Heart valve repair device and delivery device thereof

Abstract

A device is configured to be positioned within a native heart valve to impede regurgitation through the native heart valve. The device may include one or more of an expandable mating element and / or an extension or a blocking member. The size, shape, or both of the expandable involution element may be adjusted to control the area of the native heart valve filled by the involution element. The expandable involution element, the extension, and / or the blocking member may be positioned in the native heart valve such that reflux blood flow is blocked or obstructed.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 403,671, filed on September 2, 2022, and claims the benefit of U.S. Provisional Application No. 63 / 441,146, filed on January 25, 2023, which are incorporated herein by reference in their entireties. Background Art

[0003] The native heart valves (i.e. aortic valve, pulmonary valve, tricuspid valve and mitral valve) play a key role in ensuring the forward flow of sufficient blood supply through the cardiovascular system. These heart valves may be damaged, for example, due to congenital malformations, inflammatory processes, infectious conditions, diseases, etc., and thus reduce effectiveness. Such damage to the valve may cause serious cardiovascular damage or death. The damaged valve can be surgically repaired or replaced during open heart surgery. However, open heart surgery is highly invasive and complications may occur. Transvascular technology can be used to introduce and deploy / implant devices to treat the heart in a much less invasive manner than open heart surgery. As an example, the transvascular technology that can be used to enter the native mitral valve and aortic valve is the transseptal technology. The transseptal technology includes advancing the catheter into the right atrium (e.g., inserting the catheter into the right femoral vein, upward along the inferior vena cava and entering the right atrium). Then pierce the septum and allow the catheter to enter the left atrium. A similar transvascular technique can be used to deploy / implant the device within the tricuspid valve, which is initially similar to the transseptal technique, but instead of puncturing the septum, the delivery catheter is diverted toward the tricuspid valve in the right atrium.

[0004] A healthy heart is generally conical in shape, tapering to a lower tip. The heart is four-chambered and includes a left atrium, a right atrium, a left ventricle, and a right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has an anatomical structure that is distinct from other native heart valves. The mitral valve includes a valve ring portion and a pair of cusps or leaflets, the valve ring portion being an annular portion of native valve tissue surrounding the mitral valve orifice, the pair of cusps or leaflets extending downward from the valve ring into the left ventricle. The mitral valve ring can form a "D" shape, an oval, or other non-circular cross-sectional shape having a major axis and a minor axis. The anterior leaflet can be larger than the posterior leaflet, thereby forming a generally "C" shaped boundary between the adjacent sides of the leaflets when the leaflets are closed together.

[0005] When operating correctly, the anterior and posterior leaflets act together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle expands (also known as "ventricular diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also known as "ventricular contraction" or "systole"), the increased blood pressure in the left ventricle pushes the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back into the left atrium, but instead is discharged from the left ventricle through the aortic valve. In order to prevent the two leaflets from prolapsing under pressure and folding in half toward the left atrium through the mitral valve annulus, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0006] Valvular regurgitation involves the valve improperly allowing some blood to flow through the valve in the wrong direction. For example, mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows from the left ventricle into the left atrium during the systolic phase of the heart contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, papillary muscle dysfunction, left ventricular dilation causing stretching of the mitral annulus, more than one of these, and so on. Mitral regurgitation at the central portion of the leaflet may be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one of the leaflets (i.e., the location where the leaflets meet) may be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle, and therefore the valve does not close and regurgitation is present. Tricuspid regurgitation may be similar, but on the right side of the heart. Summary of the invention

[0007] The present invention is intended to provide some examples, and is not intended to limit the scope of the disclosed subject matter in any way. For example, any feature included in the examples of the present invention is not necessary for the claims unless the claims clearly describe these features. In addition, the features, parts, steps, concepts, etc. described in the examples of the present invention and elsewhere in the present disclosure can be combined in various ways. Various features and steps as described elsewhere in the present disclosure can be included in the examples summarized here.

[0008] Devices for repairing and / or treating a patient's native valve are disclosed. The device may be a valve repair device, an implantable device, a valve treatment device, an implant, etc. Although in some examples herein, the device may be described as an implantable device, similar configurations may also be used for other devices, such as valve repair devices, treatment devices, etc., which are not necessarily implanted and may be removed after treatment.

[0009] In some embodiments, a device (e.g., a therapeutic device, a repair device, an implantable device, an implant, etc.) is provided, the device being configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal. In some embodiments, the device is part of a system (e.g., a valve repair system, a valve treatment system, etc.) comprising a delivery system having a catheter and a control handle, wherein the device is coupled to the delivery system.

[0010] In some embodiments, a device (e.g., a therapeutic device, a prosthetic device, an implantable device, an implant, etc.) includes an anchoring portion. In some embodiments, the anchoring portion includes one anchor. In some embodiments, the anchoring portion includes two anchors. In some embodiments, the anchoring portion includes three or more anchors.

[0011] In some embodiments, each anchor includes a plurality of paddles, each paddle being movable between an open position and a closed position.

[0012] In some embodiments, an expandable apposition element (eg, a spacer, gap filler, plug, etc.) for inhibiting regurgitation between leaflets of a native heart valve can be transitioned between an unexpanded configuration and an expanded configuration.

[0013] In some embodiments, an expandable apposition element (e.g., a spacer, a gap filler, a plug, etc.) for inhibiting regurgitation between leaflets of a native heart valve includes an expandable mechanism. The expandable mechanism may be the same or similar to any of the expandable mechanisms described anywhere in this disclosure. The expandable mechanism may include one or more of the following: a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, a pivot and / or scissor extension and / or a strut, an expansion pulley mechanism, a Hoberman mechanism, a cam, a worm, a rack and pinion, foam, etc.

[0014] In some embodiments, the expandable apposition element comprises two or more shell components.

[0015] In some embodiments, the expandable mechanism is configured to move between an expanded configuration and an unexpanded or collapsed configuration.

[0016] In some embodiments, the two or more shell components are attached to the expandable mechanism.

[0017] In some embodiments, a pair of shell members among the two or more shell members nest together when the expandable mechanism is in the collapsed configuration.

[0018] In some embodiments, the expandable mechanism comprises a plurality of struts.

[0019] In some embodiments, the expandable mechanism is configured to expand in a single direction. In some embodiments, the expandable mechanism is configured to expand in multiple directions. In some embodiments, the expandable mechanism is configured to expand in two opposite directions.

[0020] A device (e.g., a therapeutic device, a repair device, a valve repair device, an implantable device, an implant, etc.) may include the expandable coaptation element and the anchoring portion. A system (e.g., a therapeutic system, a repair system, a valve repair system, a valve treatment system, etc.) may include one or more catheters and the device.

[0021] In some embodiments, an expandable coaptation element for inhibiting regurgitation between leaflets of an autologous heart valve comprises an expandable mechanism. The expandable mechanism may be the same or similar to any of the expandable mechanisms described anywhere in this disclosure. The expandable mechanism may include one or more of the following: a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, a pivoting and / or scissor-type extension and / or a strut, an expansion pulley mechanism, a Hoberman mechanism, a cam, a worm, a rack and pinion, foam, etc.

[0022] In some embodiments, an expandable apposition element for inhibiting regurgitation between leaflets of an autologous heart valve comprises an expandable sleeve or an expandable frame. In some embodiments, the expandable sleeve or the expandable frame is arranged around the expandable mechanism. The expandable mechanism may be the same or similar to any of the expandable mechanisms described anywhere in this disclosure. The expandable mechanism may include one or more of the following: a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, a pivot and / or scissor extension and / or a strut, an expansion pulley mechanism, a Hoberman mechanism, a cam, a worm, a rack and pinion, foam, etc.

[0023] In some embodiments, the expandable mechanism is configured to move between an expanded configuration and an unexpanded or collapsed configuration.

[0024] In some embodiments, the sleeve (or frame) comprises overlapping end portions. In some embodiments, the expandable mechanism comprises a plurality of struts.

[0025] In some embodiments, the expandable mechanism is configured to expand in a single direction. In some embodiments, the expandable mechanism is configured to expand in multiple directions. In some embodiments, the expandable mechanism is configured to expand in two opposite directions.

[0026] A device (eg, a valve repair device, a valve treatment device, an implant, etc.) may include the expandable coaptation element and the anchoring portion. A system (eg, a valve repair system, a valve treatment system, etc.) may include one or more catheters and the device.

[0027] In some embodiments, an expandable apposition (e.g., spacer, gap filler, plug, etc.) element for inhibiting regurgitation between leaflets of a native heart valve comprises one or more shape-changing components. In some embodiments, applying a stretching 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.

[0028] In some embodiments, the expandable apposition element includes a compressible filling material disposed between a pair of shape-changing components of the one or more shape-changing components. In some embodiments, the one or more shape-changing components have a kirigami configuration. In some embodiments, a pair of shape-changing components of the one or more shape-changing components are parallel and spaced apart in the flat configuration. In some embodiments, the shape-changing components are bent toward each other in the bent configuration.

[0029] A device (eg, a valve repair device, a valve treatment device, an implant, etc.) may include the expandable coaptation element and the anchoring portion. A system (eg, a valve repair system, a valve treatment system, etc.) may include one or more catheters and the device.

[0030] In some embodiments, an expandable apposition element for inhibiting regurgitation between leaflets of a native heart valve includes a cell grid.

[0031] In some embodiments, the unit grid includes a first controllable unit and a second controllable unit. In some embodiments, the first controllable unit is configured so that the size of the first controllable unit can be increased and decreased. In some embodiments, the second controllable unit is configured so that the size of the second controllable unit can be increased and decreased.

[0032] In some embodiments, the size of the first controllable unit is configured to be controlled independently of the size of the second controllable unit.

[0033] A device (eg, a valve repair device, a valve treatment device, an implant, etc.) may include the expandable coaptation element and the anchoring portion. A system (eg, a valve repair system, a valve treatment system, etc.) may include one or more catheters and the device.

[0034] In some embodiments, the system includes a first control member and a second control member. In some embodiments, the first control member is configured to move in the direction of the height of the first controllable unit. In some embodiments, the second control member is configured to move in the direction of the width of the second controllable unit.

[0035] In some embodiments, an expandable apposition element (e.g., a spacer, a gap filler, a plug, etc.) for inhibiting regurgitation between leaflets of a native heart valve comprises a receptacle, a shape-changing element, and a shaft. In some embodiments, the shape-changing element has a first end and a second end, the first end being disposed in the receptacle, and the second end being disposed outside the receptacle.

[0036] In some embodiments, the shaft is disposed in the receptacle and is connected to the first end of the shape changing element. In some embodiments, pushing the shaft in the receptacle pushes a portion of the shape changing element out of the receptacle to increase the size of the shape changing element.

[0037] In some embodiments, the shape-changing component comprises a plurality of wires. In some embodiments, the shape-changing element comprises a braided material or a mesh material. In some embodiments, the shape-changing element has a teardrop shape in an expanded state. In some embodiments, the shape-changing component has a substantially cylindrical configuration in a retracted state. A device (e.g., a valve repair device, a valve treatment device, an implant, etc.) may include the expandable apposition element and the anchoring portion. A system (e.g., a valve repair system, a valve treatment system, etc.) may include one or more catheters and the device.

[0038] In some embodiments, a device (eg, a valve repair device, a valve treatment device, an implant, etc.) comprises an anchoring portion and / or an extension or a barrier member. The anchoring portion is configured to attach to a leaflet of a native heart valve.

[0039] In some embodiments, the extension or barrier member is attached to the anchoring portion. In some embodiments, the extension or barrier member is configured to impede regurgitant flow through the native heart valve.

[0040] In some embodiments, the extension or barrier member is expandable.

[0041] In some embodiments, a system (eg, a valve repair system, a valve therapy system, etc.) includes a catheter, a device (eg, a valve repair device, a valve therapy device, an implant, etc.), and an extension or barrier member. The device is coupled to the catheter.

[0042] In some embodiments, the extension or blocking member is configured to slide over the catheter and attach to the device.

[0043] In some embodiments, the extension or barrier member is expandable.In some embodiments, the device comprises an apposition element (eg, a spacer, a gap filler, a plug, etc.) configured to engage the leaflets of a native heart valve.

[0044] In some embodiments, an expandable apposition element (e.g., a spacer, a gap filler, a plug, etc.) for inhibiting regurgitation between leaflets of an autologous heart valve comprises an expandable frame member and an expandable mechanism mounted within the expandable frame member. The expandable mechanism may be the same or similar to any of the expandable mechanisms described anywhere in this disclosure. The expandable mechanism may include one or more of the following: a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, a pivot and / or scissor extension and / or a strut, an expansion pulley mechanism, a Hoberman mechanism, a cam, a worm, a rack and pinion, foam, etc.

[0045] In some embodiments, the expandable mechanism may include an expandable member or expansion member connected to the expandable frame and an actuation mechanism mounted inside the expandable / expandable member.

[0046] In some embodiments, the actuation mechanism is configured to move the expandable / expandable member and the expandable framework member between an expanded configuration and a collapsed configuration.

[0047] In some embodiments, the actuation mechanism may include one or more of the following: an actuation wire, an actuation element, a pivot linkage, a joint, a cam, a rack and pinion, a worm, a lever, a pulley, an articulated arm, and the like.

[0048] In some embodiments, the expandable / expandable member includes a distal portion, a proximal portion opposite the distal portion, and an intermediate portion between the distal portion and the proximal portion.

[0049] In some embodiments, the intermediate portion expands when the expandable framework member moves from the collapsed configuration to the expanded configuration.

[0050] In some embodiments, the middle portion comprises a plurality of longitudinally spaced strips, the plurality of longitudinally spaced strips being configured to bend when the middle portion expands. In some embodiments, the middle portion comprises 4 to 8 equally spaced strips. In some embodiments, each of the plurality of strips is attached to the frame member.

[0051] In some embodiments, the actuation mechanism includes a distal member and a proximal member, wherein the distal member is axially fixed relative to the distal portion of the expandable / expandable member and the proximal member is axially fixed relative to the proximal portion of the expandable / expandable member.

[0052] In some embodiments, the distal member includes a pair of protrusions that are received within a pair of openings in the distal portion of the expandable / expandable member.

[0053] In some embodiments, the distal member is axially secured to the distal portion of the expandable / expandable member by a stopper positioned within the channel of the expandable / expandable member.

[0054] In some embodiments, a portion of the proximal member is axially secured relative to the distal portion between a stopper positioned within the channel of the expandable / expandable member and an end cap received within the channel at the proximal portion of the expandable / expandable member.

[0055] In some embodiments, relative movement of the distal member and the proximal member toward each other causes expansion of the intermediate portion.

[0056] In some embodiments, the distal member and the proximal member can be threadably coupled, and relative rotation between the distal member and the proximal member causes relative movement of the distal member and the proximal member toward each other.

[0057] In some embodiments, the distal end of the proximal member is received within a channel of the distal member, and the distal end of the proximal member includes external threads threadably coupled to internal threads in the channel.

[0058] In some embodiments, the proximal end of the distal member is received within a channel of the proximal member, and the distal member is axially movable within the channel.

[0059] In some embodiments, the distal member includes one or more locks configured to lock the axial position of the distal member relative to the proximal member.

[0060] In some embodiments, each lock of the one or more locks engages a corresponding slot in the proximal member to lock the axial position of the distal member relative to the proximal member.

[0061] In some embodiments, the proximal end of the distal member includes a coupling portion configured to be engaged by an actuating element extending through the channel in the proximal member to move the distal member, and the distal member is axially movable within the channel.

[0062] In some embodiments, the height of the frame members remains the same between the collapsed configuration and the expanded configuration.

[0063] In some embodiments, the frame member comprises a plurality of fixed height struts interconnected by a plurality of struts. In some embodiments, the plurality of struts are arranged in a plurality of diamond patterns. In some embodiments, the expandable / expandable member is connected to one or more fixed height struts of the frame.

[0064] In some embodiments, a retractable cover covers at least a portion of the frame member. In some embodiments, the cover is connected to the frame member.

[0065] In some embodiments, the covering comprises a plurality of spaced-apart woven sections connected by a plurality of stretchable sections.

[0066] In some embodiments, the frame member comprises a plurality of fixed height struts interconnected by a plurality of struts.In some embodiments, one or more of the woven portions are connected to corresponding one or more of the struts.

[0067] In some embodiments, the frame member has six struts and the covering has six woven portions, wherein each woven portion is connected to a corresponding one of the struts.

[0068] In some embodiments, each of the woven portions is connected to the corresponding stretchable portion by a Lenostitch.

[0069] In some embodiments, the stretchable covering is treated to reduce the permeability of the covering.

[0070] The stretchable covering may be coated with a polymer to reduce the permeability of the covering.

[0071] In some embodiments, one or more polymer strands made of one or more of TPU, silicone, polyolefin, and elastic yarn are woven into the stretchable covering to reduce the permeability of the covering.

[0072] In some embodiments, the expandable commissural element is part of a system (e.g., a valve repair system, a valve treatment system, etc.), which includes a delivery system, the delivery system including a catheter and a control handle, and a device (e.g., a valve repair device, a valve treatment device, an implant, etc.) connected to the delivery system.

[0073] In some embodiments, the device includes an anchoring portion configured to attach to a leaflet of a native heart valve. In some embodiments, the expandable apposition element is attached to the anchoring portion.

[0074] In some embodiments, a method for inhibiting regurgitation between leaflets of a native heart valve includes positioning a device (e.g., a valve repair device, a valve treatment device, an implant, etc.) between the valve leaflets, attaching an anchoring portion of the device to the valve leaflets, and expanding a symmetric element attached to the anchoring portion.

[0075] In some embodiments, expanding the apposition elements includes expanding an expandable member or an expansion member positioned within a frame member to move the frame member from a collapsed position to an expanded position.

[0076] In some embodiments, the height of the frame members remains the same in both the collapsed position and the expanded position.

[0077] In some embodiments, expanding the expandable / expandable member includes bending a plurality of strips on the expandable / expandable member.

[0078] In some embodiments, expanding the expandable / expandable member includes axially moving one of a distal member and a proximal member relative to the other of the distal member and the proximal member within a channel of the expandable / expandable member.

[0079] In some embodiments, axially moving one of the distal member and the proximal member relative to the other of the distal member and the proximal member includes rotating the proximal member relative to the distal member.

[0080] In some embodiments, axially moving one of the distal member and the proximal member relative to the other of the distal member and the proximal member further comprises threading the proximal member into the channel of the distal member.

[0081] In some embodiments, 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 channel of the proximal member.

[0082] In some embodiments, the method includes locking the position of the distal member within the channel of the proximal member. In some embodiments, the method includes inhibiting axial movement of the proximal member while allowing rotational movement.

[0083] In some embodiments, an expandable apposition element for inhibiting regurgitation between leaflets of a native heart valve includes an expandable frame or spacer. In some embodiments, the expandable frame or spacer is configured to move between an expanded configuration and a collapsed configuration.

[0084] In some embodiments, an expandable coaptation element for inhibiting regurgitation between leaflets of an autologous heart valve comprises an expandable mechanism. In some embodiments, the expandable mechanism is configured to move between an expanded configuration and a collapsed configuration. The expandable mechanism may be the same or similar to any of the expandable mechanisms described anywhere in this disclosure. The expandable mechanism may include one or more of the following: a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, a pivot and / or scissor extension and / or a strut, an expansion pulley mechanism, a Hoberman mechanism, a cam, a worm, a rack and pinion, foam, etc.

[0085] In some embodiments, the expandable frame is attached around the expandable mechanism.

[0086] In some embodiments, the expandable mechanism is configured to expand only in two opposing directions.

[0087] In some embodiments, when the expandable mechanism is in the collapsed configuration, the expandable frame has a circular cross-section, and when the expandable mechanism is in the expanded configuration, the expandable frame has an oval cross-section.

[0088] In some embodiments, the expandable mechanism comprises a plurality of struts.

[0089] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or on a simulator (e.g., a cadaver, a cadaver heart, a virtual human, an anthropomorphic ghost, a simulated body, such as a computer simulated body, e.g., having simulated body parts, tissues, etc.). In the case of a simulator, the body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissues, etc.), and can include, for example, a computerized and / or physical representation.

[0090] Any of the above-described systems, components, devices, equipment, parts, etc. may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use by patients, and the above-described methods may include (or additional methods may include or consist of) sterilization (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, equipment, parts, etc. herein.

[0091] 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 have like reference numerals. BRIEF DESCRIPTION OF THE DRAWINGS

[0092] In order to further clarify various aspects of the examples in the present disclosure, certain examples and embodiments will be described in more detail with reference to various aspects of the drawings. These drawings depict only exemplary embodiments of the present disclosure and should not be considered as limiting the scope of the present disclosure. In addition, although the drawings may be drawn to scale for some examples, they are not necessarily drawn to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained in conjunction with additional features and details through the use of the drawings, in which:

[0093] Figure 1 A cross-section of a human heart in diastole is shown;

[0094] Figure 2 A cross-section of a human heart in the systolic phase is shown;

[0095] Figure 3 A cross-section of a human heart in systole is shown, illustrating valvular regurgitation;

[0096] Figure 4 yes Figure 3 A cross-sectional view of the mitral valve with annotations illustrating the natural shape of the mitral valve leaflets during systole;

[0097] Figure 5 shows a healthy mitral valve with closed leaflets as viewed from the atrial side of the mitral valve;

[0098] Figure 6 shows a dysfunctional mitral valve with visible gaps between the leaflets as viewed from the atrial side of the mitral valve;

[0099] Figure 7 The tricuspid valve is shown as viewed from the atrial side of the valve;

[0100] Figure 8-14 Example devices or implants are shown in various stages of deployment;

[0101] Fig.15Shown with Figure 8-14 An exemplary device similar to the one shown but in which the paddles are independently controllable;

[0102] Figure 16-21 Delivered and deployed within a native valve Figure 8-14 An exemplary device of

[0103] Fig. 22 showing a perspective view of an exemplary device in a closed position;

[0104] Fig.23 showing a perspective view of an exemplary device in a closed position;

[0105] Fig.24 An exemplary device is shown with a paddle in an open position;

[0106] Fig.25A An exemplary device is shown with a paddle in a closed position;

[0107] Fig.25B A top view of an exemplary device is shown;

[0108] Fig.26 A perspective view of an exemplary device having a width-adjustable paddle is shown;

[0109] Fig. 27 yes Fig.26 A cross-section of an exemplary device, wherein the device is bisected;

[0110] Fig.28 yes Fig.26 Another cross-section of an exemplary device wherein the device is arranged perpendicular to Fig.28 The plane of the plane shown is bisected;

[0111] Fig.29 is a schematic diagram of an exemplary catheter assembly coupled to an exemplary device, wherein an actuation element is coupled to a paddle actuation control and a driver head of the device;

[0112] Fig.30 yes Fig.29 a schematic diagram of an assembly of an exemplary device with the exemplary device rotated 90 degrees to show a blade width adjustment element coupled to an inner end of a connector of the device and coupled to a blade width control;

[0113] Fig.31 A perspective view showing an exemplary expandable apposition element of the device;

[0114] Fig.32 Demonstrated the presence of a native valve implanted within Fig.31 A view of an exemplary device of an expandable apposition element is shown;

[0115] Fig.33 A perspective view of an exemplary device having an expandable apposition element having a shell is shown;

[0116] Figure 34-35 Shows Fig.33 An exemplary configuration of the components of the shell is shown;

[0117] Fig.36 Shown Fig.33 A front view of the device;

[0118] Fig.37 Shown Fig.33 A top view of the device;

[0119] Fig.38 Shown in an expanded position Fig.33 A side view of the device;

[0120] Fig.39 Shown in a narrowed position Fig.33 A side view of the device;

[0121] Fig.40 A perspective view showing an exemplary embodiment of an expandable sleeve of an apposition element;

[0122] Fig.41 Shown in a narrowed position Fig.40 A top view of the expandable sleeve of the mating element;

[0123] Fig.42 The expandable apposition element is shown in the expanded position. Fig.40 A perspective view of an expandable sleeve of an mate element;

[0124] Fig.43 Shown in an expanded position Fig.42 A top view of the expandable sleeve of the mating element;

[0125] Fig.44 The expandable apposition element is shown in a non-tensioned state;

[0126] Fig.45 The expandable apposition element is shown in a tensioned position;

[0127] Figures 46-48 Different types of expansion of the expandable apposition element are shown from a top view;

[0128] Fig.49 Demonstrated the use of implanted native heart valves Fig.44 and 45A top view of an exemplary device of an expandable apposition element, wherein the expandable apposition element is in a non-tensioned state;

[0129] Fig.50 Shown Fig.49 Side view of the device and native heart valve;

[0130] Fig.51 Demonstrated the use of implanted native heart valves Fig.44 and 45 A top view of an exemplary device of an expandable apposition element, wherein the expandable apposition element is in a tensioned state;

[0131] Fig.52 Shown Fig.51 Side view of the device and native heart valve;

[0132] Fig.53 A perspective view of an exemplary expandable spacer or apposition element is shown in an expanded state;

[0133] Fig.54 Shown Fig.53 A front view of an expandable spacer or apposition element;

[0134] Fig.55 Shows along the Fig.54 The line 598-598 is intercepted Fig.53 A perspective cross-sectional view of an exemplary expandable spacer or apposition element;

[0135] Fig.56 Shows along the Fig.54 The line 598-598 is intercepted Fig.53 A cross-sectional view of an exemplary expandable spacer or apposition element;

[0136] Fig.57 A perspective view of an exemplary expandable spacer or apposition element is shown in an expanded state;

[0137] Fig.58 Shown Fig.57 A front view of an expandable spacer or apposition element;

[0138] Fig.59 Shown along Fig.58 The line 602-602 is intercepted Fig.57 A perspective cross-sectional view of an exemplary expandable spacer or apposition element;

[0139] Fig.60 Shown along Fig.58 The line 602-602 is intercepted Fig.57 A cross-sectional view of an exemplary expandable spacer or apposition element;

[0140] Fig.61 A perspective view of an exemplary expandable spacer or apposition element is shown in a non-expanded state with a latch tube in an unlocked state;

[0141] Fig.62 Shown Fig.61 A front view of an expandable spacer or apposition element;

[0142] Fig.63 Shown along Fig.62 The line 606-606 is intercepted Fig.61 A perspective cross-sectional view of an exemplary expandable spacer or apposition element;

[0143] Fig.64 Shown along Fig.62 The line 606-606 is intercepted Fig.61 A cross-sectional view of an exemplary expandable spacer or apposition element;

[0144] Fig.65 Shown Fig.61 A perspective view of an exemplary expandable spacer or apposition element of , wherein the latch tube is in a latched state;

[0145] Fig.66 Shown Fig.65 A front view of an expandable spacer or apposition element;

[0146] Fig.67 Shown along Fig.66 The line 610-610 is intercepted Fig.65 A perspective cross-sectional view of an exemplary expandable spacer or apposition element;

[0147] Fig.68 Shown along Fig.66 The line 610-610 is intercepted Fig.65 A cross-sectional view of an exemplary expandable spacer or apposition element;

[0148] Fig.69 Shown in Fig.63 The area 607 is captured Fig.61 An enlarged detailed view of an exemplary expandable spacer or apposition element;

[0149] Fig.70 Shown in Fig.67 The area 611 is captured Fig.65 An enlarged detailed view of an exemplary expandable spacer or apposition element;

[0150] Fig.71 An exemplary embodiment of a portion of an expandable apposition element is shown;

[0151] Fig.72 Shown Fig.71 A unit within a framework of an expandable involute element;

[0152] Fig.73 Shown in extended position Fig.72 The unit within the framework;

[0153] Fig.74 An exemplary actuation member is shown. Fig.71 Units;

[0154] Fig.75 Exemplary embodiments of expandable apposition elements for use with the device are shown;

[0155] Fig.76 Exemplary embodiments of expandable apposition elements for use with the device are shown;

[0156] Fig.77 Exemplary embodiments of expandable apposition elements for use with the device are shown;

[0157] Fig.78 A side view of an example exemplary embodiment of a device attached to a leaflet of a heart valve is shown;

[0158] Fig.79 Shown Fig.78 A top view of the device and heart valve;

[0159] Fig.80 A side view of an example exemplary embodiment of a device and an extension or blocking member for a heart valve in an open configuration is shown;

[0160] Fig.81 Shown Fig.80 a device and a cover, wherein the device is in a closed configuration;

[0161] Fig.82 A perspective view showing an exemplary frame member of an expandable apposition element;

[0162] Fig.83 Shown Fig.82 A cross-sectional perspective view of a frame member;

[0163] Fig.84 An exemplary expandable / expandable member is shown attached. Fig.82 A top view of the frame member;

[0164] Fig.85 Shown Fig.84 A side cross-sectional view of an expandable / expandable member and a frame member;

[0165] Fig.86 Shown Fig.84 A cross-sectional perspective view of an expandable / expandable member and a frame member;

[0166] Fig.87 Shown in expanded configuration Fig.84 A perspective view of an expandable / expandable member;

[0167] Fig.88 Shown in collapsed configuration Fig.84 A perspective view of an expandable / expandable member;

[0168] Fig.89 An exploded perspective view of an expandable / expandable member and an exemplary actuation mechanism for an expandable apposition element is shown;

[0169] Fig.90 Shows a cut along the 90-90 line Fig.89 A cross-sectional view of an expandable / expandable member and an actuation mechanism;

[0170] Fig.91 Shows a shot taken along line 91-91 Fig.89 A cross-sectional view of an expandable / expandable member and an actuation mechanism;

[0171] Fig.92 Shown Fig.89 A perspective view of an expandable / expandable member and an actuation mechanism;

[0172] Fig.93 Shown Fig.89 A front view of an expandable / expandable member and an actuating mechanism;

[0173] Fig.94 A front view of an exemplary expandable / expandable member and an exemplary actuation mechanism for an expandable apposition element is shown;

[0174] Fig.95 Shown Fig.94 an exploded view of an actuation mechanism of;

[0175] Fig.96 Shows a shot taken along line 96-96 Fig.94 A cross-sectional view of an expandable / expandable member and an actuation mechanism;

[0176] Fig.97 Shows a shot taken along line 97-97 Fig.94 A cross-sectional view of an expandable / expandable member and an actuation mechanism;

[0177] Fig.98 Shows a cross-sectional Fig.97 A perspective view of an expandable / expandable member and an actuation mechanism;

[0178] Fig.99 Exemplary expandable / expandable members and exemplary actuation mechanisms for expandable apposition elements are shown;

[0179] Fig.100 An exemplary expandable apposition element is shown in a collapsed configuration;

[0180] Fig.101 Shown in expanded configuration Fig.100 An expandable apposition element;

[0181] Fig.102 A plan view of a portion of an exemplary covering for an expandable apposition element is shown, wherein the covering is in a first state;

[0182] Fig.103 Shown Fig.102 a plan view of a portion of a retractable portion of a cover, wherein the cover is in a second state;

[0183] Fig.104 Shown Fig.102 a plan view of a portion of a retractable portion of a covering;

[0184] Fig.105 A plan view showing a plain weave of an exemplary covering for an expandable apposition element;

[0185] Fig.106 A plan view of a portion of an exemplary covering for an expandable apposition element is shown, wherein the expandable portion is in a preheated state;

[0186] Fig.107 A plan view of a portion of an exemplary covering for an expandable apposition element is shown, wherein the expandable portion is in a heated state;

[0187] Fig.108 shows a plan view of an exemplary cover having a retractable portion attached to a paddle frame of a device, wherein the paddle frame is in an expanded position and the cover is in a stretched position;

[0188] Fig.109 shows a plan view of an exemplary cover having a retractable portion attached to a paddle frame of a device, wherein the paddle frame is in a narrowed position and the cover is in a normal position;

[0189] Fig.110 A schematic diagram showing an exemplary covering for an expandable apposition element is shown;

[0190] Fig.111shows a schematic diagram of a coating layer laminated to a covering material;

[0191] Fig.112 showing a perspective view of an expandable / expandable member in a substantially non-expanded configuration;

[0192] Fig.113 A perspective view showing an exemplary framework of expandable apposition elements;

[0193] Fig.114 A perspective view showing an exemplary expandable / expandable member and an exemplary actuation mechanism for an expandable apposition element is shown;

[0194] Fig.115 Shown Fig.114 A cross-sectional view of an expandable / expandable member and an actuation mechanism;

[0195] Fig.116 Shown Fig.114 A perspective view of an expandable / expandable member and an actuation mechanism assembly and a track of a valve repair device;

[0196] Fig.117 Shown Fig.116 A side view of an assembly of

[0197] Fig.118 Shows relative to Fig.117 Rotate 90 degrees Fig.116 The view of the component;

[0198] Fig.119 A perspective view of a valve repair device is shown with an expandable spacer in an unexpanded configuration;

[0199] Fig.120 Shown Fig.119 A perspective view of a valve repair device of , wherein the spacer is in an expanded configuration;

[0200] Fig.121 Shown is the installation on the leaflets of the tricuspid valve Fig.119 a plan view of an atrial side of a tricuspid valve of a valve repair device; and

[0201] Fig.122 Demonstrated Fig.116 A perspective view of a valve repair device with components. DETAILED DESCRIPTION

[0202] The following description refers to the accompanying drawings, which illustrate exemplary embodiments of the present disclosure. Other embodiments having different structures and operations do not depart from the scope of the present disclosure.

[0203] Some embodiments of the present disclosure relate to systems, devices, methods, etc. for repairing defective heart valves. For example, some embodiments of devices, valve treatment devices, valve repair devices, implantable devices, implants, and systems (including systems for delivering them) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, unless mutually exclusive or otherwise physically impossible, the various components of the disclosed devices and systems can be combined. In addition, the treatment techniques, methods, operations, steps, etc. described or implied herein can be performed on living subjects (e.g., humans, other animals, etc.) or on non-living simulators (e.g., corpses, corpse hearts, simulated bodies, virtual people, etc.). When performed on a simulator, a body part (e.g., heart, tissue, valve, etc.) can be optionally referred to as "simulated" (e.g., simulated heart, simulated tissue, simulated valve, etc.), and can include, for example, computerized and / or physical representations of body parts, tissues, etc.

[0204] As described herein, when one or more components are described as being connected, linked, fixed, coupled, attached, or otherwise interconnected, such interconnection may be a direct interconnection between the components, or may be an indirect interconnection, such as through the use of one or more intermediate components. Also as described herein, references to "member," "component," or "portion" should not be limited to a single structural member, component, or element, but may include an assembly of components, components, or elements. Also as described herein, the terms "substantially" and "approximately" are defined as at least close to (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%). The terms "fastener" and "fastener arm" are generally used herein for specific instances, but the terms "clamping member" and / or "clamping arm" may be used in place of and function in the same or similar manner, even if they are configured differently than a typical fastener.

[0205] Figure 1 and 2 are cross-sectional views of a human heart H in diastole and systole, respectively. The right ventricle RV and the left ventricle LV are separated from the right atrium RA and the left atrium LA by the tricuspid valve TV and the mitral valve MV (i.e., the atrioventricular valves), respectively. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., Figure 3-6 The leaflets 20, 22 and Figure 7The autologous valve repair and / or treatment systems of the present application are often described and / or illustrated with respect to the mitral valve MV. Therefore, the anatomical structures of the left atrium LA and the left ventricle LV will be explained in more detail. However, the devices described herein can also be used to repair other autologous valves, for example, the devices can be used to repair the tricuspid valve TV, the aortic valve AV and the pulmonary valve PV.

[0206] The left atrium LA receives oxygenated blood from the lungs. During diastole or relaxation, e.g. Figure 1 As seen in FIG, blood previously collected in the left atrium LA (during systole) moves through the mitral valve MV and into the left ventricle LV by the expansion of the left ventricle LV. Figure 2 As seen in the , the left ventricle LV contracts to force blood into the body through the aortic valve AV and the ascending aorta AA. During contraction, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV and into the left atrium LA, and blood is collected in the left atrium from the pulmonary veins. In some embodiments, the devices described in the present application are used to repair the function of a defective mitral valve MV. That is, these devices are configured to help close the leaflets of the mitral valve to prevent, inhibit or reduce the backflow of blood from the left ventricle LV and into the left atrium LA. Many of the devices described in the present application are designed to easily grasp and secure the native leaflets around the apposition element or spacer, which beneficially acts as a filler in the regurgitation orifice to prevent or inhibit backflow or regurgitation during contraction, but this is not required.

[0207] Reference now Figure 1-7 The mitral valve MV includes two leaflets, namely an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes a valve ring 24 (see Figure 5 ), the valve annulus is a variably dense fibrous ring of tissue surrounding the leaflets 20, 22. Figure 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by the chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., muscles located at the base of the chordae tendineae CT and within the wall of the left ventricle LV) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM serve to limit the movement of the leaflets 20, 22 of the mitral valve MV and to prevent the mitral valve MV from reversing. 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. Instead, the papillary muscles PM support or brace the leaflets 20, 22 to resist the high pressure required to circulate blood throughout the body. The papillary muscles PM and the chordae tendineae CT are together referred to as the subvalvular structures, which serve to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed. As seen from Figure 3 As seen from the left ventricular outflow tract (LVOT) view shown in , the anatomical structure of the leaflets 20, 22 causes the inner sides of the leaflets to coapt at the free end portions, and the leaflets 20, 22 begin to retreat or stretch away from each other. The leaflets 20, 22 stretch in the atrial direction until each leaflet meets the mitral annulus.

[0208] Various disease processes can impair the normal function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, fibroelastic defects, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or right ventricle RV from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy, etc.) may distort the geometry of the native valve, which can lead to native valve dysfunction. However, the vast majority of patients who undergo valve surgery (e.g., surgery on the mitral valve MV) suffer from a degenerative disease that causes dysfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), which leads to prolapse and regurgitation.

[0209] Generally speaking, native valves may malfunction in different ways: including (1) valvular stenosis; and (2) valvular regurgitation. Valvular stenosis occurs when the native valve does not fully open and blood flow is thereby obstructed. Typically, valvular stenosis is caused by the accumulation of calcified material on the valve leaflets, which causes the leaflets to thicken and impairs the ability of the valve to fully open to allow forward blood flow. Valvular regurgitation occurs when the leaflets of the valve do not fully close, causing blood to leak back into the previous chamber (for example, causing blood to leak from the left ventricle into the left atrium).

[0210] There are three main mechanisms by which a native valve becomes regurgitant (or incompetent), including Carpentier Type I, II, and III dysfunctions. Carpentier Type I dysfunction involves dilation of the annulus, causing the normally functioning leaflets to diverge from each other and fail to form a tight seal (i.e., the leaflets do not appose properly). Type I mechanism dysfunction includes leaflet perforations present in endocarditis. Carpentier Type II dysfunction involves prolapse of one or more leaflets of the native valve above the plane of apposition. Carpentier Type III dysfunction involves restraining the movement of one or more leaflets of the native valve, causing the leaflets to be abnormally restrained below the plane of the annulus. Leaflet restriction may be caused by rheumatic disease or ventricular dilatation.

[0211] refer to Figure 5 When the healthy mitral valve MV is in the closed position, the anterior leaflet 20 and the posterior leaflet 22 are in close contact, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Figure 3 and 6 Mitral regurgitation MR occurs when the anterior leaflet 20 and / or posterior leaflet 22 of the mitral valve MV are displaced into the left atrium LA during contraction so that the edges of the leaflets 20, 22 do not touch each other. This failure to coapt 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 contraction, as shown in FIG. Figure 3 The MR flow path of mitral regurgitation is shown. Figure 6 , the width W of gap 26 may be between about 2.5 mm and about 17.5 mm, between about 5 mm and about 15 mm, between about 7.5 mm and about 12.5 mm, or about 10 mm. In some cases, gap 26 may have a width W greater than 15 mm or even 17.5 mm. As described above, leaflets (e.g., leaflets 20, 22 of the mitral valve MV) may malfunction in a number of different ways, which may result in valvular regurgitation.

[0212] In any of the above situations, a device or implant is desired that can engage the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent or inhibit blood regurgitation through the mitral valve MV. Figure 4 , an abstract representation of a repair or treatment device 10 (e.g., a valve treatment device, a valve repair device, an implantable device, an implant, etc.) is shown that is implanted between the leaflets 20, 22 so that regurgitation does not occur during contraction (the valve is retracted). Figure 3 and Figure 4In some embodiments, the apposition element (e.g., spacer, apposition element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) of device 10 has a generally conical or triangular shape that naturally adapts to the native valve geometry and its expanded leaflet properties (toward the annulus). In this application, the terms spacer, apposition element, apposition element, gap filler, plug, etc. are used interchangeably and refer to an element that fills a portion of the space between the leaflets of the native valve and / or is configured to cause the leaflets of the native valve to engage or "apposition" (e.g., cause the native leaflets to apposition with the apposition element, apposition element, spacer, etc., rather than just apposition with each other).

[0213] Although stenosis or regurgitation can affect any valve, stenosis is primarily found to affect the aortic valve AV or the pulmonary valve PV, and regurgitation is primarily found to affect the mitral valve MV or the tricuspid valve TV. Both valvular stenosis and valvular regurgitation increase the workload of the heart H and, if left untreated, can lead to very serious conditions; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Since the left side of the heart (i.e., the left atrium LA, left ventricle LV, mitral valve MV, and aortic valve AV) are primarily responsible for circulating blood throughout the body. Therefore, cardiac dysfunction of the mitral valve MV or aortic valve AV is particularly problematic and often life-threatening, as the pressures on the left side are significantly higher.

[0214] Dysfunctional native heart valves may be repaired or replaced. Repair typically involves preservation and correction of the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and the pulmonary valve PV are more prone to stenosis. Because the stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic valve or a stenotic pulmonary valve may be to remove the valve and replace the valve with a surgically implanted heart valve, or to replace the valve with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more susceptible to deformation of the valve leaflets and / or surrounding tissue, which, as described above, may prevent the mitral valve MV or tricuspid valve TV from closing properly and allow blood to flow back or reflux from the ventricles into the atria (e.g., a deformed mitral valve MV may allow blood to flow back or reflux from the left ventricle LV into the left atrium LA, as described above). Figure 3 ). Regurgitation or backflow of blood from the ventricles to the atria results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are generally repairable. In addition, regurgitation may occur due to the chordae tendineae CT becoming dysfunctional (e.g., the chordae CT may stretch or rupture), which allows the anterior leaflet 20 and the posterior leaflet 22 to reverse, allowing blood to flow back into the left atrium LA. Problems that arise due to chordae tendineae CT dysfunction can be repaired by repairing the structure of the chordae tendineae CT or the mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0215] The devices and procedures disclosed herein are generally directed to repairing the structure of the mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve and any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit the backflow of blood from the left ventricle into the left atrium. Regarding the tricuspid valve TV ( Figure 7 ), any device and concept provided herein can be used between any two of the anterior leaflet 30, the septal leaflet 32, and the posterior leaflet 34 to prevent or inhibit blood from flowing back from the right ventricle to the right atrium. In addition, any device and concept provided herein can be used together on all three leaflets 30, 32, 34 to prevent or inhibit blood from flowing back from the right ventricle to the right atrium. That is, the treatment device, repair device, implant, etc. provided herein can be centrally located between the three leaflets 30, 32, 34.

[0216] Exemplary devices (e.g., valve repair devices, valve treatment devices, implantable devices, implants, etc.) can optionally have an apposition element (e.g., a spacer, an apposition element, 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 embodiments, the device (e.g., a valve repair device, a valve treatment device, an implantable device, an implant, etc.) can have any combination or subcombination of the features disclosed herein without an apposition element. When an apposition element (e.g., a spacer, an apposition element, a gap filler, a membrane, a sheet, a plug, a wedge, a balloon, etc.) is included, the apposition element can be configured to be positioned within the orifice of the native heart valve to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting the above-mentioned regurgitation. The apposition element can have a structure that is impermeable to blood (or prevents blood from flowing therethrough) and allows the native valve leaflets to close around the apposition element during ventricular contraction to prevent blood from flowing back from the left ventricle or right ventricle into the left atrium or right atrium, respectively. The device can be configured to seal against two or three native valve leaflets; that is, the device can be used for native mitral (mitral or bicuspid) valves and tricuspid valves. The apposition element is sometimes referred to as a spacer in this article because the apposition element can fill the space between the dysfunctional native valve leaflets (e.g., mitral valve leaflets 20, 22 or tricuspid valve leaflets 30, 32, 34) that are not fully closed.

[0217] Optional apposition elements (e.g., spacers, apposition elements, gap fillers, membranes, sheets, plugs, wedges, balloons, etc.) can have various shapes. In some embodiments, the apposition element can have an elongated cylindrical shape, the cylindrical shape having a circular cross-sectional shape. In some embodiments, the apposition element can have an oval cross-sectional shape, an ovoid cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some embodiments, the apposition element can have an atrial portion positioned in or adjacent to the atrium, a ventricle or lower portion positioned in or adjacent to the ventricle, and a lateral surface extending between the autologous tricuspid valve leaflets. In some embodiments configured for use in a tricuspid valve, the atrium or upper portion is positioned in or adjacent to the right atrium, and the ventricle or lower portion is positioned in or adjacent to the right ventricle, and the lateral surface extends between the autologous tricuspid valve leaflets.

[0218] In some embodiments, the anchor can be configured to fix the device to one or two native leaflets so that the apposition element is positioned between the two native leaflets. In some embodiments configured for the tricuspid valve, the anchor is configured to fix the device to one, two or three tricuspid leaflets so that the apposition element is positioned between the three native leaflets. In some embodiments, the anchor can be attached to the apposition element at a position adjacent to the ventricular portion of the apposition element. In some embodiments, the anchor can be attached to an actuating element (e.g., an actuating shaft, an actuating tube, an actuating wire, etc.), and the apposition element is also attached to the actuating element. In some embodiments, the anchor and the apposition element can be positioned independently relative to each other by individually moving each of the anchor and the apposition element along the longitudinal axis of the actuating element (e.g., an actuating shaft, an actuating rod, an actuating tube, an actuating wire, etc.). In some embodiments, the anchor and the coaptation element can be positioned simultaneously by moving the anchor and the coaptation element together along the longitudinal axis of the actuation element (e.g., shaft, actuation wire, etc.) The anchor can be configured to be positioned behind the native leaflets when deployed so that the leaflets are grasped by the anchor.

[0219] The device can be configured to be deployed and / or implanted by a delivery system or other delivery member. The delivery system can include one or more of the following: a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, a combination of these, etc. The apposition element and the anchor can be compressed to a radially compressed state, and can self-expand to a radially expanded state when the compression pressure is released. The device can be configured to radially expand the anchor away from the still compressed apposition element first, so as to create a gap between the apposition element and the anchor. The autologous leaflet can then be positioned in the gap. The apposition element can be radially expanded, thereby closing the gap between the apposition element and the anchor, and the leaflet is captured between the apposition element and the anchor. In some embodiments, the anchor and the apposition element are optionally configured to self-expand. The implantation and / or deployment methods of some embodiments may be different, and a more comprehensive discussion is provided below regarding each embodiment. More information about these and other delivery methods that can be used for the concepts herein can be found in U.S. Pat. No. 8,449,599 and U.S. Patent Application Publication Nos. 2014 / 0222136, 2014 / 0067052, 2016 / 0331523, PCT Patent Application Publication Nos. WO2020 / 076898, WO2023 / 278663, WO2023 / 004098, WO2023 / 091520, WO2023 / 107296, WO2023 / 086340, WO2023 / 003755, and WO2022 / 231889, each of which is incorporated herein by reference in its entirety for all purposes. These methods may be performed mutatis mutandis on a living animal or on a mimetic (eg, on a cadaver, a cadaver heart, a mimetic body (eg, having simulated body parts, hearts, tissues, etc.), etc.).

[0220] The disclosed device or implant can be configured so that the anchors are connected to the leaflets, thereby using the tension from the native chordae tendineae to resist the high systolic pressure that pushes the device toward the left atrium. During diastole, the device can rely on the compressive and retaining forces exerted on the leaflets grasped by the anchors.

[0221] Reference now Figure 8-15, showing a schematically illustrated device 100 (e.g., a prosthetic device, a valve repair device, a valve treatment device, an implantable device, an implant, etc.) at various stages of deployment. Device 100 and other similar devices and / or implants are described in more detail in PCT Patent Application Publication Nos. WO2018 / 195215, WO2020 / 076898, WO2019 / 139904, WO2023278663, WO2023 / 004098, WO2023 / 091520, WO2023 / 107296, WO2023 / 086340, WO2023 / 003755, and WO2022 / 231889, which are incorporated herein by reference in their entirety for all purposes. The devices herein may include any other features of another device or implant discussed in this application or the above-mentioned applications, and the devices herein may be positioned to engage valve tissue (e.g., leaflets 20, 22, 30, 32, 34) as part of any suitable treatment and / or repair system (e.g., any valve repair system and / or valve treatment system disclosed in this application or the above-mentioned applications).

[0222] The device 100 is deployed from a delivery system 102. The delivery system 102 can include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a passageway, combinations of these, etc. The device 100 includes an apposition portion 104 and an anchoring portion 106.

[0223] In some embodiments, the apposition portion 104 of the device 100 includes an apposition element 110, which is suitable for deployment and / or implantation between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and is slidably attached to an actuation element 112 (e.g., an actuation wire, shaft, tube, hypotube, thread, suture, braid, etc.). The anchoring portion 106 includes one or more anchors 108, which are actuable between an open state and a closed state and can take various forms, such as paddles, clamping elements, etc. Actuation of the actuation element 112 causes the anchoring portion 106 of the device 100 to open and close to grasp the leaflets of the native valve during deployment and / or implantation. The actuation element 112 (as well as other actuation elements disclosed herein) can take a variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, threads, strips, combinations of these, etc.), can be made of a variety of different materials, and can have a variety of configurations. As an example, the actuation element can be threaded such that rotation of the actuation element moves the anchor portion 106 relative to the mating portion 104. Alternatively, the actuation element can be non-threaded such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the mating portion 104.

[0224] The anchoring portion 106 and / or anchoring member of the device 100 includes an outer paddle 120 and an inner paddle 122, which in some embodiments are connected between the cover 114 and the coaptation element 110 by portions 124, 126, 128. Portions 124, 126, 128 can be connected and / or flexible to move between all positions described below. The interconnection of the outer paddle 120, the inner paddle 122, the coaptation element 110, and the cover 114 by portions 124, 126, and 128 can constrain the device to the positions and movements shown herein.

[0225] In some embodiments, the delivery system 102 includes a steerable catheter, an implant catheter, and an actuating element 112 (e.g., an actuating wire, shaft, tube, hypotube, thread, suture, braid, etc.). These can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some embodiments, the actuating element 112 extends through the delivery catheter and the apposition element 110 to the distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchoring portion 106). Extending and retracting the actuating element 112 increases and decreases the spacing between the apposition element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), respectively. In some embodiments, a loop or other attachment element (e.g., a clamp, clip, lock, suture, friction fit, clasp, snap fit, lasso, etc.) removably attaches the mating element 110 directly or indirectly to the delivery system 102 such that the actuating element 112 slides through the loop or other attachment element, and in some embodiments, slides through the mating element 110 during actuation to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0226] In some embodiments, the anchor portion 106 and / or the anchor 108 can include an attachment portion or clamping member (e.g., a clamping arm, a buckle arm, etc.). The illustrated clamping member can include a buckle 130, which includes a base or fixed arm 132, a movable arm 134, an optional friction enhancing element, other fixing structures 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and a joint portion 138. The fixed arm 132 is attached to the inner blade 122. In some embodiments, the fixed arm 132 is attached to the inner blade 122, wherein the joint portion 138 is disposed proximate to the mating element 110. The joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the buckle 130. The joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, etc. In some embodiments, the joint portion 138 is a flexible material piece formed integrally with the fixed arm 132 and the movable arm 134. The stationary arm 132 is attached to the inner paddle 122 and remains stationary or substantially stationary relative to the inner paddle 122 when the movable arm 134 is opened to open the catch 130 and expose the optional barbs or other friction enhancing elements 136 .

[0227] In some embodiments, the buckle 130 is opened by applying tension to an actuation wire 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, flex, or pivot on the joint portion 138. The actuation wire 116 extends through the delivery system 102 (e.g., through a steerable catheter, an implant catheter, etc.). Other actuation mechanisms are also possible.

[0228] The actuation wire 116 can take a variety of forms, such as a thread, suture, wire, rod, catheter, etc. The buckle 130 can be spring loaded so that in the closed position, the buckle 130 continues to provide a clamping force on the grasped native leaflet. The optional barbs or other friction enhancing elements 136 of the buckle 130 can grasp, clamp and / or pierce the native leaflet to further secure the native leaflet.

[0229] During deployment and / or implantation, paddles 120, 122 can open and close, for example, to grasp native leaflets (e.g., native mitral valve leaflets, etc.) between paddles 120, 122 and / or between paddles 120, 122 and a matching element 110 (e.g., a spacer, a plug, a membrane, etc.).

[0230] The fastener 130 may be used to grasp and / or further secure the native leaflet by engaging the leaflet with optional barbs or other friction enhancing elements 136 and clamping the leaflet between the movable arm 134 and the fixed arm 132. The optional barbs or other friction enhancing elements 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) of the fastener 130 increase friction with the leaflet or may partially or completely pierce the leaflet.

[0231] In some embodiments, the actuation wires 116 can be actuated individually (or both individually and simultaneously) so that each catch 130 can be opened and closed individually. The individual operations allow for grasping one leaflet at a time, or for repositioning an insufficiently grasped catch 130 on a leaflet without altering the successful grasp of another leaflet. The catches 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing the leaflets to be grasped in a variety of positions as required for a particular situation.

[0232] Reference now Figure 8 , the device 100 is shown in an extended or fully open state for deployment from a delivery catheter of a delivery system 102. The device 100 is disposed at the end of a catheter of the delivery system 102 in a fully open position. In the extended state, the cover 114 is spaced apart from the apposition element 110 so that the paddles 120, 122 are fully extended. In some embodiments, the angle formed between the outer paddle 120 and the interior of the inner paddle 122 is approximately 180 degrees. The buckle 130 can remain in a closed state during deployment through the delivery system. The actuation wire 116 can extend and be attached to the movable arm 134.

[0233] Reference now Fig. 9 , the device 100 is shown in an extended state, similar to Figure 8 , but where the buckle 130 is in the fully open position, the range between the fixed arm 132 and the movable arm 134 of the buckle 130 is about 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or about 180 degrees.

[0234] Reference now Fig.10 , the device 100 is shown in a shortened or fully closed state. In order to move the device 100 from the elongated state to the shortened state, the actuating element 112 is retracted to pull the cover 114 toward the mating element 110. The movement of the connecting portion 126 (e.g., a joint, a flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is restricted so that the compressive force acting on the outer paddle 120 from the cover 114 retracted toward the mating element 110 causes the paddle or clamping element to move radially outward. During the movement from the open position to the closed position, the outer paddle 120 maintains an acute angle with 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 considerable angle because they are oriented away from the mating element 110 in the open state and collapse along the sides of the mating element 110 in the closed state.

[0235] Reference now Figure 11-13, the device 100 is shown in a partially open, ready-to-grasp state. In order to transition from the fully closed state to the partially open state, the actuating element (e.g., an actuating wire, shaft, tube, hypotube, thread, suture, braid, etc.) is extended to push the cover 114 away from the mating element 110, thereby pulling the outer paddle 120, and then pulling the inner paddle 122, so that the anchor or anchoring portion 106 is partially deployed. The actuating wire 116 is also retracted to open the fastener 130 so that the leaflet can be grasped. In some embodiments, a pair of inner and outer paddles 122, 120 are moved together by a single actuating element 112, rather than independently. And, the position of the fastener 130 depends on the position of the paddles 122, 120. For example, referring to Fig.10 , closing the paddles 122, 120 will also close the buckle. In some embodiments, the paddles 120, 122 may be independently controllable. Fig.15 In the example shown, the device 100 may have two actuating elements 111, 113 and two independent covers 115, 117 (or other attached portions), such that one independent actuating element (e.g., an actuating wire, shaft, tube, hypotube, thread, suture, braid, etc.) and cover (or other attached portion) is used to control one paddle and another independent actuating element and cover (or other attached portion) is used to control the other paddle.

[0236] Reference now Fig.12 , one of the actuation wires 116 is extended to allow one of the clasps 130 to close. Referring now to Fig.13 , the other actuation wire 116 extends to allow the other clasp 130 to close. Either or both of the actuation wires 116 can be repeatedly actuated to repeatedly open and close the clasp 130.

[0237] Reference now Fig.14, the device 100 is shown in a fully closed and deployed state. The delivery system 102 and the actuating element 112 are retracted, and the paddles 120, 122 and the fastener 130 are maintained in a fully closed position. Once deployed, the device 100 can be maintained in a fully closed position with a mechanical latch, or can be biased to remain closed by using a spring material such as steel, other metals, plastics, composite materials, etc., or a shape memory alloy such as nitinol. For example, the connecting portion 124, 126, 128, the joint portion 138 and / or the inner and outer paddles 122 and / or an additional biasing member (not shown) can be formed of a metal such as steel or a shape memory alloy such as nitinol (e.g., produced in wire, sheet, tubing or laser sintering powder), and is biased to keep the outer paddle 120 closed around the apposition element 110 and the fastener 130 clamped around the native valve leaflet. Similarly, the fixed arm 132 and the movable arm 134 of the buckle 130 are biased to clamp the leaflets. In some embodiments, the attachment or connecting portions 124, 126, 128, the joint portion 138 and / or the inner and outer paddles 122 and / or additional biasing members (not shown) can be formed of any other suitable resilient material, such as a metal or polymer material, to maintain the device 100 in a closed state after deployment and / or implantation.

[0238] Fig.15 An example is shown where blades 120, 122 are independently controllable. Fig.15 The device 101 shown is Fig.11 The device shown is similar except that Fig.15 The device 100 includes an actuation element configured as two independent actuation elements 111, 113 coupled to two independent covers 115, 117. To transition the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, the actuation element 111 extends to push the cover 115 away from the mate element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, thereby partially deploying the first anchor 108. To transition the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, the actuation element 113 extends to push the cover 115 away from the spacer or mate element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, thereby partially deploying the second anchor 108. Fig.15 The independent blade control shown can be implemented on any device disclosed in this application. Fig.11 In the illustrated example, a pair of inner blades 122 and outer blades 120 are moved together by a single actuating element 112 rather than independently.

[0239] Reference now Figure 16-21 , Figure 8-14The device 100 is shown delivered and deployed within the native mitral valve MV of the heart H. Fig.16 , the delivery sheath / catheter is inserted through the septum into the left atrium LA, and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state, as shown. Fig.16 Next, the actuator 112 is retracted to move the implant / device to Fig.17 Shown in fully closed position.

[0240] exist Fig.18 As can be seen in FIG. 1 , the implant / device is moved to a position within the mitral valve MV, into the ventricle LV, and partially opened so that the leaflets 20, 22 can be grasped. For example, the steerable catheter can be advanced and steered or deflected to position the steerable catheter, such as Fig.18 A device or implant catheter connected to an implant / device may be advanced from within a steerable catheter to position the implant, such as Fig.18 As displayed.

[0241] Reference now Fig.19 , the device catheter can be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 in the catches 130. The actuation wire 116 is extended to close one of the catches 130, thereby capturing the leaflet 20. Fig. 20 Another actuation wire 116 is shown, which then extends to close another catch 130, thereby capturing the remaining leaflets 22. Finally, as can be seen in FIG. Fig.21 As seen in , the delivery system 102 (eg, steerable catheter, implant catheter, etc.), actuation element 112, and actuation wire 116 are then retracted, and the device 100 is fully closed and deployed in the native mitral valve MV.

[0242] Any of the features disclosed in this application can be used in a variety of different therapeutic and / or prosthetic devices. Figure 22-24 Examples of valve treatment and / or repair devices that can be modified to include any of the features disclosed in this application are shown. Any combination or subcombination of the features disclosed in this application can be used with Figure 8-24 Any combination or sub-combination of features of the devices shown may be combined, substituted and / or added.

[0243] Reference now Fig. 22 , an example of a device 200 (e.g., a treatment device, a repair device, an implantable device, an implant, etc.) is shown. The device 200 can be configured as an implantable device or implant or other valve treatment device (e.g., a device that does not necessarily remain implanted). The device 200 is Figure 8-14100 can be one of many different configurations that the device 100 schematically shown in FIG. 100 can take. The device 200 can include any other features for the devices or implants discussed in this application, and the device 200 can be positioned to engage the valve tissue 20, 22 as part of any suitable treatment and / or repair system (e.g., any valve repair system and / or treatment system disclosed in this application). The device / implant 200 can be a prosthetic spacer device, a valve repair device, a treatment device, or another type of implant attached to the leaflets of a native valve.

[0244] In some embodiments, the device 200 includes a commissure portion 204, a proximal or attachment portion 209, an anchoring portion 206, and a distal portion 207. In some embodiments, the commissure portion 204 of the device optionally includes a commissure element 210 (e.g., a spacer, a commissure element, 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 the native valve. In some embodiments, the anchoring portion 206 includes a plurality of anchors 208. The anchors can be configured in various ways. In some embodiments, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a fastener 230. In some embodiments, the attachment portion 209 includes a first or proximal collar 211 (or other attachment element) for engaging with a capture mechanism of a delivery system. The delivery system of device 200 can be the same or similar to the delivery system 102 described above, and can include one or more of the following: a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, tubing, a channel, a passage, combinations of these, etc. The capture mechanism can be configured in a variety of ways, and in some embodiments, can include one or more of the following: a clamp, a clip, a pin, a suture, a thread, a lasso, a lanyard, a snare, a buckle, a lock, a latch, etc.

[0245] In some embodiments, the apposition element 210 and the paddles 220, 222 are formed of a flexible material, which may be a metal fabric (such as a mesh) that is woven, braided, or formed in any other suitable manner, or a flexible material that is cut by laser or otherwise. The material may be cloth, a shape memory alloy wire such as Nitinol for providing shape-holding capabilities, or any other flexible material suitable for deployment and / or implantation in the human body.

[0246] An actuation element (e.g., an actuation wire, shaft, tube, hypotube, thread, suture, braid, etc.) can extend from a delivery system (not shown) to engage the device or implant 200 and effect actuation of the device or implant. In some embodiments, the actuation element extends through the proximal collar 211 and the spacer or apposition element 210 to engage the cap 214 of the distal portion 207. The actuation element can be configured to removably engage the cap 214 using a threaded connection or the like, so that the actuation element can be disengaged and removed from the device 200 after implantation.

[0247] The mating element 210 extends from the proximal collar 211 (or other attachment element) to the inner paddle 222. In some embodiments, the mating element 210 has a generally elongated and circular shape, but other shapes and configurations are possible. In some embodiments, the mating element 210 has an elliptical shape or cross-section when viewed from above, and a conical shape or cross-section when viewed from the front, and a circular shape or cross-section when viewed from the side. The combination of these three geometric shapes can produce the three-dimensional shape of the illustrated mating element 210, which achieves the benefits described herein. When viewed from above, it can also be seen that the circular shape of the mating element 210 substantially follows or approximates the shape of the paddle frame 224.

[0248] The size and / or shape of the apposition element 210 can be selected to minimize the number of implants (preferably one) that a single patient will need while maintaining a low transvalvular gradient. In some embodiments, the front-to-back distance at the top of the apposition element is about 5 mm, and the inside-outside distance of the apposition element at its widest point is about 10 mm. In some embodiments, the overall geometry of the device 200 can be based on these two dimensions and the above-mentioned overall shape strategy. It should be easily apparent that using other front-to-back distances and inside-outside distances as the starting point of the device will cause the device to have different sizes. In addition, using other sizes and the above-mentioned shape strategy will also cause the device to have different sizes.

[0249] In some embodiments, outer paddle 220 is connectably attached to cover 214 of distal portion 207 via connecting portion 221 and is connectably attached to inner paddle 222 via connecting portion 223. Inner paddle 222 is connectably attached to the apposition element via connecting portion 225. In this manner, anchor 208 is configured to resemble a leg, as inner paddle 222 resembles an upper portion of a leg, outer paddle 220 resembles a lower portion of a leg, and connecting portion 223 resembles a knee portion of a leg.

[0250] In some embodiments, inner blade 222 is hard, relatively hard, rigid, has rigid portions and / or is reinforced by reinforcing members or fixed portions of fastener 230. Inner blade 222, outer blade 220, and mate elements may all be interconnected as described herein.

[0251] In some embodiments, paddle frame 224 is attached to cover 214 at distal portion 207 and extends to connecting portion 223 between inner paddle 222 and outer paddle 220. In some embodiments, paddle frame 224 is formed of a material that is more rigid and harder than the material forming paddles 222, 220, such that paddle frame 224 provides support for paddles 222, 220.

[0252] Paddle frame 224 can provide additional clamping force between inner paddle 222 and coaptation element 210 and help wrap the leaflet around the side of coaptation element 210. That is, paddle frame 224 can be configured to have a rounded three-dimensional shape with a connection portion 223 extending from cover 214 to anchor 208. The connection between paddle frame 224, outer and inner paddles 220, 222, cover 214, and coaptation element 210 can constrain each of these components to movement and position as described herein. In particular, connection portion 223 is constrained by its connection between outer and inner paddles 220, 222 and by its connection to paddle frame 224. Similarly, paddle frame 224 is constrained by its attachment to connection portion 223 (and therefore inner and outer paddles 222, 220) and cover 214.

[0253] The wide configuration of the paddle frame 224 provides an increased surface area compared to the individual inner paddles 222. The increased surface area can distribute the clamping force of the paddles 220 and paddle frame 224 on the native leaflets over a relatively large surface of the native leaflets to further protect the native leaflet tissue.

[0254] Additional features of device 200, modified versions of the device, delivery systems of 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. WO 2018 / 195215) and other applications incorporated herein. Any combination or subcombination of features disclosed by the present application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO 2018 / 195215) and / or other applications incorporated herein. Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO 2018 / 195215) is incorporated herein by reference in its entirety.

[0255] Reference now Fig.23 , an example of a device 300 (eg, a valve repair device, a valve treatment device, an implantable device, an implant, etc.) is shown. The device 300 is Figure 8-141 and 2. The device 300 schematically illustrates one of many different configurations that the device 100 can take. The device 300 can include any other features for the devices or implants discussed in this application, and the device 300 can be positioned to engage the valve tissue 20, 22 as part of any suitable treatment and / or repair system (e.g., any valve repair system and / or treatment system disclosed in this application).

[0256] The device or implant 300 includes a proximal or attachment portion 305, an anchoring portion 306, and a distal portion 307. In some embodiments, the device / implant 300 includes a commissure portion 304, and the commissure portion 304 may optionally include a commissure element 310 (e.g., a spacer, a plug, a membrane, a sheet, etc.) for deployment and / or implantation between the leaflets 20, 22 of the native valve. In some embodiments, the anchoring portion 306 includes a plurality of anchors 308. In some embodiments, each anchor 308 may include one or more paddles, for example, an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchor may also include a fastener 330 and / or be coupled to a fastener. In some embodiments, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging with a capture mechanism of a delivery system.

[0257] 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, welded, sutured, adhesive, linkage, latch, integrally formed, a combination of some or all of these, etc.) In some embodiments, the anchor 308 is attached to the apposition element 310 via a connecting portion 325 and to the cover 314 via a connecting portion 321.

[0258] Anchor 308 may include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connecting portion 323. Connecting portion 323 may be attached to a paddle frame 324 that is hingedly attached to cover 314 or other attachment portion. In this manner, anchor 308 is configured to resemble a leg because inner paddle 322 resembles an upper portion of a leg, outer paddle 320 resembles a lower portion of a leg, and connecting portion 323 resembles a knee portion of a leg.

[0259] In embodiments of the apposition element 310, the apposition element 310 and the anchor 308 can be coupled together in a variety of ways. As shown in the illustrated example, the apposition element 310 and the anchor 308 can be coupled together by integrally forming the apposition element 310 and the anchor 308 as a single, unitary component. This can be achieved, for example, by forming the apposition element 310 and the anchor 308 from a continuous strip 301 of a braided or woven material, such as a braided or woven nitinol wire. In the illustrated example, the apposition element 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, 325 are formed from a continuous strip 301.

[0260] Similar to the anchor 208 of the device 200 described above, the anchor 308 can be configured to move between various configurations by axially moving the distal end of the device (e.g., cap 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.). This movement can be along a longitudinal axis extending between the distal end of the device (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.).

[0261] In some embodiments, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some embodiments, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the spacer or apposition element 310. For example, the anchor 308 can be moved from the straight configuration to a fully folded configuration (e.g., Fig.23 ).

[0262] In some embodiments, the clasp includes a movable arm coupled to an anchor. In some embodiments, 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, wherein the joint portion 338 is disposed proximate to the mating 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 a closed state.

[0263] The fixed arm 332 is attached to the inner paddle 322 with sutures through a hole or slot. The fixed arm 332 can be attached to the inner paddle 322 by any suitable means, such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, etc. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is opened to open the catch 330 and expose the optional barbs 336. The catch 330 is opened by applying tension to an actuation wire attached to the movable arm 334, thereby causing the movable arm 334 to articulate, pivot and / or flex on the joint portion 338.

[0264] Briefly, device 300 is similar in configuration and operation to device 200 described above, except that apposition 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 embodiments, strip of material 301 is attached to proximal collar 311, cover 314, and paddle frame 324 by weaving or inserting through openings in proximal collar 311, cover 314, and paddle frame 324 configured to receive a continuous strip of material 301. Continuous strip 301 can be a single layer of material or can include two or more layers. In some embodiments, portions of device 300 have a single layer of strip of material 301, and other portions are formed from multiple overlapping or superimposed layers of strip of material 301.

[0265] For example, Fig.23 The juxtaposed element 310 and inner paddle 322 are shown formed from multiple overlapping layers of a strip of material 301. A single continuous strip of material 301 may begin and end at various locations of the device 300. The ends of the strip of material 301 may be at the same location or at different locations of the device 300. For example, at Fig.23 In the example shown, the material strip 301 begins and ends at the location of the inner blade 322.

[0266] As with the device 200 described above, the size of the apposition element 310 can be selected to minimize the number of implants that will be required for a single patient (preferably one) while maintaining a low transvalvular gradient. In particular, forming many of the components of the device 300 from the strip of material 301 allows the device 300 to be made smaller than the device 200. For example, in some embodiments, the anterior-posterior distance at the top of the apposition element 310 is less than 2 mm, and the medial-lateral distance of the device 300 at its widest point (i.e., the width of the paddle frame 324, which is wider than the apposition element 310) is about 5 mm.

[0267] Additional features of the device 300, modified versions of the device, delivery systems of 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. WO 2020 / 076898) and / or any other application incorporated herein. Any combination or subcombination of features disclosed by the present application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO 2020 / 076898) and / or any other application incorporated herein. Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO 2020 / 076898) is incorporated herein by reference in its entirety.

[0268] Fig.24 An example of one of many 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 is shown. The treatment and / or repair system 400 includes a delivery device 401 and a treatment and / or repair device 402.

[0269] In some embodiments, the treatment device or repair device 402 includes a base assembly 404, a pair of paddles 406 and a pair of clamping members 408 (e.g., a fastener, a fastener arm, a clamp, a clamp arm, a latch, etc.). In one example, the paddle 406 can be formed integrally with the base assembly. For example, the paddle 406 can be formed as an extension of the connecting rod of the base assembly. In the example shown, the base assembly 404 of the device 402 has an axis 403, a coupler 405 configured to move along the axis, and a lock 407 configured to lock the coupler in a fixed position on the axis. The coupler 405 is mechanically connected to the paddle 406 so that the movement of the coupler 405 along the axis 403 moves the paddle between an open position and a closed position. In this way, the coupler 405 acts as a device for mechanically coupling the paddle 406 to the axis 403 and for moving the paddle 406 between its open position and a closed position when moving along the axis 403.

[0270] In some embodiments, the clamping member 408 is pivotally connected to the base assembly 404 (e.g., the clamping member 408 can be pivotally connected to the shaft 403 or any other suitable member of the base assembly) so that the clamping member can move to adjust the width of the opening 414 between the paddle 406 and the clamping member 408. The clamping member 408 can include an optional barbed portion 409 for attaching the clamping member to the valve tissue when the device 402 is attached to the valve tissue. When the paddle 406 is in the closed position, the paddle engages the clamping member 408 so that when the valve tissue is attached to the barbed portion 409 of the clamping member, the paddle secures the device 402 to the valve tissue. In some embodiments, the clamping member 408 is configured to engage the paddle 406 so 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 desirable to maintain paddles 406 in an open position and move clamping members 408 outwardly toward paddles 406 to engage valve tissue and paddles 406 .

[0271] although Fig.24 The illustrated example shows a pair of paddles 406 and a pair of clamping members 408, but it will be appreciated that the device 402 may include any suitable number of paddles and clamping members.

[0272] In some embodiments, the system 400 includes a placement shaft 413 that is removably attached to the shaft 403 of the base assembly 404 of the device 402. In some embodiments, after the device 402 is secured to the valve tissue, the placement shaft 413 can be removed from the shaft 403 to remove the device 402 from the rest of the treatment and / or repair system 400, such that the device 402 can remain attached to the valve tissue and the delivery device 401 can be removed from the patient's body.

[0273] The treatment and / or repair system 400 may also include a paddle control mechanism 410, a clamp control mechanism 411, and a lock control mechanism 412. The paddle control mechanism 410 is mechanically attached to the coupler 405 to move the coupler along the shaft, which moves the paddle 406 between an open position and a closed position. The paddle control mechanism 410 may take any suitable form and may include, for example, a shaft, wire, tube, hypotube, rod, suture, wire, etc. For example, the paddle control mechanism may include a hollow shaft, catheter, or sleeve that fits over the placement shaft 413 and shaft 403 and is connected to the coupler 405.

[0274] Gripper control mechanism 411 is configured to move gripping member 408 so that the width of opening 414 between the gripping member and paddle 406 can be varied. Gripper control mechanism 411 can take any suitable form, such as a thread, suture or wire, rod, catheter, tube, hypotube, etc.

[0275] The lock control mechanism 412 is configured to lock and unlock the lock. The lock 407 locks the coupler 405 in a fixed position relative to the shaft 403 and can take a variety of different forms, and the type of lock control mechanism 412 can be determined by the type of lock used. In the example where the lock 407 includes a pivotable plate, the lock control mechanism 412 is configured to engage the pivotable plate to move the plate between the tilted position and the substantially non-tilted position. The lock control mechanism 412 can be, for example, a rod, a suture, a wire, or any other member capable of moving the pivotable plate of the lock 407 between the tilted position and the substantially non-tilted position.

[0276] The device 402 is movable from an open position to a closed position. The base assembly 404 includes a linkage that is moved by a coupler 405. The coupler 405 is movably attached to the 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 linkage.

[0277] The clamp control mechanism 411 moves the clamp member 408 to provide a wider or narrower gap at the opening 414 between the clamp member and the paddle 406. In the illustrated example, the clamp control mechanism 411 includes a line, such as a suture, wire, etc., connected to the opening in the end of the clamp member 408. When the line is pulled, the clamp member 408 moves inward, which causes the opening 414 between the clamp member and the paddle 406 to become wider.

[0278] To move the device 402 from the open position to the closed position, the lock 407 is moved to the unlocked state by the lock control mechanism 412. Once the lock 407 is in the unlocked state, the coupler 405 can be moved along the shaft 403 by the paddle control mechanism 410.

[0279] After the paddle 406 is moved to the closed position, the lock 407 is moved to the locked state by the lock control mechanism 412 to hold the device 402 in the closed position. After the device 402 is held in the locked state by the lock 407, the device 402 is removed from the delivery device 401 by disconnecting the shaft 403 from the placement shaft 413. In addition, the device 402 is disengaged from the paddle control mechanism 410, the gripper control mechanism 411, and the lock control mechanism 412.

[0280] Additional features of device 402, modified versions of the device, delivery systems of 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 application incorporated herein. Any combination or subcombination of features disclosed by the present application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) and / or any other application incorporated herein. Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO 2019139904) is incorporated herein by reference in its entirety.

[0281] The fasteners or leaflet clamping devices disclosed herein can take a variety of different forms. Examples of fasteners are disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO 2018195201). Any combination or subcombination of features disclosed by the present application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO 2018195201). Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO 2018195201) is incorporated herein by reference in its entirety.

[0282] refer to Figures 25A-25B , an exemplary embodiment of a treatment and / or repair device 402 has an apposition element 3800. The device 402 may have an Fig.24 The same configuration as the device shown, with the addition of an engagement element. The engagement element 3800 can take a variety of different forms. The engagement element 3800 can be compressible and / or expandable. For example, the engagement element can be compressed to fit inside one or more catheters of the delivery system, can be expanded when removed from one or more catheters, and / or can be compressed by paddles 406 to adjust the size of the engagement element. Fig.25A and 25B In the example shown, the size of the apposition element 3800 can be reduced by compressing the apposition element with the paddles 406, and the size can be increased by moving the paddles 406 away from each other. As shown, the apposition element 3800 can extend beyond the outer edge 4001 of the clamping member or clasp 408 to provide additional surface area for closing the gap of the mitral valve.

[0283] The apposition element 3800 can be coupled to the device 402 in a variety of different ways. For example, the apposition element 3800 can be fixed to the shaft 403, can be slidably disposed about the shaft, can be connected to the coupler 405, can be connected to the lock 407, and / or can be connected to the central portion of the clasp or clamp member 408. In some embodiments, the coupler 405 can take the form of the apposition element 3800. That is, a single element can serve as the coupler 405 that moves the paddle 406 between the open position and the closed position, and the apposition element 3800 that closes the gap between the leaflets 20, 22 when the device 402 is attached to the leaflets.

[0284] Coupling element 3800 may be disposed about one or more of the axes or other control elements of system 400. For example, coupling element 3800 may be disposed about axis 403, axis 413, blade control mechanism 410, and / or lock control mechanism 412.

[0285] Device 402 may include any other features of the devices, treatment devices, repair devices, implants, etc. discussed in this application, and device 402 may be positioned to engage valve tissue as part of any suitable treatment and / or repair system (e.g., any valve repair system and / or treatment system disclosed in this application). 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 by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO 2019139904). Any combination or subcombination of features disclosed by the present application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO 2019139904).

[0286] Figure 26-30 An example of one of many systems for treating and / or repairing a patient's native valve to which the concepts of the present application may be applied is shown. Fig.29 and 30 , the system includes a catheter assembly 1611 (eg, a device catheter assembly, an implant catheter assembly, a treatment catheter assembly, etc.) and a treatment and / or repair device 8200. Reference Figure 26-28 , device 8200 includes a proximal or attachment portion 8205, a paddle frame 8224, and a distal portion 8207. The attachment portion 8205, the distal portion 8207, and the paddle frame 8224 can be configured in a variety of ways.

[0287] exist Fig.26In the example shown in , the blade frame 8224 can be symmetrical along the longitudinal axis YY. However, in some embodiments, the blade frame 8224 is not symmetrical about the axis YY. Fig.26 , the blade frame 8224 includes an outer frame portion 8256 and an inner frame portion 8260.

[0288] In some embodiments, a connector 8266 (e.g., a formed metal part, a formed plastic part, a tether, a wire, a strut, a line, a rope, a suture, etc.) is attached to the outer frame portion 8256 at an outer end of the connector 8266 and to a 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 shape, wherein the outer frame portion 8256 is wider toward the attachment portion 8205 and narrower toward the distal portion 8207. However, in some embodiments, the outer frame portion 8256 can be shaped in other ways.

[0289] The inner frame portion 8260 extends from the attachment portion 8205 toward the distal portion 8207. The inner frame portion 8260 then extends inwardly to form a retaining portion 8272 that is attached to the actuation cover 8214. The retaining portion 8272 and the actuation cover 8214 can be configured to be attached in any suitable manner.

[0290] In some embodiments, the inner frame portion 8260 is a rigid frame portion and the outer frame portion 8256 is a flexible frame portion. Fig.26 As shown, the proximal end of the outer frame portion 8256 is connected to the proximal end of the inner frame portion 8260.

[0291] The width adjustment element 8211 (e.g., a width adjustment wire, a width adjustment shaft, a width adjustment tube, a width adjustment line, a width adjustment rope, a width adjustment suture, a width adjustment screw or bolt, etc.) is configured to Fig.28 ) and a portion of connector 8266 are pulled into actuation cap 8214 to move outer frame portion 8256 from an expanded position to a narrowed position. According to some embodiments disclosed herein, actuation element 8102 is configured to move inner frame portion 8260 to open and close the paddle.

[0292] like Fig. 27 and 28As shown, connector 8266 has an inner end 8968 engaged with width adjustment element 8211, so that the user can move the inner end 8968 inside the container 8912 (e.g., internal thread element, column, pipe, hollow member, notched receiving portion, tube, shaft, sleeve, pillar, shell, cylinder, track, etc.) to move the outer frame portion 8256 between the narrowed position and the expanded position. In the example shown, the inner end 8968 includes a pillar 8970 attached to the outer frame portion 8256 and a coupler 8972 extending from the pillar 8970. The coupler 8972 is configured to attach both the width adjustment element 8211 and the container 8912 and detach from both. The coupler 8972 can take a variety of different forms. For example, the coupler 8972 can include one or more of the following: threaded connection, a feature that cooperates with a thread, a pawl connection, such as an arm, a wall or other part biased outward. When the coupler 8972 is attached to the width adjustment element 8211, the coupler is released from the receptacle 8912. When the coupler 8972 is detached from the width adjustment element 8211, the coupler is fixed to the receptacle. However, the inner end 8968 of the connector can be configured in various ways. Any configuration in which the outer frame portion 8256 can be appropriately attached to the coupler to allow the width adjustment element 8211 to move the outer frame portion 8256 between the narrowed position and the expanded position can be used. The coupler can also be configured in various ways and can be a separate component or integrated with another part of the device (e.g., a connector or the inner end of the connector).

[0293] The width adjustment element 8211 allows a user to expand or contract the outer frame portion 8256 of the device 8200. Fig. 27 and 28 In the example shown, the width adjustment element 8211 includes an externally threaded end that screws into the coupler 8972. The width adjustment element 8211 moves the coupler within the receptacle 8912 to adjust the width of the outer frame portion 8256. When the width adjustment element 8211 is unscrewed from the coupler 8972, the coupler engages the inner surface of the receptacle 8912 to set the width of the outer frame portion 8256.

[0294] In some embodiments, the receptacle 8912 can be integrally formed with the distal cover 8214. Moving the cover 8214 relative to the body of the attachment portion 8205 opens and closes the paddle. In the illustrated example, the receptacle 8912 slides inside the body of the attachment portion. When the coupler 8972 is detached from the width adjustment element 8211, the width of the outer frame portion 8256 is fixed, and the actuating element 8102 moves the receptacle 8912 and the cover 8214 relative to the body of the attachment portion 8205. The movement of the cover can open and close the device in the same manner as some of the examples disclosed above.

[0295] In the example shown, the driver head 8916 is disposed at the proximal end of the actuating element 8102. The driver head 8916 releasably couples the actuating element 8102 to the receptacle 8912. In the example shown, the width adjustment element 8211 extends through the actuating element 8102. The actuating element is axially advanced in a direction opposite to the direction Y to move the distal cover 8214. Fig. 27 As indicated by the arrow in , the movement of the distal cover 8214 relative to the attachment portion 8205 effectively opens and closes the paddle. That is, the movement of the distal cover 8214 in the direction Y closes the device, and the movement of the distal cover in the direction opposite to the direction Y opens the device.

[0296] Still Fig. 27 and 28 8968 to engage a coupler 8972 attached to the inner end 8968. Moving the outer frame portion 8256 to the narrowed position can allow the device or implant 8200 to be more easily manipulated into a deployment and / or implantation position in the heart by reducing contact and / or friction between the heart's native structures (e.g., chordae tendineae) and the device 8200. Moving the outer frame portion 8256 to the expanded position provides a greater surface area for the anchoring portion of the device 8200 to engage and capture the leaflets of the native heart valve.

[0297] refer to Fig.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.), wherein a fastener actuation wire 624 extends through a handle 1616, an actuation element 8102 is coupled to a paddle actuation control 1626, and a width adjustment element 8211 is coupled to a paddle width control 1628. A proximal portion 1622a of a shaft or catheter of the catheter assembly 1611 can be coupled to the handle 1616, and a distal portion 1622b of the shaft or catheter can be coupled to the device 8200. The actuation element 8102 can extend distally from the paddle actuation control 1626, through the handle 1616, through a 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 actuation element 8102 can be axially movable relative to the outer shaft and handle 1616 of the catheter assembly 1611 to open and close the device.

[0298] The width adjustment element 8211 can extend distally from the blade width control 1628, through the blade actuation control 1626 and through the actuation element 8102 (and therefore through the handle 1616, the outer shaft of the implant catheter assembly 1611 and through the device 8200), where it is connected to the movable connector 8972. The width adjustment element 8211 can be axially movable relative to the actuation element 8102, the outer shaft of the implant catheter assembly 1611 and the handle 1616. The fastener actuation line 624 can extend through the handle 1616 and the outer shaft of the implant catheter assembly 1611 and be axially movable relative to the handle and the outer shaft. The fastener actuation line 624 can also be axially movable relative to the actuation element 8102.

[0299] refer to Fig.29 and 30 , width adjustment element 8211 may be releasably coupled to coupler 8972 of device 8200. Advancing and retracting width adjustment element 8211 with paddle width control 1628 widens or narrows the paddle. Advancing and retracting actuation element 8102 with paddle actuation control 1626 opens and closes the paddle of the device.

[0300] exist Fig.29 and 30 In the example of the present invention, the catheter or shaft of the catheter assembly 1611 is an elongated shaft extending axially between a proximal portion 1622a coupled to the handle 1616 and a distal portion 1622b coupled to the device 8200. The outer shaft of the catheter assembly 1611 may also include an intermediate portion 1622c disposed between the proximal portion 1622a and the distal portion 1622b.

[0301] In some embodiments, such as Fig.31 As shown, an exemplary expandable mechanism 10002 can be formed from one or more struts 10010. In some embodiments, the struts 10010 have multiple rigid portions 10020 connected together at flexible proximal connection regions 10030 and flexible distal connection regions 10050. In some embodiments, the flexible proximal connection regions 10030 and flexible distal connection regions 10050 enable the rigid portions 10020 to move relative to each other.

[0302] In some embodiments, the connection regions 10030, 10050 can be solid pieces of the same material that makes up the rigid portion 10020. In some embodiments, the flexible connection regions 10030, 10050 can be connected by interconnecting couplers or other means for connection.

[0303] The expandable mechanism 10002 can be used in various devices, implants, valve repair devices, such as Figure 33-39In the illustrated apparatus 15000 and / or other apparatus disclosed herein.

[0304] The rigid portion 10020 may include an attachment area 10040 for attaching another component of the expandable apposition element 10000. For example, the shell component 15090 and / or the sleeve 17000 described below can be attached to the attachment area 10040. The shell component 15090 and / or the sleeve 17000 can provide a substantially continuous and / or smooth outer surface for the expandable apposition element 10000.

[0305] Some or all of the struts 10010 may be movable between a collapsed state and an expanded state. The struts may be movable between a collapsed state and an expanded state in a variety of different ways. Fig.31 In the example shown, a pair of struts 10010 are moved between a collapsed state and an expanded state by screws 10080 and nuts 10090. Adjusting the nuts 10090 extends or pulls the screws 10080, which causes the struts 10010 to expand and / or contract.

[0306] In some embodiments, the screw 10080 extends through the shaft 10060 and extends to the actuation member 10070. Fig.31 In the example shown, advancing the screw through the nut moves the actuation member 10070 distally. In this example, the distal movement of the actuation member 10070 forces the attachment area 10040 outward to increase the width of the expandable mechanism 10002. Conversely, retracting the screw through the nut moves the actuation member 10070 proximally. The proximal movement of the actuation member 10070 moves the attachment area 10040 inwardly to reduce the width of the expandable mechanism 10002.

[0307] exist Fig.31 In the illustrated example, expandable mechanism 10002 expands in one direction because only one pair of struts 10010 are coupled to actuation member 10070. However, in some embodiments, two pairs or different strut arrangements can be coupled to one or more actuation members such that the expandable mechanism can expand in more than one direction.

[0308] In some embodiments, adjusting the nut 10090 and the screw 10080 relative to each other 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 embodiments, 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 the two pairs of struts 10010 can be adjusted by a single adjustment mechanism (e.g., actuation member 10070, screw 10080, and nut 10090), or two independent adjustment mechanisms can be used to independently adjust each strut in the strut pair. Control can be achieved individually, simultaneously, sequentially, or in other ways.

[0309] The rigid portion 10020 and the flexible portion 10050 of the strut 10010 may include an optional covering over the strut 10010. The strut 10010 may include a shaped portion and / or may include a flexible or pliable portion 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 close to the expandable coaptation element 10000. This can improve the 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 provide coaptation surface expansion and contraction. Different struts can include rigid portions 10020 with different shapes and lengths to provide different expansion and contraction rates and different maximum expansion positions to form expandable coaptation elements 10000 of various shapes.

[0310] Fig.32 An expandable coaptation element 10000 of a device 15000 (e.g., a therapeutic device, a repair device, an implantable device, an implant, etc.) implemented between the leaflets of a native valve of a tricuspid valve or a native mitral valve as shown is shown. Once 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 the regurgitation through the native valve during ventricular systole and / or the flow through the valve during ventricular diastole. For example, the size of the expandable coaptation element 10000 can be adjusted to provide maximum regurgitation reduction, which allows the native valve to provide acceptable flow from the atrium to the ventricle. In some embodiments, direction 10500 is the gap width of the septum-lateral annulus, and direction 10502 is along the gap length of the anterior-posterior annulus.

[0311] Figure 33-39An example of a device 15000 (e.g., a valve repair device, a valve treatment device, an implantable device, an implant, etc.) having an expandable apposition element 10000 is shown. The expandable apposition 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 in the present application. For example, any of the expandable apposition elements disclosed herein can be used Figure 8-14 In the device schematically shown in .

[0312] Device 15000 (see Fig.33 )yes Figure 8-14 The device 15000 may include any other features of the devices discussed in this application, and the expandable coaptation element 10000 may be positioned to engage the leaflets 30, 32, 34 (see Figure 7 and 34 ) or leaflets 20, 22 (see Figure 6 and 36 ) as part of any suitable device (e.g., any therapeutic and / or prosthetic device disclosed in this application).

[0313] The device 15000 can be deployed from a delivery sheath, a device catheter, and / or an implant catheter. The device 15000 can include an expandable mechanism 10002 (which can be the same or similar to any of the expandable mechanisms described anywhere in this disclosure) and an anchoring portion having one or more anchors (which can be the same or similar to any anchoring portion and / or anchor described anywhere in this disclosure). The expandable mechanism can include one or more of the following: a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, a pivoting and / or scissor extension and / or strut, an expansion pulley mechanism, a Hoberman mechanism, a cam, a worm, a rack and pinion, foam, etc.

[0314] Device 15000 can be a prosthetic spacer device, a valve repair device, a valve treatment device, an implant, or another type of device that is attached to the leaflets of a native valve.

[0315] Reference now Fig.33 , a device 15000 (eg, a valve repair device, an implantable device, an implant, a valve treatment device, etc.) having an expandable apposition element 10000 is shown. The implantable device 15000 is Figure 8-14 One of many different configurations that the device 100 with the addition of an expandable apposition element can take, as schematically shown in FIG.

[0316] In some embodiments, the device 15000 includes an expandable coaptation element 10000, a proximal or attachment portion 15006, an anchoring portion 15008, and a distal portion 15010. In some embodiments, the expandable coaptation element 10000 is configured to be adjustably implanted between the leaflets of a native valve. In some embodiments, the anchoring portion 15008 includes a plurality of anchors 15014. The anchors can be configured in various ways. In some embodiments, each of the anchors 15014 includes an outer paddle 15016, an inner paddle 15018, a paddle extension member or paddle frame 15020, and a buckle 15022. In some embodiments, the attachment portion 15006 includes a first or proximal collar 15030 (or other attachment element) for engaging with a capture mechanism of a delivery system. The delivery system for the device or implant 15000 can be the same or similar to the delivery system 102 described above, and can include one or more of the following: a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a passage, combinations of these, etc.

[0317] In some embodiments, portions or components of the expandable apposition element 10000 and / or the outer paddle 15016 and the inner paddle 15018 are formed of a flexible material, which may be a metal fabric (such as a mesh) woven, braided, or formed in any other suitable manner, or a flexible material cut by laser or otherwise. The material may be cloth, a shape memory alloy wire such as Nitinol for providing shape-setting capabilities, or any other flexible material suitable for implantation in the human body.

[0318] An actuation element (e.g., an actuation shaft, an actuation rod, an actuation tube, an actuation wire, an actuation wire, etc.) can extend from a delivery system (not shown) to engage the device 15000 and effect actuation of the device (see Figure 8-14 In some embodiments, the actuating element extends through the proximal collar 15030 and the expandable apposition element 10000 to engage the cap 15040 of the distal portion 15010. The actuating element can be configured to removably engage the cap 15040 with a threaded connection or the like, so that the actuating element can be disengaged and removed from the implant 15000 after implantation.

[0319] The expandable coaptation element 10000 extends from the proximal collar 15030 (or other attachment) to the cap 15040. In some embodiments, the expandable coaptation element 10000 has a generally elongated and circular shape, but other shapes and configurations are possible. In some embodiments, the expandable coaptation element 10000 has an elliptical shape or cross-section when viewed from above, and has a conical shape or cross-section when viewed from a front view, and has a circular shape or cross-section when viewed from a side view. A mixture of these three geometric shapes can produce the three-dimensional shape of the expandable coaptation element 10000 shown.

[0320] The size and / or shape of the expandable apposition element 10000 can be selected and / or adjusted to minimize the number of implants (preferably one) that a single patient will need while maintaining a low transvalvular gradient. In some embodiments, the anterior-posterior distance of the top of the spacer or apposition element is about 5 mm, and the inner-outer distance of the spacer or apposition element at its widest point is about 10 mm. In some embodiments, the overall geometry of the device 15000 can be based on these two dimensions and the above-described overall shape strategy. It should be readily apparent that using other anterior-posterior distances and inner-outer distances as the starting point for the device will result in the device having different sizes. In addition, using other dimensions and the above-described shape strategies will also result in the device having different sizes.

[0321] In some embodiments, outer paddle 15016 is connectably attached to cover 15040 of distal portion 15010 via connecting portion 15080 and is connectably attached to inner paddle 15018 via transition portion 15082. Inner paddle 15018 is connectably attached to a spacer or apposition element via extension 15084. In this manner, anchor 15014 is configured to resemble a leg in that inner paddle 15018 resembles an upper portion of a leg, outer paddle 15016 resembles a lower portion of a leg, and transition portion 15082 resembles a knee portion of a leg. As described above, expandable apposition element 10000 includes nut 10090 and screw 10080 (see Fig.31 ). The adjusting nut 10090 adjusts the screw 10080 so that the expandable coupling element 10000 can be expanded or contracted.

[0322] In some embodiments, paddle frame 15020 is attached to cover 15040 at distal portion 15010 and extends to transition portion 15082 between inner blade 15018 and outer blade 15016. In some embodiments, paddle frame 15020 is formed of a material that is more rigid and harder than the material forming paddles 15018, 15016, such that paddle frame 15020 provides support for paddles 15018, 15016.

[0323] Paddle frame 15020 can provide additional clamping force between inner paddle 15018 and expandable apposition element 10000 and help wrap the leaflets around the sides of expandable apposition element 10000. That is, paddle frame 15020 can be configured to have a rounded three-dimensional shape with transition portion 15082 extending from cover 15040 to anchor 15014. The connections between paddle frame 15020, outer and inner paddles 15016, 15018, cover 15040, and expandable apposition element 10000 can constrain each of these components to movement and position of the therapeutic and / or prosthetic devices described herein.

[0324] The wider configuration of the paddle frame 15020 can provide an increased surface area compared to the individual inner paddles 15018. The increased surface area can distribute the clamping force of the outer paddles 15016 and the paddle frame 15020 on the native leaflets over a relatively large surface of the native leaflets to further protect the native leaflet tissue.

[0325] In some embodiments, the expandable apposition element 10000 may include an expandable shell 15090. The shell 15090 may be configured as a solid surface, a grid (e.g., a honeycomb or other pattern leaving solid portions and cutout portions), a braided or woven material, or configured in other ways. The shell 15090 may be composed of a single piece, two pieces, or multiple pieces. The shell 15090 may be composed of any other material that is rigid, semi-rigid, soft, or suitable for implantation in the human body. One or more fasteners 15097 may be used to attach the shell 15090 to the expandable mechanism 10002.

[0326] In some embodiments, the portion of the expandable mechanism 10002 covered by the shell can be selected so that the shell 15090 contacts the native valve leaflets and the expandable mechanism 10002 does not contact the native valve leaflets. For example, the expandable mechanism 10002 can be enclosed by the shell 15090, or can be partially enclosed by the shell 15090. In the example shown, the shell 15090 includes two pieces that are opposite to each other and move relative to each other. For example, one of the shell pieces can be telescoped into the other shell piece.

[0327] Reference now Figure 34-35 , shows an example of a half portion of a shell 15090. The shell 15090 can comprise two or more pieces and / or flexible materials, allowing the shell to conform to the overall size of the expandable mechanism 10002. Such a shell 15090 can provide a smooth profile for the native valve leaflets to coapt directly or through a covering.

[0328] The covering can be provided in a variety of different ways. For example, components of the shell 15090 can be laminated with a polymer or covered with a fabric to improve interaction with the leaflets and / or to seal the expandable mechanism 10002 against the liquid. Fig.34 A shell 15090 is shown having a substantially solid surface. Fig.35 A shell 15090 is shown with cutouts forming a semi-solid surface. In some embodiments, the shell 15090 can be replaced by another structure, such as a balloon, balloon material, or other flexible material.

[0329] Reference now Fig.36 , showing Fig.33 Attached to native valve leaflets 20, 22 is a front perspective view of the device 15000 described in FIG. 1 . The expandable apposition element 10000 is positioned between the leaflets 20, 22. A top plan view of the device 15000 is shown in FIG. Fig.37 , and a side view of a device 15000 having an expandable apposition element 10000 in an expanded configuration and a contracted configuration, respectively. Fig.38 and Fig.39 For example, the expandable mechanism 10002 is adjusted by rotating the screw 10080 to expand or contract the shell 15090 to adjust the flow through the native valve (by increasing the size of the shell to reduce the regurgitation through the native valve or by reducing the size of the shell to increase the flow through the native valve).

[0330] refer to Fig.38 , the struts 10010 of the expandable mechanism 10002 are separated to allow the half portions of the shell 15090 to move. Therefore, the shell 15090 has a wide configuration and occupies a larger space. Fig.39 , the struts 10010 of the expandable mechanism 10002 are brought close together to move or telescope the halves of the shell 15090. Therefore, the shell 15090 has a narrow configuration and occupies less space. Fig.38 and 39 A shell 15090 is shown having two halves that move toward and away from each other via two struts 10010. However, in some embodiments, the expandable apposition element 10000 can have one, two, three, four, or any number of struts that can move toward and away from the central axis of the expandable apposition element 10000, and one, two, three, four, or any number of shell components that can move toward and away from the central axis of the expandable apposition element 10000. The number of shell components can be the same as or different than the number of movable struts.

[0331] The expandable apposition element 10000 can take a variety of different forms. For example, Figure 40-41An expandable sleeve 17000 is shown that can be used in place of shell 15090. Sleeve 17000 can be used with various expandable mechanisms, such as expandable mechanism 10002 described above or any other expandable mechanism described in the present disclosure. The expandable mechanism can include one or more of the following: a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, pivoting and / or scissor extensions and / or struts, an expansion pulley mechanism, a Hoberman mechanism, a cam, a worm, a rack and pinion, foam, etc.

[0332] Figure 40-41 Various forms of expandable sleeve 17000 are shown. The expandable sleeve 17000 can have a variety of different shapes. For example, the expandable sleeve can be cylindrical, conical, truncated conical, oval, pyramidal, a portion of a pyramidal, diamond-shaped, a combination of these shapes, etc. Fig.40 and 41 In some embodiments, the expandable sleeve 17000 has a circular shape with an overlap 17004. In one example, Fig.40 and Fig.41 The sleeve 17000 is shown in a collapsed configuration.

[0333] Fig.42 and 43 The sleeve 17000 is shown in an expanded configuration. For example, the expandable mechanism 10002 can be expanded to allow the sleeve 17000 to expand from Fig.40 and 41 The configuration shown moves to Fig.42 and 43 The configuration shown. Fig.42 and 43 , the sleeve 17000 has an elliptical cylindrical shape. Fig.42 and 43 Only one of many configurations that the expandable sleeve 17000 can take when expanded is shown. The sleeve 17000 can be configured to expand to a variety of different shapes. For example, the sleeve can be configured to expand to a larger cylindrical shape, a non-cylindrical shape, such as a shape that tapers from one end to the other. Fig.42 As shown, the overlap 17004 decreases as the sleeve expands.

[0334] The sleeve 17000 can be made of a variety of different materials. For example, the expandable sleeve 17000 can be formed of a flexible material, which can be a metal fabric (such as a mesh) that is woven, braided, or formed in any other suitable manner, or a flexible material that is cut by laser or otherwise. The material can be cloth, a shape memory alloy wire such as Nitinol that is used to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body.

[0335] Figure 44-45 An example of an expandable apposition element 18000 is shown. Fig.44 and 45 In the illustrated example, the expandable apposition 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 stretching force, is applied to the shape-changing component. For example, the shape-changing component 18012 can be changed from a desired shape to a desired shape by applying a stretching force to the shape-changing component 18012 using the adjustment mechanism 18002. Fig.44 The flat or substantially flat configuration shown is changed to Fig.45 The curved configuration shown. Fig.44 and 45 In the example shown, an optional filler material or core 18004 is positioned between the shape changing components 18012. Fig.44 The configuration shown moves to Fig.45 In the configuration shown, the optional filler material or core 18004 is compressed by the shape changing component 18012. In some embodiments, the optional filler material or core material 18004 holds the shape changing component 18012 apart to facilitate Fig.44 The configuration shown Fig.45 Movement of the configuration shown.

[0336] The shape changing member 18012 can take a variety of different forms having a variety of different expanded and contracted shapes. Fig.44 In the expanded state shown, the shape changing components 18012 can be generally parallel plate-like structures, as shown. In some embodiments, the shape changing components 18012 can be cylindrical, conical, frustoconical, oval, pyramidal, a portion of a pyramidal, diamond-shaped, combinations of these shapes, etc. when in the expanded configuration. Fig.45 In the collapsed state shown, the shape changing component 18012 can be generally circular to compress the optional filler material or core 18004 into a generally cylindrical configuration, as shown. In some embodiments, the shape changing component 18012 can be conical, frustoconical, oval, pyramidal, a portion of a pyramidal, diamond-shaped, combinations of these shapes, etc. when in the collapsed configuration.

[0337] In some embodiments, the shape changing component 18012 is formed of a flat material and has a cutout 18015. The flat material and the cutout 18015 are configured such that applying a force (e.g., a stretching force) to the shape changing component 18012 causes the shape changing component to flex from a substantially flat configuration to a three-dimensional configuration. For example, a kirigami technique can be applied to a flat material to make the shape changing component 18012. The shape changing component 18012 can be made of a variety of different materials. For example, the shape changing component 18012 can be formed of any metal or polymer material suitable for implantation in a human body.

[0338] The shape changing member 18012 can be transformed from an expanded configuration to a compressed configuration in a variety of different ways. In the illustrated example, the shape changing member includes a tab 18016. Applying tension to the tab 18016 causes the shape changing member 18012 to change from an expanded configuration to a compressed configuration. Fig.44 The configuration shown transforms to Fig.45 However, the tabs 18016 are optional and other arrangements for applying force to the shape changing component 18012 may be used. As mentioned above, the shape changing component 18012 can be formed using paper cutting so that applying tension to the tabs 18016 causes the shape changing component to transition from a flat configuration to a curved three-dimensional configuration.

[0339] A variety of different mechanisms can be used to move the shape changing component 18012 from the expanded configuration to the collapsed configuration. In some embodiments, a screw or bolt 18008 and a nut 18022 or other fastening arrangement can be used to move the shape changing component 18012 from the expanded configuration to the collapsed configuration. Rotating the nut 18022 relative to the screw or bolt 18008 can apply tension to the shape changing component 18012 to move the shape changing component from the expanded configuration to the collapsed configuration. Fig.44 ) moves to the contracted configuration ( Fig.45 ). For example, wire 18026 can be connected to tab 18016 and coupled to nut 18022. Rotating nut 18022 pulls wire 18026 to move shape changing member 18012 from an expanded configuration to a collapsed configuration. In some embodiments, tension on tab 18016 causes shape changing member 18012 to move from an expanded configuration to a collapsed configuration. Fig.44 The configuration shown transforms to Fig.45 Configuration shown.

[0340] The optional filling material or core 18004 can take a variety of different forms. The optional filling material or core 18004 can be made of soft, semi-soft, or semi-hard. The optional filling material or core 18004 can be hollow or solid. The optional filling material or core 18004 can be spongy and porous, and can be made of a material (such as a net) woven, braided, or formed in any other suitable manner, or a flexible material cut by laser or otherwise. The material can be cloth, shape memory alloy, foam, sponge (such as Poron), or any other flexible material suitable for implantation in the human body. Applying force to the shape changing component 18012 causes the shape changing component to change shape, and thereby reshapes the optional filling material or core 18004.

[0341] In the example shown, when the shape changing component 18012 is in Fig.44 When the shape changing component 18012 is in the non-tensioned configuration, the optional filler material or core 18004 can have a rectangular shape. Fig.45 Optional filler material or core 18004 can have a cylindrical or substantially cylindrical configuration when in the canister's tensioned configuration. However, the optional filler material or core 18004 can have a variety of different shapes when in the expanded and compressed configurations. For example, when in the expanded canister's compressed configuration, the optional filler material can be cylindrical, conical, frustoconical, oval, pyramidal, a portion of a pyramidal, diamond-shaped, wedge-shaped, combinations of these shapes, etc.

[0342] The expandable apposition element 18000, as well as other expandable apposition elements disclosed herein (10000, 17000, etc.), can be configured to expand and contract in a variety of different ways. Figures 46-48 is a schematic top plan view of an expandable apposition element. Fig.46 The expandable apposition element 18000 is shown in a normal or starting position. The expandable apposition element 18000 can be expanded in a variety of different ways. Fig.46 The configuration shown expands and / or contracts. For example, in some embodiments, the expandable apposition element 18000 can:

[0343] -Only in Fig.47 expansion or contraction in the direction 18050 shown;

[0344] -Only in Fig.48 expansion or contraction in the direction 18052 shown;

[0345] -At the same time Fig.47 The directions shown are 18050 and Fig.48 expansion and contraction in the direction 18052 shown;

[0346] - expand or contract sequentially, so that the expandable coupling element 18000 is first Fig.47 expand or contract in the direction 18050 shown, and then Fig.48 expansion or contraction in the direction 18052 shown;

[0347] - expand or contract sequentially, so that the expandable coupling element 18000 is first Fig.48 expand or contract in the direction 18052 shown, and then Fig.47 expansion or contraction in the direction 18050 shown;

[0348] - Independently Fig.47 The directions shown are 18050 and Fig.48 Expansion or contraction in the second direction 18052 shown;

[0349] -exist Fig.47 Partially expand or contract in the direction 18050 shown, and then Fig.47 The directions shown are 18050 and Fig.48 expansion or contraction in both directions 18052 shown; and / or

[0350] -exist Fig.48 Partially expand or contract in the direction 18052 shown, and then Fig.47 The directions shown are 18050 and Fig.48 The directions 18052 shown both expand or contract.

[0351] Thus, when the shape changing component 18012 is manipulated between the tensioned configuration and the non-tensioned configuration, the shape changing component 18012 and / or the expandable material 18004 can expand sequentially, simultaneously, or otherwise.

[0352] Figure 49-52 An example of a device 19000 (eg, a valve repair device, a valve treatment device, an implantable device, an implant, etc.) is shown, the device comprising Fig.44 and 45 The expandable apposition element 18000 shown. The expandable apposition 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 in this application. For example, the expandable apposition element 18000 can be used Figure 8-14 The implantable device 19000 is Figure 8-14 One of many different configurations that a device having expandable apposition elements 18000 schematically shown in FIG. 1 can take.

[0353] Device 19000 may include any other features of the devices discussed herein (e.g., therapeutic and / or repair devices, etc.), and expandable apposition element 18000 may be positioned to engage leaflets 30, 32, 34 (see Figure 7 and 34 ) or leaflets 20, 22 (see Figure 6 and 36 ) as part of any suitable device 19000 (e.g., any therapeutic and / or prosthetic device disclosed herein). Device 19000 can be deployed from a delivery sheath, a device catheter, and / or an implant catheter. Device 19000 can include an adjustment mechanism 18002 and an anchoring portion having two or more anchors, such as the anchoring portions and anchors described herein. Figure 49-52 In the example shown, the anchor of device 19000 includes fastener 18040.

[0354] exist Figure 49-52 In the example shown, the fasteners 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 fasteners 18040 position the adjustable coaptation element between the leaflets of the native valve 18030. In some embodiments, the leaflet fastener or leaflet fasteners 18040 attach to the top or atrial side and the bottom or ventricular side of the leaflets of the native valve 18030.

[0355] The adjustable apposition element 18000 is adjusted to change the shape and / or size of the area of ​​the native valve that is blocked by the adjustable apposition element 18000 . Fig.49 and 50 The device 19000 is shown attached to a native valve 18030, wherein the adjustable apposition element 18000 is in an expanded configuration. Relative rotation of the screw or bolt 18008 and the nut 18022 can apply tension to the shape changing component 18012. For example, a wire 18026 can be connected to the tab 18016 and coupled to the nut 18022. Rotating the bolt 18008 relative to the nut 18022 pulls the wire 18026 to move the shape changing component 18012 from Fig.44 The expansion configuration moves to Fig.45 contraction configuration.

[0356] Fig.49 A top plan view of an adjustable apposition element 18000 in an expanded configuration is shown, positioned between the leaflets of a native valve 18030. The screws or bolts 18008 may extend into or through the spacer material 18004. Fig.50 A side perspective view of the adjustable coaptation element 18000 showing expansion between leaflets of a native valve 18030 . Fig.51A top plan view of the adjustable apposition element 18000 in a compressed configuration is shown positioned between the leaflets of a native valve 18030 .

[0357] Fig.52 A side perspective view of the adjustable coaptation element 18000 showing compression between leaflets of a native valve 18030 .

[0358] A variety of different mechanisms may be used to move the expandable or adjustable apposition elements between the expanded and collapsed configurations. Figure 53-70 Examples of expandable mechanisms that can be used with any of the devices described herein are shown. Figure 53-56 In the example shown, the expandable mechanism expands and contracts in two directions. A device (e.g., a therapeutic device, a repair device, an implantable device, etc.) including an expandable mechanism may include any other features of the devices discussed in this application, and the device may be positioned to engage valve tissue as part of any suitable therapeutic and / or repair system (e.g., any therapeutic and / or repair system disclosed in this application). The device may be deployed from a delivery sheath or delivery device by a pusher (e.g., a rod or tube as described above).

[0359] The device can include a commissure portion and an anchoring portion having two or more anchors, such as the anchoring portions and anchors described herein. The commissure portion includes an expandable mechanism 13110 that can be actuated between a contracted state and an expanded state. An optional outer surface, such as a shell 15090, a sleeve 17000, a shape-changing component 18012, etc., can be included to cover a portion or the entire expandable mechanism 13110.

[0360] The expandable mechanism 13110 is formed of one or more struts 13112. The struts 13112 have a plurality of rigid portions 13114 connected together by hinge portions 13116, which enable the rigid portions 13114 to bend relative to each other. A fixed end portion 13118 is connected to each of the struts 13112 by the hinge portion 13116. The struts 13112 extend from the fixed end portions 13118 to a movable end portion 13120, which is connected to each of the struts 13112 by one of the hinge portions 13116. One or more of the rigid portions 13114 may include an attachment area 13122 for attaching another component of the device.

[0361] The strut 13112 is moved between a collapsed state and an expanded state by actuation of a threaded actuation shaft 13124 that extends through the expandable mechanism 13110 to a fixed actuation member 13126. The fixed end portion 13118 is attached to the fixed actuation member 13126, and the movable end portion 13120 is attached to the movable actuation member 13128. The fixed actuation member 13126 extends proximally from the fixed actuation member 13126 and through the movable actuation member 13128. The threaded actuation shaft 13124 can be hollow, and the fixed actuation member 13126 and the movable actuation member 13128, as shown in FIG. Figure 55-56 As shown in , other actuation members and other components of the device can extend through the expandable mechanism 13110 and can be moved or actuated independently of the actuation of the expandable mechanism 13110.

[0362] The movable actuation member 13128 includes a threaded opening 13130 ​​that engages the threads of the threaded actuation shaft 13124 such that rotation of the threaded actuation shaft 13124 relative to the movable actuation member 13128, or vice versa, moves the movable actuation member 13128 toward and away from the fixed actuation member 13126. That is, rotating the movable actuation member 13128 via the actuation shaft or other mechanism (not shown) moves the movable actuation member 13128 proximally away from the fixed actuation member 13126 and distally toward the fixed actuation member 13126. As the movable actuation member 13128 moves along the threaded actuation shaft 13124, the struts 13112 expand and contract to change the overall width of the expandable mechanism 13110. When the struts 13112 are stretched to a nearly or straight state and / or when the fixed end portion 13118 and the movable end portion 13120 are moved closer to each other, the expandable mechanism 13110 has a minimum width, so that the rigid portions 13114 are folded against each other. In this way, the expandable mechanism 13110 can be expanded and contracted laterally to accommodate the different sizes and shapes of gaps 26 left between the leaflets 20, 22 during diastole when the native heart valve is closed around the device (see Figure 6 ).

[0363] The rigid portion 13114 of the strut 13112 and the optional covering covering the strut 13112 may include a shaped portion, or may include a flexible or pliable portion to allow the surface of the device to conform to the shape of the native leaflets 20, 22 when the leaflets 20, 22 are close to the device to improve the engagement between the strut 13112 and the native leaflets 20, 22. Although four struts 13112 are shown, any number of struts 13112 can be combined to achieve expansion and contraction of the coaptation surface. Different struts can include rigid portions 13114 with different shapes and lengths to provide different expansion and contraction rates and different maximum expansion positions to form a variety of different shapes of expandable mechanisms 13110.

[0364] Reference now Figures 57-60 , an example of an expandable mechanism 13210 for a device (e.g., a therapeutic device, a repair device, an implantable device, an implant, etc.) is shown. The device can include any other features of the devices (e.g., therapeutic devices, repair devices, etc.) discussed in this application, and the device can be positioned to engage valve tissue as part of any suitable therapeutic and / or repair system (e.g., any therapeutic system and / or repair system disclosed in this application).

[0365] The device can be deployed from a delivery sheath or delivery device by a pusher (such as a rod or tube described above). The device may include a juxtaposition portion and an anchoring portion having two or more anchors, such as the anchoring portion and anchors described herein. In some embodiments, the juxtaposition portion includes an expandable mechanism 13210 that can be actuated between a contracted state and an expanded state. In some embodiments, an optional outer surface, such as a shell 15090, a sleeve 17000, a shape-changing component 18012, etc., may be included to cover a portion or the entire expandable mechanism 13210.

[0366] In some embodiments, the expandable mechanism 13210 is formed by one or more struts 13212. In some embodiments, the struts 13212 have multiple rigid portions 13214 connected together by hinge portions 13216, which enable the rigid portions 13214 to pivot relative to each other. In some embodiments, a first end portion 13218 is connected to each of the struts 13212 by a hinge portion 13216. In some embodiments, the struts 13212 extend from the first end portion 13218 to a second end portion 13220 connected to each of the struts 13212 by one of the hinge portions 13216. One or more of the rigid portions 13214 can include an attachment area 13222 for attaching another component of the device.

[0367] In some embodiments, the strut 13212 is moved between the collapsed state and the expanded state by actuation of a threaded actuation shaft 13224 that extends through a first actuation member 13226 and a second actuation member 13228 of the expandable mechanism 13210. In some embodiments, the first end portion 13218 of the strut 13212 is attached to the first actuation member, and the second end portion 13220 is attached to the second actuation member 13228.

[0368] In some embodiments, the threaded actuation shaft 13224, the first actuation member 13226, and the second actuation member 13228 can be hollow so that other actuation members and other components of the device can extend through the expandable mechanism 13210 and can move or actuate independently of the actuation of the expandable mechanism 13210.

[0369] In some embodiments, the threaded actuation shaft 13224 includes a first threaded portion 13230 extending from a distal end to a second threaded portion 13232, and the second threaded portion 13232 extends from the first threaded portion 13230 to a proximal end. In some embodiments, the threads of the first threaded portion 13230 and the second threaded portion 13232 are oriented in opposite directions; that is, if the threads of the first threaded portion 13230 are right-hand threads, the threads of the second threaded portion 13232 are left-hand threads, and vice versa.

[0370] In some embodiments, the first actuation member 13226 engages the first threaded portion 13230 and includes a threaded opening 13234 having threads that are oriented to match the threads of the first threaded portion 13230. In some embodiments, the second actuation member 13228 engages the second threaded portion 13232 and includes a threaded opening 13234 having threads that are oriented to match the threads of the second threaded portion 13232. Thus, rotating the threaded actuation shaft 13224 in one direction moves the first actuation member 13226 and the second actuation member 13228 in opposite directions. Because the first actuation member 13226 and the second actuation member 13228 move in opposite directions at the same rate when the threaded actuation shaft 13224 rotates, the midplane formed between the first actuation member 13226 and the second actuation member 13228 does not move when the expandable mechanism 13210 expands and contracts.

[0371] In some embodiments, during operation of the expandable mechanism 13210, for example, rotating the threaded actuation shaft 13224 can move the first actuation member 13226 in a proximal direction and the second actuation member 13228 in a distal direction, thereby reducing the distance between the first actuation member 13226 and the second actuation member 13228. In some embodiments, rotating the threaded actuation shaft 13224 in the opposite direction will move the first actuation member 13226 in a distal direction and the second actuation member 13228 in a proximal direction, thereby increasing the distance between the first actuation member 13226 and the second actuation member 13228. In this way, rotation of the threaded actuation shaft 13224 is used to expand and contract the struts 13212 of the expandable mechanism 13210. In this manner, rotation of the threaded actuation shaft 13224 causes the outer perimeter or size of the expandable mechanism 13210 to increase and decrease to accommodate the different sizes and shapes of gaps 26 left between the leaflets 20, 22 during diastole when the native heart valve is closed around the device (see Figure 6 ).

[0372] In some embodiments, the rigid portion 13214 of the strut 13212 and / or the shell, sleeve, etc. covering the strut 13212 may include a shaped portion, or may include a flexible or pliable portion to allow the surface of the device to conform to the shape of the native leaflets 20, 22 when the leaflets 20, 22 are close to the device to improve the engagement between the strut 13212 and the native leaflets 20, 22. Although four struts 13212 are shown, any number of struts 13212 can be combined to achieve expansion and contraction of the coaptation surface. Different struts can include rigid portions 13214 with different shapes and lengths to provide different expansion and contraction rates and different maximum expansion positions to form expandable mechanisms 13210 of various shapes.

[0373] Reference now Figures 61-70 , an expandable mechanism 13310 for a device (e.g., a therapeutic device, a repair device, an implantable device, an implant, etc.) is shown. The device can include any other features of the devices discussed in this application (e.g., a therapeutic device, a repair device, etc.), and the device can be positioned to engage valve tissue as part of any suitable therapeutic and / or repair system (e.g., any therapeutic and / or repair system disclosed in this application). The device can be deployed from a delivery sheath or delivery device by a pusher (such as a rod or tube as described above).

[0374] In some embodiments, the device can include a commissure portion and an anchoring portion having two or more anchors, such as the anchoring portions and anchors described herein. In some embodiments, the commissure portion 13304 includes an expandable mechanism 13310 that can be actuated between a contracted state and an expanded state. An optional outer surface, such as a shell 15090, a sleeve 17000, a shape-changing component 18012, etc., can be included to cover a portion or the entire expandable mechanism 13310.

[0375] The expandable mechanism 13310 is formed of one or more struts 13312. The struts 13312 have a plurality of rigid portions 13314 connected together by hinge portions 13316, which enable the rigid portions 13314 to pivot relative to each other. A first end portion 13318 is connected to each of the struts 13312 by hinge portions 13316. The struts 13312 extend from the first end portion 13318 to a second end portion 13320 connected to each of the struts 13312 by one of the hinge portions 13316. One or more of the rigid portions 13314 may include an attachment area for attaching the expandable mechanism 13310 or another component of the prosthetic device.

[0376] The expandable mechanisms disclosed herein (and usable with any of the devices herein) can be moved 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 move the expandable mechanism to various expanded and contracted positions and hold the expandable mechanism in place. Additionally or alternatively, the expandable mechanism herein may include one or more of the following: a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, a pivot and / or scissor extension and / or strut, an expansion pulley mechanism, a Hoberman mechanism, a cam, a worm, a rack and pinion, foam, and the like.

[0377] Various other mechanisms may additionally or alternatively be used. For example, Figure 63-64and 67-70 show examples of mechanisms for moving an expandable mechanism to various expanded and contracted positions and holding the expandable mechanism in place. In this example, the strut 13312 moves between a collapsed state and an expanded state by extension and retraction of the actuating tube 13322. The actuating tube 13322 extends to a distal end 13324 that is attached to the first end portion 13318 and moves within a latch tube 13326 that includes a plurality of openings 13328 for engaging with a latch member 13330 of the actuating tube 13322. A retaining or fixing member 13334 secures the connection between the actuating tube 13322 and the latch tube 13326 by engaging the latch member 13330; the relationship between the actuating tube 13322, the latch tube 13326, the latch member 13330, and the fixing member 13334 is shown in FIG. Figure 63-64 and 67-70, and described below.

[0378] In some embodiments, the latch tube 13326 is attached to a proximal collar or head 13332 of the device, which can be coupled to a delivery mechanism for delivering the device into a native valve. In some embodiments, the proximal collar or head 13332 is also attached to the second end portion 13320 of the strut 13312. Thus, extension and retraction of the actuation tube 13322 changes the distance between the first end portion 13318 and the second end portion 13320 of the strut 13312 to move the strut 13312 between a contracted state and an expanded state. The proximal collar or head 13332 can be engaged and actuated in various ways as described herein to facilitate deployment and / or implantation of the device described herein, for example, by opening and closing the paddles of the device.

[0379] In some embodiments, the latch member 13330 of the actuation tube 13322 can be moved between a latched state and an unlocked state. The actuation tube 13322 can include any number of latch members 13330 adapted to engage corresponding openings 13328 in the latch tube 13326. Referring now to Figures 61-64 69, the latch member 13330 of the actuator tube 13322 is shown in an unlocked state. When the latch member 13330 is in the unlocked state, the actuator tube 13322 can move freely along the length of the latch tube 13326 to extend and retract the first end portion 13318, thereby expanding and contracting the expandable mechanism 13310. Figures 65-68 In the latched state shown in FIGS. 70 and 70 , the latch member 13330 in the latched state engages the opening 13328 of the latch tube 13326 to fix the position of the actuating tube 13322 relative to the latch tube 13326 .

[0380] In some embodiments, the latch member 13330 can be integrally formed in the side of the actuation tube 13322, optionally by laser cutting a portion of the actuation tube 13322. The latch member 13330 is bent and shaped in the latched state so that in the free state, the latch member 13330 is angled relative to the central axis of the actuation tube 13322. For example, Figures 67-68 As shown, the proximal or upper end of the latch member 13330 is biased radially outward, and the opposite lower or distal end of the latch member 13330 is biased radially inward.

[0381] In some embodiments, the proximal end of the latch member 13330 can be biased radially inward, and the opposite distal end of the latch member 13330 can be biased radially outward. In some embodiments, the expandable mechanism 13310 is biased to expand or contract, and the latch member 13330 is angled outward to oppose the bias of the expandable mechanism 13310. In an example in which the expandable mechanism 13310 is biased to move the actuation tube 13322 in a proximal direction, the proximal end of the latch member 13330 can be biased radially outward so that the latch member 13330 engages the opening 13328 of the latch tube 13326 so that proximal movement of the actuation tube 13322 is blocked by the latch member 13330.

[0382] In some embodiments, the latch member 13330 is held in an unlocked state by a retaining or fixing member 13334 that prevents the latch member 13330 from pivoting to a latched state. During deployment and / or implantation of the device, the width of the expandable mechanism 13310 is adjusted by extending and retracting the actuating tube 13322. When the desired width of the expandable mechanism has been reached, the retaining and fixing member 13334 is retracted from the actuating tube 13322 to allow the latch member 13330 to pivot to a latched state to engage the opening 13328 of the latch tube 13326. In some embodiments, extension and retraction of the actuating tube 13322 increases and decreases the size of the expandable mechanism 13310 to accommodate the different sizes and shapes of gaps 26 left between the leaflets 20, 22 during diastole when the native heart valve is closed around the coaptation element (see Figure 6 ). The width of the expandable mechanism 13310 is maintained by locking the actuator tube 13322 relative to the latch tube 13326 in an appropriate position against the force applied by the leaflets 20, 22 via the latch member 13330.

[0383] In some embodiments, the retaining or fixing member 13334 can optionally have a tapered distal end to facilitate reengagement of the latch member 13330 so that the latch member 13330 can be pivoted from a latched state to an unlocked state, thereby enabling further adjustment of the width of the expandable mechanism 13310.

[0384] In some embodiments, the rigid portion 13314 of the strut 13312 and / or the shell, sleeve, etc. covering the strut 13312 may include a shaped portion, or may include a flexible or pliable portion to allow the surface of the expandable apposition element to conform to the shape of the native leaflets 20, 22 when the leaflets 20, 22 are close to the implanted device to improve the engagement between the strut 13312 and the native leaflets 20, 22. Although four struts 13312 are shown, any number of struts 13312 can be combined to achieve expansion and contraction of the apposition surface. Different struts can include rigid portions 13314 with different shapes and lengths to provide different expansion and contraction rates and different maximum expansion positions to form a variety of different shapes of expandable apposition mechanisms 13310.

[0385] The expandable apposition element can take a variety of different forms. In some embodiments, the expandable apposition element is made of a strut grid and / or can have a stent-like configuration. The strut grid can be formed in a variety of different ways. For example, the expandable apposition element can be cut from sheet material (e.g., laser cut), molded, made by additive manufacturing technology (e.g., 3D printing), etc.

[0386] Reference now Figures 71-74 , shows an exemplary portion of an expandable apposition element 20002 for use in a device (e.g., a therapeutic device, a repair device, an implantable device, an implant, etc.). The expandable apposition element 20002 can be used in a variety of different devices, including but not limited to any of the therapeutic and / or repair devices disclosed in the present application. For example, the expandable apposition element 20002 can be used Figure 8-14 The device with expandable coaptation element 20002 can include any other features of the devices discussed in this application (e.g., treatment devices, repair devices, etc.) and 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 in this application). The expandable coaptation element 20002 can be deployed from a delivery sheath or delivery device by a pusher (e.g., a rod or tube).

[0387] refer to Figures 71-73 , the apposition element 20002 can include a lattice frame 20004, which can allow the width and length of the apposition element to be controlled to accommodate different sizes of leaflet gaps. Width and length are relative terms 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 transverse to the width (e.g., between the commissures). The expandable apposition element 20002 can be composed of a shape memory alloy (such as Nitinol) for providing shape-setting capabilities or any other flexible material suitable for implantation in the human body.

[0388] The expandable coaptation element 20002 can be latticed, tubular, oval / bowl-shaped, or any other shape that facilitates implantation between the leaflets of an autologous valve. In some embodiments, the expandable coaptation element 20002 comprises a stent-like lattice frame having triangular, diamond, and / or hexagonal honeycomb cells. In some embodiments, the structure can be tubular, wherein the length is greater than the width, wherein the length ends have an arcuate shape. The coaptation element 20002 can have multiple ends (on the length of the coaptation element) and / or multiple sides (on the width of the coaptation element).

[0389] In some embodiments, the apposition element 20002 can have one or more tabs or extensions 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 apposition element 20002 can expand and / or contract vertically and / or horizontally. The expansion and / or contraction can be achieved by an actuating portion or actuating member 20008 extending from the tab or extension 20006. The actuating portion or actuating member 20008 can be coupled to the frame 20004, such as being integrally formed with the frame as shown in the figure. In some embodiments, the actuating portion or actuating member 20008 can be arranged diametrically around the central axis of the expandable apposition element 20002. Figures 71-74 One or more sides of the expandable apposition element 20002 mentioned in the above can expand sequentially, simultaneously, or in other ways when manipulated and / or actuated.

[0390] The expandable apposition element 20002 can expand and / or contract in a variety of different ways. For example, the expandable apposition element 20002 can:

[0391] - expand or contract only in length;

[0392] - expand or contract in width only;

[0393] - expand and contract in length and width simultaneously;

[0394] - sequential expansion or contraction, such that the expandable apposition element 20002 first expands or contracts in length, and then expands or contracts in width;

[0395] - sequential expansion or contraction, such that the expandable apposition element 20002 first expands or contracts in width, and then expands or contracts in length;

[0396] - expand or contract independently in length or width;

[0397] - partially expand or contract in length, and then expand or contract in both length and width; and / or

[0398] - Partially expand or contract in width, and then expand or contract in both length and width.

[0399] Thus, the shape changing elements 20002 can expand sequentially, simultaneously, or in other ways.

[0400] In some embodiments, one or more auxiliary controls 20012 can be used to change the size of one or more units independently of the actuating portion or member 20008. The auxiliary controls 20012 can take a variety of different forms. For example, the auxiliary controls can include lines (such as sutures, wires, etc.), adjustable width fasteners, springs, or any other components that can be controlled to change the size of one or more units in the unit 20014. One or more auxiliary controls 20012 can be attached to individual units 20014 of the frame 20004. The individual units 20014 can be dedicated, such as by having a different shape (e.g., hexagonal, heptagonal, rectangular, triangular, etc.) from other units of the frame 20004, different strut thickness, different strut width, etc. In some embodiments, the auxiliary controls 20012 can be used to adjust the width of the frame 20004 by pulling the dedicated unit to narrow the dedicated unit 20014, and thus narrow the frame 20004 as a whole.

[0401] The narrowing and expansion of the individual cells 20014 with the auxiliary controls 20012 changes the shape of the expandable apposition element 20002, which is different from the movement of the actuation portion or member 20008. By adjusting the actuation portion or member 20008 and the auxiliary controls 20012, the expandable apposition element can be adjusted to a variety of different shapes and sizes.

[0402] Figure 72-73 A control unit 20010 is depicted that forms part of a frame 20004 of an expandable apposition element 20002. The control unit 20010 can expand by shortening, narrowing, and / or bending or flexing at certain points. The actuating portion or member 20008 is connected to the control unit 20010 by a plurality of tabs, connectors, or connecting portions 20006 that are coupled to the upstream and downstream ends of the unit at bending points 20023. In some embodiments, the elastic properties of the material, the change in the width of the material, and / or the change in the thickness of the material can be used to produce a control unit 20010 with bending points 20021, 20023 that bend or flex before each other and / or before other parts of the control unit 20010 and / or bend or flex out of the plane of the control unit. In some embodiments, a force applied to the control unit will initially overwhelm the bending points 20021 and / or the bending points 20023, causing these points to bend and causing the shape of the expandable apposition element 20002 to change.

[0403] For example, the inflection points 20021, 20023 may be configured such that:

[0404] - Point 20021 is flexed before point 20023;

[0405] - Point 20023 is flexed before point 20021;

[0406] - Point 20021 and point 20023 are flexed simultaneously;

[0407] - Point 20021 partially flexes, and then points 20021 and 20023 flex; and / or

[0408] - Point 20023 partially flexes, and then point 20021 and point 20023 flex.

[0409] Fig.72 A control unit 20010 is shown having bending points 20021 that bend around multiple bending axes 20022 and bending points 20023 that bend around axis 20020. Fig.72 and 73 The comparison of 20008 and 20010 demonstrates how the control unit 20010 can be bent / manipulated by adjusting the actuating portion or member 20008 in an upward or downward direction. In some embodiments, by adjusting the actuating portion or member 20008 in an upward or downward direction, the bending point 20023 on the actuator will first bend and lengthen the control unit 20010. Then, the bending point 20021 will bend along the bending axis 20022, thereby further lengthening or shortening the control unit 20010. Fig.73 The control unit 20010 is depicted within the frame 20004 after the actuation portion or member 20008 has been manipulated in an upward and downward direction to lengthen and narrow the control unit 20010.

[0410] The control unit 20010 can be expanded and contracted in a variety of different ways. Any mechanism capable of moving the actuating member 20008 can be used, such as Fig.72 As shown by arrow 20009 in FIG. Fig.74 An exemplary actuating member 20030 is shown. Figures 71-73 The control unit 20010 described in the above. The actuation member may include a catheter 20032 and a rod 20034 to manipulate the control unit 20010 in an upward and / or downward direction and expand and / or contract it. When expanding and / or contracting, the catheter 20032 and the rod 20034 extend and / or contract one or more struts 20040, thereby adjusting the size of the control unit 20010.

[0411] Figures 75-77 An example of an expandable apposition element 20500 is shown. Figures 75-77 In the illustrated example, the expandable apposition 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 receptacle 20513 of the adjustment mechanism 20502.

[0412] The shape changing member 20512 can take a variety of different forms having a variety of different expanded and contracted shapes. Fig.76 In the example shown, the shape changing component 20512 can be made of a single wire having a stirrer configuration or a stirrer-like configuration. Fig.77 In the illustrated example, the shape changing component 20512 can be made of 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, frustoconical, oval, pyramidal, a portion of a pyramidal, diamond-shaped, combinations of these shapes, etc. when in the expanded and / or contracted configuration. The shape changing component 20512 can be formed from a braided or woven tube of material (such as nitinol wire) or any other flexible material suitable for implantation in the human body.

[0413] The shape changing member 20512 can be transformed from an expanded configuration to a compressed configuration in a variety of different ways. In the illustrated example, the shape changing member is pulled into or pushed out of the receptacle 20513 of the adjustment mechanism 20502. In the illustrated example, pushing the shape changing member 20512 out of the receptacle 20513 expands the shape changing member 20512, and pulling the shape changing member 20512 into the receptacle reduces the size of the shape changing member. In some embodiments, the shape changing member 20512 expands and contracts laterally without increasing or substantially increasing the height of the expandable apposition element 20500.

[0414] A variety of different mechanisms can be used to move the shape changing member 20512 from the expanded configuration to the collapsed configuration. In some embodiments, the inner shaft 20508 moves along the axis 20516 inside the outer shaft 20522 to move the shape changing member 20512 from the expanded configuration to the collapsed configuration. In some embodiments, nuts and bolts can be used to move the shape changing member 20512 between the expanded configuration and the collapsed configuration.

[0415] In the illustrated example, the shape changing member 20512 has a first end 20510 (e.g., a proximal / upstream end) fixedly attached to the outer shaft 20522. The shape changing member 20512 has a distal end 20514 attached to the inner shaft 20508. The inner shaft 20508 and the attached distal end 20514 are axially movably attached inside the receptacle 20513. Axially adjusting the second end or distal end 20514 within the receptacle 20513 exposes more or less of the shape changing member 20512. The shape changing member 20512 can be biased to expand toward a generally teardrop or oval shape such that exposure of more of the shape changing member 20512 makes the expandable apposition element 20500 wider.

[0416] The expandable apposition element 20500 can be used in a variety of different devices, including but not limited to any of the therapeutic and / or repair devices disclosed in this application. For example, any of the expandable apposition elements disclosed herein can be used Figure 8-14 In the device schematically shown in FIG. 2050, the expandable coaptation element 20500 can be positioned to engage the leaflets 30, 32, 34 (see FIG. Figure 7 and 34 ) or leaflets 20, 22 (see Figure 6 and 36 ) as part of any suitable device (e.g., any therapeutic and / or repair device disclosed in this application). The device can be deployed from a delivery sheath, a steerable catheter, and / or an implant catheter. The device can include an expandable apposition element 20500 and an anchoring portion having two or more anchors, such as the anchoring 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 leaflets of a native valve.

[0417] refer to Figures 78-81 In some embodiments, an extension or barrier member, etc. (e.g., a cover, an umbrella, a canopy, a cover-like extension, an umbrella-like extension, a canopy-like extension, etc.) can be attached to a device (e.g., a therapeutic device, a repair device, etc.) to block, divert, or inhibit regurgitant blood flow through a native valve (such as a native mitral valve). The extension or barrier member can take a variety of different forms. The size and shape of the extension or barrier member can be set to reduce regurgitation while maximizing flow from the atrium to the ventricle. For example, the extension or barrier member can be shaped to match or substantially match the contour of the regurgitant flow and / or have a shape corresponding to the annulus of the native valve but smaller than the annulus of the native valve.

[0418] Reference now Figures 78-81, an example of a device 20600 (e.g., a valve repair device, a valve treatment device, an implantable device, an implant, etc.) is shown. The device 20600 (e.g., a treatment device, a repair device, etc.) can include an extension or blocking member 20602 (e.g., a cover, an umbrella, a cover, a canopy, a cover-like extension, an umbrella-like extension, a cover-like extension, etc.), a frame or base 20604, and a fastener or multiple fasteners 20606. The extension 20602 can be used to cover the gap between the closed leaflets to block or partially block the regurgitation through the native valve. The extension 20602 can be connected to the frame or base 20604 in a variety of different ways. In the example shown, the extension has a rod 20610 that is fixed to a complementary socket 20612 on the frame 20604. However, the extension 20602 can be attached to the frame or base 20604 in any manner, or the extension 20602 can be directly connected to one or more fasteners 20606.

[0419] In some embodiments, the extension 20602 is expandable. For example, the extension can take the form of an amplatzer, an occluder, or a plug or include features thereof. In some embodiments, the extension has a fixed size when deployed, but can be compressed to fit inside the delivery catheter. The extension 20602 can be made of cloth, semi-rigid material, rigid material, or a shape memory alloy wire (such as nitinol) for providing shape-setting ability, or any other flexible material suitable for implantation in the human body.

[0420] A fastener or fasteners 20606 can be attached to the frame 20604 to attach the leaflets of the native valve 20608 to each other. In some embodiments, the frame 20604 can be omitted. For example, the fasteners 20606 can be connected to each other, integrally formed, and / or directly connected to the extension 20602.

[0421] Fig.79 A top plan view of an exemplary device 20600 including an extension 20602 is shown. Fig.79 As seen in FIG. 2 , the extension 20602 covers the gap between the closed leaflets to block or partially block regurgitation through the native valve.

[0422] Extension 20602 can be used in a variety of different devices, including but not limited to any of the therapeutic and / or repair devices disclosed in this application. As an example, any extension, blocking member, etc. disclosed herein can be used Figure 8-14 In the device schematically shown in FIG. 20600 is Figure 8-1420600 can include any other features of the devices discussed in this application (e.g., therapeutic devices, repair devices, etc.), and the extension 20602 can be positioned to block or impede passage through the leaflets 30, 32, 34 (see Figure 7 and 34 ) or leaflets 20, 22 (see Figure 6 and 36 ) of the reverse flow. The device 20600 can be deployed from a delivery sheath, a steerable catheter, and / or an implant catheter. The device 20600 can include an anchoring portion having two or more anchors, such as the anchoring portions and anchors described herein.

[0423] Fig.80 An exemplary valve system 20700 is shown having an extension or barrier member 20702 (e.g., a cover, an umbrella, a cover, a canopy, a cover-like extension, an umbrella-like extension, a cover-like extension, etc.) mounted on a device 200 (e.g., a therapeutic device, a prosthetic device, etc.). In the example shown, the device 200 can be used with Fig. 22 The devices shown are the same or similar. However, the extension 20702 can be mounted on any device, such as any device shown and described in this application (e.g., therapeutic and / or prosthetic devices, etc.).

[0424] The extension 20702 can be mounted on the device 200 in a variety of different ways. In the illustrated example, the extension 20702 is advanced as indicated by arrow 20750 over the implant catheter 102 used to deploy the device 200. Once in place, the extension 20702 is attached to the device 200. For example, the extension 20702 can be attached to the collar 211. However, the extension 20702 can be attached to the device 200 in any manner. The extension 20702 can be used to cover the remaining gap after the apposition portion 204 of the device 200 is positioned. Covering the remaining gap can block or hinder regurgitation through the native valve.

[0425] In some embodiments, the extension 20702 is expandable. For example, the extension can take the form of or include features of an amplatzer occluder or plug. In some embodiments, the extension has a fixed size when deployed, but can be compressed to fit inside the delivery catheter. The extension 20702 can be made of cloth, semi-rigid material, rigid material, or shape memory alloy wire (such as nitinol) or any other flexible material for providing shape-setting capabilities.

[0426] Extension 20702 can be inserted simultaneously with device 200 or after device 200 has been implanted. For example, the device can be positioned. Then, reflux can be assessed. Based on the remaining reflux, extension 20702 can be selected and added to device 200. Fig.81 The device 200 is shown with a fixed extension 20702.

[0427] Figures 82-83 A method for use with an expandable apposition element 21000 (e.g., Figure 100-101 ) of an exemplary frame member 21002 (e.g., a frame, body, cage, fixture, chassis, form, etc.). The expandable apposition element 21000 (e.g., a spacer, apposition element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) can be part of a device for repairing a native heart valve (e.g., a treatment device, a repair device, etc.) and can be used as part of any device described herein.

[0428] In some embodiments, the frame member 21002 is configured to move between a first radially contracted configuration and a second radially expanded configuration. The frame member 21002 can be configured in various ways. In some embodiments, the frame member 21002 has a generally cylindrical shape (i.e., a circular cross-section) having a proximal end 21004, a distal end 21006 opposite the proximal end 21004, and a diameter D that can collapse (i.e., be in a first configuration) and expand (i.e., be in a second configuration). However, in some embodiments, the frame member 21002 can have a shape other than a cylindrical shape (e.g., an oval, rectangular, elliptical, or other suitable cross-section).

[0429] In some embodiments, the frame member 21002 may include a plurality of interconnected struts 21008 configured to flex or bend to allow the frame member 21002 to move between a first configuration and a second configuration. The interconnected struts 21008 may be configured in a variety of ways, such as the number and size of the struts, the shape of each strut, the arrangement 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 21002 may be used. In some embodiments, the struts 21008 are arranged in a diamond pattern 21010 having a height HD and a width WD ( Fig.83 ).

[0430] In some embodiments, the exemplary frame member 21002 includes a plurality of struts 21012 interconnected by a plurality of struts 21008. The struts 21012 can be configured in a variety of ways, such as the number and size of the struts, the shape of each strut, the arrangement and connection of the struts relative to the struts, and the like.

[0431] In the illustrated example, each strut 21012 extends linearly from the proximal end 21004 to the distal end 21006 and has a height HP and a width WP ( Fig.83 ). In the example shown, the width WP is greater than the width WS of each strut. In some examples, the width WP is two or three times the width WS of each strut 21008. In some embodiments, the width WP of the strut is less than or equal to the width WS of each strut.

[0432] In the example shown, each strut 21012 is connected on either side along a midpoint 21014 to one of the diamond patterns 21010 of the brace 21008. In the example shown, the frame member 21002 includes six (6) struts 21012 evenly positioned around the perimeter of the frame member 21002. Each of the six (6) struts 21012 is separated by two interconnected diamond patterns 21010 of the brace 21008. The struts 21012 and the brace 21008 may be interconnected in any suitable manner.

[0433] In some embodiments, the frame member 21002 is formed as a unitary piece. For example, the frame member 21002 can be laser cut from a tube. However, in other embodiments, some of the braces 21008 and struts 21012 can be formed separately and connected in any suitable manner (e.g., welded together).

[0434] In some embodiments, the frame member 21002 can include a flexible material, which can be a metal fabric (such as a mesh) that is woven, braided, or formed in any other suitable manner, or formed by a flexible material that is laser cut or otherwise cut. The material can be cloth, a shape memory alloy wire such as Nitinol that provides shape-setting capabilities, or any other flexible material suitable for implantation in the human body.

[0435] In some embodiments, when the diameter D of the frame member 21002 expands, the height HD of each diamond pattern in the diamond pattern 21010 decreases, while the width WD increases. In contrast, the height HP of each strut 21012 does not change. Thus, the frame member 21002 has a fixed height (i.e., the height HP of the strut) that does not change between the first configuration and the second configuration.

[0436] In some embodiments, the frame member 21002 can be configured to change height between the first configuration and the second configuration. For example, the pillars can be replaced with a diamond pattern so that the height of the entire frame member 21002 decreases as the width of the frame member increases.

[0437] The frame member 21002 can be moved between the first configuration and the second configuration by any suitable means. For example, the frame member 21002 can be mounted around the expandable mechanism 21016 (see Figures 84-86 ), the expandable mechanism is configured to engage the frame member 21002 to move the frame member 21002 between the first configuration and the second configuration. A variety of different mechanisms can be used to move the frame member 21002 between the first configuration and the second configuration. For example, any expandable mechanism disclosed herein can be used. The expandable mechanism can include one or more of the following: a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, a pivot and / or scissor extension and / or strut, an expansion pulley mechanism, a Hoberman mechanism, a cam, a worm, a rack and pinion, foam, etc.

[0438] In some embodiments, such as Fig.89 As shown, the expandable mechanism 21016 includes an expandable member or expansion member 21018 (e.g., a frame, a body, a strut assembly, a tube, a shaft, etc.) and an actuation mechanism. Figures 84-86 In some embodiments, the frame member 21002 is mounted around the expandable / expandable member 21018. The expandable / expandable member 21018 can be configured in a variety of ways. Any configuration that enables the frame member 21002 to move between a first configuration and a second configuration can be used.

[0439] refer to Figures 87-88 In some embodiments, the expandable / expandable member 21018 is configured into an elongated cylindrical shape having a proximal portion 21022, a distal portion 21024 opposite the proximal portion 21022, an intermediate portion 21026 connecting the proximal portion 21022 and the distal portion 21024, and a channel 21027 extending from the proximal portion 21022 through the expandable / expandable member 21018 to the distal portion 21024.

[0440] In some embodiments, the middle portion 21026 is formed by a plurality of strips 21028 configured to bend or flex. In some embodiments, each strip 21028 has a proximal end 21030 attached to the proximal portion 21022 of the expandable / expandable member 21018, a distal end 21032 attached to the distal portion 21024, and a middle portion 21034 between the proximal end 21030 and the distal end 21032.

[0441] In some embodiments, the expandable / expandable member 21018 includes six (6) strips 21028 equally spaced around the perimeter of the expandable / expandable member 21018. However, in some embodiments, the strips 21028 may not be equally spaced and / or the intermediate portion 21026 may include more or less than six (6) strips.

[0442] In some embodiments, the expandable / expandable member 21018 can be in a first configuration (i.e., a collapsed or narrow configuration) ( Fig.88 ) and a second configuration (i.e., an expanded or wide configuration) ( Fig.87 ). Fig.88 As shown, in the first configuration, each of the plurality of strips 21028 extends parallel to the longitudinal axis LA of the expandable / expandable member 21018, and the expandable / expandable member 21018 has a first length L1. In the first configuration, the proximal portion 21022, the distal portion 21024, and the intermediate portion 21026 have the same first diameter D1.

[0443] In some embodiments, the expandable / expandable member 21018 can be formed as a unitary piece. For example, the expandable / expandable member 21018 can be laser cut from a tube. In some embodiments, the expandable / expandable member 21018 can be formed from multiple pieces (e.g., a pair of Nitinol sheets).

[0444] In some embodiments, the expandable / expandable member 21018 can include a flexible material, which can be a metal fabric (such as a mesh) that is woven, braided, or formed in any other suitable manner, or formed by a flexible material that is laser cut or otherwise cut. The material can be cloth, a shape memory alloy wire such as Nitinol that is used to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body.

[0445] In some embodiments, such as Fig.87 As shown, in the second configuration, the proximal portion 21022 moves toward the distal portion 21024, or vice versa, causing the strip 21028 to bend or flex outwardly, so that the middle portion 21026 expands to a second diameter D2 that is greater than the first diameter D1. In addition, in the second configuration, the expandable / expandable member 21018 has a second length L2 that is less than the first length L1, and the diameters of the proximal portion 21022 and the distal portion 21024 remain at the first diameter D1, while the middle portion 21026 expands to the second diameter D2.

[0446] like Figures 84-86As shown, in some embodiments, the expandable / expandable members 21018 are positioned within the perimeter of the frame member 21002 to engage the frame member 21002. In some embodiments, the middle portion 21034 of each strip 21028 is attached to the frame member 21002. In some embodiments, the middle portion 21034 of each strip 21028 is attached to the corresponding strut 21012 of the frame member 21002. The middle portion 21034 of each strip 21028 can be attached to the frame member 21002 in any suitable manner, such as welding.

[0447] In some embodiments, because the expandable / expandable member 21018 is positioned within the perimeter of the frame member 21002 and attached to the frame member 21002, the expandable / expandable member 21018 is in a first configuration (i.e., a collapsed or narrow configuration) ( Fig.88 ) and a second configuration (i.e., an expanded or wide configuration) ( Fig.87 ) causes the frame member 21002 to move between a first configuration of the frame member (ie, a collapsed configuration) and a second configuration (ie, an expanded configuration).

[0448] In some embodiments, the frame members 21002 and / or the expandable / expandable members 21018 can be configured to be generally in a first configuration (i.e., a collapsed or narrow configuration), in a second configuration (i.e., an expanded or wide configuration), or some intermediate position between the first and second configurations. Thus, in some embodiments, movement of the expandable / expandable members 21018 resists the bias of the frame members 21002 to pull the frame members 21002 inward toward the first position. In some embodiments, movement of the expandable / expandable members 21018 resists the bias of the frame members 21002 to push the frame members outward to the second position.

[0449] In some embodiments, the actuation mechanism 21020 is configured to move the expandable / expandable member 21018 between the first configuration and the second configuration. The actuation mechanism 21020 can be configured in various ways. Any actuation mechanism capable of moving the expandable / expandable member 21018 between the first configuration and the second configuration can be used. In some embodiments, the actuation mechanism 21020 is installed within the expandable / expandable member 21018, between the proximal portion 21022 and the distal portion 21024 of the expandable / expandable member 21018.

[0450] refer to Figures 87-88In some embodiments, the expandable / expandable member 21018 may include a structure configured to mount the actuation mechanism 21020 within the expandable / expandable member 21018. The structure may be configured in a variety of ways. In some embodiments, the proximal portion 21022 of the expandable / expandable member 21018 includes a first pair of radially opposed openings 21036 and a second pair of radially opposed openings 21038 distal to the first pair of radially opposed openings 21036, and the distal portion 21024 of the expandable / expandable member 21018 includes a third pair of radially opposed openings 21040.

[0451] In some embodiments, the actuation mechanism 21020 is configured as a threaded connection. Fig.89 , the exemplary actuation mechanism 21020 includes a distal member 21042 (e.g., a tube, a body, a shaft, etc.) that is configured to be threadably coupled 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 ways. In the illustrated example, the distal member 21042 is formed as a cylindrical tube having a circular cross-section. However, in some embodiments, the distal member 21042 can have a shape other than a cylindrical shape (e.g., a cross-section of an oval, rectangular, elliptical, or other suitable shape).

[0452] In some embodiments, the distal member 21042 includes a proximal end 21046, a distal end 21048 opposite the proximal end 21046, and an internal channel 21050 extending from the proximal end 21046 through the distal member 21042 to the distal end 21048. The internal channel 21050 includes an internal thread 21052 ( Figure 90-91 ).

[0453] In some embodiments, the distal member 21042 is sized to be received within the channel 21027 of the expandable / expandable member 21018. In some embodiments, the distal member 21042 includes structure that secures the distal member 21042 in position within the channel 21027 relative to the expandable / expandable member 21018. In the illustrated example, the distal end 21048 includes a pair of opposing protrusions 21054 that are configured to be received within the third pair of radially opposing openings 21040, as shown. Figures 90-93 shown.

[0454] In some embodiments, the proximal member 21044 is formed as a cylindrical tube having a circular cross-section. In some embodiments, the proximal member 21044 can have a shape other than a cylindrical shape (e.g., an oval, rectangular, elliptical, or other suitable shape in cross-section).

[0455] In some embodiments, the proximal member 21044 includes a proximal end 21056 , a distal end 21058 opposite the proximal end 21056 , and an internal channel 21059 extending from the proximal end 21056 through the proximal member 21044 to the distal end 21058 .

[0456] In some embodiments, the proximal member 21044 may include external threads 21060 ( Figure 90-91 ). The external thread 21060 is configured to cooperate with the internal thread 21052 of the distal member 21042.

[0457] In some embodiments, the proximal member 21044 is sized to be received within the channel 21027 of the expandable / expandable member 21018. In some embodiments, the actuation mechanism 21020 can include a structure for limiting axial movement of the proximal member 21044 within the channel 21027 relative to the expandable / expandable member 21018.

[0458] In some embodiments, the structure limits axial movement of the proximal member 21044 within the channel 21027 relative to the expandable / expandable member 21018 while allowing rotational movement of the proximal member 21044 relative to the expandable / expandable member 21018. The structure for limiting axial movement of the proximal member 21044 can be configured in a variety of ways.

[0459] In some embodiments, the actuation mechanism 21020 includes a circumferential radially extending ridge 21062 at the proximal end 21056. In some embodiments, the ridge 21062 is configured to engage with a stopper 21064 and an end cap 21066 to limit the axial movement of the proximal member 21044 within the channel 21027. The stopper 21064 can be configured in a variety of ways. In some embodiments, the stopper 21064 is configured to inhibit the proximal member 21044 from moving distally within the channel 21027.

[0460] In some embodiments, the stopper 21064 is formed as a ring having a central channel 21068 that is sized to receive a portion of the proximal member 21044 therethrough. In some embodiments, the stopper 21064 is further sized to be received within the channel 21027.

[0461] In some embodiments, the stop 21064 can include a structure configured to fix the position of the stop 21064 relative to the expandable / expandable member 21018. In some embodiments, the stop 21064 includes a pair of opposing protrusions 21070 that are configured to be received within a second pair of radially opposing openings 21038 of the expandable / expandable member 21018, such as Figures 90-93 shown.

[0462] The end cap 21066 can be configured in a variety of ways. In some embodiments, the end cap 21066 is configured to inhibit the proximal member 21044 from moving proximally within the channel 21027. In some embodiments, 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 channel 21076 extending from the distal end 21072 through the end cap 21066 to the proximal end 21074.

[0463] In some embodiments, the central channel 21076 is sized to receive at least a portion of the proximal end 21056 of the proximal member 21044. In some embodiments, the proximal end 21056 of the proximal member 21044 can further include one or more engagement surfaces 21077 accessible through the central channel 21076 of the end cap 21066. In some embodiments, the one or more engagement surfaces 21077 are configured to engage to rotate the proximal member 21044.

[0464] In some embodiments, the end cap 21066 is further sized to be received within the channel 21027. In some embodiments, the end cap 21066 can include structure configured to fix the position of the end cap 21066 relative to the expandable / expandable member 21018.

[0465] In some embodiments, the end cap 21066 includes a pair of opposing protrusions 21078 at the distal end 21072 that are configured to be received within the first pair of radially opposing openings 21036 of the expandable / expandable member 21018, such as Figures 90-93 shown.

[0466] In some embodiments, the end cap 21066 can include a radial flange 21080 at the proximal end 21074 that is configured to inhibit over-insertion of the end cap 21066 into the channel 21076 .

[0467] refer to Figures 90-93In some embodiments, when assembled, the actuation mechanism 21020 can move the expandable / expandable member 21018 between the first configuration and the second configuration. Specifically, the distal member 21042 is received in the channel 21027 of the expandable / expandable member 21018.

[0468] In some embodiments, a pair of opposing protrusions 21054 on the distal member 21042 are received within the third pair of radially opposing openings 21040 , thereby axially and rotationally fixing the distal member 21042 relative to the expandable / expandable member 21018 .

[0469] In some embodiments, the distal portion 21024 and / or the distal member 21042 of the expandable / expandable member 21018 can be configured to move or flex to allow a pair of opposing protrusions 21054 to be positioned adjacent to the third pair of radially opposing openings 21040 .

[0470] In some embodiments, the distal portion 21024 of the expandable / expandable member 21018 includes one or more open-ended longitudinal slots 21082 that allow the distal portion 21024 to flex outwardly when the pair of opposing protrusions 21054 are moved into a position received within the third pair of radially opposing openings 21040. In some embodiments, once the pair of opposing protrusions 21054 are received within the third pair of radially opposing openings 21040, the distal portion 21024 returns to its normal state.

[0471] In some embodiments, the stop 21064 is received within the channel 21027 such that the pair of opposing protrusions 21070 are received within the second pair of radially opposing openings 21038 of the expandable / expandable member 21018. In some embodiments, the proximal portion 21022 of the expandable / expandable member 21018 and / or the stop 21064 can be configured to move or flex to allow the pair of opposing protrusions 21070 to be positioned adjacent to the second pair of radially opposing openings 21038.

[0472] In some embodiments, the proximal portion 21022 of the expandable / expandable member 21018 includes one or more open-ended longitudinal slots 21084 that allow the proximal portion 21022 to flex outwardly when the pair of opposing protrusions 21070 are moved into a position received within the second pair of radially opposing openings 21038. In some embodiments, once the pair of opposing protrusions 21070 are received within the second pair of radially opposing openings 21038, the proximal portion 21022 returns to its normal state.

[0473] In some embodiments, the proximal member 21044 is received within the channel 21027 proximal to the distal member 21042. In some embodiments, the distal end 21058 of the proximal member 21044 is received in the channel 21050 in the proximal end 21046 of the distal member 21042 such that the external threads 21060 of the proximal member 21044 can threadably engage the internal threads 21052 of the distal member 21042. In some embodiments, the proximal member 21044 is screwed into the distal member 21042 until the ridge 21062 engages the stop 21064.

[0474] In some embodiments, the distal end 21072 of the end cap 21066 is received within the channel 21027 such that the pair of opposing protrusions 21078 are received within the first pair of radially opposing openings 21036 of the expandable / expandable member 21018. The proximal portion 21022 of the expandable / expandable member 21018 and / or the end cap 21066 can be configured to move or flex to allow the pair of opposing protrusions 21078 to be positioned adjacent to the first pair of radially opposing openings 21036.

[0475] In some embodiments, the proximal portion 21022 of the expandable / expandable member 21018 includes an open-ended longitudinal slot 21084 that allows the proximal portion 21022 to flex outwardly when the pair of opposing protrusions 21078 are moved into a position received within the first pair of radially opposing openings 21036. In some embodiments, once the pair of opposing protrusions 21078 are received within the first pair of radially opposing openings 21036, the proximal portion 21022 returns to its normal state.

[0476] like Figure 90-91 As shown, in some embodiments, when assembled, the ridge 21062 is sandwiched between the end cap 21066 and the stop 21064, so that the axial movement of the proximal member 21044 relative to the proximal portion 21022 of the expandable / expandable member 21018 is inhibited. However, rotational movement of the proximal member 21044 is allowed.

[0477] In some embodiments, a rotation device or tool (not shown) can engage one or more engagement surfaces 21077 through a channel 21076 in the end cap 21066 to rotate the proximal member 21044 in a first rotational direction (i.e., to screw the proximal member 21044 into the distal member 21042). With the proximal member 21044 axially secured to the proximal portion 21022 of the expandable / expandable member 21018 and the distal member 21042 axially secured to the distal portion 21024 of the expandable / expandable member 21018, screwing the proximal member 21044 into the distal member 21042 pulls the proximal portion 21022 of the expandable / expandable member 21018 toward the distal portion 21024. As a result, the strips 21028 of the intermediate portion 21026 bend or flex outward. Because the middle portion 21034 of the strap 21028 is attached to the struts 21012 of the frame member 21002 , outward expansion of the strap 21028 causes outward expansion of the frame member 21002 .

[0478] Conversely, in some embodiments, rotating the proximal member 21044 in the second rotational direction (i.e., unscrewing the proximal member 21044 from the distal member 21042) pushes the proximal portion 21022 of the expandable / expandable member 21018 away from the distal portion 21024. As a result, the strips 21028 of the intermediate portion 21026 are pulled inwardly, causing the frame members 21002 to retract inwardly.

[0479] Figures 94-98 An exemplary expandable mechanism 22016 that can be used in an expandable apposition element is shown. The expandable mechanism can be the same or similar to any of the expandable mechanisms described anywhere in this disclosure. The expandable mechanism can include one or more of the following: a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, a pivoting and / or scissor extension and / or strut, an expansion pulley mechanism, a Hoberman mechanism, a cam, a worm, a rack and pinion, foam, etc.

[0480] In some embodiments, the expandable mechanism 22016 can be positioned and / or mounted within an expandable frame member (e.g., frame member 21002). Figures 82-83 ). The exemplary expandable mechanism 22016 includes an expandable / expandable member 22018 and an actuating mechanism 22020 ( Figures 94-95 ).

[0481] The expandable / expandable member 22018 can be configured in a variety of ways. In the illustrated example, the expandable / expandable member 22018 is substantially similar to Figures 87-88The expandable / expandable member 21018, therefore the description of the expandable / expandable member 21018 is also applicable to the expandable / expandable member 22018.

[0482] In some embodiments, the expandable / expandable member 22018 is configured into an elongated cylindrical shape having a proximal portion 22022, a distal portion 22024, an intermediate portion 22026, and a channel 22027 extending from the proximal portion 22022 through the expandable / expandable member 22018 to the distal portion 22024.

[0483] In some embodiments, the middle portion 22026 is composed of a plurality of strips 22028 ( Fig.94 )form.

[0484] In some embodiments, the expandable / expandable member 22018 can include a structure configured to mount the actuation mechanism 22020 within the expandable / expandable member 22018. In some embodiments, the proximal portion 22022 of the expandable / expandable member 22018 includes a first pair of radially opposing openings 22036 and a second pair of radially opposing openings 22038 distal to the first pair of radially opposing openings 22036, and the distal portion 22024 of the expandable / expandable member 22018 includes a third pair of radially opposing openings 22040.

[0485] In some embodiments, the expandable / expandable member 22018 can be moved between a first configuration (ie, a collapsed or narrow configuration) and a second configuration (ie, an expanded or wide configuration). Fig.94 As shown, in some embodiments, in a first configuration, each of the plurality of strips 22028 extends parallel to the longitudinal axis LA2 of the expandable / expandable member 22018, and in a second configuration (see Fig.87 ), the strip 22028 is bent or flexed outwardly, causing the middle portion 22026 to expand radially outward.

[0486] In some embodiments, the actuation mechanism 22020 is configured to move the expandable / expandable member 22018 between a first configuration and a second configuration. The actuation mechanism 22020 can be configured in a variety of ways. Figures 95-98 In some embodiments, the actuation mechanism 22020 includes a distal member 22042 and a proximal member 22044 .

[0487] The distal member 22042 and the proximal member 22044 can be configured in various ways. In the illustrated example, the distal member 22042 is formed as a cylindrical tube having a circular cross-section with a sidewall 22045. However, in some embodiments, the distal member 22042 can have a shape other than a cylindrical shape (e.g., an oval, rectangular, elliptical or other suitable cross-section).

[0488] In some embodiments, the distal member 22042 includes a proximal end 22046, a distal end 22048 opposite the proximal end 22046, and an internal channel 22050 extending through the distal member 22042 from the proximal end 22046 to the distal end 22048. In some embodiments, the proximal end 22046 includes a coupling portion 22051 configured to couple to an actuation element (e.g., an actuation shaft, an actuation rod, an actuation tube, an actuation wire, etc.) (not shown).

[0489] In some embodiments, the distal member 22042 includes one or more locking members 22052 configured to engage 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 a variety of ways.

[0490] In the illustrated embodiment, each locking member 22052 is formed by the side wall 22045. For example, each locking member 22052 can be formed by laser cutting through the 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 between the first end 22053 and the second end 22057.

[0491] In some embodiments, each locking member 22052 is configured to be in a first position (eg, Figures 95-98 The locking member 22052 pivots about the intermediate portion 22059 between a first position 22053 and a second position 22057 in which the locking member 22052 pivots such that the first end 22053 extends outside the side wall 22045 and the second end 22057 extends into the channel 22050.

[0492] In some embodiments, 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 the shape of one or more locking members 22052 can be set to the second position.

[0493] In some embodiments, the distal member 22042 is sized to be received within the channel 22027 of the expandable / expandable member 21018. In some embodiments, the distal member 22042 can include features for securing the distal member 22042 in position within the channel 22027 relative to the expandable / expandable member 22018. In the example shown, the distal end 22048 includes a pair of apertures 22061.

[0494] In some embodiments, the proximal member 22044 is formed as a cylindrical tube having a circular cross-section with a sidewall 22055. However, in some embodiments, the proximal member 22044 can have a shape other than cylindrical (e.g., an oval, rectangular, elliptical, or other suitable shape in cross-section).

[0495] In some embodiments, the proximal member 22044 includes a proximal end 22056, a distal end 22058 opposite the proximal end 22056, and an internal channel 22063 extending from the proximal end 22056 through the proximal member 22044 to the distal end 22058. In some embodiments, the proximal member 22044 includes a structure configured to interact with one or more locking members 22052 of the distal member 22042. In some embodiments, the structure is formed as two series of grooves 22060 formed on opposite sides of each other in the side wall 22055. Each groove 22060 can be arranged transversely to (e.g., perpendicular to) the longitudinal axis LA2, and each series of grooves 22060 can be aligned with the locking member 22052.

[0496] In some embodiments, the proximal member 22044 is sized to be received within the channel 22027 of the expandable / expandable member 22018. In some embodiments, the proximal member 22044 includes a structure for limiting the rotational movement of the proximal member 22044 relative to the expandable / expandable member 22018 within the channel 22027. The structure for limiting the axial movement of the proximal member 21044 can be configured in a variety of ways. In some embodiments, the proximal member 22044 includes one or more tabs 22062 extending axially from the proximal end 22056.

[0497] In some embodiments, the actuation mechanism 22020 includes an end cap 22066. The end cap 22066 can be configured in a variety of ways. In some embodiments, the end cap 22066 is configured to inhibit the proximal member 22044 from moving proximally and rotationally within the channel 22027.

[0498] In some embodiments, 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 channel 22076 extending through the end cap 22066 from the distal end 22072 to the proximal end 22074. In some embodiments, the end cap 22066 is configured to receive each of the one or more tabs 22062 in a groove or recess 22077 to inhibit rotation of the proximal member 22044 within the channel 22027.

[0499] In some embodiments, the distal end 22072 of the end cap 22066 is sized to be received within the channel 22027. In some embodiments, the end cap 22066 can include structure configured to fix the position of the end cap 22066 relative to the expandable / expandable member 22018.

[0500] In some embodiments, the end cap 22066 includes a pair of opposing protrusions 22078 at the distal end 22072 that are configured to be received within the first pair of radially opposing openings 22036 of the expandable / expandable member 22018, such as Figures 90-93 In some embodiments, the end cap 22066 can include a radial flange 22080 at the proximal end 22074 that is configured to inhibit over-insertion of the end cap 22066 into the channel 22076 .

[0501] In some embodiments, the actuation mechanism 22020 includes a stop 22084 (eg, a stop member 22084a) for limiting movement of the distal member 22042 relative to the expandable / expandable member 22018. Fig.95 ). The stop 22084 can be configured in a variety of ways. In some embodiments, the stop 22084 is formed as a ring having a central channel 22088 sized to receive the distal end 22048 of the distal member 22042 therein.

[0502] In some embodiments, the stop 22084 is further sized to be received within the channel 22027 of the expandable / expandable member 22018. In some embodiments, the stop 22084 can include a structure configured to fix the position of the distal member 22042 relative to the expandable / expandable member 22018. In some embodiments, the stop 22084 includes a pair of opposing first protrusions 22090 that extend radially outward and are configured to be received within a third pair of radially opposing openings 22040 of the expandable / expandable member 22018, such as Fig.94 and 97In some embodiments, the stopper 22084 includes a pair of opposing second protrusions 22092 that extend radially inward and are configured to be received within a pair of apertures 22061 at the distal end 22048 of the distal member 22042 .

[0503] In some embodiments, when assembled, the actuation mechanism 22020 can move the expandable / expandable member 22018 between a first configuration and a second configuration. Figures 96-98 , the distal member 22042 is received within the channel 22027 of the expandable / expandable member 21018. In some embodiments, the stopper 22084 is positioned within 22027 so that a pair of opposing first projections 22090 are received within the third pair of radially opposing openings 22040 of the expandable / expandable member 22018, and a pair of opposing second projections are received within a pair of apertures 22061 at the distal end 22048 of the distal member 22042. Thus, the distal member 22042 is held in position relative to the expandable / expandable member 22018.

[0504] Furthermore, in some embodiments, the proximal member 22044 is received within the channel 22027 of the expandable / expandable member 21018, and the proximal end 22046 of the distal member 22042 is received within the channel 22063 of the proximal member 22044. In some embodiments, the distal end 22072 of the end cap 22066 is secured to the proximal member.

[0505] In some embodiments, the distal end 22072 of the end cap 22066 can be received within the channel 22027 such that the protrusion 22078 of the end cap 22066 is received in the first pair of radially opposed openings 22036 of the expandable / expandable member 22018. Thus, the end cap 22066 secures the proximal member 22044 at the proximal portion 22022 of the expandable / expandable member 22018.

[0506] In some embodiments, the proximal member 22044 is separate from the end cap 22066 and the proximal member 22044 is separately attached to the expandable / expandable member 22014. For example, the proximal member 22044 can be attached to the expandable / expandable member 22014 in the same manner as in the Figures 89-93 In the illustrated embodiment, the proximal member 21044 is attached to the expandable / expandable member 22014 in the same or similar manner as the expandable / expandable member 21014.

[0507] In some embodiments, a device (e.g., device 100 or another device herein) can be delivered by a delivery system (e.g., delivery system 102). In some embodiments, the delivery system can include a first actuation element (e.g., an actuation shaft, an actuation rod, an actuation tube, an actuation wire, etc.) (not shown) that extends through a channel 22076 in the end cap 22066, through a channel 22063 in the proximal member 22044, and is coupled to the coupling portion 22051 at the proximal end 22046 of the distal member 22042.

[0508] In some embodiments, the delivery system can include an optional second actuation element (e.g., an actuation shaft, an actuation rod, an actuation tube, an actuation wire, etc.) (not shown), which coaxially extends through the first actuation element (not shown) and into the channel 22050 of the distal member 22042.

[0509] In some embodiments, the locking members 22052 are held in the first configuration by the first actuation member and / or the second actuation member (not shown) when the first actuation member and / or the second actuation member (not shown) are in position within the channel 22050 adjacent to the one or more locking members 22052. Conversely, when the first actuation member and / or the second actuation member (not shown) are moved within the channel 22050 such that the first actuation member and / or the second actuation member (not shown) are not adjacent to the one or more locking members 22052, the locking members 22052 move to their second configuration (e.g., an outwardly extended locking configuration).

[0510] In some embodiments, in order to move the expandable / expandable member 22018 between the first configuration and the second configuration, the distal member 22042 can be moved axially within the channel 22063 of the proximal member 22044.

[0511] In some embodiments, the distal member 22042 can be moved proximally within the channel 22063 by pulling a first actuation element (not shown) coupled to the proximal end 22046 of the distal member 22042. Since the distal end 22048 of the distal member 22042 is secured to the distal portion 22024 of the expandable / expandable member 22018 by the stop 22084, and the end cap 22066 secures the proximal member 22044 in position relative to the expandable / expandable member 22018, pulling the first actuation element (not shown) with sufficient force moves the distal portion 22024 of the expandable / expandable member 22018 closer to the proximal portion 22022 of the expandable / expandable member 22018. As a result, the strips 22028 of the intermediate portion 22026 bend or flex outward. Because the straps 22028 are attached to a frame member (eg, frame member 21002), outward expansion of the straps 22028 causes outward expansion of the frame member.

[0512] In some embodiments, once the expandable / expandable member 22018, and thus the expandable apposition element, has been expanded to a desired width or diameter, the distal member 22042 can be locked in position relative to the proximal member 22044. Specifically, the first actuation member and / or the second actuation member (not shown) can be axially moved within the channel 22050 such that the first actuation member and / or the optional second actuation member (not shown) are not adjacent to the one or more locking members 22052. Thus, the one or more locking members 22052 are pivoted to their second configuration such that the first end 22053 of each of the locking members 22052 engages one of the slots 22060 in the proximal member 22044. In some embodiments, the engagement of the first end 22053 of each of the locking members 22052 with the corresponding slot 22060 locks the distal member 22042 from axial movement in the proximal direction within the channel 22063.

[0513] In some embodiments, the frame members (e.g., frame member 21002) and / or expandable / expandable members 22018 can be configured to be generally in a first configuration (i.e., a collapsed or narrow configuration), in a second configuration (i.e., an expanded or wide configuration), or in some intermediate position between the first and second configurations. In some embodiments, movement of the distal member 22042 relative to the proximal member 22044 resists the bias of the frame members and / or expandable / expandable members 22018 to pull the frame members and / or expandable / expandable members 22018 inward toward the first position, or in some embodiments, resists the bias of the frame members and / or expandable / expandable members 22018 to push the frame members and / or expandable / expandable members 22018 outward to the second position.

[0514] Fig.99 An exemplary expandable mechanism 22116 for use in an expandable apposition element is shown. The expandable mechanism 22116 can be the same or similar to any of the expandable mechanisms described anywhere in this disclosure. The expandable mechanism can include one or more of the following: a balloon, an expandable container, an expandable material, a self-expanding material, a self-expanding frame, a stent, a mechanically expandable frame, a pivoting and / or scissor extension and / or strut, an expansion pulley mechanism, a Hoberman mechanism, a cam, a worm, a rack and pinion, foam, etc.

[0515] In some embodiments, the expandable mechanism 22116 can be positioned and / or mounted within an expandable frame member (e.g., frame member 21002). Figures 82-83 ). Exemplary expandable mechanism 22116 includes expandable / expandable member 22118 and actuating mechanism 22120. Expandable / expandable member 22118 can be configured in various ways, for example, the same or similar to any other expandable / expandable member herein. Actuating mechanism 22120 can be configured in various ways, for example, the same or similar to any other actuating mechanism herein.

[0516] In the example shown, the expandable / expandable member 22118 is substantially similar to Figures 87-88 The expandable / expandable member 21018 of the present invention is described in detail, and thus the description of the expandable / expandable member 21018 is equally applicable to the expandable / expandable member 22118. Specifically, the expandable / expandable member 22118 is configured in an elongated cylindrical shape having a proximal portion 22122, a distal portion 22124, a middle portion 22126, and a channel 22127 extending from the proximal portion 22122 through the expandable / expandable member 22118 to the distal portion 22124. In some embodiments, the middle portion 22126 is formed by a plurality of strips 22128 configured to bend or flex.

[0517] In some embodiments, the expandable / expandable member 22118 can be in a first configuration (ie, a collapsed or narrow configuration) (eg, for the expandable / expandable member 21018 to Fig.88 ) and a second configuration (i.e., an expanded or wide configuration), such as Fig.99 In some embodiments, in a first configuration, each of the plurality of strips 22128 extends parallel to the longitudinal axis LA3 of the expandable / expandable member 22118, and in a second configuration, the strips 22128 bend or flex outwardly such that the intermediate portion 22126 expands radially outwardly.

[0518] The actuation mechanism 22120 can be configured in various ways, for example, in any of the configurations of other actuation mechanisms herein. In the illustrated example, the actuation mechanism 22120 includes a distal member 22142 and a proximal member 22144. In some embodiments, the distal member 22142 and the proximal member 22144 are coaxially arranged in a telescopic manner so that a portion of the proximal member 22144 is housed within the distal member 22142 and can be axially moved relative to the distal member 22142, or vice versa. In some embodiments, the axial movement of the distal member 22142 and the proximal member 22144 relative to each other causes the expandable / expandable member 22118 to move between a first configuration and a second configuration. The distal member 22142 and the proximal member 22144 can be moved relative to each other by any suitable means, such as any of the actuation mechanisms disclosed herein.

[0519] Figure 100-101 An exemplary expandable coaptation element 21000 is shown as part of a device (e.g., a valve repair device, a valve treatment device, an implantable device, an implant, etc.) configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal. The expandable coaptation element 21000 is shown attached to a clamping member (e.g., a clamping arm, a fastener arm, etc.), such as clamping member 130.

[0520] In some embodiments, the clamping member 130 can be used to attach the expandable coaptation element 21000 to the native leaflets of the native heart valve. For example, the clamping member 130 can be opened to receive the leaflets of the native mitral valve or the native tricuspid valve, and then closed to capture the leaflets and thereby attach the expandable coaptation element 21000 to the native heart valve.

[0521] In some embodiments, the expandable apposition element 21000 includes a frame member 21002 and an expandable / expandable member 21018. Fig.100 The expandable apposition element 21000 is shown in a first configuration (ie, a collapsed or narrow configuration), and Fig.101 The expandable apposition element 21000 is shown in a second configuration (ie, an expanded or wide configuration). The expandable apposition element 21000 can be moved between the first configuration and the second configuration by any suitable means (eg, any of the actuation mechanisms disclosed herein).

[0522] In some embodiments, the expandable apposition element 21000 can include an optional covering over the frame member 21002. The covering can cover a portion or the entire frame member 21002.

[0523] refer to Figures 102-110, an example of a covering 102951 for an expandable apposition element 21000 is shown. The covering 102951 can be used with any suitable expandable apposition element 21000, such as any expandable apposition element 21000 described herein. In some embodiments, the covering 102951 is configured to be attached to the frame member 21002. However, it should be understood that the covering 102951 can be configured for connection to any component of the device.

[0524] The covering 102951 can be configured in various ways. In some embodiments, the covering 102951 can include a sheet, material, fabric, layer or film attached to the frame member 21002 by a plurality of connectors (e.g., stitches, adhesives, mechanical fasteners, ultrasonic welding, etc.). In some embodiments, the sheet, material, fabric, layer and / or film can be made of a flexible material, a porous material and / or a material that is not permeable to the blood flow. In some embodiments, the sheet, material, fabric, layer and / or film is made of a biocompatible material, such as a woven biocompatible fabric configured to promote tissue ingrowth. The covering 102951 can be configured to cover or not cover any component or portion of the device.

[0525] In some embodiments, the covering 102951 can have one or more retractable portions 102953 that allow the covering 102951 to maintain a substantially taut state when in the normal position, while also allowing the covering 102951 to stretch to an expanded state. This is advantageous for situations where the covering 102951 is attached to a component of the device (such as the expandable apposition element 21000) that can move between a narrowed position and an expanded position. That is, the covering 102951 is maintained in a taut state when in the normal position, and any excess material on the device that may contact the vasculature is reduced when the expandable apposition element 21000 is in the narrowed position.

[0526] In some embodiments, the retractability of the covering 102951 then allows the expandable apposition element 21000 to move to an expanded state, wherein the covering 102951 remains substantially taut and maintains coverage of the device. The retractable portion 102953 can take a variety of different forms. Any material that can retract and return to its original size, or substantially return to its original size, can be used.

[0527] refer to Figure 102-103, a portion of an exemplary cover 102951 is shown as or formed as a flat sheet of material. In some embodiments, the cover 102951 includes sections or portions of different shapes for attachment to different portions of the frame member 21002. In some embodiments, the cover 102951 can be shaped as a smooth transition between portions of the device to reduce catch points and provide a smoother exterior to the device.

[0528] In the example shown, the covering 102951 includes a plurality of plain woven portions 102963 that are spaced apart and connected by a retractable portion 102953. In some embodiments, the plain woven portions 102963 are configured to be attached to the frame member 21002. For example, each of the plain woven portions 102963 can be attached to a corresponding strut 21012 of the frame member 21002.

[0529] In some embodiments, when the frame member 21002 is Fig.102 The first configuration shown (i.e., the collapsed or narrow configuration) is expanded to Fig.103 In the second configuration (ie, the expanded or wide configuration) shown, the telescoping portion 102953 stretches laterally from a width W2 to a width W1 that is greater than the width W2 to accommodate the expansion of the frame member 21002.

[0530] refer to Fig.105 , the plain woven portion 102963 may include weft yarns 102965 and warp yarns 102967 woven in a perpendicular weave pattern. However, the plain woven portion 102963 may take any other suitable form, or the covering 102951 may include any other type of primary weave pattern in which the retractable portion 102953 is positioned. In some embodiments, the plain woven portion 102963 is made of a woven biocompatible fabric configured to promote tissue ingrowth. The plain woven portion 102963 may also be configured to reduce blood reflux.

[0531] refer to Fig.104 and 106 -107, in some embodiments, the stretchable portion 102953 may include a pair of transition portions 102969, such as a leno weave, with a stretchable material or float 102971 connected therebetween. In some embodiments, the transition portion (such as a leno weave) provides a transition, connection or interface between the plain weave 102963 and the stretchable material or float.

[0532] refer to Fig.104, the float 102971 can include a portion of a thread that is not interwoven with any other thread. In some embodiments, the float 102971 includes a textured yarn. However, other configurations are contemplated.

[0533] In some embodiments, the leno weave 102969 can include warp yarns 102973 and weft yarns 102975 woven in a perpendicular weave pattern, wherein at least one leno yarn 102977 is wrapped around the warp yarns 102973 .

[0534] In the example shown, a single leno yarn 102977 is wrapped around four warp yarns 102973, and the weft yarn 102975 is an extension of the yarn from the float yarn 102971. In some embodiments, the weft yarn 102975 from the leno weave 102969 extends to the weft yarn 102965 of the plain weave 102963 ( Fig.105 ). In some embodiments, the plain weave 102963 is separated from the leno weave 102969, and the weft yarns 102975 of the leno weave 102969 are folded back or otherwise connected to the warp yarns 102973 and / or the leno yarns 102977 of the leno weave 102969. However, other configurations of the retractable portion 102953 are contemplated. The leno weave 102969 creates an open fabric that prevents or inhibits slippage or misalignment of the threads. The leno weave 102969 can provide further resistance to blood reflux.

[0535] refer to Figures 106-107 In some embodiments, the retractable portion 102953 may be provided by taking a position including being in an initial state (e.g. Fig.106 The above-mentioned plain weave 102963, two or more leno weaves 102969 and a covering 102951 of one or more floating threads 102971 are prepared and the covering 102951 is heated so that the floating threads 102971 shrink to a narrowed state (such as Fig.107 For example, the yarn of the float 102971 can crimp and / or curl during heating and move the float 102971 to a narrowed state. Heat setting or heat pressing the cover 102951 can shrink the float 102971 to a narrowed state.

[0536] In some embodiments, once the float line 102971 is contracted to the narrowed state, the covering 102951 generally has a width based on the float line in the narrowed state, but the float line can be pulled to expand to the stretched state such that the width of the covering expands when tension is applied to the covering 102951. For example, pulling the stretchable material or float line can temporarily straighten curled and / or kinked strands of the stretchable material or float line.

[0537] In some embodiments, removing tension from the cover 102951 moves the float back to the narrowed state, causing the cover 102951 to move back to a normal position. That is, the strands are pulled back into the curled and / or kinked heat-set configuration.

[0538] 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 and / or increase the density of the plain weave 102963, which can be advantageous in preventing or inhibiting blood reflux.

[0539] In some embodiments, the float line 102971 can have a width W1 ( Fig.106 ), and after being heated may have a width W2 ( Fig.107 ). In some embodiments, the width W1 can be between about 3 mm and about 7 mm, or any sub-range, and the width W2 can be between about 1 mm and about 3 mm, or any sub-range. The ratio of the width W1 to the width W2 can be between about 1.1:1 and about 7:1, or any sub-range. However, the width W1 and the width W2 can be of any other suitable size based on the portion of the device to which the covering 102951 is connected or the desired amount of stretch for the covering 102951.

[0540] In some embodiments, the covering 102951 is configured to maintain a substantially taut state when in a normal position while also allowing the covering 102951 to stretch to an expanded state, but the covering 102951 does not include a discrete stretchable portion 102953.

[0541] The covering 102951 can be configured to be retractable and / or elastic in a variety of different ways. In some embodiments, the covering 102951 is retractable by rotating the material of the covering so that the horizontal and vertical yarns of the woven fabric are no longer horizontal and vertical before the covering is cut from the material. For example, the material forming the covering can be rotated between 30 degrees and 60 degrees, such as between 40 degrees and 50 degrees, such as about 45 degrees or 45 degrees. The rotation of the fabric of the material forming the covering allows the covering to stretch when the frame member moves between the narrow configuration and the wide configuration. However, it should be understood that the covering 102951 can be configured to stretch in a variety of different ways.

[0542] refer to Figures 108-109 In some embodiments, the covering 102951 can be attached to a frame member for an expandable apposition device (e.g., Fig.82 In the illustrated example, the cover 102951 includes a single retractable portion 102953 that is configured to include a first support 102980 and a second support 102982 of the frame member 21002. Figures 106-107 However, the cover 102951 can have any suitable number of retractable portions 102953 between the first support 102980 and the second support 102982. Fig.108 When the struts 102980, 102982 are in the expanded state, the retractable portion 102953 can be stretched so that the float line 102971 has a width W1, which can be substantially equal to or less than Fig.106 The width W1 of the preheating float line 102971 is shown. Fig.109 When the struts 102980, 102982 are in the narrowed state, the retractable portion 102953 moves back to the normal position so that the float line 102971 has a width W2, which can be substantially equal to or greater than Fig.107 The width W2 of the heat set float line 102971 is shown.

[0543] Fig.110A schematic top view of an exemplary covering 102951 of an expandable apposition element in both a narrowed state and an expanded state is shown. In some embodiments, the covering 102951 includes a plurality of plain woven portions 102963 that are spaced apart and connected to one or more telescoping portions 102953. In the illustrated example, the covering 102951 includes six plain woven portions 102963 that are evenly spaced apart. However, in some embodiments, the covering 102951 can include more or less than six plain woven portions 102963 and / or the plain woven portions 102963 can be unevenly spaced apart. In some embodiments, two or more plain woven portions 102963 can be connected side by side.

[0544] In the example shown, each plain woven portion 102963 is connected to another plain woven portion 102963 by a pair of stretchable portions 102953. However, in some embodiments, the covering 102951 can include more or less than two stretchable portions 102953 connecting two plain woven portions 102963. A plain woven portion 102963 can be connected to a stretchable portion 102953 or other plain woven portions 102963, and a stretchable portion 102953 can be connected to other stretchable portions 102953 in any suitable manner. In the example shown, a leno stitch 102964 is used to connect the two stretchable portions 102953 together and to connect the plain woven portion 102963 to the stretchable portion 102953.

[0545] like Fig.110 As shown, the covering 102951 can be stretched from a first diameter D1 in a first state to a second diameter D2 in a second state. In some embodiments, the ratio of D2:D1 is in the range of 1.5:1 to 3:1. Fig.110 As shown, the telescoping portion 102953 is responsible for most of the increase in diameter of the covering 102951 when expanded. For example, in some embodiments, the length of the plain woven portion 102963 expands by less than 5%, less than 4%, less than 3%, or less than 2% when the covering expands from the first state to the second state.

[0546] Any of the coverings disclosed herein (e.g. Fig.110 The illustrated covering 102951) can be formed in a variety of different ways. In some embodiments, the covering is woven into a tube. For example, the material of the covering 102951 can be woven into a tube around a core shaft and / or through a circular loom.

[0547] In some embodiments, the covering 102951 can be woven into a flat sheet. A covering material woven into a flat sheet can be formed into a tube or another shape, for example, by connecting two opposite ends of the flat sheet together (e.g., with stitches).

[0548] Any of the coverings disclosed herein may be woven into a tube, woven into a flat sheet, woven into some other shape / configuration, and / or some portions of the covering may be woven into a tube while other portions of the covering may be woven into a sheet, etc.

[0549] In some embodiments, a covering, such as any of the coverings described herein, can be configured and / or treated to reduce blood flow through the covering. In some embodiments, the covering configured and / or treated to reduce blood flow through the covering can be expandable / retractable or non-expandable / retractable.

[0550] The covering can be configured and / or treated in a variety of different ways to reduce blood flow through the covering. For example, the covering can be configured and / or treated to reduce blood flow through the covering by reducing the pore size. The pore size can be reduced in a variety of different ways. For example, the pore size can be reduced by increasing the density of the fabric, by laminating the fabric, by coating the fabric, by layering the fabric, and / or by other means.

[0551] The density of the fabric can be increased in a variety of different ways. In some embodiments, the number of warp threads per inch (EPI) and / or weft threads per inch (PPI) of one or more portions of the fabric can be increased to increase the density of the fabric and reduce the permeability of the fabric. For example, the EPI x PPI can be between 160 x 152 and 400 x 500 or any sub-range. The EPI x PPI of polyethylene terephthalate (PET) yarn can be between 160 x 152 and 400 x 500 or any sub-range. The EPI x PPI of 50% polyethylene terephthalate (PET) and 50% polyolefin (PO) yarn can be between 160 x 152 and 400 x 500 or any sub-range. The EPI x PPI can be 160 x 196. The EPI x PPI can be 160 x 256. The EPI x PPI can be 160 x 304. The EPI x PPI can be 160 x 152. For PET yarn, EPI X PPI can be 160X 196. For PET yarn, EPI X PPI can be 160X 256. For PET yarn, EPI X PPI can be 160X 304. For 50 / 50PET and PO yarn, EPI X PPI can be 160X 152.

[0552] refer to Fig.111 In some embodiments, the covering material 27000 comprises a fabric 27002 laminated with a coating 27004 to reduce the permeability of the covering material. The coating 27004 can be a variety of different materials configured to reduce the permeability of the covering material 27000. For example, the coating 27004 can be silicone, TPU, polyolefin, and / or other polymer-based coatings.

[0553] The fabric 27002 can take a variety of different forms. For example, the fabric 27002 can be any of the expandable and / or non-expandable fabrics disclosed herein.

[0554] exist Fig.111 In the example shown, the release paper 27010 is coated with the coating 27004. In some embodiments, the coated release paper 27010 and the fabric 27002 pass through a pair of nip rollers 27020. The nip rollers 27020 compress the coating and transfer the coating from the release paper 27010 to the fabric 27002. In some embodiments, the release paper 27010 is separated from the fabric 27002, so that the coated cover material 27000 has reduced permeability.

[0555] In some embodiments, the permeability reducing yarns may be woven into the fabric of the covering material. For example, TPU, silicone, polyolefin, and / or elastic yarns may be woven into any of the covering materials disclosed herein.

[0556] In some embodiments, the covering material comprises a fabric that is dip-coated to reduce the permeability of the covering material. The coating can be a variety of different materials configured to reduce the permeability of the covering material. For example, the dip-coated coating can be silicone, TPU, polyolefin, and / or other polymer-based coatings. 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.

[0557] In some embodiments, the fabric of the covering material is optionally dip coated by first dipping the fabric in acetone. Then, the fabric is optionally immersed in water or distilled water. Then, the fabric is immersed in a coating, such as a polyurethane or TPU or another polymer coating material. Then, the excess coating is optionally removed from the fabric. For example, the fabric can be optionally passed through a press roll to press out the excess coating. Then, the coated fabric can be optionally dried.

[0558] Fig.113 A method for use with an expandable apposition element 23000 (e.g., Figures 119-121) of an exemplary frame member 23002 (e.g., a frame, body, cage, fixture, chassis, form, etc.). The expandable apposition element 23000 (e.g., a spacer, apposition element, gap filler, membrane, sheet, plug, wedge, balloon, etc.) can be part of a device 24000 for repairing a native heart valve (e.g., a treatment device, a repair device, etc.) and can be used as part of any device described herein.

[0559] In some embodiments, the frame member 23002 is configured to be in a first collapsed configuration (see Fig.119 ) and the second expanded configuration (see Fig.120 ) between. The frame members 23002 can be configured in a variety of ways. In some embodiments, the frame members 23002 have a generally cylindrical shape (i.e., a circular cross-section) in a collapsed state and an oval, elliptical, rectangular, etc. shape (i.e., an oval, elliptical, rectangular, etc. cross-section) in an expanded configuration. However, in some embodiments, the frame members 23002 can have other shapes in a collapsed and / or expanded configuration.

[0560] In some embodiments, the frame member 23002 can include a plurality of interconnected struts 23008 that are configured to flex or bend to allow the frame member 23002 to move between a first configuration and a second configuration. The interconnected struts 23008 can be configured in various ways, such as the number and size of the struts, the shape of each strut, the arrangement 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 embodiments, the struts 23008 are arranged in a diamond pattern.

[0561] In some embodiments, the exemplary frame member 23002 includes a plurality of struts 23012 interconnected by a plurality of struts 23008. The struts 23012 can be configured in a variety of ways, such as the number and size of the struts, the shape of each strut, the arrangement and connection of the struts relative to the struts, etc. In the illustrated example, each strut 23012 extends linearly from a proximal end 23004 to a distal end 23006. In the illustrated example, each strut 23012 is connected to one of the diamond patterns 23010 of the struts 23008 along a midpoint 23014 on either side.

[0562] In some embodiments, the frame member 23002 is formed as a unitary piece. For example, the frame member 23002 can be laser cut from a tube. However, in some embodiments, some of the braces 23008 and struts 23012 can be formed separately and can be connected (e.g., welded together) in any suitable manner.

[0563] In some embodiments, the frame member 23002 can include a flexible material, which can be a metal fabric (such as a mesh) that is woven, braided, or formed in any other suitable manner, or formed by a flexible material that is laser cut or otherwise cut. In some embodiments, the material can include cloth, a shape memory alloy wire such as Nitinol for providing shape-setting capabilities, or any other flexible material suitable for implantation in the human body.

[0564] In some embodiments, when the frame member 23002 expands, the height of each of the diamond patterns 23010 decreases, while the width increases. In contrast, the height of each strut 23012 does not change. Thus, the frame member 23002 has a fixed height (i.e., the height of the strut) that does not change between the first configuration and the second configuration.

[0565] In some embodiments, the frame member 23002 can be configured to change height between a first configuration and a second configuration. For example, the pillars can be replaced with a diamond pattern so that the height of the entire frame member 23002 decreases as the width of the frame member increases.

[0566] The frame member 23002 can be moved between the first configuration and the second configuration by any suitable means. For example, in some embodiments, the frame member 23002 can be mounted around the expandable mechanism 23016 (see Figures 116-118 ), the expandable mechanism is configured to engage the frame member 23002 to move the frame member 23002 between the first configuration and the second configuration. Various different mechanisms can be used to move the frame member 23002 between the first configuration and the second configuration. For example, any expandable mechanism disclosed herein can be used.

[0567] In some embodiments, such as Fig.112 and 114 -118, the expandable mechanism 23016 includes an expandable or dilatable member 23018 (e.g., a frame, a body, a strut assembly, a tube, a shaft, a hinge member, a foldable member, a balloon, a cam, etc.) and an actuating mechanism 23020. In some embodiments, the frame member 23002 is installed around the expandable / dilatable member 23018.

[0568] The expandable or dilation member 23018 can be configured in a variety of ways. Any configuration that enables the frame member 23002 to move between a first configuration and a second configuration can be used.

[0569] refer to Fig.112In some embodiments, the expandable or dilating member 23018 is configured in an elongated shape having a proximal portion 23022, a distal portion 23024 opposite the proximal portion 23022, and a middle portion 23026 connecting the proximal portion 23022 and the distal portion 23024. In some embodiments, the middle portion 23026 is formed by a pair of strips 23028 configured to bend or flex.

[0570] In some embodiments, the expandable / expandable member 23018 comprises two opposing strips 23028. However, in other embodiments, the strips 23028 may not be equally spaced and / or the intermediate portion 23026 may comprise more or less than two (2) strips.

[0571] In some embodiments, the expandable / expandable member 23018 can be in a first configuration (e.g., an unexpanded, collapsed, and / or narrow configuration) ( Fig.112 ) and a second configuration (e.g., an expanded or wide configuration) ( Fig.114 ). Fig.112 As shown, in the first configuration, each of the plurality of strips 23028 extends parallel or substantially parallel to the longitudinal axis of the expandable / expandable member 23018, and the expandable / expandable member 23018 has a first length L1.

[0572] In some embodiments, in the first configuration, the proximal portion 23022, the distal portion 23024, and the middle portion 23026 have the same or substantially the same width.

[0573] In some embodiments, the expandable / expandable member 23018 can be formed as a unitary piece. For example, the expandable / expandable member 23018 can be laser cut from a single piece of sheet material. In some embodiments, the expandable / expandable member 23018 can be formed from multiple pieces (e.g., a pair of Nitinol sheets).

[0574] In some embodiments, the expandable / expandable member 23018 can include a flexible material, which can be a metal fabric (such as a mesh), a woven material, a braided material, or a material formed in any other suitable manner, or a material cut by a laser or otherwise. The material can be a cloth, a shape memory alloy wire such as Nitinol for providing shape-setting capabilities, or any other flexible material suitable for implantation in the human body.

[0575] In some embodiments, such as Fig.114As shown, in the second configuration, the proximal portion 23022 moves toward the distal portion 23024, or vice versa, or the proximal and distal portions move toward each other simultaneously, causing the strip 23028 to bend or flex outwardly, so that the middle portion 23026 expands to a second width greater than the first width.

[0576] In some embodiments, in the second configuration, the expandable / expandable member 23018 has a second length L2 that is less than the first length L1, and the width of the proximal portion 23022 and the distal portion 23024 remain at the first width while the middle portion 23026 expands to the second width.

[0577] In some embodiments, the expandable / expandable member 23018 is positioned within the perimeter of the frame member 23002 to engage the frame member 23002. In some embodiments, the midpoint 23034 of each of the two strips 23028 is attached to the frame member 23002. In some embodiments, the midpoint 23034 of each strip 23028 is attached to one of the struts 23012 of the frame member 23002.

[0578] In some embodiments, the midpoint 23034 of each strip 23028 can be attached to the frame member 23002 in any suitable manner (e.g., welds, sutures, fasteners, rivets, etc.).

[0579] In some embodiments, because the expandable / expandable member 23018 is positioned within the perimeter of the frame member 23002 and attached to the frame member 23002, the expandable / expandable member 23018 is in a first configuration (e.g., an unexpanded, collapsed, and / or narrow configuration) ( Fig.112 ) and a second configuration (e.g., an expanded and / or wide configuration) ( Fig.114 ) between which the frame members 23002 are moved in a first configuration of the frame member (eg, an unexpanded or collapsed configuration- Fig.119 ) and a second configuration (eg, an expanded configuration- Fig.120 )

[0580] In some embodiments, the frame members 23002 and / or expandable / expandable members 23018 can be configured to be generally in a first configuration (e.g., unexpanded, collapsed, and / or narrow configuration), in a second configuration (e.g., expanded, wide configuration, etc.), or some intermediate position between the first configuration and the second configuration.

[0581] In some embodiments, movement of the expandable / expandable member 23018 against the bias of the frame member 23002 pulls the frame member 23002 inward toward the first position. In some embodiments, movement of the expandable / expandable member 23018 against the bias of the frame member 23002 pushes the frame member outward to the second position.

[0582] refer to Figures 114-115 In some embodiments, the actuation mechanism 23020 is configured to move the expandable / expandable member 23018 between a first configuration and a second configuration. The actuation mechanism 23020 can be configured in various ways. Any actuation mechanism capable of moving the expandable / expandable member 23018 between a first configuration and a second configuration can be used, for example, the actuation mechanism can include one or more of the following: an actuation wire, an actuation element, a pivoting linkage, a cam, a rack and pinion, a worm, a lever, a pulley, an articulated arm, etc. In some embodiments, the actuation mechanism 23020 is mounted within the expandable / expandable member 23018.

[0583] refer to Figures 114-118 In some embodiments, the expandable / expandable member 23018 can include a structure configured to mount the actuation mechanism 23020 within the expandable / expandable member 23018. The structure can be configured in a variety of ways. In some embodiments, the proximal portion 23022 of the expandable / expandable member 23018 includes a first opening 23036, and the distal portion 23024 of the expandable / expandable member 23018 includes a second opening 23040.

[0584] In some embodiments, the actuation mechanism 23020 is configured as a threaded connection. Figures 114-115 , an exemplary actuation mechanism 23020 includes a distal member or external member 23042 (e.g., a tube, a body, a shaft, etc.), which is configured to be threadably connected to a proximal member or internal member 23044 (e.g., a tube, a body, a shaft, etc.).

[0585] The proximal or inner member 23044 and the distal or outer member 23042 can be configured in various ways. In the illustrated example, the distal member 23042 is formed as a cylindrical tube with a circular cross section. However, in some embodiments, the distal member 23042 can have a shape other than a cylindrical shape (e.g., an oval, rectangular, elliptical or other suitable cross section).

[0586] In some embodiments, the distal member 23042 includes a proximal end, a distal end opposite the proximal end, and an internal channel 23050 extending from the proximal end through the distal member 23042 member to the distal end. In some embodiments, the internal channel 23050 may include an internal thread for threadably coupling with the proximal member.

[0587] In some embodiments, the distal member 23042 is sized to be received within the expandable / expandable member 23018. In some embodiments, the assembly includes structure for securing the distal member 23042 in place within the expandable / expandable member 23018. In the illustrated example, a nut or collar 23149 secures the distal end of the distal member 23042 to the distal portion 23024 of the expandable / expandable member 23018, as shown. Figures 114-115 shown.

[0588] In some embodiments, the proximal member 23044 is formed as a cylindrical tube with a circular cross-section. In some embodiments, the proximal member 23044 can have a shape other than a cylindrical shape (e.g., an oval, rectangular, elliptical, conical, or other suitable cross-section). In some embodiments, the proximal member 23044 includes a proximal end, a distal end opposite the proximal end, and an internal channel 23059 extending from the proximal end through the proximal member 23044 to the distal end. In some embodiments, the size of the internal channel is set to accommodate an actuating element (e.g., an actuating element 112 for opening and closing the paddles of the valve repair device).

[0589] In some embodiments, the proximal member 23044 can include external threads extending along at least a portion of the exterior of the proximal member 23044. In some embodiments, the external threads are configured to mate with internal threads of the distal member 23042. In some embodiments, the proximal member 23044 is sized to be received within the expandable / expandable member 23018. In some embodiments, the actuation mechanism 23020 can include a structure for limiting axial movement of the proximal member 23044 relative to the expandable / expandable member 23018.

[0590] In some embodiments, the structure limits axial movement of the proximal member 23044 within the expandable / expandable member 23018 while allowing rotational movement of the proximal member 23044 relative to the expandable / expandable member 23018.

[0591] The structure that limits the axial movement of the proximal member 23044 can be configured in various ways. For example, fasteners such as clips, pins, rivets, etc. can be used to limit the axial movement of the proximal member 23044 within the expandable / expandable member 23018 while allowing the rotational movement of the proximal member 23044 relative to the expandable / expandable member 23018.

[0592] refer to Fig.112 , 114 115, in some embodiments, when assembled, the actuation mechanism 23020 can move the expandable / expandable member 23018 between the first configuration and the second configuration. Specifically, the distal member 23042 is housed within the expandable / expandable member 23018. In some embodiments, the distal member 23042 can be axially and rotationally fixed to the expandable / expandable member 23018.

[0593] exist Fig.114 and 115 In the example shown, the expandable mechanism 23016 is configured to move in one plane (ie, the two strips 23028 move apart). In some embodiments, the expandable mechanism can move in two planes. For example, the second pair of strips can be arranged orthogonally to the first pair of strips.

[0594] In some embodiments, 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 to the first plane. Thus, the frame or spacer 23002 can expand in more than one direction.

[0595] In some embodiments, the expandable mechanism can be configured such that expansion in a first plane can be controlled independently of expansion in a second plane (eg, the widths of two pairs of strips can be independently controlled).

[0596] In some embodiments, the proximal member 23044 is received in the channel 23050 of the distal member 23042 such that the external threads of the proximal member 23044 can threadably engage the internal threads of the distal member 23042. In some embodiments, a rotation device or tool (not shown) can engage the one or more engagement surfaces 23077 to rotate the proximal member 23044 in a first rotational direction (i.e., to screw the proximal member 23044 into the distal member 23042).

[0597] In some embodiments, with the proximal member 23044 axially secured to the proximal portion 23022 of the expandable / expandable member 23018 and the distal member 23042 axially secured to the distal portion 23024 of the expandable / expandable member 23018, threading the proximal member 23044 into the distal member 23042 pulls the proximal portion 23022 of the expandable / expandable member 23018 toward the distal portion 23024. As a result, the strips 23028 bend or flex outward.

[0598] In some embodiments, when the midpoint 23034 of the strap 23028 is attached to the strut 23012 of the frame member 23002 , outward expansion of the strap 23028 causes outward expansion of the frame member 23002 .

[0599] Conversely, in some embodiments, rotating the proximal member 23044 in the second rotational direction (i.e., unscrewing the proximal member 23044 from the distal member 23042) pushes the proximal portion 23022 of the expandable / expandable member 23018 away from the distal portion 23024. As a result, the straps 23028 are pulled inwardly, causing the frame members 23002 to retract inwardly. In some embodiments, the proximal member 23044 may be rotated in the second rotational direction (i.e., unscrewing the proximal member 23044 from the distal member 23042). Figures 94-98 The actuation mechanism 22016 shown replaces the actuation mechanism 23020.

[0600] refer to Figures 116-118 , the expandable mechanism 23016 can be assembled with the frame 25100 of the device 24000. The frame 25100 can take a variety of different forms. In some embodiments, the frame 25100 includes a pair of rails 25102 connected together by a central ring 25104.

[0601] In some embodiments, the proximal end 23022 and / or the distal end 23024 of the expandable / expandable member 23018 can be slidably coupled to the track 25102. The slidable coupling allows the proximal end 23022 and / or the distal end 23024 to slide relative to the frame.

[0602] The proximal end 23022 and / or the distal end 23024 can be slidably coupled to the track 25102 in a variety of different ways. Any slidable coupling can be used. In some embodiments, the proximal end 23022 includes a pair of tabs 25020 that fit around the track 25102 to slidably couple the proximal end 23022 to the frame 25100. In some embodiments, the distal end 23024 includes a pair of tabs 25020 that fit around the track 25102 to slidably couple the distal end 23024 to the frame 25100.

[0603] In some embodiments, the expandable frame member 23002 or spacer is attached to the center ring 25104 and the expandable / expandable member 23018. Since the size of the center ring 25104 is fixed, the length of the expandable frame member 23002 or spacer (when viewed from the end) is fixed by the connection with the ring. Since the size of the expandable / expandable member 23018 is adjustable, the width of the expandable frame member 23002 or spacer can be adjusted by adjusting the width of the expandable / expandable member 23018.

[0604] The expandable framework member 23002 or spacer can be attached to the center ring 25104 and the expandable / expandable member 23018 in a variety of different ways. In some embodiments, the expandable framework member 23002 or spacer can include two opposing attachment points 25110 (e.g., holes) in two of the struts 23012 for connecting to the attachment point 25111 of the ring 25104. In some embodiments, the expandable framework member 23002 or spacer can include two opposing attachment points 25112 (e.g., holes) in two of the struts 23012 for connecting to the attachment point 25113 of the expandable / expandable member 23018.

[0605] In some embodiments, the expandable framework member 23002 or spacer is attached to both the ring 25104 and the expandable / expandable member 23018 to keep the expandable mechanism 23016 centered relative to the frame 25100 regardless of the amount of expansion of the expandable / expandable member 23018. In some embodiments, when the expandable mechanism 23016 expands, the proximal end 23022 slides along the track 25102 toward the distal end 23024, and the distal end 23024 slides along the track 25102 toward the proximal end 23022.

[0606] In some embodiments, when the expandable mechanism moves between the contracted position and the expanded position, 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 / expandable member 23018) keep the midpoint 23034 of the expandable / expandable member 23018 aligned with the ring 25104.

[0607] Figures 119-122 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 apposition element 23000 is shown. The expandable apposition 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 in the present application. For example, any of the expandable apposition elements disclosed herein can be used Figure 8-14 In the device schematically shown in .

[0608] Device 24000 is Figure 8-14 The device 24000 may include any other features of any of the devices discussed in this application, and the expandable coaptation element 23000 may be positioned to engage the leaflets 30, 32, 34 (see Figure 7 and 34) or leaflets 20, 22 (see Figure 6 and 36 ) as part of any suitable device (e.g., any therapeutic and / or prosthetic device disclosed in this application).

[0609] In some embodiments, the device 24000 can be deployed from a delivery sheath and / or an implant catheter. In some embodiments, the device 24000 can include an expandable mechanism 23016, an expandable frame or spacer 23002, and / or an anchoring portion having two or more anchors, such as the anchoring portions and anchors described herein.

[0610] In some embodiments, device 24000 can be a prosthetic spacer device, a valve repair device, a valve treatment device, an implant, a treatment device, and / or another type of device that is attached to the leaflets of a native valve.

[0611] Reference now Figures 119-122 , shows a device 24000 (eg, 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. The device 24000 is Figure 8-14 One of many different configurations that the device 100 can take, shown schematically in FIG. 1 , wherein an expandable mechanism 23016 and an expandable frame or spacer 23002 are added.

[0612] In some embodiments, the device 24000 includes an expandable mechanism 23016 , an expandable frame or spacer 23002 , a proximal or attachment portion 26006 , an anchoring portion 26008 , and / or a distal portion 26010 .

[0613] In some embodiments, the expandable mechanism 23016 and / or the expandable frame or spacer 23002 are configured to be adjustably implanted between the leaflets of a native valve.

[0614] In some embodiments, anchoring portion 26008 includes a plurality of anchors 26014. Anchors can be configured in various ways. In some embodiments, anchor 26014 includes an outer blade 26016, an inner blade 26018, a blade extension member or blade frame 26020, and a fastener 26022.

[0615] In some embodiments, the attachment portion 26006 includes a first or proximal collar 26030 (or other attachment element) for engaging with a capture mechanism or coupler of a delivery system.

[0616] The delivery system for implant 24000 can be the same or similar to the delivery system 102 described above, and can include one or more of the following: a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a passage, combinations of these, etc.

[0617] In some embodiments, portions or components of expandable mechanism 23016, expandable frame or spacer 23002, and / or outer paddles 26016 and inner paddles 26018 are formed of a flexible material, which may be a metal fabric (such as a mesh) woven, braided, or formed in any other suitable manner, or a flexible material cut by laser or otherwise. The material may be cloth, a shape memory alloy wire such as Nitinol for providing shape-setting capabilities, or any other flexible material suitable for implantation in a human body.

[0618] An actuation element (e.g., an actuation shaft, an actuation rod, an actuation tube, an actuation wire, an actuation wire, etc.) can extend from a delivery system (not shown) to engage the device 24000 and effect actuation of the device (see Figure 8-14 112 in the implant 24000). In some embodiments, the actuating element extends through the proximal collar 26030, the expandable mechanism 23016, and the expandable frame or spacer 23002 to engage the cover 26040 of the distal portion 26010. The actuating element can be configured to removably engage the cover 26040 with a threaded connection or the like, so that the actuating element can be disengaged and removed from the implant 24000 after implantation.

[0619] The frame 25100 to which the expandable mechanism 23016 is mounted extends from the proximal collar 26030 (or other attachment) 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) that will be required for a single patient while maintaining a low transvalvular gradient.

[0620] In some embodiments, outer paddle 26016 is connectably attached to cover 26040 of distal portion 26010 by connecting portion 26080, and is connectably attached to inner paddle 26018 by transition portion 26082. In some embodiments, paddle frame 26020 is attached to cover 26040 at distal portion 26010, and extends to transition portion 26082 between inner paddle 26018 and outer paddle 26016. In some embodiments, paddle frame 26020 is formed of a material that is more rigid and harder than the material from which paddles 26018, 26016 are formed, such that paddle frame 26020 provides support for paddles 26018, 26016.

[0621] Paddle frame 26020 can provide additional clamping force between inner paddles 26018 and expandable frame or spacer 23002. In some embodiments, the connections between paddle frame 26020, outer and inner paddles 26016, 26018, cover 26040, and expandable frame or spacer 23002 can constrain each of these components to movement and position of the therapeutic and / or prosthetic devices described herein.

[0622] Reference now Fig.121 , the expandable frame or spacer 23002 is positioned between the leaflets 30, 32, as shown in the top plan view. The anchor 26014 is Fig.121 26014 is shown in phantom because, in addition to the fasteners, the mounted anchors 26014 are positioned on the ventricular side of the native valve leaflets. Fig.120 The device 24000 is shown with the expandable frame or spacer 23002 in an expanded configuration.

[0623] Fig.119 and 121 The device 24000 is shown with the expandable frame or spacer 23002 in an unexpanded, collapsed, or contracted configuration. In some embodiments, the expandable mechanism 23016 is adjusted to expand or contract the expandable frame or spacer 23002 to adjust the flow through the native valve (by increasing the size of the shell to reduce regurgitation through the native valve or by decreasing the size of the shell to increase flow through the native valve), for example by rotating the engagement surface 23077 of the head 23079.

[0624] refer to Fig.122 , the strips 23028 of the expandable mechanism 23016 are separated to allow the expandable frame or spacer 23002 to move. Thus, the expandable frame or spacer 23002 has a wide configuration and occupies a larger space. Fig.119 , the strips 23028 of the mechanism 23016 are brought together to move the expandable frame or spacer 23002 to a collapsed configuration. Therefore, the expandable frame or spacer 23002 has a narrow configuration (or unexpanded configuration) and occupies less space.

[0625] The following are some non-limiting examples of some of the concepts covered herein:

[0626] Example 1. A commissural element (e.g., an expandable commissural element, etc.) for inhibiting regurgitation between leaflets of a native heart valve, the commissural element comprising: (i) an expandable mechanism configured to move between an expanded configuration and a collapsed configuration; and / or (ii) two or more shell components attached to the expandable mechanism.

[0627] Example 2. The apposition element of example 1, wherein a pair of shell components of the two or more shell components are nested together when the expandable mechanism is in the collapsed configuration.

[0628] Example 3. The apposition element of any one of Examples 1 to 2, wherein the expandable mechanism comprises a plurality of struts.

[0629] Example 4. The apposition element of any one of Examples 1 to 3, wherein the expandable mechanism is configured to expand in a single direction.

[0630] Example 5. The apposition element of any one of Examples 1 to 4, wherein the expandable mechanism is configured to expand in two opposite directions.

[0631] Example 6. A device comprising: (A) an anchoring portion, which is configured to attach to the leaflets of a native heart valve; and / or (B) an apposition element (e.g., an expandable apposition element, etc.), which is attached to the anchoring portion, wherein the apposition element comprises: (i) an expandable mechanism, which is configured to move between an expanded configuration and a collapsed configuration; and / or (ii) two or more shell components, which are attached to the expandable mechanism.

[0632] Example 7. The device of Example 6, wherein a pair of the two or more shell members are nested together when the expandable mechanism is in the collapsed configuration.

[0633] Example 8. A device according to any one of Examples 6 to 7, wherein the expandable mechanism comprises a plurality of struts.

[0634] Example 9. A device according to any one of Examples 6 to 8, wherein the expandable mechanism is configured to expand in a single direction.

[0635] Example 10. A device according to any one of Examples 6 to 9, wherein the expandable mechanism is configured to expand in two opposite directions.

[0636] Example 11. A system comprising: (A) a delivery system comprising a catheter and a control handle; and / or (B) a device connected to the delivery system, the device comprising: (i) an anchoring portion configured to attach to the leaflets of a native heart valve; (ii) an apposition element (e.g., an expandable apposition element, etc.) attached to the anchoring portion, wherein the apposition element comprises: (1) an expandable mechanism configured to move between an expanded configuration and a collapsed configuration; and / or (2) two or more shell components attached to the expandable mechanism.

[0637] Example 12. The system of Example 11, wherein a pair of the two or more shell components are nested together when the expandable mechanism is in the collapsed configuration.

[0638] Example 13. A system according to any one of Examples 11 to 12, wherein the expandable mechanism comprises a plurality of struts.

[0639] Example 14. A system according to any one of Examples 11 to 13, wherein the expandable mechanism is configured to expand in a single direction.

[0640] Example 15. A system according to any one of Examples 11 to 14, wherein the expandable mechanism is configured to expand in two opposite directions.

[0641] Example 16. An apposition element (e.g., an expandable apposition element, etc.) for inhibiting regurgitation between leaflets of a native heart valve, the apposition element comprising: (i) an expandable mechanism configured to move between an expanded configuration and a collapsed configuration; and / or (ii) an expandable sleeve disposed around the expandable mechanism.

[0642] Example 17. The mate element of Example 16, wherein the expandable sleeve includes overlapping end portions.

[0643] Example 18. The apposition element of any one of Examples 16 to 17, wherein the expandable mechanism comprises a plurality of struts.

[0644] Example 19. The apposition element of any one of Examples 16 to 18, wherein the expandable mechanism is configured to expand in a single direction.

[0645] 20. The mate element of any one of Examples 16 to 19, wherein the expandable mechanism is configured to expand in two opposite directions.

[0646] Example 21. A device comprising: (A) an anchoring portion, which is configured to attach to the leaflets of a native heart valve; and / or (B) an apposition element (e.g., an expandable apposition element, etc.), which is attached to the anchoring portion, wherein the apposition element comprises: (i) an expandable mechanism, which is configured to move between an expanded configuration and a collapsed configuration; and / or an expandable sleeve, which is disposed around the expandable mechanism.

[0647] Example 22. A device according to Example 21, wherein the expandable sleeve includes overlapping end portions.

[0648] Example 23. A device according to any one of Examples 21 to 22, wherein the expandable mechanism comprises a plurality of struts.

[0649] Example 24. A device according to any one of Examples 21 to 23, wherein the expandable mechanism is configured to expand in a single direction.

[0650] Example 25. A device according to any one of Examples 21 to 24, wherein the expandable mechanism is configured to expand in two opposite directions.

[0651] Example 26. A treatment and / or repair system comprising: (A) a delivery system comprising a catheter and a control handle; and (B) a valve repair device connected to the delivery system, the valve repair device comprising: (i) an anchoring portion configured to attach to the leaflets of a native heart valve; and / or (ii) an apposition element (e.g., an expandable apposition element, etc.) attached to the anchoring portion, wherein the apposition element comprises: (1) an expandable mechanism configured to move between an expanded configuration and a collapsed configuration; and / or (2) an expandable sleeve disposed around the expandable mechanism.

[0652] Example 27. A treatment and / or repair system according to Example 26, wherein the expandable sleeve includes overlapping end portions.

[0653] Example 28. A treatment and / or repair system according to any one of Examples 26 to 27, wherein the expandable structure comprises a plurality of struts.

[0654] 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.

[0655] 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.

[0656] Example 31. A symmetric element (e.g., an expandable symmetric element, etc.) for inhibiting regurgitation between leaflets of a native heart valve, the symmetric element comprising: (i) one or more shape-changing components; and / or wherein a tensile force is applied to the one or more shape-changing components to change the one or more shape-changing components from a flat configuration to a curved configuration.

[0657] Example 32. The mate element of Example 31, further comprising a compressible filler material disposed between a pair of the one or more shape changing components.

[0658] Example 33. The commensurate element of any of Examples 31 to 32, wherein the one or more shape changing components have a kirigami configuration.

[0659] Example 34. The mate element of any one of Examples 31 to 33, wherein a pair of shape changing components of the one or more shape changing components are parallel and spaced apart in the flat configuration.

[0660] Example 35. The mate element of Example 34, wherein the pair of shape changing components of the one or more shape changing components are bent toward each other in the bent configuration.

[0661] Example 36. A device comprising: (A) an anchoring portion configured to attach to a leaflet of a native heart valve; and / or (B) an apposition element (e.g., an expandable apposition element, etc.) attached to the anchoring portion, wherein the apposition element comprises: (i) one or more shape changing components; and / or (ii) wherein a tensile force is applied to the one or more shape changing components to cause the one or more shape changing components to change from a flat configuration to a curved configuration.

[0662] Example 37. The device of Example 36, further comprising a compressible filling material disposed between a pair of the one or more shape changing components.

[0663] Example 38. A device according to any of Examples 36 to 37, wherein the one or more shape changing components have a kirigami configuration.

[0664] Example 39. A device according to any of Examples 36 to 38, wherein a pair of shape changing components of the one or more shape changing components are parallel and spaced apart in the flat configuration.

[0665] Example 40. A device according to Example 39, wherein the pair of shape changing components of the one or more shape changing components are bent toward each other in the bent configuration.

[0666] Example 41. A system comprising: (A) a delivery system comprising a catheter and a control handle; (B) a device connected to the delivery system, the device comprising: (i) an anchoring portion, the anchoring portion being configured to attach to the leaflets of a native heart valve; and / or (ii) an apposition element (e.g., an expandable apposition element, etc.) attached to the anchoring portion, wherein the apposition element comprises: (1) one or more shape changing components; and / or (2) wherein a tensile force is applied to the one or more shape changing components to cause the one or more shape changing components to change from a flat configuration to a curved configuration.

[0667] Example 42. The system of Example 41, further comprising a compressible filling material disposed between a pair of the one or more shape changing components.

[0668] Example 43. A system according to any of Examples 41 to 42, wherein the one or more shape changing components have a kirigami configuration.

[0669] Example 44. A system as described in any of Examples 41 to 43, wherein a pair of shape changing components of the one or more shape changing components are parallel and spaced apart in the flat configuration.

[0670] Example 45. The system of Example 44, wherein the pair of shape changing components of the one or more shape changing components are bent toward each other in the bent configuration.

[0671] Example 46. An apposition element (e.g., an expandable apposition element, etc.) for inhibiting regurgitation between leaflets of a native heart valve, the apposition element comprising: (A) a unit grid, the unit grid comprising: (i) a first controllable unit, the first controllable unit being configured to increase and decrease the size of the first controllable unit; (ii) a second controllable unit, the second controllable unit being configured to increase and decrease the size of the second controllable unit; and / or (ii) wherein the size of the first controllable unit is configured to be controlled independently of the size of the second controllable unit.

[0672] Example 47. A device comprising: (A) an anchoring portion configured to attach to a leaflet of a native heart valve; and / or (B) a cell grid connected to the anchoring portion, the cell grid comprising: (i) a first controllable cell configured to enable the size of the first controllable cell to increase and decrease; (ii) a second controllable cell configured to enable the size of the second controllable cell to increase and decrease; and / or (iii) wherein the size of the first controllable cell is configured to be controlled inde...

Claims

1. A coaptation element for inhibiting regurgitation between leaflets of a native heart valve, the coaptation element comprising: an expandable mechanism configured to move between an expanded configuration and a collapsed configuration; and Two or more shell components are attached to the expandable mechanism.

2. The apposition element of claim 1, wherein a pair of shell members among the two or more shell members are nested together when the expandable mechanism is in the collapsed configuration.

3. The apposition element according to any one of claims 1 to 2, wherein the expandable mechanism comprises a plurality of struts.

4. The apposition element according to any one of claims 1 to 3, wherein the expandable mechanism is configured to expand in a single direction.

5. The apposition element according to any one of claims 1 to 4, wherein the expandable mechanism is configured to expand in two opposite directions.

6. A device comprising: an anchoring portion configured to attach to a leaflet of a native heart valve; an apposition element attached to the anchoring portion, wherein the apposition element comprises: an expandable mechanism configured to move between an expanded configuration and a collapsed configuration; and Two or more shell components are attached to the expandable mechanism.

7. The device of claim 6, wherein a pair of the two or more shell members are nested together when the expandable mechanism is in the collapsed configuration.

8. The device according to any one of claims 6 to 7, wherein the expandable mechanism comprises a plurality of struts.

9. The device according to any one of claims 6 to 8, wherein the expandable mechanism is configured to expand in a single direction.

10. The device according to any one of claims 6 to 9, wherein the expandable mechanism is configured to expand in two opposite directions.

11. A system comprising: a delivery system comprising a catheter and a control handle; A device coupled to the delivery system, the device comprising: an anchoring portion configured to attach to a leaflet of a native heart valve; an apposition element attached to the anchoring portion, wherein the apposition element comprises: an expandable mechanism configured to move between an expanded configuration and a collapsed configuration; and Two or more shell components are attached to the expandable mechanism.

12. The system of claim 11, wherein a pair of the two or more shell members are nested together when the expandable mechanism is in the collapsed configuration.

13. The system of any one of claims 11 to 12, wherein the expandable mechanism comprises a plurality of struts.

14. The system of any one of claims 11 to 13, wherein the expandable mechanism is configured to expand in a single direction.

15. The system of any one of claims 11 to 14, wherein the expandable mechanism is configured to expand in two opposite directions.

16. An apposition element for inhibiting regurgitation between leaflets of a native heart valve, the apposition element comprising: an expandable mechanism configured to move between an expanded configuration and a collapsed configuration; and An expandable sleeve is disposed around the expandable mechanism.

17. The apposition element of claim 16, wherein the expandable sleeve includes overlapping end portions.

18. The apposition element of any one of claims 16 to 17, wherein the expandable mechanism comprises a plurality of struts.

19. The apposition element of any one of claims 16 to 18, wherein the expandable mechanism is configured to expand in a single direction.

20. The apposition element of any one of claims 16 to 19, wherein the expandable mechanism is configured to expand in two opposite directions.

21. An apparatus comprising: an anchoring portion configured to attach to a leaflet of a native heart valve; an apposition element attached to the anchoring portion, wherein the apposition element comprises: an expandable mechanism configured to move between an expanded configuration and a collapsed configuration; and An expandable sleeve is disposed around the expandable mechanism.

22. The device of claim 21, wherein the expandable sleeve comprises overlapping end portions.

23. The device of any one of claims 21 to 22, wherein the expandable mechanism comprises a plurality of struts.

24. The device of any one of claims 21 to 23, wherein the expandable mechanism is configured to expand in a single direction.

25. The device according to any one of claims 21 to 24, wherein the expandable mechanism is configured to expand in two opposite directions.

26. A therapeutic and / or repair system comprising: a delivery system comprising a catheter and a control handle; A therapeutic and / or prosthetic device coupled to the delivery system, the therapeutic and / or prosthetic device comprising: an anchoring portion configured to attach to a leaflet of a native heart valve; an apposition element attached to the anchoring portion, wherein the apposition element comprises: an expandable mechanism configured to move between an expanded configuration and a collapsed configuration; and An expandable sleeve is disposed around the expandable mechanism.

27. A treatment and / or repair system according to claim 26, wherein the expandable sleeve includes overlapping end portions.

28. A treatment and / or repair system according to any one of claims 26 to 27, wherein the expandable structure comprises a plurality of struts.

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

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

31. An apposition element for inhibiting regurgitation between leaflets of a native heart valve, the apposition element comprising: one or more shape changing components; and Wherein applying a stretching 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.

32. The apposition element of claim 31 , further comprising a compressible filler material disposed between a pair of the one or more shape changing components.

33. The apposition element of any one of claims 31 to 32, wherein the one or more shape changing components have a kirigami configuration.

34. The mate element of any one of claims 31 to 33, wherein a pair of shape changing components of the one or more shape changing components are parallel and spaced apart in the flat configuration.

35. The apposition element of claim 34, wherein the pair of shape changing components of the one or more shape changing components are bent toward each other in the bent configuration.

36. An apparatus comprising: an anchoring portion configured to attach to a leaflet of a native heart valve; an apposition element attached to the anchoring portion, wherein the apposition element comprises: one or more shape changing components; and Wherein applying a stretching 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.

37. The device of claim 36, further comprising a compressible filler material disposed between a pair of the one or more shape changing components.

38. The device of any one of claims 36 to 37, wherein the one or more shape changing components have a kirigami configuration.

39. The device of any one of claims 36 to 38, wherein a pair of shape changing components of the one or more shape changing components are parallel and spaced apart in the flat configuration.

40. The device of claim 39, wherein the pair of shape changing components of the one or more shape changing components are bent toward each other in the bent configuration.

41. A system comprising: a delivery system comprising a catheter and a control handle; A device coupled to the delivery system, the device comprising: an anchoring portion configured to attach to a leaflet of a native heart valve; an apposition element attached to the anchoring portion, wherein the apposition element comprises: one or more shape changing components; and Wherein applying a stretching 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.

42. The system of claim 41, further comprising a compressible filler material disposed between a pair of the one or more shape changing components.

43. The system of any one of claims 41 to 42, wherein the one or more shape changing components have a kirigami configuration.

44. The system of any one of claims 41 to 43, wherein a pair of shape changing components of the one or more shape changing components are parallel and spaced apart in the flat configuration.

45. The system of claim 44, wherein the pair of shape changing components of the one or more shape changing components are bent toward each other in the bent configuration.

46. ​​An apposition element for inhibiting regurgitation between leaflets of a native heart valve, the apposition element comprising: A unit grid, the unit grid comprising: a first controllable unit configured such that a size of the first controllable unit can be increased and decreased; a second controllable unit configured such that a size of the second controllable unit can be increased and decreased; and Wherein the size of the first controllable unit is configured to be controlled independently of the size of the second controllable unit.

47. An apparatus comprising: an anchoring portion configured to attach to a leaflet of a native heart valve; a unit grid connected to the anchoring portion, the unit grid comprising: a first controllable unit configured such that a size of the first controllable unit can be increased and decreased; a second controllable unit configured such that a size of the second controllable unit can be increased and decreased; and Wherein the size of the first controllable unit is configured to be controlled independently of the size of the second controllable unit.

48. A system comprising: a first control element; a second control element; A unit grid, the unit grid comprising: a first controllable unit, the first controllable unit being coupled to the first control element; wherein the movement of the first control element causes the size of the first controllable unit to change; a second controllable unit coupled to the second control element; and The movement of the second control element causes the size of the second controllable unit to change.

49. The system of claim 48, wherein the first control element is configured to move in a direction of a height of the first controllable unit.

50. The system of claim 49, wherein the second control element is configured to apply a force in a direction of a width of the second controllable unit.

51. An apposition element for inhibiting regurgitation between leaflets of a native heart valve, the apposition element comprising: Containers; a shape changing element having a first end and a second end, the first end being disposed in the container and the second end being disposed outside the container; a shaft disposed in the receptacle and connected to the first end of the shape changing element; and Wherein pushing the shaft in the receptacle pushes a portion of the shape changing element out of the receptacle to increase the size of the shape changing element.

52. The apposition element of claim 51, wherein the shape changing element comprises a plurality of wires.

53. The apposition element of any one of claims 51 to 52, wherein the shape changing element comprises a woven or mesh material.

54. The apposition element of any one of claims 51 to 53, wherein the shape changing element has at least one of a tear drop shape in an expanded state and a substantially cylindrical configuration in a retracted state.

55. An apparatus comprising: an anchoring portion configured to attach to a leaflet of a native heart valve; an apposition element attached to the anchoring portion, wherein the apposition element comprises: Containers; a shape changing element having a first end and a second end, the first end being disposed in the container and the second end being disposed outside the container; a shaft disposed in the receptacle and connected to the first end of the shape changing element; and Wherein pushing the shaft in the receptacle pushes a portion of the shape changing element out of the receptacle to increase the size of the shape changing element.

56. The device of claim 55, wherein the shape changing element comprises at least one of a plurality of wires, a braided material, and / or a mesh material.

57. The device of any one of claims 55 to 56, wherein the shape changing element has at least one of a teardrop shape in an expanded state and a substantially cylindrical configuration in a retracted state.

58. A therapeutic and / or repair system comprising: a delivery system comprising a catheter and a control handle; A therapeutic and / or prosthetic device coupled to the delivery system, the therapeutic and / or prosthetic device comprising: an anchoring portion configured to attach to a leaflet of a native heart valve; an apposition element attached to the anchoring portion, wherein the apposition element comprises: Containers; a shape changing element having a first end and a second end, the first end being disposed in the container and the second end being disposed outside the container; a shaft disposed in the receptacle and connected to the first end of the shape changing element; and wherein pushing the shaft in the receptacle with the delivery system pushes a portion of the shape changing element out of the receptacle to increase the size of the shape changing element.

59. A treatment and / or repair system according to claim 58, wherein the shape changing element comprises at least one of a plurality of wires, a braided material and / or a mesh material.

60. A treatment and / or repair system according to any one of claims 58 to 59, wherein the shape changing element has at least one of a teardrop shape in an expanded state and a substantially cylindrical configuration in a retracted state.

61. A therapeutic and / or repair device comprising: an anchoring portion configured to attach to a leaflet of a native heart valve; an extension portion attached to the anchor portion; and Wherein the extension is configured to impede regurgitant flow through the native heart valve.

62. A therapeutic and / or prosthetic device according to claim 61, wherein the extension is expandable.

63. A system comprising: catheter; a device coupled to the catheter; and An extension is configured to slide over the catheter and attach to the device.

64. The system of claim 63, wherein the extension is expandable.

65. The system of any one of claims 63 to 64, wherein the device comprises an apposition element configured to engage leaflets of a native heart valve.

66. An apposition element for inhibiting regurgitation between leaflets of a native heart valve, the apposition element comprising: expandable frame members; an expandable mechanism, the expandable mechanism being mounted within the expandable frame member, the expandable mechanism comprising: an expandable / expandable member connected to the expandable framework member; and An actuation mechanism is mounted within the expandable / expandable member, the actuation mechanism being configured to move the expandable / expandable member and the expandable framework member between an expanded configuration and a collapsed configuration.

67. An apposition element according to claim 66, wherein the expandable / expandable member includes a distal portion, a proximal portion opposite to the distal portion, and a middle portion located between the distal portion and the proximal portion, wherein the middle portion expands when the expandable framework member moves from the collapsed configuration to the expanded configuration.

68. The apposition element of claim 67, wherein the intermediate portion comprises a plurality of strips extending longitudinally and spaced apart, the plurality of strips being configured to bend when the intermediate portion expands.

69. The apposition element of any one of claims 66 to 68, further comprising a retractable cover covering at least a portion of the expandable framework member.

70. The apposition element of claim 69, wherein the stretchable covering comprises a plurality of woven portions, the plurality of woven portions being spaced apart and connected by a plurality of stretchable portions.

71. An apposition element according to claim 70, wherein the expandable frame member comprises a plurality of fixed height struts, the plurality of fixed height struts being interconnected by a plurality of struts, and wherein one or more of the plurality of woven portions are connected to corresponding one or more of the plurality of fixed height struts.

72. The mate element of claim 71, wherein the expandable frame member comprises six struts and the retractable covering comprises six woven portions, each of the plurality of woven portions being connected to a corresponding one of the plurality of fixed height struts.

73. A system comprising: a delivery system comprising a catheter and a control handle; A device coupled to the delivery system, the device comprising: an anchoring portion configured to attach to a leaflet of a native heart valve; an apposition element attached to the anchoring portion, wherein the apposition element comprises: expandable frame members; an expandable mechanism, the expandable mechanism being mounted within the expandable frame member, the expandable mechanism comprising: an expandable / expandable member connected to the expandable framework member; and an actuating mechanism mounted inside the expandable / expandable member, The actuation mechanism is configured to move the expandable / expandable member and the expandable framework member between an expanded configuration and a collapsed configuration.

74. A system according to claim 73, wherein the expandable / expandable member includes a distal portion, a proximal portion opposite the distal portion, and an intermediate portion located between the distal portion and the proximal portion, wherein the intermediate portion expands when the expandable framework member moves from the collapsed configuration to the expanded configuration.

75. The system of claim 74, wherein the middle portion comprises a plurality of strips extending longitudinally and spaced apart, the plurality of strips being configured to bend when the middle portion expands.

76. The system of claim 75, wherein the middle portion comprises 4 to 8 equally spaced strips.

77. A system according to any one of claims 73 to 76, wherein the actuation mechanism comprises a distal member and a proximal member, wherein the distal member is axially fixed relative to the distal portion of the expandable / expandable member, and the proximal member is axially fixed relative to the proximal portion of the expandable / expandable member.

78. The system of any one of claims 73 to 77, further comprising a retractable cover covering at least a portion of the expandable frame member.

79. The system of claim 78, wherein the retractable cover is connected to the expandable frame member.

80. The system of claim 78 or 79, wherein the stretchable covering comprises a plurality of spaced-apart woven sections connected by a plurality of stretchable sections.

81. The system of any one of claims 78 to 80, wherein the retractable covering (1) is treated to reduce the permeability of the retractable covering, (2) is coated with a polymer to reduce the permeability of the retractable covering.

82. The system of any one of claims 78 to 81, wherein one or more polymer strands made of one or more of TPU, silicone, polyolefin, and elastic yarn are woven into the stretchable covering to reduce the permeability of the stretchable covering.

83. An expandable coaptation element for inhibiting regurgitation between leaflets of a native heart valve, the expandable coaptation element comprising: an expandable mechanism configured to move between an expanded configuration and a collapsed configuration; an expandable frame attached around the expandable mechanism; and Wherein the expandable mechanism is configured to expand only in two opposite directions.

84. An expandable apposition element according to claim 83, wherein when the expandable mechanism is in the collapsed configuration, the expandable frame has a circular cross-section, and when the expandable mechanism is in the expanded configuration, the expandable frame has an oval cross-section.

Images