations, whether currently known or later developed. Those skilled in the art may readily incorporate one or more of the aspects, concepts, or features of the present disclosure into additional implementations and uses, even if such implementations are not explicitly disclosed herein.

[0204] Furthermore, although some features, concepts, or aspects of the present disclosure may be described herein as being preferred arrangements or methods, such description is not intended to imply that such features are essential or required unless expressly so stated. Still further, while example or representative values ​​and ranges may be included to aid in the understanding of the present application, such values ​​and ranges should not be construed in a limiting sense, and are intended to be significant values ​​or ranges only when expressly so stated.

[0205] Furthermore, while various aspects, features, and concepts may be expressly identified herein as inventive or forming part of the disclosure, such identification is not intended to be exclusive; 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 particular disclosure, and the disclosure is instead set forth in the appended claims. The description of an exemplary method or process is not limited to the inclusion of all steps that are essential in all cases, nor is the order in which steps are presented such that they are construed as essential or required unless expressly stated as such. Furthermore, the techniques, methods, acts, steps, etc. described or suggested herein can be performed in live animals or in non-life simulations, e.g., cadavers, cadaver hearts, simulators (e.g., simulated body parts, tissues, etc.). Terms used in the claims have their full ordinary meaning and are not limited in any way by the description of implementations herein.

Claims

1. 1. An implantable device comprising: an anchor portion configured to attach to one or more leaflets of a native heart valve, the anchor portion including a plurality of paddles actuatable between an open state and a closed state; a first cover portion attached to the plurality of paddles; a second cover portion attached to the plurality of paddles; The implantable device, wherein the second cover portion has a lower coefficient of friction than the first cover portion.

2. the second cover portion covers an edge of each of the plurality of paddles; The implantable device of claim 1 , wherein the second cover portion covers a portion of an edge of the anchor portion.

3. The implantable device of claim 1 or 2, wherein the second cover portion covers an outer portion of each of the plurality of paddles.

4. The implantable device of any one of claims 1 to 3, wherein the second cover portion is formed from a different material than the first cover portion.

5. The implantable device of any one of claims 1 to 4, wherein the second cover portion is joined to the first cover portion with a stitch.

6. The implantable device of any one of claims 1 to 5, wherein at least a portion of the second cover part is disposed over a portion of the first cover part.

7. the first cover portion and the second cover portion are integrally formed from the same material; The implantable device of any one of claims 1 to 6, wherein the second cover portion comprises a plurality of embedded particles of a low friction material.

8. the second cover portion is made from the same material as the first cover portion; The implantable device of any one of claims 1 to 7, wherein the second cover portion comprises a friction-reducing material.

9. 9. The implantable device of claim 8, wherein the friction-reducing material is a coating applied to the second cover portion.

10. The implantable device of claim 9, wherein the coating is a temporary coating.

11. The implantable device of claim 10, wherein the temporary coating dissolves within one hour or more of application to the second cover portion.

12. The implantable device of any one of claims 1 to 11, wherein the second cover portion comprises a coating.

13. The implantable device of claim 12 , wherein the coating is a temporary coating.

14. The implantable device of claim 13, wherein the temporary coating dissolves within one hour or more of application to the second cover portion.

15. The implantable device of any one of claims 1 to 14, wherein the second cover portion comprises a hydrophilic material.

16. An implantable device as described in claim 15, wherein the hydrophilic material is a coating applied to the second cover portion.

17. The implantable device of any one of claims 1 to 16, wherein the second cover portion comprises a knitted material.

18. An implantable device as described in claim 17, wherein the wales of the knitted material are oriented longitudinally.

19. The implantable device of any one of claims 1 to 16, wherein the second cover portion comprises a woven material.

20. The implantable device of claim 19, wherein the longitudinal strands of the woven material are oriented longitudinally.

21. 21. An implantable device according to any preceding claim, further comprising a clasp attached to each of the plurality of paddles.

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