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) perform important functions in ensuring proper forward flow of blood supply through the cardiovascular system. These heart valves may be damaged and therefore less effective, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc. Damage to such valves may result in severe cardiovascular disability or death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and complications may occur. 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 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 compartments, 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 of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annulus portion, which is a circular portion of native valve tissue that surrounds the mitral orifice, and a pair of leaflets or cusps that extend downward from the annulus into the left ventricle. The mitral annulus can form a "D"-shaped, elliptical, or otherwise non-circular cross-sectional shape with long and short axes. The anterior leaflet is larger than the posterior leaflet, and can form a generally "C"-shaped boundary between the abutting sides of the leaflets when they are closed together.

[0004] When operating properly, the anterior and posterior leaflets function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle expands (also called "ventricular diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricle muscle contracts (also called "ventricular systole" or "systole"), the increase in blood pressure in the left ventricle closes the one-way mitral valve by drawing both sides of the two leaflets together, so that blood cannot flow back into the left atrium, but instead is expelled from the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, multiple fibrous cords called chordae tendineae connect the leaflets to the papillary muscles of the left ventricle.

[0005] Valve regurgitation involves the 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 heart 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, incompetent papillary muscles, stretching of the mitral annulus due to dilation of the left ventricle, or two or more of these. Mitral regurgitation in the central portion of the leaflets can be referred to as central jet mitral regurgitation, and 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, and therefore the valve does not close and regurgitation is present. Tricuspid regurgitation is similar, but can be 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 can be included in the examples summarized herein.

[0007] An implantable device or implant (such as, for example, an implantable prosthetic device) is configured to be positioned within a native heart valve such 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 has at least one anchor configured to attach the device to at least one leaflet of the native heart valve. 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.

[0009] In some implementations, an implantable device or implant includes a plurality of paddles, a first cover portion, and a second cover portion, the first and second cover portions being 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 to fill the space through which the native valve regurgitates and help form a more effective seal. The coaptation element can be impermeable to blood and have a structure that allows the native valve leaflets to close around the coaptation element during ventricular systole to prevent 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 an 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 an interface portion, an anchor portion, and a cover assembly. The interface portion has an interface 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, and 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 interface 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] In order to further clarify various aspects of the implementation of the present disclosure, a more particular description of certain embodiments and implementations will be made by referring to various aspects of the attached drawings. It is understood that these drawings depict only exemplary implementations of the present disclosure and therefore are not to be considered as limiting the scope of the present disclosure. Moreover, while the figures may be to scale for some embodiments, the figures are not necessarily to scale for all embodiments. The embodiments and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the attached drawings. [Brief description of the drawings]

[0017] [Figure 1] FIG. 1 shows a cut-away view of a human heart during diastole. [Diagram 2] FIG. 2 shows a cut-away view of a human heart during systole. [Diagram 3] FIG. 3 is another cut-away 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. [Diagram 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 viewed 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 illustrates an embodiment of an implantable device or implant in another stage of deployment. [Figure 10] FIG. 10 illustrates an embodiment of an implantable device or implant in another stage of deployment. [Figure 11] FIG. 11 illustrates an embodiment of an implantable device or implant in another stage of deployment. [Figure 12] FIG. 12 illustrates an embodiment of an implantable device or implant in another stage of deployment. [Figure 13] FIG. 13 illustrates an embodiment of an implantable device or implant in another stage of deployment. [Figure 14] FIG. 14 illustrates 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 illustrates an embodiment of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 17] FIG. 17 illustrates an embodiment of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 18] FIG. 18 illustrates an embodiment of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 19] FIG. 19 illustrates an embodiment of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 20] FIG. 20 illustrates an embodiment of the implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 21] FIG. 21 illustrates an embodiment 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. [Diagram 25]FIG. 25 shows a front view of the implantable device or implant of FIG. 22 with a cover over the paddle and the 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 an 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. [Diagram 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. [Diagram 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. [Diagram 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. [Diagram 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. [Diagram 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. [Diagram 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. [Diagram 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 an open position. [Figure 38] FIG. 38 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 39] FIG. 39 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 40] FIG. 40 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 41] FIG. 41 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 42] FIG. 42 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 43] FIG. 43 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 44] FIG. 44 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 45] FIG. 45 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 46] FIG. 46 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 47] FIG. 47 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 48] FIG. 48 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 49]FIG. 49 illustrates the exemplary implantable device or implant of FIGS. 30-38, including a 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. [Diagram 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 a 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 covering 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 covering 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 illustrates a second side of the first knitted material of FIG. [Figure 95] FIG. 95 illustrates a first side of a second knitted material for covering an exemplary implantable device or implant. [Figure 96] FIG. 96 illustrates a second side of the second knitted 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 and a first surface of a 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 and 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 illustrates 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 a woven material disposed on the exterior. [Figure 103]FIG. 103 shows a perspective view of an exemplary implantable device having paddles with adjustable width. [Figure 104] FIG. 104 is a cross-section of the implantable device of FIG. 103, where the implantable device has been bisected. [Figure 105] 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. [Fig. 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. [Fig. 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. [Fig. 117A] FIG. 117A illustrates an exemplary clasp cover for covering the clasp of FIG. [Fig. 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 PREFERRED EMBODIMENTS

[0018] The following description refers to the accompanying drawings which 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, etc. 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 on simulations, such as, for example, cadavers, cadaver hearts, simulators (e.g., simulated body parts, hearts, tissues, etc.).

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

[0021] 1 and 2 are 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. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in Figs. 3-6 and leaflets 30, 32, 34 shown in Fig. 7) that extend inward across their respective valve orifices, which come together or "coapt" in flow to form a one-way fluid-occluding 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 anatomy of the left atrium LA and the 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 as seen in FIG. 1, blood already collected in the left atrium LA (during systole) moves to the left ventricle LV through the mitral valve MV by the expansion of the left ventricle LV. During the systolic phase or systole as seen 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 into the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In some implementations, the device described by the present application is used to restore the function of a defective mitral valve MV. That is, the device is configured to help close the leaflets of the mitral valve to prevent blood from returning from the left ventricle LV into 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 Figures 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24, which is a variably dense ring of fibrous tissue that surrounds the leaflets 20, 22. Referring to Figures 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 serve to 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 leaflets 20, 22 against the high pressures necessary 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 closes. When viewed from the left ventricular outflow tract (LVOT) view shown in FIG. 3, the anatomy of the leaflets 20, 22 is such that the inner sides of the leaflets coapt at the free end portions and the leaflets 20, 22 begin to retract or spread apart from each other. The leaflets 20, 22 spread apart in the direction of the atrium until each leaflet contacts the mitral annulus.

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

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

[0026] There are three main mechanisms by which native valves become regurgitant or incompetent, including Carpentier's Type I, Type II, and Type III insufficiency. Carpentier's Type I insufficiency involves dilation of the annulus such that the normally functioning leaflets are deflected away from one another and are unable to form a tight seal (i.e., the leaflets do not coapt properly). Included in the Type I mechanism of insufficiency is leaflet perforation, such as present in endocarditis. Carpentier's Type II insufficiency involves prolapse of one or more leaflets of the native valve above the plane of coaptation. Carpentier's Type III insufficiency involves restriction of the movement of one or more leaflets of the native valve, such that the leaflets are abnormally constrained below the plane of the annulus. The restriction of the leaflets may be caused by rheumatic disease (MA) or ventricular dilation (IIIb).

[0027] With reference to FIG. 5, when a healthy mitral valve MV is in a closed position, the anterior leaflets 20 and posterior leaflets 22 coapt, which prevents blood from leaking from the left ventricle LV into the left atrium LA. With reference to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflets 20 and / or posterior leaflets 22 of the mitral valve MV are displaced into the left atrium LA during systole, so that the edges of the leaflets 20, 22 do not contact each other. This failure to coapt causes a gap 26 between the anterior leaflets 20 and posterior leaflets 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. With reference 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 a number of different ways in which a valve leaflet (eg, leaflets 20, 22 of the mitral valve MV) may be dysfunctional, thereby causing valve regurgitation.

[0028] In any of the above situations, a valve repair device or implant is desirable that can engage the anterior leaflets 20 and posterior leaflets 22 to close the gap 26 and prevent backflow of blood through the mitral valve MV. As seen in FIG. 4, an abstract representation of an implantable device, valve repair device, or implant 10 is shown implanted between the leaflets 20, 22 such that no backflow occurs during systole (compare FIG. 3 with FIG. 4). In some implementations, the coaptation elements (e.g., spacers, coaption elements, coaptation members, gap fillers, etc.) of the device 10 have a generally tapered or triangular shape that naturally accommodates the geometry of the native valve and its propensity to expand (towards the annulus). In this application, the terms spacer, coaption 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 cause the leaflets of the native valve to engage or "coapt" (e.g., so that the native leaflets coapt against the coaption element, coaptation element, spacer, etc. instead of only against each other).

[0029] Although stenosis or regurgitation can affect any valve, stenosis has been found to primarily affect either the aortic valve AV or pulmonary valve PV, and regurgitation has been found to primarily affect either the mitral valve MV or tricuspid valve TV. Both valve stenosis and valve regurgitation increase the workload of the heart H and, if left untreated, can lead to very serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. 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 flow throughout the body. Therefore, because the 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] Insufficiency of native heart valves may 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 the stenotic damage sustained by the valve leaflets is irreversible, treatment of a stenotic aortic valve or pulmonary valve may involve removal of the valve and replacement of the valve with a surgically implanted heart valve, or replacement of the valve with 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, may prevent the mitral valve MV or tricuspid valve TV from closing properly, allowing regurgitation or backflow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow regurgitation or backflow from the left ventricle LV into the left atrium LA, as shown in FIG. 3). Regurgitation or backflow of blood from the ventricle into the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. Additionally, regurgitation may occur because the chordae tendineae CT become incompetent (e.g., the chordae tendineae CT may stretch or rupture), allowing the anterior leaflet 20 and the posterior leaflet 22 to be pushed back, thus allowing blood to flow back into the left atrium LA. Problems caused by incompetent chordae tendineae CT may be repaired by repairing the structure of the chordae tendineae CT, or the mitral valve MV (e.g., by fixing 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 as well as any component of the 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 together on all three of the leaflets 30, 32, 34 to prevent or inhibit the backflow of blood from the right ventricle into the right atrium. That is, the valve repair device or implant provided herein can be centrally located between the three leaflets 30, 32, 34.

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

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

[0034] In some implementations, the anchors can be configured to secure the device to one or both of the native leaflets such 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 such 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 elements can be positioned independently relative to one another by separately moving each of the anchors and coaptation elements along a longitudinal axis of the actuating element (e.g., actuating shaft, actuating rod, actuating tube, actuating wire, etc.). In some implementations, the anchors and coaptation elements can be positioned simultaneously by moving the anchors and coaptation elements together along a longitudinal axis of the actuating element, e.g., shaft, actuating wire, etc.). The anchors can be configured to be positioned behind the native leaflets when implanted such that the leaflets are grasped 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, and the like. The coaptation element and anchor may be compressible to a radially compressed state and self-expandable to a radially expanded state when the compressive pressure is released. The device may be configured such that the anchor is first expanded radially away from the still compressed coaptation element to create a gap between the coaptation element and the anchor. The native leaflet may then be positioned within the gap. The coaptation element may be radially expanded to close the gap between the coaptation element and the anchor and capture the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to self-expand. The implantation methods for various implementations may differ and are discussed more fully below with respect to 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 be performed mutatis mutandis 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 may be configured with anchors connected to the leaflets and utilizing tension from the native chordae tendineae to resist high systolic pressures that pull the device toward the left atrium. During diastole, the device may rely on compressive and retaining forces exerted on the leaflets that are gripped by the anchors.

[0037] 8-15, a schematic illustrated implantable device or implant 100 (e.g., an artificial spacer device, a valve repair device, etc.) is shown in various stages of deployment. The 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. The device 100 can include any other features of an implantable device or implant discussed in this or any of the above-listed applications, and the 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 of the valve repair systems disclosed in this or any of 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 pathway, 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, coaption element, etc.) adapted to be embedded between the leaflets of a native valve (e.g., native mitral valve, 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, e.g., paddles, gripping elements, etc. Actuation of the actuation means or actuation means 112 opens and closes the anchor portion 106 of the device 100 to grip the leaflets of the native valve during implantation. The actuation means or actuation elements 112 (as well as other actuation means and actuation 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 one 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 interface means or interface element 110 by portions 124, 126, 128. The portions 124, 126, 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, interface 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., actuation wire, 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 interface 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 interface element 110 and the distal end (e.g., a 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 interface element 110 to the delivery system 102 such that an actuation means or element 112 slides through the collar or other attachment element, and in some implementations, through the interface 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, an optional barb, friction enhancing element, or other fastening means 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, 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 with the joint portion 138 located proximate to the joining means or joining element 110. In some implementations, the clasp (e.g., a barbed clasp, etc.) 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 a surface of the inner paddle 122. The joint portion 138 provides a spring force between the fixed arm and the movable arms 132, 134 of the clasp 130. The joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, etc. In some implementations, the joint portion 138 is a piece of flexible material integrally formed with the fixed and movable arms 132, 134. The fixed arm 132 is attached to the inner paddle 122 and remains fixed or substantially fixed relative to the inner paddle 122 when the movable arm 134 is opened to open the clasp 130 and expose the return, friction enhancing element, or fastening 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 actuating line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, etc. In the closed position, the clasp 130 can be spring loaded such that it continues to provide a clamping force to the grasped native leaflet. This clamping force remains constant regardless of the position of the inner paddle 122. Optional barbs, friction enhancing elements, or other securing means 136 of the clasp 130 can grasp, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0045] During implantation, the paddles 120, 122 may be opened and closed to grasp the native leaflets (e.g., native mitral leaflets, etc.) 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 may be used to grasp and / or further secure the native 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 may increase friction with the leaflets or partially or completely puncture the leaflets. The actuation wire 116 may be actuated separately such that each clasp 130 may be opened and closed separately. The separate actuation 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 the leaflets to be grasped 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 placed at the end of the catheter 102 in the fully open position, as the fully open position takes up the least amount of 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 away 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 about 180 degrees. The clasp 130 is held closed during deployment through the delivery system 102, so that the barbs, friction enhancing elements, or other fastening means 136 (FIG. 9) do not catch or damage tissue within the delivery system 102 or the patient's heart. The actuation wire 116 can extend through a coupler 117, around a collar 115, and attached to a movable arm 134.

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

[0048] Referring now to FIG. 10, the device 100 is shown in a shortened or fully closed state. The compact size of the device 100 in the shortened state allows for easier manipulation and placement within the heart. To move the device 100 from the elongated state to the shortened state, the actuation means or element 112 is retracted to pull the cap 114 towards 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 from moving such that a compressive force acting on the outer paddle 120 retracted from the cap 114 towards 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 towards the closed position. During the same movement, the inner paddles 122 move through a much larger angle because they are oriented away from the joining means or elements 110 in the open state and folded along both sides of the joining means or elements 110 in the closed state. In some implementations, the inner paddles 122 are thinner and / or narrower than the outer paddles 120, and the connecting portions 126, 128 (e.g., joints, flexible connections, etc.) connected to the inner paddles 122 can be thinner and / or more flexible. For example, this increased flexibility can allow more movement than the connecting portion 124 connecting the outer paddle 120 to the cap 114. In some implementations, the outer paddles 120 are narrower than the inner paddles 122. The connecting portions 126, 128 connected to the inner paddles 122 can be more flexible to allow more movement than the connecting portion 124 connecting the outer paddle 120 to the cap 114, for example. 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 move from the fully closed state to the partially open state, the actuation means or element (e.g., 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 spread. The actuation wire 116 is also retracted to open the clasp 130, which may then grasp the 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. Also, the position of the clasp 130 depends on the position of the paddles 122, 120. For example, referring to FIG. 10, closing of 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 parts), whereby one independent actuation element (e.g., a wire, shaft, etc.) and cap (or other mounting part) is used to control one paddle and the other independent actuation element and cap (or other mounting part) 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 FIGURE 13, the other actuation line 116 is extended to allow the other clasp 130 to close. Either or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0051] 14, the device 100 is shown in a fully closed and deployed state. The delivery system or delivery means 102 and the actuation means or actuation elements 112 are retracted, with the paddles 120, 122 and clasp 130 still remaining in the fully closed position. Once deployed, the device 100 may be maintained in the fully closed position by a mechanical latch, or may be biased to remain closed by the use of spring materials such as steel, other metals, plastics, composites, or shape memory alloys such as Nitinol. For example, the connecting portions 124, 126, 128, joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from metals such as steel, or shape memory alloys such as Nitinol manufactured from wires, sheets, tubes, or laser sintered powders, and biased to hold the outer paddle 120 closed around the coaptation means or coaptation elements 110, and the clasp 130 is clamped around the native 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 closed 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 an actuation element 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 mating means or element 110, thereby pulling the outer paddle 120, which pulls the inner paddle 122, causing 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 shown by Fig. 15 may be implemented in any of the devices disclosed by the present application. 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 Fig. 18, the implant / device is moved into the ventricle LV and into a position within 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 Fig. 18. An implant catheter connected to the implant / device can be advanced from inside the steerable catheter to position the implant as illustrated by Fig. 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 embodiment 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 take. The device 200 can include any other features of an implantable device or implant discussed in this application, and the device 200 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). The device / implant 200 can be an artificial spacer device, a valve repair device, or another type of implant that attaches to the leaflets of a native valve.

[0057] In some implementations, 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 implementations, the coaptation portion 204 of the device optionally includes a coaptation element 210 (e.g., a spacer, a coaption element, a plug, a membrane, a sheet, etc.) for implantation between the leaflets of a native valve. In some implementations, the anchor portion 206 includes a plurality of anchors 208. The anchors may be configured in a variety of ways. In some implementations, 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 implementations, 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 joint elements 210 and paddles 220, 222 may be formed from a flexible material, which may be a metal fabric such as a mesh, woven, braided, or formed in any other suitable manner, or a laser cut or otherwise cut flexible material. The material may be cloth, wire such as Nitinol to provide shape fixation capabilities, or any other flexible material suitable for implantation in the human body.

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

[0060] The coaptation element 210 extends from a proximal collar 211 (or other attachment element) to an 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), and a round shape or cross-section when viewed from the side (e.g., FIG. 24). A mixture of these three geometric shapes can result in a 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 may be selected to minimize the number of implants (preferably one) required by a single patient while at the same time maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the top of the coaptation element is about 5 mm, and the medial-lateral distance of the coaptation element at its widest portion is about 10 mm. In some implementations, the overall geometry of the device 200 may 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 devices with different dimensions. Additionally, using other dimensions and shape strategies described above will also result in devices with different dimensions.

[0062] In some implementations, the outer paddle 220 is articulably attached to the cap 214 of the distal portion 207 by connecting portion 221 and to the inner paddle 222 by connecting portion 223. The inner paddle 222 is articulably attached to the joint element by connecting portion 225. In this manner, the anchor 208 is configured similar to a leg in that the inner paddle 222 is like the top part of the leg, the outer paddle 220 is like the bottom part of the leg, and the 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 fixed portion 232 of a reinforcing member or 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, joints may all be interconnected as described herein, thereby constraining 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 round three-dimensional shape that extends 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 may limit each of these portions to the movements and positions described herein. In particular, the connecting portion 223 is limited by its connections between the outer and inner paddles 220, 222 and by its connections 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 leaflets. The increased surface area can also distribute the clamping force of the paddles 220 and paddle frame 224 against the native leaflets over a relatively larger surface area of ​​the native leaflets to further protect the native leaflet tissue. Referring again to FIG. 51, the increased surface area of ​​the paddle frame 224 can also allow the native leaflets to be secured to the implantable device or implant 200 such that the native leaflets are fully coapted about the coaptation member or element 210. This can, for example, improve the sealing of the native 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 disposed proximate to the joining element 210. The joint portion 238 is spring loaded such 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 fastening, such as barbs, protrusions, ridges, grooves, textured surfaces, adhesives, and the like.

[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, a weld, an adhesive, etc. The fixed arm 232 remains substantially fixed relative to the inner paddle 222 when the movable arm 234 opens to open the clasp 230 and expose the barb or other friction enhancing element 236. The clasp 230 is opened by applying tension to an actuation line 216 (e.g., shown 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 fixed arms 234 of the clasp 230. The tissue of the leaflets 20, 22 is not pierced by the barbs or frictional enhancement 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 frictional enhancement elements 236 relative to the movable arms 234 helps secure the leaflets 20, 22 within the clasp 230. In particular, the force of pulling the implant away from the native leaflets 20, 22 will encourage the barbs or frictional enhancement 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 fixed arms 232 near the barbs / frictional enhancement elements 236 when the clasp 230 is closed. In this arrangement, the tissue is formed into an S-shaped, distorted path by the fixed and movable arms 232, 234 and the barbs / frictional enhancement elements 236. Thus, the force pulling the leaflets 20, 22 away from the clasp 230 will encourage the tissue to further engage the barbs / frictional enhancement elements 236 before the leaflets 20, 22 can prolapse. For example, tension on the leaflets during diastole can urge the barbs 236 to pull towards the end portions of the leaflets 20, 22. Thus, the S-shaped path can take advantage of the leaflet tension during diastole to more tightly engage the leaflets 20, 22 with the barbs / frictional enhancement 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 interface elements 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 the ingrowth of autologous tissue. 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 leaflets 20, 22 of the native valve between the paddles 220, 222 and the coaptation element 210. The anchor 208 is moved between a closed position (FIGS. 22-25) to 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, such that the change in spacing between the coaptation element 210 and the cap 214 moves the paddles 220, 220 between different positions to grip the leaflets 20, 22 of the mitral valve during implantation.

[0072] As the 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 the clasp 230 depends on the position of the paddles 222, 220. For example, the clasp 230 is positioned such that closing of the anchor 208 simultaneously closes the clasp 230. In some implementations, the device 200 can be made to have paddles 220, 222 that are independently controllable in the same manner (e.g., the device 100 illustrated in FIG. 15).

[0073] In some implementations, the clasp 230 further secures the native leaflets 20, 22 by engaging the leaflets 20, 22 with barbs and / or other friction enhancing elements 236 and by sandwiching the leaflets 20, 22 between the movable and fixed arms 234, 232. In some implementations, the clasp 230 is a barbed clasp that includes barbs that can increase friction with the leaflets 20, 22 and / or partially or fully pierce the leaflets 20, 22. The actuation lines 216 (FIGS. 43-48) can be actuated separately such that each clasp 230 can be opened and closed separately. Separate actuation allows one leaflet 20, 22 to be grasped at a time or repositioning of the clasp 230 on a poorly grasped 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 paddle 222 is 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 disposed between the outer paddle 220 and the coaptation element 210. The clasp 230 is disposed between the inner paddle 222 and the coaptation element 210. Upon successful capture of the native leaflets 20, 22, the device 200 is moved 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 Figures 30-37 from the closed position shown in Figures 22-25 of the actuating element 212 to a fully retracted position to a fully extended position.

[0076] 30-31, the device 200 is shown in a partially open position. The device 200 is moved to the partially open position by extending the actuation element 212. The extension of the actuation element 212 pulls down the bottom portion of the outer paddle 220 and the paddle frame 224. The outer paddle 220 and the paddle frame 224 pull down the inner paddle 222, which is connected to the outer paddle 220 and the paddle frame 224. The inner paddle 222 is caused to articulate, pivot, and / or bend toward the opening as the proximal collar 211 (or other attachment element) and the interface element 210 are held in place by the capture mechanism 213. The inner paddle 222, the outer paddle 220, and the 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 actuating element 212 described above, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207. Continuing to extend the actuating element 212 pulls down the outer paddle 220 and the paddle frame 224, thereby causing the inner paddle 222 to splay 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 angle of about 90 degrees with the coaptation element 210. Similarly, the paddle frame 224 are in their maximum splayed position when the device 200 is in 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 further (FIG. 33) before engaging the joint 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 actuating element 212 described above, thereby increasing the distance between the interface element 210 and the cap 214 of the distal portion 207. Continuing to extend the actuating 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 interface element 210. In the three-quarters extended position, the inner paddle 222 opens to an angle of more than 90 degrees to about 135 degrees with the interface element 210. The paddle frame 224 spreads less than in the laterally extended or open position, and begins to move inward toward the actuating element 212 as the actuating element 212 extends further. The outer paddle 220 also bends backward toward the actuating 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, an 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 described above, 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 the paddle frame 224, thereby causing the inner paddle 222 to spread further away from the coaptation element 210. The outer paddle 220 and the 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 at an angle of approximately 180 degrees with the coaptation element 210. The inner and outer paddles 222, 220 are straightened out in the fully extended position, forming an angle of approximately 180 degrees between the paddles 222, 220. The fully extended position of the device 200 provides the maximum size of the gap between the coaptation element 210 and the inner paddle 222, and in some implementations also allows the clasp 230 to fully open to about 180 degrees between the fixed and movable arms 232, 234 of the clasp 230 ( FIG. 37 ). The position of the device 200 is the 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 may be a desired position for placement of the device into a delivery catheter, etc.

[0080] Configuring the device or implant 200 such that the anchors 208 can extend to a straight or nearly straight configuration (e.g., about 120 degrees to 180 degrees relative to the coaptation element 210) can provide several advantages. For example, this configuration can reduce the radial corrugated profile of the device or implant 200. It 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 to grasp the native leaflets 20, 22. Additionally, the relatively narrow straight configuration can prevent or reduce the possibility 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 within the delivery system 202.

[0081] 38-49, an exemplary implantable device 200 is shown delivered and implanted within the native mitral valve MV of the heart H. As described above, the device 200 shown in FIGS. 38-49 includes an optional cover 240 (e.g., FIG. 25) over the coaptation element 210, the clasp 230, the inner paddle 222, and / or 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 the actuation element 212. Fingers of the capture mechanism 213 removably attach the 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 detach 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 may 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 a 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 leaflets. Next, as shown in FIGS. 43 and 44, the partial opening device 200 is inserted (e.g., by advancing an implant catheter from the steerable catheter) through the native valve 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 grip the missed leaflet 22. Once both leaflets 20, 22 are properly gripped, 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 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 that the leaflets 20, 22 need to be coapted to close the mitral valve MV, thereby facilitating the repair of functional valve disease that may 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 the stress experienced by the native valve. The shorter approximation distance of the leaflets 20, 22 may also require less approximation force, which may result in less tension experienced by the leaflets 20, 22 and less diameter reduction of the annulus. Lesser, or no, reduction of the annulus may result in less reduction in the orifice area compared to devices without a coaptation element or spacer. In this manner, the coaptation element 210 may reduce transvalvular gradients.

[0085] To adequately fill the gap 26 between the leaflets 20, 22, the device 200 and its components may have a wide variety of different shapes and sizes. For example, the outer paddle 220 and paddle frame 224 may be configured to match 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 may 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 leaflets 20, 22 completely surround or "hugge" the coaptation element 210 in their entirety, thus preventing small leaks at the outer and inner surfaces 201, 203 of the coaptation element 210. The interaction of the leaflets 20, 22 and the 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 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 (as viewed from the atrial side in FIG. 52, and from the ventricular side in FIG. 53) would seem 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 regurgitant gap 26, and the regurgitant gap 26 is smaller than the width (medial surface minus lateral surface) of the coaptation element 210, then the distance the leaflets 20, 22 need to be approximated is still minimized.

[0087] FIG. 50 illustrates the geometry of the coaptation element 210 and the 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 the area closer to where the inner surfaces of the leaflets 20, 22 need to coapt and larger dimensions as the coaptation element 210 extends toward the atrium. Thus, the illustrated native valve geometry is accommodated by the tapered coaptation element geometry. With further reference to FIG. 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 end of the leaflets, reduce stress, and minimize transvalvular gradients.

[0088] 54, the shapes of the coaptation element 210 and the paddle frame 224 may be defined based on a view of the native valve and the inner commissure of the device 200. Two factors in these shapes are leaflet coaptation against the coaptation element 210 and reducing stress on the leaflets due to coaptation. With reference to FIG. 54 and FIG. 24, the coaptation element 210 may have a round or rounded shape and the paddle frame 224 may have a full radius that spans nearly the entirety of the paddle frame 224, both to coapt the leaflets 20, 22 against the coaptation element 210 and to reduce stress applied to the leaflets 20, 22 of the valve by the coaptation element 210 and / or the paddle 224. The round shape of the coaptation element 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 area 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, there is shown an embodiment of an implantable device or implant 300. 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 valve tissue 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 a plurality of 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 delivery system 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, combinations of any or all of these, etc.) In some implementations, the anchors 308 are attached to the interface member or element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0092] The 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. The connecting portion 323 can be attached to a paddle frame 324 that is hinged to the cap 314 or other mounting portion. In this manner, the anchor 308 is configured similar to a leg in that the inner paddle 322 is like an upper portion of a leg, the outer paddle 320 is like a lower portion of a leg, and the connecting portion 323 is like a knee portion of the leg.

[0093] In implementations using the interface member or element 310, the interface member or element 310 and the anchor 308 may be coupled together in a variety of ways. For example, as shown in the illustrated implementation, the interface element 310 and the anchor 308 may be coupled together by integrally forming the interface element 310 and the anchor 308 as a single, unitary component. This may be accomplished, for example, by forming the interface 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 embodiment, the interface 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 may 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 may occur along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and proximal end (e.g., collar 311 or other attachment element, etc.) of the device. For example, the anchor 308 may 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 straight in the direction of 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 the 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. First, 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 the 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 (as 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 located 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 a closed state.

[0097] The fixed arm 332 is attached to the inner paddle 322 with a suture (not shown) through a hole or slot 331. The fixed arm 332 may be attached to the inner paddle 322 by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, a weld, an adhesive, etc. The fixed arm 332 remains substantially fixed relative to the inner paddle 322 when the movable arm 334 opens to open the barbed clasp 330 and expose the barb 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 a hole 335 in the movable arm 334, thereby causing the movable arm 334 to articulate, pivot, and / or bend on a 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, the outer paddle 320, the inner paddle 322, and the 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, the cap 314, and the paddle frame 324 by weaving or inserting through openings in the proximal collar 311, the cap 314, and the 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, and 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 may be selected to minimize the number of implants (preferably one) required by a single patient while at the same time maintaining a low transvalvular gradient. In particular, forming many components of the device 300 from strips of material 301 allows the device 300 to be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance of the device 300 at its widest portion (i.e., the width of the paddle frame 324, which is wider than the coaptation element 310) is about 5 mm.

[0101] During implantation of an implantable device or implant into a native heart valve, movement of the device to the implanted location may be impeded or impeded 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, or temporarily be blocked by the chordae tendineae CT (shown in Figures 3 and 4) that extend to the valve leaflets. An exemplary implantable device or implant may be configured to reduce the likelihood that the device or implant will be temporarily captured or blocked by the CT. For example, the implantable device or implant may take on a wide 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 or slippery or smooth exterior surface to reduce friction due to engagement between the heart's native structures, e.g., chordae tendineae, and the device 400. This reduction in 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 valve repair system 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 number of paddles 420 (e.g., two in the illustrated implementation) and a number 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 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 the actuation element 412 moves the anchor portion 406 relative to the interface portion 404.

[0106] The interface element 410 extends from a proximal portion 419 that is assembled to the collar 411 to a distal portion 417 that connects to the anchor 408. The interface element 410 and the anchor 408 may be coupled together in a variety of manners. For example, as shown in the illustrated implementation, the interface element 410 and the anchor 408 may optionally be coupled together by integrally forming the interface element 410 and the anchor 408 as a single, unitary component. This may be accomplished, for example, by forming the interface 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] As with device 200 shown in FIGS. 22-37, anchor 408 may be configured to move between various configurations by axially moving cap 414 relative to proximal collar 411, and thus anchor 408 relative to coaptation element 410, along a longitudinal axis extending between cap 414 and proximal collar 411. For example, anchor 408 may be positioned in a straight configuration by moving cap 414 away from coaptation element 410. The anchor 408 may also be positioned in a closed configuration (e.g., FIG. 57) by moving cap 414 toward coaptation element 410. As cap 414 is pulled all the way toward coaptation element 410 by actuation element 412, paddle portion 420 closes against coaptation element 410 and any autologous tissue (e.g., valve leaflets, not shown) captured between coaptation element 410 and paddle portion 420 is pinched to secure device 400 to the autologous tissue.

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

[0110] The movable portion 434 can articulate, pivot, and / or bend 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 to a closed configuration. In the open configuration, the fixed portion 432 and the movable portion 434 articulate, pivot, and / or bend away from each other such that the native 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 bend toward each other, thereby clamping the native leaflets between the fixed portion 432 and the movable portion 434 (e.g., Fig. 47). In the closed position, the clasp 430 can be spring loaded such that the clasp 430 continues to provide a clamping force to the grasped native leaflets. 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 pull the movable portion 434 of the clasp 430 in a rearward 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 capture direction by retracting the pusher tube or rod 413 into the catheter 402 and / or moving the catheter 402 to position the 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 actuating line 416 is released, thereby allowing the actuating line 416 to move in the release direction, such that the spring-loaded hinge portion 438 closes 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 the ingrowth of autologous cardiac tissue and improves the connection between the autologous cardiac tissue and the device 400, while the second cover portion 450 provides a more lubricious or slippery surface to improve the 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, such that the device 400 moves more easily against and / or over the autologous cardiac structures, such as the 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, due to the thickness of the material, the size of the openings.

[0113] The first cover portion 440 is formed from a flexible material that promotes tissue ingrowth to further secure the implantable device / implant 400 between the native valve leaflets over time. 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 may 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 by stitching 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 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 example implementation similar to the configuration of Figures 64-67, where 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, where 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 wide variety of forms to provide a lower coefficient of friction between the device 400 and the native tissue in 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 the second cover portion 450 may be a permanent coating or a temporary coating that dissolves in the blood after an hour or more, such as 1 hour to 1 year, 1 hour to 6 months, 1 hour to 3 months, 1 hour to 1 month, 1 hour to 2 weeks, 1 hour to 1 week, etc. The temporary coating may provide a desired reduction in friction during the implantation procedure, and then dissolve to expose more of the first cover portion 440, which may come into contact with the autologous tissue and provide additional gripping surface area. The coating that forms the second cover portion 450 may be applied during manufacture of the device 400 or may be applied by the person performing the implantation procedure.

[0121] In an exemplary implementation, 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 surface of the device to which the material is added. Hydrophilic materials absorb liquids easily, like a fine sponge, providing 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 form an exterior surface that reduces friction due to engagement between the autogenous structures of the heart, e.g., chordae tendineae, and the device 500. 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 valve repair system 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 joint 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 joint 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 number of paddles 520 (e.g., two in the illustrated implementation) and a number 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 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 the actuation element 512 moves the anchor portion 506 relative to the interface portion 504.

[0126] The interface element 510 extends from a proximal portion 519 that is assembled to a collar 511 to a distal portion 517 that connects to the anchor 508. The interface element 510 and the anchor 508 may be coupled together in a variety of manners. For example, as shown in the illustrated implementation, the interface element 510 and the anchor 508 may optionally be coupled together by integrally forming the interface element 510 and the anchor 508 as a single unitary component. This may be accomplished, for example, by forming the interface 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] As with device 200 shown in FIGS. 22-37, anchor 508 may be configured to move between various configurations by axially moving cap 514 relative to proximal collar 511, and thus anchor 508 relative to coaptation element 510, along a longitudinal axis extending between cap 514 and proximal collar 511. For example, anchor 508 may be positioned in a straight configuration by moving cap 514 away from coaptation element 510. The anchor 508 may also be positioned in a closed configuration (e.g., FIG. 72) by moving cap 514 toward coaptation element 510. As cap 514 is pulled all the way toward coaptation element 510 by actuation element 512, paddle portion 520 closes against coaptation element 510 and any autologous tissue (e.g., valve leaflets, not shown) captured between coaptation element 510 and paddle portion 520 is pinched to secure device 500 to the autologous tissue.

[0129] The clasp 530 may include an attachment or fixation portion 532 hingedly connected to an arm or movable portion 534 by a hinge portion 538. The movable portion 534 may include barbs or fixation means 536 that can pierce the native leaflet to further secure the native leaflet captured between the fixed portion 532 and the movable portion 534 of the clasp 530. The attachment or fixation portion 532 may be coupled or connected to the paddle portion 520 of the 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 bend 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 to a closed configuration. In the open configuration, the fixed portion 532 and the movable portion 534 articulate, pivot, and / or bend away from each other such that the native 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 bend toward each other, thereby clamping the native leaflets between the fixed portion 532 and the movable portion 534 (e.g., Fig. 47). In the closed position, the clasp 530 can be spring loaded such that the clasp 530 continues to provide a clamping force to the grasped native 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 pull the movable portion 534 of the clasp 530 in a rearward 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 capture direction by retracting the pusher tube or rod 513 into the catheter 502 and / or moving the catheter 502 to position the 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 leaflets 20, 22, tension in the actuating line 516 is released, thereby allowing the actuating line 516 to move in the release direction, such that the spring-loaded hinge portion 538 closes the clasp 530 as described above, capturing and clamping the 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 the ingrowth of autologous cardiac tissue and improves the connection between the autologous cardiac tissue and the device 500, while the second cover portion 550 provides a more lubricious or slippery surface to improve 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, such that the device 500 moves more easily against and / or over the autologous cardiac structures, such as the 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, due to 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 to further secure the implantable device / implant 500 between the native valve leaflets over time. 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 may 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 a stitch 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 edges of the paddle portion 520 as shown in Figures 73-86. For example, the second cover portion 550 illustrated by Figures 79-80 covers all of the edge portion, while the second cover portion 550 does not cover the ends of the paddle portion 520 in Figures 81-82. Providing increased friction areas at the ends 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 to avoid entanglement with the chordae 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 edges of the paddle portion 520, with raised portions oriented along the edges on the sides of the paddle portion 520 and across the edges on the end portions 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 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 may 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 may extend to cover all of the first cover portion 540 shown in Figure 80. Figures 83-86 show an example implementation similar to the configuration of Figures 79-82, where 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 configuration of Figures 81-82, where the second cover portion 550 does not extend to cover the end of the upper paddle portion 520 of the device 500.

[0139] The second cover portion 550 can take a variety of forms to provide a lower coefficient of friction between the device 500 and the native tissue within the heart. The second cover portion 550 may be formed from the same material, but processed differently than the first cover portion 540, and / or may be oriented differently to create a lower coefficient of friction between the second cover portion 550 and the native tissue than between the 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 cardiac 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 possibility that a portion of the device 500 will be 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 knitted material are oriented longitudinally.

[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 knitted material or longitudinal strands of woven material oriented in the circumferential direction, 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., longitudinally or along the direction of movement of the device 500 during implantation. Exemplary covering materials and their interaction with native cardiac tissue are discussed in more detail below.

[0142] 87-92, an abstract representation of an implantable device having a cover with circumferentially or laterally oriented and longitudinally oriented surface features is shown to interact with chordae tendineae CT. As used herein, the orientation terms "circumferential" or "lateral" refer to a direction generally or substantially across the width of the exemplary implantable devices described herein, such as, for example, 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 orthogonal 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 CT. In FIG. 87, the device 600 can be moved in the direction indicated by the double arrow 601, with the chordae extending into or out of the page. FIG. 88 and FIG. 89 are cross-sectional views taken along the plane indicated by lines 88-88 and 89-89, respectively, in FIG. 87. 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 FIG. 88 and FIG. 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 CT.

[0144] The device 600 includes a device body 602 covered by a cover 610. The cover 610 includes raised portions 612 having a larger outer diameter spaced apart by valley portions 614 having a smaller outer diameter. 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, the chordae CT with lower tension are more likely to become trapped within the valley portion 614. As the chordae CT moves into the valley portion 614, the force required to move the device 600 increases significantly as the chordae CT becomes trapped in one place on the adjacent ridge portion 612. Thus, 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 valve repair device shown and described herein, or any other known valve repair device. The device 700 is positioned between two chordae CT. In FIG. 90, the device 700 can be moved in the direction indicated by the double arrow 701, with the chordae extending into or out 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 CT such that the direction of movement 601 of the device 700 is in or out of the plane of the page. In this way, the device 700 is moved in a direction 701 perpendicular to the length of the chordae CT.

[0146] The device 700 includes a device body 702 covered by a cover 710. The cover 710 includes raised portions 712 with a large outer diameter spaced apart by valley portions 714 with a small outer diameter. 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 remain substantially constant in 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 way, friction between the chordae CT and the device 700 is reduced.

[0147] The cover 710 of the device 700 can also be flipped inside out, 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 material thickness 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 flipped inside out, 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 the 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 the 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 showing 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 cover 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 into 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] 93-96, an example of a knitted cover for an implantable device / implant is shown. The knitted material may be formed from one or more threads or strands of material that are stitched together by forming a series of loops. The threads or strands of material follow a serpentine path, or course, through the material as loops of stitches 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 the courses are made by adding stitches to each wale until the knitted material reaches the desired size.

[0151] 93-94, a first knit cover 800 is shown with an outwardly facing first side 810 in FIG. 93 and an outwardly facing second side 820 in FIG. 94. That is, the cover 800 of FIG. 93 is turned inside out to become the cover 800 of FIG. 94. The courses 802 of the first knit cover 800 are circumferentially oriented such that the courses 802 encase the tubular shape of the first knit cover 800. The wales 804 of the first knit cover 800 are longitudinally oriented such that the wales 804 extend along the tubular length of the first knit cover 800. Circumferentially oriented ridges 812 spaced apart by circumferentially oriented valleys 814 are formed on the first side 810 of the first knit cover 800 by the 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 knitted 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 knitted cover 900 is shown with a first surface 910 facing outward in FIG. 95 and a second surface 920 facing outward in FIG. 96. That is, the cover 900 of FIG. 95 is turned inside out to become the cover 900 of FIG. 96. The second knitted cover 900 is knitted in a similar manner to the first knitted cover 800, but the knit pattern is rotated 90 degrees so that the surface features of the second knitted cover 900 are orthogonal to the surface features of the first knitted cover 800. For example, the courses 902 of the second knitted cover 900 are oriented longitudinally such that the courses 902 extend along the length of the tubular shape of the second knitted cover 900. The wales 904 of the second knitted cover 900 are oriented circumferentially such that the wales 904 envelop the tubular shape of the second knitted 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 knitted 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 knitted 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 by first and second knitted covers 800, 900 having first surfaces 810, 910 and second surfaces 820, 920 facing outwardly for engaging a tissue sample were tested.

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

[0155] As seen in FIG. 97, the force data 811 rises to a first peak and 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 being trapped in the valley portion 814 against one of the raised portions 812. The trapped raised portion 812 may then move with the self-tissue and collide with the successive raised portions 812, bunching the material of the first knitted cover 800 and forming 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, shown as a large peak followed by a sharp drop in the force data 811. Similar sticking and slippage may be seen 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 being trapped on one or more raised portions 812. The force data 911 recorded for the first surface 910 of the second knitted 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., smaller peaks and valleys in the data, rather than larger peaks that may result from bunching.

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

[0157] Comparing the two data sets for surfaces with longitudinally oriented features, i.e., the second side 820 of the first knitted cover 800 and the first side 910 of the second knitted cover 900, it becomes further apparent that the raised portions 822 formed by the wales 804 of the first knitted cover 800 provide a lower friction surface than the raised portions 912 formed by the courses 902 of the second knitted cover 900. As can be seen in FIG. 96, the wales 904 (and similarly the wales 804 of the first knitted cover 800) form larger raised portions 822, 922, and as a result, 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 the courses 902, and as a result, the total contact patch between the autologous tissue and the raised portions 822 is smaller than that between the autologous tissue and the raised portions 912.

[0158] 99-100, the first and second woven covers 1000, 1100 are shown with the first faces 1010, 1110 oriented outward. The second faces of the first and second woven covers 1000, 1100 are not shown and are similar in appearance to the respective figures 99-100. Woven materials can be formed by weaving one or more weft threads or strands of material in and out of multiple warp threads or strands. The weft strands follow a somewhat straight path that is perpendicular to the warp strands. The relatively straight path of the weft and warp strands, as opposed to the tortuous path of the strands of the knitted material, is less stretchy than the knitted material. 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 the knitted material. 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 longitudinal strands 1002 of the first woven cover 1000 are oriented in a circumferential direction such that the longitudinal strands 1002 are wrapped around the tubular shape of the first woven cover 1000. The transverse strands 1004 of the first woven cover 1000 are oriented in a longitudinal direction such that the transverse 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 longitudinal strands 1002. Note that the ridge portions 1012 and valley portions 1014 are smaller in height and width than the ridge portions 812 and valley portions 814 of the first knitted cover 800, for example.

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

[0161] 101-102, data are shown showing the force required to displace a probe covered by a first and second woven fabric covering 1000, 1100 having a first surface 1010, 1110 and a second surface (not shown) facing outwardly to engage 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 shows that the first surface 1110 of the second knitted covering 1100 requires less force to move while engaging with the autologous tissue and therefore has a lower coefficient of friction than the first surface 1010 of the first knitted covering 1000. Data for the second surface (not shown) of the first and second woven fabric coverings 1000, 1100 are shown in data series 1021, 1121 of FIG.

[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 autogenous tissue. The data also indicate that the autogenous 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 autogenous tissue.

[0163] Comparing the knitted cover 800, 900 to the woven cover 1000, 1100, it can also be seen that the orientation of the material forming the knitted cover 800, 900 has a more pronounced effect on the friction between the cover material and the self-organization. In other words, the woven cover 1000, 1100 is less sensitive to changes in orientation. This is likely due to the smaller overall surface features of the woven cover 1000, 1100. Thus, the advantage of woven materials such as the woven cover 1000, 1100 is that the orientation of the weave does not need to be tightly controlled during manufacturing. Knitted materials such as those used to make the knitted cover 800, 900 are more stretchy than woven materials due to the tortuous path of the yarns or strands used to form the knitted material. Thus, the advantage of knitted materials such as those used to make the knitted cover 800, 900 is that the resulting cover will 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. With reference 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 may 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, with reference 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 an outer end portion of a w-shaped connector 11660 (e.g., a molded metal part, molded plastic part, tether, wire, post, 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 shape, 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 inwardly to form a retaining portion 11720 that is attached to the actuation cap 11140. The retaining portion 11720 and the actuation cap 11140 may 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, a proximal end of the outer frame portion 11560 connects to a proximal end of the inner frame portion 11600.

[0169] The width adjustment element 11110 is configured to move the outer frame portion 11560 from an expanded position to a narrow position by pulling an inner end 11680 of the connector 11660 (FIGS. 105 and 107) proximally relative to the actuation cap 11140. In some implementations, as the outer frame portion 11560 moves 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 and can be moved relatively within the receiver 11120 by a user 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 is attached to the outer frame portion 11560 and a coupler 11130 that extends 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 is released from the receiver 11120. When the coupler 11130 is removed 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 screws into a coupler 11130. The width adjustment element 11110 moves a coupler in 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 an 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 attachment 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 the 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 a 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 the 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 an inner end 11680 of the connector 11660. Movement of 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. Movement of 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, an implementation of an implant catheter assembly 11010 is shown 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 actuating 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 can extend through and 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 a coupler 11130 of the device 11000. Advancing and retracting the width adjustment element 11110 with control 11280 widens or narrows the width of the paddle. Advancing and retracting the actuation element 11020 with 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 (each of which is incorporated by reference in its entirety 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 mating portion 12040 having a mating element 12100, an anchor portion 12060, and a distal portion 12070. The proximal portion 12050, the mating 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 applications cited above.

[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 application or the applications mentioned above.

[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 application or the applications mentioned above.

[0183] The anchor portion 12060 may include one or more anchors 12080 actuatable between an open position and a closed position. The anchors 12080 may take a wide variety of forms, such as, for example, any of the methods described in this application or the applications cited above. In the illustrated implementation, each of the anchors 12080 has an inner paddle 12220, an outer paddle 12200, and a gripping element or clasp 12300. The anchors 12080 may also have a paddle frame 12240. The paddle frame 12240 may 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 application or the applications cited above. 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 wide variety of different forms (e.g., wires, rods, shafts, tubes, threads, 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, referring 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 inner frame portion 11600 and the outer frame portion 11560 are not covered, the paddle frame 12240 may be the same or substantially the same as the paddle frame 11240, 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 posts or elongated wire-like portions of the inner frame portion 12600, and one sleeve on each of the two posts or elongated wire-like portions of the outer frame portion 12560). Because there is 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, the illustrated implementation shows the sleeve 12010 being a cylindrical tube, but 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 compression of the sleeve 12010 increases the diameter of the lumen and expansion of the sleeve 12010 decreases the diameter of the lumen.

[0187] In certain implementations, the sleeve 12010 can allow the cover (e.g., a portion of the cover assembly 12030 described herein) to easily attach to the device 12000 and / or provide low friction edges of the device to allow easy passage through autogenous structures of the heart 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 hold 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 autogenous structures, such as the chordae tendineae, and the edges of the device 11000 covered by the sleeve, thereby allowing the device 12000 to be more easily manipulated into position for implantation into the heart. For example, in implementations where 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 components 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 migration of blood through the native valve, assist in coaptation of the valve leaflets by providing further engagement with the leaflets, and / or 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 sheets, materials, fabrics, layers, and / or membranes may be made from any suitable material, such as, for example, polyethylene. For example, the sheets, materials, fabrics, layers, and / or membranes may be made from 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 attachment to the paddle frame 12240, a second cover 12420 for attachment to the inner paddle 12220, and a third cover 12440 for attachment to the interface element 12100 and clasp 12300. With reference 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 transition between portions of the device 12000 to reduce catch points and provide 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 by 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 cover 12400 disposed over the paddle frame and outer paddle) or to 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 be smoothly wrapped around the inner paddle 12220. In some implementations, the second cover 12420 also covers the securing arm (not shown) of the clasp 12300 that is secured 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 indicators shown in U.S. Provisional Patent Application No. 63 / 225,387, filed July 23, 2021, which is incorporated herein by reference in its entirety, 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 having 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 a proximal end of the device 12000. In the illustrated implementation, the cover 12440 has an opening 12570 for attachment to a 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 cut-out 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 may have threads 12439 (e.g., by laser cutting the cover 12440) that extend at an angle α. The angle α may be from about 30 degrees to about 60 degrees, for example, about 45 degrees. The angled orientation of the threads 12419 may allow for easy attachment of a connector to the cover 12440 (e.g., via holes 12610, 12650) and may also allow the cover to be stretched in a variety of directions. While the third cover 12440 is shown having threads 12439 that extend 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 to 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 the paddle frame 12240 of each of the anchors 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 that include 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 barb 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 or over the barb 12360 is advantageous because the barb 12360 can engage the valve tissue and the clasp cover 12750 configured to promote tissue ingrowth can 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 FIGS. 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 be smoothly wrapped 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 the cover to extend in the vertical direction V3. It should be understood that while the clasp cover 12750 is shown having horizontally extending threads 12751, 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 actuating element of a delivery device such that a user can move the actuating 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 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 an opening 12790 in the connector 12660 and an 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 the 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 another sleeve. In these implementations, the connecting elements 12830 can extend through the sleeves 12790 and the openings 12810 to secure the connectors 12660 to the paddle frames 12240 of each anchor 12080.

[0203] Although various inventive aspects, concepts, and features of the present disclosure may be described and illustrated herein as being 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 the various aspects, concepts, and features of the present disclosure, such as alternative materials, structures, configurations, methods, devices, and components, alternatives for forming, fitting, and functioning, may be described herein, such descriptions are not intended to be a complete or comprehensive enumeration 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 expressly 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 described. 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 if expressly so described.

[0205] Furthermore, although 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 in the order in which the steps are presented to be construed as essential or necessary unless expressly stated to be so. Furthermore, the techniques, methods, operations, steps, etc. described or suggested herein can be performed in live animals or in non-living simulations, such as cadavers, cadaver hearts, simulators (e.g., body parts, tissues, etc. being simulated). The terms used in the claims have their full ordinary meaning and are not limited in any way by the description of the 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. 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 from 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 from 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. The implantable device of 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. The implantable device of 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 vertical 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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