Heart valve repair device and delivery device therefor - Patent application

Abstract

The device is configured to be positioned within the native heart valve to obstruct retrograde blood flow through the native heart valve. The device can include one or more of an expandable coaptation element and / or an extension member or a blocking member. The expandable coaptation element can be adjustable in size, shape, or both to control the area of ​​the native heart valve filled by the coaptation element. The expandable coaptation element, extension member, and / or blocking member can be positioned within the native heart valve to block or obstruct retrograde blood flow.

Description

[Technical Field]

[0001] Related Applications This application claims priority to U.S. Provisional Application No. 63 / 403,671, filed September 2, 2022, and to U.S. Provisional Application No. 63 / 441,146, filed January 25, 2023, which are incorporated by reference in their entireties. [Background technology]

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform a critical function in ensuring forward flow for adequate blood supply throughout the cardiovascular system. These heart valves can be damaged, for example, by congenital malformations, inflammatory processes, infections, diseases, etc., which can reduce their effectiveness. Such damage to the valves can lead to serious cardiovascular problems or even death. Damaged valves can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and can result in complications. Using transvascular techniques, devices can be introduced and deployed / implanted to treat the heart in a much less invasive manner than open-heart surgery. As an example, a transvascular technique that can be used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting a catheter into the right femoral vein, ascending the inferior vena cava, and advancing the catheter into the right atrium). The septum is then punctured and the catheter is passed into the left atrium. A similar transvascular technique can be used to deploy / implant a device into the tricuspid valve, starting similarly to the transseptal technique, but instead of puncturing the septum, the delivery catheter is guided within the right atrium towards the tricuspid valve.

[0003] A healthy heart has an overall conical shape tapering from the apex to the base. The heart is a four-chamber structure, including the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The natural mitral valve in the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure from other natural heart valves. The mitral valve includes an annulus, which is a circular portion of natural valve tissue surrounding the mitral valve opening, and a pair of leaflets, or cusps, that extend downward from the annulus into the left ventricle. The mitral valve annulus may form a "D" shape, an ellipse, or other non-circular cross-sectional shape with a major axis and a minor axis. Because the anterior leaflet is larger than the posterior leaflet, when they are occluded together, a roughly "C"-shaped boundary may be formed between the abutting sides of the leaflets.

[0004] When operating properly, the anterior and posterior leaflets function together as a one-way valve that allows blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle relaxes (also called "ventricular diastole" or "diastole"), oxygenated blood collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricle muscle contracts (also called "ventricular systole" or "systole"), rising blood pressure in the left ventricle forces the two leaflets side-to-side together, thereby closing the one-way mitral valve and preventing blood from flowing back into the left atrium. Instead, blood is expelled from the left ventricle through the aortic valve. To prevent the leaflets from prolapsing under pressure or from folding back through the mitral annulus into the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the 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 valve regurgitation occurs when the native mitral valve fails to close properly during the systolic phase of cardiac contraction, allowing blood to flow from the left ventricle into the left atrium. Mitral valve regurgitation is one of the most common forms of valvular heart disease. Mitral valve regurgitation can have many different causes, including leaflet prolapse, papillary muscle dysfunction, stretching of the mitral annulus due to left ventricular dilation, or a combination of these. Mitral valve regurgitation in the central portion of the valve leaflets can be referred to as central jet mitral regurgitation, while mitral valve regurgitation closer to one of the leaflet commissures (i.e., where the leaflets meet) can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the leaflet edges do not meet midway, resulting in non-closure of the valve and regurgitation. Tricuspid regurgitation is similar but can be on the right side of the heart. Summary of the Invention [Problem to be solved by the invention]

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

[0007] Devices for repairing and / or treating a patient's native valves are disclosed. The devices may be valve repair devices, implantable devices, valve treatment devices, implants, etc. Although the devices may be described in some examples herein as implantable devices, similar configurations may be used with other devices, such as valve repair devices or treatment devices, that do not necessarily need to be implanted but may be removed after treatment. [Means for solving the problem]

[0008] In some implementations, a device (e.g., a treatment device, repair device, implantable device, implant, etc.) configured to be positioned within the native heart valve to enable the native heart valve to form a more effective seal is provided. In some implementations, the device is part of a system (e.g., a valve repair system, a valve therapy system, etc.) that includes a delivery system having a catheter and a control handle, where the device is coupled to the delivery system.

[0009] In some implementations, a device (e.g., a therapeutic device, a repair device, an implantable device, an implant, etc.) includes an anchor portion. In some implementations, the anchor portion includes one anchor. In some implementations, the anchor portion includes two anchors. In some implementations, the anchor portion includes three or more anchors.

[0010] In some implementations, each anchor includes multiple paddles, each of which is transitionable between an open position and a closed position.

[0011] In some implementations, an expandable coaptation element (e.g., a spacer, gap filler, plug, etc.) for preventing backflow between the leaflets of a native heart valve can transition between an unexpanded configuration and an expanded configuration.

[0012] In some implementations, an expandable coaptation element (e.g., a spacer, gap filler, plug, etc.) for preventing regurgitation between the leaflets of a native heart valve includes an expandable mechanism. The expandable mechanism can be the same as or similar to any of the expandable mechanisms described elsewhere in this disclosure. The expandable mechanism can include one or more of a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, pivoting or scissoring extension members and / or struts, an expanding pulley mechanism, a Hoberman mechanism, a cam, a worm screw, a rack and pinion, foam, etc.

[0013] In some implementations, the expandable joint element includes two or more shell components.

[0014] In some implementations, the expandable mechanism is configured to transition between an expanded configuration and an unexpanded or collapsed configuration.

[0015] In some implementations, two or more shell components are attached to the expandable mechanism.

[0016] In some implementations, when the expandable mechanism is in the collapsed configuration, pairs of two or more shell components nest within one another.

[0017] In some implementations, the expandable mechanism includes a plurality of struts.

[0018] In some implementations, the expandable mechanism is configured to expand in a single direction, in some implementations, the expandable mechanism is configured to expand in multiple directions, and in some implementations, the expandable mechanism is configured to expand in two opposing directions.

[0019] A device (e.g., a treatment device, a repair device, a valve repair device, an implantable device, an implant, etc.) can include an expandable coaptation element and an anchor portion. A system (e.g., a treatment system, a repair system, a valve repair system, a valve treatment system, etc.) can include one or more catheters and a device.

[0020] In some implementations, an expandable coaptation element for preventing regurgitation between the leaflets of a native heart valve includes an expandable mechanism, which can be the same as or similar to any of the expandable mechanisms described elsewhere in this disclosure, and can include one or more of a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, pivoting or scissoring extension members and / or struts, an expanding pulley mechanism, a Hoberman mechanism, a cam, a worm screw, a rack and pinion, foam, etc.

[0021] In some implementations, the expandable coaptation element for preventing regurgitation between the leaflets of a native heart valve comprises an expandable sleeve or an expandable frame. In some implementations, the expandable sleeve or expandable frame is disposed around an expandable mechanism. The expandable mechanism can be the same or similar to any of the expandable mechanisms described elsewhere in this disclosure. The expandable mechanism can include one or more of a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, pivoting or scissoring extension members and / or struts, an expanding pulley mechanism, a Hoberman mechanism, a cam, a worm screw, a rack and pinion, foam, etc.

[0022] In some implementations, the expandable mechanism is configured to transition between an expanded configuration and an unexpanded or collapsed configuration.

[0023] In some implementations, the sleeve (or frame) includes overlapping end portions, hi some implementations, the expandable mechanism includes a plurality of struts.

[0024] In some implementations, the expandable mechanism is configured to expand in a single direction, in some implementations, the expandable mechanism is configured to expand in multiple directions, and in some implementations, the expandable mechanism is configured to expand in two opposing directions.

[0025] A device (e.g., a valve repair device, a valve treatment device, an implant, etc.) can include an expandable coaptation element and an anchor portion. A system (e.g., a valve repair system, a valve treatment system, etc.) can include one or more catheters and a device.

[0026] In some implementations, an expandable coaptation (e.g., spacer, gap filler, plug, etc.) member for preventing regurgitation between the leaflets of a native heart valve includes one or more shape-changing components, In some implementations, application of a tensile force to the one or more shape-changing components causes the one or more shape-changing components to change from a flat configuration to a curved configuration.

[0027] In some implementations, the expandable joint element includes a compressible filler material disposed between one or more pairs of shape-changing components. In some implementations, the one or more shape-changing components have a kirigami configuration. In some implementations, the one or more pairs of shape-changing components are parallel and spaced apart in the flat configuration. In some implementations, the shape-changing components are curved toward each other in the curved configuration.

[0028] A device (e.g., a valve repair device, a valve treatment device, an implant, etc.) can include an expandable coaptation element and an anchor portion. A system (e.g., a valve repair system, a valve treatment system, etc.) can include one or more catheters and a device.

[0029] In some implementations, an expandable coaptation element for preventing regurgitation between the leaflets of a native heart valve includes a lattice of cells.

[0030] In some implementations, the grid of cells includes a first controllable cell and a second controllable cell, in some implementations, the first controllable cell is configured to be scalable in size, and in some implementations, the second controllable cell is configured to be scalable in size.

[0031] In some implementations, the size of the first controllable cell is configured to be controlled independently of the size of the second controllable cell.

[0032] A device (e.g., a valve repair device, a valve treatment device, an implant, etc.) can include an expandable coaptation element and an anchor portion. A system (e.g., a valve repair system, a valve treatment system, etc.) can include one or more catheters and a device.

[0033] In some implementations, the system includes a first control member and a second control member, in some implementations, the first control element configured to move in a height direction of the first controllable cell, and in some implementations, the second control element configured to move in a width direction of the second controllable cell.

[0034] In some implementations, an expandable coaptation element (e.g., a spacer, gap filler, plug, etc.) for preventing regurgitation between the leaflets of a native heart valve includes a receiver, a shape-changing element, and a shaft. In some implementations, the shape-changing element has a first end disposed within the receiver and a second end disposed outside the receiver.

[0035] In some implementations, the shaft is disposed within the receiver and connected to a first end of the shape-changing element, and in some implementations, forcing the shaft within the receiver forces a portion of the shape-changing element out of the receiver, thereby increasing the size of the shape-changing element.

[0036] In some implementations, the shape-changing component comprises a plurality of wires. In some implementations, the shape-changing component comprises a braided or mesh material. In some implementations, the shape-changing component has a teardrop shape in the expanded state. In some implementations, the shape-changing component has a substantially cylindrical configuration in the retracted state. A device (e.g., a valve repair device, a valve therapy device, an implant, etc.) can include an expandable coaptation element and an anchor portion. A system (e.g., a valve repair system, a valve therapy system, etc.) can include one or more catheters and a device.

[0037] In some implementations, a device (e.g., a valve repair device, a valve therapy device, an implant, etc.) includes an anchor portion and / or an extension or blocking member, wherein the anchor portion is configured to attach to the leaflets of a native heart valve.

[0038] In some implementations, the extension member or blocking member is attached to the anchor portion. In some implementations, the extension member or blocking member is configured to obstruct retrograde flow through the native heart valve.

[0039] In some implementations, the extension or blocking member is expandable.

[0040] In some implementations, a system (e.g., a valve repair system, a valve therapy system, etc.) includes a catheter, a device (e.g., a valve repair device, a valve therapy device, an implant, etc.), and an extension member or a blocking member. The device is coupled to the catheter.

[0041] In some implementations, the extension member or blocking member is configured to slide over the catheter and attached to the device.

[0042] In some implementations, the extension member or blocking member is expandable. In some implementations, the device includes a coaptation element (e.g., a spacer, gap filler, plug, etc.) configured to engage the leaflets of the native heart valve.

[0043] In some implementations, an expandable coaptation element (e.g., a spacer, gap filler, plug, etc.) for preventing regurgitation between the leaflets of a native heart valve includes an expandable frame member and an expandable mechanism attached to the interior of the expandable frame member. The expandable mechanism can be the same or similar to any of the expandable mechanisms described elsewhere in this disclosure. The expandable mechanism can include one or more of a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, pivoting or scissoring extension members and / or struts, an expanding pulley mechanism, a Hoberman mechanism, a cam, a worm screw, a rack and pinion, foam, etc.

[0044] In some implementations, the expandable mechanism can include an expandable or expanding member connected to an expandable frame and a drive mechanism attached within the expandable / expanding member.

[0045] In some implementations, the drive mechanism is configured to transition the expandable / expansion member and the expandable frame member between the expanded configuration and the collapsed configuration.

[0046] In some implementations, the drive mechanism may include one or more of a drive wire, a drive element, a pivot link, a joint, a cam, a rack and pinion, a worm screw, a lever, a pulley, an articulated arm, or the like.

[0047] In some implementations, the expandable / expanding member includes a distal end portion, a proximal end portion located opposite the distal end portion, and an intermediate portion located between the distal end portion and the proximal end portion.

[0048] In some implementations, when the expandable frame member transitions from the collapsed configuration to the expanded configuration, the intermediate portion expands.

[0049] In some implementations, the intermediate section includes a plurality of longitudinally spaced strips configured to bend when the intermediate section expands. In some implementations, the intermediate section includes between four and eight equally spaced strips. In some implementations, each of the plurality of strips is attached to a frame member.

[0050] In some implementations, the drive mechanism includes a distal member axially fixed relative to a distal end portion of the expandable / expanding member, and a proximal member axially fixed relative to a proximal end portion of the expandable / expanding member.

[0051] In some implementations, the distal member includes a pair of protrusions received within a pair of openings in the distal end portion of the expandable / expanding member.

[0052] In some implementations, the distal member is axially secured to the distal end portion of the expandable / expanding member by a stop positioned within the passageway of the expandable / expanding member.

[0053] In some implementations, a portion of the proximal member is axially fixed relative to the distal end portion between a locking body positioned within the passageway of the expandable / expanding member and an end cap received within the passageway at the proximal end portion of the expandable / expanding member.

[0054] In some implementations, relative movement of the distal and proximal members toward one another causes expansion of the intermediate section.

[0055] In some implementations, the distal and proximal members are threadedly coupled, and relative rotation of the distal and proximal members causes relative movement of the distal and proximal members relative to one another.

[0056] In some implementations, the distal end of the proximal member is received within the passageway of the distal member, and the distal end of the proximal member includes external threads that are threadably coupled to the internal threads within the passageway of the distal member.

[0057] In some implementations, the proximal end of the distal member is received within the passageway of the proximal member, and the distal member is axially movable within the passageway of the proximal member.

[0058] In some implementations, the distal member includes one or more locking members configured to lock the axial position of the distal member relative to the proximal member.

[0059] In some implementations, each of the one or more locking members engages with a corresponding slot in the proximal member to lock the axial position of the distal member relative to the proximal member.

[0060] In some implementations, the proximal end of the distal member includes a coupling portion configured to be engaged by a drive element extending through a passage in the proximal member to enable the distal member to move axially within the passage.

[0061] In some implementations, the frame members have a height that remains the same between the collapsed and expanded configurations.

[0062] In some implementations, the frame member includes a plurality of fixed height posts interconnected by a plurality of struts. In some implementations, the plurality of struts are arranged in a plurality of diamond-shaped patterns. In some implementations, the expandable / expanding member is connected to one or more fixed height posts of the frame.

[0063] In some implementations, the expandable cover covers at least a portion of the frame member, hi some implementations, the cover is connected to the frame member.

[0064] In some implementations, the cover includes a plurality of spaced apart woven fabric portions connected by a plurality of expandable portions.

[0065] In some implementations, the frame member includes a plurality of fixed height posts interconnected by a plurality of struts, and in some implementations, one or more of the woven fabric portions are connected to a corresponding one or more of the posts.

[0066] In some implementations, the frame member includes six posts and the cover includes six fabric sections, each of the fabric sections connected to a corresponding one of the posts.

[0067] In some implementations, each of the woven portions is connected to a corresponding expandable portion by a leno stitch.

[0068] In some implementations, the expandable cover is treated to reduce the transparency of the cover.

[0069] In some implementations, the expandable cover can be coated with a polymer to reduce the permeability of the cover.

[0070] In some implementations, one or more polymer strands formed from one or more of TPU, silicone, polyolefin, and elastic thread are woven into the expandable cover to reduce the permeability of the cover.

[0071] In some implementations, the expandable joint element is part of a system (e.g., a valve repair system, a valve therapy system, etc.) that includes a delivery system that includes a catheter and a control handle, and a device (e.g., a valve repair device, a valve therapy device, an implant, etc.) coupled to the delivery system.

[0072] In some implementations, the device includes an anchor portion configured to attach to the leaflets of the native heart valve, hi some implementations, the expandable coaptation element is attached to the anchor portion.

[0073] In some implementations, a method for preventing regurgitation between the leaflets of a native heart valve includes positioning a device (e.g., a valve repair device, a valve therapy device, an implant, etc.) between the leaflets, attaching an anchor portion of the device to the leaflets, and expanding a coaptation element attached to the anchor portion.

[0074] In some implementations, expanding the coaptation element includes expanding an expandable or expanding member positioned within the frame member to transition the frame member from a collapsed position to an expanded position.

[0075] In some implementations, the frame members have a height that remains the same in both the collapsed and expanded positions.

[0076] In some implementations, expanding the expandable / expanding member includes bending a plurality of strips on the expandable / expanding member.

[0077] In some implementations, expanding the expandable / expanding member includes axially moving one of the distal member and the proximal member relative to the other of the distal member and the proximal member within the passage of the expandable / expanding member.

[0078] In some implementations, axially moving one of the distal and proximal members relative to the other of the distal and proximal members includes rotating the proximal member relative to the distal member.

[0079] In some implementations, axially moving one of the distal and proximal members relative to the other of the distal and proximal members further includes threading the proximal member into the passage of the distal member.

[0080] In some implementations, axially moving one of the distal member and the proximal member relative to the other of the distal member and the proximal member includes axially moving the distal member within a passageway of the proximal member.

[0081] In some implementations, the method includes locking the position of the distal member within the passageway of the proximal member, hi some implementations, the method includes preventing axial movement of the proximal member while allowing rotational movement.

[0082] In some implementations, the expandable coaptation element for preventing regurgitation between the leaflets of a native heart valve includes an expandable frame or spacer configured to transition between an expanded configuration and a collapsed configuration.

[0083] In some implementations, an expandable coaptation element for preventing regurgitation between the leaflets of a native heart valve includes an expandable mechanism. In some implementations, the expandable mechanism is configured to transition between an expanded configuration and a collapsed configuration. The expandable mechanism can be the same as or similar to any of the expandable mechanisms described elsewhere in this disclosure. The expandable mechanism can include one or more of a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, a pivoting or scissor-shaped extension member and / or strut, an expanding pulley mechanism, a Hoberman mechanism, a cam, a worm screw, a rack and pinion, foam, etc.

[0084] In some implementations, the expandable frame is attached around the expandable mechanism.

[0085] In some implementations, the expandable mechanism is configured to expand only in two opposing directions.

[0086] In some implementations, the expandable frame has a circular cross-section when the expandable mechanism is in a collapsed configuration, and the expandable frame has an oval cross-section when the expandable mechanism is in an expanded configuration.

[0087] In some implementations, the expandable mechanism includes a plurality of struts.

[0088] Any of the above methods may be performed on a living subject (e.g., a human, other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, an anthropomorphic ghost, a simulator such as a computer simulator in which body parts, tissues, etc. are simulated). In a simulation, the body parts may optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and may include, for example, computerized and / or physical representations.

[0089] Any of the above systems, assemblies, devices, components, apparatus, etc. may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure safe use on patients, and the above methods may include (or additional methods may include or consist of) sterilizing (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) the systems, devices, apparatus, components, etc. herein.

[0090] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings, in which like parts are designated with like reference numerals and in which:

[0091] To further clarify various aspects of the examples within the present disclosure, a more detailed description of specific examples and implementations will be provided by reference to various aspects of the accompanying drawings. These drawings depict only exemplary implementations of the present disclosure and therefore should not be considered to limit the scope of the present disclosure. Moreover, while the drawings may be drawn to scale for some examples, the drawings are not necessarily drawn to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0092] [Figure 1] FIG. 1 illustrates a cross-section of a human heart in diastole. [Figure 2] FIG. 2 illustrates a cross-section of a human heart during systole. [Figure 3] FIG. 3 illustrates a cross-section of a human heart during systole, showing valvular regurgitation. [Figure 4] FIG. 4 is a cross-sectional view of FIG. 3, annotated to illustrate the natural shape of the mitral valve leaflets during systole. [Figure 5] FIG. 5 illustrates a healthy mitral valve with the leaflets in occlusion as viewed from the atrial side of the mitral valve. [Figure 6] FIG. 6 illustrates a dysfunctional mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 7] FIG. 7 illustrates the tricuspid valve as viewed from the atrial side of the tricuspid valve. [Figure 8] FIG. 8 shows an exemplary device or implant at various stages of deployment. [Figure 9] FIG. 9 shows an exemplary device or implant at various stages of deployment. [Figure 10] FIG. 10 shows an exemplary device or implant at various stages of deployment. [Figure 11] FIG. 11 shows an exemplary device or implant at various stages of deployment. [Figure 12] FIG. 12 shows an exemplary device or implant at various stages of deployment. [Figure 13] FIG. 13 shows an exemplary device or implant at various stages of deployment. [Figure 14] FIG. 14 shows an exemplary device or implant at various stages of deployment. [Figure 15] FIG. 15 shows an exemplary device similar to the devices shown in FIGS. 8-14, but in which the paddles are independently controllable. [Figure 16] FIG. 16 illustrates the exemplary device of FIGS. 8-14 as delivered and implanted within a native valve. [Figure 17] FIG. 17 illustrates the exemplary device of FIGS. 8-14 as delivered and implanted within a native valve. [Figure 18] FIG. 18 illustrates the exemplary device of FIGS. 8-14 as delivered and implanted within a native valve. [Figure 19] FIG. 19 illustrates the exemplary device of FIGS. 8-14 as delivered and implanted within a native valve. [Figure 20] FIG. 20 illustrates the exemplary device of FIGS. 8-14 as delivered and implanted within a native valve. [Figure 21] FIG. 21 illustrates the exemplary device of FIGS. 8-14 as delivered and implanted within a native valve. [Figure 22]FIG. 22 shows a perspective view of an exemplary device in an occluded position. [Figure 23] FIG. 23 shows a perspective view of an exemplary device in an occluded position. [Figure 24] FIG. 24 illustrates an exemplary device with the paddle in the open position. [Figure 25A] FIG. 25A illustrates an exemplary device with the paddles in the closed position. [Figure 25B] FIG. 25B illustrates a top view of an exemplary device. [Figure 26] FIG. 26 illustrates a perspective view of an exemplary device with adjustable width paddles. [Figure 27] FIG. 27 is a cross-sectional view of the exemplary device of FIG. 26, where the device has been bisected. [Figure 28] FIG. 28 is another cross-sectional view of the exemplary device of FIG. 26, with the device bisected along a plane perpendicular to the plane in which FIG. 28 is depicted. [Figure 29] FIG. 29 is a schematic illustration of an exemplary catheter assembly coupled to an exemplary device, with a drive element coupled to a paddle drive control member and to a driver head of the device. [Figure 30] FIG. 30 is an illustration of the assembly of FIG. 29 rotated 90 degrees to show the paddle width adjustment element coupled to the inner end of the connector of the device and further coupled to the paddle width control member. [Figure 31] FIG. 31 illustrates a perspective view of an exemplary expandable coaptation element of the device. [Figure 32] FIG. 32 illustrates an exemplary device having the expandable coaptation element shown in FIG. 31 implanted inside a native valve. [Figure 33] FIG. 33 illustrates a perspective view of an exemplary device with an expandable coaptation element having a shell. [Figure 34]FIG. 34 shows an exemplary configuration of one component in the shell shown in FIG. [Figure 35] FIG. 35 shows an exemplary configuration of one component in the shell shown in FIG. [Figure 36] FIG. 36 illustrates a front view of the device of FIG. [Figure 37] FIG. 37 illustrates a plan view of the device of FIG. [Figure 38] FIG. 38 illustrates a side view of the device of FIG. 33 in an expanded position. [Figure 39] FIG. 39 illustrates a side view of the device of FIG. 33 in the constricted position. [Figure 40] FIG. 40 illustrates a perspective view of an exemplary implementation of an expandable sleeve of a coaptation element. [Figure 41] FIG. 41 illustrates a top view of the expandable sleeve of the coaptation element of FIG. 40 in a constricted position. [Figure 42] FIG. 42 illustrates a perspective view of the expandable sleeve of the coaptation element of FIG. 40 when the expandable coaptation element is in the expanded position. [Figure 43] FIG. 43 illustrates a top view of the expandable sleeve of the coaptation element of FIG. 42 in an expanded position. [Figure 44] FIG. 44 illustrates the expandable coaptation element in an untensioned position. [Figure 45] FIG. 45 illustrates the expandable coaptation element in a tensioned position. [Figure 46] FIG. 46 illustrates various types of expansion of the expandable coaptation element in plan view. [Figure 47] FIG. 47 illustrates various types of expansion of the expandable coaptation element in plan view. [Figure 48] FIG. 48 illustrates various types of expansion of the expandable coaptation element in plan view. [Figure 49]FIG. 49 illustrates a plan view of an exemplary device comprising the expandable coaptation elements of FIGS. 44 and 45 implanted within a native heart valve with the expandable coaptation elements in an untensioned state. [Figure 50] FIG. 50 illustrates a side view of the device of FIG. 49 and a native heart valve. [Figure 51] FIG. 51 illustrates a plan view of an exemplary device comprising the expandable coaptation elements of FIGS. 44 and 45 implanted within a native heart valve with the expandable coaptation elements in a tensioned state. [Figure 52] FIG. 52 illustrates a side view of the device of FIG. 51 and a native heart valve. [Figure 53] FIG. 53 illustrates a perspective view of an exemplary expandable spacer or coaptation element in an expanded state. [Figure 54] FIG. 54 illustrates a front view of the expandable spacer or coaptation element of FIG. [Figure 55] FIG. 55 illustrates a perspective cross-sectional view of the exemplary expandable spacer or coaptation element of FIG. 53 as viewed along line 598-598 of FIG. [Figure 56] FIG. 56 illustrates a cross-sectional view of the exemplary expandable spacer or coaptation element of FIG. 53 as viewed along line 598-598 of FIG. [Figure 57] FIG. 57 illustrates a perspective view of an exemplary expandable spacer or coaptation element in an expanded state. [Figure 58] FIG. 58 illustrates a front view of the expandable spacer or coaptation element of FIG. [Figure 59] FIG. 59 illustrates a perspective cross-sectional view of the exemplary expandable spacer or coaptation element of FIG. 57 as viewed along line 602-602 of FIG. [Figure 60] FIG. 60 illustrates a cross-sectional view of the exemplary expandable spacer or coaptation element of FIG. 57 as viewed along line 602-602 of FIG. [Figure 61]FIG. 61 illustrates a perspective view of an exemplary expandable spacer or coaptation element in an unexpanded state with the latch tubes unlatched. [Figure 62] FIG. 62 illustrates a front view of the expandable spacer or coaptation element of FIG. [Figure 63] FIG. 63 illustrates a perspective cross-sectional view of the exemplary expandable spacer or coaptation element of FIG. 61 as viewed along line 606-606 of FIG. [Figure 64] FIG. 64 illustrates a cross-sectional view of the exemplary expandable spacer or coaptation element of FIG. 61 as viewed along line 606-606 of FIG. [Figure 65] FIG. 65 illustrates a perspective view of the exemplary expandable spacer or coaptation element of FIG. 61 with the latch tube in a latched state. [Figure 66] FIG. 66 illustrates a front view of the expandable spacer or coaptation element of FIG. [Figure 67] FIG. 67 illustrates a perspective cross-sectional view of the exemplary expandable spacer or coaptation element of FIG. 65 as viewed along line 610-610 of FIG. [Figure 68] FIG. 68 illustrates a cross-sectional view of the exemplary expandable spacer or coaptation element of FIG. 65 as viewed along line 610-610 of FIG. [Figure 69] FIG. 69 illustrates an enlarged detail view of the exemplary expandable spacer or coaptation element of FIG. 61 as viewed in area 607 of FIG. [Figure 70] FIG. 70 illustrates an enlarged detail view of the exemplary expandable spacer or coaptation element of FIG. 65 as viewed in area 611 of FIG. [Figure 71] FIG. 71 illustrates an exemplary implementation of a portion of an expandable coaptation element. [Figure 72] FIG. 72 illustrates the internal cells of the frame of the expandable coaptation element of FIG. [Figure 73] FIG. 73 illustrates the cells within the frame of FIG. 72 in the extended position. [Figure 74]FIG. 74 illustrates the cell of FIG. 71 with an exemplary drive member. [Figure 75] FIG. 75 illustrates an exemplary implementation of an expandable joint element for a device. [Figure 76] FIG. 76 illustrates an exemplary implementation of an expandable joint element for the device. [Figure 77] FIG. 77 illustrates an exemplary implementation of an expandable joint element for a device. [Figure 78] FIG. 78 illustrates a side view of an exemplary implementation of the device attached to the leaflets of a heart valve. [Figure 79] FIG. 79 illustrates a plan view of the device and heart valve of FIG. [Figure 80] FIG. 80 illustrates a side view of an exemplary implementation of the device in an open configuration and an extension or blocking member for a heart valve. [Figure 81] FIG. 81 illustrates the device and cap of FIG. 80, with the device in an occluded configuration. [Figure 82] FIG. 82 illustrates a perspective view of an exemplary frame member of an expandable coaptation element. [Figure 83] FIG. 83 illustrates a cross-sectional perspective view of the frame member of FIG. [Figure 84] FIG. 84 illustrates a top view of the frame member of FIG. 82 with an exemplary expandable / expansion member attached. [Figure 85] FIG. 85 illustrates a side cross-sectional view of the expandable / expansion member and frame member of FIG. [Figure 86] FIG. 86 illustrates a cross-sectional perspective view of the expandable / expansion member and frame member of FIG. [Figure 87] FIG. 87 illustrates a perspective view of the expandable / expanding member of FIG. 84 in an expanded configuration. [Figure 88] FIG. 88 illustrates a perspective view of the expandable / expanding member of FIG. 84 in a collapsed configuration. [Figure 89]FIG. 89 illustrates an exploded perspective view of an expandable / expansion member and an exemplary drive mechanism for an expandable coaptation element. [Figure 90] FIG. 90 illustrates a cross-sectional view of the expandable / expansion member and drive mechanism of FIG. 89 taken along line 90-90. [Figure 91] FIG. 91 illustrates a cross-sectional view of the expandable / expansion member and drive mechanism of FIG. 89 taken along line 91-91. [Figure 92] FIG. 92 illustrates a perspective view of the expandable / expansion member and drive mechanism of FIG. [Figure 93] FIG. 93 illustrates a front view of the expandable / expanding member and drive mechanism of FIG. [Figure 94] FIG. 94 illustrates a front view of an exemplary expandable / expansion member and an exemplary drive mechanism for an expandable coaptation element. [Figure 95] FIG. 95 illustrates an exploded view of the drive mechanism of FIG. [Figure 96] FIG. 96 illustrates a cross-sectional view of the expandable / expansion member and drive mechanism of FIG. 94 taken along line 96-96. [Figure 97] FIG. 97 illustrates a cross-sectional view of the expandable / expansion member and drive mechanism of FIG. 94 taken along line 97-97. [Figure 98] FIG. 98 illustrates a perspective view of the cross-sectioned expandable / expansion member and drive mechanism of FIG. [Figure 99] FIG. 99 illustrates an exemplary expandable / expansion member and an exemplary drive mechanism for an expandable coaptation element. [Figure 100] FIG. 100 illustrates an exemplary expandable coaptation element in a collapsed configuration. [Figure 101] FIG. 101 illustrates the expandable coaptation element of FIG. 100 in an expanded configuration. [Figure 102] FIG. 102 illustrates a top view of a portion of an exemplary cover for an expandable coaptation element, the cover in a first state. [Figure 103]FIG. 103 illustrates a plan view of a portion of the expandable portion of the cover of FIG. 102, with the cover in a second state. [Figure 104] FIG. 104 illustrates a plan view of a portion of the expandable portion of the cover of FIG. [Figure 105] FIG. 105 illustrates a plan view of a plain weave of an exemplary cover for an expandable coaptation element. [Figure 106] FIG. 106 illustrates a top view of a portion of an exemplary cover for an expandable coaptation element, with the expandable portion in a preheated state. [Figure 107] FIG. 107 illustrates a top view of a portion of an exemplary cover for an expandable coaptation element, with the expandable portion in a post-heated state. [Figure 108] FIG. 108 illustrates a top view of an exemplary cover having a scalable portion attached to a paddle frame of a device, with the paddle frame in an extended position and the cover in an extended position. [Figure 109] FIG. 109 illustrates a top view of an exemplary cover having an expandable portion attached to a paddle frame of a device, with the paddle frame in a constricted position and the cover in a normal position. [Figure 110] FIG. 110 shows a schematic diagram of an exemplary cover for an expandable coaptation element. [Figure 111] FIG. 111 shows a schematic diagram of a coating laminated onto a cover material. [Figure 112] FIG. 112 illustrates a perspective view of the expandable / expanding member in a substantially unexpanded configuration. [Figure 113] FIG. 113 illustrates a perspective view of an exemplary frame of an expandable coaptation element. [Figure 114] FIG. 114 illustrates a perspective view of an exemplary expandable / expansion member and an exemplary drive mechanism for an expandable coaptation element. [Figure 115] FIG. 115 illustrates a cross-sectional view of the expansion member and drive mechanism of FIG. [Figure 116] FIG. 116 illustrates a perspective view of the assembly of the expandable / expansion member and drive mechanism of FIG. 114 and the rails of a valve repair device. [Figure 117] FIG. 117 illustrates a side view of the assembly of FIG. [Figure 118] FIG. 118 shows the assembly of FIG. 116 rotated 90 degrees relative to FIG. [Figure 119] FIG. 119 illustrates a perspective view of the valve repair device with the expandable spacer in an unexpanded configuration. [Figure 120] FIG. 120 illustrates a perspective view of the valve repair device of FIG. 119 with the spacer in an expanded configuration. [Figure 121] FIG. 121 illustrates a plan view of the valve repair device of FIG. 119 placed on the leaflets of the tricuspid valve, as viewed from the atrial side of the tricuspid valve. [Figure 122] FIG. 122 illustrates a perspective view of a valve repair device having the assembly of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0093] In the following description, reference is made to the accompanying drawings that illustrate exemplary implementations of the present disclosure. Other implementations having different structure and operation do not depart from the scope of the present disclosure.

[0094] Exemplary implementations of the present disclosure are directed to systems, devices, methods, etc. for repairing defective heart valves. For example, various implementations of devices, valve therapy devices, valve repair devices, implantable devices, implants, and systems (including systems for delivering the same) are disclosed herein, and any combination of these options may be made unless specifically excluded. In other words, individual components of the disclosed devices and systems may be combined unless mutually exclusive or physically impossible. Furthermore, the techniques, methods, operations, steps, etc. described or suggested herein may be performed on living subjects (e.g., humans, other animals, etc.) or on non-biological simulations such as cadavers, cadaver hearts, simulators, virtual humans, etc. When performed on a simulation, body parts, e.g., hearts, tissues, valves, etc., may optionally be referred to as “simulated” (e.g., simulated hearts, simulated tissues, simulated valves, etc.) and may include, for example, computerized and / or physical representations of body parts, tissues, etc.

[0095] As described herein, when one or more components are described as being connected, joined, fastened, coupled, attached, or otherwise interconnected, such interconnection can be direct, such as between the components, or indirect, such as through the use of one or more intermediate components. Also, as described herein, references to a "member," "component," or "portion" are not limited to a single structural member, component, or element, but can include 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%). Although the terms "clasp" and "clasp arms" are often used herein with reference to specific examples, the terms "gripping member" and / or "gripping arms" can be used instead, even if they are not configured exactly like a typical clasp and can function in the same or similar manner.

[0096] 1 and 2 illustrate 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. Additionally, an aortic valve AV separates the left ventricle LV from the ascending aorta AA, and a pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20 and 22 shown in FIGS. 3-6 and leaflets 30, 32, and 34 shown in FIG. 7 ) that extend inward across their respective openings and meet, or "coapt," in flow to form a unidirectional fluid-blocking surface. The native valve repair and / or treatment systems of the present application are frequently described and / or illustrated with respect to the mitral valve MV. Accordingly, the anatomy of the left atrium LA and left ventricle LV will now be described in more detail. However, the devices described herein can also be used in the repair of other native valves, for example, the devices can be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0097] The left atrium LA receives oxygen-rich blood from the lungs. During the diastolic phase, as shown in FIG. 1 , blood previously collected in the left atrium LA (during the contraction phase) moves into the left ventricle LV through the mitral valve MV due to the expansion of the left ventricle LV. During the systolic phase, as shown in FIG. 2 , the left ventricle LV contracts, pumping blood through the aortic valve AV and the ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close, preventing blood from flowing back from the left ventricle LV into the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In some implementations, the devices described herein are used to restore the function of a defective mitral valve MV. That is, the devices are configured to assist in the closure of the mitral valve leaflets to prevent, inhibit, or reduce blood from flowing back from the left ventricle LV into the left atrium LA. Although 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 within the regurgitant orifice to prevent or inhibit backflow during systole, this is not required.

[0098] Referring now to FIGS. 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24 (see FIG. 5), which is a variably dense, fibrous ring of tissue surrounding the leaflets 20, 22. Referring to FIGS. 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., muscles located at the base of the chordae tendineae CT and within the wall of the left ventricle LV) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM 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, they support and brace the valve leaflets 20, 22 against the high pressures required to circulate blood throughout the body. The papillary muscles PM and chordae tendineae CT are collectively known as the subvalvular tissue, which functions to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve MV is closed. As can be seen from the left ventricular outflow tract (LVOT) diagram shown in FIG. 3 , the anatomy of the valve leaflets 20, 22 is such that the medial surfaces of the leaflets coapt at their free ends and the leaflets 20, 22 begin to retract and diverge from each other. The leaflets 20, 22 diverge toward the atrium until each leaflet contacts the mitral annulus.

[0099] Various disease processes can impair the proper function of one or more native valves in 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 cardiac diseases (e.g., cardiomyopathy, etc.) can distort the shape of the native valve, which can cause the native valve to malfunction. However, the majority of patients undergoing 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.

[0100] In general, natural valves can malfunction in different ways, including (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when the natural valve does not open completely, causing obstruction to blood flow. Typically, valve stenosis is caused by the accumulation of calcified material on the valve leaflets, which thicken the leaflets and impair the valve's ability to open completely to allow forward blood flow. Valve regurgitation occurs when the valve leaflets do not close completely, allowing blood to leak back into the previous chamber (e.g., blood leaking from the left ventricle into the left atrium).

[0101] There are three major mechanisms by which native valves become regurgitant or incompetent, including Carpentier Type I, Type II, and Type III insufficiency. Carpentier Type I insufficiency involves dilatation of the valve annulus, causing normally functioning valve leaflets to separate and no longer form a tight seal (i.e., the leaflets do not coapt properly). Included in Type I insufficiency is leaflet perforation, such as occurs in endocarditis. Carpentier Type II insufficiency involves prolapse of one or more native valve leaflets above the plane of coaptation. Carpentier Type III insufficiency involves restricted movement of one or more native valve leaflets, resulting in abnormal constraining of the leaflets below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease or by ventricular dilation.

[0102] Referring to FIG. 5, when a healthy mitral valve MV is in the occluded position, the anterior leaflet 20 and the posterior leaflet 22 coapt, thereby preventing blood from leaking from the left ventricle LV into the left atrium LA. Referring 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 displace into the left atrium LA during systole, causing the edges of the leaflets 20, 22 to no longer contact each other. This lack of coaptation 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 into the left atrium LA during systole, as illustrated by the mitral regurgitation MR flow path shown in FIG. 3. Referring to FIG. 6, the gap 26 can have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some circumstances, gap 26 may have a width W 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., leaflets 20, 22 of the mitral valve MV) may become incompetent, causing valve regurgitation.

[0103] In any of the above situations, a valve repair device or implant is desirable that can engage the anterior and posterior leaflets 20 and 22, thereby closing the gap 26 and preventing or inhibiting backflow of blood through the mitral valve MV. As can be seen in FIG. 4, an abstract representation of a repair or treatment device 10 (e.g., a valve treatment device, valve repair device, implantable device, implant, etc.) is shown implanted between the valve leaflets 20, 22 to prevent backflow during systole (compare FIG. 3 with FIG. 4). In some implementations, the coaptation elements (e.g., spacers, coupling members, gap fillers, membranes, sheets, plugs, wedges, balloons, etc.) of the device 10 have a generally tapered or triangular shape to naturally conform to the shape of the native valve and the nature of its expanded (toward the annulus) leaflets. In this application, the terms spacer, coaptation element, connecting member, gap filler, plug, etc. are used interchangeably and refer to a member that fills a portion of the space between the leaflets of a native valve and / or is configured to engage or "coapt" the leaflets of a native valve (e.g., to cause the leaflets to coapt not only to each other but also to the coaptation element, connecting member, spacer, etc.).

[0104] Although stenosis or regurgitation can affect any valve, stenosis has been found to primarily affect either the aortic valve (AV) or the pulmonary valve (PV), while regurgitation has been found to primarily affect either the mitral valve (MV) or the tricuspid valve (TV). Both valve stenosis and valve regurgitation increase the burden on the heart (H) and, if left untreated, can lead to very serious conditions, including endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. The left side of the heart (i.e., the left atrium (LA), left ventricle (LV), mitral valve (MV), and aortic valve (AV)) is primarily responsible for circulating blood throughout the body. Therefore, because pressures are substantially higher on the left side of the heart, malfunction of the mitral valve (MV) or aortic valve (AV) is particularly problematic and often life-threatening.

[0105] Dysfunctional native heart valves can be either repaired or replaced. Repair typically involves preserving and modifying a patient's native valve. Replacement typically involves replacing a patient's native valve with a biological or mechanical substitute. Typically, the aortic valve (AV) and pulmonary valve (PV) are more prone to stenosis. Because stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic or pulmonary valve can involve removal of the valve and replacement with a surgically implanted heart valve or a transcatheter heart valve. The mitral valve (MV) and tricuspid valve (TV) are more prone to deformation of the leaflets and / or surrounding tissue, which, as described above, can prevent the mitral valve (MV) or tricuspid valve (TV) from closing properly, allowing regurgitation or backflow of blood from the ventricle into the atrium (e.g., a deformed mitral valve (MV) can allow regurgitation or backflow from the left ventricle (LV) into the left atrium (LA), as shown in FIG. 3). Regurgitation, or backflow, of blood from the ventricle to the atrium results in valvular insufficiency. Deformities in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. Additionally, regurgitation can occur due to dysfunction of the chordae tendineae CT (e.g., the chordae tendineae CT can stretch or rupture), allowing the anterior and posterior leaflets 20 and 22 to evertate, allowing blood to flow back into the left atrium LA. Problems caused by dysfunctional chordae tendineae CT can be corrected by repairing the chordae tendineae CT or by repairing the structure of the mitral valve MV (e.g., by fixating the leaflets 20, 22 at the affected portion of the mitral valve).

[0106] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it will be understood that the devices and concepts provided herein can be used to repair any native valve, as well as any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or block the backflow of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts provided herein can be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or block the backflow of blood from the right ventricle into the right atrium. Additionally, any of the devices and concepts provided herein can be used together on all three leaflets 30, 32, and 34 to prevent or block the backflow of blood from the right ventricle into the right atrium. That is, the treatment devices, repair devices, implants, etc. provided herein can be centrally positioned between the three leaflets 30, 32, and 34.

[0107] Exemplary devices (e.g., valve repair devices, valve treatment devices, implantable devices, implants, etc.) can optionally include a coaptation element (e.g., a spacer, a coupling member, a gap filler, a membrane, a sheet, a plug, a wedge, a balloon, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, a device (e.g., a valve repair device, a valve treatment device, an implantable device, an implant, etc.) can include any combination or subcombination of the features disclosed herein without a coaptation element. When included, the coaptation element (e.g., a spacer, a coupling member, a gap filler, a membrane, a sheet, a plug, a wedge, a balloon, etc.) is configured to be positioned within the native heart valve opening to help fill the space between the valve leaflets and form a more effective seal, thereby reducing or preventing the aforementioned regurgitation. The coaptation element can be structured to be impermeable to blood (or resist blood flow therethrough) and to allow the native valve leaflets to close around the coaptation element during ventricular systole, thereby blocking backflow of blood from the left ventricle into the left atrium and from the right ventricle into the right atrium. The device can be configured to seal against two or three native valve leaflets, i.e., the device can be used in native mitral (bicuspid) and tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because it can fill the space between native valve leaflets (e.g., mitral valve leaflets 20, 22 or tricuspid valve leaflets 30, 32, 34) that are not fully closed and are not functioning properly.

[0108] The optional coaptation elements (e.g., spacers, coaptation elements, gap fillers, membranes, sheets, plugs, wedges, balloons, etc.) can have a variety of shapes. In some implementations, the coaptation elements can have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the coaptation elements can have an elliptical, oval, crescent, rectangular, or various other non-cylindrical shapes. In some implementations, the coaptation elements can have an atrial portion positioned within or adjacent to the atrium, a ventricular or lower portion positioned within or adjacent to the ventricle, and lateral sides extending between the native tricuspid valve leaflets. In some implementations configured for use in a tricuspid valve, the atrial or upper portion is positioned within or adjacent to the right atrium, the ventricular or lower portion is positioned within or adjacent to the right ventricle, and the lateral sides extend between the native tricuspid valve leaflets.

[0109] In some implementations, the anchor can be configured to secure the device to one or both of the native valve leaflets, such that the coaptation element is positioned between two native leaflets. In some implementations configured for use in a tricuspid valve, the anchor can be configured to secure the device to one, two, or three of the tricuspid valve leaflets, such that the coaptation element is positioned between three native leaflets. In some implementations, the anchor can be attached to the coaptation element adjacent to the ventricular portion of the coaptation element. In some implementations, the anchor can be attached to the drive element (e.g., drive shaft, drive tube, drive wire, etc.) to which the coaptation element is also attached. In some implementations, the anchor and the coaptation element can be independently positioned relative to each other by separately moving the anchor and the coaptation element along the longitudinal axis of the drive element (e.g., drive shaft, drive rod, drive tube, drive wire, etc.). In some implementations, the anchor and the coaptation element can be simultaneously positioned by moving the anchor and the coaptation element together along the longitudinal axis of the drive element (e.g., shaft, drive wire, etc.). The anchors can be configured to be positioned behind the native valve leaflets when deployed so that the leaflets are grasped by the anchors.

[0110] The device can be configured to be deployed and / or implanted via a delivery system or other delivery means. The delivery system can include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, etc. The coaptation elements and anchors can be compressible to a radially compressed state and self-expandable to a radially expanded state when the compressive pressure is released. The device can be configured so that the anchors expand radially away from the initially still-compressed coaptation elements to form a gap between the coaptation elements and the anchors. The native valve leaflets can then be positioned within the gap. The coaptation elements can radially expand to close the gap between the coaptation elements and the anchors, thereby capturing the leaflets between the coaptation elements and the anchors. In some implementations, the anchors and coaptation elements are optionally configured to self-expand. The implantation and / or deployment methods for some implementations can vary and are described more fully below for each implementation. Additional information regarding these and other delivery methods that may be used with the concepts herein can be found in U.S. Pat. No. 8,449,599, U.S. Pat. App. Pub. No. 2014 / 0222136, U.S. Pat. App. Pub. No. 2014 / 0067052, U.S. Pat. App. Pub. No. 2016 / 0331523, PCT Pat. App. Pub. No. WO2020 / 076898, PCT Pat. App. Pub. No. WO2023 / 2786 ... Publication Nos. 3 / 004098, PCT Patent Application Publication No. WO2023 / 091520, PCT Patent Application Publication No. WO2023 / 107296, PCT Patent Application Publication No. WO2023 / 086340, PCT Patent Application Publication No. WO2023 / 003755, and PCT Patent Application Publication No. WO2022 / 231889, which are incorporated by reference in their entireties for all purposes.These methods can be performed, mutatis mutandis, on live animals, or can be performed on simulations such as cadavers, cadaver hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0111] The disclosed device or implant can be configured with anchors connected to the valve leaflets, utilizing tension from the natural chordae tendineae to resist the large systolic pressures that urge the device toward the left atrium. During diastole, the device can rely on compressive and retaining forces applied to the leaflets gripped by the anchors.

[0112] 8-15, a generally illustrated device 100 (e.g., a prosthetic device, a valve repair device, a valve treatment device, an implantable device, an implant, etc.) is shown in various stages of deployment. Device 100, as well as other similar devices and / or implants, are described in PCT Patent Application Publication Nos. WO2018 / 195215, WO2020 / 076898, WO2019 / 139904, WO2023278663, WO2023 / 004098, and PCT Patent Application Publication Nos. WO2023278663, WO2023 / 004098, WO2023 / 00409 ... This is described in more detail in PCT Patent Application Publication Nos. WO2023 / 091520, WO2023 / 107296, WO2023 / 086340, WO2023 / 003755, and WO2022 / 231889, which are incorporated by reference in their entireties for all purposes. The devices herein can include any other features of another device or implant described in this or the above-cited applications, and the devices herein can be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable treatment and / or repair system (e.g., any valve repair and / or treatment system disclosed in this or the above-cited applications).

[0113] The device 100 is deployed from a delivery system 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 100 includes a joint portion 104 and an anchor portion 106.

[0114] In some implementations, the coaptation portion 104 of the device 100 includes a coaptation element 110 configured to be deployed and / or implanted between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and slidably attached to an actuation element 112 (e.g., a drive wire, a shaft, a tube, a hypotube, a line, a suture, a braid, etc.). The anchor portion 106 includes one or more anchors 108 that are actuatable between an open state and a closed state and can take a variety of forms, such as, for example, paddles, gripping members, or the like. Actuation of the actuation element 112 opens and closes the anchor portion 106 of the device 100 to grip the native valve leaflets during deployment and / or implantation. The drive element 112 (as well as the other drive elements disclosed herein) can take a variety of different forms (e.g., wire, rod, shaft, tube, screw, suture, line, strip, combinations thereof, etc.), can be formed from a variety of different materials, and can have a variety of configurations. As an example, the drive element can be threaded so that rotating the drive element moves the anchor portion 106 relative to the interface portion 104. Alternatively, the drive element can be unthreaded so that pushing or pulling the drive element 112 moves the anchor portion 106 relative to the interface portion 104.

[0115] 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 can 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 can constrain the device to the positions and movements illustrated herein.

[0116] In some implementations, the delivery system 102 includes a steerable catheter, an implant catheter, and a drive element 112 (e.g., a drive wire, shaft, tubing, hypotube, line, suture, braid, etc.), which can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the drive element 112 extends through the delivery catheter and through the joint element 110 to its distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the drive element 112 increases and decreases the spacing, respectively, between the joint element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion). In some implementations, a collar or other attachment member (e.g., a clamp, clip, locking member, suture, friction bond, buckle, snap engagement, lasso, etc.) directly or indirectly removably attaches the joint element 110 to the delivery system 102, whereby the actuation element 112 slides through the collar or other attachment member, and in some implementations, through the joint element 110 when actuated, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0117] In some implementations, the anchor portion 106 and / or the anchor 108 may include an attachment portion or gripping member (e.g., a gripping arm, a clasp arm, etc.). The illustrated gripping member may include a clasp 130 including a base or fixed arm 132, a movable arm 134, optional friction-enhancing elements or other securing structures 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.), and a joint portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 with the joint portion 138 positioned proximate to the joining element 110. The joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the clasp 130. The joint portion 138 may be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, joint portion 138 is a flexible member 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 opens, thereby opening clasp 130 and exposing optional barbs or other friction-enhancing elements 136.

[0118] In some implementations, the clasp 130 is opened by applying tension to a drive line 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, bend, or pivot on a joint portion 138. The drive line 116 extends through the delivery system 102 (e.g., through a steerable catheter, an implant catheter, etc.). Other drive mechanisms are also possible.

[0119] The drive 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 against the grasped native valve leaflet in the occluded position. Optional barbs or other friction-enhancing elements 136 of the clasp 130 can grasp, pinch, and / or pierce the native valve leaflet to further secure the native valve leaflet.

[0120] During deployment and / or implantation, the paddles 120, 122 open and close, allowing natural valve leaflets (e.g., leaflets of a natural mitral valve, etc.) to be grasped between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation element 110 (e.g., a spacer, plug, membrane, etc.).

[0121] The clasp 130 can be used to grasp and / or further secure the native valve leaflet by engaging it with optional barbs or other friction-enhancing elements 136 and clamping it between the movable arm 134 and the fixed arm 132. The optional barbs or other friction-enhancing elements 136 of the clasp 130 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) can increase friction against the leaflet or partially or fully pierce the leaflet.

[0122] In some implementations, the drive lines 116 can be actuated individually (or both separately and simultaneously) so that each clasp 130 can be opened and closed individually. Individual actuation allows for grasping one leaflet at a time, or for repositioning the clasp 130 on a leaflet that was not adequately grasped without altering the good grip on the other leaflets. The clasps 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), allowing for grasping of the leaflets in various positions as the particular situation requires.

[0123] Referring now to FIG. 8 , the device 100 is shown in an extended or fully open state for deployment from a delivery catheter of a delivery system 102. In the fully open position, the device 100 is positioned at the end of the catheter in the delivery system 102. In the extended state, the cap 114 is spaced apart from the coaptation element 110 so 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 approximately 180 degrees. The clasp 130 can be maintained in an occluded state during deployment through the delivery system. The drive line 116 can be extendable and attached to a movable arm 134.

[0124] Referring now to FIG. 9, device 100 is shown in an extended state similar to that of FIG. 8, but with clasp 130 in a fully open position, at an angle between fixed portion 132 and movable portion 134 of clasp 130 in the range of about 140 degrees to about 200 degrees, in the range of about 170 degrees to about 190 degrees, or about 180 degrees.

[0125] Referring now to FIG. 10 , the device 100 is shown in a retracted or fully occluded state. To transition the device 100 from the extended state to the retracted state, the actuating element 112 is retracted, pulling the cap 114 toward the coaptation element 110. The connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained in movement such that a compressive force acting from the cap 114 on the outer paddle 120 retracts the paddle or gripping member toward the coaptation element 110, moving radially outward. When transitioning from the open position to the closed position, the outer paddle 120 maintains an acute angle relative to the actuating element 112. The outer paddle 120 can optionally be biased toward the closed position. During the same movement, the inner paddle 122 moves through a significant angle to orient itself away from the open coaptation element 110 and to fold along the side of the closed coaptation element 110.

[0126] 11-13, the device 100 is shown in a partially open state and ready to grasp. To transition from the fully occluded state to the partially open state, an actuation element (e.g., a drive wire, shaft, tube, hypotube, line, suture, braid, etc.) is extended to push the cap 114 away from the coaptation element 110, thereby pulling the outer paddle 120 and the inner paddle 122, partially expanding the anchor or anchor portion 106. The actuation line 116 is also retracted, thereby releasing the clasp 130 so that it can grasp the valve leaflets. In some implementations, the pair of inner and outer paddles 122, 120 are actuated together, rather than individually, by a single actuation element 112. The position of the clasp 130 also depends on the position of the paddles 122, 120. For example, with reference 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 example illustrated in FIG. 15, the device 100 can have two actuation elements 111, 113 and two independent caps 115, 117 (or other attachment portions), such that one independent actuation element (e.g., drive wire, shaft, tubing, hypotube, line, suture, braid, etc.) and cap (or other attachment portion) can be used to control one paddle, and the other independent actuation element and cap (or other attachment portion) can be used to control the other paddle.

[0127] Referring now to Figure 12, extending one drive line 116 can close one clasp 130. Referring now to Figure 13, extending another drive line 116 can close another clasp 130. By repeatedly driving one or both drive lines 116, the clasps 130 can be repeatedly opened and closed.

[0128] 14, device 100 is shown in a fully occluded and deployed state. Delivery system 102 and drive element 112 are retracted, and paddles 120, 122 and clasp 130 remain in the fully occluded position. After deployment, device 100 can be maintained in the fully occluded position by a mechanical latch, or it can be biased to remain occluded using a spring material such as steel, other metals, plastics, composites, etc., or using a shape memory alloy such as Nitinol. For example, the connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from a metal such as steel or from a shape memory alloy such as Nitinol, which may be fabricated from a wire, sheet, tube, or laser-sintered powder, and are biased to hold the outer paddle 120 in an occluded state around the coaptation element 110 and to clamp the clasp 130 around the native valve leaflets. Similarly, the fixed and movable arms 132, 134 of the clasp 130 are biased to clamp the leaflets. In some implementations, the attachment or connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) can be formed from a metal or any other suitable resilient material, such as a polymeric material, to maintain the device 100 in an occluded state after deployment and / or implantation.

[0129] Figure 15 illustrates an example in which the paddles 120, 122 are independently controllable. The device 101 illustrated in Figure 15 is similar to the device illustrated 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. To transition the first inner paddle 122 and the first outer paddle 120 from a fully occluded state to a partially open state, the actuation element 111 is extended to push the cap 115 away from the coaptation element 110, thereby pulling the outer paddle 120 and pulling the inner paddle 122, thereby partially expanding the first anchor 108. To transition the second inner paddle 122 and the second outer paddle 120 from the fully closed state to the partially open state, the actuation element 113 is extended to push the cap 115 away from the spacer or joint element 110, thereby pulling the outer paddle 120 and pulling the inner paddle 122, partially expanding the second anchor 108. The independent paddle control illustrated in Figure 15 can be implemented in any of the devices disclosed herein. For comparison, in the example illustrated in Figure 11, the pair of inner and outer paddles 122 and 120 are driven together, rather than individually, by a single actuation element 112.

[0130] 16-21, the implantable device 100 of FIGS. 8-14 is shown being delivered and deployed within the native mitral valve MV of the heart H. Referring to FIG. 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 the fully open state as shown in FIG. 16. The actuating element 112 is then retracted, transitioning the implant / device to the fully occluded state shown in FIG. 17.

[0131] As can be seen in Figure 18, the implant / device is moved into position within the mitral valve MV and into the ventricle LV, partially opening the valve leaflets 20, 22 to grasp them. For example, the steerable catheter can be advanced to steer or bend the steerable catheter, thereby positioning it as shown in Figure 18. A device or implant catheter connected to the implant / device can be advanced from within the steerable catheter, thereby positioning the implant as shown in Figure 18.

[0132] 19, the device catheter is retracted into the steerable catheter, thereby positioning the mitral valve leaflets 20, 22 within the clasps 130. The drive line 116 is extended to occlude one of the clasps 130 and capture the leaflet 20. FIG. 20 illustrates that the other drive line 116 is then extended to occlude the other clasp 130 and capture the remaining leaflet 22. Furthermore, as can be seen in FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), drive element 112, and drive line 116 are then retracted to fully occlude and deploy the device 100 within the native mitral valve MV.

[0133] Any feature disclosed herein can be used in a wide variety of different treatment and / or repair devices. Figures 22-24 illustrate examples of valve treatment and / or repair devices that may be modified to include any feature disclosed herein. Any combination or subcombination of the features disclosed herein can be combined with, substituted for, and / or added to any combination or subcombination of the features of the devices illustrated in Figures 8-24.

[0134] Referring now to FIG. 22 , an example of a device 200 (e.g., a treatment device, repair device, implantable device, implant, etc.) is shown. Device 200 can be configured as an implantable device, an implant, or other valve treatment device (e.g., a device that does not necessarily remain implanted). Device 200 is one of many different configurations of device 100, shown generally in FIGS. 8-14 . Device 200 can include any other features of devices or implants described herein, and device 200 can be positioned to engage valve tissue 20, 22 as part of any suitable treatment and / or repair system (e.g., any of the valve repair and / or therapy systems disclosed herein). Device / implant 200 can be a prosthetic spacer device, a valve repair device, a therapy device, or another type of implant that attaches to the leaflets of a native valve.

[0135] In some implementations, device 200 includes a coaptation portion 204, a proximal or attachment portion 209, an anchor portion 206, and a distal portion 207. In some implementations, device coaptation portion 204 optionally includes a coaptation element 210 (e.g., a spacer, a coupling member, a plug, a membrane, a sheet, a gap filler, a plug, a wedge, a balloon, etc.) for deployment and / or implantation between the leaflets of a native valve. In some implementations, anchor portion 206 includes multiple anchors 208. The anchors can be configured in various manners. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clasp 230. In some implementations, attachment portion 209 includes a first or proximal collar 211 (or other attachment member) for engaging a capture mechanism 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 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 capture mechanism may be configured in various manners and, in some implementations, may include one or more of a clamp, a clip, a pin, a suture, a line, a lasso, a noose, a snare, a buckle, a locking member, a latch, etc.

[0136] In some implementations, the joint elements 210 and paddles 220, 222 are formed from a flexible material, such as a metallic fabric, such as a mesh, woven fabric, braid, or formed in any other suitable manner, or cut by laser cutting or otherwise. The material can be fabric, shape-setting shape-memory alloy wire such as Nitinol, or any other flexible material suitable for deployment and / or implantation within the human body.

[0137] A drive element (e.g., a drive wire, shaft, tube, hypotube, line, suture, braid, etc.) extends from a delivery system (not shown) to engage the device or implant 200 and enable actuation of the device or implant 200. In some implementations, the drive element extends through the proximal collar 211 and the spacer or joint element 210 to engage the cap 214 of the distal portion 207. The drive element can be configured to releasably engage the cap 214 via a threaded or similar connection, allowing the drive element to be disengaged and removed from the device 200 after implantation.

[0138] The coaptation element 210 extends from the proximal collar 211 (or other attachment member) to the 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 oval 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 blend of these three geometries can result in a three-dimensional shape for the illustrated coaptation element 210 that achieves the benefits described herein. It can be appreciated that the circular shape of the coaptation element 210 also substantially conforms to or approximates the shape of the paddle frame 224 when viewed from above.

[0139] The size and / or shape of the coaptation element 210 can be selected to minimize the number of implants (preferably one) required per patient while maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the apex of the coaptation element is approximately 5 mm, and the medial-lateral distance at the widest point of the coaptation element is approximately 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and the overall shape strategy described above. It 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. Furthermore, using other size and shape strategies described above will also result in a device with different dimensions.

[0140] In some implementations, outer paddle 220 is articulably attached to cap 214 of distal portion 207 by connecting portion 221 and to inner paddle 222 by connecting portion 223. Inner paddle 222 is articulably attached to the joint element by connecting portion 225. In this manner, anchor 208 is configured similar to a leg in that inner paddle 222 resembles the upper portion of the leg, outer paddle 220 resembles the lower portion of the leg, and connecting portion 223 resembles the knee portion of the leg.

[0141] In some implementations, the inner paddle 222 is hard, relatively hard, rigid, has a stiff portion, and / or is stiffened by a reinforcing member or fastening portion of the clasp 230. The inner paddle 222, the outer paddle 220, and the joining element may all be interconnected as described herein.

[0142] 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 stiffer and more rigid material compared to the material forming the paddles 222, 220 such that the paddle frame 224 provides support for the paddles 222, 220.

[0143] Paddle frame 224 can provide additional clamping force between inner paddle 222 and coaptation element 210 and can assist in wrapping the leaflets around the sides of coaptation element 210. That is, paddle frame 224 can be configured with a rounded, three-dimensional shape extending from cap 214 to connecting portion 223 of anchor 208. The connections between paddle frame 224, outer and inner paddles 220 and 222, cap 214, and coaptation element 210 can constrain each of these components to the movements and positions described herein. In particular, connecting portion 223 is constrained by its connections between outer and inner paddles 220 and 222 and by its connection to paddle frame 224. Similarly, paddle frame 224 is constrained by its attachment to connecting portion 223 (and thus to inner and outer paddles 222 and 220) and by its attachment to cap 214.

[0144] The wider configuration of the paddle frame 224 provides an increased surface area compared to the inner paddle 222 alone. The increased surface area allows the clamping force of the paddles 220 and paddle frame 224 against the native leaflet to be distributed over a larger surface area of ​​the native leaflet to further protect the native leaflet tissue.

[0145] Additional features of device 200, modified versions of the device, delivery systems for the device, and methods for using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) and other applications incorporated herein by reference. Any combination or subcombination of features disclosed in this application can be combined with any combination or subcombination of features disclosed in Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) and / or other applications incorporated herein by reference. Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) is incorporated herein by reference in its entirety.

[0146] 23, an example of a device 300 (e.g., a valve repair device, a valve treatment device, an implantable device, an implant, etc.) is shown. Device 300 is one of many different configurations that device 100, illustrated generally in FIGS. 8-14, may take. Device 300 may include any other features of a device or implant described herein, and device 300 may be positioned to engage valve tissue 20, 22 as part of any suitable treatment and / or repair system (e.g., any of the valve repair and / or treatment systems disclosed herein).

[0147] The device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 includes a coaptation portion 304, which can optionally include a coaptation element 310 (e.g., a spacer, plug, membrane, sheet, etc.) for deployment and / or implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes multiple anchors 308. In some implementations, each anchor 308 can include one or more paddles, such as an outer paddle 320, an inner paddle 322, and a paddle extension or 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 member) for engaging a capture mechanism of a delivery system.

[0148] The anchors 308 can be attached to other portions of the device and / or to each other in a variety of different ways (e.g., directly, indirectly, by welding, by sutures, by adhesive, by links, by latches, by integral formation, by some or all of these combinations, etc.) In some implementations, the anchors 308 are attached to the joining element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0149] Anchor 308 can include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connecting portion 323. Connecting portion 323 can be attached to a paddle frame 324 that is hingedly attached to cap 314 or to another attachment portion. In this manner, anchor 308 is configured similar to a leg in that inner paddle 322 is like the upper portion of a leg, outer paddle 320 is like the lower portion of a leg, and connecting portion 323 is like the knee portion of the leg.

[0150] In implementations including the interface element 310, the interface element 310 and the anchor 308 can be coupled together in a variety of ways. As shown in the illustrated example, the interface element 310 and the anchor 308 can be coupled together by integrally forming the interface element 310 and the anchor 308 as a single, unitary component. This can be accomplished, for example, by forming the interface element 310 and the anchor 308 from a continuous strip 301 of braided or woven material, such as braided or woven Nitinol wire. In the illustrated example, the interface element 310, outer paddle portion 320, inner paddle portion 322, and connecting portions 321, 323, and 325 are formed from the continuous strip 301.

[0151] Similar to anchor 208 in device 200 described above, anchor 308 can be configured to transition 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 member, etc.). This movement can 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 member, etc.) of the device.

[0152] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight with respect to the orientation 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.

[0153] In some implementations, the clasp includes 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 a joint portion 338. The fixed arm 332 is attached to the inner paddle 322 with the joint portion 338 positioned proximate to the joining element 310. The joint portion 338 is spring loaded so that the fixed arm 332 and the movable arm 334 are biased toward each other when the clasp 330 is in the closed state.

[0154] The fixed arm 332 is attached to the inner paddle 322 using sutures and through a hole or slot. The fixed arm 332 can 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, an adhesive, or the like. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is opened, thereby opening the clasp 330 and exposing the optional barb 336. The clasp 330 is opened by applying tension to the drive line attached to the movable arm 334, thereby causing the movable arm 334 to articulate, pivot, and / or bend on a joint portion 338.

[0155] In summary, device 300 is similar in construction and operation to device 200 described above, except that joint element 310, outer paddle 320, inner paddle 322, and connecting portions 321, 323, 325 are formed from a single strip of material 301. In some implementations, strip of material 301 is attached to proximal collar 311, cap 314, and paddle frame 324 by weaving or inserting through openings in proximal collar 311, cap 314, and paddle frame 324 configured to receive continuous strip of material 301. Continuous strip 301 can be a single layer of material or can include two or more layers. In some implementations, portions of device 300 have a single layer of strip of material 301, while other portions are formed from multiple overlapping or superimposed layers of strip of material 301.

[0156] For example, Figure 23 shows the joining element 310 and inner paddle 322 as formed from multiple overlapping layers of strip of material 301. The single continuous strip of material 301 can start and end at various locations on the device 300. The ends of the strip of material 301 can be located at the same or different locations on the device 300. For example, in the example illustrated in Figure 23, the strip of material 301 starts and ends at the location of the inner paddle 322.

[0157] As with device 200 described above, the size of coaptation element 310 can be selected to minimize the number of implants (preferably one) required per patient while maintaining a low transvalvular gradient. In particular, forming many components of device 300 from strips of material 301 allows device 300 to be smaller than device 200. For example, in some implementations, the anterior-posterior distance at the top of coaptation element 310 is less than 2 mm, and the medial-lateral distance at device 300's widest point (i.e., the width of paddle frame 324, which is wider than coaptation element 310) is approximately 5 mm.

[0158] Additional features of device 300, modified versions of the device, delivery systems for the device, and methods for using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) and / or any other applications incorporated herein. Any combination or subcombination of features disclosed in this application can be combined with any combination or subcombination of features disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) and / or any other applications incorporated herein. Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) is incorporated herein by reference in its entirety.

[0159] 24 illustrates one example of a number of treatment and / or repair systems 400 for treating and / or repairing a patient's native valve to which the concepts of the present application may be applied. Treatment and / or repair system 400 includes a delivery device 401 and a treatment and / or repair device 402.

[0160] In some implementations, the treatment or repair device 402 includes a base assembly 404, a pair of paddles 406, and a pair of gripping members 408 (e.g., clasps, clasp arms, gripping members, gripping arms, latches, etc.). In one example, the paddles 406 can be integrally formed with the base assembly. For example, the paddles 406 can be formed as extensions of links of the base assembly. In the illustrated example, the base assembly 404 of the device 402 includes a shaft 403, a coupler 405 configured to move along the shaft, and a locking member 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 movement of the coupler 405 along the shaft 403 moves the paddles between an open position and a closed position. In this manner, coupler 405 serves as a means for mechanically coupling paddles 406 to shaft 403, transitioning paddles 406 between their open and closed positions as coupler 405 moves along shaft 403.

[0161] In some implementations, the gripping member 408 is pivotally connected to the base assembly 404 so that the width of the opening 414 between the paddle 406 and the gripping member 408 can be adjusted by moving the gripping member (e.g., the gripping member 408 can be pivotally connected to the shaft 403 or to any other suitable member of the base assembly). The gripping member 408 can include an optional barbed portion 409 for attaching the gripping member to the valve tissue when the device 402 is attached to the valve tissue. When the paddle 406 is in the occluded position, the paddle engages the gripping member 408, thereby securing the device 402 to the valve tissue when the valve tissue is attached to the gripping member's barbed portion 409. 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 device 402 to the valve tissue member. For example, in certain circumstances, it may be advantageous for the paddle 406 to remain in an open position and for the gripping member 408 to move outward toward the paddle 406 to engage the valve tissue with the paddle 406.

[0162] Although the example shown in FIG. 24 illustrates a pair of paddles 406 and a pair of gripping members 408, it will be appreciated that device 402 may include any suitable number of paddles and gripping members.

[0163] In some implementations, the system 400 includes a deployment shaft 413 that is removably attached to the shaft 403 of the base assembly 404 of the device 402. In some implementations, after the device 402 is secured to the valve tissue, the deployment shaft 413 can be removed from the shaft 403, thereby removing the device 402 from the rest of the treatment and / or repair system 400, so that the device 402 can remain attached to the valve tissue and the delivery device 401 can be removed from the patient's body.

[0164] The treatment and / or repair system 400 can also include a paddle control mechanism 410, a gripping member control mechanism 411, and a locking control mechanism 412. The paddle control mechanism 410 is mechanically attached to the coupler 405 such that moving the coupler along the shaft transitions the paddles 406 between open and closed positions. The paddle control mechanism 410 can take any suitable form and can include, for example, a shaft, wire, tubing, hypotube, rod, suture, line, etc. For example, the paddle control mechanism can include a hollow shaft, catheter tubing, or sleeve that fits over the deployment shaft 413 and over the shaft 403 and connected to the coupler 405.

[0165] The gripping member control mechanism 411 is configured to move the gripping member 408 to vary the width of the opening 414 between the gripping member and the paddle 406. The gripping member control mechanism 411 may take any suitable form, such as, for example, a line, suture or wire, a rod, a catheter, a tube, a hypotube, etc.

[0166] The locking control mechanism 412 is configured to lock and unlock the locking member. The locking member 407 locks the coupler 405 in a stationary position relative to the shaft 403 and can take a variety of different forms, and the type of locking control mechanism 412 can be dictated by the type of locking member used. In examples where the locking member 407 includes a pivotable plate, the locking control mechanism 412 is configured to engage the pivotable plate to move the plate between a tilted position and a substantially non-tilted position. The locking control mechanism 412 can be, for example, a rod, a suture, a wire, or any other member capable of moving the pivotable plate of the locking member 407 between a tilted position and a substantially non-tilted position.

[0167] The device 402 is movable from an open position to a closed position. The base assembly 404 includes a link driven by a coupler 405. The coupler 405 is movably mounted relative to a shaft 403. To move the device from the open position to the closed position, the coupler 405 is moved along the shaft 403, thereby moving the link.

[0168] The gripping member control mechanism 411 moves the gripping member 408 to provide a wider or narrower gap at the opening 414 between the gripping member and the paddle 406. In the illustrated example, the gripping member control mechanism 411 includes a line, such as a suture, wire, or the like, connected to an opening in the end of the gripping member 408. When the line is pulled, the gripping member 408 is driven inward, causing the opening 414 between the gripping member and the paddle 406 to become wider.

[0169] To move device 402 from the open position to the closed position, locking member 407 is moved to an unlocked state by lock control mechanism 412. After locking member 407 is in the unlocked state, paddle control mechanism 410 can move coupler 405 along shaft 403.

[0170] After the paddle 406 is moved to the closed position, the locking member 407 is moved to a locked state by the lock control mechanism 412, thereby maintaining the device 402 in the closed position. After the device 402 is maintained in the locked state by the locking member 407, the device 402 is removed from the delivery device 401 by disconnecting the shaft 403 from the deployment shaft 413. In addition, the device 402 is decoupled from the paddle control mechanism 410, the grip control mechanism 411, and the lock control mechanism 412.

[0171] Additional features of device 402, modified versions of the device, delivery systems for the device, and methods for using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) and / or any other applications incorporated herein. Any combination or subcombination of features disclosed in this application can be combined with any combination or subcombination of features disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) and / or any other applications incorporated herein. Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) is incorporated herein by reference in its entirety.

[0172] The clasps or leaflet grasping devices disclosed herein can take a wide variety of different forms. Examples of clasps are disclosed in Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Any combination or subcombination of each feature disclosed in this application can be combined with any combination or subcombination of each feature disclosed in Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201) is incorporated herein by reference in its entirety.

[0173] 25A-25B, one exemplary implementation of a treatment and / or repair device 402 includes a coaptation element 3800. With the addition of the coaptation element, the device 402 can have the same configuration as the device illustrated in FIG. 24. The coaptation element 3800 can take a variety of different forms. The coaptation element 3800 can be compressible and / or expandable. For example, the coaptation element can be compressed to fit within one or more catheters of a delivery system, and / or can expand upon removal from one or more catheters, and / or can be compressed by paddles 406 to adjust the size of the coaptation element. In the example illustrated in FIGS. 25A and 25B, the size of the coaptation element 3800 can be reduced by compressing it with the paddles 406 and increased by moving the paddles 406 apart. The coaptation element 3800 can extend beyond the outer edge 4001 of the grasping member or clasp 408 as shown to provide additional surface area for occluding the mitral valve gap.

[0174] The coaptation element 3800 can be coupled to the device 402 in a variety of different ways. For example, the coaptation element 3800 can be fixed to the shaft 403, slidably disposed about the shaft, connected to a coupler 405, connected to a locking member 407, and / or connected to a central portion of a clasp or gripping member 408. In some implementations, the coupler 405 can take the form of the coaptation element 3800. That is, a single member can be used as both the coupler 405 that transitions the paddle 406 between the open and closed positions and the coaptation element 3800 that closes the gap between the valve leaflets 20, 22 when the device 402 is attached to the leaflets.

[0175] Interface element 3800 can be disposed around one or more of the shafts or other control elements of system 400. For example, interface element 3800 can be disposed around shaft 403, shaft 413, paddle control mechanism 410, and / or lock control mechanism 412.

[0176] Device 402 can include any other features for devices, treatment devices, repair devices, implants, etc. described herein, and device 402 can be positioned to engage valve tissue as part of any appropriate treatment and / or repair system (e.g., any valve repair and / or treatment system disclosed herein). Additional features of device 402, modified versions of the device, delivery systems for the device, and methods for using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Any combination or subcombination of each feature disclosed in this application can be combined with any combination or subcombination of each feature disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904).

[0177] 26-30 illustrate one example of a number of systems for treating and / or 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 system includes a catheter assembly 1611 (e.g., a device catheter assembly, an implant catheter assembly, a treatment catheter assembly, etc.) and a treatment and / or repair device 8200. With reference to FIGS. 26-28, the device 8200 includes a proximal or mounting portion 8205, a paddle frame 8224, and a distal portion 8207. The mounting portion 8205, the distal portion 8207, and the paddle frame 8224 can be configured in a variety of ways.

[0178] In the example illustrated in Figure 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. Moreover, with reference to Figure 26, the paddle frame 8224 includes an outer frame portion 8256 and an inner frame portion 8260.

[0179] In some implementations, the connector 8266 (e.g., a molded metal member, molded plastic member, tether, wire, strut, line, cord, 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 example, the shape of the outer frame portion 8256 resembles an apple in that the outer frame portion 8256 widens toward the attachment portion 8205 and narrows toward the distal portion 8207. However, in some implementations, the outer frame portion 8256 can have other shapes.

[0180] The inner frame portion 8260 extends from the mounting portion 8205 toward the distal portion 8207. The inner frame portion 8260 then extends inward to form a retaining portion 8272 that is attached to the drive cap 8214. The retaining portion 8272 and the drive cap 8214 can be configured to be attached in any suitable manner.

[0181] In some implementations, the inner frame portion 8260 is a rigid frame portion and the outer frame portion 8256 is a flexible frame portion, with the proximal end of the outer frame portion 8256 connected to the proximal end of the inner frame portion 8260, as shown in FIG.

[0182] Width adjustment element 8211 (e.g., 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 transition outer frame portion 8256 from an expanded position to a constricted position by retracting inner end 8968 ( FIG. 28 ) and a portion of connector 8266 into drive cap 8214. Drive element 8102 is configured to move inner frame portion 8260 to open and close the paddles, according to some implementations disclosed herein.

[0183] As shown in FIGS. 27 and 28 , the connector 8266 has an inner end 8968 that engages with the width adjustment element 8211 so that a user can move the inner end 8968 within the receiver 8912 (e.g., an internally threaded member, a column, a conduit, a hollow member, a notched receiving portion, a tube, a shaft, a sleeve, a post, a housing, a cylinder, a track, etc.) to transition the outer frame portion 8256 between a constricted position and an expanded position. In the illustrated example, the inner end 8968 includes a post 8970 attached to the outer frame portion 8256 and a coupler 8972 extending 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 variety of different forms. For example, the coupler 8972 may include one or more of a threaded connection, a thread-engaging feature, a detent connection such as an outwardly biased arm, 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 adequately attach the outer frame portion 8256 to the coupler to enable the width adjustment element 8211 to transition the outer frame portion 8256 between the constricted and expanded positions. The coupler may also be configured in a variety of ways, and may be a separate component of the connector or the inner end of the connector, for example, or may be integral to another portion of the device.

[0184] Width adjustment element 8211 allows a user to expand or contract outer frame portion 8256 of device 8200. In the example depicted in FIGS. 27 and 28 , width adjustment element 8211 includes an externally threaded end that threads into coupler 8972. Width adjustment element 8211 moves the coupler within receiver 8912, thereby adjusting the width of outer frame portion 8256. When width adjustment element 8211 is unscrewed from coupler 8972, the coupler engages the inner surface of receiver 8912, setting the width of outer frame portion 8256.

[0185] In some implementations, the receiver 8912 can 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 example, the receiver 8912 slides within the body of the mounting portion. When the coupler 8972 is removed from the coupler width adjustment element 8211, the width of the outer frame portion 8256 is fixed, and the actuation element 8102 moves the receiver 8912 and cap 8214 relative to the body of the mounting portion 8205. Moving the cap can open and close the device in a manner similar to some of the examples disclosed above.

[0186] In the illustrated example, a driver head 8916 is disposed at the proximal end of the drive element 8102. The driver head 8916 removably couples the drive element 8102 to the receiver 8912. In the illustrated example, a width adjustment element 8211 extends through the drive element 8102. The drive element is advanced axially in a direction opposite to direction Y to move the distal cap 8214. Movement of the distal cap 8214 relative to the mounting portion 8205 is effective to open and close the paddles, as shown by the arrows in FIG. 27 . That is, moving the distal cap 8214 in direction Y closes the device, and moving the distal cap opposite direction Y opens the device.

[0187] 27 and 28 , the width adjustment element 8211 extends through the drive element 8102, driver head 8916, and receiver 8912 to engage a coupler 8972 attached to the inner end 8968. Moving the outer frame portion 8256 to the constricted position reduces contact and / or friction between the device 8200 and natural structures of the heart, such as the chorda notochord, thereby allowing the device or implant 8200 to be more easily maneuvered into position for deployment and / or implantation within the heart. Moving the outer frame portion 8256 to the expanded position provides the anchor portions of the device 8200 with a larger surface area for engagement and capture against the leaflets of the natural heart valve.

[0188] 29 and 30 , an example of a catheter assembly 1611 (e.g., a device catheter assembly, an implant catheter assembly, a treatment catheter assembly, etc.) is shown in which the clasp drive line 624 extends through the handle 1616, the drive element 8102 is coupled to a paddle drive control member 1626, and the width adjustment element 8211 is coupled to a paddle width control member 1628. A proximal end portion 1622a of the shaft or catheter of the catheter assembly 1611 can be coupled to the handle 1616, and a distal end portion 1622b of the shaft or catheter can be coupled to the device 8200. The drive element 8102 can extend distally from the paddle drive control member 1626, through the handle 1616, through the delivery shaft or catheter of the catheter assembly 1611, and through the proximal end of the device 8200, where it is coupled to a driver head 8916. The drive element 8102 may be axially movable relative to the outer shaft of the catheter assembly 1611 and relative to the handle 1616 to open and close the device.

[0189] The width adjustment element 8211 can extend distally from the paddle width control 1628, through the paddle drive control member 1626, and through the drive element 8102 (and thus through the handle 1616, through the outer shaft of the implant catheter assembly 1611, and through the device 8200), where it is coupled to a movable coupler 8972. The width adjustment element 8211 can be axially movable relative to the drive element 8102, relative to the outer shaft of the implant catheter assembly 1611, and relative to the handle 1616. The clasp drive line 624 can extend through the handle 1616 and through the outer shaft of the implant catheter assembly 1611, and can be axially movable relative to the handle 1616 and the outer shaft of the implant catheter assembly 1611. The clasp drive line 624 can also be axially movable relative to the drive element 8102.

[0190] 29 and 30, width adjustment element 8211 can be removably coupled to coupler 8972 of device 8200. The paddles are expanded or constricted by advancing or retracting width adjustment element 8211 with paddle width control member 1628. The paddles of the device are opened or closed by advancing or retracting drive element 8102 with paddle drive control member 1626.

[0191] 29 and 30, the catheter or shaft of the catheter assembly 1611 is an elongate shaft extending axially between a proximal end portion 1622a coupled to the handle 1616 and a distal end portion 1622b coupled to the device 8200. The outer shaft of the catheter assembly 1611 can also include an intermediate portion 1622c disposed between the proximal and distal end portions 1622a and 1622b.

[0192] 31, the exemplary expandable mechanism 10002 can be formed from one or more struts 10010. In some implementations, the struts 10010 have multiple rigid portions 10020 connected to one another at flexible proximal connection regions 10030 and flexible distal connection regions 10050. In some implementations, the flexible proximal connection regions 10030 and flexible distal connection regions 10050 allow the rigid portions 10020 to move relative to one another.

[0193] In some implementations, the connection regions 10030, 10050 can be solid members made of the same material that makes up the rigid portion 10020. In some implementations, the flexible connection regions 10030, 10050 can be connected via an interconnect coupler or other connection means.

[0194] The expandable mechanism 10002 can be used in a variety of devices, implants, valve repair devices, such as the device 15000 illustrated in Figures 33 and 39, and / or other devices disclosed herein.

[0195] The rigid portion 10020 can include an attachment region 10040 for attachment to another component of the expandable joint element 10000. For example, a shell component 15090 and / or a sleeve 17000, as described below, can be attached to the attachment region 10040. The shell component 15090 and / or sleeve 17000 can provide a substantially continuous and / or smooth outer surface for the expandable joint element 10000.

[0196] Some or all of the struts 10010 may be transitionable between a collapsed state and an expanded state. Struts may transition between a collapsed state and an expanded state in a variety of different ways. In the example shown in FIG. 31 , a pair of struts 10010 transition between a collapsed state and an expanded state via a screw 10080 and a nut 10090. By adjusting the nut 10090, the screw 10080 is extended or retracted, thereby expanding or contracting the struts 10010.

[0197] In some implementations, the screw 10080 extends through the shaft 10060 and into the drive member 10070. In the example shown in FIG. 31 , advancing the screw through the nut drives the drive member 10070 distally. In this example, distal movement of the drive member 10070 drives the attachment region 10040 outward, thereby increasing the width of the expandable mechanism 10002. Conversely, retracting the screw through the nut drives the drive member 10070 proximally. Proximal movement of the drive member 10070 drives the attachment region 10040 inward, thereby decreasing the width of the expandable mechanism 10002.

[0198] 31, only one pair of struts 10010 is coupled to the drive member 10070, causing the expandable mechanism 10002 to expand in one direction. However, in some implementations, both pairs of struts, or differently positioned struts, can be coupled to one or more drive members, allowing the expandable mechanism to expand in more than one direction.

[0199] In some implementations, adjusting the nut 10090 and screw 10080 relative to one another can expand and contract the two pairs of struts 10010 of the expandable mechanism 10002 in the same direction (i.e., both expand or both contract). In some implementations, adjusting the nut 10090 relative to the screw 10080 can expand and contract the two pairs of struts 10010 of the expandable mechanism 10002 in opposite directions (i.e., one pair expands and the other pair contracts). The width of both pairs of struts 10010 can be adjusted by a single adjustment mechanism (e.g., drive member 10070, screw 10080, and nut 10090), or two separate adjustment mechanisms can be used to independently adjust each pair of struts. Control can occur individually, simultaneously, sequentially, or in other manners.

[0200] The rigid portions 10020 and flexible portions 10050 of the struts 10010 can include optional coverings on the struts 10010. The struts 10010 can include shaped and / or flexible or pliable portions to allow the shape of the expandable mechanism 10002 to conform to the shape of the native leaflets 20, 22 when the leaflets 20, 22 are closed against the expandable coaptation element 10000. This can improve engagement between the expandable coaptation element 10000 and the native leaflets 20, 22. Although four struts 10010 are shown, any number of struts 10010 can be combined to expand or contract the coaptation surface. Different struts can include rigid portions 10020 with different shapes and lengths to provide different expansion and contraction rates and different maximum expansion positions, thereby creating a wide variety of differently shaped expandable coaptation elements 10000.

[0201] FIG. 32 shows an expandable coaptation element 10000 of a device 15000 (e.g., a treatment device, repair device, implantable device, implant, etc.) implemented between the leaflets of a native valve, such as the tricuspid valve or native mitral valve shown. After the device is deployed as described above, the size of the expandable coaptation element 10000 can be adjusted in direction 10500 and / or direction 10502. The size of the expandable coaptation element 10000 can be adjusted based on regurgitation through the native valve during ventricular systole and / or based on flow rate through the valve during ventricular diastole. For example, the size of the expandable coaptation element 10000 can be adjusted to provide maximum regurgitation reduction so that the native valve can provide an acceptable flow rate from the atrium to the ventricle. In some implementations, direction 10500 is the gap width between the septum and the lateral annulus, and direction 10502 is along the gap length between the anterior and posterior annulus.

[0202] 33-39 illustrate an example of a device 15000 (e.g., a valve repair device, a valve treatment device, an implantable device, an implant, etc.) having an expandable coaptation element 10000. The expandable coaptation element 10000 can be used in a variety of different devices, including, but not limited to, any of the treatment and / or repair devices disclosed herein. For example, any of the expandable coaptation elements disclosed herein can be used in the devices generally illustrated in FIGS. 8-14.

[0203] Device 15000 (see FIG. 33) is one of many different configurations possible for the device illustrated generally in FIGS. 8-14 with expandable coaptation element 10000. Device 15000 can include any other features for the devices described herein, and expandable coaptation element 10000 can be positioned to engage leaflets 30, 32, 34 (see FIGS. 7 and 34) or leaflets 20, 22 (see FIGS. 6 and 36) as part of any suitable device (e.g., any of the treatment and / or repair devices disclosed herein).

[0204] Device 15000 can be deployed from a delivery sheath, a device catheter, and / or an implant catheter. Device 15000 can include an expandable mechanism 10002 (which can be the same as or similar to any expandable mechanism described elsewhere in this disclosure) and an anchor portion having one or more anchors (which can be the same as or similar to any anchor portion and / or any anchor described elsewhere in this disclosure). The expandable mechanism can include one or more of a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, pivoting or scissored extension members and / or struts, an expanding pulley mechanism, a Hoberman mechanism, a cam, a worm screw, a rack and pinion, foam, etc.

[0205] The device 15000 may be a prosthetic valve spacer device, a valve repair device, a valve therapy device, an implant, or another type of device attached to the natural valve leaflets.

[0206] 33, there is shown a device 15000 (e.g., a valve repair device, an implantable device, an implant, a valve treatment device, etc.) having an expandable coaptation element 10000. The implantable device 15000 is one of many different configurations that the device 100 shown generally in FIGS. 8-14 may assume with the addition of an expandable coaptation element.

[0207] In some implementations, the device 15000 includes an expandable coaptation element 10000, a proximal or attachment portion 15006, an anchor portion 15008, and a distal portion 15010. In some implementations, the expandable coaptation element 10000 is configured to be adjustably implanted between the native valve leaflets. In some implementations, the anchor portion 15008 includes multiple anchors 15014. The anchors can be configured in various manners. In some implementations, each of the anchors 15014 includes an outer paddle 15016, an inner paddle 15018, a paddle extension member or paddle frame 15020, and a clasp 15022. In some implementations, the attachment portion 15006 includes a first or proximal collar 15030 (or other attachment member) for engaging a capture mechanism of a delivery system. The delivery system for the device or implant 15000 may be the same or similar to the delivery system 102 described above and may include one or more of a catheter, sheath, guide catheter / sheath, delivery catheter / sheath, steerable catheter, implant catheter, tube, channel, pathway, combinations thereof, etc.

[0208] In some implementations, portions or components of the expandable joint element 10000 and / or the outer paddle 15016 and the inner paddle 15018 are formed from a flexible material, such as a metallic fabric, such as a mesh, woven fabric, braid, or formed in any other suitable manner, or cut by laser cutting or otherwise. The material can be a fabric, a shape-setting shape memory alloy wire such as Nitinol, or any other flexible material suitable for implantation in the human body.

[0209] A drive element (e.g., drive shaft, drive rod, drive tube, drive wire, drive line, etc.) can extend from a delivery system (not shown) to engage and enable actuation of the device 15000 (see drive element 112 in FIGS. 8-14). In some implementations, the drive element extends through the proximal collar 15030 and through the expandable joint element 10000 to engage the cap 15040 of the distal portion 15010. The drive element can be configured to releasably engage the cap 15040 via a threaded or similar connection, allowing the drive element to disengage and remove from the implant 15000 after implantation.

[0210] The expandable coaptation element 10000 extends from the proximal collar 15030 (or other attachment member) to the cap 15040. In some implementations, the expandable coaptation element 10000 has a generally elongated, round shape, although other shapes and configurations are possible. In some implementations, the expandable coaptation element 10000 has an oval 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 can result in the three-dimensional shape of the illustrated expandable coaptation element 10000.

[0211] The size and / or shape of the expandable coaptation element 10000 can be selected to minimize the number of implants (preferably one) required per patient while maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the apex of the spacer or coaptation element is approximately 5 mm, and the medial-lateral distance at the widest point of the spacer or coaptation element is approximately 10 mm. In some implementations, the overall geometry of the device 15000 can be based on these two dimensions and the overall shape strategy 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. Furthermore, using other size and shape strategies described above will also result in a device with different dimensions.

[0212] In some implementations, the outer paddle 15016 is articulably attached to the cap 15040 of the distal portion 15010 by a connecting portion 15080 and to the inner paddle 15018 by a connecting portion 15082. The inner paddle 15018 is articulably attached to the spacer or joint element by an extension member 15084. In this manner, the anchor 15014 is configured similar to a leg, in that the inner paddle 15018 is like the upper portion of the leg, the outer paddle 15016 is like the lower portion of the leg, and the transition portion 15082 is like the knee portion of the leg. As described above, the expandable joint element 10000 includes a nut 10090 and a screw 10080 (see FIG. 31 ). Adjusting the nut 10090 adjusts the screw 10080, thereby expanding or contracting the expandable joint element 10000.

[0213] In some implementations, the paddle frame 15020 is attached to the cap 15040 at the distal portion 15010 and extends to a transition portion 15082 between the inner paddle 15018 and the outer paddle 15016. In some implementations, the paddle frame 15020 is formed from a stiffer and more rigid material compared to the material forming the paddles 15018, 15016 such that the paddle frame 15020 provides support for the paddles 15018, 15016.

[0214] The paddle frame 15020 can provide additional clamping force between the inner paddle 15018 and the expandable coaptation element 10000 and can assist in wrapping the leaflets around the sides of the expandable coaptation element 10000. That is, the paddle frame 15020 can be configured with a rounded three-dimensional shape that extends from the cap 15040 to the transition portion 15082 of the anchor 15014. The connections between the paddle frame 15020, the outer and inner paddles 15016 and 15018, the cap 15040, and the expandable coaptation element 10000 can constrain each of these members to the movements and positions of the treatment and / or repair devices described herein.

[0215] The paddle frame 15020 can be configured wider to provide an increased surface area compared to the inner paddle 15018 alone. The increased surface area can distribute the clamping force of the outer paddle 15016 and paddle frame 15020 against the native leaflet over a larger surface area of ​​the native leaflet to further protect the native leaflet tissue.

[0216] In some implementations, the expandable coaptation element 10000 can include an expandable shell 15090. The shell 15090 can be configured as a solid surface, a lattice (e.g., a honeycomb pattern or other pattern that leaves solid and cut-out portions), a braided or woven material, or other configuration. The shell 15090 can be configured from a single member, two members, or multiple members. The shell 15090 can be configured from a rigid material, a semi-rigid material, a flexible material, or any other material suitable for implantation within the human body. One or more fasteners 15097 can be used to attach the shell 15090 to the expandable mechanism 10002.

[0217] In some implementations, the portion of the expandable mechanism 10002 covered by the shell can be selected so that the shell 15090 contacts the valve leaflets and the expandable mechanism 10002 does not contact the native valve leaflets. For example, the expandable mechanism 10002 can be encapsulated by the shell 15090 or can be partially encapsulated by the shell 15090. In the illustrated example, the shell 15090 includes two members that oppose each other and move relative to each other. For example, one shell member can expand and contract into the other shell member.

[0218] 34-35, there are shown example halves of a shell 15090. The shell 15090 can include two or more members and / or flexible materials, which allows the shell to conform to the overall size of the expandable mechanism 10002. Such a shell 15090 can provide a smooth contour for the native valve leaflets to engage, either directly or via a cover.

[0219] The covering can be provided in various ways. For example, components of the shell 15090 can be laminated with a polymer or covered with a fabric to improve interaction with the valve leaflets and / or to seal the expandable mechanism 10002 from liquids. FIG. 34 illustrates a shell 15090 having a substantially solid surface. FIG. 35 illustrates a shell 15090 with cutouts to form a semi-solid surface. In some implementations, the shell 15090 can be replaced by another structure, such as a balloon, balloon material, or other flexible material.

[0220] 36, a front perspective view of the device 15000 described in FIG. 33 is shown attached to the native valve leaflets 20, 22. An expandable coaptation element 10000 is positioned between the leaflets 20, 22. A plan view of the device 15000 is shown in FIG. 37, and side views of the device 15000 with the expandable coaptation element 10000 are shown in FIGS. 38 and 39, in expanded and contracted configurations, respectively. Adjusting the expandable mechanism 10002, for example, by rotating the screw 10080, expands or contracts the shell 15090, thereby adjusting the flow rate through the native valve (increasing the size of the shell reduces reflux through the native valve, or decreasing the size of the shell increases flow rate through the native valve).

[0221] Referring to FIG. 38, the struts 10010 of the expandable mechanism 10002 are spread apart to move the halves of the shell 15090 together. Thus, the shell 15090 has a wider configuration and occupies more space. Referring to FIG. 39, the struts 10010 of the expandable mechanism 10002 are moved closer together to move or expand / contract the halves of the shell 15090 together. Thus, the shell 15090 has a narrower configuration and occupies less space. FIGS. 38 and 39 show a shell 15090 having two halves that are moved toward and away from each other by the two struts 10010. However, in some implementations, the expandable joint element 10000 can have one, two, three, four, or any number of struts that can move toward or away from the central axis of the expandable joint element 10000, and one, two, three, four, or any number of shell components that can move toward or away from the central axis of the expandable joint element 10000. The number of shell components can be the same or different from the number of movable struts.

[0222] The expandable joint element 10000 can take a variety of different forms. For example, FIGS. 40-41 show an expandable sleeve 17000 that can be used in place of the shell 15090. The sleeve 17000 can be used with a variety of expandable mechanisms, such as the expandable mechanism 10002 described above, or any other expandable mechanism described in this disclosure. The expandable mechanism can include one or more of a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, pivoting or scissored extension members and / or struts, an expanding pulley mechanism, a Hoberman mechanism, a cam, a worm screw, a rack and pinion, foam, etc.

[0223] 40-41 illustrate various configurations of the expandable sleeve 17000. The expandable sleeve 17000 can have various shapes. For example, the expandable sleeve can be cylindrical, conical, frustoconical, oval, pyramidal, partial pyramidal, diamond-shaped, combinations of these shapes, etc. Referring to FIGS. 40 and 41, in some implementations, the expandable sleeve 17000 has a circular shape with an overlap 17004. In one example, FIGS. 40 and 41 illustrate the sleeve 17000 in a contracted configuration.

[0224] FIGS. 42 and 43 illustrate the sleeve 17000 in an expanded configuration. For example, expanding the expandable mechanism 10002 can transition the sleeve 17000 from the configuration shown in FIGS. 40 and 41 to the configuration shown in FIGS. 42 and 43. In FIGS. 42 and 43, the sleeve 17000 has an oval cylindrical shape. FIGS. 42 and 43 illustrate only one of many configurations that the expandable sleeve 17000 can assume when expanded. The sleeve 17000 can be configured to expand into a variety of shapes. For example, the sleeve can be configured to expand into a larger cylindrical shape, or into a non-cylindrical shape, such as a shape that tapers from one end to the other. As shown in FIG. 42, the overlap 17004 decreases as the sleeve expands.

[0225] The sleeve 17000 can be formed from a variety of different materials. For example, the expandable sleeve 17000 can be formed from a flexible material, such as a metallic fabric, such as a mesh, woven fabric, braid, or formed in any other suitable manner, or cut by laser cutting or otherwise. The material can be a fabric, a shape-setting shape memory alloy wire such as Nitinol, or any other flexible material suitable for implantation within the human body.

[0226] 44-45 show an example of an expandable joint element 18000. In the example shown in FIGS. 44 and 45, the expandable joint element 18000 can include one or more shape-changing components 18012, an adjustment mechanism, and an optional filler material or core 18004. The shape-changing component 18012 is configured to change size and / or shape when a force, such as a tensile force, is applied to the shape-changing component. For example, the shape-changing component 18012 can change from a flat or generally flat configuration, shown in FIG. 44, to a curved configuration, shown in FIG. 45, by applying a tensile force to the shape-changing component 18012 using the adjustment mechanism 18002. In the example shown in FIGS. 44 and 45, the optional filler material or core 18004 is positioned between the shape-changing components 18012. When the shape-changing components transition from the configuration illustrated in Figure 44 to the configuration illustrated in Figure 45, the optional filler material or core 18004 is compressed by the shape-changing components 18012. In some implementations, the optional filler material or core 18004 holds the shape-changing components 18012 apart to facilitate the transition from the configuration illustrated in Figure 44 to the configuration illustrated in Figure 45.

[0227] The shape-changing component 18012 can take on a wide variety of forms, with a variety of different expanded and contracted shapes. In the expanded state shown in FIG. 44 , the shape-changing component 18012 can be a generally parallel-plate structure, as shown. In some implementations, the shape-changing component 18012 can be cylindrical, conical, frusto-conical, oval, pyramidal, partial pyramidal, diamond-shaped, combinations of these shapes, etc. in the expanded configuration. In the contracted state shown in FIG. 45 , the shape-changing component 18012 can be generally circular, as shown, to compress the optional filler material or core 18004 into a generally cylindrical configuration. In some implementations, the shape-changing component 18012 can be conical, frusto-conical, oval, pyramidal, partial pyramidal, diamond-shaped, combinations of these shapes, etc. in the contracted configuration.

[0228] In some implementations, the shape-changing component 18012 is formed from a flat material and has a notch 18015. The flat material and notch 18015 are configured such that application of a force, such as a tensile force, to the shape-changing component 18012 causes the shape-changing component to deflect from a substantially flat configuration to a three-dimensional configuration. For example, kirigami techniques can be applied to the flat material to form the shape-changing component 18012. The shape-changing component 18012 can be formed from a wide variety of different materials. For example, the shape-changing component 18012 can be formed from any metallic or polymeric material suitable for implantation within a human.

[0229] The shape-changing component 18012 can transform from the expanded configuration to the compressed configuration in a variety of different ways. In the illustrated example, the shape-changing component includes a tab 18016. Applying tension to the tab 18016 transitions the shape-changing component 18012 from the configuration illustrated in FIG. 44 to the configuration illustrated in FIG. 45. However, the tab 18016 is optional, and other configurations for applying force to the shape-changing component 18012 can be used. As described above, the shape-changing component 18012 can be formed using paper cutting such that applying tension to the tab 18016 transforms the shape-changing component from a flat configuration to a curved, three-dimensional configuration.

[0230] A variety of different mechanisms can be used to transition the shape-changing component 18012 from the expanded configuration to the contracted configuration. In some implementations, the shape-changing component 18012 can be transitioned from the expanded configuration to the contracted configuration using a screw or bolt 18008 and a nut 18022, or other fastening arrangement. Rotating the nut 18022 relative to the screw or bolt 18008 applies tension to the shape-changing component 18012, transitioning the shape-changing component from the expanded configuration ( FIG. 44 ) to the contracted configuration ( FIG. 45 ). For example, a line 18026 can be connected to the tab 18016 and coupled to the nut 18022. Rotating the nut 18022 pulls the line 18026, transitioning the shape-changing component 18012 from the expanded configuration to the contracted configuration. In some implementations, tension on the tab 18016 causes the shape-changing component 18012 to transition from the configuration illustrated in FIG. 44 to the configuration illustrated in FIG.

[0231] The optional filler or core 18004 can take a variety of different forms. The optional filler or core 18004 can be configured as soft, semi-soft, or semi-rigid. The optional filler or core 18004 can be hollow or solid. The optional filler or core 18004 can be spongy and porous, and can be formed from a material such as a mesh, woven fabric, braid, or any other suitable formed, or flexible material cut by laser or other manner. The material can be a fabric, shape memory alloy, foam, sponge such as Poron, or any other flexible material suitable for implantation within the human body. Applying a force to the shape-changing component 18012 causes the shape-changing component to change shape, thus reshaping the optional filler or core 18004.

[0232] In the illustrated example, when the shape-changing component 18012 is in the untensioned configuration of FIG. 44 , the optional filler or core 18004 can have an elliptical shape. After the shape-changing component 18012 is in the tensioned configuration of FIG. 45 , the optional filler or core 18004 can have a cylindrical or generally cylindrical configuration. However, the optional filler or core 18004 can have a variety of different shapes in the expanded and compressed configurations. For example, the optional filler can be cylindrical, conical, frustoconical, oval, pyramidal, partial pyramidal, diamond-shaped, wedge-shaped, combinations of these shapes, etc. in the expanded and compressed configurations.

[0233] The expandable joint element 18000, as well as other expandable joint elements disclosed herein (e.g., 10000, 17000), can be configured to expand and / or contract in a variety of different ways. FIGS. 46-48 are schematic plan views of an expandable joint element. FIG. 46 illustrates the expandable joint element 18000 in a normal or starting position. The expandable joint element 18000 can expand and / or contract in a variety of different ways from the configuration illustrated in FIG. 46. For example, in some exemplary implementations, the expandable joint element 18000:

[0234] - can be scaled only in the direction 18050 shown in Figure 47;

[0235] - can be scaled only in the direction 18052 shown in Figure 48;

[0236] - can be simultaneously scaled in the direction 18050 shown in FIG. 47 and the direction 18052 shown in FIG. 48;

[0237] the expandable coaptation element 18000 can be sequentially expanded and contracted, first in the direction 18050 shown in FIG. 47 and then in the direction 18052 shown in FIG. 48;

[0238] the expandable coaptation element 18000 can be sequentially expanded and contracted, first in the direction 18052 shown in FIG. 48 and then in the direction 18050 shown in FIG. 47;

[0239] - be able to scale independently in a direction 18050 shown in FIG. 47 and a second direction 18052 shown in FIG. 48;

[0240] - be partially scalable in the direction 18050 shown in FIG. 47 and then be scalable in both the direction 18050 shown in FIG. 47 and the direction 18052 shown in FIG. 48; and / or

[0241] - It can be partially scaled in the direction 18052 shown in Figure 48, and then scaled in both the direction 18050 shown in Figure 47 and the direction 18052 shown in Figure 48.

[0242] Thus, the shape-changing component 18012 and / or the expandable material 18004 can expand sequentially, simultaneously, or in other manners when the shape-changing component 18012 is manipulated between the tensioned and untensioned configurations.

[0243] 49-52 illustrate an example of a device 19000 (e.g., a valve repair device, a valve treatment device, an implantable device, an implant, etc.) that includes the expandable coaptation element 18000 illustrated in FIGS. 44 and 45. The expandable coaptation element 18000 can be used in a variety of different devices, including, but not limited to, any of the treatment and / or repair devices disclosed herein. For example, the expandable coaptation element 18000 can be used in the device schematically illustrated in FIGS. 8-14. The implantable device 19000 is one of many different configurations that the device schematically illustrated in FIGS. 8-14 with the expandable coaptation element 18000 can have.

[0244] The device 19000 can include any other features for a device described herein (e.g., a treatment and / or repair device, etc.), and the expandable coaptation element 18000 can be positioned to engage the valve leaflets 30, 32, 34 (see FIGS. 7 and 34) or the valve leaflets 20, 22 (see FIGS. 6 and 36) as part of any suitable device 19000 (e.g., any treatment and / or repair device disclosed herein). The device 19000 can be deployed from a delivery sheath, a device catheter, and / or an implant catheter. The device 19000 can include an adjustment mechanism 18002 and an anchor portion having two or more anchors, such as the anchor portions and anchors described herein. In the example illustrated in FIGS. 49-52, the anchor of the device 19000 includes a clasp 18040.

[0245] 49-52, the clasps 18040 attach the adjustable coaptation element 18000 to the leaflets of a native valve 18030 (e.g., a native mitral valve or a native tricuspid valve). The clasps 18040 position the adjustable coaptation element between the leaflets of the native valve 18030. In some implementations, one or more leaflet clasps 18040 are attached to the apical or atrial side and the basal or ventricular side of the leaflets of the native valve 18030.

[0246] The adjustable coaptation element 18000 is adjusted to change the shape and / or size of the region of the native valve blocked by the adjustable coaptation element 18000. FIGS. 49 and 50 illustrate a device 19000 with the adjustable coaptation element 18000 in an expanded configuration attached to a native valve 18030. Tension can be applied to the shape-changing component 18012 by rotating the screw or bolt 18008 relative to the nut 18022. For example, a line 18026 can be connected to the tab 18016 and coupled to the nut 18022. Rotating the bolt 18008 relative to the nut 18022 tensions the line 18026, transitioning the shape-changing component 18012 from the expanded configuration of FIG. 44 to the contracted configuration of FIG. 45.

[0247] Figure 49 shows a plan view of the adjustable coaptation element 18000 positioned between the leaflets of the native valve 18030 in an expanded configuration. Screws or bolts 18008 can extend into or through the spacer material 18004. Figure 50 shows a side perspective view of the expanded adjustable coaptation element 18000 between the leaflets of the native valve 18030. Figure 51 shows a plan view of the adjustable coaptation element 18000 positioned between the leaflets of the native valve 18030 in a compressed configuration. Figure 52 shows a side perspective view of the compressed adjustable coaptation element 18000 between the leaflets of the native valve 18030.

[0248] A variety of different mechanisms can be used to transition the expandable or adjustable coaptation element between the expanded and contracted configurations. Figures 53-70 illustrate examples of expandable mechanisms that may be used with any of the devices described herein. In the examples illustrated in Figures 53-56, the expandable mechanism expands and contracts in two directions. A device (e.g., a treatment device, repair device, implantable device, etc.) including an expandable mechanism can include any other features for devices described herein, and the device can be positioned to engage valve tissue as part of any suitable treatment and / or repair system (e.g., any treatment and / or repair system disclosed herein). The device can be deployed from a delivery sheath or delivery means for delivery by a pushing member, such as a rod or tube, as described above.

[0249] The device can include a joint portion and an anchor portion having two or more anchors, such as the anchor portions and anchors described herein. The joint portion includes an expandable mechanism 13110 that can be actuated between a contracted state and an expanded state. An optional exterior surface, such as a shell 15090, a sleeve 17000, a shape-changing component 18012, etc., can be provided to cover some or all of the expandable mechanism 13110.

[0250] The expandable mechanism 13110 is formed from one or more struts 13112. The struts 13112 have multiple rigid portions 13114 connected to each other by hinge portions 13116 that allow the rigid portions 13114 to bend relative to each other. A fixed end portion 13118 is connected to each strut 13112 by the hinge portions 13116. The struts 13112 extend from the fixed end portion 13118 to a movable end portion 13120 that is connected to each strut 13112 by one of the hinge portions 13116. One or more of the rigid portions 13114 can include an attachment region 13122 for attaching another component of the device.

[0251] The struts 13112 are transitioned between the collapsed and expanded states by driving a threaded drive shaft 13124 that extends through the expandable mechanism 13110 to a fixed drive member 13126. The fixed end portion 13118 is attached to the fixed drive member 13126 and the movable end portion 13120 is attached to a movable drive member 13128. The fixed drive member 13126 extends proximally from the fixed drive member 13126 and through the movable drive member 13128. The threaded drive shaft 13124, the fixed drive member 13126, and the movable drive member 13128 can be hollow, as shown in FIGS. 55-56 , allowing other drive members and other components of the device to extend through the expandable mechanism 13110 and move or be driven independently of driving the expandable mechanism 13110.

[0252] The movable drive member 13128 includes a threaded opening 13130 ​​that engages the threads of the threaded drive shaft 13124, such that rotation of the threaded drive shaft 13124 relative to the movable drive member 13128, or vice versa, moves the movable drive member 13128 toward or away from the fixed drive member 13126. That is, by rotating the movable drive member 13128 via a drive shaft or other mechanism (not shown), the movable drive member 13128 moves proximally away from and distally toward the fixed drive member 13126. As the movable drive member 13128 moves along the threaded drive shaft 13124, the struts 13112 expand and contract, thereby changing the overall width of the expandable mechanism 13110. The expandable mechanism 13110 has a minimum width when the struts 13112 are extended to a generally straight or linear state and / or when the fixed end portion 13118 and the movable end portion 13120 are moved closer together causing the stiff portions 13114 to collapse against each other. In this manner, the expandable mechanism 13110 can be expanded and contracted laterally to accommodate the different sizes and shapes of gaps 26 (see FIG. 6 ) left between the valve leaflets 20, 22 during diastole when the native heart valve is closed around the device.

[0253] The rigid portions 13114 of the struts 13112, and the optional covering over the struts 13112, can include shaped portions or can include flexible or soft portions to allow the surface of the device to conform to the shape of the native leaflets 20, 22 when the leaflets 20, 22 are closed against the device in order to improve engagement between the struts 13112 and the native leaflets 20, 22. Although four struts 13112 are shown, any number of struts 13112 can be combined to provide a varying coaptation surface. Different struts can include rigid portions 13114 with different shapes and lengths to provide different expansion and contraction rates and different maximum expanded positions, thereby creating a wide variety of different shapes of the expandable mechanism 13110.

[0254] 57-60 , one example of an expandable mechanism 13210 for use in a device (e.g., a treatment device, a repair device, an implantable device, an implant, etc.) is shown. The device may include any other features for a device (e.g., a treatment device, a repair device, etc.) described herein, and the device may be positioned to engage valve tissue as part of any suitable treatment and / or repair system (e.g., any treatment and / or repair system disclosed herein).

[0255] The device can be deployed from a delivery sheath or delivery means for delivery by a pushing member, such as a rod or tube, as described above. The device can include a joint portion and an anchor portion having two or more anchors, such as the anchor portion and anchors described herein. In some implementations, the joint portion includes an expandable mechanism 13210 that can be actuated between a contracted state and an expanded state. In some implementations, an optional outer surface, such as a shell 15090, a sleeve 17000, a shape-changing component 18012, etc., can be provided to cover some or all of the expandable mechanism 13210.

[0256] In some implementations, the expandable mechanism 13210 is formed from one or more struts 13212. In some implementations, the struts 13212 have multiple rigid portions 13214 connected to one another by hinge portions 13216 that allow the rigid portions 13214 to pivot relative to one another. In some implementations, a first end portion 13218 is connected to each strut 13212 by a hinge portion 13216. In some implementations, the struts 13212 extend from the first end portion 13218 to a second end portion 13220 that is connected to each strut 13212 by one of the hinge portions 13216. One or more of the rigid portions 13214 can include an attachment region 13222 for attaching another component of the device.

[0257] In some implementations, the struts 13212 are transitioned between the collapsed state and the expanded state by driving a threaded drive shaft 13224 that extends through a first drive member 13226 and a second drive member 13228 of the expandable mechanism 13210. In some implementations, a first end portion 13218 of the strut 13212 is attached to the first drive member and a second end portion 13220 is attached to the second drive member 13228.

[0258] In some implementations, the threaded drive shaft 13224, the first drive member 13226, and the second drive member 13228 can be hollow, allowing other drive members and other components of the device to extend through the expandable mechanism 13210 and to move or be driven independently of the drive of the expandable mechanism 13210.

[0259] In some implementations, the threaded drive shaft 13224 includes a first threaded portion 13230 extending from a distal end to a second threaded portion 13232, which extends from the first threaded portion 13230 to a proximal end. In some implementations, the threads of the first threaded portion 13230 and the second threaded portion 13232 are oppositely oriented, i.e., if the threads of the first threaded portion 13230 are right-handed, then the threads of the second threaded portion 13232 are left-handed, and vice versa.

[0260] In some implementations, the first drive member 13226 engages the first threaded portion 13230 and includes a threaded opening 13234 having threads that match the orientation of the threads of the first threaded portion 13230. In some implementations, the second drive member 13228 engages the second threaded portion 13232 and includes a threaded opening 13234 having threads that match the orientation of the threads of the second threaded portion 13232. As a result, rotating the threaded drive shaft 13224 in one direction drives the first drive member 13226 and the second drive member 13228 in opposite directions. When the threaded drive shaft 13224 is rotated, the first drive member 13226 and the second drive member 13228 are driven in opposite directions at the same speed, such that the interface formed between the first drive member 13226 and the second drive member 13228 does not move as the expandable mechanism 13210 is expanded or contracted.

[0261] In some implementations, during operation of the expandable mechanism 13210, for example, rotating the threaded drive shaft 13224 can move the first drive member 13226 proximally and the second drive member 13228 distally, thereby decreasing the distance between the first drive member 13226 and the second drive member 13228. In some implementations, rotating the threaded drive shaft 13224 in the opposite direction drives the first drive member 13226 distally and the second drive member 13228 proximally, thereby increasing the distance between the first drive member 13226 and the second drive member 13228. In this manner, rotation of the threaded drive shaft 13224 is used to expand and contract the struts 13212 of the expandable mechanism 13210. In this manner, rotation of the threaded drive shaft 13224 expands or contracts the circumference or size of the expandable mechanism 13210 to accommodate the different sizes and shapes of gaps 26 (see FIG. 6) left between the valve leaflets 20, 22 during diastole when the native heart valve closes around the device.

[0262] In some implementations, the rigid portions 13214 of the struts 13212, and / or the shell, sleeve, etc. covering the struts 13212, can include shaped portions or can include flexible or soft portions to allow the surface of the device to conform to the shape of the native leaflets 20, 22 when the leaflets 20, 22 are closed against the device in order to improve engagement between the struts 13212 and the native leaflets 20, 22. Although four struts 13212 are shown, any number of struts 13212 can be combined to provide a varying coaptation surface. Different struts can include rigid portions 13214 with different shapes and lengths to provide different expansion / contraction rates and different maximum expanded positions, thereby creating a wide variety of different shapes of the expandable mechanism 13210.

[0263] 61-70, an expandable mechanism 13310 for use in a device (e.g., a treatment device, a repair device, an implantable device, an implant, etc.) is shown. The device may include any other features for a device (e.g., a treatment device, a repair device, etc.) described herein, and the device may be positioned to engage valve tissue as part of any suitable treatment and / or repair system (e.g., any treatment and / or repair system disclosed herein). The device may be deployed from a delivery sheath or delivery means for delivery by a pushing member, such as a rod or tube, as described above.

[0264] In some implementations, the device can include a junction portion and an anchor portion having two or more anchors, such as the anchor portions and anchors described herein. In some implementations, the junction portion 13304 includes an expandable mechanism 13310 that can be actuated between a contracted state and an expanded state. An optional exterior surface, such as a shell 15090, a sleeve 17000, a shape-changing component 18012, etc., can be provided to cover some or all of the expandable mechanism 13310.

[0265] The expandable mechanism 13310 is formed from one or more struts 13312. The struts 13312 have multiple rigid portions 13314 connected to each other by hinge portions 13316, which allow the rigid portions 13314 to pivot relative to each other. A first end portion 13318 is connected to each strut 13312 by a hinge portion 13316. The struts 13312 extend from the first end portion 13318 to a second end portion 13320 connected to each strut 13312 by one of the hinge portions 13316. One or more of the rigid portions 13314 can include an attachment region for attaching another component of the expandable mechanism 13310 or of the repair device.

[0266] The expandable mechanisms disclosed herein (and usable with any of the devices herein) can be transitioned to various expanded and contracted positions and held in place by a variety of different mechanisms. As disclosed above, threaded members can be used to transition the expandable mechanism to various expanded and contracted positions and to hold the expandable mechanism in place. Additionally or alternatively, the expandable mechanisms disclosed herein can include one or more of a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, pivoting or scissoring extension members and / or struts, an expanding pulley mechanism, a Hoberman mechanism, a cam, a worm screw, a rack and pinion, foam, etc.

[0267] A wide variety of other mechanisms can additionally or alternatively be used. For example, Figures 63-64 and 67-70 illustrate one example of a mechanism for moving the expandable mechanism to various expanded and contracted positions and for holding the expandable mechanism in place. In this example, the struts 13312 are transitioned between a collapsed state and an expanded state by extending and retracting the drive tube 13322. The drive tube 13322 extends to a distal end 13324 attached to the first end portion 13318 and travels within a latch tube 13326 that includes a plurality of openings 13328 for engaging the latch members 13330 of the drive tube 13322. The retaining or securing member 13334 engages with the latch member 13330 to secure the connection between the drive tube 13322 and the latch tube 13326, and the relationship between the drive tube 13322, the latch tube 13326, the latch member 13330 and the securing member 13334 is shown in Figures 63-64 and 67-70 and described below.

[0268] In some implementations, the latch tube 13326 is attached to a proximal collar or head 13332 of the device, which can be coupled to a delivery mechanism to deliver the device within the native valve. In some implementations, the proximal collar or head 13332 is also attached to the second end portion 13320 of the strut 13312. As a result, extending and retracting the drive tube 13322 changes the distance between the first end portion 13318 and the second end portion 13320 of the strut 13312, thereby transitioning the strut 13312 between a contracted state and an expanded state. The proximal collar or head 13332 can be engaged or actuated in a variety of manners described herein to facilitate deployment and / or implantation of the devices described herein, such as by opening and closing paddles on the device.

[0269] In some implementations, the latch members 13330 of the drive tube 13322 can be transitioned between a latched state and an unlatched state. The drive tube 13322 can include any number of latch members 13330 adapted to engage with corresponding openings 13328 in the latch tube 13326. Referring now to FIGS. 61-64 and 69, the latch members 13330 of the drive tube 13322 are shown in an unlatched state. When the latch members 13330 are unlatched, the drive tube 13322 is free to move along the length of the latch tube 13326 to extend or retract the first end portion 13318, thereby expanding or contracting the expandable mechanism 13310. In the latched state shown in FIGS. 65 to 68 and 70, the latch member 13330 in the latched state engages with the opening 13328 of the latch tube 13326, thereby fixing the position of the drive tube 13322 relative to the latch tube 13326.

[0270] In some implementations, the latch member 13330 may optionally be integrally formed into the side of the drive tube 13322 by laser cutting a portion of the drive tube 13322. The latch member 13330 is bent and shaped in the latched state such that in the free state, the latch member 13330 is angled relative to the central axis of the drive tube 13322. For example, as shown in FIGS. 67-68 , a proximal or upper end of the latch member 13330 is biased radially outward, and an opposite lower or distal end of the latch member 13330 is biased radially inward.

[0271] In some implementations, a proximal end of the latch member 13330 can be biased radially inward and an opposite distal end of the latch member 13330 can be biased radially outward. In some implementations, the expandable mechanism 13310 is biased to expand or contract and the latch member 13330 is angled outward to counter the bias of the expandable mechanism 13310. In examples where the expandable mechanism 13310 is biased to move the drive tube 13322 proximally, the proximal end of the latch member 13330 can be biased radially outward such that the latch member 13330 engages the opening 13328 in the latch tube 13326 such that proximal movement of the drive tube 13322 is resisted by the latch member 13330.

[0272] In some implementations, the latch member 13330 is held in the unlatched state by a retaining or fixation member 13334 that prevents the latch member 13330 from pivoting to the latched state. During deployment and / or implantation of the device, the width of the expandable mechanism 13310 is adjusted by extending and retracting the drive tube 13322. Once the expandable mechanism reaches the desired width, the retaining or fixation member 13334 is retracted from the drive tube 13322, allowing the latch member 13330 to pivot to the latched state and engage with the opening 13328 in the latch tube 13326. In some implementations, extending and retracting the drive tube 13322 increases or decreases the size of the expandable mechanism 13310 to accommodate the different sizes and shapes of gaps 26 (see FIG. 6 ) left between the valve leaflets 20, 22 during diastole when the native heart valve closes around the coaptation element. Locking the drive tube 13322 in place relative to the latch tube 13326 via the latch member 13330 maintains the width of the expandable mechanism 13310 against the forces applied by the valve leaflets 20,22.

[0273] In some implementations, the retaining or securing member 13334 can optionally have a tapered distal end to facilitate re-engagement of the latching member 13330, thereby allowing the latching member 13330 to swing from a latched state to an unlatched state, thereby further allowing the width of the expandable mechanism 13310 to be adjusted.

[0274] In some implementations, the rigid portions 13314 of the struts 13312 and / or the shell, sleeve, etc. covering the struts 13312 can include shaped portions or can include flexible or soft portions to allow the surfaces of the expandable coaptation elements to conform to the shape of the native leaflets 20, 22 when the leaflets 20, 22 are closed relative to the implanted device in order to improve engagement between the struts 13312 and the native valve leaflets 20, 22. Although four struts 13312 are shown, any number of struts 13312 can be combined to provide a coaptation surface that expands and contracts. Different struts can include rigid portions 13314 with different shapes and lengths to provide different expansion and contraction rates and different maximum expanded positions, thereby creating a wide variety of different shapes of the expandable coaptation mechanism 13310.

[0275] Expandable joint elements can take a variety of different forms. In some implementations, the expandable joint elements are formed from a lattice of struts and / or can have a stent-like configuration. The lattice of struts can be formed in a variety of different ways. For example, the expandable joint elements can be cut (e.g., laser cut) from a sheet of material, molded, manufactured by additive manufacturing techniques (e.g., 3D printing), etc.

[0276] 71-74, an exemplary portion of an expandable coaptation element 20002 for use in a device (e.g., a treatment device, a repair device, an implantable device, an implant, etc.) is shown. The expandable coaptation element 20002 can be used in a variety of different devices, including, but not limited to, any of the treatment and / or repair devices disclosed herein. For example, the expandable coaptation element 20002 can be used in the devices schematically illustrated in FIGS. 8-14. A device having the expandable coaptation element 20002 can include any of the other features for devices described herein (e.g., a treatment device, a repair device, etc.) and can be positioned to engage valve tissue as part of any suitable treatment and / or repair system (e.g., any of the treatment and / or repair systems disclosed herein). The expandable coaptation element 20002 can be deployed from a delivery sheath or delivery means for delivery by a pushing member, such as a rod or tube.

[0277] 71-73, the coaptation element 20002 can include a cellular frame 20004 that can control both the width and length of the coaptation element to accommodate different sizes of leaflet gaps. Both width and length are relative terms and are defined by the plane of the native valve. In one example, the width is the dimension on the axis between the leaflets, and the length is the dimension transverse to the width (e.g., between the commissures). The expandable coaptation element 20002 can be constructed from a shape-memory alloy that provides shape-setting capabilities, such as nitinol, or any other flexible material suitable for implantation in the human body.

[0278] The expandable coaptation element 20002 can be cellular, tubular, oval / bowl-shaped, or any other shape that aids in implantation between the native valve leaflets. In some implementations, the expandable coaptation element 20002 comprises a stent-like cellular frame with triangular, diamond-shaped, and / or hexagonal honeycomb cells. In some implementations, the structure can be tubular, where the length is greater than the width and both longitudinal ends have arc shapes. The coaptation element 20002 can have multiple ends (over the length of the coaptation element) and / or multiple sides (over the width of the coaptation element).

[0279] In some implementations, the coaptation element 20002 can have one or more tabs or extension members 20006 on one or more sides (e.g., at each point on the frame 20004 where the minor axis of the cross section intersects the frame). The coaptation element 20002 can be vertically and / or horizontally expandable and contractible. Expansion and contraction can be achieved by a drive portion or member 20008 extending from the tabs or extension members 20006. The drive portion or member 20008 can be coupled to the frame 20004, such as by being integrally formed with the frame as shown. In some implementations, the drive portion or member 20008 can be radially disposed about a central axis of the expandable coaptation element 20002. One or more sides of the expandable coaptation element 20002 referenced in FIGS. 71-74 can expand sequentially, simultaneously, or otherwise when manipulated and / or actuated.

[0280] The expandable coaptation element 20002 can expand and / or contract in a variety of different ways. For example, the expandable coaptation element 20002 can:

[0281] -Only the length can be increased or decreased.

[0282] -Only the width can be increased or decreased.

[0283] -Length and width can be increased or decreased simultaneously.

[0284] The expandable joint element 20002 can be expanded and contracted sequentially, first expanding and contracting in length and then in width;

[0285] The expandable joint element 20002 can be expanded and contracted sequentially, first expanding in width and then expanding and contracting in length;

[0286] -Length and width can be scaled independently.

[0287] - the length can be partially scaled and then both the length and the width can be scaled, and / or

[0288] The width can be partially scaled and then both the length and width can be scaled.

[0289] In this manner, the shape-changing elements 20002 can expand sequentially, simultaneously, or in other manners.

[0290] In some implementations, one or more secondary control members 20012 can be used to change the size of one or more cells independently of the drive portion or member 20008. The secondary control members 20012 can take a wide variety of different forms. For example, the secondary control members can include lines such as sutures, wires, etc., fasteners with adjustable widths, springs, or any other components that can be controlled to change the size of one or more cells 20014. The one or more secondary control members 20012 can be attached to individual cells 20014 of the frame 20004. The individual cells 20014 can be specialized, such as by having a different shape (e.g., hexagonal, heptagonal, rectangular, triangular, etc.), different strut thicknesses, different strut widths, etc., compared to other cells of the frame 20004. In some implementations, the secondary control member 20012 can be used to adjust the width of the frame 20004 by pulling the specialized cells 20014 to narrow them, thereby adjusting the frame 20004 as a whole.

[0291] The constriction and expansion of the individual cells 20014 by the secondary control member 20012, as opposed to the movement of the drive portion or member 20008, changes the shape of the expandable coaptation element 20002. By adjusting the drive portion or member 20008 and the secondary control member 20012, the expandable coaptation element can be adjusted to a variety of different shapes and sizes.

[0292] 72-73 illustrate a control cell 20010 that forms part of the frame 20004 of the expandable joint element 20002. The control cell 20010 can be expanded by shortening, constricting, and / or bending or flexing at specific points. A drive portion or member 20008 is connected to the control cell 20010 via a plurality of tabs, connectors, or connecting portions 20006 that are coupled to the upstream and downstream ends of the cell at bending points 20023. In some implementations, elastic properties of the material, variations in the width of the material, and / or variations in the thickness of the material can be used to form the control cell 20010 with bending points 20021, 20023 that bend or flex relative to each other and / or prior to other portions of the control cell 20010 and / or out of the plane of the control cell. In some implementations, a force applied to the control cell first overcomes bending point 20021 and / or bending point 20023 , causing the points to bend and changing the shape of expandable coaptation element 20002 .

[0293] For example, bending points 20021 and 20023 are

[0294] - Point 20021 bends before point 20023.

[0295] - Point 20023 bends before point 20021.

[0296] -Points 20021 and 20023 are deflected simultaneously.

[0297] - so that point 20021 is partially deflected, and then points 20021 and 20023 are deflected, and / or

[0298] It can be configured so that point 20023 is partially deflected, and then points 20021 and 20023 are deflected.

[0299] FIG. 72 shows a control cell 20010 having bending points 20021 that bend about multiple bending axes 20022 and bending points 20023 that bend about axis 20020. A comparison of FIG. 72 with FIG. 73 illustrates how the control cell 20010 can be bent / manipulated by adjusting the drive portion or member 20008 upward or downward. In some implementations, adjusting the drive portion or member 20008 upward or downward first bends the bending points 20023 on the actuators, lengthening the control cell 20010. The bending points 20021 then bend along bending axes 20022, further lengthening or shortening the control cell 20010. FIG. 73 illustrates the control cell 20010 within the frame 20004 after the drive portion or drive member 20008 has been manipulated in an up and down direction to lengthen and shorten the control cell 20010.

[0300] The control cell 20010 can be expanded or contracted in a variety of different ways. Any mechanism capable of moving the drive member 20008, as illustrated by arrow 20009 in FIG. 72, can be used. FIG. 74 shows the control cell 20010 described in FIGS. 71-73 with an exemplary drive member 20030. The drive member can include a catheter 20032 and a rod 20034 to manipulate the control cell 20010 upward and / or downward, or to expand or contract. When expanding or contracting, the catheter 20032 and rod 20034 lengthen and / or contract one or more struts 20040, thereby adjusting the size of the control cell 20010.

[0301] 75-77 illustrate one example of an expandable joint element 20500. In the example depicted in FIGS. 75-77, the expandable joint element 20500 can include one or more shape-changing components 20512 and an adjustment mechanism 20502. The shape-changing component 20512 is configured to change size and / or shape when a portion of the shape-changing component 20512 is pulled into or pushed out of a receiver 20513 of the adjustment mechanism 20502.

[0302] The shape-changing component 20512 can take a variety of different forms with a variety of different expanded and contracted shapes. In the example depicted in FIG. 76, the shape-changing component 20512 can be formed from individual wires having a whisk or whisk-like configuration. In the example depicted in FIG. 77, the shape-changing component 20512 can be formed from a braided or mesh material. For example, the shape-changing component 20512 can include a plurality of crossed wires. The shape-changing component 20512 can have a variety of different shapes. For example, the shape-changing component 20512 can be teardrop-shaped, spherical, cylindrical, conical, frusto-conical, oval, pyramidal, partial pyramidal, diamond-shaped, combinations of these shapes, etc. in the expanded and / or retracted configuration. The shape-changing component 20512 can be formed from a braided or woven tube, such as nitinol wire, or any other flexible material suitable for implantation within the human body.

[0303] The shape-changing component 20512 can be transformed from the expanded configuration to the compressed configuration in a variety of different ways. In the illustrated example, the shape-changing component is pulled into or pushed out of a receiver 20513 of the adjustment mechanism 20502. In the illustrated example, pushing the shape-changing component 20512 out of the receiver 20513 causes the shape-changing component 20512 to expand, while pulling the shape-changing component 20512 into the receiver causes the shape-changing component to decrease in size. In some implementations, the shape-changing component 20512 is laterally expanded or contracted without increasing or substantially increasing the height of the expandable coaptation element 20500.

[0304] A variety of different mechanisms can be used to transition the shape-changing component 20512 from the expanded configuration to the contracted configuration. In some implementations, the inner shaft 20508 is moved along the axis 20516 within the outer shaft 20522 to transition the shape-changing component 20512 from the expanded configuration to the contracted configuration. In some implementations, a nut and bolt can be used to transition the shape-changing component 20512 between the expanded and contracted configurations.

[0305] In the illustrated example, the shape-changing component 20512 has a first end 20510 (e.g., proximal / upstream end) fixedly attached to the outer shaft 20522. The shape-changing component 20512 has a distal end 20514 attached to the inner shaft 20508. The inner shaft 20508 and attached distal end 20514 are axially movably mounted within the receiver 20513. Axial adjustment of the second or distal end 20514 within the receiver 20513 exposes more or less of the shape-changing component 20512. The shape-changing component 20512 can be biased to expand toward an overall teardrop or oval shape to expose more of the shape-changing component 20512 and thereby make the expandable coaptation element 20500 wider.

[0306] The expandable coaptation element 20500 can be used in a variety of different devices, including, but not limited to, any of the treatment and / or repair devices disclosed herein. For example, any of the expandable coaptation elements disclosed herein can be used in the devices schematically illustrated in FIGS. 8-14. The expandable coaptation element 20500 can be positioned to engage valve leaflets 30, 32, 34 (see FIGS. 7 and 34) or valve leaflets 20, 22 (see FIGS. 6 and 36) as part of any suitable device (e.g., any of the treatment and / or repair devices disclosed herein). The device can be deployed from a delivery sheath, from a steerable catheter, and / or from an implant catheter. The device can include the expandable coaptation element 20500 and an anchor portion having two or more anchors, such as the anchor portions and anchors described herein. The device can be a prosthetic spacer device, a valve repair device, a valve treatment device, or another type of device attached to the native valve leaflets.

[0307] 78-81 , in some implementations, an extension or blocking member, or the like (e.g., a cap, umbrella, canopy, shade, cap-like extension, umbrella-like extension, canopy-like extension, etc.) can be attached to a device (e.g., a treatment device, a repair device, etc.) to block, divert, or prevent regurgitant blood flow through a native valve, such as a native mitral valve. The extension or blocking member can take a variety of different forms. The extension or blocking member can be sized and shaped to reduce regurgitant flow while maximizing flow from the atrium to the ventricle. For example, the extension or blocking member can have a shape that matches or substantially matches the profile of the regurgitant flow and / or can have a shape that corresponds to, but is smaller than, the annulus of the native valve.

[0308] 78-81 , an example of a device 20600 (e.g., a valve repair device, a valve therapy device, an implantable device, an implant, etc.) is shown. The device 20600 (e.g., a therapy device, a repair device, etc.) can include an extension or blocking member 20602 (e.g., a cap, an umbrella, a canopy, a shade, a cap-like extension, an umbrella-like extension, a canopy-like extension, etc.), a frame or base 20604, and one or more clasps 20606. The extension member 20602 can be used to cover the gap between the occluded valve leaflets, thereby blocking or partially blocking regurgitation through the native valve. The extension member 20602 can be connected to the frame or base 20604 in a variety of different ways. In the illustrated example, the extension member has a stem 20610 secured to a complementary socket 20612 on the frame 20604. However, the extension member 20602 can be attached to the frame or base 20604 in any manner, or the extension member 20602 can be directly connected to one or more clasps 20606.

[0309] In some implementations, the extension member 20602 is expandable. For example, the extension member can take the form of or include the functionality of an ampulzer, occluder, or plug. In some implementations, the extension member has a predetermined size when deployed but can be compressed to fit inside a delivery catheter. The extension member 20602 can be constructed from fabric, a semi-rigid material, a rigid material, or a shape memory alloy wire that provides shape-setting functionality, such as Nitinol, or any other flexible material suitable for implantation within the human body.

[0310] One or more clasps 20606 can be attached to the frame 20604 to attach the leaflets of the native valve 20608 to one another. In some implementations, the frame 20604 can be omitted. For example, the clasps 20606 can be connected to one another and / or can be integrally formed and / or can be directly connected to the extension member 20602.

[0311] Figure 79 shows a plan view of an exemplary device 20600 including an extension member 20602. As can be seen from Figure 79, the extension member 20602 covers the gap between the occluded leaflets, thereby blocking or partially blocking backflow through the native valve.

[0312] The extension member 20602 can be used in a variety of different devices, including, but not limited to, any of the treatment and / or repair devices disclosed herein. By way of example, any of the extension members, blocking members, etc. disclosed herein can be used in the devices schematically illustrated in FIGS. 8-14. Device 20600 is one of many different configurations that the device schematically illustrated in FIGS. 8-14 may have, including the extension member 20602. Device 20600 can include any other features for devices described herein (e.g., treatment devices, repair devices, etc.), and extension member 20602 can be positioned as part of any suitable device (e.g., any of the treatment and / or repair devices disclosed herein) to block or impede retrograde flow through leaflets 30, 32, 34 (see FIGS. 7 and 34) or through leaflets 20, 22 (see FIGS. 6 and 36). The device 20600 can be deployed from a delivery sheath, from a steerable catheter, and / or from an implant catheter. The device 20600 can include an anchor portion having two or more anchors, such as the anchor portions and anchors described herein.

[0313] FIG. 80 illustrates an exemplary valve system 20700 in which an extension or blocking member 20702 (e.g., a cap, umbrella, canopy, shade, cap-like extension, umbrella-like extension, canopy-like extension, etc.) is mounted on a device 200 (e.g., a treatment device, a repair device, etc.). In the illustrated example, the device 200 can be the same as or similar to the device illustrated in FIG. 22. However, the extension member 20702 can be mounted on any device, such as any of the devices (e.g., treatment and / or repair devices, etc.) shown and described in this application.

[0314] The extension member 20702 can be attached to the device 200 in a variety of different ways. In the illustrated example, the extension member 20702 is advanced over the implant catheter 102 used to deploy the device 200, as indicated by arrow 20750. Once in position, the extension member 20702 is attached to the device 200. For example, the extension member 20702 can be attached to the collar 211. However, the extension member 20702 can be attached to the device 200 in any manner. The extension member 20702 can be used to cover any gaps that remain after the interface portion 204 of the device 200 is positioned. Covering the gaps can block or impede retrograde flow through the native valve.

[0315] In some implementations, the extension member 20702 is expandable. For example, the extension member can take the form of or include the functionality of an ampulzer, occluder, or plug. In some implementations, the extension member has a predetermined size when deployed but can be compressed to fit inside the delivery catheter. The extension member 20702 can be constructed from fabric, a semi-rigid material, a rigid material, or a shape memory alloy wire that provides shape setting functionality, such as Nitinol, or any other flexible material.

[0316] The extension member 20702 can be inserted simultaneously with the device 200 or can be inserted after the device 200 has been implanted. For example, the device can be positioned. Reflux can then be assessed. Based on the remaining reflux, an extension member 20702 can be selected and added to the device 200. FIG. 81 shows the device 200 with the extension member 20702 secured thereto.

[0317] 82-83 illustrate an exemplary frame member 21002 (e.g., frame, body, cage, fixation member, chassis, foam, etc.) for the expandable coaptation element 21000 (e.g., FIGS. 100-101). The expandable coaptation element 21000 (e.g., spacer, coaptation element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) can be part of a device (e.g., treatment device, repair device, etc.) for repairing a native heart valve and can be used as part of any of the devices described herein.

[0318] In some implementations, the frame member 21002 is configured to transition between a first radially contracted configuration and a second radially expanded configuration. The frame member 21002 can be configured in a variety of ways. In some implementations, the frame member 21002 has a generally cylindrical shape (i.e., a circular cross-section) with a proximal end 21004, a distal end 21006 opposite the proximal end 21004, and a diameter D such that it can be collapsed (i.e., the first configuration) and expanded (i.e., the second configuration). However, in some implementations, the frame member 21002 can have a shape other than cylindrical (e.g., an oval, rectangular, elliptical, or other suitable shaped cross-section).

[0319] In some implementations, the frame member 21002 may include a plurality of interconnected struts 21008 configured to flex or bend to enable the frame member 21002 to transition between a first configuration and a second configuration. The interconnected struts 21008 may be configured in a variety of ways, for example, in terms of the number and size of the struts, the shape of each strut, the placement of the struts relative to other struts, the interconnection of the struts, etc. Any configuration that may facilitate expansion and contraction of the frame member 21002 may be used. In some implementations, the struts 21008 are arranged in a diamond pattern 21010 having a height HD and a width WD ( FIG. 83 ).

[0320] In some implementations, the example frame member 21002 includes a plurality of posts 21012 interconnected by a plurality of struts 21008. The posts 21012 can be configured in a variety of ways, such as in terms of the number and size of the posts, the shape of each post, the placement and connection of the posts relative to the struts, etc.

[0321] In the illustrated example, each post 21012 extends linearly from the proximal end 21004 to the distal end 21006 and has a height HP and a width WP ( FIG. 83 ). The width WP is greater than the width WS of each strut in the illustrated example. In some examples, the width WP is three or more times, or four or more times, the width WS of each strut 21008. In some implementations, the width WP of the post is less than or equal to the width WS of each strut.

[0322] In the illustrated example, each post 21012 is connected to one diamond pattern 21010 of struts 21008 on each side along a midpoint 21014. In the illustrated example, the frame member 21002 includes six posts 21012 evenly spaced around the periphery of the frame member 21002. Each of the six posts 21012 is spaced apart by two interconnected diamond patterns 21010 of struts 21008. The posts 21012 and struts 21008 may be interconnected in any suitable manner.

[0323] In some implementations, the frame member 21002 is formed as a unitary member. For example, the frame member 21002 can be laser cut from a tube. However, in other implementations, some of the struts 21008 and some of the posts 21012 can be formed separately and connected in any suitable manner (e.g., by welding together).

[0324] In some implementations, the frame member 21002 can include a flexible material, such as a metallic fabric, such as a mesh, woven fabric, braid, or formed in any other suitable manner, or cut by laser cutting or otherwise. The material can be a fabric, a shape-setting memory alloy wire such as Nitinol, or any other flexible material suitable for implantation within the human body.

[0325] In some implementations, when the diameter D of the frame member 21002 expands, the height HD of each diamond pattern 21010 decreases and the width WD increases. Conversely, the height HP of each post 21012 does not change. Thus, the frame member 21002 has a predetermined height (i.e., post height HP) that does not change between the first and second configurations.

[0326] In some implementations, the frame member 21002 can be configured to change height between the first and second configurations. For example, the posts can be replaced by a diamond pattern such that the entire frame member 21002 decreases in height as it increases in width.

[0327] The frame member 21002 can be transitioned between the first and second configurations by any suitable means. For example, the frame member 21002 can be mounted around an expandable mechanism 21016 (see FIGS. 84-86 ) configured to engage the frame member 21002 to transition the frame member 21002 between the first and second configurations. A variety of different mechanisms can be used to transition the frame member 21002 between the first and second configurations. For example, any of the expandable mechanisms disclosed herein can be used. The expandable mechanism can include one or more of a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, pivoting or scissoring extension members and / or struts, an expanding pulley mechanism, a Hoberman mechanism, a cam, a worm screw, a rack and pinion, foam, etc.

[0328] In some implementations, as shown in FIG. 89, the expandable mechanism 21016 includes an expandable or expanding member 21018 (e.g., a frame, body, strut assembly, tube, shaft, etc.) and a drive mechanism. Referring to FIGS. 84-86, in some implementations, the frame member 21002 is attached around the expandable / expanding member 21018. The expandable / expanding member 21018 can be configured in a variety of ways. Any configuration that allows the frame member 21002 to transition between the first and second configurations can be used.

[0329] Referring to Figures 87-88, in some implementations, the expandable / expanding member 21018 is configured as an elongated cylindrical shape and has a proximal end portion 21022, a distal end portion 21024 located opposite the proximal end portion 21022, an intermediate portion 21026 connecting the proximal end portion 21022 and the distal end portion 21024, and a passageway 21027 extending through the expandable / expanding member 21018 from the proximal end portion 21022 to the distal end portion 21024.

[0330] In some implementations, the intermediate portion 21026 is formed from a plurality of strips 21028 configured to bend or flex. In some implementations, each strip 21028 has a proximal end 21030 attached to the proximal end portion 21022 of the expandable / expanding member 21018, a distal end 21032 attached to the distal end portion 21024, and an intermediate portion 21034 located between the proximal end 21030 and the distal end 21032.

[0331] In some implementations, the expandable / expanding member 21018 includes six strips 21028 spaced evenly around the circumference of the expandable / expanding member 21018. However, in some implementations, the strips 21028 may not be evenly spaced apart and / or the intermediate portion 21026 can include more or fewer than six strips.

[0332] In some implementations, the expandable / expanding member 21018 is transitionable between a first configuration (i.e., a collapsed or constricted configuration) ( FIG. 88 ) and a second configuration (i.e., an expanded or widened configuration) ( FIG. 87 ). As shown in FIG. 88 , in the first configuration, each of the plurality of strips 21028 extends parallel to the longitudinal axis LA of the expandable / expanding member 21018, and the expandable / expanding member 21018 has a first length L1. In the first configuration, the proximal end portion 21022, the distal end portion 21024, and the intermediate portion 21026 have the same first diameter D1.

[0333] In some implementations, the expandable / expanding member 21018 can be formed as a unitary member. For example, the expandable / expanding member 21018 can be laser cut from a tube. In some implementations, the expandable / expanding member 21018 can be formed from multiple members, such as, for example, a pair of Nitinol sheets.

[0334] In some implementations, the expandable / expanding member 21018 can include a flexible material, such as a metallic fabric, such as a mesh, woven fabric, braid, or formed in any other suitable manner, or cut by laser cutting or otherwise. The material can be a fabric, a shape-setting memory alloy wire such as Nitinol, or any other flexible material suitable for implantation within the human body.

[0335] 87, in the second configuration, the proximal end portion 21022 is driven toward the distal end portion 21024, or vice versa, causing the strip 21028 to bend or flex outward, thereby expanding the intermediate portion 21026 to a second diameter D2 that is greater than the first diameter D1. Further, in the second configuration, the expandable / expanding member 21018 has a second length L2 that is less than the first length L1, such that the diameters of the proximal end portion 21022 and the distal end portion 21024 remain at the first diameter D1, and the intermediate portion 21026 expands to the second diameter D2.

[0336] As shown in FIGS. 84-86 , in some implementations, the expandable / expansion members 21018 are engaged to the frame member 21002 by being positioned within the periphery of the frame member 21002. In some implementations, the intermediate portion 21034 of each strip 21028 is attached to the frame member 21002. In some implementations, the intermediate portion 21034 of each strip 21028 is attached to a corresponding post 21012 of the frame member 21002. The intermediate portion 21034 of each strip 21028 can be attached to the frame member 21002 in any suitable manner, such as, for example, by welding.

[0337] In some implementations, as a result of the expandable / expanding member 21018 being positioned within the periphery of the frame member 21002 and as a result of its attachment to the frame member 21002, the expandable / expanding member 21018 transitions between a first configuration (i.e., a collapsed or constricted configuration) (FIG. 88) and a second configuration (i.e., an expanded or wide configuration) (FIG. 87), thereby causing the frame member 21002 to transition between its first configuration (i.e., a collapsed configuration) and its second configuration (i.e., an expanded configuration).

[0338] In some implementations, the frame member 21002 and / or the expandable / expanding member 21018 can be configured to normally reside in a first configuration (i.e., collapsed or constricted), a second configuration (i.e., expanded or wide), or some intermediate position between the first and second configurations. Thus, in some implementations, transitioning the expandable / expanding member 21018 pulls the frame member 21002 inward toward the first position against the bias of the frame member 21002. In some implementations, transitioning the expandable / expanding member 21018 pushes the frame member 21002 outward toward the second position against the bias of the frame member 21002.

[0339] In some implementations, the drive mechanism 21020 is configured to transition the expandable / expanding member 21018 between the first and second configurations. The drive mechanism 21020 can be configured in various manners. Any drive mechanism capable of transitioning the expanding member 21018 between the first and second configurations can be used. In some implementations, the drive mechanism 21020 is attached to the interior of the expandable / expanding member 21018, between the proximal end portion 21022 and the distal end portion 21024 of the expandable / expanding member 21018.

[0340] 87-88 , in some implementations, the expandable / expanding member 21018 can include structure configured to attach the drive mechanism 21020 to the interior of the expandable / expanding member 21018. This structure can be configured in various ways. In some implementations, the proximal end portion 21022 of the expandable / expanding member 21018 includes a first pair of radially opposed openings 21036 and a second pair of radially opposed openings 21038 that are distal to the first pair of radially opposed openings 21036, and the distal end portion 21024 of the expandable / expanding member 21018 includes a third pair of radially opposed openings 21040.

[0341] In some implementations, the drive mechanism 21020 is configured as a threaded connection. With reference to FIG. 89 , the exemplary drive mechanism 21020 includes a distal member 21042 (e.g., a tube, a body, a shaft, etc.) configured to threadably couple to a proximal member 21044 (e.g., a tube, a body, a shaft, etc.). The distal member 21042 and the proximal member 21044 can be configured in various manners. In the illustrated example, the distal member 21042 is formed as a cylindrical tube having a circular cross-section. However, in some implementations, the distal member 21042 can have a shape other than cylindrical (e.g., a cross-section that is oval, rectangular, elliptical, or other suitable shape).

[0342] In some implementations, the distal member 21042 includes a proximal end 21046, a distal end 21048 opposite the proximal end 21046, and an internal passageway 21050 extending through the distal member 21042 from the proximal end 21046 to the distal end 21048. The internal passageway 21050 includes internal threads 21052 (FIGS. 90-91) for threadably coupling to the proximal member 21044.

[0343] In some implementations, the distal member 21042 is sized to be received within the passageway 21027 of the expandable / expanding member 21018. In some implementations, the distal member 21042 includes structure for securing the distal member 21042 relative to the expandable / expanding member 21018 in position within the passageway 21027. In the illustrated example, the distal end 21048 includes a pair of diametrically opposed protrusions 21054 configured to be received within a third pair of diametrically opposed openings 21040, as shown in FIGS.

[0344] In some implementations, the proximal member 21044 is formed as a cylindrical tube having a circular cross-section, hi some implementations, the proximal member 21044 can have a shape other than cylindrical (e.g., an oval, rectangular, elliptical, or other suitable shaped cross-section).

[0345] In some implementations, the proximal member 21044 includes a proximal end 21056, a distal end 21058 located opposite the proximal end 21056, and an internal passage 21059 extending through the proximal member 21044 from the proximal end 21056 to the distal end 21058.

[0346] In some implementations, the proximal member 21044 can include external threads 21060 (FIGS. 90-91) extending along at least a portion of the exterior of the proximal member 21044. The external threads 21060 are configured to engage with the internal threads 21052 of the distal member 21042.

[0347] In some implementations, the proximal member 21044 is sized to be received within the passageway 21027 of the expandable / expanding member 21018. In some implementations, the drive mechanism 21020 can include structure for limiting axial movement of the proximal member 21044 relative to the expandable / expanding member 21018 within the passageway 21027.

[0348] In some implementations, this structure limits axial movement of the proximal member 21044 relative to the expandable / expanding member 21018 within the passageway 21027, while still allowing rotational movement of the proximal member 21044 relative to the expandable / expanding member 21018. The structure for limiting axial movement of the proximal member 21044 can be configured in various manners.

[0349] In some implementations, the drive mechanism 21020 includes a circumferentially radially extending ridge 21062 at the proximal end 21056. In some implementations, the ridge 21062 is configured to engage with the stop 21064 and with the end cap 21066 to limit axial movement of the proximal member 21044 within the passageway 21027. The stop 21064 can be configured in a variety of manners. In some implementations, the stop 21064 is configured to prevent distal movement of the proximal member 21044 within the passageway 21027.

[0350] In some implementations, the locking body 21064 is formed as a ring having a central passageway 21068 sized to receive a portion of the proximal member 21044 therethrough. In some implementations, the locking body 21064 is further sized to be received within the passageway 21027.

[0351] In some implementations, the locking body 21064 can include structure configured to secure the position of the locking body 21064 relative to the expandable / expanding member 21018. In some implementations, the locking body 21064 includes a pair of diametrically opposed protrusions 21070 configured to be received within a second pair of diametrically opposed openings 21038 in the expandable / expanding member 21018, as shown in FIGS.

[0352] The end cap 21066 can be configured in a variety of ways. In some implementations, the end cap 21066 is configured to prevent proximal movement of the proximal member 21044 within the passageway 21027. In some implementations, the end cap 21066 is formed as a ring having a distal end 21072, a proximal end 21074 opposite the distal end 21072, and a central passageway 21076 extending through the end cap 21066 from the distal end 21072 to the proximal end 21074.

[0353] In some implementations, the central passage 21076 is sized to receive at least a portion of the proximal end 21056 of the proximal member 21044. In some implementations, the proximal end 21056 of the proximal member 21044 can further include one or more engagement surfaces 21077 accessible through the central passage 21076 of the end cap 21066. In some implementations, the one or more engagement surfaces 21077 are configured to rotationally engage the proximal member 21044.

[0354] In some implementations, the end cap 21066 is further sized to be received within the passageway 21027. In some implementations, the end cap 21066 can include structure configured to fix the position of the end cap 21066 relative to the expandable / expansion member 21018.

[0355] In some implementations, the end cap 21066 includes a pair of diametrically opposed protrusions 21078 at the distal end 21072 configured to be received within a first pair of diametrically opposed openings 21036 of the expandable / expansion member 21018, as shown in FIGS. 90-93.

[0356] In some implementations, the end cap 21066 can include a radial flange 21080 at the proximal end 21074 configured to prevent over-insertion of the end cap 21066 into the passageway 21076 .

[0357] 90-93 , in some implementations, when assembled, the drive mechanism 21020 can transition the expandable / expanding member 21018 between a first configuration and a second configuration. In particular, the distal member 21042 is received within the passageway 21027 of the expandable / expanding member 21018.

[0358] In some implementations, a pair of diametrically opposed protrusions 21054 on the distal member 21042 are received within a third pair of diametrically opposed openings 21040, thereby securing the distal member 21042 both axially and rotationally relative to the expandable / expanding member 21018.

[0359] In some implementations, the distal end portion 21024 of the expandable / expanding member 21018 and / or the distal member 21042 can be configured to move or flex to allow a pair of diametrically opposed protrusions 21054 to be positioned adjacent a third pair of diametrically opposed openings 21040.

[0360] In some implementations, the distal end portion 21024 of the expandable / expansion member 21018 includes one or more open-ended longitudinal slots 21082 that allow the distal end portion 21024 to flex outward as the pair of diametrically opposed protrusions 21054 move into a position where they are received within the third pair of diametrically opposed openings 21040. In some implementations, the distal end portion 21024 returns to its normal state after the pair of diametrically opposed protrusions 21054 are received within the third pair of diametrically opposed openings 21040.

[0361] In some implementations, the locking body 21064 is received within the passageway 21027 such that the pair of diametrically opposed protrusions 21070 are received within the second pair of diametrically opposed openings 21038 of the expandable / expanding member 21018. In some implementations, the proximal end portion 21022 of the expandable / expanding member 21018 and / or the locking body 21064 can be configured to move or flex to allow the pair of diametrically opposed protrusions 21070 to be positioned adjacent the second pair of diametrically opposed openings 21038.

[0362] In some implementations, the proximal end portion 21022 of the expandable / expansion member 21018 includes one or more open-ended longitudinal slots 21084 that allow the proximal end portion 21022 to flex outward as the pair of diametrically opposed protrusions 21070 move into a position where they are received within the second pair of diametrically opposed openings 21038. In some implementations, the proximal end portion 21022 returns to its normal state after the pair of diametrically opposed protrusions 21070 are received within the second pair of diametrically opposed openings 21038.

[0363] In some implementations, the proximal member 21044 is received within the passageway 21027 adjacent to the distal member 21042. In some implementations, the distal end 21058 of the proximal member 21044 is received within the passageway 21050 in the proximal end 21046 of the distal member 21042 such that the external threads 21060 of the proximal member 21044 threadably engage with the internal threads 21052 of the distal member 21042. In some implementations, the proximal member 21044 is threaded into the distal member 21042 until the ridges 21062 engage the stops 21064.

[0364] In some implementations, the distal end 21072 of the end cap 21066 is received within the passageway 21027 such that the pair of diametrically opposed protrusions 21078 are received within the pair of diametrically opposed openings 21036 of the expandable / expansion member 21018. The proximal end portion 21022 of the expandable / expansion member 21018 and / or the end cap 21066 can be configured to move or flex to allow the pair of diametrically opposed protrusions 21078 to be positioned adjacent the pair of diametrically opposed openings 21036.

[0365] In some implementations, the proximal end portion 21022 of the expandable / expansion member 21018 includes an open-ended longitudinal slot 21084 that allows the proximal end portion 21022 to flex outward as the pair of diametrically opposed protrusions 21078 move into a position where they are received within the pair of diametrically opposed openings 21036. In some implementations, the proximal end portion 21022 returns to its normal state after the pair of diametrically opposed protrusions 21078 are received within the pair of diametrically opposed openings 21036.

[0366] 90-91 , in some implementations, when assembled, the ridge 21062 is recessed between the end cap 21066 and the locking body 21064, thereby preventing axial movement of the proximal member 21044 relative to the proximal end portion 21022 of the expandable / expanding member 21018. However, rotational movement of the proximal member 21044 is permitted.

[0367] In some implementations, a rotation device or tool (not shown) can be engaged through the passageway 21076 in the end cap 21066 with one or more engagement surfaces 21077 to rotate the proximal member 21044 in a first rotational sense (i.e., thread the proximal member 21044 into the distal member 21042). With the proximal member 21044 axially fixed relative to the proximal end portion 21022 of the expandable / expanding member 21018 and the distal member 21042 axially fixed relative to the distal end portion 21024 of the expandable / expanding member 21018, threading the proximal member 21044 into the distal member 21042 pulls the proximal end portion 21022 of the expandable / expanding member 21018 towards the distal end portion 21024. As a result, the strips 21028 of the intermediate portion 21026 bend or flex outward. Because the intermediate portions 21034 of the strips 21028 are attached to the posts 21012 of the frame members 21002, the outward expansion of the strips 21028 causes the frame members 21002 to expand outward.

[0368] Conversely, in some implementations, rotating the proximal member 21044 in a second rotational sense (i.e., unthreading the proximal member 21044 from the distal member 21042) pushes the proximal end portion 21022 of the expandable / expanding member 21018 away from the distal end portion 21024. As a result, the strips 21028 of the intermediate portion 21026 are pulled inward, which causes the frame member 21002 to contract inward.

[0369] 94-98 illustrate an exemplary expandable mechanism 22016 that may be used in an expandable coaptation element. The expandable mechanism may be the same or similar to any of the expandable mechanisms described elsewhere in this disclosure. The expandable mechanism may include one or more of a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, pivoted or scissored extension members and / or struts, an expanding pulley mechanism, a Hoberman mechanism, a cam, a worm screw, a rack and pinion, foam, etc.

[0370] In some implementations, the expandable mechanism 22016 can be positioned and / or installed within an expandable frame member, such as the frame member 21002 (FIGS. 82-83). An exemplary expandable mechanism 22016 includes an expandable / expansion member 22018 and a drive mechanism 22020 (FIGS. 94-95).

[0371] The expansion member 22018 can be configured in a variety of ways. In the illustrated example, the expandable / expanding member 22018 is substantially similar to the expandable / expanding member 21018 of FIGS. 87-88 , and therefore, the discussion regarding the expandable / expanding member 21018 also applies to the expandable / expanding member 22018.

[0372] In some implementations, the expandable / expanding member 22018 is configured as an elongated cylindrical shape having a proximal end portion 22022, a distal end portion 22024, an intermediate portion 22026, and a passageway 22027 extending through the expandable / expanding member 22018 from the proximal end portion 22022 to the distal end portion 22024.

[0373] In some implementations, the intermediate portion 22026 is formed from a plurality of strips 22028 (FIG. 94) configured to bend or flex.

[0374] In some implementations, the expandable / expanding member 22018 can include structure configured to locate the drive mechanism 22020 within the expandable / expanding member 22018. In some implementations, the proximal end portion 22022 of the expandable / expanding member 22018 includes a first pair of diametrically opposed openings 22036 and a second pair of diametrically opposed openings 22038 that are distal to the first pair of diametrically opposed openings 22036, and the distal end portion 22024 of the expandable / expanding member 22018 includes a third pair of diametrically opposed openings 22040.

[0375] In some implementations, the expandable / expanding member 22018 is transitionable between a first configuration (i.e., a collapsed or constricted configuration) and a second configuration (i.e., an expanded or widened configuration). As shown in FIG. 94, in some implementations, in the first configuration, each of the plurality of strips 22028 extends parallel to the longitudinal axis LA2 of the expandable / expanding member 22018, and in the second configuration (see FIG. 87), the strips 22028 bend or flex outward such that the intermediate portions 22026 expand radially outward.

[0376] In some implementations, the drive mechanism 22020 is configured to transition the expandable / expanding member 22018 between the first configuration and the second configuration. The drive mechanism 22020 can be configured in various manners. With reference to FIGS. 95-98 , in some implementations, the drive mechanism 22020 includes a distal member 22042 and a proximal member 22044.

[0377] The distal member 22042 and the proximal member 22044 can be configured in a variety of ways. In the illustrated example, the distal member 22042 is formed as a cylindrical tube having a sidewall 22045 with a circular cross section. However, in some implementations, the distal member 22042 can have a shape other than cylindrical (e.g., a cross section that is oval, rectangular, elliptical, or other suitable shape).

[0378] In some implementations, the distal member 22042 includes a proximal end 22046, a distal end 22048 opposite the proximal end 22046, and an internal passageway 22050 extending through the distal member 22042 from the proximal end 22046 to the distal end 22048. In some implementations, the proximal end 22046 includes a coupling portion 22051 configured to be coupled to a drive element (e.g., a drive shaft, a drive rod, a drive tube, a drive wire, etc.) (not shown).

[0379] In some implementations, the distal member 22042 includes one or more locking members 22052 configured to engage with the proximal member 22044 to lock the position of the distal member 22042 relative to the proximal member 22044. The one or more locking members 22052 can be configured in various manners.

[0380] In the illustrated example, each locking member 22052 is formed from side wall 22045. For example, each locking member 22052 can be formed from a laser cut through side wall 22045. Each locking member 22052 can include a first end 22053, a second end 22057 opposite the first end 22053, and an intermediate portion 22063 located between the first end 22053 and the second end 22057.

[0381] In some implementations, each locking member 22052 is configured to pivot about an intermediate portion 22059 between a first position in which the locking member 22052 is parallel to the side wall 22045, as shown in FIGS. 95-98, and a second position (not shown) in which the locking member 22052 is pivoted so that the first end 22053 extends out of the side wall 22045 and the second end 22057 extends into the passageway 22050.

[0382] In some implementations, each locking member 22052 is biased to the second position. For example, at least a portion of the distal member 22042 can include a shape memory alloy, and one or more locking members 22052 can be shape-set to the second position.

[0383] In some implementations, the distal member 22042 is sized to be received within the passageway 22027 of the expandable / expanding member 21018. In some implementations, the distal member 22042 can include structure for securing the distal member 22042 in position relative to the expandable / expanding member 22018 within the passageway 22027. In the illustrated example, the distal end 22048 includes a pair of openings 22061.

[0384] In some implementations, the proximal member 22044 is formed as a cylindrical tube having a circular cross-section of the sidewall 22055. However, in some implementations, the proximal member 22044 can have a shape other than cylindrical (e.g., an oval, rectangular, elliptical, or other suitable shaped cross-section).

[0385] In some implementations, the proximal member 22044 includes a proximal end 22056, a distal end 22058 opposite the proximal end 22056, and an internal passageway 22063 extending through the proximal member 22044 from the proximal end 22056 to the distal end 22058. In some implementations, the proximal member 22044 includes a structure configured to interact with one or more locking members 22052 of the distal member 22042. In some implementations, the structure is formed as a pair of slots 22060 formed in the sidewall 22055 on opposite sidewalls. Each slot 22060 can be disposed transversely (e.g., perpendicularly) to the longitudinal axis LA2, and each series of slots 22060 can be aligned with the locking members 22052.

[0386] In some implementations, the proximal member 22044 is sized to be received within the passageway 22027 of the expandable / expanding member 22018. In some implementations, the proximal member 22044 includes structure for limiting rotational movement of the proximal member 22044 relative to the expandable / expanding member 22018 within the passageway 22027. The structure for limiting axial movement of the proximal member 22044 can be configured in various manners. In some implementations, the proximal member 22044 includes one or more tabs 22062 extending axially from the proximal end 22056.

[0387] In some implementations, the drive mechanism 22020 includes an end cap 22066. The end cap 22066 can be configured in various manners. In some implementations, the end cap 22066 is configured to prevent proximal and rotational movement of the proximal member 22044 within the passageway 22027.

[0388] In some implementations, the end cap 22066 is formed as a ring having a distal end 22072, a proximal end 22074 opposite the distal end 22072, and a central passageway 22076 extending through the end cap 22066 from the distal end 22072 to the proximal end 22074. In some implementations, the end cap 22066 is configured to receive each of the one or more tabs 22062 in a groove or recess 22077 to prevent rotation of the proximal member 22044 within the passageway 22027.

[0389] In some implementations, the distal end 22072 of the end cap 22066 is sized to be received within the passageway 22027. In some implementations, the end cap 22066 can include structure configured to fix the position of the end cap 22066 relative to the expandable / expanding member 22018.

[0390] In some implementations, the end cap 22066 includes a pair of diametrically opposed projections 22078 at the distal end 22072 that are configured to be received within a pair of diametrically opposed openings 22036 in the expandable / expansion member 22018, as shown in FIGS. 90-93. In some implementations, the end cap 22066 can include a radial flange 22080 at the proximal end 22074 that is configured to prevent over-insertion of the end cap 22066 into the passageway 22076.

[0391] In some implementations, the drive mechanism 22020 includes a stop 22084 ( FIG. 95 ) for limiting the movement of the distal member 22042 relative to the expandable / expanding member 22018. The stop 22084 can be configured in various ways. In some implementations, the stop 22084 is formed as a ring having a central passage 22088 sized to receive the distal end 22048 of the distal member 22042 therein.

[0392] In some implementations, the locking body 22084 is further sized to be received within the passageway 22027 of the expandable / expanding member 22018. In some implementations, the locking body 22084 can include structure configured to secure the position of the distal member 22042 relative to the expandable / expanding member 22018. In some implementations, the locking body 22084 includes a pair of diametrically opposed first protrusions 22090 extending radially outward, the pair of diametrically opposed first protrusions 22090 configured to be received within a third pair of diametrically opposed openings 22040 of the expandable / expanding member 22018, as shown in FIGS. In some implementations, the locking body 22084 includes a pair of radially opposed second protrusions 22092 extending radially inward and configured to be received within a pair of openings 22061 at the distal end 22048 of the distal member 22042.

[0393] In some implementations, when assembled, the drive mechanism 22020 can transition the expandable / expanding member 22018 between a first configuration and a second configuration. Referring to FIGS. 96-98 , the distal member 22042 is received within the passageway 22027 of the expandable / expanding member 22018. In some implementations, the locking body 22084 is positioned within 22027 such that the pair of first diametrically opposed projections 22090 are received within the third pair of diametrically opposed openings 22040 of the expandable / expanding member 22018 and the pair of second diametrically opposed projections are received within the pair of openings 22061 at the distal end 22048 of the distal member 22042. As a result, the distal member 22042 is held in place relative to the expandable / expanding member 22018.

[0394] Further, in some implementations, the proximal member 22044 is received within the passageway 22027 of the expandable / expanding member 21018, and the proximal end 22046 of the distal member 22042 is received within the passageway 22063 of the proximal member 22044. In some implementations, the distal end 22072 of the end cap 22066 is fixed relative to the proximal member.

[0395] In some implementations, the distal end 22072 of the end cap 22066 can be received within the passageway 22027 such that the protrusions 22078 of the end cap 22066 are received within a pair of diametrically opposed openings 22036 of the expandable / expanding member 22018. As a result, the end cap 22066 secures the proximal member 22044 at the proximal end portion 22022 of the expandable / expanding member 22018.

[0396] In some implementations, the proximal member 22044 is separate from the end cap 22066, and the proximal member 22044 is separately attached to the expandable / expanding member 22014. For example, the proximal member 22044 can be secured to the expandable / expanding member 22014 in the same or similar manner as the proximal member 21044 is attached to the expandable / expanding member 21014 in the implementations illustrated in FIGS.

[0397] In some implementations, a device (e.g., device 100, or another device herein) can be delivered by a delivery system (e.g., delivery system 102). In some implementations, the delivery system can include a first drive element (e.g., a drive shaft, drive rod, drive tube, drive wire, etc.) (not shown) extending through the passageway 22076 of the end cap 22066 and through the passageway 22063 of the proximal member 22044, and coupled to the coupling portion 22051 at the proximal end 22046 of the distal member 22042.

[0398] In some implementations, the delivery system can include an optional second drive element (e.g., a drive shaft, drive rod, drive tube, drive wire, etc.) (not shown) extending coaxially through the first drive element (not shown) and further extending into the passageway 22050 of the distal member 22042.

[0399] In some implementations, the locking members 22052 are held in a first configuration by the first and / or second drive members (not shown) when the first and / or second drive members (not shown) are positioned adjacent one or more locking members 22052 within the passageway 22050. Conversely, when the first and / or second drive members (not shown) are moved within the passageway 22050 away from the one or more locking members 22052, the locking members 22052 move to their second configuration (e.g., the outwardly extended locking configuration).

[0400] In some implementations, the distal member 22042 can be moved axially within the passageway 22063 of the proximal member 22044 to transition the expandable / expanding member 22018 between the first configuration and the second configuration.

[0401] In some implementations, the distal member 22042 can be moved proximally within the passageway 22063 by pulling a first drive element (not shown) coupled to the proximal end 22046 of the distal member 22042. Because the distal end 22048 of the distal member 22042 is secured relative to the distal end portion 22024 of the expandable / expanding member 22018 by the locking element 22084, and because the end cap 22066 secures the proximal member 22044 in place relative to the expandable / expanding member 22018, pulling the first drive element (not shown) with sufficient force moves the distal end portion 22024 of the expandable / expanding member 22018 closer to the proximal end portion 22022 of the expandable / expanding member 22018. As a result, the strip 22028 of the intermediate portion 22026 bends or flexes outward. Because the strips 22028 are attached to a frame member (eg, frame member 21002), outward expansion of the strips 22028 causes the frame member to expand outward.

[0402] In some implementations, after the expandable / expansion member 22018, and thus the expandable coaptation element, is expanded to a desired width or diameter, the distal member 22042 can be locked in position relative to the proximal member 22044. In particular, the first drive member and / or second drive member (not shown) can be moved axially within the passageway 22050 such that the first drive member and / or optional second drive member (not shown) are not adjacent to the one or more locking members 22052. As a result, the one or more locking members 22052 pivot to a second configuration such that the first end 22053 of each locking member 22052 is engaged with one slot 22060 in the proximal member 22044. In some implementations, engagement of the first end 22053 of each locking member 22052 with a corresponding slot 22060 locks the distal member 22042 from axial proximal movement within the passageway 22063.

[0403] In some implementations, the frame member (e.g., frame member 21002) and / or the expandable / expanding member 22018 can be configured to normally be in a first configuration (i.e., collapsed or constricted), a second configuration (i.e., expanded or wide), or some intermediate position between the first and second configurations. In some implementations, moving the distal member 22042 relative to the proximal member 22044 pulls the frame member and / or expandable / expanding member 22018 inward toward the first position against the bias of the frame member and / or expandable / expanding member 22018, or in some implementations pushes the frame member and / or expandable / expanding member 22018 outward toward the second position against the bias of the frame member and / or expandable / expanding member 22018.

[0404] 99 illustrates an exemplary expandable mechanism 22116 for use within an expandable coaptation element. The expandable mechanism 22116 can be the same as or similar to any of the expandable mechanisms described elsewhere in this disclosure. The expandable mechanism can include one or more of a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, pivoted or scissored extension members and / or struts, an expanding pulley mechanism, a Hoberman mechanism, a cam, a worm screw, a rack and pinion, foam, etc.

[0405] In some implementations, the expandable mechanism 22116 can be positioned and / or located within an expandable frame member, such as the frame member 21002 (FIGS. 82-83). The exemplary expandable mechanism 22116 includes an expandable / expanding member 22118 and a drive mechanism 22120. The expandable / expanding member 22118 can be configured in a variety of ways, for example, the same as or similar to any other expandable / expanding member herein. The drive mechanism 22120 can be configured in a variety of ways, for example, the same as or similar to any other drive mechanism herein.

[0406] In the illustrated example, the expandable / expanding member 22118 is substantially similar to the expandable / expanding member 21018 of Figures 87-88, and thus, the description of the expandable / expanding member 21018 equally applies to the expandable / expanding member 22118. In particular, the expandable / expanding member 22118 is configured as an elongated cylindrical shape having a proximal end portion 22122, a distal end portion 22124, an intermediate portion 22126, and a passageway 22127 extending through the expandable / expanding member 22118 from the proximal end portion 22122 to the distal end portion 22124. In some implementations, the intermediate portion 22126 is formed from a plurality of strips 22128 configured to bend or flex.

[0407] In some implementations, the expandable / expanding member 22118 is transitionable between a first configuration (i.e., a collapsed or constricted configuration) (e.g., FIG. 88 for the expandable / expanding member 21018) and a second configuration (i.e., an expanded or widened configuration) as shown in FIG. 99. In some implementations, in the first configuration, each of the plurality of strips 22128 extends parallel to the longitudinal axis LA3 of the expandable / expanding member 22118, and in the second configuration, the strips 22128 bend or flex outward such that the intermediate portions 22126 expand radially outward.

[0408] The drive mechanism 22120 can be configured in a variety of ways, including any of the ways other drive mechanisms are configured herein. In the illustrated example, the drive mechanism 22120 includes a distal member 22142 and a proximal member 22144. In some implementations, the distal member 22142 and the proximal member 22144 are coaxially arranged in a telescopic manner such that a portion of the proximal member 22144 is received within the distal member 22142 and is axially movable relative to the distal member 22142, or vice versa. In some implementations, axially moving the distal member 22142 and the proximal member 22144 relative to one another transitions the expandable / expanding member 22118 between a first configuration and a second configuration. The distal member 22142 and the proximal member 22144 are movable relative to one another by any suitable means, such as any of the drive mechanisms disclosed herein.

[0409] 100-101 illustrate an exemplary expandable coaptation element 21000 as part of a device (e.g., a valve repair device, a valve therapy device, an implantable device, an implant, etc.) configured to be positioned within a native heart valve to enable the native heart valve to form a more effective seal. The expandable coaptation element 21000 is shown attached to a grasping member (e.g., a grasping arm, a clasp arm, etc.), such as grasping member 130.

[0410] In some implementations, the gripping members 130 can be used to attach the expandable coaptation element 21000 to the native leaflets of a native heart valve. For example, the gripping members 130 can be opened to receive the leaflets of a native mitral or tricuspid valve and then closed to capture the leaflets, thereby attaching the expandable coaptation element 21000 to the native heart valve.

[0411] In some implementations, the expandable joint element 21000 includes a frame member 21002 and an expandable / expanding member 21018. FIG. 100 illustrates the expandable joint element 21000 in a first configuration (i.e., collapsed or constricted), and FIG. 101 illustrates the expandable joint element 21000 in a second configuration (i.e., expanded or wide). The expandable joint element 21000 can transition between the first and second configurations by any suitable means, such as, for example, any of the drive mechanisms disclosed herein.

[0412] In some implementations, the expandable joint element 21000 can include an optional cover on the frame member 21002. The cover can cover part or all of the frame member 21002.

[0413] 102-110, an example of a cover 102951 for an expandable joint element 21000 is shown. The cover 102951 can be used with any suitable expandable joint element 21000, such as, for example, any of the expandable joint elements 21000 described herein. In some implementations, the cover 102951 is configured to be attached to the frame member 21002. However, it will be understood that the cover 102951 can be configured to be connected to any component of the device.

[0414] The cover 102951 can be configured in various manners. In some implementations, the cover 102951 can include a sheet, material, fabric, layer, or membrane attached to the frame member 21002 by a number of connectors (e.g., stitches, adhesives, mechanical fasteners, ultrasonic welding, etc.). In some implementations, the sheet, material, fabric, layer, or membrane can be formed from a flexible material, a porous material, and / or a material that is impermeable to blood flow. In some implementations, the sheet, material, fabric, layer, or membrane is formed from a biocompatible material, such as a biocompatible fabric configured to facilitate tissue ingrowth. The cover 102951 can be configured to cover or not cover any component or portion of the device.

[0415] In some implementations, the cover 102951 can have one or more expandable portions 102953 that allow the cover 102951 to remain substantially taut when in a normal position, while also allowing the cover 102951 to extend to an expanded position. This is advantageous in situations where the cover 102951 is attached to a device component, such as the expandable joint element 21000, that is transitionable between a constricted position and an expanded position. That is, the cover 102951 remains taut when in a normal position, reducing any excess material on the device that may come into contact with the vasculature when the expandable joint element 21000 is in the constricted position.

[0416] In some implementations, the expandability of the cover 102951 allows the expandable coaptation element 21000 to transition to an expanded state while the cover 102951 remains substantially taut and covers the device. The expandable portion 102953 can take a variety of different forms. Any material can be used that can expand and contract and return to or substantially to its original size.

[0417] 102-103, a portion of an exemplary cover 102951 is shown as a flat sheet of material or formed as a flat sheet. In some implementations, the cover 102951 includes differently shaped segments or portions for attachment to different portions of the frame member 21002. In some implementations, the cover 102951 can be shaped to smooth the transitions between various portions of the device, which can reduce snag points and provide a smoother exterior surface for the device.

[0418] In the illustrated example, the cover 102951 includes a plurality of spaced apart woven sections 102963 connected by expandable sections 102953. In some implementations, the woven sections 102963 are configured to attach to the frame member 21002. For example, each of the woven sections 102963 can be attached to a corresponding post 21012 of the frame member 21002.

[0419] In some implementations, when the frame member 21002 expands from a first configuration (i.e., collapsed or constricted) as shown in FIG. 102 to a second configuration (i.e., expanded or wide) as shown in FIG. 103, the expandable portion 102953 extends laterally from width W2 to width W1, which is greater than width W2, to accommodate the expansion of the frame member 21002.

[0420] 105 , the plain weave portion 102963 can include weft yarns 102965 and warp yarns 102967 woven in a perpendicular weave pattern. However, the plain weave portion 102963 can take any other suitable form, or the cover 102951 can include any other type of primary weave pattern with the expandable portion 102953 positioned therein. In some implementations, the plain weave portion 102963 is formed from a woven biocompatible fabric configured to facilitate tissue ingrowth. The plain weave portion 102963 can also be configured to reduce backflow of blood.

[0421] 104 and 106-107, in some implementations, the expandable portion 102953 can include a pair of transition sections 102969, such as a leno weave, connected by an expandable material or float 102971. In some implementations, the transition sections, such as a leno weave, provide a transition, connection, or interface between the plain weave 102963 and the expandable material or float.

[0422] 104, the float 102971 can include a yarn portion that does not intersect with any other yarn. In some implementations, the float 102971 includes a textured yarn. However, other configurations are also contemplated.

[0423] In some implementations, the leno weave 102969 can include warp yarns 102973 and weft yarns 102975 woven in a vertical weave pattern with at least one leno yarn 102977 wrapping around the warp yarns 102973.

[0424] In the illustrated example, a single leno thread 102977 wraps around four warp yarns 102973, and the weft yarns 102975 are an extension of the yarns from the float 102971. In some implementations, the weft yarns 102975 from the leno weave 102969 extend into the weft yarns 102965 of the plain weave 102963 ( FIG. 105 ). In some implementations, the plain weave 102963 is separate from the leno weave 102969, and the weft yarns 102975 of the leno weave 102969 are folded back onto or otherwise connected to the warp yarns 102973 and / or the leno yarns 102977 of the leno weave 102969. However, other configurations for the expandable portion 102953 are also contemplated. Leno weave 102969 creates an open fabric, which prevents or inhibits thread slippage or shifting. Leno weave 102969 can provide additional resistance to backflow of blood.

[0425] 106-107, in some implementations, the expandable / contractable portion 102953 can be formed by initializing a cover 102951 (as shown in FIG. 106) including a plain weave 102963, two or more leno weaves 102969, and one or more floats 102971 as described above, and then heating the cover 102951 (as shown in FIG. 107) to cause the floats 102971 to contract and assume a constricted state. For example, the yarns of the floats 102971 can shrink and / or curl when heated, transitioning the floats 102971 to a constricted state. The floats 102971 can be contracted and assume a constricted state by heat-setting or heat-pressing the cover 102951.

[0426] In some implementations, after the float 102971 has contracted to the constricted state, the cover 102951 normally has a width based on the constricted float, but the float can be pulled to expand to the extended state, so that when tension is applied to the cover, the width of the cover 102951 can expand. For example, pulling on the expandable material or float can temporarily straighten curled and / or twisted strands of the expandable material or float.

[0427] In some implementations, removing tension from the cover 102951 causes the float to return to the constricted state, causing the cover 102951 to return to its normal position, i.e., the strands to return to their curled and / or twisted heat-set shape.

[0428] Heating the cover 102951 can also provide advantages to the plain weave 102963. For example, heat setting or heat pressing the plain weave 102963 can reduce the pore size of the plain weave 102963 and / or increase the density of the plain weave 102963, which can be advantageous in preventing or inhibiting backflow of blood.

[0429] In some implementations, the float 102971 can have a preheated width W1 (FIG. 106) and a post-heated width W2 (FIG. 107). In some implementations, the width W1 can be between about 3 mm and about 7 mm, or any subrange, and the width W2 can be between about 1 mm and about 3 mm, or any subrange. The ratio of the width W1 to the width W2 can be between about 1.1:1 and about 7:1, or any subrange. However, the widths W1 and W2 can be any other suitable sizes based on the portion of the device to which the cover 102951 is connected or the desired amount of expansion or contraction for the cover 102951.

[0430] In some implementations, the cover 102951 is configured to remain substantially taut when in a normal position while allowing the cover 102951 to extend to an expanded state, but the cover 102951 does not include a discrete expandable portion 102953.

[0431] The cover 102951 can be configured to be expandable and / or elastic in a variety of different ways. In some implementations, the cover 102951 is made expandable and / or contractible by rotating the material of the cover so that the horizontal and vertical threads of the fabric are no longer horizontal and vertical before the cover is cut from the material. For example, the material forming the cover can be rotated between 30 and 60 degrees, such as between 40 and 50 degrees, such as between about 45 and 45 degrees. Rotating the fabric forming the material of the cover allows the cover to stretch as the frame members transition between narrow and wide configurations. However, it will be understood that the cover 102951 can be configured to stretch in a variety of different ways.

[0432] 108-109 , in some implementations, a cover 102951 can be attached to a first post 102980 and a second post 102982 of a frame member (e.g., frame member 21002 of FIG. 82) for an expandable joint device. In the illustrated example, the cover 102951 includes a single expandable / contractable portion 102953 in the form of the expandable / contractable portion shown in FIGS. 106-107 . However, the cover 102951 can have any suitable number of expandable / contractable portions 102953 between the first post 102980 and the second post 102982. 108, when the posts 102980, 102982 are in an expanded state, the expandable portion 102953 can expand such that the float 102971 has a width W1, which can be substantially the same as or less than the width W1 of the float 102971 in the preheated state shown in FIG. 106. Referring to FIG. 109, when the posts 102980, 102982 are in a constricted state, the expandable portion 102953 returns to a normal position such that the float 102971 has a width W2, which can be substantially the same as or greater than the width W2 of the heat-set float 102971 shown in FIG.

[0433] FIG. 110 shows a schematic plan view of an exemplary covering 102951 for an expandable coaptation element in both a constricted state and an expanded state. In some implementations, the covering 102951 includes a plurality of spaced apart plain weave portions 102963 connected to one or more expandable and contractible portions 102953. In the illustrated example, the covering 102951 includes six evenly spaced plain weave portions 102963. However, in some implementations, the covering 102951 can include more or fewer than six plain weave portions 102963 and / or the plain weave portions 102963 can be unevenly spaced. In some implementations, two or more plain weave portions 102963 can be connected side by side.

[0434] In the illustrated example, each plain woven portion 102963 is connected to another plain woven portion 102963 by a pair of expandable portions 102953. However, in some implementations, the cover 102951 can include more or fewer than two expandable portions 102953, such as connecting two plain woven portions 102963. The plain woven portions 102963 can be connected to the expandable portions 102953 or to other plain woven portions 102963 in any suitable manner, and the expandable portions 102953 can be connected to other expandable portions 102953 in any suitable manner. In the illustrated example, leno stitching 102964 is used to connect the two expandable portions 102953 to each other and to connect the plain woven portions 102963 to the expandable portions 102953.

[0435] As shown in FIG. 110, the cover 102951 can expand from a first diameter D1 in the first state to a second diameter D2 in the second state. In some implementations, the ratio of D2:D1 is in the range of 1.5:1 to 3:1. As shown in FIG. 110, the expandable portion 102953 accounts for the majority of the increase in diameter of the cover 102951 when expanded. For example, in some exemplary implementations, the plain weave portion 102963 expands in length by less than 5%, less than 4%, less than 3%, or less than 2% when the cover expands from the first state to the second state.

[0436] Any cover disclosed herein, such as the cover 102951 illustrated in FIG. 110, can be formed in a variety of different ways. In some implementations, the cover is woven as a tube. For example, the material of the cover 102951 can be woven as a tube around a mandrel and / or can be woven on a circular loom.

[0437] In some implementations, the cover 102951 can be woven as a flat sheet. The woven cover material can be formed into a tube or another shape, for example, by connecting (e.g., by stitching) two opposing ends of the flat sheet.

[0438] Any cover disclosed herein can be woven as a tube, woven as a flat sheet, woven in some other shape / configuration, and / or part of the cover can be woven as a tube and another part of the cover can be woven as a sheet, etc.

[0439] In some implementations, a covering, such as any covering described herein, can be configured and / or treated to reduce blood flow therethrough. In some implementations, a covering configured and / or treated to reduce blood flow therethrough can be expandable / retractable or non-expandable / non-retractable.

[0440] The cover can be configured and / or treated in a variety of different ways to reduce blood flow through the cover. For example, the cover can be configured and / or treated to reduce blood flow through the cover by reducing pore size. The pore size can be reduced in a variety of ways. For example, the pore size can be reduced by increasing the density of the fabric, by stacking the fabric, by coating the fabric, by overlapping the fabric, and / or by other means.

[0441] The density of a fabric can be increased in a variety of different ways. In some implementations, increasing the ends per inch (EPI) and / or picks per inch (PPI) for one or more portions of the fabric can increase the density of the fabric and decrease the permeability of the fabric. For example, EPI x PPI can be 160 x 152 to 400 x 500, or any subrange. For polyethylene terephthalate (PET) yarns, EPI x PPI can be 160 x 152 to 400 x 500, or any subrange. For 50% polyethylene terephthalate (PET) and 50% polyolefin (PO) yarns, EPI x PPI can be between 160 x 152 and 400 x 500, or any subrange. EPI x PPI can be 160 x 196. EPI x PPI can be 160 x 256. EPI x PPI can be 160 x 304. EPI x PPI can be 160 x 152. EPI x PPI can be 160 x 196 for PET yarns. EPI x PPI can be 160 x 256 for PET yarns. EPI x PPI can be 160 x 304 for PET yarns. EPI x PPI can be 160 x 152 for 50 / 50 PET / PO yarns.

[0442] 111 , in some implementations, the cover material 27000 includes a fabric 27002 having a coating 27004 laminated thereto to reduce the permeability of the cover material. The coating 27004 can be a variety of different materials configured to reduce the permeability of the cover material 27000. For example, the coating 27004 can be a silicone, TPU, polyolefin, and / or other polymer-based coating.

[0443] The fabric 27002 can take a variety of different forms. For example, the fabric 27002 can be any expandable and / or non-expandable fabric disclosed herein.

[0444] In the example shown in FIG. 111 , a release paper 27010 is coated with a coating 27004. In some implementations, the coated release paper 27010 and fabric 27002 are passed between a pair of nip rollers 27020. The nip rollers 27020 apply pressure to transfer the coating from the release paper 27010 to the fabric 27002. In some implementations, the release paper 27010 is separated from the fabric 27002, and the coated cover material 27000 has reduced permeability.

[0445] In some implementations, permeability-reducing yarns can be woven into the fabric of the cover material. For example, TPU, silicone, polyolefin, and / or elastic yarns can be woven into any of the cover materials disclosed herein.

[0446] In some implementations, the cover material includes a dip-coated fabric to reduce the permeability of the cover material. The coating can be a variety of different materials configured to reduce the permeability of the cover material. For example, the dip coating can be a silicone, TPU, polyolefin, and / or other polymer-based coating. The fabric can take a variety of different forms. For example, the fabric can be any of the expandable and / or non-expandable fabrics disclosed herein.

[0447] In some implementations, the fabric forming the cover material is optionally dip-coated by first immersing the fabric in acetone. The fabric is then optionally immersed in water or distilled water. The fabric is then immersed in a coating, such as polyurethane or TPU or another polymer coating material. Excess coating is then optionally removed from the fabric. For example, the fabric is optionally passed through nip rollers to remove excess coating. The coated fabric can then optionally be dried.

[0448] 113 illustrates an exemplary frame member 23002 (e.g., frame, body, cage, fixation member, chassis, foam, etc.) for an expandable coaptation element 23000 (e.g., FIGS. 119-121). The expandable coaptation element 23000 (e.g., spacer, coaptation element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) can be part of a device 24000 (e.g., treatment device, repair device, etc.) for repairing a native heart valve and can be used as part of any device described herein.

[0449] In some implementations, the frame member 23002 is configured to transition between a first, contracted configuration (see FIG. 119 ) and a second, expanded configuration (see FIG. 120 ). The frame member 23002 can be configured in various manners. In some implementations, the frame member 23002 has a generally cylindrical shape (i.e., circular cross-section) in the contracted state and an oval, elliptical, oblong, etc. shape (i.e., oval, elliptical, oblong, etc. cross-section) in the expanded configuration. However, in some implementations, the frame member 23002 can have other shapes in the contracted and / or expanded configurations.

[0450] In some implementations, the frame member 23002 can include a plurality of interconnected struts 23008 configured to flex or bend to transition the frame member 23002 between a first configuration and a second configuration. The interconnected struts 23008 can be configured in a variety of ways, such as in terms of the number and size of the struts, the shape of each strut, the placement of the struts relative to other struts, the interconnection of the struts, etc. Any configuration that can facilitate expansion and contraction of the frame member 23002 can be used. In some implementations, the struts 23008 are arranged in a diamond pattern.

[0451] In some implementations, the exemplary frame member 23002 includes a plurality of posts 23012 interconnected by a plurality of struts 23008. The posts 23012 can be configured in a variety of ways, for example, in terms of the number and size of the posts, the shape of each post, the placement and connection of the posts to the struts, etc. In the illustrated example, each post 23012 extends linearly from the proximal end 23004 to the distal end 23006. In the illustrated example, each post 23012 is connected along a midpoint 23014 to one diamond pattern 23010 of struts 23008 on each side.

[0452] In some implementations, the frame member 23002 is formed as a unitary member. For example, the frame member 23002 can be laser cut from a tube. However, in some implementations, some of the struts 23008 and some of the posts 23012 can be formed separately and connected in any suitable manner (e.g., by welding together).

[0453] In some implementations, the frame member 23002 can comprise a flexible material, such as a metallic fabric, such as a mesh, woven fabric, braid, or formed in any other suitable manner, or cut by laser cutting or otherwise. In some implementations, the material can be a fabric, a shape-setting shape memory alloy wire such as Nitinol, or any other flexible material suitable for implantation within the human body.

[0454] In some implementations, when the frame member 23002 expands, the height of each diamond pattern 23010 decreases and the width increases. Conversely, the height of each post 23012 does not change. Thus, the frame member 23002 has a predetermined height (i.e., post height) that does not change between the first and second configurations.

[0455] In some implementations, the frame member 23002 can be configured to change height between the first and second configurations. For example, the posts can be replaced by a diamond pattern such that the entire frame member 23002 decreases in height as it increases in width.

[0456] The frame member 23002 can be transitioned between the first and second configurations by any suitable means. For example, in some implementations, the frame member 23002 can be attached around an expandable mechanism 23016 (see FIGS. 116-118 ) configured to engage the frame member 23002 to transition the frame member 23002 between the first and second configurations. A variety of different mechanisms can be used to transition the frame member 23002 between the first and second configurations. For example, any of the expandable mechanisms disclosed herein can be used.

[0457] 112 and 114-118, the expandable mechanism 23016 includes an expandable or expanding member 23018 (e.g., a frame, a body, a strut assembly, a tube, a shaft, an articulating member, a collapsible component, a balloon, a cam, etc.) and a drive mechanism 23020. In some implementations, a frame member 23002 is attached around the expandable / expanding member 23018.

[0458] The expandable or expanding member 23018 can be configured in a variety of ways. Any configuration that allows the frame member 23002 to transition between the first and second configurations can be used.

[0459] 112, in some implementations, the expandable or expanding member 23018 is configured as an elongate shape and has a proximal end portion 23022, a distal end portion 23024 opposite the proximal end portion 23022, and an intermediate portion 23026 connecting the proximal end portion 23022 and the distal end portion 23024. In some implementations, the intermediate portion 23026 is formed from a pair of strips 23028 configured to bend or flex.

[0460] In some implementations, the expandable / expansion member 23018 includes two oppositely positioned strips 23028. However, in other implementations, the strips 23028 may not be equally spaced and / or the intermediate portion 23026 can include more or fewer than two strips.

[0461] In some implementations, the expandable / expanding member 23018 is transitionable between a first configuration (e.g., an unexpanded, collapsed, and / or constricted configuration) ( FIG. 112 ) and a second configuration (e.g., an expanded or widened configuration) ( FIG. 114 ). As shown in FIG. 112 , in the first configuration, each of the plurality of strips 23028 extends parallel or generally parallel to the longitudinal axis of the expandable / expanding member 23018, and the expandable / expanding member 23018 has a first length L1.

[0462] In some implementations, in the first configuration, the proximal end portion 23022, the distal end portion 23024, and the intermediate portion 23026 have the same width or substantially the same width.

[0463] In some implementations, the expandable / expanding member 23018 can be formed as a unitary member. For example, the expandable / expanding member 23018 can be laser cut from a single piece of sheet material. In some implementations, the expandable / expanding member 23018 can be formed from multiple members, such as a pair of Nitinol sheets.

[0464] In some implementations, the expandable / expanding member 23018 can comprise a flexible material, such as a metallic fabric, such as a mesh, woven material, braided material, or any other suitable formed material, or cut by laser cutting or otherwise. The material can be a cloth, a shape-setting shape memory alloy wire such as Nitinol, or any other flexible material suitable for implantation within the human body.

[0465] In some implementations, as shown in FIG. 114 , in the second configuration, driving the proximal end portion 23022 toward the distal end portion 23024, or vice versa, or driving the proximal and distal end portions toward each other simultaneously, causes the strip 23028 to bend or flex outward, thereby expanding the intermediate portion 23026 to a second diameter greater than the first diameter.

[0466] In some implementations, in the second configuration, the expandable / expanding member 23018 has a second length L2 that is shorter than the first length L1, the widths of the proximal end portion 23022 and the distal end portion 23024 remain the first width, and the intermediate portion 23026 expands to a second width.

[0467] In some implementations, the expandable / expansion member 23018 engages the frame member 23002 by being positioned within the periphery of the frame member 23002. In some implementations, the midpoint 23034 of each of the two strips 23028 is attached to the frame member 23002. In some implementations, the midpoint 23034 of each strip 23028 is attached to one post 23012 of the frame member 23002.

[0468] In some implementations, the intermediate point 23034 of each strip 23028 can be attached to the frame member 23002 in any suitable manner, such as, for example, by welding, sutures, fasteners, rivets, etc.

[0469] In some implementations, as a result of the expandable / expanding member 23018 being positioned within the periphery of the frame member 23002 and as a result of being attached to the frame member 23002, the expandable / expanding member 23018 transitions between a first configuration (e.g., an unexpanded configuration, a collapsed configuration, and / or a constricted configuration) (FIG. 112) and a second configuration (e.g., an expanded configuration and / or a wide configuration) (FIG. 114), thereby causing the frame member 23002 to transition between its first configuration (e.g., unexpanded or collapsed, FIG. 119) and its second configuration (e.g., expanded, FIG. 120).

[0470] In some implementations, the frame member 23002 and / or the expandable / expanding member 23018 can be configured to normally be in a first configuration (e.g., unexpanded, collapsed, and / or constricted), a second configuration (e.g., expanded, wide, etc.), or some intermediate position between the first and second configurations.

[0471] In some implementations, transitioning the expandable / expanding member 23018 pulls the frame member 23002 inward toward the first position against the bias of the frame member 23002. In some implementations, transitioning the expandable / expanding member 23018 pushes the frame member outward toward the second position against the bias of the frame member 23002.

[0472] 114-115 , in some implementations, the drive mechanism 23020 is configured to transition the expandable / expanding member 23018 between the first and second configurations. The drive mechanism 23020 can be configured in a variety of ways. Any drive mechanism capable of transitioning the expansion member 23018 between the first and second configurations can be used, and for example, the drive mechanism can include one or more of a drive wire, a drive element, a pivot link, a cam, a rack and pinion, a worm screw, a lever, a pulley, an articulating arm, etc. In some implementations, the drive mechanism 23020 is mounted internally to the expandable / expanding member 23018.

[0473] 114-118 , in some implementations, the expandable / expanding member 23018 can include a structure configured to attach the drive mechanism 23020 to the interior of the expandable / expanding member 23018. This structure can be configured in a variety of ways. In some implementations, the proximal end portion 23022 of the expandable / expanding member 23018 includes a first opening 23036 and the distal end portion 23024 of the expandable / expanding member 23018 includes a second opening 23040.

[0474] 114-115, the exemplary drive mechanism 23020 includes a distal or outer member 23042 (e.g., a tube, body, shaft, etc.) configured to threadably couple to a proximal or inner member 23044 (e.g., a tube, body, shaft, etc.).

[0475] The proximal or inner member 23044 and the distal or outer member 23042 can be configured in a variety of ways. In the illustrated example, the distal member 23042 is formed as a cylindrical tube having a circular cross section. However, in some implementations, the distal member 23042 can have a shape other than cylindrical (e.g., an oval, rectangular, elliptical, or other suitable shaped cross section).

[0476] In some implementations, the distal member 23042 includes a proximal end, a distal end opposite the proximal end, and an internal passageway 23050 extending through the distal member 23042 from the proximal end to the distal end. In some implementations, the internal passageway 23050 can include internal threads for threadably coupling to the proximal member.

[0477] In some implementations, the distal member 23042 is sized to be received within the expandable / expanding member 23018. In some implementations, the assembly includes structure for securing the distal member 23042 in place within the expandable / expanding member 23018. In the illustrated example, a nut or collar 23149 secures the distal end of the distal member 23042 to the distal end portion 23024 of the expandable / expanding member 23018, as shown in FIGS. 114-115.

[0478] In some implementations, the proximal member 23044 is formed as a cylindrical tube having a circular cross-section. In some implementations, the proximal member 23044 can have a shape other than cylindrical (e.g., an oval, rectangular, elliptical, or other suitable shaped cross-section). In some implementations, the proximal member 23044 includes a proximal end, a distal end opposite the proximal end, and an internal passageway 23059 extending through the proximal member 23044 from the proximal end to the distal end. In some implementations, the internal passageway is sized to accommodate an actuation element (e.g., actuation element 112 for opening and closing paddles of a valve repair device).

[0479] In some implementations, the proximal member 23044 can include external threads extending along at least a portion of the exterior of the proximal member 23044. In some implementations, the external threads are configured to engage with internal threads of the distal member 23042. In some implementations, the proximal member 23044 is sized to be received within the expandable / expanding member 23018. In some implementations, the drive mechanism 23020 can include structure for limiting axial movement of the proximal member 23044 relative to the expandable / expanding member 23018.

[0480] In some implementations, the structure limits axial movement of the proximal member 23044 within the expandable / expanding member 23018 while allowing rotational movement of the proximal member 23044 relative to the expandable / expanding member 23018.

[0481] The structure for limiting axial movement of the proximal member 23044 can be configured in a variety of ways. For example, fasteners such as clips, pins, rivets, etc. can be used to limit axial movement of the proximal member 23044 within the expandable / expanding member 23018 while still allowing rotational movement of the proximal member 23044 relative to the expandable / expanding member 23018.

[0482] 112, 114, and 115, in some implementations, when assembled, the drive mechanism 23020 can transition the expandable / expanding member 23018 between a first configuration and a second configuration. In particular, the distal member 23042 is received within the expandable / expanding member 23018. In some implementations, the distal member 23042 can be fixed both axially and rotationally relative to the expandable / expanding member 23018.

[0483] 114 and 115, the expandable mechanism 23016 is configured to move in one plane (i.e., the two strips 23028 move apart). In some implementations, the expandable mechanism can move in two planes. For example, the second pair of strips can be positioned orthogonal to the first pair of strips.

[0484] In some implementations, the second pair of strips can move in a second plane that is orthogonal to the first plane. However, the second plane can be at any angle relative to the first plane. In this manner, the frame or spacer 23002 can expand in more than one direction.

[0485] In some implementations, the expandable mechanism can be configured such that expansion in a first plane can be controlled independently of expansion in a second plane (e.g., the widths of two pairs of strips can be controlled independently).

[0486] In some implementations, the proximal member 23044 is received within the passageway 23050 of the distal member 23042 such that the male threads of the proximal member 23044 threadably engage with the female threads of the distal member 23042. In some implementations, a rotation device or rotation tool (not shown) can be engaged with one or more engagement surfaces 23077 to rotate the proximal member 23044 in a first rotational sense (i.e., thread the proximal member 23044 into the distal member 23042).

[0487] In some implementations, with the proximal member 23044 axially fixed relative to the proximal end portion 23022 of the expandable / expanding member 23018 and the distal member 23042 axially fixed relative to the distal end portion 23024 of the expandable / expanding member 23018, threading the proximal member 23044 into the distal member 23042 pulls the proximal end portion 23022 of the expandable / expanding member 23018 towards the distal end portion 23024. As a result, the strips 23028 bend or flex outward.

[0488] In some implementations, an intermediate point 23034 of the strip 23028 is attached to a post 23012 of the frame member 23002 such that outward expansion of the strip 23028 causes outward expansion of the frame member 23002 .

[0489] Conversely, in some implementations, rotating the proximal member 23044 in a second rotational sense (i.e., unthreading the proximal member 23044 from the distal member 23042) pushes the proximal end portion 23022 of the expandable / expanding member 23018 away from the distal end portion 23024. As a result, the strips 23028 are pulled inward, thereby causing the frame member 23002 to contract inward. In some implementations, the drive mechanism 22016 illustrated in FIGS. 94-98 can be used in place of the drive mechanism 23020.

[0490] 116-118, the expandable mechanism 23016 can be assembled to a frame 25100 of the device 24000. The frame 25100 can take a wide variety of different forms. In some implementations, the frame 25100 includes a pair of rails 25102 connected to one another by a central ring 25104.

[0491] In some implementations, the proximal end 23022 and / or the distal end 23024 of the expandable / expansion member 23018 are slidably coupled to the rail 25102. The slidable coupling allows the proximal end 23022 and / or the distal end 23024 to slide relative to the frame.

[0492] The proximal end 23022 and / or the distal end 23024 can be slidably coupled to the rail 25102 in a variety of different ways. Any slidable coupling can be used. In some implementations, the proximal end 23022 includes a pair of tabs 25020 that fit around the periphery of the rail 25102 to slidably couple the proximal end 23022 to the frame 25100. In some implementations, the distal end 23024 includes a pair of tabs 25020 that fit around the periphery of the rail 25102 to slidably couple the distal end 23024 to the frame 25100.

[0493] In some implementations, the expandable frame member 23002 or spacer is attached to the central ring 25104 and to the expandable / expanding member 23018. Because the size of the central ring 25104 is fixed, the length of the expandable frame member 23002 or spacer (as viewed from the end) is fixed by the connection to the ring. Because the size of the expandable / expanding member 23018 is adjustable, the width of the expandable frame member 23002 or spacer is adjustable by adjusting the width of the expandable / expanding member 23018.

[0494] The expandable frame member 23002 or spacer can be attached to the central ring 25104 and to the expandable / expansion member 23018 in a variety of different ways. In some implementations, the expandable frame member 23002 or spacer can include two opposing attachment points 25110, such as holes, on two of the posts 23012 for connection to attachment points 25111 on the ring 25104. In some implementations, the expandable frame member 23002 or spacer can include two opposing attachment points 25112, such as holes, on two of the posts 23012 for connection to attachment points 25113 on the expandable / expansion member 23018.

[0495] In some implementations, attachment of the expandable frame member 23002 or spacers to both the ring 25104 and the expandable / expanding member 23018 maintains the expandable mechanism 23016 in a centered position relative to the frame 25100 regardless of the degree of expansion of the expandable / expanding member 23018. In some implementations, when the expandable mechanism 23016 expands, the proximal end 23022 slides along the rails 25102 toward the distal end 23024, and the distal end 23024 slides along the rails 25102 toward the proximal end 23022.

[0496] In some implementations, the connection between attachment point 25110 and attachment point 25111 (i.e., the connection between the expandable frame member 23002 and the ring 25104) and the connection between attachment point 25112 and attachment point 25113 (i.e., the connection between the expandable frame member 23002 and the expandable / expansion member 23018) maintains the intermediate point 23034 of the expandable / expansion member 23018 in alignment with the ring 25104 as the expandable mechanism transitions between the contracted and expanded positions.

[0497] 119-122 illustrate an example of a device 24000 (e.g., a valve repair device, a valve treatment device, an implantable device, an implant, etc.) having an expandable coaptation element 23000. The expandable coaptation element 23000 can be used in a variety of different devices, including, but not limited to, any of the treatment and / or repair devices disclosed herein. For example, any of the expandable coaptation elements disclosed herein can be used in the devices generally illustrated in FIGS. 8-14.

[0498] Device 24000 is one of many different configurations possible for the device illustrated generally in Figures 8-14 with expandable coaptation element 23000. Device 24000 can include any other features for any device described herein, and expandable coaptation element 23000 can be positioned to engage leaflets 30, 32, 34 (see Figures 7 and 34) or leaflets 20, 22 (see Figures 6 and 36) as part of any suitable device (e.g., any of the treatment and / or repair devices disclosed herein).

[0499] In some implementations, the device 24000 can be deployed from a delivery sheath and / or from an implant catheter. In some implementations, the device 24000 can include an expandable mechanism 23016, an expandable frame or spacer 23002, and / or an anchor portion having two or more anchors, such as the anchor portions and anchors described herein.

[0500] In some implementations, the device 24000 can be an artificial spacer device, a valve repair device, a valve treatment device, an implant, a treatment device, and / or another type of device attached to the leaflets of a native valve.

[0501] 119-122, there is shown a device 24000 (e.g., a valve repair device, an implantable device, an implant, a valve treatment device, etc.) having an expandable mechanism 23016 and an expandable frame or spacer 23002. Device 24000 is one of many different configurations that device 100, shown generally in FIGS. 8-14, may take, with the addition of an expandable mechanism 23016 and an expandable frame or spacer 23002.

[0502] In some implementations, the device 24000 includes an expandable mechanism 23016, an expandable frame or spacer 23002, a proximal or attachment portion 26006, an anchor portion 26008, and / or a distal portion 26010.

[0503] In some implementations, the expandable mechanism 23016 and / or the expandable frame or spacer 23002 are configured to be adjustably implanted between the native valve leaflets.

[0504] In some implementations, the anchor portion 26008 includes multiple anchors 26014. The anchors can be configured in various manners. In some implementations, the anchors 26014 include an outer paddle 26016, an inner paddle 26018, a paddle extension or paddle frame 26020, and a clasp 26022.

[0505] In some implementations, the attachment portion 26006 includes a first or proximal collar 26030 (or other attachment member) for engaging a capture mechanism or coupler of a delivery system.

[0506] The delivery system for implant 24000 may be the same or similar to the delivery system 102 described above and may include one or more of a catheter, sheath, guide catheter / sheath, delivery catheter / sheath, steerable catheter, implant catheter, tube, channel, pathway, combinations thereof, etc.

[0507] In some implementations, portions or components of the expandable mechanism 23016, the expandable frame or spacer 23002, and / or the outer paddle 26016 and the inner paddle 26018 are formed from a flexible material, such as a metallic fabric, such as a mesh, woven fabric, braid, or formed in any other suitable manner, or cut by laser cutting or otherwise. The material can be a fabric, a shape-setting shape memory alloy wire such as Nitinol, or any other flexible material suitable for implantation in the human body.

[0508] A drive element (e.g., drive shaft, drive rod, drive tube, drive wire, drive line, etc.) can extend from a delivery system (not shown) to engage and drive the device 24000 (see drive element 112 in FIGS. 8-14). In some implementations, the drive element extends through the proximal collar 26030, the expandable mechanism 23016, and the expandable frame or spacer 23002 to engage the cap 26040 of the distal portion 26010. The drive element can be configured to releasably engage the cap 26040 via a threaded or similar connection, allowing the drive element to disengage and remove from the implant 24000 after implantation.

[0509] The frame 25100 with the expandable mechanism 23016 attached extends from the proximal collar 26030 (or other attachment member) to the cap 26040. The size and / or shape of the expandable frame or spacer 23002 can be selected and / or adjusted to minimize the number of implants (preferably one) required per patient while maintaining a low transvalvular gradient.

[0510] In some implementations, the outer paddle 26016 is articulably attached to the cap 26040 of the distal portion 26010 by a connecting portion 26080 and to the inner paddle 26018 by a connecting portion 26082. In some implementations, the paddle frame 26020 is attached to the cap 26040 at the distal portion 26010 and extends to a transition portion 26082 between the inner paddle 26018 and the outer paddle 26016. In some implementations, the paddle frame 26020 is formed from a stiffer and more rigid material compared to the material forming the paddles 26018, 26016 such that the paddle frame 26020 provides support for the paddles 26018, 26016.

[0511] The paddle frame 26020 can provide additional clamping force between the inner paddle 26018 and the expandable frame or spacer 23002. In some implementations, the connections between the paddle frame 26020, the outer and inner paddles 26016, 26018, the cap 26040, and the expandable frame or spacer 23002 can constrain each of these components to the movements and positions of the treatment and / or repair devices described herein.

[0512] 121, the expandable frame or spacer 23002 is positioned between the valve leaflets 30, 32 as shown in plan view. The anchors 26014 are shown in dashed lines in FIG. 121 because, except for the clasps, the deployed anchors 26014 are positioned onto the ventricular side of the native valve leaflets. FIG. 120 shows the device 24000 with the expandable frame or spacer 23002 in the expanded configuration.

[0513] 119 and 121 show the device 24000 with the expandable frame or spacer 23002 in an unexpanded, collapsed, or contracted configuration. In some implementations, flow through the native valve is adjusted by expanding or contracting the expandable frame or spacer 23002 by adjusting the expandable mechanism 23016, for example, by rotating the engagement surface 23077 of the head 23079 (increasing the size of the shell to reduce reflux through the native valve, or decreasing the size of the shell to increase flow through the native valve).

[0514] 122, the strips 23028 of the expandable mechanism 23016 are pushed apart to move the expandable frame or spacer 23002. This causes the expandable frame or spacer 23002 to assume a wider configuration and occupy a larger space. Referring to FIG. 119, the strips 23028 of the mechanism 23016 are moved closer together to move the expandable frame or spacer 23002 to a contracted configuration. This causes the expandable frame or spacer 23002 to assume a narrowed configuration (or unexpanded configuration) and occupy a smaller space. The following are some non-limiting examples of some of the concepts addressed herein. [Example]

[0515] Below are some non-limiting examples of some of the concepts addressed herein.

[0516] Example 1 1. A coaptation element (e.g., an expandable coaptation element, etc.) for preventing backflow between the leaflets of a native heart valve, the coaptation element including: (i) an expandable mechanism configured to transition between an expanded configuration and a collapsed configuration; and / or (ii) two or more shell components attached to the expandable mechanism.

[0517] Example 2. The coaptation element of example 1, wherein the pair of two or more shell components nest within one another when the expandable mechanism is in the collapsed configuration.

[0518] Example 3. 3. The coaptation element of example 1 or 2, wherein the expandable mechanism comprises a plurality of struts.

[0519] Example 4. The coaptation element of any one of Examples 1 to 3, wherein the expandable mechanism is configured to expand in a single direction.

[0520] Example 5. The coaptation element of any one of Examples 1 to 4, wherein the expandable mechanism is configured to expand in two opposing directions.

[0521] Example 6 A device comprising: (A) an anchor portion configured to be attached to a leaflet of a native heart valve; and / or (B) a coaptation element (e.g., an expandable coaptation element, etc.) attached to the anchor portion, the coaptation element including: (i) an expandable mechanism configured to transition between an expanded configuration and a collapsed configuration; and / or (ii) two or more shell components attached to the expandable mechanism.

[0522] Example 7 7. The device of example 6, wherein the pair of two or more shell components nest within one another when the expandable mechanism is in the collapsed configuration.

[0523] Example 8 The device of Example 6 or 7, wherein the expandable mechanism comprises a plurality of struts.

[0524] Example 9. A device described in any one of Examples 6 to 8, wherein the expandable mechanism is configured to expand in a single direction.

[0525] Example 10. A device described in any one of Examples 6 to 9, wherein the expandable mechanism is configured to expand in two opposite directions.

[0526] Example 11 A system comprising: (A) a delivery system including a catheter and a control handle; and / or (B) a device coupled to the delivery system, the device comprising: (i) an anchor portion configured to be attached to a leaflet of a native heart valve; and (ii) a coaptation element (e.g., an expandable coaptation element, etc.) attached to the anchor portion, the coaptation element comprising: (1) an expandable mechanism configured to transition between an expanded configuration and a collapsed configuration; and / or (2) two or more shell components attached to the expandable mechanism.

[0527] Example 12 The system of example 11, wherein the pair of two or more shell components nest within one another when the expandable mechanism is in the collapsed configuration.

[0528] Example 13 The system of example 11 or 12, wherein the expandable mechanism comprises a plurality of struts.

[0529] Example 14. A system described in any one of Examples 11 to 13, wherein the expandable mechanism is configured to expand in a single direction.

[0530] Example 15. A system described in any one of Examples 11 to 14, wherein the expandable mechanism is configured to expand in two opposite directions.

[0531] Example 16. 1. A coaptation element (e.g., an expandable coaptation element, etc.) for preventing backflow between the leaflets of a native heart valve, the coaptation element including: (i) an expandable mechanism configured to transition between an expanded configuration and a collapsed configuration; and / or (ii) an expandable sleeve disposed around the expandable mechanism.

[0532] Example 17. 17. The coaptation element of example embodiment 16, wherein the expandable sleeve comprises overlapping end portions.

[0533] Example 18. 18. The coaptation element of example 16 or 17, wherein the expandable mechanism comprises a plurality of struts.

[0534] Example 19. The coaptation element of any one of Examples 16 to 18, wherein the expandable mechanism is configured to expand in a single direction.

[0535] 20. 20. The joining element of any one of Examples 16 to 19, wherein the expandable mechanism is configured to expand in two opposite directions.

[0536] Example 21. A device comprising: (A) an anchor portion configured to be attached to a leaflet of a native heart valve; and / or (B) a coaptation element (e.g., an expandable coaptation element, etc.) attached to the anchor portion, the coaptation element including: (i) an expandable mechanism configured to transition between an expanded configuration and a collapsed configuration, and / or an expandable sleeve disposed about the expandable mechanism.

[0537] Example 22. 22. The device of Example 21, wherein the expandable sleeve comprises overlapping end portions.

[0538] Example 23. 23. The device of Example 21 or 22, wherein the expandable mechanism comprises a plurality of struts.

[0539] Example 24. A device described in any one of Examples 21 to 23, wherein the expandable mechanism is configured to expand in a single direction.

[0540] Example 25. A device described in any one of Examples 21 to 24, wherein the expandable mechanism is configured to expand in two opposite directions.

[0541] Example 26. 1. A treatment and / or repair system comprising: (A) a delivery system including a catheter and a control handle; and (B) a valve repair device coupled to the delivery system, wherein the valve repair device comprises: (i) an anchor portion configured to be attached to a leaflet of a native heart valve; and / or (ii) a coaptation element (e.g., an expandable coaptation element, etc.) attached to the anchor portion, wherein the coaptation element comprises: (1) an expandable mechanism configured to transition between an expanded configuration and a collapsed configuration; and / or (2) an expandable sleeve disposed around the expandable mechanism.

[0542] Example 27. The treatment and / or repair system of Example 26, wherein the expandable sleeve comprises overlapping end portions.

[0543] Example 28. The treatment and / or repair system of Example 26 or 27, wherein the expandable mechanism comprises a plurality of struts.

[0544] Example 29. A treatment and / or repair system according to any one of Examples 26 to 28, wherein the expandable mechanism is configured to expand in a single direction.

[0545] Example 30. A treatment and / or repair system according to any one of Examples 26 to 29, wherein the expandable mechanism is configured to expand in two opposite directions.

[0546] Example 31. A coaptation element (e.g., an expandable coaptation element, etc.) for preventing backflow between the leaflets of a native heart valve, the coaptation element (i) including one or more shape-changing components and / or wherein application of a tensile force to the one or more shape-changing components causes the one or more shape-changing components to change from a flat configuration to a curved configuration.

[0547] Example 32. 32. The joining element of example example 31, further comprising a compressible filler disposed between the pair of one or more shape-changing components.

[0548] Example 33. 33. The joining element of example 31 or 32, wherein the one or more shape-changing components have a kirigami configuration.

[0549] Example 34. 34. The joining element of any one of Examples 31-33, wherein the pair of shape-changing components is parallel and spaced apart in the flat configuration.

[0550] Example 35. 35. The joining element of example 34, wherein the pair of shape-changing components are curved toward each other in the curved configuration.

[0551] Example 36. A device comprising: (A) an anchor portion configured to attach to a leaflet of a native heart valve; and / or (B) a coaptation element (e.g., an expandable coaptation element, etc.) attached to the anchor portion, wherein the coaptation element (i) includes one or more shape-changing components; and / or (ii) application of a tensile force to the one or more shape-changing components causes the one or more shape-changing components to change from a flat configuration to a curved configuration.

[0552] Example 37. The device of example 36, further comprising a compressible filler disposed between the pair of one or more shape-changing components.

[0553] Example 38. 38. The device of example 36 or 37, wherein the one or more shape-changing components have a kirigami configuration.

[0554] Example 39. A device described in any one of Examples 36 to 38, wherein one or more paired shape-changing components are parallel and spaced apart in the flat configuration.

[0555] Example 40. 40. The device of example 39, wherein the pair of shape-changing components are curved toward each other in the curved configuration.

[0556] Example 41. A system comprising: (A) a delivery system including a catheter and a control handle; and (B) a device coupled to the delivery system, the device including: (i) an anchor portion configured to attach to a leaflet of a native heart valve; and / or (ii) a coaptation element (e.g., an expandable coaptation element, etc.) attached to the anchor portion, the coaptation element (1) including one or more shape-changing components; and / or (2) applying a tensile force to the one or more shape-chan...

Claims

1. An expandable connecting element for preventing regurgitation between the leaflets of a natural heart valve, An expandable mechanism configured to transition between an expanded configuration and a compressed configuration, An expandable frame attached around the expandable mechanism, Includes, The expandable mechanism is an expandable joint element configured to expand in two opposite directions.

2. The expandable joint element according to claim 1, wherein the expandable frame has a circular cross-section when the expandable mechanism is configured as the crushed configuration, and the expandable frame has an elliptical cross-section when the expandable mechanism is configured as the expanded configuration.

3. The expandable joint element according to claim 1, wherein the expandable frame includes two or more shell components attached to the expandable mechanism.

4. The expandable frame includes an expandable sleeve disposed around the expandable mechanism, as described in Claim 1.

5. The expandable joint element according to claim 1, further comprising an expandable cover that covers at least a portion of the expandable frame.

6. The expandable joint element according to claim 1, wherein the expandable mechanism includes a plurality of struts.

7. The expandable joint element according to claim 1, further comprising a drive mechanism mounted inside the expandable mechanism, wherein the drive mechanism is configured to move the expandable mechanism and the expandable frame between the expanded configuration and the crushed configuration.

8. The expandable joint element according to claim 7, wherein the expandable mechanism includes a distal end portion, a proximal end portion located opposite to the distal end portion, and an intermediate portion located between the distal end portion and the proximal end portion, and the intermediate portion expands when the expandable frame transitions from the compressed configuration to the expanded configuration.

9. The expandable joint element according to claim 1, wherein the expandable mechanism is configured to expand only in two opposite directions.

10. A valve repair device, An anchor configured to be attached to the leaflets of a natural heart valve, The system includes an expandable joint element connected to the anchor, the expandable joint element being, An expandable mechanism configured to transition between an expanded configuration and a compressed configuration, Includes an expandable frame mounted around the expandable mechanism, The valve repair device is configured such that the expandable mechanism expands in two opposite directions.

11. The valve repair device according to claim 10, wherein the expandable frame has a circular cross-section when the expandable mechanism is configured as the crushed configuration, and the expandable frame has an elliptical cross-section when the expandable mechanism is configured as the expanded configuration.

12. The valve repair device according to claim 10, wherein the expandable frame includes two or more shell components attached to the expandable mechanism.

13. The valve repair device according to claim 10, wherein the expandable frame includes an expandable sleeve disposed around the expandable mechanism.

14. The valve repair device according to claim 10, wherein the expandable mechanism includes a plurality of struts.

15. The valve repair device according to claim 10, further comprising a drive mechanism mounted inside the expandable mechanism, wherein the drive mechanism is configured to move the expandable mechanism and the expandable frame between the expanded configuration and the crushed configuration.

16. The valve repair device according to claim 15, wherein the expandable mechanism includes a distal end portion, a proximal end portion located opposite to the distal end portion, and an intermediate portion located between the distal end portion and the proximal end portion, and the intermediate portion expands when the expandable frame transitions from the compressed configuration to the expanded configuration.

17. The valve repair device according to claim 16, wherein the intermediate portion includes a plurality of longitudinally extending and spaced apart strips, the plurality of strips being configured to bend when the intermediate portion expands.

18. The valve repair device according to claim 10, further comprising an expandable cover that covers at least a portion of the expandable frame.

19. A valve repair system, Delivery device and The delivery device comprises a valve repair device attached to the delivery device, The valve repair device is An anchor configured to be attached to the leaflets of a natural heart valve, The system includes an expandable joint element connected to the anchor, the expandable joint element being, An expandable mechanism configured to transition between an expanded configuration and a compressed configuration, Includes an expandable frame mounted around the expandable mechanism, The valve repair system is configured such that the expandable mechanism expands in two opposite directions.

20. The valve repair system according to claim 19, further comprising a drive mechanism mounted inside the expandable mechanism, wherein the drive mechanism is configured to move the expandable mechanism and the expandable frame between the expanded configuration and the crushed configuration.

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