HEART VALVE REPAIR DEVICE AND DELIVERY DEVICE THEREFOR - Patent application

Abstract

The implantable device or implant is configured to be positioned inside the native heart valve so that the native heart valve may form a more effective seal. In some embodiments, a plurality of sutures are used to secure a frame portion of the implantable device to a connector of the implantable device. Each of the sutures may pass through one or more lacing holes in the frame portion and the connector. In some embodiments, the implantable device includes an actuation cap having a flexible portion or biasing element positioned between an end portion of the actuation cap and an anchor portion of the implantable device. The flexible portion or biasing element is bent or compressed in response to a force between the connector and the actuation cap.

Description

[Technical field]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 310,553, filed February 15, 2022, which is incorporated by reference in its entirety herein. [Background technology]

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform important functions in ensuring the forward flow of blood to be properly delivered through the cardiovascular system. These heart valves can be damaged, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc., and therefore can be less effective. Such damage to the valves can lead to severe cardiovascular disorders or death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and complications can occur. Transvascular techniques can be used to introduce and implant devices to treat the heart in a much less invasive manner than open-heart surgery. As one example, a transvascular technique that can be used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting a catheter into the right femoral vein, ascending the inferior vena cava, and into the right atrium). The septum is then punctured and the catheter passed into the left atrium. A similar transvascular technique may be used, beginning as the transseptal technique but not going as far as puncturing the septum, and instead implanting a device inside the tricuspid valve that pivots the delivery catheter into the right atrium toward the tricuspid valve.

[0003] A healthy heart has a generally conical shape that tapers toward the apex and base. The heart is a four-chambered structure, including the left atrium, the right atrium, the left ventricle, and the right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure than other native heart valves. The mitral valve includes an annulus portion, which is a ring-shaped portion of native valve tissue that surrounds the mitral valve opening, and a pair of cusps or leaflets that extend downward from the annulus into the left ventricle. The mitral valve annulus may form a "D" shape, an elliptical shape, or other non-circular cross-sectional shape with major and minor axes. The anterior leaflet may be larger than the posterior leaflet, and when closed together, form a generally "C" shaped boundary between the abutting sides of the leaflets.

[0004] When operating properly, the anterior and posterior leaflets function together as a one-way valve that can only allow blood to flow from the left atrium to the left ventricle. The left atrium receives oxygen-rich blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle expands (also called "ventricular diastole" or "diastole"), the oxygen-rich blood that is 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 rising blood pressure in the left ventricle urges the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back into the left atrium, but instead is ejected out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, multiple fibrous chordae, called chordae tendineae, anchor the leaflets to papillary muscles in the left ventricle.

[0005] Valve regurgitation involves a valve inappropriately 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, allowing blood to flow from the left ventricle to the left atrium. Mitral regurgitation is one of the most common conditions of valvular heart disease. Mitral regurgitation can have many different causes, such as prolapse of the leaflets, insufficient papillary muscles, stretching of the mitral annulus from dilation of the left ventricle, or a combination 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 of the commissures 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 can be similar, except on the right side of the heart. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Pat. No. 8,449,599 [Patent Document 2] US Patent Application Publication No. 2014 / 0222136 [Patent Document 3] US Patent Application Publication No. 2014 / 0067052 [Patent Document 4] US Patent Application Publication No. 2016 / 0331523 [Patent Document 5] International Publication No. 2020 / 076898 Brochure [Patent Document 6] International Publication No. 2018 / 195215 Brochure [Patent Document 7] International Publication No. 2019 / 139904 Brochure [Patent Document 8] International Publication No. 2018 / 195201 Brochure Summary of the Invention

[0007] This summary of the present invention is intended to provide some examples and is not intended to limit the scope of the present invention in any way. For example, any feature included in the examples of this summary of the present invention is not required by the claims unless the claims explicitly recite that feature. 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.

[0008] In some implementations, a device or implant (eg, an implantable device, etc.) is provided that is configured to be positioned within the native heart valve so that the native heart valve can form a more effective seal.

[0009] In some implementations, the implantable device or implant includes an anchor portion, each anchor including a plurality of paddles, each movable between an open position and a closed position.

[0010] In some implementations, multiple sutures are used to secure the outer frame portion of the paddle to the connector, with each of the sutures passing through one or more lacing holes in the outer frame portion and the connector. One or more sutures optionally pass through connection anchors in the connector, providing additional strength and stability to the interface.

[0011] In some implementations, a device for repairing a native heart valve includes an anchor portion, a connector, and a plurality of sutures or other connection lines. The anchor portion is configured to connect to the leaflets of the native valve. The anchor portion includes a pair of frame portions that are movable between an expanded position and a stenotic position. The frame width in the stenotic position is smaller than the frame width in the expanded position.

[0012] In some implementations, each of the pair of frame portions has a lacing hole, and in some implementations, the connector has a lacing hole and a connection anchor (e.g., a tapered slot, a locking aperture, etc.) proximate the first end of the connector.

[0013] In some implementations, the lacing hole of the connector is positioned between the connection anchor and the first end of the connector, hi some implementations, the connector is positioned at least partially between a pair of frame portions such that the lacing holes of the frame portions and the lacing holes of the connector are aligned.

[0014] In some implementations, a plurality of sutures are configured to pass through the lacing holes of the connector and through the lacing holes of each of the pair of frame portions to connect the pair of frame portions to the connector.

[0015] In some implementations, at least one of the plurality of sutures passes through the connection anchor.

[0016] In some implementations, the plurality of sutures includes at least two sutures that pass through the connection anchor.

[0017] In some implementations, the multiple sutures pass through the lacing holes of the connector and each of the pair of frame portions more than once.

[0018] In some implementations, one or more of the plurality of sutures is secured to itself.

[0019] In some implementations, the plurality of sutures includes a first suture, a second suture, a third suture, and a fourth suture. In some implementations, the first suture and the second suture pass through the lacing hole of the connector and the lacing hole of each of the pair of frame portions and do not pass through the connection anchor. In some implementations, the third suture and the fourth suture pass through the lacing hole of the connector, the lacing hole of each of the pair of frame portions, and the connection anchor.

[0020] In some implementations, a sleeve is disposed around each of the frame portions.

[0021] In some implementations, each of the first suture and the second suture passes through a lacing hole of the connector and a lacing hole of each of the pair of frame portions, passes through a sleeve of the first frame portion, and passes back through the lacing hole of the connector and a lacing hole of each of the pair of frame portions.

[0022] In some implementations, a pair of frame portions rotate coaxially relative to the connector while the frame portions move between an expanded position and a constricted position.

[0023] In some implementations, the lacing holes of a pair of frame portions and the lacing holes of the connector are aligned along a common central axis while the frame portions move between the expanded and constricted positions.

[0024] The device may be used in methods of repairing a native heart valve. Such methods may be performed on a live animal or may be performed on a simulation, such as a cadaver, a cadaver heart, an anthropomorphic ghost, a simulator (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0025] In some implementations, a device for repairing a native heart valve includes an anchor portion, a connector, a first plurality of sutures, and a second plurality of sutures. The anchor portion can be configured to connect to the leaflets of the native valve. In some implementations, the anchor portion includes a pair of frame portions that are movable between a constricted position and an expanded position.

[0026] In some implementations, the frame portion has a frame width that is less than the width of the frame portion in the extended position.

[0027] In some implementations, each of the pair of frame portions has a lacing hole. In some implementations, the connector has a lacing hole and a connection anchor proximate the first end of the connector. In some implementations, the lacing hole of the connector is positioned between the connection anchor and the first end of the connector.

[0028] In some implementations, the connector is at least partially positioned between a pair of frame portions such that lacing holes in the frame portions and lacing holes in the connector are aligned.

[0029] In some implementations, a first plurality of sutures pass through the lacing hole of the connector and through the lacing hole of each of the pair of frame portions, hi some implementations, a second plurality of sutures pass through the lacing hole of the connector, through the lacing hole of each of the pair of frame portions, and through the connection anchor.

[0030] In some implementations, the first plurality of sutures do not pass through the connection anchor.

[0031] In some implementations, the first plurality of sutures and the second plurality of sutures are configured to attach the connector between the pair of frame portions such that the frame portions rotate coaxially relative to the connector while the frame portions move between the expanded and constricted positions.

[0032] In some implementations, the first plurality of sutures pass through the lacing holes of the connector and each of the pair of frame portions two or more times.

[0033] In some implementations, a sleeve is disposed around each of the frame portions.

[0034] In some implementations, the first plurality of sutures, at least a portion of the second plurality of sutures, or the first plurality of sutures and the second plurality of sutures pass through a sleeve of at least one of the frame portions.

[0035] In some implementations, each suture of the first plurality of sutures is secured to itself.

[0036] The device may be used in methods of repairing a native heart valve. Such methods may be performed on a live animal or may be performed on a simulation, such as a cadaver, a cadaver heart, an anthropomorphic ghost, a simulator (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0037] In some implementations, the implantable device includes an actuation cap having a flexible portion or biasing element positioned between a rounded portion of the actuation cap and a retention portion of the implantable device, In some implementations, the flexible portion or biasing element bends or compresses as a result of a force between the connection portion and the actuation cap, thereby reducing strain on the connector during delivery of the implantable device.

[0038] In some implementations, the implantable device includes a cap and an anchor portion. In some implementations, the cap has a hole that traverses the cap from a proximal end to a distal end. In some implementations, the anchor portion is configured to connect to the leaflets of the native valve. In some implementations, the anchor portion optionally includes a paddle frame, a connector, and a biasing element. In some implementations, the connector is coupled to the paddle frame. In some implementations, the connector has an inner end that extends through the hole in the cap.

[0039] In some implementations, retracting the inner end into the cap moves the paddle frame from an expanded position having an expanded width to a constricted position having a constricted width, hi some implementations, the expanded width is greater than the constricted width.

[0040] In some implementations, the biasing element is positioned between the cap and the anchor portion. In some implementations, the biasing element is configured to reduce a force between the cap and the paddle frame.

[0041] In some implementations, the anchor portion is configured to move between the closed and open positions with movement of the cap.

[0042] In some implementations, the cap includes a rounded portion extending between the interface element and the paddle frame and an attachment portion extending into the interface element, the attachment portion being configured to couple the cap to the interface element.

[0043] In some implementations, the biasing element is positioned between the rounded portion of the cap and the interface element.

[0044] In some implementations, the biasing element comprises a coil spring and / or a wave spring.

[0045] In some implementations, the biasing element is configured to reduce the force between the cap and the connector when the inner end of the connector moves into the cap to move the frame portion from the expanded position to the constricted position.

[0046] The device may be used in methods of repairing a native heart valve. Such methods may be performed on a live animal or may be performed on a simulation, such as a cadaver, a cadaver heart, an anthropomorphic ghost, a simulator (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0047] In some implementations, the implantable device includes a cap and an anchor portion. The cap has a hole traversing the cap from a proximal end to a distal end. In some implementations, the cap has one or more flexible portions at a distal end extending away from the hole. In some implementations, the anchor portion is configured to connect to the leaflets of the native valve. In some implementations, the anchor portion includes a paddle frame and a connector.

[0048] In some implementations, the connector is coupled to the paddle frame, hi some implementations, the connector has an inner end that extends through the hole in the cap.

[0049] In some implementations, retracting the inner end into the cap moves the paddle frame from an expanded position having an expanded width to a constricted position having a constricted width.

[0050] In some implementations, the expanded width is greater than the narrowed width.The anchor portion is configured to move between the open and closed positions with movement of the cap.

[0051] In some implementations, the one or more flexible portions are positioned between the frame portion and the interface element.

[0052] In some implementations, bending of the one or more flexible portions reduces the force between the cap and the connector.

[0053] In some implementations, the flexible portion bends toward the interface element when the inner end is retracted into the cap to move the paddle frame from the expanded position to the constricted position.

[0054] The device may be used in methods of repairing a native heart valve. Such methods may be performed on a live animal or may be performed on a simulation, such as a cadaver, a cadaver heart, an anthropomorphic ghost, a simulator (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0055] Any of the above systems, assemblies, devices, equipment, components, etc. may be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for patient use, and the above methods may include (or the additional methods may include or consist of) sterilization (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, equipment, components, etc. described herein.

[0056] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like elements bear like reference numerals and in which:

[0057] To further clarify various aspects of the implementation of the present disclosure, certain embodiments and implementations will be described in more detail by reference to various aspects of the accompanying drawings. These drawings depict only exemplary implementations of the present disclosure and are therefore not to be considered as limiting the scope of the present disclosure. Furthermore, the drawings may be drawn to scale for some embodiments, but 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 accompanying drawings. [Brief description of the drawings]

[0058] [Figure 1] FIG. 1 shows a cross-section of a human heart in diastole. [Diagram 2] FIG. 2 shows a cross-section of a human heart during systole. [Diagram 3] FIG. 3 shows a cross-section of a human heart during systole, showing mitral valve regurgitation. [Figure 4] FIG. 4 is a cross-sectional 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 an incompetent 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 illustrates one embodiment of an implantable device or implant at various stages of deployment. [Figure 9] FIG. 9 illustrates one embodiment of an implantable device or implant at various stages of deployment. [Figure 10] FIG. 10 illustrates one embodiment of an implantable device or implant at various stages of deployment. [Figure 11] FIG. 11 illustrates one embodiment of an implantable device or implant at various stages of deployment. [Figure 12] FIG. 12 illustrates one embodiment of an implantable device or implant at various stages of deployment. [Figure 13] FIG. 13 illustrates one embodiment of an implantable device or implant at various stages of deployment. [Figure 14] FIG. 14 illustrates one embodiment of an implantable device or implant at various stages of deployment. [Figure 15] FIG. 15 illustrates one embodiment of an implantable device or implant similar to the device illustrated in FIGS. 8-14, but in which the paddles are independently controllable. [Figure 16] FIG. 16 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 17] FIG. 17 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 18] FIG. 18 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 19] FIG. 19 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 20] FIG. 20 illustrates the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 21] FIG. 21 illustrates the exemplary 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 perspective view of an exemplary implantable device or implant in a closed position. [Figure 24] FIG. 24 illustrates an exemplary valve repair device with the paddles in the open position. [Figure 25A] FIG. 25A shows another exemplary valve repair device with the paddles in a closed position. [Figure 25B] FIG. 25B shows a top view of an exemplary valve repair device. [Figure 26] FIG. 26 shows a perspective view of an exemplary implantable device having paddles with adjustable width. [Figure 27] FIG. 27 is a cross-sectional view of the implantable device of FIG. 26, where the implantable device is bisected. [Figure 28] 28 is another cross-sectional view of the implantable device of FIG. 26, where the implantable device is bisected along a plane perpendicular to the plane shown in FIG. [Figure 29] FIG. 29 is a schematic diagram of an exemplary implant catheter assembly coupled to an implantable device, where the actuation elements are coupled to the paddle actuation controls and driver head of the implantable device. [Diagram 30] FIG. 30 is a view of the assembly of FIG. 29 with the implantable device rotated 90 degrees to show the paddle width adjustment element coupled to the inner end of the implantable device connector and coupled to the paddle width control. [Diagram 31] FIG. 31 is a diagram of an exemplary interface between a connector and an outer frame portion of an implantable device having adjustable paddle width. [Diagram 32] FIG. 32 is a side view of an exemplary interface including multiple sutures extending through connector lacing holes and an outer frame portion of an implantable device having adjustable paddle width. [Diagram 33] FIG. 33 is a perspective view of the example interface of FIG. [Figure 34A]FIG. 34A is an illustration of an embodiment of an interface that includes a first suture that extends through an lacing hole in the connector and outer frame portion and through a connection anchor in the connector of the implantable device. [Figure 34B] FIG. 34B is an illustration of an embodiment of an interface in which a second suture has been added to the interface of FIG. 34A, extending through an lacing hole in the connector and outer frame portion and through a connection anchor in the connector. [Figure 34C] FIG. 34C is an illustration of an embodiment of an interface in which a third suture has been added to the interface of FIG. 34B, the third suture extending through the connector and lacing holes in the outer frame portion. [Fig. 34D] FIG. 34D is an illustration of an embodiment of an interface in which a fourth suture has been added to the interface of FIG. 34C, extending through the connector and an eyelet in the outer frame portion. [Figure 35A] FIG. 35A is an illustration of an embodiment of an interface that includes a first suture that extends through an lacing hole in the connector and outer frame portion and through a connection anchor in the connector of the implantable device. [Figure 35B] FIG. 35B is an illustration of an embodiment of an interface in which the ends of the sutures of FIG. 34A are threaded through the lacing holes of the connector a second time. [Figure 35C] FIG. 35C is an illustration of an embodiment of an interface in which one end of a suture extending through an eyelet of the connector of FIG. 35B is threaded through one or more sleeves that surround the outer frame portion and connector. [Figure 35D] FIG. 35D shows an embodiment of an interface that includes three sutures that connect the connector to the outer frame portion of the implantable device. [Figure 35E] FIG. 35E shows an embodiment of an interface that includes three sutures that connect the connector to the outer frame portion of the implantable device. [Fig. 35F]FIG. 35F shows an embodiment of an interface that includes three sutures that connect the connector to the outer frame portion of the implantable device. [Figure 35G] FIG. 35G shows an embodiment of an interface that includes three sutures that connect the connector to the outer frame portion of the implantable device. [Fig. 35H] FIG. 35H shows an embodiment of an interface that includes three sutures that connect the connector to the outer frame portion of the implantable device. [Fig. 35I] FIG. 35I shows one embodiment of an interface that includes three sutures that connect the connector to the outer frame portion of the implantable device. [Diagram 36] FIG. 36 is a diagram of an embodiment of a distal end of an implantable device that includes an actuation cap having a rounded portion that extends between a retaining portion of the implantable device and a connector of a paddle of the implantable device. [Figure 37] FIG. 37 is a diagram of an embodiment of a distal end of an implantable device including an actuation cap having one or more flexible portions extending between a retaining portion of the implantable device and a connector of a paddle of the implantable device. [Figure 38] FIG. 38 is an illustration of an embodiment of a distal end of an implantable device that includes a biasing element positioned between a retaining portion of the implantable device and an actuation cap. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0059] In the following description, reference is made to the accompanying drawings which illustrate implementations of the present disclosure. Other implementations having different structure and operation do not depart from the scope of the present disclosure.

[0060] Implementations of the present disclosure are directed to systems, devices, methods, etc., for repairing defective heart valves. For example, implementations of valve repair devices, implantable devices, implants, and systems (including systems for delivering them) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or physically impossible. Furthermore, the techniques and methods herein can be performed on live animals, or on simulations such as cadavers, cadaver hearts, simulators (e.g., where body parts, hearts, tissues, etc. are simulated). The term "simulation" encompasses performing the method on a cadaver, a computer simulator, a virtual person (e.g., showing in air on a virtual heart), and the like.

[0061] As described herein, when one or more components are described as being connected, joined, fastened, coupled, attached, or otherwise interconnected, such interconnection may be direct, such as between the components, or may be indirect, such as through the use of one or more intermediate components. Also, references to a "member," "component," or "portion" described herein are not limited to a single structural member, component, or element, but may include an assembly of components, members, or elements. Also, as described herein, the terms "substantially" and "about" are defined as at least close to (and including) a given value or condition (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0062] 1 and 2 are cross-sectional 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 inwardly across their respective openings, which come together or "coapt" in flow to form a unidirectional fluid occlusion surface. The native 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.

[0063] The left atrium LA receives oxygen-rich blood from the lungs. During the expansion phase or diastole, seen in FIG. 1, blood already collected in the left atrium LA (during systole) moves through the mitral valve MV to the left ventricle LV due to the expansion of the left ventricle LV. During the contraction phase or systole, seen in FIG. 2, the left ventricle LV contracts to pump blood through the aortic valve AV and the ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV to the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In some implementations, the device described in this application is used to restore the function of a defective mitral valve MV. That is, the device is configured to assist in the closure of the leaflets of the mitral valve to prevent, inhibit, or reduce blood from flowing back from the left ventricle LV to the left atrium LA. Many of the devices described in this application are designed to easily grasp and secure the native valve leaflets around a coaptation element or spacer that beneficially acts as a filler in the regurgitant opening to prevent or reduce backflow or regurgitation during systole, although this is not required.

[0064] 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 (see Figure 5), which is a variably dense fibrous ring of 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 in the wall of the left ventricle LV at the base of the chordae tendineae CT) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM function to limit the movement of the leaflets 20, 22 of the mitral valve MV and to prevent the mitral valve MV from everting. 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 required to circulate blood throughout the body. Together, the papillary muscles PM and chordae tendineae CT are known as the subvalvular apparatus, which function to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As can be seen from the left ventricular outflow tract (LVOT) diagram shown in Figure 3, the anatomy of the leaflets 20, 22 is such that the inner surfaces of the leaflets meet at their free ends and the leaflets 20, 22 begin to retract or spread apart from each other. The leaflets 20, 22 spread apart toward the atrium until each leaflet contacts the mitral valve annulus.

[0065] 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 due to a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathies, etc.) can distort the geometry of the native valve, which can cause the native valve to malfunction. However, the majority of patients who undergo valve surgery, such as mitral valve MV surgery, 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), resulting in prolapse and regurgitation.

[0066] 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 impaired 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, causing blood to leak back into the previous heart chamber (e.g., blood leaks from the left ventricle into the left atrium).

[0067] There are three main mechanisms by which native valves become regurgitant or incompetent, including Carpentier's Type I, II, and III insufficiencies. Carpentier's Type I insufficiency involves dilatation of the valve annulus, so that normally functioning leaflets move apart and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in the insufficiency of the Type I mechanism is leaflet perforation, as occurs 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 restricted movement of one or more leaflets of the native valve, so that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease or ventricular dilatation.

[0068] With reference to FIG. 5, when a healthy mitral valve MV is in a closed position, the anterior leaflet 20 and the posterior leaflet 22 are coapted, thereby preventing blood from leaking from the left ventricle LV to the left atrium LA. With reference to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV are displaced into the left atrium LA during systole, so that the edges of the leaflets 20, 22 do not contact each other. Such malcoaptation creates a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow back from the left ventricle LV to the left atrium LA during systole, as shown by the mitral regurgitation MR flow path in FIG. 3. With reference to FIG. 6, the gap 26 may 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 may have a width W of greater than 15 mm or even greater than 17.5 mm. As discussed above, there are several different ways in which a valve leaflet (e.g., the leaflets 20, 22 of the mitral valve MV) may become incompetent, causing valve regurgitation.

[0069] In any of the above situations, a valve repair device or implant that can engage the anterior leaflets 20 and posterior leaflets 22 and close the gap 26 to prevent or inhibit backflow of blood through the mitral valve MV is desirable. As can be seen from 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 backflow does not occur during systole (compare FIG. 3 with FIG. 4). In some implementations, the coaptation elements (e.g., spacers, coaptation elements, gap fillers, etc.) of the device 10 have a generally tapered or triangular shape that naturally matches the geometry of the native valve and its tendency to expand (towards the annulus). In this application, terms such as spacer, coaption element, coaptation element and gap filler are used interchangeably and refer to elements that are 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 not only to each other but also to the coaptation element, spacer, etc.).

[0070] 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 burden on the heart H and, if left untreated, can result in extremely 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 pressure on the left side of the heart is substantially higher, insufficiency of the mitral valve MV or aortic valve AV is particularly problematic and often life-threatening.

[0071] Malfunctioning native heart valves can be either repaired or replaced. Repair typically involves preserving and correcting the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Because the stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic valve or pulmonary valve can be removal of the valve and replacing it with a surgically implanted heart valve, or replacing it 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, prevents the mitral valve MV or tricuspid valve TV from closing properly and allows regurgitation or backflow of blood from the ventricle to the atrium (e.g., a deformed mitral valve MV can allow regurgitation or backflow from the left ventricle LV to the left atrium LA, as shown in FIG. 3). Regurgitation or backflow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. In addition, regurgitation can occur due to incompetence of the chordae tendineae CT (e.g., the chordae tendineae CT can stretch or rupture), allowing the anterior leaflet 20 and the posterior leaflet 22 to evertate, resulting in blood flowing back into the left atrium LA. Problems caused by incompetent chordae tendineae CT can be ameliorated by repairing the structure of the chordae tendineae CT or the mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0072] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it is understood that the devices and concepts provided herein can be used to repair any native valve, as well as any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit 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, the septal leaflet 32, and the posterior leaflet 34 to prevent or inhibit backflow of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein can be used on all three of the leaflets 30, 32, 34 together to prevent or inhibit backflow of blood from the right ventricle to the right atrium. That is, the valve repair device or implant provided herein can be centrally located between the three leaflets 30, 32, 34.

[0073] An exemplary implantable device or implant may optionally have a coaptation element (e.g., a spacer, coaptation element, 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 coaptation element, a spacer, etc.) is configured to be positioned within the native heart valve opening to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting the above-mentioned backflow. The coaptation element may be impermeable to blood (or resist blood flow therethrough) and may have a structure that allows the native leaflets to close around the coaptation element during ventricular systole, thereby blocking backflow of blood 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 native tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element may fill the space between dysfunctional native valve leaflets (e.g., mitral leaflets 20, 22 or tricuspid leaflets 30, 32, 34) that do not close completely.

[0074] The optional coaptation elements (spacers, coaptation elements, gap fillers, etc.) may have a variety of shapes. In some implementations, the coaptation elements may have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the coaptation elements may have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or a variety of other non-cylindrical shapes. In some implementations, the coaptation elements may have an atrial portion positioned in or adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a lateral surface extending between the native leaflets. In some implementations configured for use with a tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the lateral surface extends between the native tricuspid leaflets.

[0075] 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 are configured to secure the device to one, two, or three of the tricuspid leaflets 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 actuation element (e.g., actuation shaft, actuation tube, actuation wire, etc.) to which the coaptation element is also attached. In some implementations, the anchors and coaptation elements can be independently positioned relative to one another by separately moving each of the anchors and coaptation elements along a longitudinal axis of the actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.). In some implementations, the anchors and coaptation elements can be simultaneously positioned by moving the anchors and coaptation elements together along a longitudinal axis of the actuation element (e.g., shaft, actuation wire, etc.). The anchors can be configured to be positioned behind the native valve leaflets when implanted such that the leaflets are grasped by the anchors.

[0076] 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 may be self-expandable to a radially expanded state when the compressive pressure is released. The device may be configured such that the anchor is expanded radially away from the initially 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 expanded radially to close the gap between the coaptation element and the anchor to capture the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to be self-expanding. The implantation method may vary and is described more fully below for each implementation. Additional information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599, U.S. Patent Application Publication No. 2014 / 0222136, U.S. Patent Application Publication No. 2014 / 0067052, U.S. Patent Application Publication No. 2016 / 0331523, and PCT Patent Application Publication No. WO2020 / 076898, which are incorporated by reference in their entirety for all purposes. These methods can be performed, mutatis mutandis, on live animals or can be performed on simulations, such as cadavers, cadaver hearts, virtual people, simulators (e.g., where body parts, hearts, tissues, etc. are simulated), etc.

[0077] The disclosed device or implant may be configured such that anchors are connected to the leaflets and utilize tension from the natural chordae tendineae to resist high systolic pressures that urge 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.

[0078] 8-15, a schematic representation of an implantable device or implant 100 (e.g., an implantable prosthetic device, prosthetic spacer device, valve repair device, etc.) is shown in various stages of deployment. The device or implant 100, as well as 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. The device 100 may include any other features of another implantable device or implant described in this application or the applications cited above, and the device 100 may be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the applications cited above).

[0079] 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.

[0080] In some implementations, the interface portion 104 of the device or implant 100 is adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and includes an interface element 110 slidably attached to an actuation element 112 (e.g., an actuation wire, an actuation shaft, an actuation tube, etc.). The anchor portion 106 includes one or more anchors 108 that are actuable between an open state and a closed state and can take a wide variety of forms, such as, for example, a paddle, a gripping element, or the like. When the actuation element 112 is actuated, the anchor portion 106 of the device 100 opens and closes to grip the leaflets of the native valve during implantation. The actuation element 112 (as well as other actuation elements disclosed herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), can be made from a variety of different materials, and can have a variety of configurations. As one example, the actuating element can be threaded such that when the actuating element is rotated, the anchor portion 106 moves relative to the interface portion 104. Alternatively, the actuating element can be unthreaded such that pushing or retracting the actuating element 112 moves the anchor portion 106 relative to the interface portion 104.

[0081] 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 element 110 by portions 124, 126, 128. The portions 124, 126, 128 may be articulated and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 120, inner paddle 122, interface element 110, and cap 114 by portions 124, 126, 128 may constrain the device to the positions and movements shown herein.

[0082] In some implementations, the delivery system 102 includes a steerable catheter, an implant catheter, and an actuating element 112 (e.g., an actuating wire, an actuating shaft, etc.), which may be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuating element 112 extends through the delivery catheter and the interface 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 actuating element 112 increases and decreases the spacing between the interface element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), 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 element 110 during actuation, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0083] 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 catch 130 including a base or fixed arm 132, a movable arm 134, optional friction enhancing elements, other securing structures 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and an interface 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 interface portion 138 disposed proximate to the interface element 110. The interface portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the catch 130. The interface portion 138 may be any suitable interface, such as a flexible interface, a spring interface, a pivot interface, or the like. In some implementations, interface 138 is a flexible piece of material integrally formed with fixed arm 132 and movable arm 134. Fixed arm 132 is attached to inner paddle 122 and remains stationary or substantially stationary relative to inner paddle 122 when movable arm 134 is in an open state, opening clasp 130 and exposing optional barbs or other friction enhancing elements 136 (ridges, roughened surfaces, etc.).

[0084] 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 138. The actuation line 116 extends through the delivery system 102 (e.g., through the steerable catheter and / or the implant catheter). Other actuation mechanisms are also possible.

[0085] The actuation line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The clasp 130 can be spring loaded so that the clasp 130 continues to provide a clamping force to the grasped native leaflet in the closed position. Optional barbs or frictional reinforcement elements 136 of the clasp 130 can grasp, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0086] During implantation, the paddles 120, 122 may be opened and closed, for example, to grip the native leaflets (e.g., leaflets of a native mitral valve, etc.) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation element 110 (e.g., spacer, plug, membrane, etc.). The clasps 130 may be used to grip and / or further secure the native leaflets by engaging the leaflets with optional barbs or other friction enhancing elements 136 and clamping the leaflets between the movable arm 134 and the fixed arm 132. The optional barbs, friction enhancing elements or other fixation structures 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) of the clasps 130 may increase friction with the leaflets or partially or completely puncture the leaflets. The actuation lines 116 may be actuated separately such that each clasp 130 may be opened and closed separately. Acting separately allows one leaflet to be grasped at a time, or the clasp 130 to be repositioned on a leaflet that was not adequately grasped without changing the good grip on the other leaflets. 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), allowing the leaflets to be grasped in various positions as the particular situation requires.

[0087] 8, the device 100 is shown in an extended 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 of the delivery system 102 in the fully open position. In the extended state, the cap 114 is spaced apart from the interface element 110 such that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the interior of the outer paddle 120 and the inner paddle 122 is about 180 degrees. The clasp 130 can be held closed during deployment through the delivery system. The actuation line 116 can extend to and be attached to a movable arm 134.

[0088] 9, device 100 is shown in an extended state similar to FIG. 8, but with clasp 130 in a range of about 140 degrees to about 200 degrees, in a range of about 170 degrees to about 190 degrees, or in a fully open position of about 180 degrees between fixed portion 132 and movable portion 134 of clasp 130.

[0089] 10, the device 100 is shown in a contracted or fully closed state. To move the device 100 from the extended state to the contracted state, the actuation element 112 is retracted, pulling the cap 114 towards the interface 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, so that the compressive force acting on the outer paddle 120 from the cap 114 retracting towards the interface element 110 moves the paddle or gripping element radially outward. The outer paddle 120 maintains an acute angle with the actuation element 112 during movement from the open position to the closed position. The outer paddle 120 can optionally be biased towards the closed position. The inner paddle 122 moves over a very large angle and crushes along the side of the closed interface element 110 because it is oriented away from the open interface element 110 during the same movement.

[0090] 11-13, the device 100 is shown in a partially open, ready-to-grasp state. To move from a fully closed state to a partially open state, an actuation element (e.g., actuation wire, actuation shaft, etc.) is extended to push the cap 114 away from the coaptation element 110, thereby pulling the outer paddle 120 and then the inner paddle 122, causing the anchor or anchor portion 106 to partially unfold. The actuation line 116 is also retracted to open the clasp 130 so that the leaflets can be grasped. In some implementations, the pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation 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 the paddles 122, 120 also closes the clasp. In some implementations, the paddles 120, 122 can be independently controllable. In the embodiment shown in FIG. 15, the device 100 may have two actuating elements 111, 113 and two independent caps 115, 117 (or other mounting parts), such that one independent actuating element (e.g., a wire, shaft, etc.) and cap (or other mounting part) is used to control one paddle and the other independent actuating element and cap (or other mounting part) is used to control the other paddle.

[0091] 12, one of the actuation lines 116 can be extended to close one of the clasps 130. Now, referring to FIGURE 13, the other actuation line 116 can be extended to close the other clasp 130. Either or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0092] 14, the device 100 is shown in a fully closed and deployed state. The delivery system 102 and actuation element 112 are retracted and the paddles 120, 122 and clasp 130 remain in a 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 a spring material such as steel, other metals, plastics, composites, or a shape memory alloy such as Nitinol. For example, the connecting portions 124, 126, 128, the interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from a metal such as steel or from a shape memory alloy such as Nitinol that is fabricated into a wire, sheet, tube, or laser sintered powder and biased to hold the outer paddle 120 closed around the interface element 110 and the clasp 130 in a clamped state 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 interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from metal or any other suitable resilient material, such as a polymeric material, to maintain the device 100 in a closed state after implantation.

[0093] Figure 15 shows an embodiment in which the paddles 120, 122 are independently controllable. The device 101 shown in Figure 15 is similar to the device shown in 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. The actuation element 111 is extended to push the cap 115 away from the interface element 110 to transition the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the first anchor 108 to partially expand. The actuation element 113 is extended to push the cap 115 away from the spacer or mating element 110 to transition the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchor 108 to partially expand. The independent paddle control shown in Figure 15 can be implemented in any of the devices disclosed in this application. For comparison, in the embodiment shown in Figure 11, the pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation element 112.

[0094] 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. With reference 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 shown in Figure 16. The actuating element 112 is then retracted, moving the implant / device to a fully closed state as shown in Figure 17.

[0095] As can be seen from Figure 18, the implant / device can be moved into position within the mitral valve MV and into the ventricle LV and partially opened to grasp the leaflets 20, 22. For example, the steerable catheter can be advanced and steered or bent to position the steerable catheter as Figure 18 shows. An implant catheter connected to the implant / device can be advanced from within the steerable catheter to position the implant as Figure 18 shows.

[0096] 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 line 116 is extended to close one of the clasps 130, capturing the leaflet 20. FIG. 20 shows the other actuating line 116 then being extended to close the other clasp 130, capturing the remaining leaflet 22. Finally, as can be seen from FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), actuating element 112 and actuating line 116 are then retracted and the device or implant 100 is fully closed and deployed within the native mitral valve MV.

[0097] Any of the features disclosed herein may be used in a wide variety of different valve repair devices. Figures 22-24 show examples of valve repair devices that may be modified to include any of the features disclosed herein. Any combination or subcombination of the features disclosed herein may be combined with, substituted for, and / or added to any combination or subcombination of the features of the valve repair devices shown in Figures 8-24.

[0098] 22, an embodiment of an implantable device or implant 200 is shown. The implantable device 200 is one of many different configurations that the device 100, shown generally in FIGS. 8-14, may take. The device 200 may include any of the other features of an implantable device or implant described herein, and the device 200 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system, such as any of the valve repair systems disclosed herein. The device / implant 200 may be an artificial spacer device, a valve repair device, or another type of implant that is attached to the leaflets of a native valve.

[0099] In some implementations, the implantable device or implant 200 includes a coaptation portion 204, a proximal or attachment portion 209, 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, coaptation element, plug, membrane, sheet, gap filler, etc.) for implantation between the leaflets of the native valve. In some implementations, the anchor portion 206 includes multiple 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 or frame 224, and a clasp 230. In some implementations, the attachment portion 209 includes a first or proximal collar 211 (or other attachment element) for engaging a capture mechanism (e.g., a coupler, etc.) of a delivery system. The delivery system for device 200 may be the same as or similar to delivery system 102 described above and may comprise 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.

[0100] In some implementations, the joint elements 210 and paddles 220, 222 are formed from a flexible material, which may be a metal fabric formed as a mesh, woven fabric, braided fabric, or the like, or in any other suitable manner, or a flexible material that is laser cut or otherwise cut. The material may be a fabric, a shape memory alloy wire, such as Nitinol, to provide shape setting capabilities, or any other flexible material suitable for implantation within the human body.

[0101] An actuating element (e.g., an actuating shaft, actuating rod, actuating tube, actuating wire, actuating line, etc.) may extend from the delivery system and engage the implantable device or implant 200 to enable actuation thereof. In some implementations, the actuating element extends through the proximal collar 211 and the spacer or interface element 210 and engages the cap 214 of the distal portion 207. The actuating element may be configured to releasably engage the cap 214, such as with a threaded connection, such that the actuating element may be disengaged and removed from the device 200 after implantation.

[0102] 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, circular shape, although other shapes and configurations are possible. In some implementations, the coaptation element 210 has an elliptical shape or cross-section when viewed from above, a tapered shape or cross-section when viewed from the front, and a circular shape or cross-section when viewed from the side. A mixture of these three geometries may result in the illustrated three-dimensional shape of the coaptation element 210 that achieves the benefits described herein. The round shape of the coaptation element 210 may also be seen to substantially follow or approximate the shape of the paddle frame 224 when viewed from above.

[0103] The size and / or shape of the coaptation element 210 may be selected to minimize the number of implants required per patient (preferably one) while maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the apex of the coaptation element is about 5 mm, and the medial-lateral distance at the widest point of the coaptation element 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 plan described above. It will be readily apparent that using other anterior-posterior and medial-lateral distances as a starting point for the device will result in a device with different dimensions. Additionally, using other dimensions and the shape plan described above will also result in a device with different dimensions.

[0104] In some implementations, the outer paddle 220 is joinably 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 joinably 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 an upper portion of a leg, the outer paddle 220 is like a lower portion of a leg, and the connecting portion 223 is like a knee portion of a leg.

[0105] In some implementations, the inner paddle 222 is hard, relatively hard, rigid, has a rigid portion, and / or is rigidified by a stiffening member (e.g., a bar, plate, laminate, etc.) or a fixed portion of the fastener 230. The inner paddle 222, the outer paddle 220, and the interface elements may all be interconnected as described herein.

[0106] 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 paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is formed from a material that is stiffer and harder than the material forming the paddles 222, 220 such that the paddle frame 224 provides support to the paddles 222, 220.

[0107] The paddle frame 224 may provide additional clamping force between the inner paddle 222 and the coaptation element 210 and may help wrap the leaflets around the sides of the coaptation element 210. That is, the paddle frame 224 may be configured with a rounded 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 and 222, the cap 214, and the coaptation element 210 may constrain each of these components to the movements and positions described herein. In particular, the connecting portion 223 is constrained by its connections between the outer and inner paddles 220 and 222, and by its connections to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connecting portion 223 (and thus the inner and outer paddles 222 and 220) and by its attachment to the cap 214.

[0108] Configuring the paddle frame 224 in this manner widens the surface area, as compared to only the inner paddle 222. The increased surface area may also distribute the clamping force of the paddles 220 and paddle frame 224 against the native leaflet over a larger area of ​​the native leaflet to further protect the native leaflet tissue.

[0109] Additional features of the device 200, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215). Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215). Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) is incorporated herein by reference in its entirety.

[0110] 23, there is shown one embodiment of an implantable device or implant 300. The implantable device 300 is one of many different configurations that the device 100 may assume, as shown generally in Figures 8-14. The device 300 may include any of the other features of an implantable device or implant described herein, and the device 300 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0111] 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 that optionally includes 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 can include one or more paddles, for example, an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchors can 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 a capture mechanism of a delivery system.

[0112] The anchors 308 may be attached to other portions of the device and / or to each other in a variety of different manners (e.g., directly, indirectly, by welding, by sutures, by adhesive, by links, by latches, by integral formation, by combinations of any or all of these, etc.) In some implementations, the anchors 308 are attached to the interface element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0113] The anchor 308 may include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connecting portion 323. The connecting portion 323 may be attached to a paddle frame 324 that is hingedly attached 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 a leg.

[0114] In some implementations including the interface element 310, the interface element 310 and the anchor 308 may be coupled together in a variety of ways. As shown in the illustrated embodiment, 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 piece 301 of braided or woven material, such as braided or interwoven Nitinol wire. In the illustrated embodiment, the interface element 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, 325 are formed from a continuous piece of fabric 301.

[0115] 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 a distal end of the device (e.g., cap 314, etc.) relative to a proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.). This movement may be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device.

[0116] 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 spacer or coaptation element 310. From the straight configuration, the anchor 308 can be moved to a fully collapsed configuration (e.g., FIG. 23), for example, by moving the proximal and distal ends toward each other and / or toward the midpoint or center of the device.

[0117] In some implementations, the clasp comprises a movable arm coupled to the anchor. In some implementations, the clasp 330 includes a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancing element 336, and an interface portion 338. The fixed arm 332 is attached to the inner paddle 322 with the interface portion 338 disposed proximate to the interface element 310. The interface portion 338 is spring loaded such that the fixed arm 332 and the movable arm 334 are biased toward each other when the clasp 330 is in a closed state.

[0118] The fixed arm 332 is attached to the inner paddle 322 by sutures through a hole or slot. 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, welding, adhesive, or the like. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is opened to open the clasp 330 and expose the optional barb 336. The clasp 330 is opened by applying tension to an actuation line attached to the movable arm 334, thereby causing the movable arm 334 to articulate, pivot, and / or bend on the interface 338.

[0119] 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 piece of material 301. In some implementations, the piece 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, in the cap 314, and in the paddle frame 324 that are configured to receive the continuous piece of material 301. The continuous piece 301 can be a single layer of material or can include two or more layers. In some implementations, portions of the device 300 have a single layer of material 301, and other portions are formed from multiple overlapping or overlapping layers of the piece of material 301.

[0120] For example, Figure 23 shows a joining element 310 and inner paddle 322 formed from multiple overlapping layers of material strips 301. The single continuous piece of material 301 may begin and end at various locations on the apparatus 300. The ends of the piece of material 301 may be at the same location or at different locations on the apparatus 300. For example, in the illustrated embodiment of Figure 23, the piece of material 301 begins and ends at the location of the inner paddle 322.

[0121] As with the implantable device or implant 200 described above, the size of the coaptation element 310 may be selected to minimize the number of implants required per patient (preferably one), while at the same time maintaining a low transvalvular gradient. Notably, by forming many of the components of the device 300 from a single piece of material 301, the device 300 may 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 at the widest point of the device 300 (i.e., the width of the paddle frame 324, which is wider than the coaptation element 310) is approximately 5 mm.

[0122] Additional features of the device 300, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898). Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898). Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) is incorporated herein by reference in its entirety.

[0123] 24 illustrates another embodiment of one of many valve repair systems 400 for repairing a patient's native valve to which the concepts of the present application may be applied. The valve repair system 400 includes a delivery device 401 and a valve repair device 402.

[0124] The valve repair device 402 includes a base assembly 404, a pair of paddles 406, and a pair of gripping members 408. In one embodiment, the paddles 406 can be formed integrally with the base assembly. For example, the paddles 406 can be formed as an extension of a link of the base assembly. In the illustrated embodiment, the base assembly 404 of the valve repair device 402 includes a shaft 403, a coupler 405 configured to move along the shaft, and a lock 407 configured to lock the coupler in a stationary position on the shaft. The coupler 405 is mechanically connected to the paddles 406 such that moving the coupler 405 along the shaft 403 moves the paddles between an open position and a closed position. In this manner, the coupler 405 serves as a means for mechanically coupling the paddles 406 to the shaft 403 and for moving the paddles 406 between their open and closed positions when moved along the shaft 403.

[0125] In some implementations, the gripping member 408 is pivotally connected to the base assembly 404 such that the gripping member can be moved to adjust the width of the opening 414 between the paddle 406 and the gripping member 408 (e.g., the gripping member 408 can be pivotally connected to the shaft 403 or any other suitable member of the base assembly). The gripping member 408 can optionally include an optional barbed portion 409 for attaching the gripping member to the valve tissue when the valve repair device 402 is attached to the valve tissue. When the paddle 406 is in the closed position, the paddle engages the gripping member 408 such that when the valve tissue is attached to the barbed portion 409 of the gripping member, the paddle secures the valve repair device 402 to the valve tissue. In some implementations, the gripping member 408 is configured to engage the paddle 406 such that the barbed portion 409 engages the valve tissue member and the paddle 406 to secure the valve repair device 402 to the valve tissue member. For example, in certain circumstances it may be advantageous to have the paddle 406 maintain an open position and have the gripping member 408 move outwardly toward the paddle 406 to engage the valve tissue and the paddle 406.

[0126] Although the embodiment shown in FIG. 24 shows a pair of paddles 406 and a pair of gripping members 408, it will be understood that the valve repair device 402 may include any suitable number of paddles and gripping members.

[0127] In some implementations, the valve repair system 400 includes a placement shaft 413 that is removably attached to the shaft 403 of the base assembly 404 of the valve repair device 402. The placement shaft 413 is detached from the shaft 403 after the valve repair device 402 is secured to the valve tissue, removing the valve repair device 402 from the remainder of the valve repair system 400 such that the valve repair device 402 can remain attached to the valve tissue and the delivery device 401 can be removed from the patient's body.

[0128] The valve repair system 400 may also include a paddle control mechanism 410, a gripper control mechanism 411, and a lock control mechanism 412. The paddle control mechanism 410 is mechanically attached to the coupler 405 to drive the paddle 406 between the open and closed positions by driving the coupler along the shaft. The paddle control mechanism 410 may take any suitable form, such as, for example, a shaft or rod. For example, the paddle control mechanism may include a hollow shaft, a catheter tube, or a sleeve that fits over the deployment shaft 413 and over the shaft 403 and connected to the coupler 405.

[0129] Gripper control mechanism 411 is configured to drive gripping member 408 to vary the width of opening 414 between the gripping member and paddle 406. Gripper control mechanism 411 may take any suitable form, such as, for example, a line, suture or wire, a rod, a catheter, etc.

[0130] The lock control mechanism 412 is configured to lock and unlock the lock. The lock 407 serves as a locking means for locking the coupler 405 in a stationary position relative to the shaft 403 and can take a wide variety of different forms, and the type of lock control mechanism 412 can be dictated by the type of lock used. In embodiments where the lock 407 includes a pivotable plate, the lock control mechanism 412 is configured to engage the pivotable plate to move the plate between the tilted position and the substantially non-tilted position. The lock control mechanism 412 can be, for example, a rod, suture, wire, or any other member capable of moving the pivotable plate of the lock 407 between the tilted position and the substantially non-tilted position.

[0131] The valve restoration device 402 is movable from an open position to a closed position. The base assembly 404 includes a link that is moved by a coupler 405. The coupler 405 is movably attached to a shaft 403. To move the valve restoration device from the open position to the closed position, the coupler 405 is moved along the shaft 403, thereby moving the link.

[0132] The gripper control mechanism 411 moves the gripping members 408 to provide a wider or narrower gap at the opening 414 between the gripping members and the paddle 406. In the illustrated embodiment, the gripper control mechanism 411 includes a line, such as a suture, wire, or the like, that is connected to an opening in the end of the gripping members 408. When the line is pulled, the gripping members 408 move inward, causing the opening 414 between the gripping members and the paddle 406 to become wider.

[0133] To move the valve restoration device 402 from an open position to a closed position, the lock 407 is moved to an unlocked state by the lock control mechanism 412. Once the lock 407 is in the unlocked state, the coupler 405 can be moved along the shaft 403 by the paddle control mechanism 410.

[0134] After the paddle 406 is moved to the closed position, the lock 407 is moved to a locked state by the lock control mechanism 412 to maintain the valve repair device 402 in the closed position. After the valve repair device 402 is maintained in the locked state by the lock 407, the valve repair device 402 is removed from the delivery device 401 by decoupling the shaft 403 from the mounting shaft 413. Additionally, the valve repair device 402 is removed from the paddle control mechanism 410, the gripper control mechanism 411, and the lock control mechanism 412.

[0135] Additional features of the device 402, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019 / 139904). Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019 / 139904). Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019 / 139904) is incorporated herein by reference in its entirety.

[0136] The clasp or leaflet grasping device disclosed herein can take a wide variety of different forms. An example of a clasp is disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018 / 195201). Any combination or subcombination of the features disclosed by this application can be combined with any combination or subcombination of the features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018 / 195201). Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018 / 195201) is incorporated herein by reference in its entirety.

[0137] As shown in FIGS. 25A and 25B, in some implementations, the valve repair device 402 has a coaptation element 3800. The valve repair device 402 may have the same configuration as the valve repair device shown in FIG. 24 with the addition of the coaptation element. The coaptation element 3800 may take a wide variety of different shapes. The coaptation element 3800 may be compressible and / or expandable. For example, the coaptation element may be compressed to fit within one or more catheters of a delivery system, may expand when moved out of the one or more catheters, and / or may be compressed by paddles 406 to adjust the size of the spacer or coaptation element. In the example shown in FIGS. 25A and 25B, the size of the coaptation element 3800 may be decreased by squeezing the coaptation element with the paddles 406 and increased by moving the paddles 406 away from each other. The coaptation element 3800 may extend beyond the outer edge 4001 of the gripping member or clasp 408 as illustrated to provide additional surface area for closing the gap of the mitral valve.

[0138] The coaptation element 3800 may be coupled to the valve repair device 402 in a variety of different ways. For example, the coaptation element 3800 may be fixed to the shaft 403, slidably disposed about the shaft, connected to the coupler 405, connected to the lock 407, and / or connected to a central portion of the catch or gripping member 408. In some implementations, the coupler 405 may take the form of the coaptation element 3800. That is, a single element may be used as the coupler 405, which moves the paddle 406 between the open and closed positions, and the coaptation element 3800, which closes the gap between the leaflets 20, 22 when the valve repair device 402 is attached to the leaflets.

[0139] The interface element 3800 can be disposed about one or more of the shafts or other control elements of the valve repair system 400. For example, the interface element 3800 can be disposed about the shaft 403, the shaft 413, the paddle control mechanism 410, and / or the lock control mechanism 412.

[0140] The valve repair device 402 may include any other features for the valve repair device discussed in this application, and the valve repair device 402 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). Additional features of the device 402, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019 / 139904). Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019 / 139904).

[0141] 26-30 show another embodiment of one of many valve repair systems for repairing a patient's native valve to which the concepts of the present application may be applied. With reference to FIGS. 29 and 30, the valve repair system includes an implant catheter assembly 1611 and an implantable valve repair device 8200. With reference to FIGS. 26-28, the implantable device 8200 includes a proximal or attachment portion 8205, a paddle frame 8224, and a distal portion 8207. The attachment portion 8205, the distal portion 8207, and the paddle frame 8224 may be configured in a variety of ways.

[0142] 26, the paddle frame 8224 may be symmetrical along the longitudinal axis YY. However, in some implementations, the paddle frame 8224 is not symmetrical about the axis YY. Further, with reference to FIG. 26, the paddle frame 8224 includes an outer frame portion 8256 and an inner frame portion 8260.

[0143] In some implementations, the connector 8266 (e.g., a shaped metal component, a shaped plastic component, a tether, a wire, a post, a line, a cord, a suture, etc.) is attached to the outer frame portion 8256 at an outer end of the connector 8266 and to the coupler 8972 at an inner end 8968 of the connector 8266 (see FIG. 28 ). Between the connector 8266 and the attachment portion 8205, the outer frame portion 8256 forms a curved shape. For example, in the illustrated embodiment, the shape of the outer frame portion 8256 resembles an apple shape, where the outer frame portion 8256 is wider toward the attachment portion 8205 and narrower toward the distal portion 8207. However, in some implementations, the outer frame portion 8256 may be shaped in other ways.

[0144] The inner frame portion 8260 extends from the mounting portion 8205 toward the distal portion 8207. The inner frame portion 8260 then extends inwardly to form a retaining portion 8272 that is attached to the actuation cap 8214. The retaining portion 8272 and the actuation cap 8214 can be configured to be attached in any suitable manner.

[0145] In some implementations, the inner frame portion 8260 is a rigid frame portion, while the outer frame portion 8256 is a flexible frame portion. As shown in FIG. 26 , the proximal end of the outer frame portion 8256 connects to the proximal end of the inner frame portion 8260.

[0146] The width adjustment element 8211 (e.g., a width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment screw or bolt, etc.) is configured to move the outer frame portion 8256 from the expanded position to the constricted position by retracting the inner end 8968 ( FIG. 28 ) and a portion of the connector 8266 into the actuation cap 8214. The actuation element 8102, according to some implementations disclosed herein, is configured to move the inner frame portion 8260 to open and close the paddles.

[0147] As shown in FIGS. 27 and 28 , the connector 8266 has an inner end 8968 that engages with the width adjustment element 8211 such that a user can move the inner end 8968 inside the receiver 8912 (e.g., an internally threaded element, a column, a conduit, a hollow member, a notched receiving portion, a tube, a shaft, a sleeve, a post, a housing, a cylinder, a raceway, etc.) to move the outer frame portion 8256 between a constricted position and an expanded position. In the illustrated embodiment, the inner end 8968 includes a post 8970 that is attached to the outer frame portion 8256 and a coupler 8972 that extends from the post 8970. The coupler 8972 is configured to be attached to and detached from both the width adjustment element 8211 and the receiver 8912. The coupler 8972 can take a wide variety of different forms. For example, the coupler 8972 may include one or more of a threaded connection, a mechanism that mates with a thread, an outwardly biased arm, a detent connection such as a wall, or other portion. When the coupler 8972 is attached to the width adjustment element 8211, the coupler is released from the receiver 8912. When the coupler 8972 is removed from the width adjustment element 8211, the coupler is secured to the receiver. However, the inner end 8968 of the connector may be configured in a variety of ways. Any configuration may be used that can suitably attach the outer frame portion 8256 to the coupler so that the width adjustment element 8211 can move the outer frame portion 8256 between the constricted position and the expanded position. The coupler may be similarly configured in a variety of ways and may be a separate component or may be integrated with another portion of the device, such as the connector or another portion of the inner end of the connector.

[0148] The width adjustment element 8211 allows a user to expand or contract the outer frame portion 8256 of the implantable device 8200. In the embodiment shown in FIGS. 27 and 28 , the width adjustment element 8211 includes a male threaded end that screws into the coupler 8972. The width adjustment element 8211 moves the coupler into the receiver 8912 to adjust the width of the outer frame portion 8256. When the width adjustment element 8211 is unscrewed from the coupler 8972, the coupler engages the inner surface of the receiver 8912 to set the width of the outer frame portion 8256.

[0149] In some implementations, the receiver 8912 may be integrally formed with the distal cap 8214. Moving the cap 8214 relative to the body of the mounting portion 8205 opens and closes the paddle. In the illustrated embodiment, the receiver 8912 slides inside the body of the mounting portion. When the coupler 8972 is removed from the width adjustment element 8211, the width of the outer frame portion 8256 is fixed while the actuation element 8102 moves the receiver 8912 and cap 8214 relative to the body of the mounting portion 8205. Moving the cap may open and close the device in the same manner as any of the other implementations disclosed above.

[0150] In the illustrated embodiment, the driver head 8916 is disposed at a proximal end of the actuating element 8102. The driver head 8916 removably couples the actuating element 8102 to the receiver 8912. In the illustrated embodiment, the width adjustment element 8211 extends through the actuating element 8102. The actuating element is advanced axially in the opposite direction to the Y direction to move the distal cap 8214. As shown by the arrows in FIG. 27, movement of the distal cap 8214 relative to the mounting portion 8205 is effective to open and close the paddle. That is, when the distal cap 8214 is moved in the Y direction, the device is closed, and when the distal cap is moved in the opposite direction to the Y direction, the device is opened.

[0151] 27 and 28, the width adjustment element 8211 extends through the actuation element 8102, the driver head 8916, and the receiver 8912 and engages a coupler 8972 attached to the inner end 8968. When the outer frame portion 8256 is moved to the constricted position, the device or implant 8200 may be easily maneuvered into position for implantation into the heart by reducing contact and / or friction between the native structures of the heart (e.g., chordae tendineae) and the device 8200. When the outer frame portion 8256 is moved to the expanded position, the anchor portions of the device or implant 8200 are provided with a larger surface area to engage and capture the leaflets of the native heart valve.

[0152] 29 and 30, an implementation of an implant catheter assembly 1611 is shown in which the clasp actuation line 624 extends through the handle 1616, the actuation element 8102 is coupled to a paddle actuation control 1626, and the width adjustment element 8211 is coupled to a paddle width control 1628. A proximal end portion 1622a of the shaft or catheter of the implant catheter assembly 1611 may be coupled to the handle 1616, and a distal end portion 1622b of the shaft or catheter may be coupled to the implantable device 8200. The actuation element 8102 may extend distally from the paddle actuation control 1626, through the handle 1616, through the delivery shaft or catheter of the implant catheter assembly 1611, and through the proximal end of the device 8200, where the actuation element couples with a driver head 8916. The actuation element 8102 may be axially movable relative to the outer shaft of the implant catheter assembly 1611 and handle 1616 to open and close the device.

[0153] The width adjustment element 8211 may extend distally from the paddle width control 1628, through the paddle actuation control 1626, through the actuation element 8102 (and consequently through the handle 1616, the outer shaft of the implant catheter assembly 1611, and the device 8200), where the width adjustment element couples with the movable coupler 8972. The width adjustment element 8211 may be axially movable relative to the actuation element 8102, the outer shaft of the implant catheter assembly 1611, and the handle 1616. The clasp actuation line 624 may extend through and be axially movable relative to the handle 1616 and the outer shaft of the implant catheter assembly 1611. The clasp actuation line 624 may also be axially movable relative to the actuation element 8102.

[0154] 29 and 30, the width adjustment element 8211 can be removably coupled to the coupler 8972 of the device 8200. The width adjustment element 8211 is advanced and retracted via the paddle width control 1628 to increase or decrease the width of the paddle. The actuation element 8102 is advanced and retracted via the paddle width control 1626 to open and close the paddle of the device.

[0155] 29 and 30, the catheter or shaft of the implant catheter assembly 1611 is an elongate shaft extending axially between a proximal end portion 1622a that is coupled to the handle 1616 and a distal end portion 1622b that is coupled to the device 8200. The outer shaft of the implant catheter assembly 1611 may also include an intermediate portion 1622c disposed between the proximal end portion 1622a and the distal end portion 1622b.

[0156] 31-35C, an exemplary interface between an outer frame portion 8256 of device 8200 and a connector 8266 is shown in greater detail. Other interfaces are possible. As shown in FIG. 31, the interface may include a first outer frame portion 8256a, a second outer frame portion 8256b, and a connector 8266. The connector 8266 is positioned between the first outer frame portion 8256a and the second outer frame portion 8256b, as shown in FIG.

[0157] In some implementations, the first outer frame portion 8256a, the second outer frame portion 8256b, and the connector 8266 each include lacing holes 8257. The lacing holes 8257 may secure the first outer frame portion 8256a, the second outer frame portion 8256b, and the connector 8266 together, for example, through one or more sutures 8269. However, it should be understood that the outer frame portions and connecting portions may be secured together through other fastening means in some implementations. In some implementations, the fastening means allows the lacing holes 8257 to remain concentric and rotate coaxially relative to one another during expansion / contraction of the paddle. In some implementations, lacing holes are not used, and other connecting means are used.

[0158] 31 , the connector 8266 further includes an optional connection anchor 8268. The connection anchor 8268 can take a variety of different forms. In the illustrated example, the connection anchor 8268 is an additional opening or lacing hole. The connection anchor can be configured to stop or inhibit sliding movement of the suture 8269 therethrough. In some implementations, the connection anchor 8268 provides an additional attachment point between the connector 8266 and the outer frame portions 8256a, 8256b, which can improve the strength of the interface.

[0159] In the example shown in FIGS. 32-34D, the sleeve 8270 is positioned over the length of the first outer frame portion 8256a and the second outer frame portion 8256b. The sleeve 8270 can take a variety of different forms and in some implementations is a cloth material, a tube, or the like, and can be made from a wide variety of different materials, including but not limited to plastic (e.g., polyethylene terephthalate (PET)), woven fabric, and the like. However, some implementations do not include a sleeve. In some implementations, such as those shown in FIGS. 35A-35C and 35D-35I, the sleeve 8270 can be positioned over the lacing holes 8257 of the outer frame portion and / or the connector 8266. Thus, the sleeve 8270 is optional. If included, the sleeve 8270 may provide a surface to which one or more of the sutures 8269 may be secured (as shown in FIGS. 32 and 33), which may reduce or prevent the suture from shifting into place (e.g., sliding relative to the lacing holes 8257).

[0160] The suture 8269 may be threaded through the lacing hole 8257 and / or the connection anchor 8268 in any one of a variety of paths. In the implementation shown in FIG. 31 , the suture 8269 extends through the lacing hole 8257 of the first outer frame portion 8256a, across the top of the first outer frame portion 8256a, through the lacing hole 8257 of the connector 8266, across the top of the second outer frame portion 8256b, through the lacing hole of the second outer frame portion 8256b, and through the lacing hole 8257 of the connector 8266. In some implementations, the suture 8269 extends through the lacing hole 8257 of the first outer frame portion 8256a, across the top of the first outer frame portion 8256a, through the lacing hole 8257 of the connector 8266, through the lacing hole of the second outer frame portion 8256b, across the top of the second outer frame portion 8256b, and through the lacing hole 8257 of the connector 8266. Although one suture 8269 is shown in FIG. 31, it should be understood that additional sutures may be added to strengthen the interface.

[0161] 32 and 33, multiple sutures 8269 may be secured (e.g., sewn) to a sleeve 8270 of each of the first and second outer frame portions 8256a and 8256b and threaded through the lacing holes 8257. Each suture may pass through the lacing holes 8257 of the first and second outer frame portions 8256a and 8256b and the lacing holes of the connector 8266 more than once. For example, a first suture extends through the lacing hole 8257 of the first outer frame portion 8256a, the lacing hole 8257 of the connector 8266, and the lacing hole 8257 of the second outer frame portion 8256b, through the sleeve 8270 of the second outer frame portion 8256b, back through the lacing hole 8257 of the second outer frame portion 8256b, the lacing hole 8257 of the connector 8266, and the lacing hole 8257 of the first outer frame portion 8256a, through the sleeve 8270 of the first outer frame portion 8256a, and is joined at the end of the suture 8269. The second suture 8269 extends through the lacing hole 8257 of the second outer frame portion 8256b, the lacing hole 8257 of the connector 8266, and the lacing hole 8257 of the first outer frame portion 8256a, through the sleeve 8270 of the first outer frame portion 8256a, back through the lacing hole 8257 of the first outer frame portion 8256a, the lacing hole 8257 of the connector 8266, and the lacing hole 8257 of the second outer frame portion 8256b, and through the sleeve 8270 of the second outer frame portion 8256b, where it is joined at the ends of the suture 8269. Additional sutures 8269 may be included in some implementations. Additionally, in some implementations, the suture may be looped and secured at each end to, for example, a sleeve 8270, instead of being secured to itself at the ends.

[0162] The implementations illustrated in Figures 31-33 may be used to secure the connector 8266 to the outer frame portion 8256 to prevent or inhibit loosening, thereby allowing the connector 8266 and the outer frame portion 8256 to move so that the lacing holes 8257 are not coaxially and concentrically aligned with one another, as shown in Figure 28. In some implementations, one or more additional sutures 8269 may pass through the connection anchor 8268 to add strength to the interface. Additionally or alternatively, three or more sutures may be used to distribute tensile stress across the interface.

[0163] 34A-34D show an implementation for securing the outer frame portions to the connector using four sutures 8269 and connection anchors 8268. For clarity, FIGS. 34A-34D show each of the four sutures 8269 in a particular order, but the order of inserting the sutures is not limited. In FIG. 34A, the first suture 8269 extends through a sleeve 8270 of the second outer frame portion 8256b, a lacing hole 8257 of the second outer frame portion 8256b, a lacing hole 8257 of the connector 8266, and a lacing hole 8257 of the first outer frame portion 8256a, before looping around the first outer frame portion 8256a, extending through the connection anchors 8268, looping around the second outer frame portion 8256b, and joining at the end of the suture 8269. In FIG.

[0164] Next, in FIG. 34B , the second suture 8269 extends through the sleeve 8270 of the first outer frame portion 8256a, the lacing hole 8257 of the first outer frame portion 8256a, the lacing hole 8257 of the connector 8266, and the lacing hole 8257 of the second outer frame portion 8256b before looping around the second outer frame portion 8256b, extending through the connection anchor 8268, looping around the first outer frame portion 8256a and joining at the end of the suture 8269.

[0165] 34C , the third suture 8269 extends through a sleeve 8270 of the second outer frame portion 8256b, the second outer frame portion 8256b, the connector 8266, and an eyelet of the first outer frame portion 8256a. The suture 8269 then extends through the sleeve 8270 of the first outer frame portion 8256a, back through the first outer frame portion 8256a, the connector 8266, and an eyelet of the second outer frame portion 8256b, and is joined to the other end of the suture 8269.

[0166] 34D , the fourth suture 8269 extends through a sleeve 8270 of the first outer frame portion 8256a, through the first outer frame portion 8256a, the connector 8266, and through an eyelet of the second outer frame portion 8256b. The suture 8269 then extends through a sleeve 8270 of the second outer frame portion 8256b, back through the second outer frame portion 8256b, the connector 8266, and through an eyelet of the first outer frame portion 8256a, and is joined to the other end of the suture 8269.

[0167] 34D includes four sutures, it is envisioned that one or more additional sutures may be added to further increase the strength of the interface. Additionally, in some implementations, one or more of the additional sutures may pass through a connection anchor 8268. For example, in some implementations, a first plurality of sutures may pass through a lacing hole in the connector and outer frame portion and may not pass through a connection anchor, while a second plurality of sutures may pass through a lacing hole in the connector and outer frame portion and may pass through a connection anchor. In some implementations, the sleeve 8270 on the outer frame portion may be omitted.

[0168] As shown in FIG. 35A-35C, a first sleeve 8270 covers one lacing hole 8257 of the outer frame portion 8256 and the lacing hole 8257 of the connector 8266, while a second sleeve 8270 covers the other lacing hole 8257 of the outer frame portion 8256. The first sleeve 8270 may also optionally cover the connection anchor 8268 of the connector 8266. The suture 8269 may be folded in half to create a looped portion (e.g., a first loop) facing the free end of the suture. The suture passes through the first and second sleeves 8270, the lacing holes 8257 of the outer frame portion 8256 and the connector 8266, passes through the connection anchor 8268, and the free end of the suture 8269 is tied around the looped portion of the suture 8269, thereby forming a second loop, as shown in FIG. 35A. Once tied, the free end of the suture 8269 is passed back through the sleeve and outer frame portion 8256 and the eyelet 8257 of the connector 8266 and tied around a second loop, as shown in FIG. 35B.

[0169] In some implementations, after being tied around the second loop, one of the free ends of the suture 8269 is threaded through a sleeve 8270 around the lacing hole 8257 and tied to the other free end of the suture 8269, as shown in FIG. 35C. Threading of the suture 8269 may be optional, depending on the implementation, although some implementations may reduce the profile of the interface by fastening the sleeve 8270 closely to the surface of the outer frame portion. Thus, it is envisioned that in some implementations, the suture 8269 may be tied after being tied around the second loop of FIG.

[0170] 35D-35I, in some implementations, three sutures 18269, 28269, 38269 are used to connect the outer frame portions 8256a, 8256b to the connector 8266. In FIG. 35D-35I, the three sutures 18269, 28269, 38269 are indicated by lines having different weights to allow visual distinction between the three sutures. However, the three sutures 18269, 28269, 38269 may be made from the same or different materials (e.g., the same or different sutures). In Figures 35E-35G, the three sutures 18269, 28269, 38269 are shown separately on the outer frame portions 8256a, 8256b and the connector 8266 to simplify the drawings, while Figures 35H and 35I show all three sutures attaching the outer frame portions 8256a, 8256b to the connector 8266. The order in which the sutures are attached is not limited.

[0171] 35D-35I , an optional first sleeve 8270 covers one lacing hole 8257 of the outer frame portion 8256 and a lacing hole 8257 of the connector 8266, while an optional second sleeve 8270 covers the lacing hole 8257 of the other outer frame portion 8256. The first sleeve 8270 may also optionally cover a connection anchor 8268 of the connector 8266.

[0172] 35D, 35E, 35H, and 35I, the first suture 18269 may be folded in half to create a looped portion 18271 (e.g., a first loop) opposite the free end 18273 of the first suture. The first suture 18269 passes through the first and second sleeves 8270, the outer frame portion 8256, and the lacing holes 8257 of the connector 8266, and passes through the connection anchor 8268. The free end 18273 of the suture 18269 is tied together with the looped portion 18271 of the suture 18269 to form a knot 18275. FIG. 35D shows the first suture 18269 loosely positioned, and FIG. 35E shows the first suture 18269 being tightened and tied to form the knot 18275.

[0173] 35F, 35H, and 35I, the second suture 28269 may be folded in half to create a looped portion 28271 (e.g., a first loop) opposite the free end 28273 of the second suture. The second suture 28269 passes through the first and second sleeves 8270, the outer frame portion 8256, and the lacing hole 8257 of the connector 8266. The free end 28273 of the suture 28269 is positioned on one side of the outer frame portion 8256. The looped portion 28271 of the suture 18269 is tied together with the free end 18271 of the first suture 18269 at the looped portion 18271 and the knot 18275.

[0174] 35G, 35H, and 35I, the third suture 38269 is wrapped around the outer frame portion 8256 and the connector 8266. In the implementations shown in FIGS. 35G, 35H, and 35I, the third suture is wrapped around the outside of the first and second sleeves 8270. In some implementations, the third suture is sewn one or more times into the first and second sleeves 8270. The free end 38273 of the suture 38269 is positioned on one side of the outer frame portion 8256 by the free end 28273 of the suture 28269. The free end 28273 of the suture 28269 is tied together with the free end 38273 of the suture 38269 to form a knot 38275. Thus, all three sutures 18269, 28269, and 38269 are tied together to connect the optional sleeve 8270 (if included), the outer frame portion 8256, and the connector 8266 together.

[0175] 35D includes three sutures, it is envisioned that one or more additional sutures may be added or one or more of the illustrated sutures may be omitted. For example, in some implementations, a first plurality of sutures may pass through lacing holes in the connector and outer frame portion and may not pass through a connection anchor, while a second plurality of sutures may pass through lacing holes in the connector and outer frame portion and may pass through a connection anchor. In some implementations, the sleeve 8270 may be omitted.

[0176] It is envisioned that in any of the examples described herein, all or a portion of the suture may include a color or other visual indicator to make the suture identifiable by a user. The visual indicator may, for example, allow the suture to be visually observable using x-ray or other imaging techniques utilized during delivery of the implantable device.

[0177] The interface between the outer frame portion and the connector of each paddle is not the only part of the implantable device that may be stressed during implant preparation and delivery. The connector 8266 may also be strained during paddle constriction, especially when the connector 8266 is pulled into the actuation cap 8214.

[0178] FIG. 36 illustrates a distal portion of an exemplary implantable device including paddles with adjustable widths. As with various other embodiments described herein, a connector 8266 is coupled to the outer frame portion 8256 for each paddle. An actuation cap 8214 extends from a distal end of a retention portion 8272. As shown in FIG. 36, the actuation cap 8214 includes a rounded portion 8217 and an attachment portion 8218. The rounded portion 8217 extends between the retention portion 8272 and the connector 8266, while the attachment portion 8218 extends into the retention portion 8272 and couples the actuation cap 8214 to the retention portion 8272. The rounded portion 8217 of the actuation cap 8214 may exert a force on the connector 8266, which may cause the connector 8266 to deform or distort. Thus, in some implementations, mechanisms may be incorporated to reduce the strain on the connector 8266.

[0179] In some implementations, the actuation cap 8214 includes one or more flexible portions 8215. The one or more flexible portions can take a wide variety of different forms. In the example illustrated in FIG. 37, the flexible portion 8215 of the actuation cap 8214 is formed with an annular undercut 8219 forming a thin flexible cap end 8221 as shown in FIG. 37. The exemplary flexible portion 8215 is positioned between the connector 8266 of the paddle frame and the retaining portion 8272 of the inner paddle frame portion. The flexible portion 8215 includes a radius of curvature that may be similar to the radius of curvature of the rounded portion 8217 of FIG. 36. However, the flexible portion 8215 has a greater flexibility as compared to the rounded portion 8217. 37 and toward the retaining portion 8272 as the connector 8266 is pulled into the retaining portion 8272 to narrow the paddle, and / or as the actuation cap 8214 is moved relative to the body of the mounting portion 8205 to open or close the paddle, as described above. Bending of the flexible portion 8215 can be effective to reduce strain on the connector 8266.

[0180] In some implementations, the actuation cap 8214 includes a rounded portion 8217 and an attachment portion 8218, as shown in FIG. 38. As in the example shown in FIG. 36, the rounded portion 8217 extends between the retaining portion 8272 and the connector 8266, while the attachment portion 8218 extends into the retaining portion 8272 and couples the actuation cap 8214 to the retaining portion 8272. However, in contrast to the example of FIG. 36, in FIG. 38, a biasing element 8216, such as a spring as shown, is positioned between the rounded portion 8217 and the retaining portion 8272. The biasing element 8216 can be, for example, a coil spring or a wave spring, although other types of biasing elements can be used, depending on the implementation. In some implementations, a compressible material can be used as an alternative to the illustrated spring 8216. The biasing element 8216 can be made of metal or any other material known and used in the art.

[0181] In some implementations, the biasing element 8216 is configured to compress and / or expand in response to a force between the rounded portion 8217 of the actuation cap 8214 and the retaining portion 8272, including, but not limited to, a force generated on the rounded portion 8217 by retracting the connector 8266 into the retaining portion 8272. For example, as the connector 8266 is retracted into the retaining portion 8272 and against the rounded portion 8217 of the actuation cap 8214, the rounded portion 8217 of the actuation cap 8214 may be displaced toward the retaining portion 8272 by the compression of the biasing element 8216, reducing the overall load. In other words, a portion of the force between the rounded portion 8217 and the connector 8266 may be transferred to the biasing element 8216, thereby compressing and / or expanding the biasing element 8216 and allowing the rounded portion 8217 to move in the direction of the arrow in FIG. The reduced force in turn reduces the strain on the connector 8266 .

[0182] Various implementations described herein incorporate one or more features to tailor the distribution of forces across the implantable device to reduce deformation of the implantable device over time, which may result in improved function of the device during implantation and / or extended life of the device. Other advantages may also be realized, depending on the particular implementation.

[0183] Additionally, the treatment techniques, methods, operations, steps, etc. described or suggested herein may be performed on living subjects (e.g., humans, other animals, etc.) or may be performed on non-living simulations such as, for example, cadavers, cadaver hearts, simulators, virtual persons, etc. When performed in a simulation, the body parts, e.g., hearts, tissues, valves, etc., may optionally be referred to as "simulations" (e.g., simulated hearts, simulated tissues, simulated valves, etc.) and may include, for example, computerized and / or physical representations of the body parts, tissues, etc.

[0184] Any of the various systems, assemblies, devices, equipment, etc. in this disclosure may be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on a patient, and the methods described herein may include (or additional methods may include or consist of) sterilization of the associated systems, devices, equipment, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0185] Although various inventive aspects, concepts, and features of the present disclosure may be described and illustrated herein as embodied in combination in the embodiments herein, these various aspects, concepts, and features may be used in many alternatives, either individually or in various combinations and subcombinations thereof. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of the present application. Still further, although various alternatives for the various aspects, concepts, and features of the present disclosure may be described herein, such as alternative materials, alternative structures, alternative configurations, alternative methods, alternative devices, alternative components, alternatives in form, alternatives in fit, alternatives in function, and the like, such descriptions are not intended to be a complete or exhaustive list of available alternatives, 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 invention into additional embodiments and applications within the scope of the present application, even if such embodiments are not expressly disclosed herein.

[0186] Additionally, although some features, concepts, or aspects of the present disclosure may be described herein as being preferred configurations or methods, such description is not intended to imply that such features are essential or essential unless expressly stated.Furthermore, while exemplary or representative values, and even exemplary or representative ranges, may be included to aid in understanding the present application, such values ​​and ranges should not be construed in a limiting sense, and are intended to be critical values ​​or ranges only if so expressly stated.

[0187] Moreover, although various aspects, features, and concepts may be expressly identified herein as being 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, the disclosure being instead defined in the appended claims. Descriptions of exemplary methods or processes are not limited to the inclusion of every step as essential in all cases, nor is the order in which steps are presented construed as essential or essential unless expressly stated. Terms used in the claims are to be given their full ordinary meaning and are not to be limited in any way by the description of the examples herein.

Claims

1. 1. An implantable device for repairing a native heart valve, comprising: an anchor portion configured to connect to a leaflet of the native valve, The anchor portion includes a pair of frame portions movable between an expanded position and a constricted position having a frame width smaller than a frame width in the expanded position, Each of the pair of frame portions includes an anchor portion having a lacing hole; a connector having a lacing hole and a connection anchor proximate a first end of the connector, the lacing hole of the connector being positioned between the connection anchor and the first end of the connector, the connector being positioned at least partially between the pair of frame portions such that the lacing hole of the pair of frame portions and the lacing hole of the connector are aligned; a plurality of sutures passing through the lacing holes of the connector and the lacing holes of each of the pair of frame portions, the plurality of sutures configured to secure the pair of frame portions to the connector.

2. The implantable device of claim 1 , wherein at least one of the plurality of sutures passes through the connection anchor.

3. The implantable device of claim 1 or 2, wherein the plurality of sutures includes at least two sutures passing through the connection anchor.

4. The implantable device of any one of claims 1 to 3, wherein at least one of the plurality of sutures passes through the lacing hole of the connector and the lacing hole of each of the pair of frame portions more than once.

5. The implantable device of any one of claims 1 to 4, wherein each of the plurality of sutures is secured to itself.

6. The plurality of sutures include a first suture and a second suture passing through the lacing hole of the connector and the lacing hole of each of the pair of frame portions, but not passing through the connection anchor; The implantable device of any one of claims 1 to 5, further comprising a third suture and a fourth suture passing through the lacing hole of the connector, the lacing hole of each of the pair of frame portions, and the connection anchor.

7. The implantable device of claim 6 , further comprising a sleeve disposed about the pair of frame portions.

8. 8. The implantable device of claim 7, wherein each of the first suture and the second suture passes through the lacing hole of the connector and the lacing hole of each of the pair of frame portions, passes through the sleeve of a first frame portion of the pair of frame portions, and passes back through the lacing hole of the connector and the lacing hole of each of the pair of frame portions.

9. The implantable device of any one of claims 1 to 8, wherein the pair of frame portions rotate coaxially relative to the connector while the pair of frame portions move between the expanded position and the constricted position.

10. 10. The implantable device of claim 1, wherein the lacing holes of the pair of frame portions and the lacing holes of the connector are aligned along a common central axis while the pair of frame portions move between the expanded position and the narrowed position.

11. 1. An implantable device for repairing a native heart valve, comprising: an anchor portion configured to connect to a leaflet of the native valve, The anchor portion includes a pair of frame portions movable between an expanded position and a constricted position having a frame width smaller than a frame width in the expanded position, Each of the pair of frame portions includes an anchor portion having a lacing hole; a connector having a lacing hole and a connection anchor proximate a first end of the connector, the lacing hole of the connector being positioned between the connection anchor and the first end of the connector, the connector being positioned at least partially between the pair of frame portions such that the lacing hole of the pair of frame portions and the lacing hole of the connector are aligned; a first plurality of sutures passing through the lacing holes of the connector and the lacing holes of each of the pair of frame portions; a second plurality of sutures passing through the lacing holes of the connector, the lacing holes of each of the pair of frame portions, and the connection anchors; the first plurality of sutures do not pass through the connection anchor; an implantable device, wherein the first plurality of sutures and the second plurality of sutures are configured to secure the connector between the pair of frame portions such that the pair of frame portions rotate coaxially relative to the connector while the pair of frame portions move between the expanded position and the constricted position.

12. The implantable device of claim 11 , wherein the first plurality of sutures pass through the lacing holes of the connector and the lacing holes of each of the pair of frame portions two or more times.

13. 13. The implantable device of claim 11 or claim 12, further comprising a sleeve disposed about the pair of frame portions.

14. 14. The implantable device of claim 13, wherein at least a portion of the first plurality of sutures and the second plurality of sutures, or the first plurality of sutures and the second plurality of sutures, pass through the sleeve of at least one of the pair of frame portions.

15. The implantable device of any one of claims 11 to 14, wherein each suture of the first plurality of sutures is secured to itself.

16. a cap having an aperture traversing the cap from a proximal end to a distal end; An anchor portion configured to connect to a leaflet of a native valve, Paddle frame and an anchor portion comprising: a connector coupled to the paddle frame, the connector having an inner end extending through the hole in the cap, wherein retraction of the inner end into the cap causes the paddle frame to move from an expanded position having an expanded width to a constricted position having a constricted width, the expanded width being greater than the constricted width; a biasing element positioned between the cap and the anchor portion and configured to reduce a force between the cap and the paddle frame; An implantable device, wherein the anchor portion is configured to move between an open position and a closed position with movement of the cap.

17. 17. The implantable device of claim 16, wherein the cap comprises a rounded portion extending between an interface element and the paddle frame and an attachment portion extending into the interface element and configured to couple the cap to the interface element.

18. The implantable device of claim 17 , wherein the biasing element is positioned between the rounded portion of the cap and the interface element.

19. An implantable device according to any one of claims 16 to 18, wherein the biasing element comprises a coil spring.

20. The implantable device of any one of claims 16 to 18, wherein the biasing element comprises a wave spring.

21. 21. The implantable device of claim 16, wherein the biasing element is configured to reduce force between the cap and the connector when the inner end moves into the cap to move the paddle frame from the expanded position to the constricted position.

22. a cap having an aperture traversing the cap from a proximal end to a distal end and one or more flexible portions at the distal end extending away from the aperture; An anchor portion configured to connect to a leaflet of a native valve, Paddle frame and a connector coupled to the paddle frame, the connector having an inner end extending through the hole in the cap, wherein retraction of the inner end into the cap causes the paddle frame to move from an expanded position having an expanded width to a constricted position having a constricted width, the expanded width being greater than the constricted width; An implantable device, wherein the anchor portion is configured to move between an open position and a closed position with movement of the cap.

23. 23. The implantable device of claim 22, wherein the one or more flexible portions are positioned between the paddle frame and a joint element.

24. 24. The implantable device of claim 22 or claim 23, wherein when the one or more flexible portions flex, the force between the cap and the connector is reduced.

25. 24. The implantable device of claim 23, wherein the one or more flexible portions bend toward the joint element when the inner ends are retracted into the cap to move the paddle frame from the expanded position to the constricted position.

Images