HEART VALVE REPAIR DEVICE AND DELIVERY DEVICE THEREFOR - Patent application

Abstract

The device or implant is configured to be positioned within the native heart valve and to allow the native heart valve to form a more effective seal. The device or implant may include a connector that holds the moving components of the device together. The components of the device or implant may include a flexion limiting portion. The paddle frame of the device or implant may be configured to move between a wide configuration and a narrow configuration while the leaflets are substantially maintained in a position pressed against each other by the paddle frame. The paddle frame may include an outer frame portion disposed around the inner frame portion. The paddle frame and / or the connectors that widen and narrow the paddle frame may be tapered. The paddle frame may include an outer frame portion that is the same width or narrower than the inner frame portion. The paddle frame may include an outer frame portion that is substantially the same height as the inner frame portion.

Description

[Technical field]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 321,867, filed March 21, 2022, which is incorporated by reference herein in its entirety for all purposes. [Background technology]

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

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

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

[0005] Valvular regurgitation involves a valve inappropriately allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the native mitral valve fails to close properly during the systolic phase of heart contraction, allowing blood to flow from the left ventricle to the left atrium. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, papillary muscle insufficiency, stretching of the mitral annulus from left ventricular dilation, or a combination of these. Mitral regurgitation in the central portion of the leaflets can be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one of the commissures of the leaflets (i.e., where the leaflets meet) can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle, and therefore the valve does not close and regurgitation is present. Tricuspid regurgitation can be similar, except on the right side of the heart. Summary of the Invention

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

[0007] In some implementations, an implantable device or implant (such as, for example, an implantable device) is provided that is configured to be positioned within the native heart valve so that the native heart valve can form a more effective seal.

[0008] In some implementations, the implantable device or implant includes an anchor portion, each anchor including a plurality of paddles each movable between an open position and a closed position.

[0009] In some implementations, an implantable device for repairing a native heart valve includes an outer paddle, an inner paddle, a clasp, a paddle frame, and clips / connectors (e.g., frame clips, frame connectors, paddle frame clips, paddle frame connectors, strain relief devices, etc.).

[0010] In some implementations, the clip / connector couples the paddle frame to at least one of the outer paddle, the inner paddle, and the clasp.

[0011] In some implementations, the paddle frame comprises an outer frame portion and an inner frame portion.

[0012] In some implementations, the clip / connector is coupled to at least one of the outer frame portion and the inner frame portion.

[0013] In some implementations, the clip / connector includes an opening configured to connect to the paddle frame.

[0014] In some implementations, the clip / connector opening receives a portion of the paddle frame.

[0015] In some implementations, the clip / connector opening receives at least one of an outer frame portion and an inner frame portion of the paddle frame.

[0016] In some implementations, the clip / connector opening has a square cross-section.

[0017] In some implementations, the clip / connector opening has a cross-sectional shape that is the same as a cross-sectional shape of at least one of the outer frame portion and the inner frame portion.

[0018] In some implementations, the clip / connector includes a first opening and a second opening.

[0019] In some implementations, the first opening is coupled to the inner paddle portion and the second opening is coupled to the outer paddle portion.

[0020] In some implementations, the clip / connector has an open configuration and a closed configuration.

[0021] In some implementations, in the open position, the head portion of the clip / connector is open such that the opening is accessible by the channel, and in the closed configuration, the head portion is closed such that the opening is not accessible.

[0022] In some implementations, at least one of the inner and outer frame portions may be disposed through the channel and into the opening.

[0023] In some implementations, the clip / connector comprises a head portion and a stem portion.

[0024] In some implementations, the head portion includes one or more engagement members.

[0025] In some implementations, the one or more engagement members engage at least one of the inner paddle and the outer paddle.

[0026] In some implementations, the one or more engagement members are positioned at a distal end of the clip / connector.

[0027] In some implementations, the engagement members have a zigzag configuration.

[0028] In some implementations, the engagement member extends through and hooks onto at least one of the outer paddle and the inner paddle.

[0029] In some implementations, the clip / connector is a first paddle frame clip / connector and the implantable device further comprises a second paddle frame clip / connector, hi some implementations, the first paddle frame clip / connector is coupled to the outer paddle and the second paddle frame clip / connector is coupled to the inner paddle.

[0030] In some implementations, the system includes one of the implantable device implementations that includes a clip or other connector, such as a paddle frame clip or paddle frame connector, and a catheter. The implantable device is coupled to the catheter.

[0031] In some implementations, an implantable device for repairing a native heart valve includes an outer paddle, an inner paddle, a clasp, and a paddle frame. In some implementations, the paddle frame includes a flexion limiting portion.

[0032] In some implementations, the bend limiting portion includes bend limiting members that engage with each other upon bending of the bend limiting portion to stop further bending of the bend limiting portion.

[0033] In an exemplary implementation, the bend limiting portion comprises a clip / connector region disposed between the first bend limiting component and the second bend limiting component.

[0034] In some implementations, the bend-limiting component comprises an L-shaped bend.

[0035] In some implementations, the clip / connector region has a rectangular, square, trapezoidal, or irregularly shaped cross-section.

[0036] In some implementations, a clip / connector (e.g., a paddle frame clip, connector, paddle frame connector, strain relief device, etc.) is coupled to the clip / connector region between the first bend limiting component and the second bend limiting component.

[0037] In some implementations, the clip / connector region has a width that is substantially the same as the width of the clip / connector.

[0038] In some implementations, the system includes one of the implantable device implementations including a paddle frame having a bend limiting portion. The implantable device is coupled to a catheter.

[0039] In some implementations, an implantable device for repairing a native heart valve includes a pair of paddle frames configured to move between a wide configuration and a narrow configuration.

[0040] In some implementations, the pair of paddle frames are movable between an open position and a closed position in which the paddle frames press the leaflets of the native heart valve together.

[0041] In some implementations, the pair of paddle frames have a first paddle frame coaptation position where the native leaflets are first pressed together when the pair of paddle frames are in a closed position and in a wide configuration.

[0042] In some implementations, the pair of paddle frames has a second paddle frame coaptation position in which the native leaflets are initially pressed together when the pair of paddle frames is in a closed position and in a 50 percent narrowed configuration.

[0043] In some implementations, the second paddle frame bond location is within 2 mm of the first paddle frame bond location.

[0044] In some implementations, the second paddle frame bond location is within 1 mm of the first paddle frame bond location.

[0045] In some implementations, the second paddle frame bond location is within 0.75 mm of the first paddle frame bond location.

[0046] In some implementations, the second paddle frame bond location is within 0.5 mm of the first paddle frame bond location.

[0047] In some implementations, the second paddle frame bonding location is 0.25 mm to 0.75 mm from the first paddle frame bonding location.

[0048] In some implementations, an apparatus for repairing a native heart valve includes a pair of paddle frames including a pair of inner paddle frame portions and a pair of adjustable width outer paddle frame portions, the pair of paddle frames being movable between an open position and a closed position.

[0049] In some implementations, the outer frame portions are configured to sandwich one another in the closed position.

[0050] In some implementations, the pair of inner frame portions do not sandwich one another in the closed position.

[0051] In some implementations, a pair of outer frame portions are shaped to provide a clamping point.

[0052] In some implementations, the pair of outer frame portions are shaped such that one or more portions of each of the pair of outer frame portions are biased beyond a centerline CL of the device.

[0053] In some implementations, the system includes a device coupled to one or more catheters.

[0054] In some implementations, a device for repairing a native heart valve includes a pair of paddle frames movable between a fully expanded and a fully narrowed configuration, hi some implementations, the pair of paddle frames are movable between an open position and a closed position in both the fully expanded and fully narrowed configurations.

[0055] In some implementations, the pair of paddle frames has a first shoulder height when the pair of paddle frames is in a closed, fully constricted configuration. In some implementations, the pair of paddle frames has a second shoulder height when the pair of paddle frames is in a closed, fully expanded configuration. In some implementations, the first shoulder height is close to the second shoulder height.

[0056] In some implementations, the height of the first shoulder is between 70% and 100% of the height of the second shoulder.

[0057] In some implementations, the height of the first shoulder is within 1 mm of the height of the second shoulder.

[0058] In some implementations, the outer frame portions are configured to pinch together in the closed position in both the fully constricted and fully expanded configurations.

[0059] In some implementations, each paddle frame of the pair of paddle frames includes an inner frame portion of fixed width and an outer frame portion of adjustable width;

[0060] In some implementations, the adjustable width outer frame portion is movable between a fully narrowed configuration and a fully widened configuration.

[0061] In some implementations, the system includes a valve repair device coupled to one or more catheters.

[0062] In some implementations, a device for repairing a native heart valve includes a pair of paddle frames, the pair of paddle frames including a pair of inner paddle frame portions and a pair of adjustable width outer paddle frame portions, the pair of paddle frames being movable between a fully expanded configuration and a fully contracted configuration.

[0063] In some implementations, the pair of paddle frames are movable between open and closed positions in both a fully spread and a fully narrowed configuration.

[0064] In some implementations, each outer paddle frame portion is disposed around a corresponding inner paddle frame portion when viewed from the proximal end, with the pair of paddles in a closed position and / or the pair of outer paddle frame portions in a fully expanded configuration.

[0065] In some implementations, the device includes a pair of clasps disposed between a pair of inner paddle frame portions.

[0066] In some implementations, each clasp of the pair of clasps is disposed between a side surface of the inner paddle frame portion when viewed from the proximal end, and the side surface of the outer frame portion is parallel to the side surface of the inner frame portion when viewed from the proximal end.

[0067] In some implementations, the distance between the side of the outer frame portion and the inner frame portion is between 0.01 mm and 0.5 mm when viewed from the proximal end.

[0068] In some implementations, the outer frame portion curves away from the inner frame portion within 0.5 mm of a lateral edge of the inner frame portion when viewed from the proximal end.

[0069] In some implementations, the system includes a valve repair device coupled to one or more catheters.

[0070] In some implementations, a device for repairing a native heart valve includes a pair of paddle frames movable between a fully expanded and a fully narrowed configuration, hi some implementations, the pair of paddle frames are movable between an open position and a closed position in both the fully expanded and fully narrowed configurations.

[0071] In some implementations, the pair of paddle frames taper in a direction from the proximal end to the distal end when viewed from the front, when the pair of paddle frames are closed, and / or when the pair of paddle frames are in a fully narrowed configuration.

[0072] In some implementations, the pair of paddle frames are tapered at an angle of 30 to 80 degrees.

[0073] In some implementations, the connector extends from a pair of paddle frames to a cap of the device.

[0074] In some implementations, the connector tapers in a direction from the proximal end to the distal end.

[0075] In some implementations, the taper angle of the connector is within 5 degrees of the taper angle of the pair of paddle frames.

[0076] In some implementations, the taper of the connector is continuous with the taper of the pair of paddle frames.

[0077] In some implementations, the system includes a valve repair device coupled to one or more catheters.

[0078] In some implementations, an apparatus for repairing a native heart valve includes a pair of inner paddle frame portions and a pair of adjustable width outer frame portions. The pair of inner paddle frame portions have a first width. In some implementations, the pair of adjustable width paddle frame portions are movable between a fully expanded configuration and a fully narrowed configuration having a second width.

[0079] In some implementations, the pair of paddle frames are movable between an open position and a closed position. hi some implementations, the second width is less than or equal to the first width.

[0080] In some implementations, a pair of adjustable width paddle frame portions are disposed about a pair of inner paddle frame portions when viewed from the proximal end of the device.

[0081] In some implementations, the pair of adjustable width paddle frame portions are configured to sandwich one another when the pair of adjustable width paddle frame portions are in a closed position.

[0082] In some implementations, the system includes a valve repair device coupled to one or more catheters.

[0083] Any of the above systems, devices, or otherwise, may be used in one or more methods implemented on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, a cadaver heart, a virtual person, a simulator, etc.). In a simulation, the body parts may optionally be referred to as "simulations" (e.g., simulated heart, simulated tissue, etc.) and may include, for example, computerized and / or physical representations.

[0084] Any of the above systems, assemblies, devices, equipment, components, etc. may be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for patient use, and the above methods may include (or additional methods may include or consist of) sterilization (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, equipment, components, etc. herein.

[0085] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like elements bear like reference numerals and in which:

[0086] To further clarify various aspects of the implementations of the present disclosure, certain embodiments and implementations will be described in more detail by reference to various aspects of the accompanying drawings. These drawings depict only exemplary implementations of the present disclosure and therefore are not to be considered as limiting the scope of the present disclosure. Furthermore, the drawings may be drawn to scale for some embodiments, but not necessarily to scale for all embodiments. The embodiments and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0087] [Figure 1] FIG. 1 shows a cross-section of a human heart in diastole. [Diagram 2] FIG. 2 shows a cross-section of a human heart during systole. [Diagram 3] FIG. 3 shows a cross-section of a human heart in systole, illustrating mitral regurgitation. [Figure 3A] FIG. 3A shows a side perspective view of the mitral valve. [Figure 4] FIG. 4 is a cross-sectional view of FIG. 3, annotated to show the natural shape of the mitral valve leaflets during systole. [Diagram 5] FIG. 5 shows a healthy mitral valve with the leaflets closed as viewed from the atrial side of the mitral valve. [Figure 6] FIG. 6 shows an incompetent mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 7] FIG. 7 shows the tricuspid valve as viewed from the atrial side of the tricuspid valve. [Figure 8] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 9] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 10] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 11] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 12] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 13] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 14] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 15] FIG. 15 illustrates one embodiment of an implantable device or implant similar to the device illustrated in FIGS. 8-14, but in which the paddles are independently controllable. [Figure 16] 16-21 show the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within the native valve. [Figure 17] 16-21 show the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within the native valve. [Figure 18] 16-21 show the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within the native valve. [Figure 19] 16-21 show the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within the native valve. [Figure 20] 16-21 show the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within the native valve. [Figure 21] 16-21 show the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within the native valve. [Figure 22] FIG. 22 shows a perspective view of an exemplary implantable device or implant in a closed position. [Diagram 23]FIG. 23 shows a perspective view of an exemplary implantable device or implant in a closed position. [Figure 24] FIG. 24 illustrates an exemplary valve repair device with the paddle in an open position. [Figure 25A] FIG. 25A shows another exemplary valve repair device with the paddles in a closed position. [Figure 25B] FIG. 25B shows a top view of an exemplary valve repair device. [Figure 26] FIG. 26 shows a perspective view of an exemplary implantable device having paddles with adjustable width. [Figure 27] FIG. 27 is a cross-section of the implantable device of FIG. 26, dividing the implantable device in two halves. [Figure 28] 28 is another cross-section of the implantable device of FIG. 26, bisecting the implantable device along a plane perpendicular to the plane shown in FIG. [Figure 29] FIG. 29 is a schematic diagram of an exemplary implant catheter assembly coupled to an implantable device, where the actuation element is coupled to a paddle actuation control and a driver head of the implantable device. [Diagram 30] FIG. 30 is a view of the assembly of FIG. 29 with the implantable device rotated 90 degrees to show a paddle width adjustment element coupled to the inner end of the implantable device's connector and coupled to the paddle width control device. [Diagram 31] FIG. 31 shows a perspective view of the clip / connector in the open position. [Diagram 32] FIG. 32 shows a perspective view of the clip / connector in the closed position. [Figure 32A] FIG. 32A shows a perspective view of the clip / connector. [Diagram 33] 33-35 show an exemplary implantable valve repair device in a closed position. [Diagram 34] 33-35 show an exemplary implantable valve repair device in a closed position. [Diagram 35]33-35 show an exemplary implantable valve repair device in a closed position. [Figure 33A] FIG. 33A shows the clip / connector of FIG. 32A attached to a component of the exemplary implantable valve repair device of FIGS. 33-35. [Figure 36A] 36A-36C show an exemplary clip / connector on an implantable valve repair device. [Figure 36B] 36A-36C show an exemplary clip / connector on an implantable valve repair device. [Figure 36C] 36A-36C show an exemplary clip / connector on an implantable valve repair device. [Figure 37A] FIG. 37A shows an embodiment of an implantable valve repair device having a clip / connector coupled to an inner paddle portion. [Figure 37B] FIG. 37B shows an embodiment of an implantable valve repair device having a clip / connector coupled to a clasp. [Figure 38A] FIG. 38A illustrates an exemplary implantable valve repair device. [Figure 38B] FIG. 38B shows the exemplary implantable valve repair device of FIG. 38A with clips / connectors coupled to the inner and outer frame portions. [Figure 39] FIG. 39 illustrates an exemplary implantable valve repair device having clips / connectors coupled to the inner and outer frame portions. [Diagram 40] FIG. 40 illustrates an exemplary implantable valve repair device having clips / connectors coupled to the paddle portions. [Diagram 41] 41-42 show an exemplary clip or connector on an implantable valve repair device. [Diagram 42] 41-42 show an exemplary clip or connector on an implantable valve repair device. [Figure 43A] 43A-43D show an exemplary outer frame portion having a bend limiting portion. [Figure 43B] 43A-43D show an exemplary outer frame portion having a bend limiting portion. [Figure 43C] 43A-43D show an exemplary outer frame portion having a bend limiting portion. [Fig. 43D] 43A-43D show an exemplary outer frame portion having a bend limiting portion. [Diagram 44] 44-48 show exemplary bend-limiting portions of the paddle frame portion. [Diagram 45] 44-48 show exemplary bend-limiting portions of the paddle frame portion. [Figure 46] 44-48 show exemplary bend-limiting portions of the paddle frame portion. [Figure 47] 44-48 show exemplary bend-limiting portions of the paddle frame portion. [Figure 48] 44-48 show exemplary bend-limiting portions of the paddle frame portion. [Figure 49A] FIG. 49A illustrates an exemplary bend-limiting portion of the outer section in an open position. [Figure 49B] FIG. 49B illustrates an exemplary bend-limiting portion of the outer frame portion in a closed position. [Figure 50A] 50A-B show an exemplary outer frame portion in an expanded position. [Figure 50B] 50A-B show an exemplary outer frame portion in an expanded position. [Figure 51A] 51A-51B show an exemplary outer frame portion in a narrowed position. [Figure 51B] 51A-51B show an exemplary outer frame portion in a narrowed position. [Figure 52] FIG. 52 illustrates an exemplary implantable valve repair device. [Figure 53] 53-54 show an exemplary implantable valve repair device in an expanded position. [Figure 54]53-54 show an exemplary implantable valve repair device in an expanded position. [Figure 55] 55-56 show an exemplary implantable valve repair device in a narrowed position. [Figure 56] 55-56 show an exemplary implantable valve repair device in a narrowed position. [Figure 57] FIG. 57 is a schematic diagram of an exemplary valve repair device. [Figure 58] FIG. 58 is a schematic diagram of an exemplary valve repair device. [Figure 59] FIG. 59 is a schematic top view of one embodiment of an outer paddle frame portion wrapped around an inner paddle frame portion. [Figure 60] FIG. 60 is a schematic top view of FIG. 59 with the trajectory of the leaflets illustrated. [Figure 61] FIG. 61 is a schematic diagram of a valve repair device having tapered expandable paddles. [Figure 62] FIG. 62 is a partial side view of an exemplary implantable valve repair device having an embodiment disconnected from the connectors of the outer frame portion. [Figure 63] 63 is a partial top view of the valve repair device illustrated by FIG. [Figure 64] FIG. 64 is a perspective view of an outer frame portion of the device of FIGS. 62 and 63. FIG. [Figure 65] FIG. 65 is a top view of the outer frame portion of the apparatus of FIGS. 62 and 63. FIG. [Figure 66] FIG. 66 is a front view of the outer frame portion of the device of FIGS. 62 and 63. [Figure 67] FIG. 67 is a side view of the outer frame portion of the device of FIGS. [Figure 68] FIG. 68 is a partial perspective view of the device of FIGS. 62 and 63. FIG. [Figure 69] FIG. 69 is a top view of components of an exemplary valve repair device having interleaved expandable paddle frame portions. [Figure 70]70 is a side view of the components of the valve repair device of FIG. 69. [Figure 71] 71 is a front view of the components of the valve repair device of FIG. 69. FIG. [Figure 72] FIG. 72 is a top view of the components of the valve repair device of FIG. 69 with another outer frame implementation shown. [Figure 73] 73 is a front view of the components of the valve repair device of FIG. 63 with the outer frame implementation of FIG. 69 shown. [Figure 74] FIG. 74 is a side view of an exemplary implantable valve repair device showing an outer paddle frame portion having an extended height. [Figure 75] FIG. 75 is a front view of an exemplary valve repair device having tapered expandable paddles. [Figure 76] 76 is a perspective view of a valve repair device according to claim 75. [Figure 77] FIG. 77 is a partial front view of a valve repair device having a narrowed outer paddle frame portion that is wider than the inner paddle frame portion. [Figure 78] FIG. 78 is a partial front view of a valve repair device having a narrowed outer paddle frame portion that is wider than the inner paddle frame portion. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0088] In the following description, reference is made to the accompanying drawings which illustrate example implementations of the present disclosure. Other implementations having different structure and operation do not depart from the scope of the present disclosure.

[0089] Exemplary implementations of the present disclosure are directed to systems, devices, methods, etc., for repairing defective heart valves. For example, various implementations of valve repair devices, implantable devices, implants, and systems (including systems for delivering them) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible. Furthermore, the treatment techniques, methods, operations, steps, etc. described or proposed herein can be performed on living subjects (e.g., humans, other animals, etc.) or can be performed on non-living simulations, such as, for example, cadavers, cadaver hearts, simulators, virtual people, etc. When performed in a simulation, body parts, such as, for example, hearts, tissues, valves, etc., can optionally be referred to as "simulations" (e.g., simulated hearts, simulated tissues, simulated valves, etc.), and can include, for example, computerized and / or physical representations of body parts, tissues, etc.

[0090] As described herein, when one or more components are described as being connected, joined, fastened, coupled, attached, or otherwise interconnected, such interconnection may be direct, such as between the components, or may be indirect, such as through the use of one or more intermediate components. Also, references to a "member," "component," or "portion" as described herein are not limited to a single structural member, component, or element, but may include an assembly of components, members, or elements. Also, as described herein, the terms "substantially" and "about" are defined as at least close to (and including) a given value or condition (preferably within 10%, more preferably within 1%, and most preferably within 0.1%). As described herein, references to "simulation" include the use of cadavers, computer simulators, virtual people (e.g., when demonstrating with a virtual heart in the air), and the like.

[0091] 1 and 2 are cross-sectional views of a human heart H during diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, i.e., atrioventricular valves, respectively. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in Figs. 3-6 and leaflets 30, 32, 34 shown in Fig. 7) that extend inwardly across their respective openings, which flow together or "coapt" to form a unidirectional fluid occlusion surface. The native valve repair system of the present application is frequently described and / or illustrated with respect to the mitral valve MV. Accordingly, the anatomical structures of the left atrium LA and the left ventricle LV are described in more detail. However, the devices described herein may also be used in the repair of other native valves, for example, the devices may be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0092] The left atrium LA receives oxygen-rich blood from the lungs. During the expansion phase or diastole, seen in FIG. 1, blood already collected in the left atrium LA (during systole) moves through the mitral valve MV into the left ventricle LV due to the expansion of the left ventricle LV. During the contraction phase or systole, seen in FIG. 2, the left ventricle LV contracts to pump blood through the aortic valve AV and the ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close, preventing blood from flowing back from the left ventricle LV into the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In some implementations, the device described in this application is used to restore the function of a defective mitral valve MV. That is, the device is configured to assist in the closure of the leaflets of the mitral valve to prevent, inhibit, or reduce blood from flowing back from the left ventricle LV into the left atrium LA. Many of the devices described in this application are designed to easily grasp and secure the native valve leaflets around a coaptation element or spacer that beneficially acts as a filler in the regurgitant opening to prevent or reduce backflow or regurgitation during systole, although this is not required.

[0093] 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24 (see FIG. 5), which is a variably dense fibrous ring of tissue that surrounds the leaflets 20, 22. As can be seen from FIG. 3A, the leaflets 20, 22 (with leaflet 20 behind leaflet 22 in FIG. 3A) are wider at the annulus 24 than at the free or movable edge 25. Thus, there is a taper of the leaflets 20, 22 between the annulus 24 and the free or movable edge 25. As can also be seen from FIG. 3A, the spacing between the attachment points of the chordae tendineae CY to the free or movable edge 25 of the leaflets 20, 22 is small. With reference to FIGS. 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 in the wall of the left ventricle LV at the base of the chordae tendineae CT) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM function to limit the movement of the leaflets 20, 22 of the mitral valve MV and prevent the mitral valve MV from everting. As can also be seen from FIG. 3A, the spacing between the connection points of the chordae tendineae CY to the free or movable edges 25 of the leaflets 20, 22 is small, since multiple chordae tendineae CT are connected to the free or movable edges 25.

[0094] The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Rather, the papillary muscles PM support or brace the valve leaflets 20, 22 against the high pressures required to circulate blood through the body. Together, the papillary muscles PM and the chordae tendineae CT are known as the subvalvular tissue, which function to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As can be seen from the left ventricular outflow tract (LVOT) diagram shown in FIG. 3, the anatomy of the leaflets 20, 22 is such that the inner surfaces of the leaflets coapt at their free end portions and the leaflets 20, 22 begin to retract or spread apart from each other. The leaflets 20, 22 spread apart toward the atrium until each leaflet contacts the mitral valve annulus.

[0095] Various disease processes can impair the proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, elastic fiber deficiency, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or right ventricle RV from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathies, etc.) can distort the geometry of the native valve, which can cause the native valve to malfunction. However, the majority of patients who undergo valve surgery, such as mitral valve MV surgery, suffer from a degenerative disease that causes malfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), resulting in prolapse and regurgitation.

[0096] In general, native valves can malfunction in different ways, including (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when a native valve does not open completely, thereby causing impaired blood flow. Typically, valve stenosis is due to the accumulation of calcified material on the leaflets of the valve, which thickens the leaflets and impairs the ability of the valve to open completely and allow forward blood flow. Valve regurgitation occurs when the leaflets of the valve do not close completely, causing blood to leak back into the previous heart chamber (e.g., blood leaks from the left ventricle into the left atrium).

[0097] There are three main mechanisms by which native valves become regurgitant or incompetent, including Carpentier's Type I, II, and III insufficiencies. Carpentier's Type I insufficiency involves dilatation of the valve annulus, so that normally functioning leaflets move apart and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in the insufficiency of the Type I mechanism is leaflet perforation, as occurs in endocarditis. Carpentier's Type II insufficiency involves prolapse of one or more leaflets of the native valve above the plane of coaptation. Carpentier's Type III insufficiency involves restricted movement of one or more leaflets of the native valve, so that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease or ventricular dilatation.

[0098] With reference to FIG. 5, when a healthy mitral valve MV is in a closed position, the anterior leaflets 20 and posterior leaflets 22 coapt, thereby preventing blood from leaking from the left ventricle LV into the left atrium LA. With reference to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflets 20 and / or posterior leaflets 22 of the mitral valve MV are displaced into the left atrium LA during systole, such that the edges of the leaflets 20, 22 do not contact one another. This failure to coapt creates a gap 26 between the anterior leaflets 20 and posterior leaflets 22, which may allow blood to flow back from the left ventricle LV into the left atrium LA during systole, as shown by the mitral regurgitation MR flow path in FIG. 3. With reference to FIG. 6, the gap 26 may have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some circumstances, the gap 26 may have a width W of greater than 15 mm or even greater than 17.5 mm. As discussed above, there are several different ways in which a valve leaflet (e.g., the leaflets 20, 22 of the mitral valve MV) may become incompetent, causing valvular regurgitation.

[0099] In any of the above situations, a valve repair device or implant that can engage the anterior leaflets 20 and posterior leaflets 22 and close the gap 26 to prevent or inhibit backflow of blood through the mitral valve MV is desirable. As can be seen from FIG. 4, an abstract depiction of an implantable device, valve repair device, or implant 10 is shown implanted between the leaflets 20, 22 such that backflow does not occur during systole (compare FIG. 3 with FIG. 4). In some implementations, the coaptation elements (e.g., spacers, coaptation elements, gap fillers, etc.) of the device 10 have a generally tapered or triangular shape that naturally matches the geometry of the native valve and its tendency to expand (towards the annulus). In this application, the terms spacer, coaptation elements, and gap fillers are used interchangeably to refer to elements that fill a portion of the space between the leaflets of the native valve and / or are configured to engage or "coapt" the leaflets of the native valve (e.g., to coapt not only to each other but also to the coaptation elements, spacers, etc.).

[0100] Although stenosis or regurgitation can affect any valve, stenosis has been found to primarily affect either the aortic valve AV or the pulmonary valve PV, and regurgitation has been found to primarily affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the burden on the heart H and, if left untreated, can result in very serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. The left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) is primarily responsible for circulating blood flow throughout the body. Therefore, because the pressure on the left side of the heart is substantially higher, insufficiency of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening.

[0101] Malfunctioning native heart valves can be either repaired or replaced. Repair typically involves preserving and correcting the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Since the stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic valve or pulmonary valve can be to remove the valve and replace it with a surgically implanted heart valve, or to replace it with a transcatheter heart valve. The mitral valve MV and tricuspid valve TV are more prone to deformation of the leaflets and / or surrounding tissue, which, as described above, can prevent the mitral valve MV or tricuspid valve TV from closing properly and allow regurgitation or backflow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV can cause regurgitation or backflow from the left ventricle LV into the left atrium LA, as shown in FIG. 3). Regurgitation or backflow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. In addition, regurgitation can occur due to incompetence of the chordae tendineae CT (e.g., the chordae tendineae CT can be stretched or torn), which allows the anterior leaflet 20 and posterior leaflet 22 to invert so that blood flows back into the left atrium LA. Problems caused by incompetent chordae tendineae CT can be ameliorated by repairing the structure of the chordae tendineae CT or mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0102] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it is understood that the devices and concepts provided herein can be used to repair any native valve, as well as to repair any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or block the backflow of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts provided herein can be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or block the backflow of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein can be used together on all three of the leaflets 30, 32, 34 to prevent or block the backflow of blood from the right ventricle into the right atrium. That is, the valve repair device or implant provided herein can be centrally located between the three leaflets 30, 32, 34.

[0103] An exemplary implantable device or implant may optionally have a coaptation element (e.g., a spacer, coaptation element, gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, an implantable device or implant may have any combination or subcombination of the features disclosed herein without a coaptation element. The coaptation element (e.g., a spacer, coaptation element, gap filler, etc.), when included, is configured to be positioned within the native heart valve opening to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or blocking the backflow described above. The coaptation element may be impermeable to blood (or resist blood flow therethrough) and may have a structure that allows the native leaflets to close around the coaptation element during ventricular systole, thereby blocking backflow of blood from the left or right ventricle into the left or right atrium, respectively. The device or implant can be configured to seal against two or three native leaflets, i.e., the device can be used with native mitral (bicuspid) and native tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element can fill the space between dysfunctional native leaflets (e.g., mitral leaflets 20, 22 or tricuspid leaflets 30, 32, 34) that do not close completely.

[0104] The optional coaptation elements (spacers, coaptation elements, gap fillers, etc.) may have a variety of shapes. In some implementations, the coaptation elements may have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the coaptation elements may have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some implementations, the coaptation elements may have an atrial portion positioned in or adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a lateral surface extending between the native leaflets. In some implementations configured for use with a tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the lateral surface extends between the native tricuspid leaflets.

[0105] In some implementations, the anchors can be configured to secure the device to one or both of the native leaflets such that the coaptation element is positioned between two native leaflets. In some implementations configured for use with a tricuspid valve, the anchors are configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between three native leaflets. In some implementations, the anchors can be attached to the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some implementations, the anchors can be attached to an actuation element (e.g., actuation shaft, actuation tube, actuation wire, etc.) to which the coaptation element is also attached. In some implementations, the anchors and coaptation elements can be independently positioned relative to one another by separately moving each of the anchors and coaptation elements along a longitudinal axis of the actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.). In some implementations, the anchors and coaptation elements can be simultaneously positioned by moving the anchors and coaptation elements together along a longitudinal axis of the actuation element (e.g., shaft, actuation wire, etc.). The anchors may be configured to be positioned behind the native valve leaflets when implanted such that the leaflets are grasped by the anchors.

[0106] The device or implant may be configured to be implanted via a delivery system or other delivery means. The delivery system may include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, and the like. The coaptation elements and anchors may be compressible to a radially compressed state and self-expandable to a radially expanded state when the compressive pressure is released. The device may be configured such that the anchors are radially expanded away from the initially still compressed coaptation elements to create a gap between the coaptation elements and the anchors. The native leaflets may then be positioned within the gap. The coaptation elements may be radially expanded to close the gap between the coaptation elements and the anchors, capturing the leaflets between the coaptation elements and the anchors. In some implementations, the anchors and coaptation elements are optionally configured to be self-expanding. The implantation methods for various implementations may vary and are described more fully below for each implementation. Additional information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599, U.S. Patent Application Publication No. 2014 / 0222136, U.S. Patent Application Publication No. 2014 / 0067052, U.S. Patent Application Publication No. 2016 / 0331523, and PCT Patent Application Publication No. WO2020 / 076898, each of which is incorporated herein by reference in its entirety for all purposes. These methods can be performed, mutatis mutandis, on a living animal or a simulation, such as a cadaver, cadaver heart, simulator (e.g., a body part, heart, tissue, etc. is simulated).

[0107] The disclosed device or implant may be configured such that anchors are connected to the leaflets and utilize tension from the natural chordae tendineae to resist high systolic pressures that urge the device toward the left atrium. During diastole, the device may rely on compressive and retaining forces exerted against the leaflets that are gripped by the anchors.

[0108] 8-15, a schematic representation of an implantable device or implant 100 (e.g., an implantable prosthetic device, an artificial spacer device, a valve repair device, etc.) is shown in various stages of deployment. The device or implant 100 and other similar devices / implants are described in more detail in PCT Patent Application Publication Nos. WO2018 / 195215, WO2020 / 076898, and WO2019 / 139904, which are incorporated by reference in their entireties for all purposes. The device 100 may include any other features of an implantable device or implant described in this application or the applications cited above, and the device 100 may be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the applications cited above).

[0109] The device or implant 100 is deployed from a delivery system 102. The delivery system 102 may include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a passageway, combinations thereof, etc. The device or implant 100 includes a joint portion 104 and an anchor portion 106.

[0110] In some implementations, the interface portion 104 of the device or implant 100 is adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and includes an interface element 110 that is slidably attached to an actuation element 112 (e.g., an actuation wire, an actuation shaft, an actuation tube, etc.). The anchor portion 106 includes one or more anchors 108 that are actuable between an open state and a closed state and can take a wide variety of forms, such as, for example, a paddle, a gripping element, or the like. When the actuation element 112 is actuated, the anchor portion 106 of the device 100 opens and closes to grip the native leaflets during implantation. The actuation element 112 (as well as other actuation elements disclosed herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), can be made from a variety of different materials, and can have a variety of configurations. As one example, the actuation element can be threaded such that rotating the actuation element causes the anchor portion 106 to move relative to the interface portion 104. Alternatively, the actuation element can be unthreaded such that pushing or pulling on the actuation element 112 causes the anchor portion 106 to move relative to the interface portion 104.

[0111] The anchor portion 106 and / or anchor of the device 100, in some implementations, includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the interface element 110 by portions 124, 126, 128. The portions 124, 126, 128 may be interfaced and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 120, inner paddle 122, interface element 110, and cap 114 by portions 124, 126, 128 may constrain the device to the positions and movements shown herein.

[0112] In some implementations, the delivery system 102 includes a steerable catheter, an implant catheter, and an actuating element 112 (e.g., an actuating wire, an actuating shaft, etc.), which may be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuating element 112 extends through the delivery catheter and the interface element 110 to a distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuating element 112 increases and decreases the spacing between the interface element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), respectively.

[0113] In some implementations, a collar or other attachment element removably attaches, either directly or indirectly, the interface element 110 to the delivery system 102 such that the actuation element 112 slides through the collar or other attachment member, and in some implementations, through the interface element 110 during actuation, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0114] In some implementations, the anchor portion 106 and / or the anchor 108 may include an attachment portion or gripping member. The illustrated gripping member may include a catch 130 including a base or fixed arm 132, a movable arm 134, optional friction enhancing elements, other securing structures 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and an interface portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 with the interface portion 138 disposed proximate to the interface element 110. The interface portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the catch 130. The interface portion 138 may be any suitable interface, such as a flexible interface, a spring interface, a pivot interface, or the like. In some implementations, interface 138 is a flexible piece of material integrally formed with fixed arm 132 and movable arm 134. Fixed arm 132 is attached to inner paddle 122 and remains stationary or substantially stationary relative to inner paddle 122 when movable arm 134 is in an open state, opening clasp 130 and exposing optional barbs or other friction enhancing elements 136.

[0115] In some implementations, the clasp 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, bend or pivot on a joint 138. The actuation line 116 extends through the delivery system 102 (e.g., through the steerable catheter and / or the implant catheter). Other actuation mechanisms (e.g., wires, rods, etc.) are possible.

[0116] The actuation line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The clasp 130 can be spring loaded so that the clasp 130 continues to provide a clamping force against the grasped native leaflet in the closed position. Optional barbs or other friction enhancing elements 136 of the clasp 130 can grasp, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0117] During implantation, the paddles 120, 122 may be opened and closed, for example, to grip the native leaflets (e.g., leaflets of a native mitral valve, etc.) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation element 110 (e.g., spacer, plug, membrane, etc.). The clasps 130 may be used to grip and / or further secure the native leaflets by engaging the leaflets with optional barbs or other friction enhancing elements 136 and clamping the leaflets between the movable arm 134 and the fixed arm 132. The optional barbs or other friction enhancing elements 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) of the clasps or the barbed clasps 130 may increase friction with the leaflets or partially or completely puncture the leaflets. The actuation lines 116 may be actuated separately such that each clasp 130 may be opened and closed separately. Acting separately allows one leaflet to be grasped at a time, or the clasp 130 to be repositioned on a leaflet that was not adequately grasped without changing the good grip on the other leaflets. The clasp 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), allowing the leaflets to be grasped in various positions as the particular situation requires.

[0118] 8, the device 100 is shown in an extended or fully open state for deployment from an implant delivery catheter of a delivery system 102. The device 100 is placed on the end of the catheter of the delivery system 102 in the fully open position. In the extended state, the cap 114 is spaced apart from the interface element 110 such that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the interior of the outer paddle 120 and the inner paddle 122 is about 180 degrees. The clasp 130 can be held closed during deployment through the delivery system. The actuation line 116 can extend to and be attached to a movable arm 134.

[0119] 9, device 100 is shown in an extended state similar to FIG. 8, but with clasp 130 in a range of about 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or in a fully open position of about 180 degrees between fixed portion 132 and movable portion 134 of clasp 130.

[0120] 10, the device 100 is shown in a contracted or fully closed state. To move the device 100 from the extended state to the contracted state, the actuation element 112 is retracted, pulling the cap 114 towards the interface element 110. The connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained from moving, so that the compressive force acting on the outer paddle 120 from the cap 114 retracting towards the interface element 110 moves the paddle radially outward. The outer paddle 120 maintains an acute angle with the actuation element 112 during movement from the open position to the closed position. The outer paddle 120 may optionally be biased towards the closed position. The inner paddle 122 moves through a very large angle and crushes along the side of the closed interface element 110 because it is oriented away from the open interface element 110 during the same movement.

[0121] 11-13, the device 100 is shown in a partially open, ready-to-grasp state. To move from a fully closed state to a partially open state, an actuation element (e.g., actuation wire, actuation shaft, etc.) is extended to push the cap 114 away from the coaptation element 110, which pulls the outer paddle 120 and then the inner paddle 122, causing the anchor or anchor portion 106 to partially unfold. The actuation line 116 is also retracted to open the clasp 130, so that the leaflets can be grasped. In some implementations, the pair of inner and outer paddles 122 and 120 are moved together, rather than independently, by a single actuation element 112. Also, the position of the clasp 130 depends on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 will close the clasp. In some implementations, the paddles 120, 122 may be independently controllable. In the embodiment shown in FIG. 15, the device 100 may have two actuating elements 111, 113 and two independent caps 115, 117 (or other mounting parts), such that one independent actuating element (e.g., wire, shaft, etc.) and cap (or other mounting part) is used to control one paddle and the other independent actuating element and cap (or other mounting part) is used to control the other paddle.

[0122] 12, one of the actuation lines 116 can be extended to close one of the clasps 130. Now, referring to FIGURE 13, the other actuation line 116 can be extended to close the other clasp 130. One or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0123] 14, the device 100 is shown in a fully closed and deployed state. The delivery system 102 and actuation element 112 are retracted and the paddles 120, 122 and clasp 130 remain in the fully closed position. Once deployed, the device 100 may be maintained in the fully closed position by a mechanical latch or may be biased to remain closed by the use of a spring material such as steel, other metals, plastics, composites, or a shape memory alloy such as Nitinol. For example, the connecting portions 124, 126, 128, the interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from a metal such as steel or from a shape memory alloy such as Nitinol that is fabricated into a wire, sheet, tube, or laser sintered powder and biased to hold the outer paddle 120 closed around the interface element 110 and the clasp 130 in a clamped state around the native leaflets. Similarly, the fixed and movable arms 132, 134 of the clasp 130 are biased to clamp the valve leaflets. In some implementations, the attachment or connecting portions 124, 126, 128, the interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from metal or any other suitable resilient material, such as a polymeric material, to maintain the device 100 in a closed state after implantation.

[0124] Figure 15 shows an embodiment in which the paddles 120, 122 are independently controllable. The device 101 shown in Figure 15 is similar to the device shown in Figure 11, except that the device 100 of Figure 15 includes an actuation element configured as two independent actuation elements 111, 113 coupled to two independent caps 115, 117. The actuation element 111 is extended to push the cap 115 away from the interface element 110 to transition the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the first anchor 108 to partially expand. The actuation element 113 is extended to push the cap 115 away from the spacer or mating element 110 to transition the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchor 108 to partially expand. The independent paddle control shown in Figure 15 can be implemented in any of the devices disclosed in this application. For comparison, in the embodiment shown in Figure 11, the pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation element 112.

[0125] 16-21, the implantable device 100 of Figures 8-14 is shown delivered and implanted within the native mitral valve MV of the heart H. With reference to Figure 16, a delivery sheath / catheter is inserted through the septum into the left atrium LA and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state as shown in Figure 16. The actuating element 112 is then retracted, moving the implant / device to a fully closed state as shown in Figure 17.

[0126] As can be seen from Figure 18, the implant / device is moved into position within the mitral valve MV and into the ventricle LV, partially open so as to grasp the leaflets 20, 22. For example, a steerable catheter may be advanced to steer or bend the steerable catheter to position it as shown in Figure 18. An implant catheter connected to the implant / device may be advanced from within the steerable catheter to position the implant as shown in Figure 18.

[0127] 19, the implant catheter may be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 within the clasps 130. The actuating line 116 is extended to close one of the clasps 130, capturing the leaflet 20. FIG. 20 shows the other actuating line 116 then being extended to close the other clasp 130, capturing the remaining leaflet 22. Finally, as can be seen from FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), actuating element 112, and actuating line 116 are then retracted and the device or implant 100 is fully closed and deployed within the native mitral valve MV.

[0128] Any of the features disclosed herein may be used in a wide variety of different valve repair devices. Figures 22-24 show examples of valve repair devices that may be modified to include any of the features disclosed herein. Any combination or subcombination of the features disclosed herein may be combined with, substituted for, and / or added to any combination or subcombination of the features of the valve repair devices shown in Figures 8-24.

[0129] 22, an embodiment of an implantable device or implant 200 is shown. The implantable device 200 is one of many different forms that the device 100, shown generally in FIGS. 8-14, may take. The device 200 may include any of the other features of an implantable device or implant described herein, and the device 200 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system, such as any of the valve repair systems disclosed herein. The device / implant 200 may be an artificial spacer device, a valve repair device, or another type of implant that attaches to the leaflets of a native valve.

[0130] In some implementations, the implantable device or implant 200 includes a mating portion 204, a proximal or attachment portion 209, an anchor portion 206, and a distal portion 207. In some implementations, the mating portion 204 of the device optionally includes a mating element 210 (e.g., a spacer, mating element, plug, membrane, sheet, gap filler, etc.) for implantation between the leaflets of the native valve. In some implementations, the anchor portion 206 includes multiple anchors 208. The anchors may be configured in a variety of ways. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension or frame 224, and a clasp 230. In some implementations, the attachment portion 209 includes a first or proximal collar 211 (or other attachment element) for engaging a capture mechanism (e.g., a coupler, clamp, tether, etc.) of a delivery system. The delivery system for device 200 may be the same as or similar to delivery system 102 described above and may comprise one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, and the like.

[0131] In some implementations, the joint elements 210 and paddles 220, 222 are made from a flexible material, which may be a metal fabric formed as a mesh, woven fabric, braided fabric, or the like, or in any other suitable manner, or a flexible material that is laser cut or otherwise cut. The material may be a fabric, a shape memory alloy wire, such as Nitinol, to provide shape setting capabilities, or any other flexible material suitable for implantation within the human body.

[0132] An actuation element (e.g., an actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) may extend from a delivery system (not shown) and engage the implantable device or implant 200 to enable actuation thereof. In some implementations, the actuation element extends through the proximal collar 211 and spacer or interface element 210 and engages a cap 214 on the distal portion 207. The actuation element may be configured to releasably engage the cap 214 with a threaded connection, or the like, such that the actuation element may be disengaged and removed from the device 200 after implantation.

[0133] The coaptation element 210 extends from a proximal collar 211 (or other attachment element) to an inner paddle 222. In some implementations, the coaptation element 210 has a generally elongated and circular shape, although other shapes and configurations are possible. In some implementations, the coaptation element 210 has an oval shape or cross-section when viewed from above, a tapered shape or cross-section when viewed from the front, and a circular shape or cross-section when viewed from the side. A mixture of these three geometries may result in the illustrated three-dimensional shape of the coaptation element 210 that achieves the benefits described herein. The round shape of the coaptation element 210 may also be seen to substantially follow or approximate the shape of the paddle frame 224 when viewed from above.

[0134] The size and / or shape of the coaptation element 210 may be selected to minimize the number of implants required per patient (preferably one) while maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the apex of the coaptation element is about 5 mm, and the medial-lateral distance at the widest point of the coaptation element is about 10 mm. In some implementations, the overall geometry of the device 200 may be based on these two dimensions and the overall shape plan described above. It will be readily apparent that using other anterior-posterior and medial-lateral distances as a starting point for the device will result in a device with different dimensions. Additionally, using other dimensions and the shape plan described above will also result in a device with different dimensions.

[0135] In some implementations, the outer paddle 220 is joinably attached to the cap 214 of the distal portion 207 by connecting portion 221 and to the inner paddle 222 by connecting portion 223. The inner paddle 222 is joinably attached to the joint element by connecting portion 225. In this manner, the anchor 208 is configured similar to a leg in that the inner paddle 222 is like an upper portion of a leg, the outer paddle 220 is like a lower portion of a leg, and the connecting portion 223 is like a knee portion of a leg.

[0136] In some implementations, the inner paddle 222 is hard, relatively hard, rigid, has rigid portions, and / or is rigidified by stiffening members (e.g., plates, bars, rods, panels, etc.) and / or fixed portions of the fasteners 230. The inner paddle 222, outer paddle 220, and interface elements may all be interconnected as described herein.

[0137] In some implementations, the paddle frame 224 is attached to the cap 214 of the distal portion 207 and extends to a connection 223 between the inner paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is formed from a material that is stiffer and harder than the material forming the paddles 222, 220 such that the paddle frame 224 provides support to the paddles 222, 220.

[0138] The paddle frame 224 may provide additional clamping force between the inner paddle 222 and the coaptation element 210 and may help wrap the leaflets around the sides of the coaptation element 210. That is, the paddle frame 224 may be configured with a rounded three-dimensional shape that extends from the cap 214 to the connecting portion 223 of the anchor 208. The connections between the paddle frame 224, the outer and inner paddles 220 and 222, the cap 214, and the coaptation element 210 may constrain each of these members to the movements and positions described herein. For example, the connecting portion 223 is constrained by its connection between the outer and inner paddles 220 and 222 and by its connection to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connecting portion 223 (and thus the inner and outer paddles 222 and 220) and by its attachment to the cap 214.

[0139] This wider configuration of the paddle frame 224 provides an increased surface area as compared to just the inner paddle 222. The increased surface area allows the clamping force of the paddles 220 and paddle frame 224 against the native leaflets to be distributed over a larger area of ​​the native leaflets to further protect the native leaflet tissue.

[0140] Additional features of the device 200, modified versions of the device, delivery systems for the device, and methods for using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215). Any combination or subcombination of features disclosed by this 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. WO2018 / 195215). Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) is incorporated herein by reference in its entirety.

[0141] 23, there is shown one embodiment of an implantable device or implant 300. The implantable device 300 is one of many different forms that the device 100, shown generally in FIGS. 8-14, may take. The device 300 may include any of the other features of an implantable device or implant described herein, and the device 300 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0142] The implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 includes a coaptation portion 304, which can optionally include a coaptation element 310 (e.g., a spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 can include one or more paddles, for example, an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchors can also include and / or be coupled to a clasp 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging a capture mechanism of a delivery system.

[0143] The anchors 308 may be attached to other portions of the device and / or to each other in a variety of different manners (e.g., directly, indirectly, by welding, by sutures, by adhesive, by links, by latches, by integral formation, by combinations of any or all of these, etc.) In some implementations, the anchors 308 are attached to the interface element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0144] The anchor 308 may include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connecting portion 323. The connecting portion 323 may be attached to a paddle frame 324 that is hingedly attached to the cap 314 or other mounting portion. In this manner, the anchor 308 is configured similar to a leg, in that the inner paddle 322 is like an upper portion of a leg, the outer paddle 320 is like a lower portion of a leg, and the connecting portion 323 is like a knee portion of a leg.

[0145] In some implementations including the interface element 310, the interface element 310 and the anchor 308 may be coupled together in a variety of ways. As shown in the illustrated embodiment, the interface element 310 and the anchor 308 may be coupled together by integrally forming the interface element 310 and the anchor 308 as a single, unitary component. This may be accomplished, for example, by forming the interface element 310 and the anchor 308 from a continuous piece 301 of braided or woven material, such as braided or interwoven Nitinol wire. In the illustrated embodiment, the interface element 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, 325 are formed from a continuous piece of fabric 301.

[0146] Similar to the anchor 208 of the implantable device or implant 200 described above, the anchor 308 may be configured to move between various configurations by axially moving a distal end of the device (e.g., cap 314, etc.) relative to a proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.). This movement may occur along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device.

[0147] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some implementations, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the spacer or coaptation element 310. From the straight configuration, the anchor 308 can be moved to a fully collapsed configuration (e.g., FIG. 23), for example, by moving the proximal and distal ends toward each other and / or toward the midpoint or center of the device.

[0148] In some implementations, the clasp comprises a movable arm coupled to the anchor. In some implementations, the clasp 330 includes a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancing element 336, and an interface portion 338. The fixed arm 332 is attached to the inner paddle 322 with the interface portion 338 disposed proximate to the interface element 310. The interface portion 338 is spring loaded such that the fixed arm 332 and the movable arm 334 are biased toward one another when the clasp 330 is in a closed state.

[0149] The fixed arm 332 is attached to the inner paddle 322 by sutures through holes or slots. The fixed arm 332 may be attached to the inner paddle 322 by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, a weld, an adhesive, or the like. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is opened, thereby opening the clasp 330 to expose the optional barb 336. The clasp 330 is opened by applying tension to an actuation line attached to the movable arm 334, thereby allowing the movable arm 334 to articulate, pivot, and / or bend on the interface 338.

[0150] In summary, the implantable device or implant 300 is similar in form and operation to the implantable device or implant 200 described above, except that the joint element 310, the outer paddle 320, the inner paddle 322, and the connecting portions 321, 323, 325 are formed from a single piece of material 301. In some implementations, the piece of material 301 is attached to the proximal collar 311, the cap 314, and the paddle frame 324 by weaving or inserting through openings in the proximal collar 311, in the cap 314, and in the paddle frame 324 that are configured to receive the continuous piece of material 301. The continuous piece 301 can be a single layer of material or can include two or more layers. In some implementations, portions of the device 300 have a single layer of material 301, and other portions are formed from multiple overlapping or overlapping layers of the piece of material 301.

[0151] For example, Figure 23 shows a joining element 310 and inner paddle 322 formed from multiple overlapping layers of the piece of material 301. The single, continuous piece of material 301 may begin and end at various locations on the apparatus 300. The ends of the piece of material 301 may be at the same location or at different locations on the apparatus 300. For example, in the illustrated embodiment of Figure 23, the piece of material 301 begins and ends at the location of the inner paddle 322.

[0152] As with the implantable device or implant 200 described above, the size of the coaptation element 310 may be selected to minimize the number of implants required per patient (preferably one), while at the same time maintaining a low transvalvular gradient. Notably, by forming many of the components of the device 300 from a single piece of material 301, the device 300 may be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance at the widest point of the device 300 (i.e., the width of the paddle frame 324, which is wider than the coaptation element 310) is approximately 5 mm.

[0153] Additional features of the device 300, modified versions of the device, delivery systems for the device, and methods for using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898). Any combination or subcombination of features disclosed by this 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. WO2020 / 076898). Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) is incorporated herein by reference in its entirety.

[0154] 24 illustrates another embodiment of one of many valve repair systems 400 for repairing a patient's native valve to which the concepts of the present application may be applied. The valve repair system 400 includes a delivery device 401 and a valve repair device 402.

[0155] The valve repair device 402 includes a base assembly 404, a pair of paddles 406, and a pair of gripping members 408 (e.g., clasps). In one embodiment, the paddles 406 can be formed integrally with the base assembly. For example, the paddles 406 can be formed as an extension of a link of the base assembly. In the illustrated embodiment, the base assembly 404 of the valve repair device 402 includes a shaft 403, a coupler 405 configured to move along the shaft, and a lock 407 configured to lock the coupler in a stationary position on the shaft. The coupler 405 is mechanically connected to the paddles 406 such that moving the coupler 405 along the shaft 403 moves the paddles between an open position and a closed position. In this manner, the coupler 405 serves as a means for mechanically coupling the paddles 406 to the shaft 403 and for moving the paddles 406 between their open and closed positions when moved along the shaft 403.

[0156] In some implementations, the gripping member 408 is pivotally connected to the base assembly 404 such that the gripping member can be moved to adjust the width of the opening 414 between the paddle 406 and the gripping member 408 (e.g., the gripping member 408 can be pivotally connected to the shaft 403 or any other suitable member of the base assembly). The gripping member 408 can include an optional barbed portion 409 for attaching the gripping member to the valve tissue when the valve repair device 402 is attached to the valve tissue. When the paddle 406 is in the closed position, the paddle engages the gripping member 408 such that when the valve tissue is attached to the barbed portion 409 of the gripping member, the paddle secures the valve repair device 402 to the valve tissue. In some implementations, the gripping member 408 is configured to engage the paddle 406 such that the barbed portion 409 engages the valve tissue member and the paddle 406 to secure the valve repair device 402 to the valve tissue member. For example, in certain circumstances it may be advantageous to have the paddle 406 maintain an open position and have the gripping member 408 move outwardly toward the paddle 406 to engage the valve tissue and the paddle 406.

[0157] Although the embodiment shown in FIG. 24 shows a pair of paddles 406 and a pair of gripping members 408, it will be understood that the valve repair device 402 may include any suitable number of paddles and gripping members.

[0158] In some implementations, the valve repair system 400 includes a placement shaft 413 that is removably attached to the shaft 403 of the base assembly 404 of the valve repair device 402. The placement shaft 413 is detached from the shaft 403 after the valve repair device 402 is secured to the valve tissue, removing the valve repair device 402 from the remainder of the valve repair system 400 such that the valve repair device 402 can remain attached to the valve tissue and the delivery device 401 can be removed from the patient's body.

[0159] The valve repair system 400 may also include a paddle control mechanism 410 (e.g., a rod, shaft, etc.), a gripper control mechanism 411 (e.g., a line, wire, etc.), and a lock control mechanism 412 (e.g., a line, wire, etc.). The paddle control mechanism 410 is mechanically attached to the coupler 405 such that moving the coupler along the shaft moves the paddle 406 between an open position and a closed position. The paddle control mechanism 410 may take any suitable form, such as, for example, a shaft or rod. For example, the paddle control mechanism may include a hollow shaft, a catheter tube, or a sleeve that fits over the mounting shaft 413 and over the shaft 403 and connected to the coupler 405.

[0160] Gripper control mechanism 411 is configured to move gripping member 408 to vary the width of opening 414 between the gripping member and paddle 406. Gripper control mechanism 411 may take any suitable form, such as, for example, a line, suture or wire, a rod, a catheter, etc.

[0161] The lock control mechanism 412 is configured to lock and unlock the lock. The lock 407 locks the coupler 405 in a stationary position relative to the shaft 403 and can take a wide variety of different forms, and the type of lock control mechanism 412 can be dictated by the type of lock used. In embodiments where the lock 407 includes a pivotable plate, the lock control mechanism 412 is configured to engage the pivotable plate to move the plate between the tilted position and the substantially non-tilted position. The lock control mechanism 412 can be, for example, a rod, suture, wire, or any other member that can move the pivotable plate of the lock 407 between the tilted position and the substantially non-tilted position.

[0162] The valve repair device 402 is movable from an open position to a closed position. The base assembly 404 includes a link that is moved by a coupler 405. The coupler 405 is movably attached to a shaft 403. To move the valve repair device from the open position to the closed position, the coupler 405 moves along the shaft 403, thereby moving the link.

[0163] The gripper control mechanism 411 moves the gripping members 408 to provide a wider or narrower gap at the opening 414 between the gripping members and the paddle 406. In the illustrated embodiment, the gripper control mechanism 411 includes a line, such as a suture, wire, or the like, that is connected to an opening in the end of the gripping members 408. When the line is pulled, the gripping members 408 move inward, causing the opening 414 between the gripping members and the paddle 406 to become wider.

[0164] To move the valve restoration device 402 from an open position to a closed position, the lock 407 is moved to an unlocked state by the lock control mechanism 412. Once the lock 407 is in the unlocked state, the coupler 405 can be moved along the shaft 403 by the paddle control mechanism 410.

[0165] After the paddle 406 is moved to the closed position, the lock 407 is moved to a locked state by the lock control mechanism 412 to maintain the valve repair device 402 in the closed position. After the valve repair device 402 is maintained in the locked state by the lock 407, the valve repair device 402 is removed from the delivery device 401 by decoupling the shaft 403 from the mounting shaft 413. In addition, the valve repair device 402 is removed from the paddle control mechanism 410, the gripper control mechanism 411, and the lock control mechanism 412.

[0166] Additional features of the device 402, modified versions of the device, a delivery system for the device, and methods for using the device and delivery system are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Any combination or subcombination of features disclosed by this 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). Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) is incorporated herein by reference in its entirety.

[0167] The clasp or leaflet grasping device disclosed herein can take a wide variety of different forms. An example of a clasp is disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Any combination or subcombination of features disclosed by this application can be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201) is incorporated herein by reference in its entirety.

[0168] 25A and 25B, some implementations of the valve repair device 402 have a coaptation element 3800. The valve repair device 402 may have the same configuration as the valve repair device shown in FIG. 24 with the addition of the coaptation element. The coaptation element 3800 may take a wide variety of different shapes. The coaptation element 3800 may be compressible and / or expandable. For example, the coaptation element may be compressed to fit within one or more catheters of a delivery system, may expand when moved out of the one or more catheters, and / or may be compressed by a paddle 406 to adjust the size of the coaptation element.

[0169] 25A and 25B show an example, the size of the coaptation element 3800 may be decreased by compressing it with the paddles 406 and increased by moving the paddles 406 away from each other. The coaptation element 3800 may extend beyond the outer edge 4001 of the gripping member or clasp 408 as illustrated to provide additional surface area for closing the mitral valve gap.

[0170] The coaptation element 3800 may be coupled to the valve repair device 402 in a variety of different ways. For example, the coaptation element 3800 may be fixed to the shaft 403, slidably disposed about the shaft, connected to the coupler 405, connected to the lock 407, and / or connected to a central portion of the catch or gripping member 408. In some implementations, the coupler 405 may take the form of the coaptation element 3800. That is, a single element may be used as the coupler 405 to move the paddle 406 between the open and closed positions and the coaptation element 3800 to close the gap between the leaflets 20, 22 when the valve repair device 402 is attached to the leaflets.

[0171] The interface element 3800 can be disposed about one or more of the shafts or other control elements of the valve repair system 400. For example, the interface element 3800 can be disposed about the shaft 403, the shaft 413, the paddle control mechanism 410, and / or the lock control mechanism 412.

[0172] The valve repair device 402 may include any other features for the valve repair device discussed in this application, and the valve repair device 402 may be positioned to engage valve tissue as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additional features of the device 402, modified versions of the device, delivery systems for the device, and methods for using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Any combination or subcombination of features disclosed by this 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. 2019139904).

[0173] 26-30 show another embodiment of one of many valve repair systems for repairing a patient's native valve to which the concepts of the present application may be applied. With reference to FIGS. 29 and 30, the valve repair system includes an implant catheter assembly 1611 and an implantable valve repair device 8200. With reference to FIGS. 26-28, the implantable device 8200 includes a proximal or attachment portion 8205, a paddle frame 8224, and a distal portion 8207. The attachment portion 8205, the distal portion 8207, and the paddle frame 8224 may be configured in a variety of ways.

[0174] 26, the paddle frame 8224 may be symmetrical along the longitudinal axis YY. However, in some implementations, the paddle frame 8224 is not symmetrical about the axis YY. Further, with reference to FIG. 26, the paddle frame 8224 includes an outer frame portion 8256 and an inner frame portion 8260.

[0175] In some implementations, the connector 8266 (e.g., a shaped metal component, a shaped plastic component, a tether, wire, post, line, cord, suture, etc.) is attached to the outer frame portion 8256 at an outer end of the connector 8266 and to the coupler 8972 at an inner end 8968 of the connector 8266 ( FIG. 28 ). Between the connector 8266 and the attachment portion 8205, the outer frame portion 8256 forms a curved shape. In some implementations, for example, in the illustrated embodiment, the shape of the outer frame portion 8256 resembles an apple shape, where the outer frame portion 8256 is wider toward the attachment portion 8205 and narrower toward the distal portion 8207. In some implementations, the outer frame portion 8256 may be otherwise shaped in a variety of ways, for example, oval, circular, triangular, rectangular, oval, etc.

[0176] The inner frame portion 8260 extends from the mounting portion 8205 toward the distal portion 8207. The inner frame portion 8260 then extends inwardly to form a retaining portion 8272 that is attached to the actuation cap 8214. The retaining portion 8272 and the actuation cap 8214 can be configured to be attached in any suitable manner.

[0177] In some implementations, the inner frame portion 8260 is a rigid frame portion, while the outer frame portion 8256 is a flexible frame portion. In some implementations, a proximal end of the outer frame portion 8256 connects to a proximal end of the inner frame portion 8260, as shown in FIG.

[0178] In some implementations, the width adjustment element 8211 (e.g., a width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment screw or bolt, etc.) is configured to move the outer frame portion 8256 from an expanded position to a narrowed position by pulling the inner end 8968 ( FIG. 28 ) and a portion of the connector 8266 into the actuation cap 8214. In some implementations, the actuation element 8102 is configured to move the inner frame portion 8260 to open and close the paddle according to some implementations disclosed herein.

[0179] 27 and 28, the connector 8266 has an inner end 8968 that engages with the width adjustment element 8211 such that a user can move the inner end 8968 inside the receiver 8912 (e.g., an internally threaded element, a column, a conduit, a hollow member, a notched receiving portion, a tube, a shaft, a sleeve, a post, a housing, a cylinder, a raceway, etc.) to move the outer frame portion 8256 between a narrowed position and an expanded position. In the illustrated example, the inner end 8968 includes a post 8970 attached to the outer frame portion 8256 and a coupler 8972 extending from the post 8970.

[0180] In some implementations, the coupler 8972 is configured to be attached to and detached from both the width adjustment element 8211 and the receiver 8912. The coupler 8972 can take a wide variety of different forms. For example, the coupler 8972 can include one or more of a threaded connection, a thread mating feature, an outwardly biased arm, a detent connection such as a wall, or other portion. In some implementations, when the coupler 8972 is attached to the width adjustment element 8211, the coupler is released from the receiver 8912. In some implementations, when the coupler 8972 is detached from the width adjustment element 8211, the coupler is secured to the receiver.

[0181] The inner end 8968 of the connector may be configured in a variety of ways. Any form that can adequately attach the outer frame portion 8256 to the coupler can be used such that the width adjustment element 8211 can move the outer frame portion 8256 between a narrowed position and an expanded position. The coupler may likewise be configured in a variety of ways and may be a separate component or may be integrated with another portion of the device, such as the connector or another portion of the inner end of the connector.

[0182] The width adjustment element 8211 allows a user to expand or contract the outer frame portion 8256 of the implantable device 8200. In the embodiment shown in FIGS. 27 and 28, the width adjustment element 8211 includes a male threaded end that screws into the coupler 8972.

[0183] In some implementations, the width adjustment element 8211 moves the coupler into the receiver 8912 to adjust the width of the outer frame portion 8256. In some implementations, when the width adjustment element 8211 is unscrewed from the coupler 8972, the coupler engages an inner surface of the receiver 8912 to set the width of the outer frame portion 8256.

[0184] In some implementations, the receiver 8912 can be integrally formed with the distal cap 8214. Moving the cap 8214 relative to the body of the mounting portion 8205 opens and closes the paddle. In the illustrated example, the receiver 8912 slides inside the body of the mounting portion. In some implementations, when the coupler 8972 is removed from the width adjustment element 8211, the width of the outer frame portion 8256 is fixed while the actuation element 8102 moves the receiver 8912 and cap 8214 relative to the body of the mounting portion 8205. Moving the cap can open and close the device in the same manner disclosed above.

[0185] In the illustrated embodiment, the driver head 8916 is disposed at a proximal end of the actuating element 8102. The driver head 8916 removably couples the actuating element 8102 to the receiver 8912. In the illustrated embodiment, the width adjustment element 8211 extends through the actuating element 8102. The actuating element is advanced axially in the opposite Y direction to move the distal cap 8214.

[0186] In some implementations, movement of the distal cap 8214 relative to the mounting portion 8205 is effective to open and close the paddle, as shown by the arrows in Figure 27. That is, when the distal cap 8214 is moved in the Y direction, the device is closed, and when the distal cap is moved in the opposite direction to the Y direction, the device is opened.

[0187] 27 and 28, the width adjustment element 8211 extends through the actuation element 8102, the driver head 8916, and the receiver 8912 and engages a coupler 8972 attached to the inner end 8968. When the outer frame portion 8256 is moved to the narrowed position, the device or implant 8200 may be more easily maneuvered into position for implantation into the heart by reducing contact and / or friction between the native structures of the heart (e.g., chordae tendineae) and the device 8200. When the outer frame portion 8256 is moved to the expanded position, the anchor portions of the device or implant 8200 are provided with a larger surface area to engage and capture the leaflets of the native heart valve.

[0188] 29 and 30 , an implementation of an implant catheter assembly 1611 is shown in which the clasp actuation line 624 extends through the handle 1616, the actuation element 8102 is coupled to a paddle actuation control 1626, and the width adjustment element 8211 is coupled to a paddle width control 1628. A proximal end portion 1622a of the shaft or catheter of the implant catheter assembly 1611 may be coupled to the handle 1616, and a distal end portion 1622b of the shaft or catheter may be coupled to the implantable device 8200.

[0189] In some implementations, the actuating element 8102 may extend distally from the paddle actuation control 1626, through the handle 1616, through the delivery shaft or catheter of the implant catheter assembly 1611, and through the proximal end of the device 8200, where the actuating element couples with the driver head 8916. In some implementations, the actuating element 8102 may be axially movable relative to the outer shaft of the implant catheter assembly 1611 and the handle 1616 to open and close the device.

[0190] In some implementations, the width adjustment element 8211 may extend distally from the paddle width control 1628, through the paddle actuation control 1626, through the actuation element 8102 (and, consequently, through the handle 1616, the outer shaft of the implant catheter assembly 1611, and the device 8200), where the width adjustment element couples with a movable coupler 8972. In some implementations, the width adjustment element 8211 may be axially movable relative to the actuation element 8102, the outer shaft of the implant catheter assembly 1611, and the handle 1616.

[0191] In some implementations, the clasp actuation line 624 can extend through and be axially movable relative to the handle 1616 and the outer shaft of the implant catheter assembly 1611. In some implementations, the clasp actuation line 624 can also be axially movable relative to the actuation element 8102.

[0192] 29 and 30, the width adjustment element 8211 can be removably coupled to the coupler 8972 of the device 8200. In some implementations, the width adjustment element 8211 is advanced and retracted by the paddle width control 1628 to increase or decrease the width of the paddle. In some implementations, the actuation element 8102 is advanced and retracted by the paddle actuation control 1626 to open and close the paddle of the device.

[0193] 29 and 30, the catheter or shaft of the implant catheter assembly 1611 is an elongate shaft extending axially between a proximal end portion 1622a that is coupled to the handle 1616 and a distal end portion 1622b that is coupled to the device 8200. In some implementations, the outer shaft of the implant catheter assembly 1611 can also include an intermediate portion 1622c disposed between the proximal end portion 1622a and the distal end portion 1622b.

[0194] In some implementations, the implantable valve repair device may include clips or connectors (e.g., frame clips, frame connectors, paddle frame clips, paddle frame connectors, strain relief devices, etc.) that can attach various components of the implantable valve repair device, connect the components together, and / or facilitate stabilization of various components, e.g., the inner paddle, the outer paddle, the inner paddle frame, and / or the outer paddle frame. In some implementations, the clips / connectors can add column strength and enhance the stiffness of the outer paddle frame to reduce buckling or rolling that may occur during stenosis of the implantable valve repair device.

[0195] In some implementations, the clip / connector can be configured as a paddle frame clip / connector that can couple a paddle frame portion to a portion of the paddle frame. In some implementations, the paddle frame clip / connector can secure at least one of the inner and outer frame portions to at least one of the outer and inner paddles.

[0196] In some implantable valve repair devices, the frame portion is sutured to other components of the device, such as other frame components, paddle portions, etc. In some implementations, the clips / connectors can reduce or eliminate the need to suture the frame portion and other components of the device.

[0197] In some implementations, the paddle frame clip / connector is configured such that the stem portion couples with the inner paddle or the outer paddle and the head portion couples with at least one of the outer frame portion and the inner frame portion.

[0198] 31 and 32, there is shown an exemplary clip / connector 500. Clip / connector 500 may include a stem portion 510 and a head portion 520. The clip / connector may be made from a variety of materials, such as, for example, steel, other metals, plastics, composites, or shape memory alloys such as Nitinol.

[0199] The clip(s) / connector(s) herein may be configured in a variety of different sizes and shapes. In some implementations, the stem portion is straight or includes a straight portion (e.g., a straight portion that extends the majority of the length of the stem). In some implementations, the stem portion is curved or includes a curved portion (e.g., a convex curve, a concave curve, an S-shaped curve, a sinusoidal curve, etc.). In some implementations, the stem portion includes a zigzag portion.

[0200] The head can also have a variety of sizes and shapes. In some applications, the head has a shape that is at least one of circular, square, rectangular, triangular, oval, elliptical, semicircular, combinations thereof, and the like.

[0201] In some implementations, the head portion 520 of the paddle frame clip / connector 500 may include an opening 530 that extends through the paddle frame clip / connector 500. In some implementations, the opening 530 may have a cross-sectional shape that matches the cross-sectional shape of the inner or outer frame portion.

[0202] In some implementations, when the opening 530 engages the inner or outer frame portion, the opening 530 fits tightly around the frame portion, reducing rotational movement of the inner or outer frame portion relative to the head portion 520. As illustrated in Figures 31-32, the opening 530 may have a square cross-section, however, the opening may have a rectangular, circular, oval, triangular, or any other shaped cross-section. In some implementations, the opening may have an irregular shaped cross-section.

[0203] In some implementations, the head portion 520 can include one or more engagement members 522 (e.g., tongues, protrusions, extensions, projections, etc.) that engage with the inner or outer paddle. In some implementations, the stem portion 510 can include one or more engagement members 540 (e.g., tongues, protrusions, extensions, projections, etc.) that can engage with the inner or outer paddle. In some implementations, the engagement members 540 can be positioned at a distal end of the paddle frame clip / connector 500 opposite the head portion 520.

[0204] In some implementations, the engagement members 522 and 540 can couple the paddle frame portions with the inner or outer paddle in a variety of ways. With reference to FIGS. 31 and 32, the engagement members 540 can include a step and extension of the paddle frame clip / connector 500. In some implementations, the engagement members 540 can extend through and hook onto the outer paddle (see FIGS. 33-35) or the inner paddle (see FIG. 38). Similarly, in some implementations, the engagement members 522 can include a hook system that extends through and hooks onto the inner or outer paddle.

[0205] In some implementations, the paddle frame clip / connector 500 can have an open configuration (FIG. 31) and a closed configuration (FIG. 32). With reference to FIG. 31, in the open configuration, the head portion 520 is open such that an opening 530 is available through a channel 532.

[0206] In some implementations, at least one of the inner or outer frame portions can be moved through channel 532 and secured within opening 530. In the closed configuration ( FIG. 32 ), channel 532 is closed, securing the inner and / or outer frame portions within opening 530.

[0207] In some implementations, the channel 532 is fixed in a closed position when a clip / connector is installed within the inner or outer paddle, which may be rigidly connected or coupled to the inner and / or outer paddle frames by the clip / connector.

[0208] In some implementations, the paddle frame clip / connector may be coupled to a paddle formed from sheet metal such as steel or shape memory alloy, or from a continuous strip of braided or woven material such as braided or woven Nitinol wire (see, e.g., FIG. 23).

[0209] 32A , in some implementations, the clip / connector 500 includes an opening 523 through the end of the head 520. In some implementations, the clip / connector 500 illustrated by FIG. 32A may include a stem portion 510 and a head portion 520. The clip / connector 500 may be made from a variety of materials, such as, for example, steel, other metals, plastics, composites, or shape memory alloys such as Nitinol.

[0210] In some implementations, the head portion 520 of the paddle frame clip / connector 500 may include an opening 530 that extends through the paddle frame clip / connector 500. In some implementations, the opening 530 may have a cross-sectional shape that matches the cross-sectional shape of the inner and / or outer frame portions.

[0211] In some implementations, when the opening 530 engages the inner or outer frame portion, the opening 530 fits tightly around the frame portion, reducing rotational movement of the inner or outer frame portion relative to the head portion 520. As shown in FIG. 32A, the opening 530 may have a square cross-section, although the opening may have a rectangular, circular, oval, triangular, or any other shaped cross-section. In some implementations, the opening may have an irregular shaped cross-section.

[0212] In some implementations, the head portion 520 can include one or more engagement members 522 that engage with the inner or outer paddle. In some implementations, the stem portion 510 includes one or more engagement members 540 that can engage with the inner or outer paddle. The engagement members 540 can be positioned at a distal end of the paddle frame clip / connector 500 opposite the head portion 520.

[0213] The engagement members 522 and 540 can couple the paddle frame portions with the inner or outer paddle in a variety of ways. With reference to FIG. 32A, the engagement member 540 can include a step and extension of the paddle frame clip / connector 500. In some examples, the engagement member 540 can extend through and hook onto the outer paddle (see FIG. 32A). Similarly, in some implementations, the engagement member 522 can include a hook system that extends through and hooks onto the inner paddle.

[0214] In some implementations, the opening 523 in the head 520 is between two prongs 525. In some implementations, the two prongs 525 can be bent into an open configuration and snap or otherwise return to a closed configuration (FIG. 32A).

[0215] In some implementations, the head 520 may include optional relief slots 529 and / or relief holes 531 that allow or enhance flexing of the prongs 525. In some implementations, at least one of the inner or outer frame portions can bend the two prongs 525 away from each other and move through the apertures 523 and into the opening 530. In some implementations, the two prongs 525 snap back into a closed configuration, securing the inner and / or outer frame within the opening 530.

[0216] In some implementations, in the closed configuration (FIG. 32A), the flat inner surfaces 527 of the prongs 525 engage the inner and / or outer frame portions to prevent or inhibit the inner and / or outer frame portions from moving back through the openings. In some implementations, one or more of the prongs 525 are secured in the closed position when a clip / connector is attached within the inner or outer paddle. In this manner, the inner or outer paddle may be securely assembled with the inner and / or outer paddle frames by the clip / connector.

[0217] In some implementations, the paddle frame clip / connector 500 of FIG. 32A may be coupled to a paddle formed from sheet metal such as steel or a shape memory alloy, or from a continuous strip of braided or woven material such as braided or woven Nitinol wire (see, e.g., FIG. 23).

[0218] 33-35, an example of an implantable valve repair device 600 is shown. In some implementations, the implantable valve repair device 600 can include any other features of the implantable valve repair devices discussed herein, and the implantable valve repair device 600 can be positioned to engage valve tissue as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0219] In some implementations, the implantable valve repair device 600 comprises an inner frame portion 610 and an outer frame portion 620. In some implementations, between the connecting portion 630 and the proximal portion 602, the outer frame portion 620 forms a curved shape.

[0220] In some implementations, the inner frame portion 610 extends from the proximal portion 602 toward the distal portion 604. In some implementations, the inner frame portion 610 further extends inwardly for attachment to an actuation cap 640. In some implementations, the inner frame portion 610 is a rigid frame portion, while the outer frame portion 620 is a flexible frame portion.

[0221] In some implementations, the outer frame portion 620 is connected to the outer paddle 670 by a paddle frame clip / connector 650. Specifically, an engagement member 652 (e.g., a tongue, protrusion, extension, projection, etc.) and an engagement member 654 (e.g., a tongue, protrusion, extension, projection, etc.) of the paddle frame clip / connector 650 are disposed through and hook onto the outer paddle 670. The paddle frame clip / connector may have the same or similar form as the paddle frame clip / connector of FIGS. 31 and 32.

[0222] Referring to FIG. 34, in some implementations, the paddle frame clip / connector 650 is positioned from a first side A to a second side B of the outer paddle 670, and the engagement members 652, 654 hook onto the outer paddle 670 on the second side B of the outer paddle 670.

[0223] 33, a head portion 656 of the paddle frame clip / connector 650 is coupled to the outer frame portion 620. The paddle frame clip / connector 650 is shown in a closed configuration with the channel 660 closed and the opening 658 secured around the outer frame portion 620. The channel 660 is closed in some implementations by being placed onto the outer paddle portion.

[0224] 33 and 33A, the implantable valve repair device 600 of FIG. 33 may have the clip / connector 500 of FIG. 32A. FIG. 33A shows the clip / connector 500 of FIG. 33A assembled with some of the components of the valve repair device 600 of FIG. 33. However, the valve repair device having the clip / connector 500 of FIG. 32A may include any other features for the implantable valve repair device discussed in this application, and the implantable valve repair device may be positioned to engage valve tissue as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed in this application).

[0225] In some implementations, the implantable valve repair device comprises an inner frame portion 610 and an outer frame portion 620. In some implementations, the outer frame portion 620 has a curved shape. In some implementations, the inner frame portion 610 extends from the proximal portion 602 toward the distal portion 604. In some implementations, the inner frame portion 610 further extends inwardly for attachment to an actuation cap 640 (see FIG. 33). In some implementations, the inner frame portion 610 is a rigid frame portion, while the outer frame portion 620 is a flexible frame portion.

[0226] In some implementations, the outer frame portion 620 is connected to the outer paddle 670 by a paddle frame clip / connector 500. Specifically, the engagement members 522 and 540 of the paddle frame clip / connector 500 are disposed through and hook onto the outer paddle 670. The paddle frame clip / connector may have the same or similar configuration as the paddle frame clip / connector of FIG. 32A. With reference to FIG. 33A, the paddle frame clip / connector 500 is disposed from a first side A to a second side B of the outer paddle 670, and the engagement members 522, 540 hook onto the outer paddle 670 at the second side B of the outer paddle 670.

[0227] 33A, the head portion 520 of the paddle frame clip / connector 500 is coupled with the outer frame portion 620. The paddle frame clip / connector 500 is shown in a closed configuration with the prongs 525 closed and the opening 530 secured around the outer frame portion 620. The prongs 525 are closed, in some implementations, by being mounted onto the outer frame portion 620.

[0228] 36A-36C, another embodiment of a paddle frame clip / connector 750 is shown through a cross section of a paddle 740. The paddle 740 may include an inner paddle and an outer paddle.

[0229] In some implementations, the paddle frame clip / connector 750 includes a first opening 752, a second opening 754, a third opening 756, and a fourth opening 758. Any of the first opening 752, second opening 754, third opening 756, or fourth opening 758 can engage with an inner frame portion or an outer frame portion.

[0230] In some implementations, the first opening 752 is coupled to the inner frame portion and the second opening 754 is coupled to the outer frame portion, while in some implementations, the first opening 752 is coupled to the outer frame portion and the second opening 754 is coupled to the inner frame portion.

[0231] In some implementations, at least one of the third opening 756 and the fourth opening 758 are coupled to other components of the implantable valve repair device 700 to help stabilize the paddle frame clip / connector 750 to the paddle 740. In some implementations, the third opening 756 and the fourth opening 758 may be coupled via a coupling device or sutures to facilitate further stabilization of the implantable valve repair device 600.

[0232] In some implementations, the openings 756, 758 can be used as connection points for connecting the cover. For example, stitches that secure the cover to the paddle can pass through the cover material and the openings 756, 758.

[0233] In some implementations, the channel 760 extends from the first opening 752 to the second opening 754. In use, the paddle frame clip / connector 750 may first be coupled to an inner or outer frame portion and then disposed through the paddle 740. For example, one of the inner or outer frame portion may be disposed through the channel 760 into the first opening 752. The other of the inner or outer frame portion may then be disposed through the channel 760 into the second opening 754. The paddle frame clip / connector 750 may then be inserted into the opening 770 of the paddle 740 and disposed such that the engagement member engages the corresponding opening in the paddle 740.

[0234] 37A, a paddle frame clip / connector 850 can be coupled to an inner paddle 810 of an implantable valve repair device 800. In some implementations, the paddle frame clip / connector 850 includes a first opening 852 and a second opening 854. In some implementations, the first opening 852 and the second opening 854 can engage with either an inner frame portion or an outer frame portion.

[0235] In some implementations, the first opening 852 is coupled to the inner frame portion and the second opening 854 is coupled to the outer frame portion, and in some implementations, the first opening 852 is coupled to the outer frame portion and the second opening 854 is coupled to the inner frame portion.

[0236] In some implementations, the first opening 852 and the second opening 854 can abut a surface of the inner paddle 810. Thus, the inner and outer frame portions can be positioned as close as possible to or relative to the inner paddle 810.

[0237] In some implementations, the clip / connector 850 can extend along the inner paddle 810 to help reinforce the inner paddle 810 so that when the inner paddle is pulled by the outer paddle, it is strengthened and inhibits buckling of the inner paddle. For example, the clip / connector can extend along the inner paddle 810 to a second attachment point 855 that extends through the inner paddle 810. With reference to FIG. 37B, in some implementations, the paddle frame clip / connector 860 can be coupled to and / or integral with the fixed arm of the clasp 870.

[0238] 38A-B, an exemplary implantable valve repair device 900 is shown with various components removed for visualization purposes. The outer frame portion 940 can include a first portion 942 and a second portion 944. In some implementations, the first portion 942 and the second portion 944 can pivot about one or more pins that couple the outer frame portion 940 to the inner frame portion 930.

[0239] In some implementations, the surface of the inner frame portion 930 may include one or more indentations 932 to facilitate mating of the frame portion with the paddle frame clip / connector 950 (see FIG. 38B) and / or to limit movement of the paddle frame clip / connector 950.

[0240] 38B, a paddle frame clip / connector 950 can be coupled to a paddle (not shown) of the implantable valve repair device 900. In some implementations, a head portion 910 of the paddle frame clip / connector 950 includes an opening 952 that can engage with at least one of the inner frame portion 930 or the outer frame portion 940. As shown in FIG. 38B, the opening 952 can be coupled to both the inner frame portion 930 and the outer frame portion 940. FIG. 38A shows the inner frame portion 930 and the outer frame portion 940 without the paddle frame clip / connector 950 attached.

[0241] 39, an exemplary implantable valve repair device 1000 is shown with various components removed for visualization purposes. A paddle frame clip / connector 1050 may be coupled to a paddle (not shown) of the implantable valve repair device 1000. For example, in some implementations, a stem portion 1060 of the clip / connector 1050 extends along an inner paddle, not shown, such that the clip / connector is visible in FIG. 39. In some implementations, a head portion 1010 of the paddle frame clip / connector 1050 includes one or more curves and openings 1052 that may engage with both the inner frame portion 1030 and the outer frame portion 1040.

[0242] 40, an implantable valve repair device 1100 includes a paddle frame clip / connector 1150 coupled to an inner paddle and / or an attached clasp 1102. In some implementations, a head portion 1110 of the paddle frame clip / connector 1150 engages a paddle frame 1130, which may include one or both of an inner frame portion and an outer frame portion. In FIG. 40, the components of the device (e.g., interface elements, caps, couplers, actuation elements, paddle frame, etc.) are illustrated generally to show the position of the clip / connector 1150 when the device is in the elongated configuration and the clasps are closed.

[0243] 41 , a portion of an implantable valve repair device 1200 is shown. In some implementations, the implantable valve repair device 1200 may include a first paddle frame clip / connector 1250 coupled to the inner paddle 1210, as well as a second paddle frame clip / connector 1260 coupled to the outer paddle 1220. In some implementations, the first paddle frame clip / connector 1250 may include a head portion 1252 including an opening 1254 in which one of the inner frame portion 1230 or the outer frame portion 1240 may be positioned. In some implementations, the second paddle frame clip / connector 1260 may include a head portion 1262 including an opening 1264 in which one of the inner frame portion 1230 or the outer frame portion 1240 may be positioned.

[0244] 41 , the inner frame portion 1230 may be placed through an opening 1254 in the first paddle frame clip / connector 1250, and the outer frame portion 1240 may be placed through an opening 1264 in the second paddle frame clip / connector 1260. In some implementations, when the implantable valve repair device 1200 is opened, the first paddle frame clip / connector 1250 and the second paddle frame clip / connector 1260 may contact one another to reduce rotation and distal translation of the outer paddle 1220 during opening and closing of the device. That is, engagement between the clips or connectors 1250, 1260 may prevent or inhibit the transition portion 1222 between the inner paddle 1210 and the outer paddle 1220 from bending downwardly without corresponding movement of the inner paddle frame portion 1230 or the outer paddle frame portion 1240.

[0245] 42, a portion of an implantable valve repair device 1300 is shown. In some implementations, the implantable valve repair device 1300 may include a first paddle frame clip / connector 1350 coupled to the inner paddle 1310, as well as a second paddle frame clip / connector 1360 coupled to the outer paddle 1320. In some implementations, the first paddle frame clip / connector 1350 may include a head portion 1352 including an opening 1354 through which one of the inner frame portion 1330 or the outer frame portion 1340 may be positioned. In some implementations, the second paddle frame clip / connector 1360 may include a head portion 1362 including an opening 1364 through which one of the inner frame portion 1330 or the outer frame portion 1340 may be positioned.

[0246] Referring to FIG. 42, in some implementations, the inner frame portion 1330 is positioned through an opening 1354 of a first paddle frame clip / connector 1350, and the outer frame portion 1340 is positioned through an opening 1364 of a second paddle frame clip / connector 1360.

[0247] In some implementations, the implantable valve repair device 1300 also includes a connecting member 1370 (e.g., a flexible material, a spring, a strut, etc.) that couples the first paddle frame clip / connector 1350 and the second paddle frame clip / connector 1360. The connecting member 1370 can take a variety of shapes and can be made of a variety of materials. The connecting member 1370 can be integrally formed with one or both of the clips / connectors 1350, 1360, or the connecting member 1370 can be a separate member disposed between the clips / connectors 1350, 1360. In some implementations, the connecting member 1370 includes a material that can be controllably compressed and / or expanded. For example, the connecting member 1370 can be a spring.

[0248] In some implementations, when the implantable valve repair device 1300 is opened, the first paddle frame clip / connector 1250 and the second paddle frame clip / connector 1260 contact the connecting member 1370. In some implementations, the connecting member compresses and / or flexes to control the relative movement between the clips / connectors 1350, 1360.

[0249] In some implementations, the controlled movement of the clip / connectors 1350, 1360 reduces rotation and distal translation of the outer paddle 1320 during opening and closing of the device. That is, engagement of the connecting members 1370 with the clip / connectors 1350, 1360 can prevent or inhibit the transition portion 1322 between the inner paddle 1310 and the outer paddle 1320 from bending downwardly without corresponding movement of the inner paddle frame portion 1330 or the outer paddle frame portion 1340.

[0250] In some implementations, the outer frame portion may include a bend limiting portion. The bend limiting portion may include one or more protrusions, arms, notches, stops, gaps, holes, channels, openings, and / or breaks, etc. The bend limiting portion may have any structure that allows a portion of the outer paddle frame to bend a predetermined amount and then stop further bending of the portion of the outer paddle frame when the predetermined amount of bending is reached. The bend limiting portion may be integrally formed with the outer frame portion and / or may be a separate component connected to the outer frame portion. The bend limiting portion may be located on one or more portions of the outer paddle frame portion. For example, the bend limiting portion may be at a proximal end of the outer frame portion.

[0251] In some implementations, upon bending of the outer frame portion, the bend limiting portion can reshape or bend until the bend limiting portion engages and stops further bending of the portion. In some implementations, when the bend limiting portion engages and stops bending, other portions of the paddle frame can bend or bend. In this manner, the bend limiting portion can be used to control the bending or bending of the outer frame portion. In some implementations, as the implantable valve repair device narrows, the bend limiting portion limits bending at the proximal end of the outer frame portion. In some implementations, the bend limiting portion allows other portions of the paddle frame to bend after the stop of the bend limiting portion is reached. This gradual or controlled bending of the paddle frame can be used to maintain or substantially maintain the depth at which the paddle frame engages the valve leaflets from the widest to the narrowest configuration of the paddle frame.

[0252] 43A-43D , in some implementations, the outer frame portion 1400 includes a bend limiting portion 1410. The illustrated example of the bend limiting portion 1410 includes an L-shaped and an inverted L-shaped bend limiting component 1420. In some implementations, between the proximal end 1402 and the distal end 1404, the outer frame portion 1400 forms a curved shape. For example, in the illustrated example, the shape of the outer frame portion 1400 is shown in an expanded state where the outer frame portion 1400 is wider towards the proximal portion 1402 and narrower towards the distal portion 1404.

[0253] In some implementations, the bend limiting portion 1410 may include a clip / connector region 1430 between the components 1420. In some implementations, a paddle frame clip / connector (see FIGS. 31-39) may be disposed in the clip / connector region 1430 between the components 1420. In some implementations, the clip / connector region 1430 may have a width 1431 that is substantially the same as the width of the paddle frame clip / connector, or the width of the clip / connector region 1430 may be wider than the pedal frame clip / connector such that one or more gaps are formed between the paddle frame clip / connector and the bend limiting component. In this manner, the paddle frame clip / connector and the bend limiting component 1420 may combine to form the bend limiting portion 1410.

[0254] The clip / connector region 1430 can have a variety of cross-sectional shapes, such as, for example, rectangular, square, trapezoidal, and irregular shapes. In some implementations, the clip / connector region 1430 has a cross-sectional shape that matches the cross-sectional shape of the paddle frame clip / connector such that the paddle frame clip / connector can be coupled to the outer frame portion 1400 at the clip / connector region 1430.

[0255] 43B, the outer frame portion 1400 can include a first curve 1412 and a second curve 1414. With reference to FIG. 43B, the first curve has a radius that is smaller than the radius of the second curve 1414, although in some implementations the first curve 1412 can have a radius that is equal to or greater than the radius of the second curve 1414.

[0256] 43D, the clip / connector region 1430 can include a segment 1432 that extends to a surface 1434 of the clip / connector region. In some implementations, the segment 1432 can be substantially perpendicular to the surface 1434 or can be set at an angle. In some implementations, the segment 1432 has an angle of 45 degrees to 90 degrees with respect to the surface 1434. The angled segment 1432 can allow the inward bending component 1420 to bend, allowing the clip / connector region 1430 to accommodate various sizes of clips / connectors.

[0257] 44-48, 49A, and 49B, various embodiments of the bend limiting portion of the outer frame portion are shown. As shown in FIG. 44-48, 49A, and 49B, the bend limiting portion 1510, 1520, 1530 can include notches, channels, holes, and / or openings, etc.

[0258] Flexion limiting portions having a wide variety of different configurations can operate in the same or substantially the same manner as the flexion limiting component 1420 illustrated by Figures 43A-43D. For example, flexion limiting members 1512, 1514, 1516 (e.g., stops, extensions, buttresses, etc.) of Figure 44, flexion limiting members 1522, 1524, 1526 of Figure 45, flexion limiting members 1532, 1534, 1536 of Figure 46, and flexion limiting members 1552, 1554, 1556 of Figure 49A can all engage in the same or similar manner as the flexion limiting component 1420 of Figures 43A-43D.

[0259] In some implementations, as the outer frame portion bends, the bend limiting portion can reshape or bend until the bend limiting portion engages and stops further bending of the portion. The bend limiting members can engage simultaneously or sequentially. In some implementations, once the bend limiting portion engages and stops bending, other portions of the paddle frame can bend or bend or continue to bend or bend. In this way, the bend limiting portion can be used to control the bending or bending of the outer frame portion. In some implementations, the bend limiting portion limits the bend as the implantable valve repair device narrows. In some implementations, the bend limiting portion allows other portions of the paddle frame to bend after the bend limiting portion stops.

[0260] In the embodiment illustrated by FIGS. 47-48, the bend limiting portion 1540 may include one or more openings or holes 1542 in the outer frame portion. In some implementations, upon bending of the outer frame portion, the bend limiting portion 1540 may reshape or bend until the holes or openings flatten out and stop further bending of the bend limiting portion 1540. In some implementations, other portions of the paddle frame may bend or bend once the bend limiting portion stops bending. In this manner, the bend limiting portion illustrated by FIGS. 47 and 48 may be used to control the bending or bending of the outer frame portion. In some implementations, the bend limiting portion allows other portions of the paddle frame to bend after the holes in the bend limiting portion flatten out.

[0261] As shown in Figures 49A-B, the bend limiting portion 1550 includes bend limiting members 1552, 1554, 1556. The bend limiting members 1552, 1554, 1556 and the spaces between the bend limiting members may have a variety of different sizes and shapes that can be selected to control the bending of the bend limiting portion 1550. The bend limiting portion 1550 in Figure 49A is shown in an unbent or normal state. With reference to Figure 49B, the bend limiting portion 1550 is shown bent such that the bend limiting members 1552, 1554, 1556 engage each other and stop further bending of the bend limiting portion 1550.

[0262] 38A and 38B , the illustrated exemplary valve repair device 900 includes an outer frame portion 940 having an optional flexion limiting portion 960. In some implementations, the flexion limiting portion 960 includes a pair of inner flexion limiting members 962 (e.g., stops, extensions, buttresses, etc.) and a pair of outer flexion limiting members 964 (e.g., stops, extensions, buttresses, etc.). In some implementations, the inner flexion limiting portion 962 is connected to the inner frame portion 930 by a pivot connection 946, such as a pin or other fastener that allows for pivotal movement.

[0263] In some implementations, as the outer frame portion 940 narrows, the inner bend limiting portion 962 pivots about the pivot connection 946 and the first and second portions 942, 944 of the outer paddle frame portion 940 bend until the inner bend limiting portion 962 engages the outer bend limiting portion 964. Further narrowing of the outer paddle frame portion allows the engaged inner and outer bend limiting portions 962, 964 to rotate about the pivot connection 946 and / or other portions of the outer paddle frame 940 to bend.

[0264] 50A-50B, an exemplary outer frame portion 1700 with an optional bend-limiting portion 1720 is shown in an expanded or wide state. The outer frame portion 1700 has a width W1, a length L1, and a depth D1. With reference to FIGS. 51A-51B, the outer frame portion 1700 with the optional bend-limiting portion 1720 is shown in a narrowed state. The outer frame portion 1700 in the narrowed state includes a width W2, a length L2, and a depth D2.

[0265] In some implementations, as the outer frame portion 1700 narrows from the expanded state to the narrowed state, the width and depth decrease while the length measured from the proximal end 1702 to the distal end 1704 increases.

[0266] 52, an exemplary implantable valve repair device 1800 is shown. The implantable valve repair device 1800 includes an outer frame portion 1810 with a bend reinforced portion 1820. The outer frame portion 1810 includes slits 1812 on alternating sides of the outer frame portion 1810, each slit extending toward a center of the bend reinforced portion 1820 of the outer frame portion 1810. In some implementations, the slits create an undulating zigzag or serpentine bend reinforced portion as shown. The number, orientation, depth, width, etc. of the slits 1812 in the outer frame portion 1810 can be selected to control the flexibility of the bend reinforced portion 1820 of the outer frame portion 1810.

[0267] 53-56, an exemplary implantable valve repair device 1900 is illustrated with various components omitted or generally depicted to simplify the drawings. The implantable valve repair device 1900 includes an outer frame portion 1910, an optional spacer or coaptation element 1902, and a base or cap 1904. In some implementations, the implantable valve repair device 1900 may include an optional paddle frame clip / connector coupled to at least one paddle frame portion (e.g., an inner paddle frame portion or an outer paddle frame portion) and at least one paddle (e.g., an outer paddle or an inner paddle) (see FIGS. 31-42).

[0268] In some implementations, the implantable valve repair device 1900 can include an optional bend limiting portion on the outer frame portion 1910 (FIGS. 43A-52). In some implementations, the implantable valve repair device 1900 includes both an optional bend limiting portion on the outer frame portion 1910 and one or more optional paddle frame clips / connectors.

[0269] 54 and 56, the implantable valve repair device 1900 can be configured to capture one or more leaflets. In some implementations, two leaflets are captured and allowed to be brought together, pressed together, or coapted by a paddle frame 1910 when the implantable valve repair device 1900 is deployed and closed.

[0270] In some implementations, the paddle frame 1910 can be configured to bring the leaflets together along a majority of the height of the device. In the illustrated example, the leaflets are initially brought together or substantially brought together at the paddle frame coaptation locations T1, T2 by the paddle frame 1910. In some implementations, the paddle frame 1910 is configured to hold the leaflets together from the paddle frame coaptation locations T1, T2 to the depth the leaflets extend into the device.

[0271] The paddle frame 1910 is shown in a wide or substantially wide configuration in Figures 53 and 54, and the paddle frame is shown in a narrower configuration in Figures 55 and 56. In some implementations, in the wide or substantially wide configuration, the leaflets 20, 22 may be initially pressed together by the paddle frame 1910 of the implantable valve repair device 1900 at a paddle frame coaptation location T1 that is a distance C1 from the base or cap 1904.

[0272] The implantable valve repair device 1900 illustrated in Figures 55-56 is in a narrowed or partially narrowed state. In some implementations, in the partially narrowed state, the leaflets 20, 22 may first be forced together by the paddle frame of the implantable valve repair device 1900 at a coaptation position T2, which is a distance C2 from the base or cap 1904.

[0273] In some implementations, the paddle frame 1910 can be moved from a fully expanded configuration (i.e., 0% narrowed), in which the outer paddle frame portion extends far away from the inner paddle frame portion, to a fully narrowed configuration (i.e., 100% narrowed), in which the outer paddle frame portion is the same width or substantially the same width as the inner paddle frame portion, or as close as possible to the inner paddle frame portion.

[0274] In some implementations, the outer paddle frame portion may be configured such that paddle frame interface location T2 (e.g., when the paddle frame 1910 is approximately 50%-95% narrowed) and paddle frame interface location T1 (e.g., when the paddle frame 1910 is 0% narrowed) are proximate to one another. For example, the distance C2 when the paddle frame is 50%-95% narrowed or any subrange may be 70%-100% or any subrange of the distance C1 corresponding to when the paddle frame is 0% narrowed.

[0275] The coaptation location may depend on many factors, including, but not limited to, the anatomy of the leaflets, the positioning of the implantable valve repair device, and the bending of the paddle frame of the implantable valve repair device during expansion and stenosis. A more distal paddle frame coaptation location along the spacer or coaptation element 1902 (i.e., a location closer to the base or cap 1904, a location with a shorter distance C1 or C2) may result in less of the extent to which the leaflets 20, 22 are pressed together by the paddle frame 1910 of the implantable valve repair device 1900.

[0276] The valve repair device can be configured in a wide variety of different ways to maintain the distance C2 close to the distance C1. In some implementations, the outer paddle frame portion is configured to maintain the distance C2 close to the distance C1. For example, the paddle frame portion can be configured to maintain the distance C2 between 70% and 100% of the distance C1. In this example, C2 can correspond to a 50% to 95% or any subrange narrowing of the paddle frame, and C1 can correspond to a 0% narrowing of the paddle frame. For example, the outer paddle frame portion 1400, 1700 or features of the paddle frame portion 1400, 1700 can be used to maintain the distance C2 between 70% and 100% of the distance C1. In this example, C2 can correspond to a 50% to 95% or any subrange narrowing of the paddle frame, and C1 can correspond to a 0% narrowing of the paddle frame.

[0277] In some implementations, various features and / or configurations can be included to help increase the distance C2 between the paddle coaptation location T2 and the base or cap 1904. For example, the shape of the outer paddle frame portion, optional paddle frame clip, and / or optional flexion limiting portion can be configured to increase the distance C2 between the paddle coaptation locations T2 of the narrowed paddle frame. As a result, the amount of the leaflets 20, 22 pressed together by the narrowed paddle frame is increased.

[0278] In some implementations, the distance C2 between the joining location T2 and the base or cap 1904 may be substantially the same as the distance C1 between the joining location T1 and the base or cap 1904 (FIGS. 53-54). In some implementations, the distance C2 between the joining location T2 and the base or cap 1904 may be 0.0 mm to 1.0 mm or any subrange less than the distance C1 between the joining location T1 and the base or cap 1904. For example, in some implementations, the distance C2 between the joining location T2 and the base or cap 1904 may be 0.25 mm to 0.75 mm less than the distance C1 between the joining location T1 and the base or cap 1904.

[0279] 50B and 51B, the outer frame portion 1700 can include a bend 1750 corresponding to the joint locations T1, T2. In some implementations, the outer frame portion 1700 is configured to hold the bend 1750, and thus the paddle frame joint locations T1, T2, close together as the frame moves from the wide to the narrow configuration. In FIG. 50B, distance B1 is the distance from the proximal end to the bend 1750 when the outer paddle frame portion is in the wide configuration. In FIG. 51B, distance B2 is the distance from the proximal end to the bend 1750 when the outer paddle frame portion is in the narrow configuration.

[0280] In some implementations, the outer paddle frame portion 1700 can be configured to maintain distance B2 at 70%-100% of distance B1. In this example, B2 can correspond to when the paddle frame is 50%-95% narrowed or any subrange, and B1 can correspond to when the paddle frame is 0% narrowed.

[0281] 57-61, in some implementations, the outer frame portions 620 may be configured to enhance leaflet engagement by the valve repair device 600. For example, the outer frame portions 620 may be configured to sandwich one another (see FIG. 57), the outer frame portions 620 may be configured to maximize shoulder height (see FIG. 58), the outer frame portions 620 may be disposed around the inner frame portions (see FIGS. 59 and 60), and / or the outer frame portions 620 may be tapered (see FIG. 61) to increase the effectiveness of the valve repair device 600.

[0282] 57, the outer frame portions 620 can be configured to pinch together in a variety of different ways. For example, the outer frame portions 620 can be shaped to provide a pinch point, the outer frame portions can be biased together, such as by a spring or other resilient material.

[0283] In some implementations, the outer frame portions 620 can be shaped such that one or more portions 5700 of each outer frame portion 620 are biased past the centerline CL. In some implementations, when the two outer frame portions 620 are assembled into a device, the one or more portions 5700 engage each other at the centerline CL. In some implementations, the biasing force past the centerline CL creates a clamping force 5702 where the two outer frame portions 620 meet.

[0284] 57, a discrete pinch point 5704 is formed between the two outer frame portions 620 at or near the shoulders 5706 (see FIG. 58) of the two outer frame portions 620, with a space or gap 5708 between the remainder of the outer frame portions 620. However, the outer frame portions 620 may be shaped such that multiple pinch points 5704 are formed and / or such that one or more elongated pinch regions 5704 are formed. In some implementations, the outer frame portions may be configured to provide an elongated pinch force along the outer frame portions from the connectors 630 to the shoulders 5706.

[0285] 58, in some implementations, the outer frame portion 620 can be configured to maximize shoulder height C1. The implantable valve repair device 600 can capture one or more leaflets (e.g., leaflets 20, 22). Once multiple leaflets are captured, the leaflets can be brought together or pinched by a paddle frame 620 as described for FIG. 59. The paddle frame 620 can be configured to bring the leaflets together at a shoulder 5706. In some implementations, the outer frame 620 is configured to hold the leaflets together from the shoulder 5706 to the depth the leaflets extend into the device.

[0286] In some implementations, the outer frame portion 620 is configured such that the difference between the shoulder height C1 in the widened position and the shoulder height C2 in the narrowed position (see FIG. 56 ) is minimized. In the wide or substantially wide configuration, the leaflets 20, 22 are pressed together by the outer paddle frame portion 620 at a distance C1 from the base or cap 640.

[0287] In some implementations, the outer frame portion 620 can be moved from a fully expanded configuration (i.e., 0% narrowed), in which the outer paddle frame portion extends far away from the inner paddle frame portion, to a fully narrowed configuration (i.e., 100% narrowed), in which the outer paddle frame portion is the same width or substantially the same width as the inner paddle frame portion.

[0288] In some implementations, the outer paddle frame portion 620 may be configured such that the shoulder height C2 (e.g., when the paddle frame 1910 is approximately 50%-95% narrower) and the shoulder height C1 (e.g., when the paddle frame 1910 is 0% narrower) are close to each other. For example, the distance C2 when the paddle frame is 50%-95% narrower or any subrange may be 70%-100% or any subrange of the distance C1 corresponding to when the paddle frame is 0% narrower.

[0289] The valve repair device can be configured in a wide variety of different ways to keep the distance C2 close to the distance C1. In some implementations, the outer frame portion 620 is shaped to keep the distance C2 close to the distance C1 and to pinch the outer frame portion 620 together at a shoulder 5706 as shown in FIG. 57. For example, the paddle frame portion can be shaped to keep the distance C2 between 70% and 100% of the distance C1. In this example, C2 can correspond to a 50% to 95% or any subrange of narrowing of the paddle frame, and C1 can correspond to a 0% narrowing of the paddle frame. For example, the outer paddle frame portion 620 can be shaped to keep the distance C2 between 70% and 100% of the distance C1. In this example, C2 can correspond to a 50% to 95% or any subrange of narrowing of the paddle frame, and C1 can correspond to a 0% narrowing of the paddle frame.

[0290] In some implementations, the shoulder height C2 may be substantially the same as the shoulder height C1. In some implementations, the shoulder height C2 may be 0.0 mm to 1.0 mm less than the shoulder height C1, or any subrange. For example, in some implementations, the shoulder height C2 may be 0.25 mm to 0.75 mm less than the shoulder height C1.

[0291] 59 and 60, the outer frame portion 620 can be disposed around the inner frame portion 610 when viewed from above (i.e., from the proximal end). Disposing the outer frame portion 620 around the inner frame portion 610 when viewed from above or from the proximal end can help constrain the path of the outer surfaces (ventricular side) of the leaflets 20, 22. For example, referring to FIG. 60, the leaflets 20, 22 are shown engaged by the clasps 130 between the sides 5902 of the inner frame portion 610. The sides 5902 of the inner frame portion 610 guide the leaflets 20, 22 away from the clasps 130 and towards each other. In some implementations, the outer frame portion 620 is configured to be disposed around the inner frame portion 610 when viewed from above (i.e., from the proximal end), while pinching the leaflets as shown in FIG. 57 and / or maximizing the shoulder height C1 as shown in FIG. 58.

[0292] In some implementations, when viewed from the top or proximal end, the side 5904 of the outer frame portion 620 is adjacent to, and optionally parallel to, the side 5902 of the inner frame portion 610. For example, the side 5904 of the outer frame portion 620 can be a distance D3 from the side 5902 of the inner frame portion 610. The distance D3 can be between 0.01 mm and 0.5 mm, e.g., between 0.01 mm and 0.2 mm, e.g., between 0.01 mm and 0.1 mm, or any subrange of these ranges, when viewed from the top or proximal end.

[0293] In some implementations, when viewed from the top or proximal end, the side 5904 of the outer frame portion 620 is parallel to the side 5902 of the inner frame portion at least to the end 5906 of the inner frame portion 610. In some implementations, when viewed from the top or proximal end, the side 5904 of the outer frame portion 620 is parallel to the side 5902 of the inner frame portion beyond the end 5906 of the inner frame portion 610 or falls just short of the end 5906 of the side of the inner frame portion 610.

[0294] In some implementations, when viewed from the top or proximal end, the outer frame portion 620 curves away from the inner frame portion 610 at or near the end 5906 of the side 5902 of the inner frame portion 610 at a curved portion 5908. For example, the outer frame portion 620 can begin to curve away from the inner frame portion 610 within 0.5 mm of the end 5906, within 0.3 mm of the end 5906, within 0.1 mm of the end 5906, or within 0.05 mm of the end 5906.

[0295] In some implementations, the curved portion 5908 guides the leaflets 20, 22 both toward each other and toward the side 5910 of the outer frame portion. With reference to FIG. 59, the dashed line 5912 represents the area where the leaflets 20, 22 may extend without the curved portion 5908. The leaflets 20, 22 may sag, wrinkle, and / or move away from each other in this area. In some implementations, the curved portion 5908 constrains the path of the outer surface (ventricular side) of the leaflets 20, 22 of the valve to bring the leaflets together and / or prevent them from sagging or wrinkle. In some implementations, the curved portion 5908 extends to the straight portion 5914 where the leaflets 20, 22 meet when viewed from above or from the atrial side. The straight portion 5914 extends from the curved portion 5908 to a side 5910 of the outer frame portion 620 .

[0296] In some implementations, the outer frame portion 620 and / or connector 630 can taper or reduce in width from the proximal end 6100 to the distal end 6102 when viewed from the anterior or posterior as shown in FIG. 61. As described in detail herein, the outer frame portion 620 can move between a narrow and a wide configuration. The narrow configuration allows the device 600 to be manipulated through the patient's anatomy. For example, the narrow outer frame portion 620 and attached paddles can be routed through the chordae tendineae CT so that the paddles can be positioned on the lateral or ventricular side of the leaflets 20, 22. By configuring the outer frame portion 620 and / or connector 630 to be tapered in the splayed position, the connector and / or distal end of the outer frame portion 620 still fits between the chordae tendineae CT in the splayed position. Additionally, with reference to FIG. 3A, the tapered shape of the outer frame portion 620 can more closely approximate the tapered shape of the native leaflets 20, 22.

[0297] The outer frame portion 620 can be configured to taper in a variety of different ways from the proximal end 6100 to the distal end 6102. For example, the outer frame portion 620 can be shaped to taper from the proximal end 6100 to the distal end 6102. In some implementations, the taper angle 6104 can be between 30 and 80 degrees, such as between 45 and 80 degrees, between 60 and 75 degrees, or any subrange of these ranges.

[0298] In some implementations, the taper of the outer frame portion 620 is continuous with the taper of the connector 630. For example, the angle 6104 of the taper of the outer frame portion may be the same as the angle of the taper of the connector 630. In some implementations, the angle 6104 of the taper of the outer frame portion is different from the angle of the taper of the connector 630, or the connector is not tapered.

[0299] In some implementations, the outer frame portion 620 is tapered and configured to sit around the inner frame portion 610 when viewed from above (i.e., from the proximal end), as shown in Figures 59 and 60, configured to pinch the leaflets together, as shown in Figure 57, and / or to maximize shoulder height C1, as shown in Figure 58.

[0300] 62-71 show an example of a valve repair device 600. Referring to FIG. 62, in some implementations, the outer frame portions 620 can be configured to sandwich one another depending on the shape of the outer frame portions 620. In some implementations, the outer frame portions 620 are sized and shaped such that the outer frame portions 620 extend beyond the centerline CL when the outer frame portions 620 are attached to the outer paddle 670 but not yet attached to the connector when viewed from the top or side. For example, the outer frame portions 620 can be sized and shaped such that the outer frame portions 620 extend beyond the centerline CL by 0.2 mm to 3 mm, 0.3 mm to 2.5 mm, 0.4 mm to 2.0, 0.5 mm to 1.5 mm, or any subrange of these ranges. To complete the assembly of the outer frame portions 620 into the valve repair device, the outer frame portions 620 are stretched and connected to the connectors 630.

[0301] 69 and 70, when the two outer frame portions 620 are assembled with the clip / connector 500 and the connector 630, the two outer frame portions provide a pinch point 5704. In some implementations, the outer frame portions 620 can be shaped such that one or more portions 5700 of each outer frame portion 620 are biased past the centerline CL. In some implementations, when the two outer frame portions 620 are assembled into the device, the one or more portions 5700 engage each other at the centerline CL. In some implementations, the biasing force past the centerline CL creates a pinch force 5702 where the two outer frame portions 620 meet. In the embodiment illustrated by FIGS. 69 and 70, a discrete pinch point is formed between the two outer frame portions 620 at or near the shoulders 5706 (see FIG. 69) of the two outer frame portions 620, with a space or gap 5708 between the remaining portions of the outer frame portions 620.

[0302] However, the outer frame portion 620 may be shaped such that multiple clamping points 5704 are formed and / or such that one or more elongated clamping regions are formed. In some implementations, the outer frame portion may be configured to provide an elongated clamping force along the outer frame portion from the connector 630 to the shoulder 5706.

[0303] 68-71, an implantable valve repair device 600 is shown with various components omitted or shown diagrammatically to simplify the drawings. The implantable valve repair device 600 includes an outer frame portion 620, such as the outer frame portion illustrated by FIGS. 62-67, an optional coaptation element 110 (e.g., spacer, coaptation element, plug, gap filler, etc.), and a base or cap 640. In some implementations, the implantable valve repair device 600 may include one or more optional paddle frame clips / connectors 500 coupled to at least one paddle frame portion (e.g., inner paddle frame portion 610 or outer paddle frame portion 620) and at least one paddle (e.g., outer paddle 670 or inner paddle 672). In some implementations, the implantable valve repair device 600 may include an optional bend limiting portion on the outer frame portion 620. In some implementations, the implantable valve repair device 600 includes both an optional bend limiting portion on the outer frame portion 620 and one or more of the optional paddle frame clips / connectors 500.

[0304] The implantable valve repair device 600 may be configured to capture one or more leaflets. When multiple leaflets are captured and the implantable valve repair device 600 is deployed and closed, the leaflets may be brought together, pressed together, or coapted by the outer paddle frame portion 620. The outer paddle frame portion 620 may be configured to bring the leaflets together along a majority of the height of the device. In the illustrated embodiment, the leaflets are first brought together or substantially brought together by the outer frame portion 620 at the shoulder 5706.

[0305] The outer frame portion 620 is shown in a wide or substantially wide configuration in Figure 71. In some implementations, in the wide or substantially wide configuration, the leaflets 20, 22 are first pressed together by the outer paddle frame portion 620 of the implantable valve repair device 600 at a shoulder 5706 that is a distance C1 from the base or cap 640 (see Figure 58, which is also the distance C1 from the shoulder to the base or cap in Figure 70).

[0306] In some implementations, the outer frame portion 620 can be moved from a fully expanded configuration (i.e., 0% narrowed), in which the outer paddle frame portion extends far away from the inner paddle frame portion, to a fully narrowed configuration (i.e., 100% narrowed), in which the outer paddle frame portion is the same width or substantially the same width as the inner paddle frame portion, or as close as possible to the inner paddle frame portion.

[0307] In some implementations, the outer paddle frame portion 620 may be configured such that the shoulder 5706 (e.g., when the paddle frame 1910 is approximately 50%-95% narrower) and the shoulder 5706 (e.g., when the paddle frame 1910 is 0% narrower) are proximate to one another. For example, the distance from the cap 640 to the shoulder when the paddle frame is 50%-95% narrower or any subrange may be 70%-100% or any subrange of the distance C1 to the shoulder corresponding to when the paddle frame is 0% narrower.

[0308] 64-67, the outer frame portion 620 can include a bend 1750 that corresponds to the shoulder 5706. In some implementations, the outer frame portion 1700 is configured to hold the bend 1750, and therefore the shoulder 5706, close as the frame moves from the wide to the narrow configuration. In some implementations, the outer paddle frame portion 620 can be configured to maintain a cap-to-shoulder distance of 70%-100% of the distance C1. In this example, the cap-to-shoulder distance can correspond to when the paddle frame is 50%-95% narrowed or any subrange, and the distance C1 can correspond to when the paddle frame is 0% narrowed.

[0309] 69, in some implementations, the pinch point 5704 is inside the end 6900 of the connector 630 when viewed from the top or proximal end. With reference to FIGS. 72 and 73, in some implementations, the pinch point 5704 is substantially aligned with the end 6900 of the connector 630 when viewed from the top or proximal end. For example, the pinch point 5704 may be aligned within 0.5 mm, e.g., within 0.4 mm, e.g., within 0.3 mm, or e.g., within 0.2 mm, when viewed from the top or proximal end.

[0310] The pinch point 5704 may be substantially aligned with the end 6900 of the connector 630 in a variety of different ways. For example, the outer frame portion 620 may be shaped to move the pinch point 5704 into substantial alignment with the end 6900 of the connector 630 when viewed from the top or proximal end of the device 600. With reference to FIGS. 72 and 73, the dark black line 7200 represents a modified shape of the outer frame portion 620. The modified shape 7200 has a shoulder 5706 that moves outwardly or laterally to move the pinch point 5704 into substantial alignment with the end 6900 of the connector 630. However, the pinch point may be moved outwardly or laterally in any manner.

[0311] 74 shows the left outer frame portion 620 with an increased shoulder height C1. In some implementations, the device 600 may have the same outer frame portion 620 on both sides of the device, but the right outer frame portion 620 does not have an increased shoulder height to call attention to the increased shoulder height of the outer frame portion 620 on the left side of the device 600.

[0312] The shoulder height C1 can be increased in a variety of different ways. In some implementations, the shoulder height C1 is increased by sizing and shaping the outer frame portion 620. In some implementations, the top or most proximal point 7400 of the outer frame portion 620 is substantially aligned with the top or most proximal point 7402 of the inner frame portion 610. For example, the top or most proximal point 7400 of the outer frame portion 620 can be within 0.5 mm, within 0.4 mm, within 0.3 mm, within 0.2 mm, or within 0.1 mm of the top or most proximal point 7402 of the inner frame portion 610 when the device 600 is viewed from the side.

[0313] In some implementations, the paddle frame 620 can be configured to bring the leaflets together at a shoulder 5706. In some implementations, the outer frame 620 is configured to hold the leaflets together from the shoulder 5706 to the depth the leaflets extend into the device (e.g., hinge portion 138 of the clasp 130). In some implementations, the outer frame portion 620 is configured to substantially align a top or proximal-most point 7400 of the outer frame portion 620 with a top or proximal-most point 7402 of the inner frame portion 610 while being tapered and configured to lie around the inner frame portion 610 when viewed from above (i.e., from the proximal end) and / or configured to pinch the leaflets together.

[0314] 75 and 76, in some implementations, the outer frame portion 620 and / or connector 630 may taper or decrease in width from the proximal end 6100 to the distal end 6102 when viewed from the anterior or posterior. As described in detail herein, the outer frame portion 620 may move between a narrow and a wide configuration. The narrow configuration allows the device 600 to be manipulated through the patient's anatomy. For example, the narrow outer frame portion 620 and attached paddles may be routed through the chordae tendineae CT so that the paddles can be positioned on the lateral or ventricular side of the leaflets 20, 22. In some implementations, by configuring the outer frame portion 620 and / or connector 630 to be tapered in the splayed position, the connector and / or distal end of the outer frame portion 620 still fits between the chordae tendineae CT even in the splayed position. Additionally, with reference to FIG. 3A, the tapered shape of the outer frame portion 620 can more closely approximate the tapered shape of the native valve leaflets 20,22.

[0315] 75, in some implementations, the taper angle 6104 may be between 30 and 80 degrees, such as between 45 and 80 degrees, such as between 60 and 75 degrees, or any subrange of these ranges. In some implementations, the taper of the outer frame portion 620 is continuous with the taper of the connector 630. For example, the taper angle 6104 of the outer frame portion may be the same as the taper angle of the connector 630. In some implementations, the taper angle 6104 of the outer frame portion is different from the taper angle of the connector 630, or the connector is not tapered.

[0316] With further reference to the embodiment of FIGS. 75 and 76, the outer frame portions 620 may be configured to pinch one another (e.g., in the manner described in connection with FIGS. 57 and 62-73). For example, the outer frame portions 620 may be optionally shaped to provide a pinching point, the outer frame portions may be biased together, such as by a spring or other resilient material. In some implementations, the outer frame portions 620 may be shaped such that one or more portions of each outer frame portion 620 are biased past the centerline CL. When the two outer frame portions 620 are assembled into the device, the one or more portions 5700 engage one another. Any biasing force beyond the centerline CL creates a pinching force where the two outer frame portions 620 meet.

[0317] In some implementations, a discrete pinch point may be formed between the two outer frame portions 620 at or near the shoulders 5706 of the two outer frame portions 620, or the outer frame portions 620 may be shaped such that multiple pinch points are formed and / or such that one or more elongated pinch regions are formed. In some implementations, the outer frame portions may be configured to provide an elongated pinch force along the outer frame portions from the connectors 630 to the shoulders 5706.

[0318] 75 and 76, in some implementations, the outer frame portion 620 can be optionally configured to maximize the shoulder height C1. The outer frame portion 620 can be optionally configured to maximize the shoulder height C1 in any manner described herein.

[0319] The implantable valve repair device 600 can be configured to capture one or more leaflets. Once multiple leaflets are captured, the leaflets can be brought together or pinched by the paddle frame 620. The paddle frame 620 can be configured to bring the leaflets together at a shoulder 5706. In some implementations, the outer frame 620 is configured to hold the leaflets together from the shoulder 5706 to the depth the leaflets extend within the device (e.g., to the hinge portion 138 of the clasp 130; see FIG. 76 ).

[0320] 75 and 76, in some implementations, the outer frame portion 620 is configured such that the difference between the height of the shoulders in the splayed position and the height of the shoulders in the narrowed position is minimized. In some implementations, in the wide or substantially wide configuration, the leaflets 20, 22 are pressed together by the outer paddle frame portion 620 away from the base or cap 640. In some implementations, the outer frame portion 620 can move from a fully splayed configuration (i.e., 0% narrowed configuration) in which the outer paddle frame portion extends far away from the inner paddle frame portion to a fully narrowed configuration (i.e., 100% narrowed configuration) in which the outer paddle frame portion is the same width or substantially the same width as the inner paddle frame portion.

[0321] In some implementations, the outer paddle frame portion 620 may be configured such that the shoulder height (e.g., when the paddle frame 1910 is approximately 50%-95% narrower) and the shoulder height (e.g., when the paddle frame 1910 is 0% narrower) are close to each other. For example, the shoulder height when the paddle frame is 50%-95% narrower or any subrange may be 70%-100% or any subrange of the shoulder height corresponding to when the paddle frame is 0% narrower.

[0322] The valve repair device can be configured in a variety of different ways to keep the shoulder height substantially constant. In some implementations, the outer frame portions 620 are shaped to maintain the distance shoulder height substantially the same and such that the outer frame portions 620 sandwich each other at the shoulders 5706.

[0323] 75 and 76, in some implementations, the outer frame portion 620 may be optionally disposed around the inner frame portion 610 when viewed from above (i.e., from the proximal end). In some implementations, disposing the outer frame portion 620 around the inner frame portion 610 when viewed from above or from the proximal end may help to constrain the path of the outer surface (ventricular side) of the valve leaflets 20, 22. For example, the leaflets 20, 22 are engaged by the clasps 130 between the sides 5902 of the inner frame portion 610. The sides 5902 of the inner frame portion 610 guide the leaflets 20, 22 from the clasps 130 towards each other.

[0324] In some implementations, the side 5904 of the outer frame portion 620 is adjacent to and optionally parallel to the side 5902 of the inner frame portion 610 when viewed from the top or proximal end. For example, the side 5904 of the outer frame portion 620 can be a distance D3 (see FIG. 59 ) from the side 5902 of the inner frame portion 610. In some implementations, the distance D3 can be 0.01 mm to 0.5 mm, e.g., 0.01 mm to 0.2 mm, e.g., 0.01 mm to 0.1 mm, or any subrange of these ranges, when viewed from the top or proximal end. In some implementations, the side 5904 of the outer frame portion 620 is parallel to the side 5902 of the inner frame portion when viewed from the top or proximal end.

[0325] In some implementations, when viewed from the top or proximal end, the outer frame portion 620 curves away from the inner frame portion 610 at a curved portion 5908. In some implementations, the curved portion 5908 guides the leaflets 20, 22 both toward each other and toward the sides of the outer frame portion. In some implementations, the curved portion 5908 constrains the path of the outer surfaces (ventricular sides) of the leaflets 20, 22 of the valve to bring the leaflets together and / or prevent them from sagging or wrinkling.

[0326] In some implementations, the curved portion 5908 extends to a straight portion 5914 where the leaflets 20, 22 meet when viewed from above, or from the atrial side. The straight portion 5914 extends from the curved portion 5908 to a side or lateral extent 5910 of the outer frame portion 620.

[0327] In some implementations, the outer frame portion 620 can be configured to have a fully narrowed width W3 (i.e., the width of the outer frame portion in a fully narrowed configuration) that is equal to or less than the width W4 of the inner frame portion 610 when viewed from the front or rear. In some implementations, the inner frame portion 610 does not change width. FIG. 77 shows a partial view from the front or rear of the device (i.e., about half of the device) in which the outer frame portion 620 has a fully narrowed width W3 that is greater than the width W4 of the inner frame portion 610. FIG. 78 shows a partial view from the front or rear of the device 600 (i.e., about half of the device) in which the outer frame portion 620 has a fully narrowed width W3 equal to the width W4 of the inner frame portion 610.

[0328] As described in detail herein, the outer frame portion 620 can be moved between a narrow and a wide configuration. The narrow configuration allows the device 600 to be manipulated through the patient's anatomy. For example, the narrow outer frame portion 620 and attached paddles can be routed through the chordae tendineae CT to position the paddles on the lateral or ventricular side of the leaflets 20, 22. By configuring the outer frame portion 620 to have a fully narrowed width W3 that is equal to or less than the width W4 of the inner frame portion 610, the device 600 can fit through any space, such as between the chordae tendineae CT, into which the inner frame portion 610 may fit.

[0329] The outer frame portion 620 may be configured to have a fully narrowed width W3 that is less than or equal to the width W4 of the inner frame portion 610 in a variety of different ways. For example, the outer frame portion 620 may be sized and shaped such that the outer frame portion 620 has a fully narrowed width W3 that is less than or equal to the width W4 of the inner frame portion 610.

[0330] In some implementations, the outer frame portion 620 may be configured to have a fully narrowed width W3 that is less than or equal to the width W4 of the inner frame portion 610, or may be tapered (see FIG. 61), configured to sit around the inner frame portion 610 when viewed from the top or proximal end (see FIGS. 59 and 60), configured to pinch the leaflets together (see FIG. 57), and / or configured to maximize the shoulder height C1 (see FIG. 58).

[0331] Some non-limiting examples of some of the concepts herein are listed below.

[0332] Working Example Example 1 1. A device for repairing a native heart valve, comprising: an anchor portion configured to connect to a leaflet of the native valve, The outer paddle and An inner paddle, a clasp coupled to the inner paddle; Paddle frame and and a clip / connector that couples the paddle frame to at least one of the outer paddle, the inner paddle, and the clasp.

[0333] Example 2 The apparatus of example 1, wherein the paddle frame comprises an outer frame portion and an inner frame portion.

[0334] Example 3 The device of example 2, wherein the clip / connector is coupled to at least one of the outer frame portion and the inner frame portion.

[0335] Example 4 The device of any one of Examples 1 to 3, wherein the clip / connector comprises an opening configured to connect to the paddle frame.

[0336] Example 5 The apparatus of example 4, wherein the opening accommodates a portion of the paddle frame.

[0337] Example 6 The apparatus of example 4, wherein the opening accommodates at least one of the outer frame portion and the inner frame portion of the paddle frame.

[0338] Example 7 The apparatus of any of Examples 4 to 6, wherein the opening has a square cross-section.

[0339] Example 8 The device of any of Examples 4-6, wherein the opening has a cross-sectional shape that is the same as a cross-sectional shape of at least one of the outer frame portion and the inner frame portion.

[0340] Example 9 The device of any one of Examples 1 to 3, wherein the clip / connector comprises a first opening and a second opening.

[0341] Example 10 10. The apparatus of example 9, wherein the first opening is coupled to the inner paddle portion and the second opening is coupled to the outer paddle portion.

[0342] Example 11 The device described in any of Examples 4 to 10, wherein the clip / connector has an open configuration and a closed configuration.

[0343] Example 12 The device of example 11, wherein in the open position, the head portion is open so that the opening is accessible by a channel, and in the closed configuration, the head portion is closed so that the opening is not accessible.

[0344] Example 13 13. The apparatus of example 12, wherein at least one of the inner frame portion and the outer frame portion can be positioned through the channel and into the opening.

[0345] Example 14 13. The device of any preceding embodiment, wherein the clip / connector comprises a head portion and a stem portion.

[0346] Example 15 The device of example 14, wherein the head portion comprises one or an engagement member.

[0347] Example 16 The device of example embodiment 14, wherein the one or more engagement members engage with at least one of the inner paddle and the outer paddle.

[0348] Example 17 The device of example embodiment 14, wherein the one or more engagement members are positioned at a distal end of the clip / connector.

[0349] Example 18 The device according to any one of Examples 14 to 17, wherein the engagement member has a zigzag configuration.

[0350] Example 19 An apparatus as described in any of Examples 9-18, wherein the engagement member extends through and hooks onto at least one of the outer paddle and the inner paddle.

[0351] Example 20 The device of any preceding embodiment, wherein the clip / connector is a first paddle frame clip / connector, and the device further comprises a second paddle frame clip / connector, the first paddle frame clip / connector coupled to the outer paddle and the second paddle frame clip / connector coupled to the inner paddle.

[0352] Example 21 1. A system comprising: 1. A device for repairing a native heart valve, comprising: an anchor portion configured to connect to a leaflet of the native valve, The outer paddle and An inner paddle, a clasp coupled to the inner paddle; Paddle frame and a paddle frame clip / connector for coupling the paddle frame to at least one of the outer paddle, the inner paddle, or the clasp; and a device comprising an anchor portion comprising: a catheter coupled to the device; A system comprising:

[0353] Example 22 The system of example 1, wherein the paddle frame includes an outer frame portion and an inner frame portion.

[0354] Example 23 The system of example embodiment 22, wherein the paddle frame clip / connector is coupled to at least one of the outer frame portion and the inner frame portion.

[0355] Example 24 The system described in any one of Examples 1 to 23, wherein the paddle frame clip / connector has an opening.

[0356] Example 25 25. The system of example embodiment 24, wherein the opening accommodates a portion of the paddle frame.

[0357] Example 26 25. The system of claim 24, wherein the opening accommodates at least one of the outer frame portion and the inner frame portion of the paddle frame.

[0358] Example 27 27. The system of any one of Examples 24-26, wherein the opening has a square cross-section.

[0359] Example 28 The system of any one of Examples 24 to 26, wherein the opening has a cross-sectional shape that is the same as a cross-sectional shape of at least one of the outer frame portion and the inner frame portion.

[0360] Example 29 A system described in any of Examples 21 to 23, wherein the paddle frame clip / connector has a first opening and a second opening.

[0361] Example 30 30. The system of embodiment 29, wherein the first opening is coupled to the inner paddle frame portion and the second opening is coupled to the outer paddle frame portion.

[0362] Example 31 A system described in any of Examples 24 to 30, wherein the paddle frame clip / connector includes an open form and a closed form.

[0363] Example 32 The system of Example 31, wherein in the open configuration, the head portion is open such that the opening is accessible by a channel, and in the closed configuration, the head portion is closed such that the opening is not accessible.

[0364] Example 33 The system of example 32, wherein at least one of the inner frame portion and the outer frame portion can be positioned through the channel and into the opening.

[0365] Example 34 The system of any preceding embodiment, wherein the paddle frame clip / connector comprises a head portion and a stem portion.

[0366] Example 35 The system of example 34, wherein the head portion comprises one or more engagement members.

[0367] Example 36 The system of example embodiment 34, wherein the one or more engagement members engage with at least one of the inner paddle and the outer paddle.

[0368] Example 37 The system of example 34, wherein the one or more engagement members are positioned at a distal end of the paddle frame clip / connector.

[0369] Example 38 The system described in any one of Examples 34 to 37, wherein the engagement member has a zigzag configuration.

[0370] Example 39 A system described in any of Examples 29-38, wherein the engagement member extends through and hooks onto at least one of the outer paddle and the inner paddle.

[0371] Example 40 A system as described in any of the preceding examples, wherein the apparatus comprises a first paddle frame clip / connector and a second paddle frame clip / connector, the first paddle frame clip / connector coupled to an outer paddle and the second paddle frame clip / connector coupled to an inner paddle.

[0372] Example 41 1. A device for repairing a native heart valve, comprising: an anchor portion configured to connect to a leaflet of the native valve, The outer paddle and An inner paddle, a clasp coupled to the inner paddle; a paddle frame having an outer frame portion; an anchor portion comprising The apparatus, wherein the outer frame portion comprises a bend limiting portion, the bend limiting portion comprising a clip / connector region disposed between a first bend limiting component and a second bend limiting component.

[0373] Example 42 The device of Example 41, wherein at least one of the first flexion limiting component and the second flexion limiting component comprises an L-shaped bend.

[0374] Example 43 The device of Example 42, wherein the clip / connector region comprises a rectangular, square, trapezoidal, or irregular shaped cross-section.

[0375] Example 44 The device of Example 43, further comprising a paddle frame clip / connector coupled to the clip / connector region between the first flexion limiting component and the second flexion limiting component.

[0376] Example 45 The device of example 44, wherein the clip / connector region has a width substantially the same as the width of the paddle frame clip / connector.

[0377] Example 46 An apparatus as described in any of Examples 44-45, wherein the clip / connector region includes a cross-sectional shape that matches the cross-sectional shape of the paddle frame clip / connector.

[0378] Example 47 A device described in any of Examples 41 to 46, wherein the clip / connector region comprises a plurality of segments between surfaces of the clip / connector region.

[0379] Example 48 The apparatus of Example 47, wherein each of the plurality of segments has an angle of 45 degrees to 90 degrees relative to the surface.

[0380] Example 49 49. The device of any of claims 41-48, wherein the outer frame portion includes a first curve and a second curve, the radius of the first curve being smaller than the radius of the second curve.

[0381] Example 50 50. The device of any one of Examples 41 to 49, wherein the outer frame portion includes an expanded state and a narrowed state.

[0382] Example 51 1. A system comprising: 1. A device for repairing a native heart valve, comprising: an anchor portion configured to connect to a leaflet of the native valve, The outer paddle and An inner paddle, a clasp coupled to the inner paddle; a paddle frame having an outer frame portion; an anchor portion comprising an apparatus, the outer frame portion comprising a bend limiting portion, the bend limiting portion comprising a clip / connector region disposed between a first bend limiting component and a second bend limiting component; a catheter coupled to the device; A system comprising:

[0383] Example 52 The system of Example 51, wherein at least one of the first flexion limiting component and the second flexion limiting component comprises an L-shaped bend.

[0384] Example 53 The system of Example 52, wherein the clip / connector region has a rectangular, square, trapezoidal, or irregular shaped cross-section.

[0385] Example 54 The system of example 53, further comprising a paddle frame clip / connector coupled to the clip / connector region between the first flexion limiting component and the second flexion limiting component.

[0386] Example 55 The system of example 54, wherein the clip / connector region has a width substantially the same as the width of the paddle frame clip / connector.

[0387] Example 56 A system described in any of Examples 54-55, wherein the clip / connector region includes a cross-sectional shape that matches the cross-sectional shape of the paddle frame clip / connector.

[0388] Example 57 A system described in any of Examples 51 to 56, wherein the clip / connector region includes a plurality of segments between surfaces of the clip / connector region.

[0389] Example 58 58. The system of embodiment 57, wherein each of the plurality of segments has an angle of 45 degrees to 90 degrees relative to the surface.

[0390] Example 59 A system described in any of Examples 51 to 58, wherein the outer frame portion includes a first curve and a second curve, and the radius of the first curve is smaller than the radius of the second curve.

[0391] Example 60 A system described in any of Examples 51 to 59, wherein the outer frame portion includes an expanded state and a narrowed state.

[0392] Example 61 1. A device for repairing a native heart valve, comprising: a pair of paddle frames configured to move between a wide configuration and a narrow configuration; the pair of paddle frames are movable between an open position and a closed position in which the paddle frames compress the leaflets of the native heart valve against each other; the pair of paddle frames having a first paddle frame coaptation position in which the native valve leaflets are initially pressed together when the pair of paddle frames are in the closed position and in the wide configuration; the pair of paddle frames having a second paddle frame coaptation position in which the native valve leaflets are initially pressed together when the pair of paddle frames are in the closed position and in a 50% narrowed configuration; The apparatus, wherein the second paddle frame bond location is within 2 mm of the first paddle frame bond location.

[0393] Example 62 The device of Example 61, wherein the second paddle frame joint location is within 1 mm of the first paddle frame joint location.

[0394] Example 63 The device of Example 61, wherein the second paddle frame joint location is within 0.75 mm of the first paddle frame joint location.

[0395] Example 64 The device of Example 61, wherein the second paddle frame joint location is within 0.5 mm of the first paddle frame joint location.

[0396] Example 65 The apparatus of Example 61, wherein the second paddle frame joining position is 0.25 mm to 0.75 mm from the first paddle frame joining position.

[0397] Example 66 1. A device for repairing a native heart valve, comprising: A pair of paddle frames, A pair of inner paddle frame portions; A pair of adjustable width outer paddle frame sections; A pair of paddle frames having The pair of paddle frames are movable between an open position and a closed position, the outer frame portions are configured to sandwich one another in the closed position.

[0398] Example 67 67. The device of embodiment 66, wherein the pair of inner frame portions do not interdigitate with each other in the closed position.

[0399] Example 68 An apparatus as described in any one of Examples 66-67, wherein the pair of outer frame portions are shaped to provide a clamping point.

[0400] Example 69 A device described in any one of Examples 66 to 68, wherein the pair of outer frame portions are shaped so that one or more portions of each of the pair of outer frame portions are biased beyond a center line CL of the device.

[0401] Example 70 1. A system comprising: 1. A device for repairing a native heart valve, comprising: A pair of paddle frames, A pair of inner paddle frame portions; A pair of adjustable width outer paddle frame sections; A pair of paddle frames having The pair of paddle frames are movable between an open position and a closed position, an apparatus in which the outer frame portions are configured to sandwich one another in the closed position; a catheter coupled to the device; A system comprising:

[0402] Example 71 The system of Example 70, wherein the pair of inner frame portions do not intersect with each other in the closed position.

[0403] Example 72 A system described in any one of Examples 70 to 71, wherein the pair of outer frame portions are shaped to provide a clamping point.

[0404] Example 73 A system described in any one of Examples 70 to 72, wherein the pair of outer frame portions are shaped such that one or more portions of each of the pair of outer frame portions are biased beyond the center line CL of the device.

[0405] Example 74 1. A device for repairing a native heart valve, comprising: A pair of paddle frames are provided. the pair of paddle frames are movable between a fully expanded configuration and a fully contracted configuration; the pair of paddle frames are movable between an open position and a closed position in both the fully expanded and fully contracted configurations; the pair of paddle frames having a first shoulder height when the pair of paddle frames are closed and in the fully narrowed configuration; the pair of paddle frames having a second shoulder height when the pair of paddle frames are closed and in the fully expanded configuration; The height of the first shoulder portion is 70% to 100% of the height of the second shoulder portion.

[0406] Example 75 The device of Example 74, wherein the outer frame portions are configured to sandwich each other in the closed position in both the fully narrowed and fully expanded configurations.

[0407] Example 76 An apparatus described in any one of Examples 74 to 75, wherein each paddle frame of the pair of paddle frames has an inner frame portion of fixed width and an outer frame portion of adjustable width.

[0408] Example 77 77. The device of example 76, wherein the adjustable width outer frame portion is movable between the fully narrowed and fully expanded configurations.

[0409] Example 78 1. A system comprising: 1. A device for repairing a native heart valve, comprising: A pair of paddle frames are provided. the pair of paddle frames are movable between a fully expanded configuration and a fully contracted configuration; the pair of paddle frames are movable between an open position and a closed position in both the fully expanded and fully contracted configurations; the pair of paddle frames having a first shoulder height when the pair of paddle frames are closed and in the fully narrowed configuration; the pair of paddle frames having a second shoulder height when the pair of paddle frames are closed and in the fully expanded configuration; A device in which the height of the first shoulder portion is 70% to 100% of the height of the second shoulder portion; a catheter coupled to the device; A system comprising:

[0410] Example 79 The system of Example 78, wherein the outer frame portions are configured to sandwich each other in the closed position in both the fully narrowed and fully expanded configurations.

[0411] Example 80 A system described in any one of Examples 78 to 79, wherein each paddle frame of the pair of paddle frames has an inner frame portion of fixed width and an outer frame portion of adjustable width.

[0412] Example 81 The system of example 80, wherein the adjustable width outer frame portion is movable between the fully narrowed and fully widened configurations.

[0413] Example 82 1. A device for repairing a native heart valve, comprising: A pair of paddle frames are provided. the pair of paddle frames are movable between a fully expanded configuration and a fully contracted configuration; the pair of paddle frames are movable between an open position and a closed position in both the fully expanded and fully contracted configurations; the pair of paddle frames having a first shoulder height when the pair of paddle frames are closed and in the fully narrowed configuration; the pair of paddle frames having a second shoulder height when the pair of paddle frames are closed and in the fully expanded configuration; wherein the height of the first shoulder is within 1 mm of the height of the second shoulder.

[0414] Example 83 The device of Example 82, wherein the outer frame portions are configured to sandwich each other in the closed position in both the fully narrowed and fully expanded configurations.

[0415] Example 84 83. The apparatus of embodiment 82, wherein each paddle frame of the pair of paddle frames includes an inner frame portion of fixed width and an outer frame portion of adjustable width.

[0416] Example 85 The device of example 84, wherein the adjustable width outer frame portion is movable between the fully narrowed and fully expanded configurations.

[0417] Example 86 1. A system comprising: 1. A device for repairing a native heart valve, comprising: A pair of paddle frames are provided. the pair of paddle frames are movable between a fully expanded configuration and a fully contracted configuration; the pair of paddle frames are movable between an open position and a closed position in both the fully expanded and fully contracted configurations; the pair of paddle frames having a first shoulder height when the pair of paddle frames are closed and in the fully narrowed configuration; the pair of paddle frames having a second shoulder height when the pair of paddle frames are closed and in the fully expanded configuration; a device in which the height of the first shoulder is within 1 mm of the height of the second shoulder; a catheter coupled to the device; A system comprising:

[0418] Example 87 The system of Example 86, wherein the outer frame portions are configured to sandwich each other in the closed position in both the fully narrowed and fully expanded configurations.

[0419] Example 88 A system described in any one of Examples 86 to 87, wherein each paddle frame of the pair of paddle frames has an inner frame portion of fixed width and an outer frame portion of adjustable width.

[0420] Example 89 The system of example 88, wherein the adjustable width outer frame portion is movable between the fully narrowed and fully widened configurations.

[0421] Example 90 1. A device for repairing a native heart valve, comprising: A pair of paddle frames, A pair of inner paddle frame portions; A pair of adjustable width outer paddle frame sections; A pair of paddle frames having the pair of paddle frames are movable between a fully expanded configuration and a fully contracted configuration; the pair of paddle frames are movable between an open position and a closed position in both the fully expanded and fully contracted configurations; The device, wherein each outer paddle frame portion of the pair of paddle frame portions is disposed around a corresponding inner paddle frame portion of the pair of inner paddle frame portions when viewed from a proximal end, the pair of paddles being in the closed position and the pair of outer paddle frame portions being in the fully expanded configuration.

[0422] Example 91 The device of Example 90, further comprising a pair of fasteners disposed between the pair of inner paddle frame portions.

[0423] Example 92 The device of Example 91, wherein each fastener of the pair of fasteners is positioned between sides of the inner paddle frame portion when viewed from the proximal side.

[0424] Example 93 A device described in any one of Examples 90 to 92, wherein the side of the outer frame portion is parallel to the side of the inner frame portion when viewed from the proximal side.

[0425] Example 94 A device described in any one of Examples 90 to 93, wherein the distance between the side of the outer frame portion and the inner frame portion is 0.01 mm to 0.5 mm when viewed from the proximal side.

[0426] Example 95 A device described in any one of Examples 92 to 94, wherein the outer frame portion, when viewed from the proximal end, curves away from the inner frame portion by no more than 0.5 mm from the lateral end of the inner frame portion.

[0427] Example 96 1. A system comprising: 1. A device for repairing a native heart valve, comprising: A pair of paddle frames, A pair of inner paddle frame portions; A pair of adjustable width outer paddle frame sections; A pair of paddle frames having the pair of paddle frames are movable between a fully expanded configuration and a fully contracted configuration; the pair of paddle frames are movable between an open position and a closed position in both the fully expanded and fully contracted configurations; an apparatus, wherein each outer paddle frame portion of the pair of paddle frame portions is disposed about a corresponding inner paddle frame portion of the pair of inner paddle frame portions when viewed from a proximal end, the pair of paddles being in the closed position and the pair of outer paddle frame portions being in the fully expanded configuration; a catheter coupled to the device; A system comprising:

[0428] Example 97 The system of Example 96, further comprising a pair of fasteners disposed between a pair of inner paddle frame portions.

[0429] Example 98 The system of Example 97, wherein each fastener of the pair of fasteners is positioned between sides of the inner paddle frame portion when viewed from the proximal side.

[0430] Example 99 A system described in any one of Examples 96 to 98, wherein the side of the outer frame portion is parallel to the side of the inner frame portion when viewed from the proximal side.

[0431] Example 100 A system described in any one of Examples 96 to 99, wherein the distance between the side of the outer frame portion and the inner frame portion is 0.01 mm to 0.5 mm when viewed from the proximal side.

[0432] Example 101 A system described in any one of Examples 98 to 100, wherein the outer frame portion curves away from the inner frame portion within 0.5 mm of the lateral end of the inner frame portion when viewed from the proximal end.

[0433] Example 102 1. A device for repairing a native heart valve, comprising: A pair of paddle frames are provided. the pair of paddle frames are movable between a fully expanded configuration and a fully contracted configuration; the pair of paddle frames are movable between an open position and a closed position in both the fully expanded and fully contracted configurations; A device wherein the pair of paddle frames taper in a direction from the proximal end to the distal end when viewed from the front, when the pair of paddle frames are closed, and when the pair of paddle frames are in the fully narrowed configuration.

[0434] Example 103 The apparatus of Example 102, wherein the pair of paddle frames are tapered at an angle of 30 to 80 degrees.

[0435] Example 104 A device described in any one of Examples 102-103, further comprising a connector extending from the pair of paddle frames to a cap of the device.

[0436] Example 105 The device of Example 104, wherein the connector is tapered in a direction from the proximal end to the distal end.

[0437] Example 106 The device of Example 105, wherein the taper angle of the connector is within 5 degrees of the taper angle of the pair of paddle frames.

[0438] Example 107 An apparatus as described in Example 105, wherein the taper of the connector is continuous with the taper of the pair of paddle frames.

[0439] Example 108 1. A system comprising: 1. A valve repair device comprising: A pair of paddle frames are provided. the pair of paddle frames are movable between a fully expanded configuration and a fully contracted configuration; the pair of paddle frames are movable between an open position and a closed position in both the fully expanded and fully contracted configurations; a valve repair device, the pair of paddle frames tapering in a direction from a proximal end to a distal end when viewed from a front side, when the pair of paddle frames are closed, and when the pair of paddle frames are in the fully narrowed configuration; a catheter coupled to the device; A system comprising:

[0440] Example 109 The system of Example 108, wherein the pair of paddle frames are tapered at an angle of 30 to 80 degrees.

[0441] Example 110 The system described in any one of Examples 108 to 109, further comprising a connector extending from the pair of paddle frames to a cap of the device.

[0442] Example 111 The system of Example 110, wherein the connector is tapered in a direction from the proximal end to the distal end.

[0443] Example 112 The system of Example 111, wherein the taper angle of the connector is within 5 degrees of the taper angle of the pair of paddle frames.

[0444] Example 113 The system of embodiment 111, wherein the taper of the connector is continuous with the taper of the pair of paddle frames.

[0445] Example 114 1. A device for repairing a native heart valve, comprising: A pair of paddle frames, a pair of inner paddle frame portions having a first width; A pair of paddle frames having a pair of adjustable width outer paddle frame portions; the pair of adjustable width paddle frame portions are movable between a fully expanded configuration and a fully contracted configuration having a second width; The pair of paddle frames are movable between an open position and a closed position, The second width is less than or equal to the first width.

[0446] Example 115 The device described in Example 114, wherein the pair of adjustable width paddle frame portions are disposed around the pair of inner paddle frame portions when viewed from the proximal end of the device.

[0447] Example 116 An apparatus described in any one of Examples 114 to 115, wherein the pair of adjustable width paddle frame portions are configured to sandwich each other when the pair of adjustable width paddle frame portions are in the closed position.

[0448] Example 117 1. A system comprising: 1. A valve repair device comprising: A pair of paddle frames, a pair of inner paddle frame portions having a first width; A pair of adjustable width outer paddle frame sections; A pair of paddle frames having the pair of adjustable width paddle frame portions are movable between a fully expanded configuration and a fully contracted configuration having a second width; The pair of paddle frames are movable between an open position and a closed position, the second width being less than or equal to the first width; and a catheter coupled to the device; A system comprising:

[0449] Example 118 The system described in Example 117, wherein the pair of adjustable width paddle frame portions are arranged around the pair of inner paddle frame portions when viewed from the proximal end of the device.

[0450] Example 119 A system described in any one of Examples 117 to 118, wherein the pair of adjustable width paddle frame portions are configured to sandwich each other when the pair of adjustable width paddle frame portions are in the closed position.

[0451] Example 120 Any of Examples 1-119 used or implemented on a living animal, or on a non-living simulation, such as a cadaver, a cadaver heart, an anthropomorphic ghost, a simulator (e.g., where a body part, tissue, etc. is simulated), etc.

[0452] Example 121 Any of Examples 1-121, wherein one or more components of the device or system are sterilized.

[0453] The therapeutic techniques, methods, processes, devices, systems, etc. described or suggested in this specification or the references incorporated herein may be performed on living animals or on non-living simulations such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., where body parts, tissues, etc. are simulated).

[0454] Any of the various systems, devices, equipment, etc. in this disclosure may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on patients, and the methods described herein may include sterilization of the associated systems, devices, equipment, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0455] Although various inventive aspects, concepts, and features of the present disclosure may be described and illustrated herein as embodied in combination in the embodiments herein, these various aspects, concepts, and features may be used in many alternatives, either individually or in various combinations and subcombinations thereof. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of the present application. Still further, various alternative embodiments of the various aspects, concepts, and features of the present disclosure may be described herein, such as alternative materials, alternative structures, alternative forms, alternative methods, alternative devices, alternative components, alternatives in form, alternatives in fit, alternatives in function, and the like, but such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether currently known or later developed. Those skilled in the art may readily incorporate one or more of the aspects, concepts, or features of the present invention into additional embodiments and uses within the scope of the present application, even if such embodiments are not expressly disclosed herein.

[0456] Additionally, although some features, concepts, or aspects of the disclosure may be described herein as being preferred arrangements or methods, such description is not intended to imply that such features are essential or essential, unless expressly stated.Furthermore, while exemplary or representative values, and even exemplary or representative ranges, may be included to aid in understanding the present application, such values ​​and ranges should not be construed in a limiting sense, and are intended to be critical values ​​or ranges only if so expressly stated.

[0457] Moreover, although various aspects, features, and concepts may be expressly identified herein as being inventive or forming part of the disclosure, such identification is not intended to be exclusive; rather, there may be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a particular disclosure, the disclosure being instead defined in the appended claims. Descriptions of exemplary methods or processes are not limited to the inclusion of every step as essential in all cases, nor is the order in which steps are presented construed as essential or essential unless expressly stated. The terms used in the claims are to be given their full ordinary meaning and are not to be limited in any way by the description of the examples herein.

Claims

1. A device for repairing the natural valves of the heart, It comprises an anchor portion configured to connect to the valve leaflet of the natural valve, The aforementioned anchor portion, Outer paddle and, Inside paddle and, A fastener attached to the inner paddle, Paddle frame and A connector coupled to the inner paddle, Equipped with, The connector comprises a bed portion and a stem portion, The connector extends along the inner paddle to reinforce the inner paddle, A device in which the inner paddle is pulled by the outer paddle, and is reinforced by a coupling, thereby preventing buckling.

2. The apparatus according to claim 1, wherein the connector connects the paddle frame to the inner paddle.

3. The apparatus according to claim 1, wherein the paddle frame includes an outer frame portion and an inner frame portion.

4. The apparatus according to claim 3, wherein the connector is coupled to at least one of the outer frame portion and the inner frame portion.

5. The apparatus according to any one of claims 1 to 4, wherein the connector has an opening configured to connect to the paddle frame.

6. The apparatus according to claim 5, wherein the opening has a square cross-section.

7. The apparatus according to claim 5, wherein the opening has the same cross-sectional shape as at least one of the outer frame portion and the inner frame portion.

8. The apparatus according to claim 5, wherein the opening has an open proximal end.

9. The apparatus according to claim 5, wherein the opening comprises a first opening and a second opening.

10. The apparatus according to claim 9, wherein the first opening is connected to one of the inner frame portion and the outer frame portion, and the second opening is connected to the corresponding other of the inner frame portion and the outer frame portion.

11. The apparatus according to claim 9, wherein one or more engaging members are positioned at the distal end of the connector.

12. The apparatus according to claim 1, wherein the connector is a first paddle frame connector, and the apparatus further comprises a second paddle frame connector, wherein the first paddle frame connector is coupled to the outer paddle, and the second paddle frame connector is coupled to the inner paddle.

13. It is a system, Catheter and, A device for repairing the natural valves of the heart, Equipped with, The device comprises an anchor portion configured to be connected to the valve leaflet of the natural valve, The aforementioned anchor portion, Outer paddle and, Inside paddle and, A fastener attached to the inner paddle, Paddle frame and A connector for connecting the paddle frame to the inner paddle, comprising a head portion and a stem portion, Equipped with, The head portion comprises one or more engaging members, A system in which one or more of the engaging members extend through the inner paddle and hook onto it.

14. The system according to claim 13, wherein the connector connects the paddle frame to the inner paddle.

15. The system according to claim 13, wherein the paddle frame includes an inner frame portion and an outer frame portion.

16. The system according to claim 15, wherein the connector is coupled to at least one of the outer frame portion and the inner frame portion.

17. The system according to any one of claims 13 to 16, wherein the paddle frame connector has an opening.

18. The system according to claim 17, wherein the opening has an open proximal end.

19. The system according to claim 17, wherein the opening comprises a first opening and a second opening.

20. The system according to claim 19, wherein the first opening is connected to one of the inner frame portion and the outer frame portion, and the second opening is connected to the corresponding other of the inner frame portion and the outer frame portion.

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