Heart valve repair device and delivery device therefor

Abstract

An implantable device or implant is configured to be positioned within a native heart valve to allow the native heart valve to create a more efficient seal. The implantable device or implant may be deployed and contracted. For example, the implantable device or implant may be narrowed during delivery and deployed after implantation on the native heart valve.

Description

[0001] Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 354,617, filed on June 22, 2022, the entire contents of which are incorporated herein by reference in their entirety. Background Art

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

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

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

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

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

[0008] An implantable device or implant (eg, implantable device, etc.) is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal.

[0009] In some embodiments, the implantable device or implant comprises an anchoring portion comprising an anchor configured to be attached to one or more leaflets of a native heart valve. Each anchor comprises a plurality of paddles, each paddle being movable between an open position and a closed position.

[0010] In some embodiments, the implantable device or implant comprises an apposition element (e.g., a spacer, a gap filler, a contact surface, a wedge, a membrane, etc.), a cover, and an anchoring portion. In some embodiments, the anchoring portion comprises one or more anchors coupled to the apposition element and the cover. In some embodiments, the cover is movable relative to the apposition element.

[0011] In some embodiments, each anchor includes a plurality of paddle members configured to be moved between an open position and a closed position by movement of the cover relative to the engaging element.

[0012] In some embodiments, the implantable device or implant comprises an anchor comprising a paddle frame. In some embodiments, the paddle frame has an inner frame member and an outer frame member or portion having at least two outer arms. In some embodiments, each outer arm is connected to the inner frame member at a corresponding or respective distal connection point and extends proximally to a proximal portion of the device.

[0013] In some embodiments, an implantable device or implant comprises an anchor comprising a paddle frame. The paddle frame comprises a rigid inner frame member and a flexible outer frame member or portion.

[0014] In some embodiments, an implantable device or implant comprises an anchor comprising a paddle frame having an inner frame portion and at least two outer arms. In some embodiments, each outer arm is connected to the inner frame member at a corresponding or respective distal connection point and extends proximally to a proximal portion of the device.

[0015] In some embodiments, one or more actuation lines may be connected to the paddle frame such that a user can provide tension to the actuation lines to move the paddle frame from an expanded position having an expanded width to a narrowed position having a narrowed width, wherein the expanded width is greater than the narrowed width.

[0016] In some embodiments, one or more actuation lines extend from the proximal portion through the coaptation element to the distal portion, from the distal portion along each outer arm to the proximal portion, and radially inward from the proximal portion to connect to a fixed position on the device relative to the outer arm.

[0017] In some embodiments, an implantable device or implant (eg, implantable device, etc.) is configured to be positioned within a native heart valve via a delivery catheter.

[0018] In some embodiments, a method for repairing a patient's native valve comprises delivering an implantable repair device to the native valve. In some embodiments, the implantable repair device comprises an apposition element, a distal portion comprising a cover, and an anchoring portion comprising one or more anchors coupled to the apposition element and the cover.

[0019] In some embodiments, the anchor includes an inner paddle, an outer paddle, and a paddle frame having an inner frame portion and at least two outer arms connected to the inner frame member at corresponding or respective distal connection points and extending proximally to a proximal portion of the device.

[0020] In some embodiments, the implantable prosthetic device includes one or more actuation lines connected to the paddle frame.

[0021] In some embodiments, the one or more actuation lines extend from the proximal portion through the coaptation element to the distal portion, from the distal portion along each outer arm to the proximal portion, and radially inward from the proximal portion to connect to a fixed position on the device relative to the outer arm.

[0022] In some embodiments, the method includes moving the cover relative to the mate element to move the anchor from an open position to a closed position to capture the native valve leaflets between the mate element and the inner and outer paddles, and applying tension to the actuation line to move the paddle frame from an expanded position having an expanded width to a narrowed position having a narrowed width.

[0023] Any of the above methods, as well as any methods using the systems, components, devices, apparatus, etc. described herein, can be performed on a live subject (e.g., a human or other animal) or a simulated subject (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). By simulation, a body part is optionally referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.), and optionally includes a computerized and / or physical representation.

[0024] In some embodiments, the implantable device or implant comprises an anchoring portion comprising one or more anchors configured to be attached to one or more leaflets of a native heart valve. In some embodiments, each of the one or more anchors comprises a plurality of paddles and a paddle frame.

[0025] In some embodiments, the paddle frame has an inner frame member and at least two outer arms. In some embodiments, each outer arm is connected to the inner frame member at a corresponding distal connection point and extends proximally to a proximal portion of the implantable device.

[0026] In some embodiments, one or more actuation lines are connected to the paddle frame such that a user can provide tension to the one or more actuation lines to cause the paddle frame to move from an expanded position having an expanded width to a narrowed position having a narrowed width.

[0027] In some embodiments, the one or more actuation lines extend from the proximal portion to the distal portion, from the distal portion along each outer arm to the proximal portion, and radially inward from the proximal portion to connect to a fixed position on the implantable device relative to the outer arm. The one or more anchors are configured to move between an open position and a closed position.

[0028] In some embodiments, the implantable device can be used in a valve repair system comprising a delivery device having a lumen. The implantable device can be used in a method for repairing a patient's native valve.

[0029] In some embodiments, the fixing location can be on an inner frame member. The fixing location can be an opening on the inner frame member at a proximal portion of the implantable device. The opening can connect the inner frame member to a paddle of the plurality of paddles. The fixing location can be on a paddle clip.

[0030] In some embodiments, providing tension to one or more actuation lines causes each outer arm to pivot, articulate, or flex inwardly about the distal connection point.

[0031] In some embodiments, each outer arm has a first portion extending distally from its respective distal connection point, a second portion extending proximally toward the proximal portion, and a bend connecting the first portion to the second portion.

[0032] In some embodiments, providing tension to one or more actuation lines can cause each outer arm to articulate at the bend and at its respective distal connection point.

[0033] In some embodiments, when the blade frame moves from the deployed position to the narrowed position, a first distance between the first portion and the inner frame member and a second distance between the second portion and the first portion decrease.

[0034] In some embodiments, in the narrowed position, the second portion can overlap the inner frame member.

[0035] In some embodiments, each outer arm can have a proximal tip. In the narrowed position, the proximal tip can be adjacent to the fixed position.

[0036] In some embodiments, each outer arm has a length, and a plurality of openings are spaced along the length for receiving one of the one or more actuation lines.An opening of the plurality of openings may be located at the proximal tip.

[0037] In some embodiments, a biasing member is associated with each outer arm. In some embodiments, the biasing member can be configured to bias the outer arms outwardly.

[0038] In some embodiments, the biasing member can be positioned around one or more actuation lines. In some embodiments, the biasing member can include a coil. In some embodiments, the biasing member can include a cloth material. In some embodiments, the biasing member can include a unitary design. The biasing member can be integrally formed with the blade frame.

[0039] In some embodiments, the strain relief feature is incorporated into the blade frame. In some embodiments, the strain relief feature may include one or more cutouts in the blade frame. In some embodiments, the blade frame may include a shape memory alloy.

[0040] In some embodiments, each of the plurality of blades may include an inner blade and an outer blade. In some embodiments, each of the one or more anchors may include at least one buckle corresponding to a blade.

[0041] Any of the above-mentioned systems, components, devices, equipment, parts, etc. can 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 herein may include sterilizing (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) one or more systems, devices, equipment, parts, etc. herein (or additional methods include or consist of such sterilization).

[0042] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts have like reference numerals. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] In order to further illustrate various aspects of the embodiments of the present disclosure, certain examples and embodiments will be described in more detail by referring to various aspects of the drawings. These figures only depict examples of the present disclosure and should not be considered as limiting the scope of the present disclosure. In addition, although the drawings may be drawn to scale for some examples, they are not necessarily drawn to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained in conjunction with additional features and details through the use of the drawings, in which:

[0044] Figure 1 shows a cross-sectional view of a human heart in diastole;

[0045] Figure 2 shows a cross-sectional view of a human heart in systole;

[0046] Figure 3 shows a cross-sectional view of a human heart in systole, illustrating mitral valve regurgitation;

[0047] Figure 4 yes Figure 3 , with annotation showing the natural shape of the mitral valve leaflets during the systolic phase;

[0048] Figure 5 A healthy mitral valve is shown with the leaflets closed as viewed from the atrial side of the mitral valve;

[0049] Figure 6 shows a dysfunctional mitral valve with visible gaps between the leaflets as viewed from the atrial side of the mitral valve;

[0050] Figure 7 The tricuspid valve is shown as viewed from the atrial side of the tricuspid valve;

[0051] Figure 8-14 Examples of implantable devices or implants are shown at various stages of deployment;

[0052] Fig.15 An example of an implantable device or implant is shown, which is similar to Figure 8-14 The device shown, but in which the paddles are independently controllable;

[0053] Figure 16-21 Delivered and implanted in a native valve Figure 8-14 An exemplary implantable device or implant of;

[0054] Fig. 22 showing a perspective view of an example implantable device or implant in a closed position;

[0055] Fig.23 Shows Fig. 22 A front view of an implantable device or implant;

[0056] Fig.24 Shows Fig. 22 A side view of an implantable device or implant;

[0057] Fig.25 Shows Fig. 22 A front view of an implantable device or implant having a cover covering a paddle and an apposition element or spacer;

[0058] Fig.26 Shown in open position Fig. 22 A top perspective view of an implantable device or implant;

[0059] Fig. 27 Shown in open position Fig. 22 A bottom perspective view of an implantable device or implant;

[0060] Fig.28A A fastener that may be used in an implantable device or implant is shown;

[0061] Fig.28B showing a perspective view of an example fastener of an example implantable device or implant in a closed position;

[0062] Fig.29 A portion of native valve tissue is shown grasped by a fastener;

[0063] Fig.30 shows a side view of an example implantable device or implant in a partially open position with a clasp in a closed position;

[0064] Fig.31 shows a side view of an example implantable device or implant in a partially open position, wherein a fastener is in an open position;

[0065] Fig.32 shows a side view of an example implantable device or implant in a semi-open position with a clasp in a closed position;

[0066] Fig.33 shows a side view of an example implantable device or implant in a semi-open position, wherein a fastener is in an open position;

[0067] Fig.34 shows a side view of an example implantable device or implant in a three-quarter open position with a clasp in a closed position;

[0068] Fig.35 shows a side view of an example implantable device or implant in a three quarters open position, with a fastener in an open position;

[0069] Fig.36 shows a side view of an example implantable device in a fully open or fully bailout position with a fastener in a closed position;

[0070] Fig.37 shows a side view of an example implantable device in a fully open or fully disengaged position, wherein the fastener is in an open position;

[0071] Figure 38-49 Delivered and implanted in a native valve Figure 30-38 An example implantable device or implant comprising a covering;

[0072] Fig.50 is a schematic diagram showing the path of native valve leaflets along each side of an apposition element or spacer of an example valve repair device or implant;

[0073] Fig.51 is a top view schematic diagram illustrating the path of native valve leaflets around an apposition element or spacer of an example valve repair device or implant;

[0074] Fig.52 shows an apposition element or spacer in the interstitial space of a native valve as viewed from the atrial side of the native valve;

[0075] Fig.53 shows a valve repair device or implant attached to a native valve leaflet, viewed from the ventricular side of the native valve, with the apposition element or spacer in the interstitial space of the native valve;

[0076] Fig.54 is a perspective view of a valve repair device or implant attached to a native valve leaflet shown from the ventricular side of the native valve with an apposition element or spacer in the interstitial space of the native valve;

[0077] Fig.55 showing a perspective view of an example implantable device or implant in a closed position;

[0078] Fig.56A An example valve repair device is shown with paddles in an open position;

[0079] Fig.56B Shows Fig.56A A valve repair device, wherein the paddle is in an open position and the clamping member moves to form a wider gap between the clamping member and the paddle;

[0080] Fig.56C Shows Fig.56A A valve repair device, wherein the valve repair device is in Fig.56A In the position shown, the valve tissue is positioned between the clamping member and the paddle;

[0081] Fig.56D Shows Fig.56A A valve repair device, wherein the clamping member moves to reduce the gap between the clamping member and the paddle;

[0082] Figures 56E-56F Shows Fig.56A The paddles of the valve repair device move from an open position to a closed position;

[0083] Figure 56G Shown in closed position Fig.56A The valve repair device of claim 1, wherein the clamping member is engaging the valve tissue;

[0084] Figure 56H The valve is shown after being disconnected from the delivery device and attached to the valve tissue. Fig.56A A valve repair device, wherein the valve repair device is in a closed and locked state;

[0085] Fig.57 shows a top view of an example implantable device or implant having anchors each comprising a plurality of paddles and a plurality of buckles such that each buckle corresponds to an associated paddle;

[0086] Fig.58 Shows Fig.57 A front view of an example implantable device or implant;

[0087] Fig.59 Shows Fig.57 A side view of an example implantable device or implant;

[0088] Fig.60 A top view of an example implantable device or implant is shown, which is similar to Fig.57 An example implantable device of , except that only a portion of the paddle of each anchor includes a corresponding fastener;

[0089] Fig.61 Shows Fig.60 A front view of an example implantable device or implant;

[0090] Fig.62 Shows Fig.60 A side view of an example implantable device or implant;

[0091] Fig.63 A top view of an example implantable device or implant is shown, which is similar to Fig.60 An example implantable device of , except that the inner paddle of each anchor has a greater length than the outer paddle of the anchor;

[0092] Fig.64 Shows Fig.63 A front view of an example implantable device or implant;

[0093] Fig.65 Shows Fig.63 A side view of an example implantable device or implant;

[0094] Fig.66A top view of an example implantable device or implant is shown, which is similar to Fig.60 An example implantable device of , except that the inner paddle of each anchor has a shorter length than the outer paddle of the anchor;

[0095] Fig.67 Shows Fig.66 A front view of an example implantable device or implant;

[0096] Fig.68 Shows Fig.66 A side view of an example implantable device or implant;

[0097] Figures 69-73 shows the deployment phases during Fig.57 Examples of implantable devices or implants;

[0098] Fig.74 shows a top view of an example implantable device or implant having anchors each comprising a plurality of paddle members and a plurality of clasps such that each clasp corresponds to an associated paddle member;

[0099] Fig.75 Shows Fig.74 A front view of an example implantable device or implant;

[0100] Fig.76 Shows Fig.74 A side view of an example implantable device or implant;

[0101] Fig.77 A top view of an example implantable device or implant is shown, which is similar to Fig.74 An example implantable device of , but only a portion of the paddle member of each anchor includes a corresponding fastener;

[0102] Fig.78 Shows Fig.77 A front view of an example implantable device or implant;

[0103] Fig.79 Shows Fig.77 A side view of an example implantable device or implant;

[0104] Fig.80 A top view of an example implantable device or implant is shown, which is similar to Fig.77 An example implantable device of , except that the inner paddle member of each anchor has a longer length than the outer paddle member of the anchor;

[0105] Fig.81 Shows Fig.80A front view of an example implantable device or implant;

[0106] Fig.82 Shows Fig.80 A side view of an example implantable device or implant;

[0107] Fig.83 A top view of an example implantable device or implant is shown, which is similar to Fig.77 An example implantable device of , except that the inner paddle member of each anchor has a shorter length than the outer paddle member of the anchor;

[0108] Fig.84 Shows Fig.83 A front view of an example implantable device or implant;

[0109] Fig.85 Shows Fig.83 A side view of an example implantable device or implant;

[0110] Fig.86A , 87A and 88-90 show the deployment process during various stages. Fig.57 Examples of implantable devices or implants;

[0111] Fig.86B and 87B Shown with Fig.86A and 87A An example similar to the one shown, with the paddle section in the extended position;

[0112] Fig.91 A perspective view of an example paddle frame of an implantable device or implant is shown;

[0113] Fig.92 Shown when the blade frame is in the narrowed position Fig.91 A partial view of a blade frame;

[0114] Fig.93 The delivery system is shown Fig.91 The blade frame;

[0115] Fig.94 An example implantable device or implant is shown when the implantable device or implant is in an open position, comprising Fig.91 The blade frame;

[0116] Fig.95 Shown when the blade frame is in the narrowed position Fig.91 The blade frame;

[0117] Fig.96A perspective view of an example paddle frame of an implantable device or implant is shown;

[0118] Fig.97 Shows Fig.96 A partial view of a blade frame;

[0119] Fig.98 shows a partial front view of an example implantable device including an example paddle frame, wherein the implantable device or implant is in a closed position;

[0120] Fig.99 shows a partial front view of an example implantable device including an example paddle frame, wherein the implantable device or implant is in a closed position;

[0121] Fig.100 shows a partial front view of an example implantable device including an example paddle frame, wherein the implantable device or implant is in a closed position;

[0122] Fig.101 Shows Fig.98 a partial front view of an implantable device or implant of the invention, wherein the implantable device or implant is in an open position;

[0123] Fig.102 Shows Fig.99 a partial front view of an implantable device or implant of the invention, wherein the implantable device or implant is in an open position;

[0124] Fig.103 Shows Fig.100 a partial front view of an implantable device or implant of the invention, wherein the implantable device or implant is in an open position;

[0125] Fig.104 Shows Fig.98 A partial side view of an implantable device or implant of the present invention, wherein the implantable device or implant is in an open position;

[0126] Fig.105 Shows Fig.99 A partial side view of an implantable device or implant of the present invention, wherein the implantable device or implant is in an open position;

[0127] Fig.106 Shows Fig.100 A partial side view of an implantable device or implant of the present invention, wherein the implantable device or implant is in an open position;

[0128] Fig.107 A front view of an example paddle frame of an implantable device or implant is shown;

[0129] Fig.108 Shown when the blade frame is in the narrowed position Fig.107 A front view of an example blade frame;

[0130] Fig.109 A front view of an example paddle frame of an implantable device or implant is shown;

[0131] Fig.110 Shown when the blade frame is in the narrowed position Fig.109 A front view of an example blade frame;

[0132] Fig.111 A front view of an example paddle frame of an implantable device or implant is shown;

[0133] Fig.112 A front view of an example paddle frame of an implantable device or implant is shown;

[0134] Fig.113 Shows Fig.112 A front view of an example configuration of an example blade frame;

[0135] Fig.114 Shows Fig.112 A front view of an example configuration of an example blade frame;

[0136] Fig.115 A front view of an example paddle frame of an implantable device or implant is shown;

[0137] Fig.116 Shows Fig.115 A top view of an example blade frame;

[0138] Fig.117 shows a perspective view of an example implantable device or implant including an example paddle frame, wherein the implantable device or implant is in an open position;

[0139] Fig.118 Shows Fig.117 A bottom view of an implantable device or implant;

[0140] Fig.119 Shows Fig.117 a front view of an implantable device or implant of the invention, wherein the implantable device or implant is in a closed position;

[0141] Fig.120 Shown is a ventricular septum attached to a native heart valve. Fig.117 A side view of an implantable device or implant;

[0142] Fig.121 Shown is a ventricular septum attached to a native heart valve. Fig.117 A bottom view of an implantable device or implant;

[0143] Fig.122 shows a front view of an example implantable device or implant, wherein the implantable device or implant is in a closed position;

[0144] Fig.123 Shows Fig.122 An example implantable device or implant wherein the implantable device or implant is in an open position;

[0145] Fig.124 The implantable device or implant is shown in the open position. Fig.122 Example paddle frames for implantable devices or implants;

[0146] Fig.125 A front view of an example paddle frame of an implantable device or implant is shown, wherein the paddle frame is in a narrowed position;

[0147] Fig.126 Shows Fig.125 An example blade frame of the invention, wherein the blade frame is in a deployed position;

[0148] Fig.127 shows a perspective view of an example implantable device or implant including an example paddle frame, wherein the device includes an example means for moving the paddle frame from a normal position to a narrowed position;

[0149] Fig.128 Shown in a narrowed position Fig.127 The blade frame;

[0150] Fig.129 Shows Fig.127 A perspective view of an implantable device or implant of the invention, wherein the device comprises an exemplary device for moving a paddle from a normal position to a narrowed position;

[0151] Fig.130 Shows Fig.127 A perspective view of an implantable device or implant of the invention, wherein the device comprises an exemplary device for moving a paddle from a normal position to a narrowed position;

[0152] Fig.131 shows a perspective view of an example implantable device or implant including an example paddle frame;

[0153] Fig.132 Shows Fig.131 An implantable device or implant having an example means for moving a paddle frame from a normal position to a narrowed position;

[0154] Fig.133 Shows Fig.131An implantable device or implant having an example means for moving a paddle frame from a normal position to a narrowed position;

[0155] Fig.134 Shows Fig.131 An implantable device or implant having an example means for moving a paddle frame from a normal position to a narrowed position;

[0156] Fig.135 Shows Fig.131 An implantable device or implant having an example means for moving a paddle frame from a normal position to a narrowed position;

[0157] Fig.136 Shows Fig.131 An implantable device or implant having an example means for moving a paddle frame from a normal position to a narrowed position;

[0158] Fig.137 A front view of an example paddle frame of an implantable device or implant is shown;

[0159] Fig.138 shows the adjacent Fig.137 A pair of example blade frames;

[0160] Fig.139 Shown is the inclusion Fig.137 A side view of an example of an implantable device or implant having a paddle frame, wherein the paddle frame is in a narrowed position;

[0161] Fig.140 Shows Fig.139 A side view of an implantable device or implant with the paddle frame in an expanded position;

[0162] Fig.141 Shows Fig.139 A partial side view of an implantable device or implant with the paddle frame in a narrowed position;

[0163] Fig.142 Shows Fig.139 A partial side view of an implantable device or implant of the type shown in FIG. 1 , wherein the paddle frame is in an expanded position;

[0164] Fig.143 Shows that there is Fig.137 The blade frame Fig.139 A perspective view of an implantable device or implant;

[0165] Fig.144 Shows that there is Fig.137 The blade frame Fig.139 A front view of an implantable device or implant;

[0166] Fig.145 Shown for Fig.139 A perspective view of an example of an inner paddle and an outer paddle of an implantable device or implant;

[0167] Fig.146 Shows Fig.145 A side view of the inner and outer blades;

[0168] Fig.147 Shows Fig.145 A top view of the inner blade and the outer blade;

[0169] Fig.148 Shows Fig.146 The blades and Fig.137 A perspective view of an example connection between blade frames;

[0170] Fig.149 A front view of an example paddle frame of an implantable device or implant is shown;

[0171] Fig.150 A front view of an example paddle frame of an implantable device or implant is shown;

[0172] Fig.151 A front view of an example paddle frame of an implantable device or implant is shown;

[0173] Fig.152 A front view of an example paddle frame of an implantable device or implant is shown;

[0174] Figure 153-155 front views showing various configurations of example paddle frames of implantable devices or implants;

[0175] Fig.156 A front view of an example paddle frame of an implantable device or implant is shown;

[0176] Fig.157 A front view of an example paddle frame of an implantable device or implant is shown, wherein the paddle frame is shown in a deployed position;

[0177] Fig.158 Shows Fig.157 A front view of an example blade frame of FIG. 1 , wherein the blade frame is shown in a narrowed position;

[0178] Fig.159 A front view of an example paddle frame of an implantable device or implant is shown;

[0179] Fig.160 Shows Fig.159 Left side view of the blade frame;

[0180] Fig.161 Shows Fig.159 A top view of a blade frame;

[0181] Fig.162 Shown is the inclusion Fig.159 A perspective view of an example of an implantable device or implant having a paddle frame;

[0182] Fig.163 Shown is the inclusion Fig.159 The blade frame Fig.162 A front view of an implantable device or implant;

[0183] Figures 164-168 Shows Fig.162 An implantable device or implant having a Fig.159 Example apparatus for moving a paddle frame between an extended position and a narrowed position;

[0184] Fig.169 A perspective view showing an example of a paddle and apposition element frame assembly of an implantable device or implant;

[0185] Fig.170 Shows Fig.169 A rear view of the blade and mating element frame assembly;

[0186] Fig.171 Shown is the inclusion Fig.171 A perspective view of an example of an implantable device or implant having a paddle and an apposition element frame assembly, wherein the apposition element frame is in a narrowed position;

[0187] Fig.172 Shows Fig.171 A perspective view of an implantable device or implant of the type shown in FIG. 1 , wherein the apposition element framework is in an expanded position;

[0188] Fig.173 Shows Fig.171 A top view of an implantable device or implant with the apposition element framework in a narrowed position;

[0189] Fig.174 Shows Fig.172 A top view of an implantable device or implant of the type shown in FIG. 1 , wherein the apposition element framework is in an expanded position;

[0190] Fig.175 Shown when in the narrowed position Fig.169 a rear view of a paddle and coaptation element frame assembly of the implantable device or implant wherein the paddle and coaptation element frame assembly is attached to an inner paddle and an outer paddle of an anchoring portion of the implantable device or implant;

[0191] Fig.176 Shown in the deployed position Fig.169a rear view of a paddle and coaptation element frame assembly of the implantable device or implant wherein the paddle and coaptation element frame assembly is attached to an inner paddle and an outer paddle of an anchoring portion of the implantable device or implant;

[0192] Fig.177 Shown when in the narrowed position Fig.169 A perspective view of a paddle and coaptation element frame assembly of the present invention, wherein the paddle and coaptation element frame assembly is attached to an inner paddle and an outer paddle of an anchoring portion of an implantable device or implant;

[0193] Fig.178 Shown in the deployed position Fig.169 A top view of a paddle and coaptation element frame assembly of the implantable device or implant wherein the paddle and coaptation element frame assembly is attached to an inner paddle and an outer paddle of an anchoring portion of the implantable device or implant;

[0194] Fig.179 Shown in the deployed position Fig.169 A perspective view of a blade and mating element frame assembly;

[0195] Fig.180 Shows Fig.169 a perspective view of a paddle and a coaptation element frame of a coaptation element frame assembly, wherein the coaptation element frame is attached to an inner paddle of an anchoring portion of an implantable device or implant;

[0196] Fig.181 Shown when in the narrowed position Fig.169 A front view of the blade and the frame of the mating element assembly;

[0197] Fig.182 Shows Fig.181 A side view of the mating element frame;

[0198] Fig.183 Shows Fig.181 A top view of the mating element frame;

[0199] Fig.184 Shows Fig.181 A perspective view of a mating element frame;

[0200] Fig.185 Shown in the deployed position Fig.181 A front view of the mating element frame;

[0201] Fig.186 Shows Fig.185 A side view of the mating element frame;

[0202] Fig.187 Shows Fig.185 A top view of the mating element frame;

[0203] Fig.188 Shows Fig.185 A perspective view of a mating element frame;

[0204] Fig.189 a perspective view of a pair of example paddle frames showing a pair of anchors of an implantable device or implant;

[0205] Fig.190 Shows Fig.189 A front view of a blade frame;

[0206] Fig.191 Shows Fig.189 A top view of a blade frame;

[0207] Fig.192 Shows Fig.189 A side view of a blade frame;

[0208] Fig.193 Shown is the inclusion Fig.189 A top view of an example of an implantable device or implant having one of the paddle frames of FIG. 1 , wherein the paddle frame is in an expanded position;

[0209] Fig.194 Shows Fig.193 A top view of an implantable device or implant with the paddle frame in a narrowed position;

[0210] Fig.195 A lateral view of the ventricle showing the native valve, wherein Fig.193 The implantable device or implant is positioned to connect to a native valve;

[0211] Fig.196 an atrial side view showing an example implantable device or implant attached to a native heart valve;

[0212] Fig.197 The valve attached to the native Fig.196 an atrial side view of an implantable device or implant wherein tissue ingrowth has covered the device;

[0213] Fig.198 Shown is the attachment to the native valve Fig.196 An implantable device or implant of the invention is shown in a front view, wherein tissue ingrowth has covered the device;

[0214] Fig.199 shows an atrial side view of an example implantable device or implant attached to a native heart valve, wherein the device includes an example apposition extension member;

[0215] Fig.200 Shown is the attachment to the native valve Fig.199an atrial side view of an implantable device or implant wherein tissue ingrowth has covered the device;

[0216] Fig.201 shows an atrial side view of an example implantable device or implant attached to a native heart valve, wherein the device includes an example apposition extension member;

[0217] Fig.202 The valve attached to the native Fig.201 an atrial side view of an implantable device or implant wherein tissue ingrowth has covered the device;

[0218] Fig.203 shows a front view of an example implantable device or implant attached to a native heart valve, wherein the device includes an example apposition extension member;

[0219] Fig.204 The valve attached to the native Fig.203 A front view of an implantable device or implant wherein tissue ingrowth has covered the device;

[0220] Fig.205 shows a front view of an example implantable device or implant attached to a native heart valve, wherein the device includes an example apposition extension member;

[0221] Fig.206 The valve attached to the native Fig.205 A front view of an implantable device or implant wherein tissue ingrowth has covered the device;

[0222] Fig.207 shows an atrial side view of an example implantable device or implant attached to a native heart valve, wherein the device includes an example apposition extension member;

[0223] Fig.208 shows a front view of an example implantable device or implant attached to a native heart valve, wherein the device includes an example apposition extension member;

[0224] Fig.209 shows a front view of an example implantable device or implant attached to a native heart valve, wherein the device includes an example apposition extension member;

[0225] Figures 210-214 Examples of couplings between actuating elements and components of a device or implant are shown;

[0226] Figures 215-218 Examples of couplings between actuating elements and components of a device or implant are shown;

[0227] Figures 219-222Examples of couplings between actuating elements and components of a device or implant are shown;

[0228] Figures 223-224 Examples of couplings between actuating elements and components of a device or implant are shown;

[0229] Figures 225-227 Examples of couplings between actuating elements and components of a device or implant are shown;

[0230] Figures 228-230 Examples of couplings between actuating elements and components of a device or implant are shown;

[0231] Figures 231-232 Examples of couplings between actuating elements and components of a device or implant are shown;

[0232] Fig.233 Examples of couplings between actuating elements and components of a device or implant are shown;

[0233] Fig.234 Examples of couplings between actuating elements and components of a device or implant are shown;

[0234] Fig.235 Examples of couplings between actuating elements and components of a device or implant are shown;

[0235] Fig.236 Examples of couplings between actuating elements and components of a device or implant are shown;

[0236] Fig.237 Examples of couplings between actuating elements and components of a device or implant are shown;

[0237] Fig.238 Examples of couplings between actuating elements and components of a device or implant are shown;

[0238] Fig.239 Examples of couplings between actuating elements and components of a device or implant are shown;

[0239] Fig.240 Examples of couplings between actuating elements and components of a device or implant are shown;

[0240] Fig.241 Examples of couplings between actuating elements and components of a device or implant are shown;

[0241] Fig.242 Examples of couplings between actuating elements and components of a device or implant are shown;

[0242] Fig.243 Examples of couplings between actuating elements and components of a device or implant are shown;

[0243] Fig.244 Examples of couplings between actuating elements and components of a device or implant are shown;

[0244] Figures 245-250 Examples of couplings between actuating elements and components of a device or implant are shown;

[0245] Figures 251-252 Examples of couplings between actuating elements and components of a device or implant are shown; Fig.253 Examples of couplings between actuating elements and components of a device or implant are shown;

[0246] Figures 254-255 Examples of couplings between actuating elements and components of a device or implant are shown; Fig.256 Examples of couplings between actuating elements and components of a device or implant are shown;

[0247] Fig.257 Examples of couplings between actuating elements and components of a device or implant are shown;

[0248] Figures 258-259 Examples of couplings between actuating elements and components of a device or implant are shown;

[0249] Figures 260-261 Examples of couplings between actuating elements and components of a device or implant are shown; Fig.262 Examples of couplings between actuating elements and components of a device or implant are shown;

[0250] Figures 263-264 Examples of couplings between actuating elements and components of a device or implant are shown; Figures 265-266 Examples of couplings between actuating elements and components of a device or implant are shown; Figures 267-268 Examples of couplings between actuating elements and components of a device or implant are shown;

[0251] Figures 269-270 Examples of couplings between actuating elements and components of a device or implant are shown;

[0252] Fig.271 Examples of couplings between actuating elements and components of a device or implant are shown;

[0253] Fig.272 Examples of couplings between actuating elements and components of a device or implant are shown;

[0254] Fig.273 Examples of couplings between actuating elements and components of a device or implant are shown;

[0255] Fig.274 Examples of couplings between actuating elements and components of a device or implant are shown;

[0256] Fig.275 Examples of couplings between actuating elements and components of a device or implant are shown;

[0257] Fig.276 An example of an actuation device or a control device is shown;

[0258] Fig.277 An example of an actuation device or a control device is shown;

[0259] Fig.278 An example of a pulley arrangement is shown.

[0260] Fig.279 yes Fig.277 A top view of the actuator or control device shown;

[0261] Fig.280 yes Fig.277 A bottom view of the actuator or control device shown;

[0262] Fig.281 and 282 An example of an actuation device or a control device is shown;

[0263] Figures 283-285 An example of an actuation device or a control device is shown;

[0264] Fig.286 An example of a blade frame is shown;

[0265] Fig.287 An example of an actuation device or control device coupled to a blade frame is shown;

[0266] Fig.288 An example of an actuation device or control device coupled to a blade frame is shown;

[0267] Fig.289 An example of an adjustable blade frame assembly is shown;

[0268] Fig.290 Shown for Fig.289 An example of an adjustment mechanism of an adjustable blade assembly;

[0269] Fig.291 An example of an adjustable blade frame assembly is shown;

[0270] Fig.292 An example of an actuation device or a control device is shown;

[0271] Fig.293 An example of an adjustable blade frame assembly is shown;

[0272] Fig.294 An example of an adjustable blade frame assembly is shown;

[0273] Fig.295 An example of an adjustable blade frame assembly is shown;

[0274] Fig.296 Shows Fig.294 and 295 An example of an adjustment member of an adjustable blade frame assembly;

[0275] Fig.297 An example of an adjustable blade frame assembly is shown;

[0276] Figures 298-300 An example of an actuation device or a control device is shown;

[0277] Fig.301 shows a front cross-sectional view of an implantable device or implant;

[0278] Fig.302 Shows Fig.301 A perspective cross-sectional view of a device / implant;

[0279] Fig.303 Shows Fig.301 A perspective view of the device / implant;

[0280] Fig.304 Shows Fig.301 A side view of the device / implant;

[0281] Fig.305 Shows Fig.301 A top view of the device / implant;

[0282] Figures 306-311 Shown in various stages of assembly Fig.301 A partial view of the device / implant;

[0283] Fig.312 A front view of the device / implant of 301 is shown in a deployed position;

[0284] Fig.313 A side view of the device / implant 301 is shown in a deployed position;

[0285] Fig.314 A top view of the device / implant 301 is shown in a deployed position;

[0286] Fig.315 A front view of the device / implant of 301 is shown in a narrowed position;

[0287] Fig.316 A side view of the device / implant of 301 is shown in a narrowed position;

[0288] Fig.317 A top view of the device / implant of 301 is shown in a narrowed position;

[0289] Fig.318 shows a front cross-sectional view of an example of an implantable device or implant;

[0290] Fig.319 Shows Fig.318 A side view of the device / implant;

[0291] Figures 320-323 Shows Fig.318 anterior view of the device / implant in various positions moving from an expanded position to a narrowed position;

[0292] Fig.324 A front view showing an example of a portion of a paddle frame of an implantable device or implant;

[0293] Fig.325 Shows Fig.324 A perspective view of the frame;

[0294] Fig.326 Shows Fig.324 A top view of the frame;

[0295] Fig.327 Shows Fig.324 A side view of the frame;

[0296] Figures 328-331 Shows Fig.324 anterior view of the device / implant in various positions moving from an expanded position to a narrowed position;

[0297] Fig.332 A perspective view showing an example of a portion of a paddle frame of an implantable device or implant;

[0298] Fig.333 Attached to the anchor Fig.332 A front view of the frame;

[0299] Fig.334 An implantable device or part of an implant is shown. Fig.332 A partial cross-sectional front view of the frame;

[0300] Fig.335 An actuating portion of an implantable device or implant is shown. Fig.332 Framework;

[0301] Fig.336 Shows the use of Fig.332 A perspective view of an implantable device or implant with a framework;

[0302] Fig.337 Shown in the deployed position Fig.332 A front view of the device;

[0303] Fig.338 Shown in a narrowed position Fig.332 A front view of the device;

[0304] Fig.339 Shown in the deployed position Fig.332 A side view of the device;

[0305] Fig.340 Shown in a narrowed position Fig.332 A side view of the device;

[0306] Fig.341 Shown in the deployed position Fig.332 A top view of the device;

[0307] Figure 342 Shown in a narrowed position Fig.332 A top view of the device;

[0308] Fig.343 shows a front view of an implantable device or implant depicting two examples of paddle frames for the device;

[0309] Fig.344 A front view of an example paddle frame of an implantable device or implant is shown;

[0310] Figures 345-347 Shows Fig.332 A front view of the frame in various positions moving from an extended position to a narrowed position;

[0311] Fig.348 A front view of an example paddle frame of an implantable device or implant is shown;

[0312] Fig.349 An implantable device or part of an implant is shown. Fig.348 A perspective view of the frame;

[0313] Fig.350 A front view of an example paddle frame of an implantable device or implant is shown;

[0314] Fig.351 Shows Fig.350 A perspective view of the frame;

[0315] Figure 352 Shows Fig.350 A top view of the frame;

[0316] Fig.353 Shows Fig.350 A side view of the frame;

[0317] Fig.354 A front view of an example paddle frame of an implantable device or implant is shown;

[0318] Figure 355 Shows Fig.354 A perspective view of the frame;

[0319] Fig.356 Shows Figure 355 A top view of the frame;

[0320] Fig.357 Shows Fig.356 A side view of the frame;

[0321] Fig.358 A perspective view of an example paddle frame of an implantable device or implant is shown;

[0322] Fig.359 Shows Fig.358 A front cross-sectional view of a frame;

[0323] Figure 360 A front cross-sectional view of an example paddle frame of an implantable device or implant is shown;

[0324] Fig.361 Shows Figure 360 A top view of the frame;

[0325] Fig.362 A front cross-sectional view of an example paddle frame of an implantable device or implant is shown;

[0326] Fig.363 shows a perspective view of a paddle frame attached to an elongated cover;

[0327] Fig.364 Shows Fig.363 A partial front view of the frame and the elongated cover;

[0328] Figure 365 is a front view of an example of a connection mechanism between a rigid inner portion and a flexible outer portion of a blade frame;

[0329] Figure 366 yes Figure 365 A perspective view of a blade frame assembly;

[0330] Fig.367 yes Figure 365 A top view of a blade frame assembly;

[0331] Fig.368 yes Figure 365 a side view of a blade frame assembly;

[0332] Fig.369 yes Figure 365 a rear view of a blade frame assembly;

[0333] Fig.370 is a front view of an example of a connection mechanism between a rigid inner portion and a flexible outer portion of a blade frame;

[0334] Figure 371 yes Fig.370 a side view of a blade frame assembly;

[0335] Figure 372 yes Fig.370 a rear view of a blade frame assembly;

[0336] Fig.373 is a front view of an example of a connection between a rigid inner portion and a flexible outer portion of a blade frame;

[0337] Figure 374 yes Fig.373 A side view of a blade frame;

[0338] Fig.375 yes Fig.373 A perspective view of a blade frame;

[0339] Figure 376 is a front view of an example of a connection between a rigid inner portion and a flexible outer portion of a blade frame;

[0340] Figure 377 yes Figure 376 A perspective view of a blade frame assembly;

[0341] Figure 378 A schematic diagram showing an anchoring portion of an implantable device or implant in a closed position;

[0342] Fig.379 Shown in closed position Figure 378 A schematic diagram of an anchoring portion of a valve, wherein leaflets of a native valve are fixed by the anchoring portion;

[0343] Figure 380 A schematic diagram showing an example anchoring portion of an implantable device or implant in a closed position;

[0344] Figure 381 Shows Figure 380 A schematic diagram of an anchoring portion of a valve, wherein leaflets of a native valve are fixed by the anchoring portion;

[0345] Figure 382 Shown in partially open position Figure 380Schematic diagram of the anchoring part;

[0346] Fig.383 Shown in open position Figure 380 Schematic diagram of the anchoring part;

[0347] Fig.384 Shows Figure 380 A plan view of an anchoring member of an anchoring portion, wherein the anchoring member is placed flat;

[0348] Fig.385 Shown in closed position Figure 380 A schematic diagram of an anchor of an anchor portion and a fastener attached to the anchor;

[0349] Figure 386 Shown in closed position Fig.385 Schematic diagram of an anchor and a fastener, wherein the leaflets of a native valve are fixed by the anchor and the fastener;

[0350] Fig.387 Shows Fig.385 A schematic diagram of an anchor and a fastener, wherein the anchor is in an open position and the fastener is in a closed position;

[0351] Fig.388 A schematic diagram of an anchoring portion and a fastener of an implantable device or implant in a closed position showing the inward bias of the outer paddles of the anchoring portion;

[0352] Fig.389 Shown in closed position Fig.388 A schematic diagram of one side of the anchoring portion of the embodiment of the present invention, showing the inward bias of the outer blades;

[0353] Fig.390 A plan view showing an example of a fastener of an implantable device or implant, wherein the fastener is laid flat;

[0354] Figure 391 Examples of fasteners for implantable devices or implants are shown;

[0355] Figure 392 A plan view showing an example of a fastener of an implantable device or implant, wherein the fastener is laid flat;

[0356] Fig.393 A side view of an example of a fastener of an implantable device or implant is shown, wherein the fastener is in a closed position;

[0357] Fig.394 shows the positioning of the shape memory alloy fixture Fig.388 The anchoring part;

[0358] Fig.395A perspective view showing an example of an anchoring portion of an implantable device or implant;

[0359] Fig.396 Shows Fig.395 A plan view of an example of an inner member of an anchor portion and an inner blade portion;

[0360] Fig.397 A left side perspective view of an example of an implantable device or implant is shown;

[0361] Fig.398 Shows Fig.397 A right side perspective view of the device;

[0362] Fig.399 Shows Fig.397 A front view of the device;

[0363] Figure 400 Shows Fig.397 a partial perspective view of a distal portion of a device of , wherein the anchor portion is attached to the cap at the distal end of the device;

[0364] Figure 401 A perspective view showing an example of a fastener for an implantable device or implant;

[0365] Figure 402 A perspective view showing an example of a fastener for an implantable device or implant;

[0366] Figure 403 A perspective view showing an example of a fastener for an implantable device or implant;

[0367] Figure 404 A perspective view showing an example of a fastener for an implantable device or implant;

[0368] Figure 405 A perspective view showing an example of a fastener for an implantable device or implant;

[0369] Figure 406 A perspective view showing an example of a fastener for an implantable device or implant;

[0370] Figure 407A An example of a retaining or locking mechanism is shown;

[0371] Figure 407B shows the deployment in the housing Figure 407A Examples of retaining or locking mechanisms;

[0372] Figure 407C Shows Figure 407B sectional view showing a retaining or locking mechanism in the housing;

[0373] Figure 408AAn example of a cover engaging a paddle is shown;

[0374] Figure 408B Shown without blades Figure 408A A close-up of the lid;

[0375] Figure 408C yes Figure 408A a perspective view of the cover and paddles shown;

[0376] Figure 408D is a cross-sectional view showing the deflection of the blade due to the blade being retracted into the cover to varying degrees;

[0377] Figure 408E It shows Figure 408D Perspective diagram of the degree of deflection;

[0378] Figure 408F is a schematic diagram showing a configuration in which a blade is retracted into a cover by a coupling while being deflected simultaneously;

[0379] Figure 408G is a perspective view of the cover and paddle assembly;

[0380] Figure 409A is a top perspective view of an assembly of a cover and two independently adjustable paddles;

[0381] Figure 409B yes Figure 409A A bottom perspective view of an assembly of

[0382] Figure 409C It shows the Figure 409A and 409B A cross-sectional view of the independent control of the blades;

[0383] Figure 410A is a partial cross-sectional view of an adjustable paddle assembly;

[0384] Figure 410B yes Figure 410A A perspective view of an adjustable paddle assembly;

[0385] Figure 410C yes Figure 410B A cross-sectional view of an adjustable blade assembly;

[0386] Figure 410D yes Figure 410B A cross-sectional view of an adjustable blade assembly;

[0387] Figure 410E yes Figure 410B A side view of an adjustable paddle assembly;

[0388] Figure 410F is a side view of the adjustable paddle assembly showing the paddle in a first actuated position.

[0389] Figure 410G is a side view of the adjustable paddle assembly showing the paddle in a second actuated position.

[0390] Figure 410H is a side view of the adjustable paddle assembly showing the paddle in a third actuated position.

[0391] Figure 411A is a side perspective view of the adjustable paddle assembly;

[0392] Figure 411B yes Figure 411A A side view of an adjustable paddle assembly;

[0393] Figure 411C yes Figure 411A A front view of an adjustable paddle assembly;

[0394] Figure 411D and 411E Shows Figure 411A Use of an adjustable paddle assembly in a valve repair device or implant;

[0395] Figure 412A An example of a paddle structure made from sheet material is shown;

[0396] Figure 412B yes Figure 412A A side view of a blade structure;

[0397] Figure 412C yes Figure 412A A top view of a blade structure;

[0398] Figure 412D yes Figure 412A A bottom view of the blade structure;

[0399] Figure 412E yes Figure 412A Another side view of the blade structure;

[0400] Figure 412F Shows Figure 412A Details of examples of structural holes of a blade structure;

[0401] Figure 412G It is used to manufacture Figure 412A A top view of a flat material of a blade structure;

[0402] Figure 412H An example of a valve repair device or implant comprising a valve repair device or implant in a fully retracted position is shown. Figure 412A The blade structure.

[0403] Figure 412IShown in partially open position Figure 412H A valve repair device or implant having a paddle structure;

[0404] Figure 412J Shown in a laterally extended or open position Figure 412H A valve repair device or implant comprising a paddle structure.

[0405] Figure 412K Can be used to manufacture Figure 412A A perspective view of a mold of a blade structure;

[0406] Figure 412L yes Figure 412K A perspective view of the mold shown;

[0407] Figure 413A and 413B An example of a valve repair device or implant having a compressible outer paddle portion is shown;

[0408] Figure 414A is a perspective illustration of a valve repair device or implant having a compressible outer paddle portion;

[0409] Figure 414B It shows Figure 414A A perspective view of a paddle of a valve repair device or implant is shown;

[0410] Figure 415A is a side view of an example of a valve repair device or implant in an open state with a gap filling material;

[0411] Figure 415B The leaflets attached to the native valve are seen from the ventricular side of the native valve. Figure 415A a view of a valve prosthesis or implant;

[0412] Figure 415C is in a closed state Figure 415A A side view of a valve repair device or implant;

[0413] Figure 415D is in a closed state Figure 415A A front view of a valve repair device or implant;

[0414] Figure 416A is a side view of an example of a valve repair device or implant in an open state with a gap filling material;

[0415] Figure 416B The leaflets attached to the native valve are seen from the ventricular side of the native valve. Figure 416A a view of a valve prosthesis or implant;

[0416] Figure 416C is in a closed state Figure 416A a side view of the valve repair device or implant; and

[0417] Figure 416D is in a closed state Figure 416A A front view of a valve repair device or implant;

[0418] Figure 417 A perspective view showing an example of a paddle frame and a portion of an actuation device for an implantable device;

[0419] Figure 418 Shows Figure 417 A perspective cross-sectional view of a portion of a blade frame and an actuating device;

[0420] Fig.419 Shows Figure 417 A front cross-sectional view of a portion of a blade frame and an actuating device;

[0421] Figure 420 Shows Figure 417 A bottom view of a portion of a blade frame and an actuating device;

[0422] Fig.421 A front cross-sectional view showing an example of a paddle frame and a portion of an actuation device for an implantable device;

[0423] Figure 422 Shows Fig.421 a front cross-sectional view of a paddle frame and a portion of an actuation device having a conduit of a delivery device attached to the actuation device and an actuation element attached to the paddle frame;

[0424] Fig.423 Shows Fig.421 a perspective cross-sectional view of a portion of a blade frame;

[0425] Fig.424 Shows Fig.421 A top view of an actuating device;

[0426] Fig.425 Shows Fig.421 A front cross-sectional view of a portion of a blade frame and an actuator, the portion not having Figure 422 Pipes and actuating elements;

[0427] Fig.426 Shows Fig.421 A front cross-sectional view of a portion of a blade frame and an actuator having Figure 422 Pipes and actuating elements;

[0428] Figures 427-429Various views showing examples of couplings between conduits of an implantable device and components of the implantable device;

[0429] Figures 430-432 Shows Figures 427-429 various views of a coupling between a conduit and a component of an implantable device, wherein the conduit moves in a proximal direction relative to the implantable device;

[0430] Figures 433-435 Shows Figures 427-429 Various views of a connection between a conduit and a component of an implantable device, wherein the conduit is disconnected from the implantable device;

[0431] Figure 436 a front view showing an example coupling between a conduit of an implantable device and a component of the implantable device, wherein an actuation element extends through the conduit and into the implantable device;

[0432] Figure 437 Shows Figure 436 coupling between a conduit and a component of an implantable device, wherein the actuation element moves in a proximal direction relative to the conduit;

[0433] Figure 438 Shows Figure 436 a coupling between a conduit of an implantable device and a component, wherein the conduit moves in a proximal direction relative to the implantable device;

[0434] Fig.439 Shows Figure 436 a coupling between a conduit and a component of an implantable device, wherein the conduit is disconnected from the implantable device;

[0435] Figure 440 A perspective view showing an example of a coupling between a paddle frame and an actuation element of an implantable device;

[0436] Figure 441 Shown for Figure 440 A front view of an example of a coupling portion of an actuating element;

[0437] Figure 442 Shows Figure 440 A side view of an example of a coupling portion of an actuating element;

[0438] Figure 443 Shows Figure 440 A partial front view of a blade frame;

[0439] Figure 444 A front cross-sectional view showing an example of a paddle frame and a portion of an actuation device for an implantable device;

[0440] Figure 445 Shows Figure 444 An example of an actuation device of an example of a distal portion of an actuation shaft;

[0441] Figure 446 Shows Figure 444 A cross-sectional view of an example of a conduit of an actuating device, wherein Figure 445 The distal portion of the actuation shaft moves through the conduit;

[0442] Figure 447 A perspective view showing an example of an implantable device having a paddle with adjustable width;

[0443] Figure 448 yes Figure 447 A cross-sectional view of an implantable device, wherein the implantable device is bisected;

[0444] Fig.449 yes Figure 447 Another cross-sectional view of an implantable device, wherein the implantable device is arranged perpendicular to Figure 448 The plane of the plane shown in is bisected;

[0445] Figure 450 is a schematic diagram of an example implant catheter assembly coupled to an implantable device, wherein an actuation element, such as a tube, is coupled to a paddle actuation control and a driver head of the implantable device;

[0446] Figure 451 yes Figure 450 a schematic diagram of an assembly of an implantable device wherein the implantable device is rotated 90 degrees to illustrate a blade width adjustment element coupled to an inner end of the implantable device and coupled to a blade width control;

[0447] Figure 452 A front view of an example paddle frame of an implantable device or implant is shown;

[0448] Figure 453 Shown in the deployed position Figure 452 A front view of a bisected blade frame;

[0449] Figure 454 Shows Figure 453 Left side view of the blade frame;

[0450] Figure 455 Shown in a narrowed position Figure 452 A front view of a bisected blade frame;

[0451] Figure 456 Shows Figure 455 Left side view of the paddle frame. DETAILED DESCRIPTION

[0452] The following description refers to the accompanying drawings, which illustrate some embodiments of the present disclosure. Some embodiments with different structures and operations do not depart from the scope of the present disclosure.

[0453] Some embodiments of the present disclosure relate to systems, devices, methods, etc. for repairing defective heart valves. For example, embodiments of implantable devices, valve repair devices, implants, and systems (including delivery systems thereof) are disclosed herein, and unless specifically excluded, these options can be arbitrarily combined. In other words, unless mutually exclusive or otherwise physically impossible, the various components of the disclosed devices and systems can be combined. In addition, the techniques, methods, operations, steps, etc. described or suggested in this article or in the references incorporated herein can be performed on living subjects (e.g., humans, other animals, etc.) or simulated objects (e.g., corpses, corpse hearts, simulators, virtual people, etc.). When executed on a simulated object, it can be assumed that a body part (e.g., heart, tissue, valve, etc.) is simulated, or the body part is optionally referred to as "simulated" (e.g., simulated heart, simulated tissue, simulated valve, etc.) and optionally includes computerized and / or physical representations of body parts, tissues, etc. The term "simulation" covers uses on corpses, computer simulators, virtual people (e.g., if they are just air demonstrations on virtual hearts), etc.

[0454] As described herein, when one or more components are described as being connected, coupled, fixed, connected, attached, or otherwise interconnected, such interconnection may be a direct interconnection between the components, or may be an indirect interconnection, for example, through the use of one or more intermediate components. Also as described herein, references to "member," "component," or "portion" should not be limited to a single structural member, component, or element, but may include an assembly of components, components, or elements. Also as described herein, the terms "substantially" and "approximately" are defined as at least close to (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0455] Figure 1 and 2 sectional views of a human heart H during diastole and systole, respectively. The right ventricle RV and the left ventricle LV are separated from the right atrium RA and the left atrium LA by the tricuspid valve TV and the mitral valve MV (i.e., the atrioventricular valves), respectively. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., Figure 3-6 The leaflets 20, 22 and Figure 7The valve leaflets 30, 32, 34 shown in the figure are flexible valve leaflets that extend inwardly across corresponding orifices that meet or "combine" in the flow stream to form a one-way fluid blocking surface. The autologous valve repair system of the present application is mainly described and / or illustrated with respect to the mitral valve MV. Therefore, the anatomical structure of the left atrium LA and the left ventricle LV will be explained in more detail. However, the devices described herein can also be used to repair other autologous valves, for example, these devices can be used to repair the tricuspid valve TV, the aortic valve AV and the pulmonary valve PV.

[0456] The left atrium LA receives oxygenated blood from the lungs. During diastole or relaxation, e.g. Figure 1 As seen in FIG, blood previously collected in the left atrium LA (during systole) moves through the mitral valve MV and into the left ventricle LV through the expansion of the left ventricle LV. Figure 2 As seen in the , the left ventricle LV contracts to force blood into the body through the aortic valve AV and the ascending aorta AA. During contraction, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV and back into the left atrium LA, and blood is collected in the left atrium from the pulmonary veins. In some embodiments, the devices described in this application are used to repair the function of a defective mitral valve MV. That is, these devices are configured to help close the leaflets of the mitral valve to prevent blood from flowing back from the left ventricle LV and back into the left atrium LA. Many of the devices described in this application are designed to easily grasp and secure the native leaflets around the apposition elements (e.g., spacers, gap fillers, contact surfaces, wedges, membranes, etc.), which beneficially act as fillers in the regurgitation orifices to prevent or inhibit regurgitation or regurgitation during contraction, but this is not required.

[0457] Reference now Figure 1-7 The mitral valve MV includes two leaflets, namely an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes a valve ring 24, which is a tissue fiber ring of variable density surrounding the leaflets 20, 22. Figure 3 and 4 , the mitral valve MV is anchored to the wall of the left ventricle LV by the chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., muscles located at the base of the chordae tendineae CT and within the wall of the left ventricle LV) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM serve to limit the movement of the leaflets 20, 22 of the mitral valve MV and to prevent the mitral valve MV from reversing. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Instead, the papillary muscles PM support or brace the leaflets 20, 22 to resist the high pressure required to circulate blood throughout the body. The papillary muscles PM and the chordae tendineae CT are together referred to as the subvalvular structures, which serve to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed. As seen from Figure 3 As seen from the left ventricular outflow tract (LVOT) view shown in , the anatomical structure of the leaflets 20, 22 causes the inner sides of the leaflets to coapt at the free end portions, and the leaflets 20, 22 begin to retreat or stretch away from each other. The leaflets 20, 22 stretch in the atrial direction until each leaflet meets the mitral annulus.

[0458] Various disease processes may impair the normal function of one or more native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, fibroelastic 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., cardiomyopathy, etc.) may distort the geometry of the native valve, which can lead to native valve dysfunction. However, the vast majority of patients who undergo valve surgery (e.g., surgery on the mitral valve MV) suffer from a degenerative disease that causes dysfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), which leads to prolapse and regurgitation.

[0459] Generally speaking, native valves may malfunction in different ways: including (1) valvular stenosis; and (2) valvular regurgitation. Valvular stenosis occurs when the native valve does not fully open and thereby causes blood flow to be obstructed. Typically, valvular stenosis is caused by the accumulation of calcified material on the valve leaflets, which causes the leaflets to thicken and impairs the ability of the valve to fully open to allow forward blood flow. Valvular regurgitation occurs when the leaflets of the valve do not fully close, thereby causing blood to leak back into the previous chamber (for example, causing blood to leak from the left ventricle into the left atrium).

[0460] There are three main mechanisms by which a native valve becomes regurgitant (or incompetent), including Carpentier Type I, II, and III dysfunctions. Carpentier Type I dysfunction involves expansion of the annulus, causing the normally functioning leaflets to diverge from each other and fail to form a tight seal (i.e., the leaflets do not appose properly). Type I mechanism dysfunction includes leaflet perforations present in endocarditis. Carpentier Type II dysfunction involves prolapse of one or more leaflets of the native valve above the plane of apposition. Carpentier Type III dysfunction involves restraining the movement of one or more leaflets of the native valve, causing the leaflets to be abnormally restrained below the plane of the annulus. Leaflet restriction may be caused by rheumatic disease (Ma) or ventricular expansion (IIIb).

[0461] refer to Figure 5When the healthy mitral valve MV is in the closed position, the anterior leaflet 20 and the posterior leaflet 22 are in close contact, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Figure 3 and 6 Mitral regurgitation MR occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV are displaced into the left atrium LA during contraction so that the edges of the leaflets 20, 22 do not touch each other. This failure to coapt causes a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow back from the left ventricle LV into the left atrium LA during contraction, as shown in FIG. Figure 3 The MR flow path of mitral regurgitation is shown in Figure 2. Figure 6 , the width W of gap 26 may be between about 2.5 mm and about 17.5 mm, between about 5 mm and about 15 mm, between about 7.5 mm and about 12.5 mm, or about 10 mm. In some cases, the width W of gap 26 may be greater than 15 mm. As described above, leaflets (e.g., leaflets 20, 22 of the mitral valve MV) may malfunction in a number of different ways, which may result in valvular regurgitation.

[0462] In any of the above situations, it is desirable that the valve repair device or implant engages the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent or inhibit blood regurgitation through the mitral valve MV. Figure 4 As can be seen in FIG. 1 , an abstract representation of an implantable device, valve repair device or implant 10 is shown, which is implanted between the leaflets 20, 22 so that regurgitation does not occur during contraction (the Figure 3 and Figure 4 ). In some embodiments, the apposition element (e.g., spacer, gap filler, contact surface, wedge, membrane, etc.) of device 10 has a generally conical or triangular shape that naturally adapts to the native valve geometry and its unfolded leaflet properties (toward the annulus). In this application, the terms spacer, engagement element, apposition element, and gap filler are used interchangeably and refer to an element that fills a portion of the space between the leaflets of the native valve and / or is configured to cause the leaflets of the native valve to engage or "apposition" (e.g., cause the native leaflets to apposition with the engagement element, apposition element, spacer, etc., rather than just apposition with each other).

[0463] Although stenosis or regurgitation can affect any valve, stenosis is primarily found to affect the aortic valve AV or the pulmonary valve PV, and regurgitation is primarily found to affect the mitral valve MV or the tricuspid valve TV. Both valvular stenosis and valvular regurgitation increase the workload of the heart H and, if left untreated, can lead to very serious conditions; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Since the left side of the heart (i.e., the left atrium LA, left ventricle LV, mitral valve MV, and aortic valve AV) are primarily responsible for circulating blood throughout the body. Therefore, due to the significantly higher pressures on the left side of the heart, dysfunction of the mitral valve MV or aortic valve AV is particularly problematic and often life-threatening.

[0464] Dysfunctional native heart valves may be 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 the pulmonary valve PV are more prone to stenosis. Because stenotic damage to the valve leaflets is irreversible, treatment for a stenotic aortic valve or a stenotic pulmonary valve may be to remove the valve and replace it with a surgically implanted heart valve, or to replace the valve with a transcatheter heart valve. The mitral valve MV and tricuspid valve TV are more susceptible to deformation of the valve leaflets and / or surrounding tissue, which, as described above, can prevent the mitral valve MV or tricuspid valve TV from closing properly and allow blood to flow back or reflux from the ventricles into the atria (e.g., a deformed mitral valve MV may allow blood to flow back or reflux from the left ventricle LV into the left atrium LA, as described above). Figure 3 ). Regurgitation or backflow of blood from the ventricles to the atria can result in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are generally repairable. Additionally, regurgitation may occur due to the chordae tendineae CT becoming dysfunctional (e.g., the chordae tendineae CT may stretch or rupture), which allows the anterior leaflet 20 and the posterior leaflet 22 to reverse, allowing blood to flow back into the left atrium LA. Problems that arise due to chordae tendineae CT dysfunction can be repaired by repairing the structure of the chordae tendineae CT or the mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0465] The devices and procedures disclosed herein are generally directed to repairing the structure of the mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve and any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit the backflow of blood from the left ventricle into the left atrium. Regarding the tricuspid valve TV ( Figure 7), any device and concept provided herein can be used between any two of the anterior leaflet 30, the septal leaflet 32, and the posterior leaflet 34 to prevent or inhibit blood from flowing back from the right ventricle to the right atrium. In addition, any device and concept provided herein can be used together on all three leaflets 30, 32, 34 to prevent or inhibit blood from flowing back from the right ventricle to the right atrium. That is, the valve repair device or implant provided herein can be located in a central position between the three leaflets 30, 32, 34.

[0466] Example implantable devices (e.g., implantable devices, etc.) or implants may optionally have an apposition element (e.g., a spacer, a coaptation element, a gap filler, etc.) and at least one anchor (e.g., one, two, three or more). In some embodiments, the implantable device or implant may have any combination or subcombination of the features disclosed herein without an apposition element. When included, the apposition element (e.g., a coaptation element, a spacer, etc.) is configured to be positioned within the orifice of the native heart valve to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing the above-mentioned regurgitation. The apposition element may have a structure that is impermeable to blood (or prevents blood from flowing therethrough) and allows the native leaflets to close around the apposition element during ventricular contraction to prevent blood from flowing back from the left ventricle or right ventricle into the left atrium or right atrium, respectively. The device or implant may be configured to seal against two or three native valve leaflets; that is, the device may be used for native mitral (mitral or bicuspid) valves and tricuspid valves. Apposition elements are sometimes referred to herein as spacers because the apposition elements can fill the space between malfunctioning native valve leaflets (eg, mitral valve leaflets 20, 22 or tricuspid valve leaflets 30, 32, 34) that are not fully closed.

[0467] Optional apposition elements (e.g., spacers, engagement elements, etc.) can have various shapes. In some embodiments, the apposition element can have an elongated cylindrical shape having a circular cross-sectional shape. In some embodiments, the apposition element can 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 embodiments, the apposition element can have an atrial portion positioned in or adjacent to the atrium, a ventricular portion or lower portion positioned in or adjacent to the ventricle, and a side surface extending between the native tricuspid valve leaflets. In some embodiments configured for use in a tricuspid valve, the atrial portion or upper portion is positioned in or adjacent to the right atrium, and the ventricular portion or lower portion is positioned in or adjacent to the right ventricle, and the side surface extends between the native tricuspid valve leaflets.

[0468] In some embodiments, the anchor can be configured to fix the device to one or two of the autologous leaflets so that the apposition element is positioned between the two autologous leaflets. In some embodiments configured for the tricuspid valve, the anchor is configured to fix the device to one, two or three tricuspid leaflets of the tricuspid valve so that the apposition element is positioned between the three autologous leaflets. In some embodiments, the anchor can be attached to the apposition element at a position adjacent to the ventricular portion of the apposition element. In some embodiments, the anchor can be attached to the actuating element (e.g., an axis or an actuating wire), and the apposition element is also attached to the actuating element. In some embodiments, the anchor and the apposition element can be positioned independently relative to each other by moving each of the anchor and the apposition element separately along the longitudinal axis of the actuating element (e.g., an actuating shaft, an actuating rod, an actuating tube, an actuating wire, etc.). In some embodiments, by moving the anchor and the apposition element together along the longitudinal axis of the actuating element (e.g., an axis, an actuating wire, etc.), the anchor and the apposition element can be positioned simultaneously. The anchors may be configured to be positioned behind the native leaflets upon implantation such that the leaflets are grasped by the anchors.

[0469] The device or implant may be configured to be implanted via a delivery system or other device for delivery. The delivery system may include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, a combination of these, and the like. The apposition element and the anchor may be compressed to a radially compressed state, and may self-expand to a radially expanded state when the compression pressure is released. The device may be configured to radially expand the anchor away from the still compressed apposition element first, so as to create a gap between the apposition element and the anchor. The autologous leaflet may then be positioned in the gap. The apposition element may be radially expanded, thereby closing the gap between the apposition element and the anchor, and capturing the leaflet between the apposition element and the anchor. In some embodiments, the anchor and the apposition element may be optionally configured to self-expand. The implantation methods of various embodiments may be different, and a more comprehensive discussion is provided below regarding each embodiment. Additional information about these and other available delivery methods can be found in U.S. Pat. No. 8,449,599 and U.S. Patent Application Publication Nos. 2014 / 0222136, 2014 / 0067052, 2016 / 0331523 and PCT Patent Application Publication No. WO2020 / 076898, each of which is incorporated herein by reference in its entirety for all purposes. These methods can be performed on live animals or on simulated objects, such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., with simulated body parts, hearts, tissues, etc.), etc., mutatis mutandis.

[0470] The disclosed devices or implants can be configured so that the anchors are connected to the leaflets, using tension from native chordae tendineae to resist high systolic pressures that push the device toward the left atrium. During diastole, these devices can rely on the compressive and retaining forces exerted on the leaflets grasped by the anchors.

[0471] Reference now Figure 8-15 , schematically illustrating an implantable device or implant 100 (e.g., a prosthetic spacer device, a valve repair device, etc.) in various stages of deployment. The device or implant 100 and other similar devices / implants are described in more detail in PCT patent application publications No. WO2018 / 195215, No. WO2020 / 076898, and No. WO 2019 / 139904, which are incorporated herein by reference in their entirety. The device 100 may include any other features of the implantable device or implant discussed in the present application or the above-mentioned application, and the device 100 may be positioned to engage valve tissue (e.g., leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application or the above-mentioned application).

[0472] The device or implant 100 is deployed from a delivery system or other device for delivery 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 of these, etc. The device or implant 100 includes an apposition portion 104 and an anchoring portion 106.

[0473] In some embodiments, the apposition portion 104 of the device or implant 100 includes an apposition element or a device for apposition 110 (e.g., a spacer, a plug, a filler, a foam, a sheet, a membrane, a coaptation element, etc.) adapted for implantation between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and slidably attached to an actuation element 112 (e.g., an actuation wire, an actuation shaft, an actuation tube, etc.). The anchoring portion 106 includes one or more anchors 108, which can be actuated between an open state and a closed state and can take a variety of forms, such as a paddle, a gripping element, etc. Actuation of the device or actuation element 112 for actuation causes the anchoring portion 106 of the device 100 to open and close to grasp the leaflets of the native valve during implantation. The means for actuation or actuation element 112 (as well as other means for actuation and actuation elements herein) can take a variety of different forms (e.g., such as wires, rods, shafts, tubes, screws, sutures, threads, strips, combinations of these, etc.), be made of a variety of different materials, and have a variety of configurations. As an example, the actuation element can be threaded, such that rotation of the actuation element moves the anchor portion 106 relative to the apposition portion 104. Alternatively, the actuation element can be non-threaded, such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the apposition portion 104.

[0474] The anchoring portion 106 and / or the anchoring member of the device 100 comprises an outer paddle 120 and an inner paddle 122, which in some embodiments are connected between the cover 114 and the device for engagement or the engagement element 110 by portions 124, 126, 128. Portions 124, 126, 128 can be connected and / or flexible to move between all positions described below. The interconnection of the outer paddle 120, the inner paddle 122, the engagement element 110, and the cover 114 by portions 124, 126, and 128 can constrain the device to the positions and movements shown herein.

[0475] In some embodiments, the delivery system 102 comprises a steerable catheter, an implant catheter, and a means or actuating element 112 for actuation (e.g., an actuating wire, an actuating shaft, etc.). These can be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some embodiments, the means or actuating element 112 for actuation extends through the delivery catheter and the means or actuating element 110 for engagement to the distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchoring portion 106). Extending and retracting the actuating element 112 increases and decreases the spacing between the engagement element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), respectively. In some embodiments, a collar or other attachment element removably attaches the engagement element 110 directly or indirectly to the delivery system 102 such that the actuation device or actuation element 112 slides through the collar or other attachment element and, in some embodiments, the engagement device or engagement element 110 is used to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor member 108 during actuation.

[0476] In some embodiments, the anchor portion 106 and / or the anchor 108 may include an attachment portion or clamping member. The illustrated clamping member may include a fastener 130 that includes a base or fixed arm 132, a movable arm 134, an optional barb, friction enhancing element, or other means for fixing 136 (e.g., a protrusion, ridge, groove, textured surface, adhesive, etc.), and a joint portion 138. The fixed arm 132 is attached to the inner blade 122. In some embodiments, the fixed arm 132 is attached to the inner blade 122, wherein the joint portion 138 is disposed proximate to the means for engaging or engaging element 110. In some embodiments, the fastener (e.g., an optionally barbed fastener, etc.) has a flat surface and does not fit into a recess of the inner blade. In fact, the flat portion of the fastener is disposed against the surface of the inner blade 122. The joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the fastener 130. Joint portion 138 may be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, etc. In some embodiments, joint portion 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 opened to open catch 130 and expose optional barbs, friction enhancing elements, or means for securing 136.

[0477] In some embodiments, the buckle 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, causing the movable arm 134 to articulate, flex, or pivot on the joint portion 138. The actuation line 116 extends through the delivery system 102 (e.g., through a steerable catheter and / or an implant catheter). Other actuation mechanisms are also possible.

[0478] The actuation line 116 can take various forms, such as a tube, suture, wire, rod, catheter, etc. The fastener 130 can be spring loaded so that in the closed position, the fastener 130 continues to provide a clamping force on the grasped native leaflet. The clamping force remains constant regardless of the position of the inner paddle 122. The optional barbs, friction enhancing elements, or other means for securing 136 of the fastener 130 can grasp, clamp, and / or pierce the native leaflet to further secure the native leaflet.

[0479] During implantation, the paddles 120, 122 can be opened and closed, for example, to grasp the native leaflets (e.g., native mitral leaflets, etc.) between the paddles 120, 122 and / or between the paddles 120, 122 and the means for coaptation or coaptation element 110. The fastener 130 can be used to grasp and / or further secure the native leaflets by engaging the leaflets with optional barbs, friction enhancing elements, or means for securing 136 and clamping the leaflets between the movable arm 134 and the fixed arm 132. The optional barbs, friction enhancing elements, or other means for securing 136 of the fastener 130 (e.g., optional barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.) increase friction with the leaflets, or can partially or completely pierce the leaflets. The actuation lines 116 can be actuated individually so that each fastener 130 can be opened and closed individually. Separate manipulation allows grasping of one leaflet at a time, or allows repositioning of an insufficiently grasped catch 130 on a leaflet without altering successful grasping of another leaflet. Catch 130 can be opened and closed relative to the position of inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing grasping of the leaflet in a variety of positions as desired for a particular situation.

[0480] Reference now Figure 8, the device 100 is shown in an elongated or fully open state for deployment from an implant delivery catheter of a delivery system 102. In the fully open position, the device 100 is disposed at the end of the catheter of the delivery system 102 because the fully open position takes up the least space and allows the smallest catheter to be used (or the largest device 100 to be used for a given catheter size). In the elongated state, the cover 114 is spaced apart from the means or means for engagement 110 so that the paddles 120, 122 are fully extended. In some embodiments, the angle formed between the outer paddle 120 and the interior of the inner paddle 122 is approximately 180 degrees. During deployment through the delivery system 102, the fastener 130 remains in a closed state so that the optional barbs, friction enhancing elements, or other means for securing 136 ( Fig. 9 ) will not snag or damage the delivery system 102 or tissue in the patient's heart. The actuation line 116 can extend and attach to the movable arm 134.

[0481] Reference now Fig. 9 , the device 100 is shown in a state similar to Figure 8 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or about 180 degrees between the fixed portion 132 and the movable portion 134 of the fastener 130. It has been found that fully opening the paddles 120, 122 and the fastener 130 can make it easier to disentangle or disengage from patient anatomy such as chordae tendineae CT during implantation of the device 100.

[0482] Reference now Fig.10, the device 100 is shown in a shortened or fully closed state. The compact size of the device 100 in the shortened state allows for easier movement and placement within the heart. In order to move the device 100 from the elongated state to the shortened state, the device or actuating element 112 for actuation is retracted to pull the cover 114 toward the device or actuating element 110 for apposition. The movement of the connecting portion 126 (e.g., a joint, a flexible connector, etc.) between the outer paddle 120 and the inner paddle 122 is constrained so that the compressive force acting on the outer paddle 120 from the cover 114 retracted toward the device or actuating element 110 for apposition causes the paddle or clamping element to move radially outward. During the movement from the open position to the closed position, the outer paddle 120 maintains an acute angle with the device or actuating element 112 for actuation. The outer paddle 120 can optionally be biased toward the closed position. When the inner paddle 122 is oriented away from the means or engagement element 110 for engagement in the open state, and folded along the side of the means or engagement element 110 for engagement in the closed state, the inner paddle 122 moves through a considerable angle during the same movement. In some embodiments, the inner paddle 122 is thinner and / or narrower than the outer paddle 120, and the connecting portions 126, 128 (e.g., joints, flexible connectors, etc.) connected to the inner paddle 122 can be thinner and / or more flexible. For example, this increased flexibility can allow more movement than the connecting portion 124 connecting the outer paddle 120 to the cover 114. In some embodiments, the outer paddle 120 is narrower than the inner paddle 122. The connecting portions 126, 128 connected to the inner paddle 122 can be more flexible, for example, to allow more movement than the connecting portion 124 connecting the outer paddle 120 to the cover 114. In some embodiments, the inner paddle 122 can have the same or substantially the same width as the outer paddle.

[0483] Reference now Figure 11-13 , the device 100 is shown in a partially open, ready-to-grasp state. In order to transition from the fully closed state to the partially open state, the actuating device or actuating element (e.g., an actuating wire, an actuating shaft, etc.) extends to push the cover 114 away from the actuating device or actuating element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor or anchor portion 106 to partially deploy. The actuating line 116 also retracts to open the fastener 130 so that the leaflet can be grasped. In some embodiments, a pair of inner and outer paddles 122, 120 are moved in unison by a single actuating device or a single actuating element 112, rather than independently. Also, the position of the fastener 130 depends on the position of the paddles 122, 120. For example, referring to Fig.10, closing paddles 122, 120 also closes the buckle. In some embodiments, paddles 120, 122 may be independently controllable. For example, device 100 may have two actuating elements and two independent covers (or other attached portions), such that one independent actuating element (e.g., wire, shaft, etc.) and cover (or other attached portion) is used to control one paddle, and another independent actuating element and cover (or other attached portion) is used to control the other paddle.

[0484] Reference now Fig.12 , one of the actuation lines 116 is extended to allow one of the fasteners 130 to close. Referring now to Fig.13 , the other actuation line 116 extends to allow the other buckle 130 to close. Either or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the buckle 130.

[0485] Reference now Fig.14 , the device 100 is shown in a fully closed and deployed state. The delivery system or device for delivery 102 and the device for actuation or actuating element 112 are retracted, and the paddles 120, 122 and the fastener 130 are maintained in the fully closed position. Once deployed, the device 100 can be maintained in the fully closed position with a mechanical latch, or can be biased to remain closed by using a spring material, such as steel, other metals, plastics, composite materials, etc., or a shape memory alloy, such as nitinol. For example, the connecting portions 124, 126, 128, the joint portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) can be formed of a metal such as steel or a shape memory alloy (such as nitinol) (produced in wires, sheets, tubes, or laser sintered powders), and are biased to keep the outer paddle 120 closed around the device for apposition or apposition element 110 and to keep the fastener 130 clamped around the native leaflet. Similarly, the fixed arm 132 and the movable arm 134 of the clasp 130 are biased to clamp the leaflets. In some embodiments, the attachment or connecting portions 124, 126, 128, the joint portion 138 and / or the inner and outer paddles 122 and / or additional biasing members (not shown) can be formed of any other suitable resilient material, such as a metal or polymer material, to maintain the device 100 in a closed state after implantation.

[0486] Fig.15 An example is shown where blades 120 , 122 are independently controllable. Fig.15 The device 101 shown is Fig.11 The device shown is similar except that Fig.15The device 100 includes an actuating element configured as two independent actuating elements 111, 113 coupled to two independent covers 115, 117. To transition the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, the means for actuating or actuating element 111 is extended to push the cover 115 away from the means for abutting or abutting element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the first anchor 108 to partially deploy. To transition the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, the means for actuating or actuating element 113 is extended to push the cover 115 away from the means for abutting or abutting element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchor 108 to partially deploy. Fig.15 The independent blade control shown can be implemented on any device disclosed in this application. Fig.11 In the example shown, the pair of inner and outer blades 122 , 120 are moved in unison rather than independently by a single means for actuation or actuation element 112 .

[0487] Reference now Figure 16-21 , Figure 8-14 The implantable device 100 is shown delivered and implanted within the native mitral valve MV of the heart H. Fig.16 , the delivery sheath / catheter is inserted through the septum into the left atrium LA, and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state, as shown. Fig.16 The means for actuation or actuating element 112 is then retracted to move the implant / device to Fig.17 Shown in fully closed position.

[0488] exist Fig.18 As can be seen in FIG. 1 , the implant / device is moved to a position within the mitral valve MV, into the ventricle LV, and partially opened so that the leaflets 20, 22 can be grasped. For example, the steerable catheter can be advanced and turned or flexed to position the steerable catheter, such as Fig.18 An implant catheter connected to the implant / device may be advanced from within the steerable catheter to position the implant, such as Fig.18 shown.

[0489] Reference now Fig.19 , the implant catheter can be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 in the catches 130. The actuation line 116 is extended to close one of the catches 130, thereby capturing the leaflet 20. Fig. 20 Another actuation line 116 is shown, which is then extended to close another catch 130, thereby capturing the remaining leaflets 22. Finally, in Fig.21As can be seen in FIG. 1 , the delivery system 102 (eg, a steerable catheter, implant catheter, etc.), the device or actuation element 112 for actuation, and the actuation line 116 are then retracted, and the device or implant 100 is fully closed and deployed in the native mitral valve MV.

[0490] Reference now Figure 22-27 , showing an example of an implantable device or implant or implant 200. The implantable device 200 is Figure 8-14 100 can be one of many different configurations that the device 100 schematically shown in FIG. 100 can include any other features of the implantable devices or implants discussed in this application, and the device 200 can be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). The device / implant 200 can be a prosthetic spacer device, a valve repair device, or another type of implant attached to the leaflets of a native valve.

[0491] In some embodiments, the implantable device or implant 200 includes a commissure portion 204, a proximal or attachment portion 205, an anchoring portion 206, and a distal portion 207. In some embodiments, the commissure portion 204 of the device optionally includes a commissure element 210 (e.g., a spacer, a coaptation element, a plug, a membrane, a sheet, etc.) between the leaflets of the implanted native valve. In some embodiments, the anchoring portion 206 includes a plurality of anchors 208. The anchors can be constructed in various ways. In some embodiments, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a fastener 230. In some embodiments, the attachment portion 205 includes a fastener 230 for attaching to the delivery system 202 ( Figure 38-42 and 49) of the capture mechanism 213 ( Figure 43-49 ) is engaged with a first or proximal collar 211 (or other attachment element). The delivery system 202 can be the same or similar to the delivery system 102 described elsewhere, and can include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations of these, and the like.

[0492] In some embodiments, the apposition element 210 and the paddles 220, 222 are formed of a flexible material, which may be a metal fabric (e.g., a mesh) that is woven, braided, or formed in any other suitable manner, or a flexible material that is cut by laser or otherwise. The material may be cloth, a shape memory alloy wire such as Nitinol to provide shape-holding capabilities, or any other flexible material suitable for implantation in a human body.

[0493] An actuating element 212 (e.g., an actuating shaft, an actuating rod, an actuating tube, an actuating wire, an actuating line, etc.) extends from the delivery system 202 to engage the implantable device or implant 200 and enable actuation of the implantable device or implant. In some embodiments, the actuating element 212 extends through the capture mechanism 213, the proximal collar 211, and the abutment element 210 to engage the cap 214 of the distal portion 207. The actuating element 212 can be configured to removably engage the cap 214 using a threaded connection, etc., so that the actuating element 212 can be disengaged and removed from the device 200 after implantation.

[0494] The engagement element 210 extends from the proximal collar 211 (or other attachment element) to the inner paddle 222. In some embodiments, the engagement element 210 has a generally elongated and circular shape, although other shapes and configurations are possible. In some embodiments, the engagement element 210 has an elliptical shape or cross-section when viewed from above (e.g., Fig.51 ), and has a tapered shape or cross-section when viewed from the front (e.g., Fig.23 ), and has a circular shape or cross-section when viewed from the side (e.g., Fig.24 ). The mixture of these three geometric shapes can produce the three-dimensional shape of the illustrated juxtaposition element 210 that achieves the benefits described herein. When viewed from above, it can also be seen that the circular shape of the juxtaposition element 210 substantially follows or approximates the shape of the blade frame 224.

[0495] The size and / or shape of the apposition element 210 can be selected to minimize the number of implants (preferably one) that a single patient will need while maintaining a low transvalvular gradient. In some embodiments, the front-to-back distance at the top of the apposition element is about 5 mm, and the inside-outside distance of the apposition element at its widest point is about 10 mm. In some embodiments, the overall geometry of the device 200 can be based on these two dimensions and the above-mentioned overall shape strategy. It should be easily apparent that using other front-to-back distances and inside-outside distances as the starting point of the device will cause the device to have different sizes. In addition, using other sizes and the above-mentioned shape strategy will also cause the device to have different sizes.

[0496] In some embodiments, outer paddle 220 is connectably attached to cover 214 of distal portion 207 via connecting portion 221 and is connectably attached to inner paddle 222 via connecting portion 223. Inner paddle 222 is connectably attached to the apposition element via connecting portion 225. In this manner, anchor 208 is configured to resemble a leg, as inner paddle 222 resembles an upper portion of a leg, outer paddle 220 resembles a lower portion of a leg, and connecting portion 223 resembles a knee portion of a leg.

[0497] In some embodiments, inner paddle 222 is hard, relatively hard, rigid, has rigid portions and / or is reinforced by a reinforcing member such as a plate, rod, or fixed portion 232 of fastener 230. The reinforcement of the inner paddle allows the device to move to the various positions shown and described herein. Inner paddle 222, outer paddle 220, and counter-joints can all be interconnected as described herein so that device 200 is constrained to the movements and positions shown and described herein.

[0498] In some embodiments, paddle frame 224 is attached to cover 214 at distal portion 207 and extends to connecting portion 223 between inner paddle 222 and outer paddle 220. In some embodiments, paddle frame 224 is formed of a material that is more rigid and harder than the material forming paddles 222, 220, such that paddle frame 224 provides support for paddles 222, 220.

[0499] The paddle frame 224 provides additional clamping force between the inner paddle 222 and the coaptation element 210 and helps wrap the leaflets around the sides of the coaptation element 210 to achieve a better seal between the coaptation element 210 and the leaflets, as shown in FIG. Fig.51 208. That is, blade frame 224 can be configured to have a circular three-dimensional shape having a connecting portion 223 extending from cover 214 to anchor 208. The connections between blade frame 224, outer blade 220 and inner blade 222, cover 214, and mating element 210 can constrain each of these components to the movement and position described herein. In particular, connecting portion 223 is constrained by its connection between outer blade 220 and inner blade 222 and by its connection to blade frame 224. Similarly, blade frame 224 is constrained by its attachment to connecting portion 223 (and therefore inner blade 222 and outer blade 220) and cover 214.

[0500] Configuring the paddle frame 224 in this manner provides an increased surface area compared to the separate outer paddles 220. This can, for example, make it easier to grasp and secure the native valve leaflets. The increased surface area can also distribute the clamping force of the paddle 220 and paddle frame 224 on the native valve leaflets over a relatively large surface of the native valve leaflets to further protect the native valve leaflet tissue. Fig.51 The increased surface area of ​​the paddle frame 224 may also allow the native leaflets to be clamped to the implantable device or implant 200 such that the native leaflets fully apposition around the apposition member or element 210. This may, for example, improve the sealing of the native leaflets 20, 22 and thereby prevent or further reduce mitral regurgitation.

[0501] In some embodiments, the fastener includes a movable arm coupled to the anchor. In some embodiments, the fastener 230 includes a base or fixed arm 232, a movable arm 234, an optional barb 236, and a joint portion 238. The fixed arm 232 is attached to the inner blade 222, wherein the joint portion 238 is disposed proximate to the mating element 210. The joint portion 238 is spring loaded so that the fixed arm 232 and the movable arm 234 are biased toward each other when the fastener 230 is in a closed state. In some embodiments, the fastener 230 includes a friction enhancing element or fixing device, such as an optional barb, a protrusion, a ridge, a groove, a textured surface, an adhesive, etc.

[0502] In some embodiments, the fixed arm 232 is attached to the inner paddle 222 with sutures (not shown) through the hole or slot 231. The fixed arm 232 can be attached to the inner paddle 222 by any suitable means, such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, clamps, latches, etc. When the movable arm 234 is opened to open the clasp 230 and expose the optional barb or other friction enhancing element 236, the fixed arm 232 remains substantially stationary relative to the inner paddle 222. By supplying an actuation line 216 (e.g., such as a cam) to the hole 235 attached to the movable arm 234, the fixed arm 232 can be moved to the inner paddle 222. Figure 43-48 As shown), tension is applied to open the buckle 230, thereby causing the movable arm 234 to hinge, pivot and / or flex on the joint portion 238.

[0503] Reference now Fig.29, shows a close-up view of one of the leaflets 20, 22 being grasped by a fastener, such as fastener 230. The leaflets 20, 22 are grasped between the movable arm and the fixed arm 234 of the fastener 230. The tissue of the leaflets 20, 22 is not pierced by the optional barbs or friction enhancing elements 236, but in some embodiments, the optional barbs 236 can partially or completely pierce the leaflets 20, 22. The angle and height of the barbs or friction enhancing elements 236 relative to the movable arms 234 help to secure the leaflets 20, 22 within the fastener 230. Specifically, the force that pulls the implant away from the native leaflets 20, 22 will promote the barbs or friction enhancing elements 236 to further engage the tissue, thereby ensuring better retention. When the fastener 230 is closed, the position of the fixed arm 232 near the optional barbs / friction enhancing elements 236 further improves the retention of the leaflets 20, 22 in the fastener 230. In this arrangement, tissue is formed into an S-shaped tortuous path by fixed arms 232 and movable arms 234 and optional barbs / friction enhancing elements 236. Thus, a force pulling leaflets 20, 22 away from clasp 230 will cause the tissue to further engage optional barbs / friction enhancing elements 236 before leaflets 20, 22 can disengage. For example, leaflet tension during diastole can cause optional barbs 236 to pull toward end portions of leaflets 20, 22. Thus, the S-shaped path can utilize leaflet tension during diastole to more tightly engage leaflets 20, 22 with optional barbs / friction enhancing elements 236.

[0504] refer to Fig.25 , the implant 200 may further include a covering 240. In some embodiments, the covering 240 may be disposed on the apposition element 210, the outer paddle 220 and the inner paddle 222 and / or the paddle frame 224. The covering 240 may be configured to prevent or reduce blood flow through the implant 200 and / or promote autologous tissue ingrowth. In some embodiments, the covering 240 may be a cloth or fabric, such as PET, velvet or other suitable fabric. In some embodiments, instead of or in addition to a fabric, the covering 240 may include a coating (e.g., a polymer) applied to the implantable device or implant 200.

[0505] During implantation, the paddles 220, 222 of the anchor 208 are opened and closed to grasp the native valve leaflets 20, 22 between the paddles 220, 222 and the apposition element 210. By extending and retracting the actuation element 212, the anchor 208 is in the closed position ( Figure 22-25 ) and various opening positions ( Figure 26-37). Extending and retracting the actuation element 212 increases and decreases the spacing between the abutment element 210 and the cap 214, respectively. During actuation, the proximal collar 211 (or other attachment element) and the abutment element 210 slide along the actuation element 212, so that the change in spacing between the abutment element 210 and the cap 214 causes the paddles 220, 220 to move between different positions to grasp the mitral valve leaflets 20, 22 during implantation.

[0506] When the device 200 is opened and closed, a pair of inner and outer paddles 222, 220 are moved in unison by a single actuating element 212, rather than independently. Also, the position of the clasp 230 is dependent upon the position of the paddles 222, 220. For example, the clasp 230 is arranged such that closing the anchor 208 simultaneously closes the clasp 230. In some embodiments, the device 200 may have paddles 220, 222 that may be independently controlled in the same manner (e.g., Fig.15 The device 100 shown).

[0507] In some embodiments, the fastener 230 further secures the native leaflets 20, 22 by engaging the leaflets 20, 22 with the barbs and / or other friction enhancing elements 236 and clamping the leaflets 20, 22 between the movable arm 234 and the fixed arm 232. In some embodiments, the fastener 230 is an optional barbed fastener that includes barbs that increase friction with the leaflets 20, 22 and / or that can partially or completely pierce the leaflets. Actuation line 216 ( Figure 43-48 ) can be individually actuated so that each catch 230 can be opened and closed individually. Individual operations allow grasping of one leaflet 20, 22 at a time, or allow repositioning of a catch 230 on a leaflet 20, 22 that is not adequately grasped without altering the successful grasping of another leaflet 20, 22. When the inner paddle 222 is not closed, the catch 230 can be fully opened and closed, allowing the leaflets 20, 22 to be grasped in a variety of positions as required by the particular situation.

[0508] Reference now Figure 22-25 , the device 200 is shown in a closed position. When closed, the inner paddle 222 is disposed between the outer paddle 220 and the mate element 210. The fastener 230 is disposed between the inner paddle 222 and the mate element 210. After successfully capturing the native leaflets 20, 22, the device 200 is moved to and maintained in a closed position such that the leaflets 20, 22 are secured within the device 200 by the fastener 230 and are pressed against the mate element 210 by the paddles 220, 22. The outer paddle 220 can have a wide curved shape that fits around the curved shape of the mate element 210 to more securely clamp the leaflets 20, 22 when the device 200 is closed (e.g., as in Fig.51The curved shape and rounded edges of the outer paddle 220 also prevent or inhibit tearing of the leaflet tissue.

[0509] Reference now Figure 30-37 , the implantable device or implant 200 is shown in various positions and configurations ranging from partially open to fully open. The paddles 220, 222 of the device 200 are Figure 30-37 Each position shown is between Figure 22-25 The closed position shown upwardly extends the actuation element 212 from the fully retracted position to the fully extended position.

[0510] Reference now Figure 30-31 , device 200 is shown in a partially open position. Device 200 is moved to the partially open position by extending actuating element 212. Extending actuating element 212 pulls downward on the bottom portion of outer paddle 220 and paddle frame 224. Outer paddle 220 and paddle frame 224 pull downward on inner paddle 222, to which inner paddle 222 is connected. Because proximal collar 211 (or other attachment element) and mating element 210 are held in place by capture mechanism 213, inner paddle 222 is caused to articulate, pivot and / or flex in the opening direction. Inner paddle 222, outer paddle 220, and paddle frame all flex to the position. Figure 30-31 The opening of the paddles 222, 220 and the paddle frame 224 creates a gap between the apposition element 210 and the inner paddle 222 that can receive and grasp the native leaflets 20, 22. This movement also exposes the valve body that can be closed ( Fig.30 ) position and open ( Fig.31 ) positions to form a second gap for grasping the native leaflets 20, 22. The range of the gap between the fixed arm 232 and the movable arm 234 of the buckle 230 is limited to the range in which the inner paddle 222 has been extended away from the coaptation element 210.

[0511] Reference now Figure 32-33, the device 200 is shown in a laterally extended or open position. By continuing to extend the above-mentioned actuating element 212, the device 200 is moved to the laterally extended or open position, thereby increasing the distance between the mating element 210 and the cover 214 of the distal portion 207. Continuing to extend the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 downward, thereby causing the inner paddle 222 to expand further away from the mating element 210. In the laterally extended or open position, the inner paddle 222 extends horizontally more than in other positions of the device 200 and forms an angle of approximately 90 degrees with the mating element 210. Similarly, when the device 200 is in the laterally extended or open position, the paddle frame 224 is in its maximum extended position. The increased gap formed between the mating element 210 and the inner paddle 222 in the laterally extended or open position allows the fastener 230 to open further (before engaging the mating element 210) before engaging the mating element 210. Fig.33 ), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0512] Reference now Figure 34-35 , the example device 200 is shown in a three-quarter extended position. By continuing to extend the above-mentioned actuating element 212, the device 200 is moved to the three-quarter extended position, thereby increasing the distance between the mate element 210 and the cover 214 of the distal portion 207. Continuing to extend the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 downward, thereby causing the inner paddle 222 to expand further away from the mate element 210. In the three-quarter extended position, the inner paddle 222 is opened more than 90 degrees, forming an angle of approximately 135 degrees with the mate element 210. The paddle frame 224 expands less than when in the lateral extension or open position, and begins to move inwardly toward the actuating element 212 as the actuating element 212 is further extended. The outer paddle 220 also flexes backward toward the actuating element 212. As with the lateral extended or open position, the increased gap formed between the engaging element 210 and the inner paddle 222 in the lateral extended or open position allows the buckle 230 to be further opened ( Fig.35 ), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0513] Reference now Figure 36-37, the example device 200 is shown in a fully extended position. By continuing to extend the above-mentioned actuating element 212, the device 200 is moved to the fully extended position, thereby increasing the distance between the apposition element 210 and the cover 214 of the distal portion 207 to the maximum distance allowed by the device 200. Continuing to extend the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 downward, thereby expanding the inner paddle 222 further away from the apposition element 210. The outer paddle 220 and the paddle frame 224 move to their positions close to the actuating element. In the fully extended position, the inner paddle 222 opens to an angle of approximately 180 degrees with the apposition element 210. The inner paddle 222 and the outer paddle 220 are stretched straight in the fully extended position to form an angle of approximately 180 degrees between the paddles 222, 220. The fully extended position of the device 200 provides a maximum size of the gap between the engaging element 210 and the inner paddle 222 and, in some embodiments, allows the buckle 230 to also be fully opened up to approximately 180 degrees (0.98 degrees) between the fixed arm 232 and the movable arm 234 of the buckle 230. Fig.37 ). The position of the device 200 is the longest and narrowest configuration. Thus, the fully extended position of the device 200 can be a desired escape position for the device 200 from an attempted implant, or can be a desired position for placing the device in a delivery catheter, etc.

[0514] Constructing the implant 200 so that the anchor 208 can extend into a straight or nearly straight configuration (e.g., approximately 120-180 degrees relative to the mate element 210) can provide several advantages. For example, such a configuration can reduce the radial curl profile of the implant 200. By providing a larger opening between the mate element 210 and the inner paddle 222 in which to grasp the native leaflets 20, 22, it can also make it easier to grasp the native leaflets 20, 22. In addition, the relatively narrow straight configuration can prevent or reduce the implant 200 from becoming entangled in the native anatomical structure (e.g., when the implant 200 is positioned and / or retracted into the delivery system 202). Figure 3 and 4 The possibility of chordae tendineae CT) shown in Figure .

[0515] Reference now Figure 38-49 , an example implantable device 200 is shown being delivered and implanted within the native mitral valve MV of the heart H. As described above, Figure 38-49 The device 200 shown includes a mating element 210, a fastener 230, an inner blade 222, and / or an optional cover 240 on the outer blade 220 (e.g., Fig.25 Device 200 is deployed from a delivery system 202 (eg, which may include an implant catheter extendable from a steerable catheter and / or an introducer sheath) and is retained by a capture mechanism 213 (see, e.g., Fig.43 and 48), and is actuated by extending or retracting the actuation element 212. The fingers of the capture mechanism 213 removably attach the collar 211 to the delivery system 202. In some embodiments, the capture mechanism 213 is held closed around the collar 211 by the actuation element 212, so that removal of the actuation element 212 allows the fingers of the capture mechanism 213 to open and release the collar 211 to decouple the capture mechanism 213 from the device 200 after the device 200 has been successfully implanted.

[0516] Reference now Fig.38 , the delivery system 202 (e.g., its delivery catheter / sheath) is inserted through the septum into the left atrium LA, and the device / implant 200 is deployed from the delivery system 202 in a fully open state for the reasons discussed above with respect to the device 100 (e.g., the implant catheter holding the device / implant can be extended to deploy the device / implant from the steerable catheter). The actuation element 212 is then retracted to move the device 200 through the partially closed state ( Fig.39 ) and reach Figure 40-41 The delivery system or catheter then moves the device / implant 200 toward the mitral valve MV, as shown in FIG. Fig.41 Now refer to Fig.42 When the device 200 is aligned with the mitral valve MV, the actuation element 212 extends to open the paddles 220, 222 to a partially open position, and the actuation line 216 ( Figure 43-48 ) is retracted to open the clasp 230 to prepare for grasping the leaflet. Next, Figure 43-44 As shown, a partially opened device 200 is inserted into the native valve (eg, by advancing an implant catheter from a steerable catheter) until the leaflets 20, 22 are properly positioned between the inner paddle 222 and the coaptation element 210 and within the opened catch 230.

[0517] Fig.45 The device 200 is shown with both clasps 230 closed, but with the optional barb 236 of one clasp 230 missing one leaflet 22. Figures 45-47 As can be seen in FIG. 2 , the out-of-place fastener 230 opens and closes again to properly grasp the missing leaflet 22. When both leaflets 20, 22 are properly grasped, the actuator 212 retracts to move the device 200 to the position in which the device 200 is positioned. Fig.48 With the device 200 fully closed and implanted in a native valve, the actuating element 212 is disengaged from the cap 214 and withdrawn to release the capture mechanism 213 from the proximal collar 211 (or other attachment element) so that the capture mechanism 213 can be withdrawn into the delivery system 202 (e.g., into a catheter / sheath), as shown. Fig.49Once deployed, the device 200 can be held in the fully closed position by a mechanical device such as a latch, or can be biased to remain closed using a spring material (e.g., steel and / or a shape memory alloy such as Nitinol). For example, the paddles 220, 222 can be formed of steel or a Nitinol shape memory alloy (produced in wire, sheet, tube, or laser sintered powder) and biased to keep the outer paddle 220 closed around the inner paddle 222, the apposition element 210, and / or to keep the clasp 230 clamped around the native leaflets 20, 22.

[0518] refer to Figure 50-54 , once the device 200 is implanted in a native valve, the apposition element 210 acts as a gap filler in the valve regurgitant orifice, e.g. Figure 6 The gap 26 in the mitral valve MV shown or in another native valve. In some embodiments, when the device 200 has been deployed between two opposing valve leaflets 20, 22, the leaflets 20, 22 are no longer in engagement with each other in the region of the engagement element 210, but are in engagement with the engagement element 210. This reduces the distance that the leaflets 20, 22 need to approach to close the mitral valve MV during contraction, thereby facilitating the repair of functional valve diseases that may cause mitral regurgitation. The reduction in the leaflet approach distance can also bring several other advantages. For example, the reduced approach distance required for the leaflets 20, 22 reduces or minimizes the stress experienced by the native valve. The shorter approach distance of the valve leaflets 20, 22 may also require a smaller approach force, which may result in less tension experienced by the leaflets 20, 22 and less reduction in the diameter of the valve annulus. Compared with a device without an engagement element or a spacer, a smaller reduction (or no reduction at all) of the valve annulus may result in less reduction in the valve orifice area. In this way, the apposition elements 210 can reduce the transvalvular gradient.

[0519] In order to fully fill the gap 26 between the leaflets 20, 22, the device 200 and its components can have a variety of different shapes and sizes. For example, the outer paddle 220 and the paddle frame 224 can be configured to conform to the shape or geometry of the apposition element 210, such as Figure 50-54 As a result, the outer paddle 220 and the paddle frame 224 can cooperate with both the coaptation element 210 and the native valve leaflets 20, 22. In some embodiments, when the leaflets 20, 22 are coapted with the coaptation element 210, the leaflets 20, 22 completely surround or "hug" the entire coaptation element 210, thereby preventing or inhibiting small leaks at the outer side 201 and the inner side 203 of the coaptation element 210. Fig.51 The interaction of the leaflets 20, 22 and the device 200 is clearly shown in FIG. 1 , which shows a schematic atrial view or surgeon's view showing a paddle frame 224 that conforms to the geometry of the apposition element 210 (which is actually in the example Fig.52Opposing leaflets 20, 22 (each end of which is located at, for example, Fig.52 ) is approached by the paddle frame 224 to completely surround or "hug" the apposition element 210.

[0520] This apposition of the leaflets 20, 22 with the outer side 201 and the inner side 203 of the apposition element 210 (from Fig.52 The atrial side and Fig.53 The ventricular side in the figure (shown in FIG. 2 ) seems to contradict the above statement that the presence of the coaptation element 210 minimizes the distance that the leaflets need to be close. However, if the coaptation element 210 is precisely placed at the regurgitant gap 26 and the regurgitant gap 26 is smaller than the width (inside and outside) of the coaptation element 210, the distance that the leaflets 20, 22 need to be close is still minimized.

[0521] Fig.50 The geometry of the coaptation element 210 and the paddle frame 224 is shown from the perspective of the LVOT. From this view, it can be seen that the coaptation element 210 has a tapered shape that is smaller in size in the area closer to the inner surface of the leaflets 20, 22 where coaptation is desired, and increases in size as the coaptation element 210 extends toward the atrium. Thus, the tapered coaptation element geometry accommodates the depicted native valve geometry. Still referring to Fig.50 The tapered coaptation element geometry combined with the illustrated expanded paddle frame 224 shape (toward the annulus) can help achieve coaptation of the inferior ends of the leaflets, reduce stress, and minimize transvalvular gradients.

[0522] refer to Fig.54 , the shapes of the coaptation element 210 and the paddle frame 224 can be defined based on an internal view of the commissure of the native valve and the device 200. Two factors in these shapes are the coaptation of the leaflets to the coaptation element 210 and the reduction of stress on the leaflets caused by the coaptation. Fig.54 and 24 In order to mate valve leaflets 20, 22 with mate element 210 and reduce the stress applied to valve leaflets 20, 22 by mate element 210 and / or paddle frame 224, mate element 210 can have a circular or rounded shape and paddle frame 224 can have a full radius that spans almost the entire paddle frame 224. The circular shape of mate element 210 and / or the fully rounded shape of paddle frame 224 shown distributes the stress on leaflets 20, 22 over a large curved coaptation area 209. For example, in Fig.54 , the forces exerted by the paddle frame on the leaflets 20 , 22 are dispersed along the entire rounded length of the paddle frame 224 as the leaflets 20 attempt to open during the diastolic cycle.

[0523] Reference now Fig.55, shows an example of an implantable device or implant 300. The implantable device 300 is Figure 8-14 100. The device 300 can include any other features of the implantable devices or implants discussed in this application, and the device 300 can be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0524] The implantable device or implant 300 includes a proximal or attachment portion 305, an anchoring portion 306, and a distal portion 307. In some embodiments, the device / implant 300 includes a mate portion 304, and the mate portion 304 can optionally include a mate element 310 (e.g., a spacer, a plug, a membrane, a sheet, etc.) for implanting between the leaflets 20, 22 of the native valve. In some embodiments, the anchoring portion 306 includes a plurality of anchors 308. In some embodiments, each anchor 308 can include one or more paddles, e.g., an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchor can also include and / or be coupled to a fastener 330. In some embodiments, the attachment portion 305 includes a fastener 330 for interfacing with a delivery system (e.g., Figure 38-42 and 49) of a capture mechanism (e.g., Figure 43-49 A first or proximal collar 311 (or other attachment element) is engaged with a capture mechanism (such as the capture mechanism 213 shown).

[0525] The anchors 308 can be attached to other portions of the device and / or to each other in a variety of different ways (e.g., directly, indirectly, welded, sutured, adhesive, linkage, latch, integrally formed, a combination of some or all of these, etc.) In some embodiments, the anchor 308 is attached to the apposition member or element 310 via a connection portion 325 and to the cover 314 via a connection portion 321.

[0526] Anchor 308 may include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connecting portion 323. Connecting portion 323 may be attached to a paddle frame 324 that is hingedly attached to cover 314 or other attachment portion. In this manner, anchor 308 is configured to resemble a leg, as inner paddle 322 resembles an upper portion of a leg, outer paddle 320 resembles a lower portion of a leg, and connecting portion 323 resembles a knee portion of a leg.

[0527] In embodiments having an apposition member or element 310, the apposition member or element 310 and the anchor 308 can be coupled together in a variety of ways. For example, as shown in the illustrated example, the apposition member 310 and the anchor 308 can be coupled together by integrally forming the apposition member 310 and the anchor 308 as a single, unitary component. This can be achieved, for example, by forming the apposition member 310 and the anchor 308 from a continuous strip 301 of a braided or woven material, such as a braided or woven nitinol wire. In the illustrated example, the apposition member 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, 325 are formed from a continuous fabric strip 301.

[0528] Similar to the anchor 208 of the implantable device or implant 200 described above, the anchor 308 can be configured to move between various configurations by axially moving the distal end of the device (e.g., the cap 314, etc.) relative to the proximal end of the device (e.g., the proximal shaft collar 311 or other attachment element, etc.), and thus the anchor 308 relative to the midpoint of the device. This movement can be along a longitudinal axis extending between the distal end (e.g., the cap 314, etc.) and the proximal end (e.g., the shaft collar 311 or other attachment element, etc.) of the device. For example, by moving the distal end (e.g., the cap 314, etc.) of the device away from the proximal end, the anchor 308 can be fully extended or in a straight configuration (e.g., similar to Fig.36 The structure of the device 200 shown is positioned.

[0529] In some embodiments, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some embodiments, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the apposition element 310 (e.g., similar to Fig.36 For example, the anchor 308 can be moved from a straight configuration to a fully folded configuration (e.g., Fig.55 Initially, as the distal end (e.g., cap 314, etc.) moves toward the proximal end and / or midpoint or center of the device, anchor 308 bends at connecting portions 321, 323, 325, and connecting portion 323 moves radially outward relative to the longitudinal axis of device 300 and axially toward the midpoint and / or proximal end of the device (e.g., similar to Fig.34 As the cap 314 continues to move toward the midpoint of the device and / or toward the proximal end, the connecting portion 323 moves radially inward relative to the longitudinal axis of the device 300 and axially toward the proximal end of the device (e.g., similar to Fig.30 The structure of the device 200 shown).

[0530] In some embodiments, the fastener includes a movable arm coupled to the anchor. In some embodiments, the fastener 330 (e.g. Fig.28B 330 ) comprises a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancing element 336, and a joint portion 338. The fixed arm 332 is attached to the inner blade 322, wherein the joint portion 338 is disposed adjacent to the mating element 310. The joint portion 338 is spring loaded so that the fixed arm 332 and the movable arm 334 are biased toward each other when the buckle 330 is in a closed state.

[0531] The fixed arm 332 is attached to the inner paddle 322 with sutures (not shown) through the hole or slot 331. The fixed arm 332 can be attached to the inner paddle 322 by any suitable means (e.g., screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, etc.). The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is opened to open the catch 330 and expose the optional barbs 336. The fixed arm 332 is connected to the inner paddle 322 by an actuation line (e.g., actuation line 336) attached to the hole 335 in the movable arm 334. Figure 43-48 An actuation line 216 is shown) applying tension to open the buckle 330, thereby causing the movable arm 334 to articulate, pivot and / or flex on the joint portion 338.

[0532] Briefly, the implantable device or implant 300 is similar in construction and operation to the implantable device or implant 200 described above, except that the apposition element 310, the outer paddle 320, the inner paddle 322, and the connecting portions 321, 323, 325 are formed by a single strip of material 301. In some embodiments, the strip of material 301 is attached to the proximal collar 311, the cover 314, and the paddle frame 324 by weaving or inserting through openings in the proximal collar 311, the cover 314, and the paddle frame 324 configured to receive the continuous strip of material 301. The continuous strip 301 can be a single layer of material or can include two or more layers. In some embodiments, portions of the device 300 have a single layer of strip of material 301, and other portions are formed by multiple overlapping or superimposed layers of the strip of material 301.

[0533] For example, Fig.55 The juxtaposed element 310 and inner paddle 322 are shown formed from multiple overlapping layers of a strip of material 301. A single continuous strip of material 301 may begin and end at various locations on the device 300. Each end of the strip of material 301 may be at the same location or at different locations on the device 300. For example, at Fig.55 In the example shown in , the material strip 301 begins and ends at the location of the inner blade 322 .

[0534] As with the implantable device or implant 200 described above, the size of the apposition element 310 can be selected to minimize the number of implants that will be required for a single patient (preferably one) while maintaining a low transvalvular gradient. In particular, many of the components of the device 300 formed from the strip of material 301 allow the device 300 to be made smaller than the device 200. For example, in some embodiments, the front-to-back distance at the top of the apposition element 310 is less than 2 mm, and the inside-out distance of the device 300 at its widest point (i.e., the width of the paddle frame 324, which is wider than the apposition element 310) is about 5 mm.

[0535] The concepts disclosed herein may be used with a variety of different valve repair devices. Figures 56A-56H Another example of a valve repair system 40056, one of many valve repair systems for repairing a patient's native valve, to which the concepts of the present application may be applied, is shown. Valve repair system 40056 includes a delivery device 40156 and a valve repair device 40256.

[0536] The valve repair device 40256 includes a base assembly 40456, a pair of paddles 40656 and a pair of clamping members 40856, such as arms with optional barbs. In one example, the paddle 40656 can be formed integrally with the base assembly. For example, the paddle 40656 can be formed as an extension of the connecting rod of the base assembly. In the example shown, the base assembly 40456 of the valve repair device 40256 has an axis 40356, a coupler 40556 configured to move along the axis, and a lock 40756 configured to lock the coupler in a fixed position on the axis. The coupler 40556 is mechanically connected to the paddle 40656 so that the movement of the coupler 40556 along the axis 40356 causes the paddle to move between an open position and a closed position. In this manner, coupler 40556 serves as a means for mechanically coupling paddle 40656 to shaft 40356 and, when moved along shaft 40356, moving paddle 40656 between its open and closed positions.

[0537] In some embodiments, the clamping member 40856 is pivotally connected to the base assembly 40456 (e.g., the clamping member 40856 can be pivotally connected to the shaft 40356 or any other suitable member of the base assembly) so that the clamping member can be moved to adjust the width of the opening 41456 between the paddle 40656 and the clamping member 40856. The clamping member 40856 can include an optional barbed portion 40956 for attaching the clamping member to the valve tissue when the valve repair device 40256 is attached to the valve tissue. The clamping member 40856 forms a device for clamping valve tissue (particularly tissue of the valve leaflets) using an adhesion device or portion such as the optional barbed portion 40956. When paddle 40656 is in the closed position, paddle engages clamping member 40856 such that when valve tissue is attached to optional barbed portion 40956 of clamping member, paddle acts as a holding or securing device to hold valve tissue at clamping member and secure valve repair device 40256 to valve tissue. In some embodiments, clamping member 40856 is configured to engage paddle 40656 such that optional barbed portion 40956 engages valve tissue member and paddle 40656 to secure valve repair device 40256 to valve tissue member. For example, in some cases, it may be desirable to hold paddle 40656 in an open position and move clamping member 40856 outward toward paddle 40656 to engage valve tissue and paddle 40656.

[0538] Although Figures 56A-56H The illustrated example shows a pair of paddles 40656 and a pair of clamping members 40856, but it will be appreciated that the valve repair device 40256 may include any suitable number of paddles and clamping members.

[0539] In some embodiments, the valve repair system 40056 includes a placement shaft 41356 removably attached to the shaft 40356 of the base assembly 40456 of the valve repair device 40256. After the valve repair device 40256 is secured to the valve tissue, the placement shaft 41356 is removed from the shaft 40356 to remove the valve repair device 40256 from the rest of the valve repair system 40056 so that the valve repair device 40256 can remain attached to the valve tissue and the delivery device 40156 can be removed from the patient.

[0540] The valve repair system 40056 can also include a paddle control mechanism 41056, a clamp control mechanism 41156, and a lock control mechanism 41256. The paddle control mechanism 41056 is mechanically attached to the coupler 40556 so that the coupler moves along the shaft, which causes the paddle 40656 to move between an open position and a closed position. The paddle control mechanism 41056 can take any suitable form, such as a shaft or a rod. For example, the paddle control mechanism can include a hollow shaft, a catheter, or a sleeve that fits over the placement shaft 41356 and the shaft 40356 and is connected to the coupler 40556.

[0541] The clamp control mechanism 41156 is configured to move the clamp member 40856 so that the width of the opening 41456 between the clamp member and the paddle 40656 can be changed. The clamp control mechanism 41156 can take any suitable form, such as a tube, suture or wire, rod, catheter, etc.

[0542] The lock control mechanism 41256 is configured to lock and unlock the lock. The lock 40756 is used as a locking device to lock the connector 40556 in a fixed position relative to the shaft 40356, and can take a variety of different forms, and the type of lock control mechanism 41256 can be determined by the type of lock used. In one example, the lock 40756 takes the form of a lock commonly used in a caulking gun. That is, the lock 40756 includes a pivotable plate having a hole, wherein the shaft 40356 of the valve repair device 40256 is disposed in the hole of the pivotable plate. In this example, when the pivotable plate is in an inclined position, the pivotable plate engages the shaft 40356 to maintain a position on the shaft 40356, but when the pivotable plate is in a substantially non-inclined position, the pivotable plate can move along the shaft (which allows the connector 40556 to move along the shaft 40356). In other words, when the pivotable plate of the lock 40756 is in the tilted (or locked) position, the connector 40556 is prevented or inhibited from moving along the axis 40356 in the direction Y (eg, Fig.56E40356) and allows the coupler to move in direction Y along axis 40356 when the pivotable plate is in a substantially non-tilted (or unlocked) position. In examples where the lock 40756 includes a pivotable plate, the lock control mechanism 41256 is configured to engage the pivotable plate to move the plate between a tilted position and a substantially non-tilted position. The lock control mechanism 41256 can be, for example, a rod, a suture, a wire, or any other member capable of moving the pivotable plate of the lock 40756 between a tilted position and a substantially non-tilted position. In some embodiments, the pivotable plate of the lock 40756 is biased to a tilted (or locked) position, and the lock control mechanism 41256 is used to move the plate from the tilted position to a substantially non-tilted (or unlocked) position. In some embodiments, the pivotable plate of the lock 40756 is biased to a substantially non-tilted (or unlocked) position, and the lock control mechanism 41256 is used to move the plate from a substantially non-tilted position to a tilted (or locked) position.

[0543] Figures 56E-56F The valve repair device 40256 is shown from the open position (eg Fig.56E ) moves to the closed position (as shown) Fig.56F 40). The base assembly 40456 includes a first link 102156 extending from point A to point B, a second link 102256 extending from point A to point C, a third link 102356 extending from point B to point D, a fourth link 102456 extending from point C to point E, and a fifth link 102556 extending from point D to point E. The coupler 40556 is movably attached to the shaft 40356, and the shaft 40356 is fixed to the fifth link 102556. The first link 102156 and the second link 102256 are pivotally attached to the coupler 40556 at point A, so that movement of the coupler 40556 along the shaft 40356 moves the position of point A, and thus moves the first link 102156 and the second link 102256. The first link 102156 and the third link 102356 are pivotally attached to each other at point B, and the second link 102256 and the fourth link 102456 are pivotally attached to each other at point C. One paddle 40656a is attached to the first link 102156 so that movement of the first link 102156 causes paddle 40656a to move, and the other paddle 40656b is attached to the second link 102256 so that movement of the second link 102256 causes paddle 40656b to move. In some embodiments, paddles 40656a, 40656b can be connected to links 102356, 102456, or can be extensions of links 102356, 102456.

[0544] To move the valve repair device from an open position (eg Fig.56E ) moves to the closed position (as shown) Fig.56FAs shown, the coupler 40556 moves along the axis 40356 in the direction Y, thereby moving the pivot point A of the first link 102156 and the second link 102256 to a new position. The movement of the coupler 40556 (and the pivot point A) in the direction Y causes the portion of the first link 102156 near point A to move in the direction H, and the portion of the first link 102156 near point B to move in the direction J. The paddle 40656a is attached to the first link 102156a, so that the movement of the coupler 40556 in the direction Y causes the paddle 40656a to move in the direction Z. In addition, the third link 102356 is pivotally attached to the first link 102156 at point B, so that the movement of the coupler 40556 in the direction Y causes the third link 102356 to move in the direction K. Similarly, movement of the coupler 40556 (and pivot point A) in direction Y causes the portion of the second link 102256 near point A to move in direction L, and the portion of the second link 102256 near point C to move in direction M. The paddle 40656b is attached to the second link 102256 such that movement of the coupler 40556 in direction Y causes the paddle 40656b to move in direction V. Additionally, the fourth link 102456 is pivotally attached to the second link 102256 at point C such that movement of the coupler 40556 in direction Y causes the fourth link 102456 to move in direction N. Fig.56F shows the connector 40556 as Fig.56E The final position of valve repair device 40256 after movement is shown.

[0545] refer to Fig.56B , valve repair device 40256 is shown in an open position (similar to Fig.56E 40656) and the gripper control mechanism 41156 is shown as moving the gripper member 40856 to provide a wider gap at the opening 41456 between the gripper member and the paddle 40656. In the example shown, the gripper control mechanism 41156 includes a line, such as a suture, wire, etc., that is threaded through an opening in one end of the gripper member 40856. Both ends of the line extend through the delivery opening 51656 of the delivery device 40156. When the line is pulled through the delivery opening 51656 in the direction Y, the gripper member 40856 moves inward in the direction X, which causes the opening 41456 between the gripper member and the paddle 40656 to become wider.

[0546] refer to Fig.56C , the valve repair device 40256 is shown such that the valve tissue 20, 22 is disposed in the opening 41456 between the clamping member 40856 and the paddle 40656. Fig.56D, after the valve tissue 20, 22 is disposed between the clamping member 40856 and the paddle 40656, the clamp control mechanism 41156 is used to reduce the width of the opening 41456 between the clamping member and the paddle. That is, in the example shown, the wire of the clamp control mechanism 41156 is released or pushed out from the opening 51656 of the delivery member in the direction H, which allows the clamping member 40856 to move in the direction D to reduce the width of the opening 41456. Although the clamp control mechanism 41156 is shown as moving the clamping member 40856 to increase the width of the opening 41456 between the clamping member and the paddle 40656 ( Fig.56C ), it should be understood that it may not be necessary to move the clamping member in order to position the valve tissue in the opening 41456. However, in some cases, the opening 41456 between the paddle 40656 and the clamping member 40856 may be wider in order to receive the valve tissue.

[0547] refer to Figure 56G , the valve repair device 40256 is in a closed position and fixed to the valve tissue 20, 22. The valve repair device 40256 is fixed to the valve tissue 20 by the paddles 40656a, 40656b and the clamping members 40856a, 40856b. Specifically, the valve tissue 20, 22 is attached to the valve repair device 40256 by the optional barbed portion 40956 of the clamping members 40856a, 40856b, and the paddles 40656a, 40656b engage the clamping members 40856 to fix the valve repair device 40256 to the valve tissue 20, 22.

[0548] To move the valve repair device 40256 from the open position to the closed position, the lock control mechanism 41256 moves the lock 40756 to the unlocked state (eg, Figure 56G 40756). Once lock 40756 is in the unlocked state, coupler 40556 can be moved along shaft 40356 by paddle control mechanism 41056. In the example shown, paddle control mechanism 41056 moves coupler 40556 along shaft in direction Y, which causes one paddle 40656a to move in direction X and another paddle 40656b to move in direction Z. Movement of paddles 40656a, 40656b in directions X and Z causes the paddles to engage clamping members 40856a, 40856b and secure valve repair device 40256 to valve tissue 20, 22.

[0549] refer to Figure 56H , the paddle 40656 is moved to a closed position to secure the valve repair device 40256 to the valve tissue 20, 22 (eg Figure 56G After that, the locking control mechanism 41256 ( Figure 56G) moves lock 40756 to a locked state to hold valve repair device 40256 in a closed position. After lock 40756 holds valve repair device 40256 in a locked state, by aligning shaft 40356 with placement shaft 41356 ( Figure 56G ) is disconnected and the valve repair device 40256 is removed from the delivery device 40156. In addition, the valve repair device 40256 is removed from the paddle control mechanism 41056 ( Figure 56G )、Gripper control mechanism 41156( Figure 56G ) and the lock control mechanism 41256 are disengaged. Removing the valve repair device 40256 from the delivery device 40156 allows the valve repair device to remain secured to the valve tissue 20, 22 when the delivery device 40156 is removed from the patient.

[0550] During implantation of an implantable device or implant in a native heart valve, movement of the device to the implanted position may be impeded or blocked by native heart structures. For example, an articulated portion of an implantable device or implant (e.g., a paddle portion of an anchor used to secure the device to the native heart valve tissue) may come into contact with chordae tendineae CT extending to the valve leaflets (e.g., Figure 3 and 4 The implantable device or implant may be configured to reduce the likelihood of the device or implant being temporarily stuck or blocked by the CT. For example, the implantable device or implant may have a variety of different configurations that are configured to actively or passively narrow to reduce the width of the paddle frame of the anchoring portion of the device, and thus reduce the surface area of ​​the device, which will make it easier for the device / implant to move past and / or through the CT.

[0551] refer to Figures 57-68 , various configurations of examples of implantable devices or implants 400 are shown. Device / implant 400 is configured to be more easily moved to an implantation location in the heart by reducing contact and / or friction between native heart structures, such as chordae tendineae, and device / implant 400. Device / implant 400 may include any other features of implantable devices or implants discussed in this application or in the applications and patents incorporated herein by reference, and device 400 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). In addition, any device or implant described herein may incorporate features of device / implant 400.

[0552] Device / implant 400 can include an apposition portion or an apposition portion 404 and an anchoring portion 406. The anchoring portion can include two or more anchors 408. In some embodiments, the apposition portion 404 optionally includes one or more apposition elements 410 (e.g., spacers, apposition elements, gap fillers, etc.). The spacers, apposition elements, apposition elements, etc. 410 can take any suitable form, such as any form described in this application.

[0553] Each anchor 408 includes a plurality of paddles 420 (e.g., three in each illustrated example) and one or more fasteners 430 (e.g., Figure 57-59 The illustrated example includes three). Fastener 430 may take any suitable form, such as any of the forms described herein.

[0554] Although the illustrated example shows anchors 408 each including three paddles 420, it should be understood that anchors 408 may include any suitable number of paddles 420, such as two or more paddles, three or more paddles, four or more paddles, five or more paddles, etc.

[0555] In some embodiments, each anchor 408 may include a fastener 430 corresponding to each paddle 420 (e.g., Figure 57-59 ), or each anchor 408 may include only a single fastener 430 corresponding to only a single blade of the plurality of blades 420 (e.g., as shown in Figure 60-68 However, it should be understood that each anchor 408 may include any number of paddles 420 that include corresponding fasteners 430 and any number of paddles 420 that do not include corresponding fasteners 430.

[0556] The apposition element 410 and the anchor 408 can be coupled together in various ways. For example, as shown in the illustrated example, the apposition element 410 and the anchor 408 can be optionally coupled together by integrally forming the apposition element 410 and the anchor 408 as a single unitary component. This can be achieved, for example, by forming the apposition element 410 and the anchor 408 from a continuous strip of braided or woven material, such as a braided or woven nitinol wire. In some embodiments, the components are formed separately and attached together.

[0557] The device or implant 400 may also include an attachment portion 405 ( Figures 69-73). Delivery system 402 can be the same or similar to other delivery systems described herein, such as 102, 202, etc., and can include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations of these, and the like. Attachment portion 405 can include a proximal collar 411 for engaging with delivery system 402 (e.g., with an implant catheter of a delivery system). For example, proximal collar 411 can be configured to engage with a capture mechanism (e.g., Figure 43-49 The capture mechanism 213 (eg, the capture mechanism of an implant catheter) is shown engaged.

[0558] The anchor 408 is configured to allow the device or implant 400 to be moved more easily to the implantation position in the heart by reducing the contact and / or friction between the native heart structure such as chordae tendineae and the anchor 408. The anchor 408 includes a plurality of paddles 420, so that one or more gaps G are formed between the paddles 420. The contact between the native heart structure and the anchor 408 is reduced because the native heart structure can extend into the gap G when the device 400 moves through the heart. This can allow the device or implant 400 to move more easily in the heart. In addition, the gap G allows the paddles to bend toward each other during contact with the native heart structure such as chordae tendineae and the anchor 408. This flexure can also allow the device / implant 400 to move more easily through the heart. The device / implant can also be configured so that opening or closing the paddles 420 causes the paddles to move toward each other. This movement of the paddles toward each other can also allow the device / implant 400 to move more easily through the heart.

[0559] The total width TW of anchor 408 can be between 4 mm and 20 mm, such as between 6 mm and 15 mm, such as between 8 mm and 12 mm, such as about 10 mm. The width W of each paddle 420 can be between 0.2 mm and 2 mm, such as between 0.3 mm and 1.5 mm, such as between 0.5 mm and 1 mm. Although each paddle 420 is shown as having the same width W, it should be understood that the width W of any paddle 420 may not be equal to the width W of the other paddles 420. The ratio of the total width TW to the width W can be between 5 / 1 and 20 / 1, such as between 7 / 1 and 15 / 1, such as about 10 / 1. The ratio of the total width to the sum of the widths W of the paddles 420 can be between about 2 / 1 and 15 / 1, such as between 3 / 1 and 10 / 1, such as about 4 / 1.

[0560] In the example shown, inner blade axes IPA of inner blades 420 of the plurality of blades 420 are substantially aligned with the central axis CA of the device 400, and outer blade axes OPA of one or more outer blades 420 extend at an angle α away from the inner blade axes IPA of the inner blades 420. The angle α may be between 5 and 60 degrees, such as between 15 and 45 degrees, such as between 20 and 35 degrees.

[0561] refer to Figure 57-62 , the length L of each blade 420 is between 6 mm and 18 mm, such as between 8 mm and 16 mm, such as between 10 mm and 14 mm, such as about 12 mm. Although each blade 420 is shown as having the same length L, it should be understood that the length L of any blade 420 may not be equal to the length L of the other blades (e.g., see Figures 63-68 ).

[0562] Figure 60-62 Shows Figure 57-59 An exemplary embodiment of an implantable device or implant 400 is shown. In this example, the device or implant 400 is Figure 57-59 The examples shown are the same, except that each anchor 408 includes only a single fastener 430 connected to one of the plurality of blades 420. In the example shown, fastener 430 is connected to the inner blade 420 of each anchor 408, and the outer blade of each anchor 408 does not include a corresponding fastener. In some embodiments, each outer blade 420 may include a corresponding fastener 430, and the inner blade 420 may not include a corresponding fastener. It should be understood that any number of blades 420 may include a corresponding fastener 430, and any number of blades 420 may not include a corresponding fastener 430.

[0563] Figure 63-65 Shows Figure 60-62 An exemplary embodiment of an implantable device or implant 400 is shown. In this example, the device 400 is connected to Figure 60-62 The examples shown are the same, except that the length IL of the inner blade 420 of each anchor 408 is greater than the length OL of the outer blade 420. The length IL can be between 6 mm and 18 mm, such as between 8 mm and 16 mm, such as between 10 mm and 14 mm, such as about 12 mm. The length OL can be between 4 mm and 16 mm, such as between 6 mm and 14 mm, such as between 8 mm and 12 mm, such as about 10 mm. The ratio of the length IL to the length OL can be between 10 / 9 and 2 / 1, such as between 8 / 7 and 3 / 2, such as about 6 / 5.

[0564] Figures 66-68 Shows Figure 60-62An exemplary embodiment of an implantable device or implant 400 is shown. In this example, the device 400 is connected to Figure 60-62 The examples shown are the same, except that the length IL of the inner blade 420 of each anchor 408 is less than the length OL of the outer blade 420. The length OL can be between 6 mm and 18 mm, such as between 8 mm and 16 mm, such as between 10 mm and 14 mm, such as about 12 mm. The length IL can be between 4 mm and 16 mm, such as between 6 mm and 14 mm, such as between 8 mm and 12 mm, such as about 10 mm. The ratio of the length OL to the length IL can be between 10 / 9 and 2 / 1, such as between 8 / 7 and 3 / 2, such as about 6 / 5.

[0565] Although Figures 63-68 The illustrated example shows each anchor 408 having a single fastener 430 corresponding to the inner blade 420, but it should be understood that each blade 420 of the anchor 408 can include a corresponding fastener 430 (e.g., Figure 57-59 As shown), or any number of blades 420 may include corresponding fasteners 430 and any number of blades 420 may not include corresponding fasteners 430.

[0566] refer to Figures 69-73 , shows the device 400 during various stages of deployment from a delivery system 402. The delivery system 402 can take any suitable form, such as any of the forms described herein. Figures 69-73 Shows Figure 57-59 The example of the device / implant 400 is shown, but it should be understood that the deployment of the device / implant 400 from the delivery system 402 is also applicable to Figure 60-68 An example of a device / implant 400 is shown.

[0567] refer to Fig.69 , the device / implant 400 is shown in a compressed position within the delivery system 402. The apposition element 410 and the paddle 420 are made of a compressible material that allows the device 400 to be in a compressed position when the device 400 is moved to a desired position within the patient's heart. When the device / implant 400 is in the delivery system 402 and after the device / implant 400 is deployed from the delivery system 402, the capture mechanism 413 is connected to the collar 411 of the device / implant 400 until the device / implant 400 is implanted on a native heart valve (e.g., native mitral valve, tricuspid valve, etc.).

[0568] Fig.70The device or implant 400 is shown in a deployed and closed position. After the device / implant 400 is deployed from the delivery system 402, the apposition elements 410 are expanded in an outward direction M, and the outer paddles 420 of each anchor 408 are pivoted or hinged outwardly in a direction N to their normal position, so that there is a gap G ( Fig.57 and 59 ).

[0569] An actuation shaft 412 extends from the delivery system 402 to engage the paddle 420 and move the paddle 420 from a closed position to an open position. Fig.71 , the actuation shaft 412 moves in the direction Y to engage the paddle 420 and provide a force thereto so that the paddle 420 moves in the outward direction X to the open position. That is, the paddle 420 can be pivotally or flexibly connected to the mating element 410 at the connection point 470 so that when a force is provided to the paddle 420, the paddle 420 can pivot, flex, and / or articulate relative to the mating element 410. Referring again to Fig.71 The tension F applied to the fastener 430 by the corresponding actuation line 416 holds the fastener 430 in an open position relative to the paddle 420 , such that a tissue capture region exists between the paddle 420 and the fastener 430 .

[0570] refer to Fig.72 After the leaflet tissue is positioned in the tissue capture region between the fastener 430 and the paddle 420, the fastener 430 moves in the direction Z to capture the device 400 and secure it to the tissue. The fastener 430 can be biased in a closed position so that the fastener 430 is activated by releasing the tension F from the actuation line 416. Fig.71 ) to move to the closed position, or the actuation line 416 can be actively controlled by the user to move the fastener 430 to the closed position.

[0571] refer to Fig.73 After the device 400 is secured to the leaflet tissue via the paddle 420 and the fastener 430, the actuation shaft 412 is disengaged from the paddle 420 and moved back into the delivery system 402, causing the paddle 420 to move back to its normal closed position. After the device 400 is secured to the tissue and the anchor 408 is in the closed position, the capture mechanism 413 is removed from the collar 411, causing the device 400 to no longer be attached to the delivery system 402, and the delivery system 402 can be removed from the patient.

[0572] refer to Figures 74-85, various configurations of examples of implantable devices or implants 500 are shown. The device or implant 500 is configured to be more easily moved to an implantation location in the heart by reducing contact and / or friction between native heart structures, such as chordae tendineae, and the device or implant 500. The device or implant 500 may include any other features of the implantable devices or implants discussed in this application or in the applications and patents incorporated herein by reference, and the device 500 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). In addition, any device / implant described herein may incorporate features of the device or implant 500.

[0573] The implantable device or implant 500 includes an apposition portion 504, a proximal or attachment portion 505, an anchoring portion 506, and a distal portion 507. In some embodiments, the apposition portion 504 includes an apposition element 510 (e.g., a spacer, a coaptation element, a gap filler, etc.) that can be implanted, for example, between the leaflets 20, 22 of a native mitral valve MV. The apposition element 510 can take any suitable form, such as any of the forms described in the present application. The attachment portion 205 includes a first or proximal collar 511 for engaging with a capture mechanism 513 of the delivery sheath or system 202 (see Fig.86A , 86B , 87A, 87B, 88 and 89). The proximal collar 511 can take any suitable form, such as any form described in this application.

[0574] The anchor portion 506 may include two or more anchors 508, wherein each anchor 508 includes a plurality of paddle members 519 (e.g., three in each illustrated example) and one or more fasteners 530 (e.g., Figures 74-76 The illustrated example shown includes three. Clamp 530 can take any suitable form, such as any form described in this application. Distal portion 507 includes cover 514, which is attached to paddle portion 519 so that movement of cover 514 causes paddle portion 519 to move between an open position and a closed position. Cover 514 can take any suitable form, such as any form described in this application.

[0575] The paddle members 519 can each include an outer paddle 520 and an inner paddle 522. The paddle members 519 can be made of a metal fabric that is woven, braided, or formed in any other suitable manner, such as a mesh, or a flexible material that is cut by laser or otherwise. The material can be cloth, a shape memory alloy wire such as Nitinol to provide shape-setting capabilities, or any other flexible material suitable for implantation in the human body. In some embodiments, the paddle members 519 also include a paddle frame (not shown) that supports the inner paddle 522 and the outer paddle 520. The paddle frame can take any suitable form, such as any form of the paddle frames described in the present application.

[0576] The apposition element 510 is optional. In the example shown, the apposition element 510 and the paddle member 519 are formed from a continuous strip of material. The material can be any material described in this application for the paddle member 519. In some embodiments, the components are formed separately and attached together. The apposition element 510 extends from the proximal collar 511 to the inner paddle 522.

[0577] The cooperating element 510 has a generally elongated and circular shape. In particular, the cooperating element 510 has an elliptical shape or cross-section when viewed from above (e.g., Fig.74 ), and has a tapered shape or cross-section when viewed from the front (as shown Fig.75 ), and has a rounded shape or cross-section when viewed from a side view (e.g., as Fig.76 ). A mix of these three geometries can produce the three-dimensional shape of the illustrated integrative element 510 that achieves the benefits described herein.

[0578] Although the illustrated example shows anchors 508 each including three paddle members 519, it should be understood that anchors 508 may include any suitable number of paddle members 519, such as two or more paddle members, three or more paddle members, four or more paddle members, five or more paddle members, etc. In addition, each anchor 508 may include a fastener 530 (e.g., a fastener 530 corresponding to each paddle member 519). Figures 74-76 ), or each anchor 508 may include only a single fastener 530 corresponding to only a single blade member of the plurality of blade members 519 (e.g., as shown in Figures 77-79 However, it should be understood that each anchor 508 may include any number of paddle members 519 that include corresponding fasteners 530 and any number of paddle members 519 that do not include corresponding fasteners 530.

[0579] The anchor 508 is configured to allow the device 500 to be moved more easily to an implantation position in the heart by reducing contact and / or friction between native heart structures such as chordae tendineae and the anchor 508. The anchor 508 includes a plurality of paddles 520, so that one or more gaps G are formed between the paddles 520. The contact between the native heart structure and the anchor 508 is reduced because the native heart structure can extend into the gaps G when the device 500 moves through the heart. This can allow the device 500 to move more easily within the heart. In addition, the gaps G allow the paddles to flex toward each other during contact with the native heart structures such as chordae tendineae and the anchor 508. This flexure can also allow the device 500 to move more easily through the heart. The device can also be configured so that opening or closing the paddles 520, 522 can cause the paddles to move toward each other. This movement of the paddles toward each other can also allow the device 500 to move more easily through the heart.

[0580] The total width TW of the anchor 508 can be between 4 mm and 20 mm, such as between 6 mm and 15 mm, such as between 8 mm and 12 mm, such as about 10 mm. The width W of each paddle 519 can be between 0.2 mm and 2 mm, such as between 0.3 mm and 1.5 mm, such as between 0.5 mm and 1 mm. Although each paddle 519 is shown as having the same width W, it should be understood that the width W of any paddle 519 may not be equal to the width W of the other paddles 519. The ratio of the total width TW to the width W can be between 5 / 1 and 20 / 1, such as between 7 / 1 and 15 / 1, such as about 10 / 1. The ratio of the total width to the sum of the widths W of the paddles 519 can be between about 2 / 1 and 15 / 1, such as between 3 / 1 and 10 / 1, such as about 4 / 1.

[0581] refer to Figures 74-79 , the length L of each inner blade 522 is between 6 mm and 18 mm, such as between 8 mm and 16 mm, such as between 10 mm and 14 mm, such as about 12 mm. Although each inner blade 522 is shown as having the same length L, it should be understood that the length L of any inner blade 522 may not be equal to the length L of the other inner blades (e.g., see Figures 63-68 ).

[0582] Figures 77-79 Shows Figures 74-76 An example of an implantable device or implant 500 is shown. In this example, the device 500 is connected to Figures 74-76The example shown is the same, except that each anchor 508 includes only a single fastener 530 attached to one of the plurality of blade members 519. In the example shown, the fastener 530 is aligned with one of the middle inner blade members 522 of each anchor 508, and the outer ones of the inner blade members 522 do not include a corresponding fastener. In some embodiments, each outer one of the blade members 519 may include a corresponding fastener 530, and the inner ones of the blade members 519 may not include a corresponding fastener. It should be understood that any number of the blade members 519 may include a corresponding fastener 530, and any number of the blade members 519 may not include a corresponding fastener 530.

[0583] Figures 80-82 Shows Figures 77-79 An exemplary embodiment of an implantable device or implant 500 is shown. In this example, the device / implant 500 and Figures 77-79 The example shown is the same, except that the length IL of the inner blade of the blade 519 of the anchor 508 is greater than the length OL of the outer blade of the blade 519. The length IL can be between 6 mm and 18 mm, such as between 8 mm and 16 mm, such as between 10 mm and 14 mm, such as about 12 mm. The length OL can be between 4 mm and 16 mm, such as between 6 mm and 14 mm, such as between 8 mm and 12 mm, such as about 10 mm. The ratio of the length IL to the length OL can be between 10 / 9 and 2 / 1, such as between 8 / 7 and 3 / 2, such as about 6 / 5.

[0584] Figures 83-85 Shows Figures 77-79 An exemplary embodiment of an implantable device or implant 500 is shown. In this example, the device 500 is coupled to Figures 77-79 The example shown is the same, except that the length IL of the inner blade member 522 of each anchor 508 is less than the length OL of the outer blade member 520. The length OL can be between 6 mm and 18 mm, such as between 8 mm and 16 mm, such as between 10 mm and 14 mm, such as about 12 mm. The length IL can be between 4 mm and 16 mm, such as between 6 mm and 14 mm, such as between 8 mm and 12 mm, such as about 10 mm. The ratio of the length OL to the length IL can be between 10 / 9 and 2 / 1, such as between 8 / 7 and 3 / 2, such as about 6 / 5.

[0585] Although Figures 80-85The illustrated example shows each anchor 508 having a single fastener 530 corresponding to the inner blade member 522, but it should be understood that each blade member 519 of the anchor 508 can include a corresponding fastener 530 (e.g., Figures 74-76 As shown), or any number of blade components 519 may include corresponding fasteners 530 and any number of blade components 519 may not include corresponding fasteners 530.

[0586] refer to Fig.86A , 87A 88-90, showing a device or implant 500 during various stages of deployment from a delivery system 502. The delivery system 502 can take any suitable form, for example, it can be the same or similar to other delivery systems described herein, such as 102, 202, 402, etc., and can include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations of these, etc. Although reference is made to Fig.86A , 87A and 88-90 show Figures 74-76 The example of the device or implant 500 is shown, but it should be understood that the deployment of the device / implant 500 from the delivery system 502 is also applicable to Figures 77-85 An example of a device / implant 500 is shown.

[0587] refer to Fig.86A , the device or implant 500 is shown in a compressed position within a delivery system 502. The apposition element 510 and the paddle member 519 are made of a compressible material that allows the device 500 to be in a compressed position when the device 500 is moved to a desired position within the patient's heart. When the device 500 is in the delivery system 502 and after the device 500 is deployed from the delivery system 502, the capture mechanism 513 is connected to the collar 511 of the device 500 until the device 500 is implanted on the native mitral valve MV (or other native heart valve).

[0588] Fig.87A 5. The device 500 is shown in a deployed and closed position. After the device 500 is deployed from the delivery system 502, the apposition elements 510 are expanded in the outward direction M, and the outer member 520 of each anchor 508 is pivoted outwardly in the direction N to its normal position, so that there is a gap G ( Fig.74 and 76 ).

[0589] Fig.86B Shown with Fig.86A , where the paddle member 519 is in an extended position within the delivery system 502. This allows for comparison with Fig.86AThe example compresses the device / implant 500 into a smaller size because the paddles are not disposed around the exterior of the apposition element 510. Fig.86B In the example shown (with Fig.86A Compared to the delivery system used in the example shown, a smaller delivery system 502 may be used to deliver the same sized device.

[0590] Fig.87B The device shown is removed from the delivery system 502. Fig.86B After the device / implant 500 is deployed from the delivery system 502, the apposition elements 510 are expanded in the outward direction M and the paddle members 519 remain in the extended state. Once out of the delivery system, the paddle members 519 can be closed (i.e., moved to the Fig.87A shown in the position).

[0591] An actuation element 512 (eg, an actuation wire, an actuation shaft, etc.) extends from the delivery system 502 to engage the cap 514 and move the paddle member 519 from the closed position to the open position. Fig.88 , the actuating element 512 moves to engage the cover 514 to move the cover 514 in the direction Y so that the paddle member 519 moves in the outward direction X to the open position (e.g., similar to the engagement between the actuating element 212 and the cover 214 to move Figure 22-37 The tension F applied to the clasp 530 by the corresponding actuation line 516 holds the clasp 530 in an open position relative to the paddle member 519 such that a tissue capture region exists between the paddle member 519 and the clasp 530.

[0592] refer to Fig.89 After the leaflet tissue is positioned in the tissue capture region between the fastener 530 and the paddle member 519, the fastener 530 moves in the direction Z to capture the device / implant 500 and secure it to the tissue. The fastener 530 can be biased in a closed position so that the fastener 530 releases the tension F from the actuation line 516 ( Fig.88 ) to move to the closed position, or the actuation line 516 can be actively controlled by the user to move the fastener 530 to the closed position.

[0593] refer to Fig.90After the device or implant 500 is secured to the leaflet tissue by the paddle member 519 and the fastener 530, the actuating element 512 moves the cover 514 back to its normal position in the direction D, so that the paddle member 519 moves to the closed position, and the actuating element 512 disengages from the cover 514 and moves back into the delivery system 502. After the device 500 is secured to the tissue and the anchor 508 is in the closed position, the capture mechanism 513 is removed from the collar 511, so that the device 500 is no longer attached to the delivery system 502, and the delivery system 502 can be removed from the patient.

[0594] refer to Figures 91-95 , implantable device or implant 600( Fig.94 ) includes an anchoring portion 606 having one or more paddle frames 624. The paddle frames 624 are configured to allow the device or implant 600 to be more easily moved to an implantation location in the heart by reducing contact and / or friction between native heart structures, such as chordae tendineae, and the device 600. That is, the paddle frames 624 are configured to move between an expanded position (when the device 600 is in a closed position) and a narrowed position (when the device 600 is in an open position), and when the paddle frames 624 are in the narrowed position, contact between the native heart structure and the device 600 is reduced. The device or implant 600 can include any other features of the implantable devices or implants discussed in this application or in the applications and patents incorporated herein by reference, and the device 600 can be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). In addition, any device / implant described herein can incorporate features of the device or implant 600.

[0595] refer to Fig.94 , the implantable device or implant 600 includes a commissure portion 604, a proximal or attachment portion 605, an anchoring portion 606, and a distal portion 607. The commissure portion 604, the attachment portion 605, and the distal portion may take any suitable form, such as Figure 22-37 The forms of these parts of the device 200 shown, or any other forms described in this application. In some embodiments, the apposition portion 604 optionally includes an apposition element 610 (e.g., a spacer, a coaptation element, a gap filler, etc.) that can be implanted, for example, between the leaflets 20, 22 of the native mitral valve MV. The apposition element 610 and the like can take any suitable form, such as any form described in this application.

[0596] Attachment portion 605 includes a connector for use with a delivery sheath or system (e.g., Figure 38-49 The delivery system 202 shown) has a capture mechanism (e.g., Figure 44-49213) is engaged with a first or proximal collar 611. The proximal collar 611 can take any suitable form, such as any form described in this application.

[0597] The distal portion 607 includes a cover 614 that is attached to the anchor 608 of the anchor portion 606 such that movement of the cover 614 causes the anchor 608 to move between an open position and a closed position. The cover 614 can take any suitable form, such as any form described in this application. The cover 614 can be moved by extending and retracting an actuation element 612, such as an actuation wire, an actuation shaft, etc. (e.g., as described in this application with respect to Figure 22-37 200 and actuating element 212 as shown).

[0598] The anchoring portion 606 of the device 600 may take any suitable form, such as Figure 22-37 The anchor portion 206 of the device 200 shown is of a form (except that the blade frame 224 is Figures 91-95 The anchor portion 606 may include a plurality of anchors 608, each anchor 608 including an outer blade 620, an inner blade 622, a blade extension member or blade frame 624, and a fastener (e.g., Figure 22-37 Fastener 230 shown).

[0599] Outer paddle 620 is engageably attached to inner paddle 622 and to cover 614 of distal portion 607 via connecting portion 623, and inner paddle 622 is engageably attached to apposition element 610. In this manner, anchor 608 is configured to resemble a leg, as inner paddle 622 resembles an upper portion of a leg, outer paddle 620 resembles a lower portion of a leg, and connecting portion 623 resembles a knee portion of a leg.

[0600] The blade frame 624 has a first connecting member 601 ( Fig.91 and 95 ) for attaching the paddle frame 624 to the cover 614 at the distal portion 607 so that the paddle frame 624 is fixedly connected to the cover 614. The connecting member 601 can be, for example, a cutout that mates with a corresponding cutout in the cover. The paddle frame 624 has one or more second connecting members 603 ( Fig.91 and 95), which is connected to the connecting portion 623 between the inner blade 622 and the outer blade 620, so that the blade frame 624 is fixedly connected to the anchor 608. The connecting member 603 can be, for example, an eyelet that allows the blade frame 624 to be sewn to the cover, which is also sewn to the inner blade 622 and the outer blade 620. In some embodiments, the blade frame 624 is formed of a material that is more rigid and harder than the material from which the blades 622, 620 are formed, so that the blade frame 624 provides support for the blades 622, 620.

[0601] Paddle frame 624 provides additional clamping force between inner paddle 622 and mating element 610. Paddle frame helps wrap the leaflets around the sides of mating element 610 to achieve a better seal between mating element 610 and the leaflets. That is, paddle frame 624 can be configured to have a circular three-dimensional shape with a connection portion 623 extending from cover 614 to anchor 608. The connection between paddle frame 624, outer paddle 620 and inner paddle 622, cover 614, and mating element 610 can constrain the movement of each of these components (e.g., constrain to a reference Figure 22-37 In particular, connecting portion 623 is constrained by its connection between outer blade 620 and inner blade 622 and by its connection to blade frame 624. Similarly, blade frame 624 is constrained by its attachment to connecting portion 623 (and thus inner blade 622 and outer blade 620) and cover 614.

[0602] Constructing the paddle frame 624 in this manner provides an increased surface area compared to the separate inner paddles 622. This can, for example, make it easier to grasp and secure the native leaflets. The increased surface area can also distribute the clamping force of the paddle 620 and the paddle frame 624 on the native leaflets over a relatively larger surface of the native leaflets to further protect the native leaflet tissue. In some embodiments, the increased surface area of ​​the paddle frame 624 can also allow the native leaflets to be clamped to the implantable device or implant 200 so that the native leaflets are fully apposed around the apposition element 610. This can, for example, improve the sealing of the native leaflets and thereby prevent or further reduce valve regurgitation.

[0603] The blade frame 624 is configured to be in the deployed position (e.g., Fig.91 ) and the narrowing position (e.g. Fig.92 and 95When in the deployed position, paddle frame 624 has an increased surface area, which provides the above-mentioned advantages for securing device 600 to a native heart valve. When in the narrowed position, paddle frame 624 has a reduced width relative to the paddle frame in the deployed position, which allows device 600 to be more easily moved to an implantation location in the heart by reducing contact and / or friction between native heart structures such as chordae tendineae and device 600. Movement of anchor 608 between the open position and the closed position causes paddle frame 624 to move between the deployed position and the narrowed position.

[0604] In the example shown, an actuation element 612 (e.g., an actuation wire, an actuation shaft, etc.) extends from a delivery system (e.g., any of the delivery systems described herein) and engages a cover 614 to move the cover 614 relative to the engagement element or spacer 610 in a direction Y to enable actuation of the device 600. The actuation element 612 may engage and move the cover by any suitable means, such as any of the means provided herein. Movement of the cover 614 away from the engagement element 610 moves the anchor 608 to an open position (e.g., Fig.94 ), and movement of the engaging element 610 toward the engaging element 610 moves the anchor to the closed position.

[0605] The configuration of paddle frame 624 and the connection of paddle frame 624 to cover 614 and connection portion 623 of anchor 608 is such that paddle frame 624 is in an extended position when anchor 608 is in a closed position, and is in a narrowed position when anchor 608 is in an open position. Fig.91 , the movement of anchor 608 to the open position generates a tension F on paddle frame 624 because cover 614 is moved in direction Y ( Fig.94 ) moves away from the mating element 610, and the blade frame 624 is fixedly connected to the connecting portion 623 of the cover 614 and the anchor member 608.

[0606] refer to Fig.91 and 92 , blade frame 624 has a width W and a thickness T that is greater than the width W. When a tension F is applied to blade frame 624, the thickness T being greater than the width W increases the degree to which blade frame 624 is compressed in direction X. This is because the stiffness of the blade frame in the direction of width W is less than the stiffness in the direction of thickness T. In some embodiments, the ratio of thickness T to width W is between 10 / 9 and 3 / 1, such as between 5 / 4 and 2 / 1, such as between 4 / 3 and 3 / 2.

[0607] refer to Fig.95, when in the narrowed position, the paddle frame 624 has a length L2 and an overall width W2. The length L2 may be between 9 mm and 21 mm, such as between 12 mm and 18 mm, such as about 15 mm. The width W2 may be between 3 mm and 12 mm, such as between 5 mm and 10 mm, such as between 7 mm and 9 mm, such as about 8 mm. The ratio of the overall width (not shown) of the paddle frame 624 in the deployed position to the overall width W2 may be between 10 / 9 and 3 / 1, such as between 5 / 4 and 2 / 1, such as between 4 / 3 and 3 / 2. The ratio of the length (not shown) of the paddle frame 624 in the deployed position to the length L2 of the paddle frame 624 may be between 10 / 9 and 3 / 1, such as between 5 / 4 and 2 / 1, such as between 4 / 3 and 3 / 2.

[0608] refer to Fig.93 , paddle frame 624 is shown in a compressed position within delivery system 602. Delivery system 602 can take any suitable form, for example, it can be the same or similar to other delivery systems described herein, such as 102, 202, 402, 502, etc., and can include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a path, a combination of these, etc. The configuration of paddle frame 624 allows the paddle frame to more easily maintain a compressed position within delivery system 602. That is, the thickness T ( Fig.91 ) is greater than its width W( Fig.91 ) allows the blade frame 624 to be compressed more easily because the stiffness of the blade frame in the direction of width W is less than the stiffness in the direction of thickness T.

[0609] refer to Figures 96-98 , 101 and 104, implantable devices or implants (e.g., Figure 22-37 The device 200 shown, Fig.94 An example of a paddle frame 724 of the device 600 shown in the figure or any other suitable device) includes a main support section 785, a first connecting member 701 for attaching to a cover of an implantable device or implant, a second connecting member 703 for attaching to an anchor of the device, and a transition portion 771 extending between the first connecting member 701 and the main support section 785. The paddle frame 724 can be attached to the connecting portion and cover of the anchor by any suitable means, such as any of the means described in the present application. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (such as Figures 91-95 as shown), or the width may be greater than the thickness.

[0610] Connecting member 701 of paddle frame 724 includes extension portion 773 configured to extend into the cover of an implantable device or implant to connect paddle frame 724 to the cover. In this example, outer surface 775 of main support section 785, outer surface 777 of transition portion 771, and outer surface 779 of connecting member 701 are generally aligned so that each of these outer surfaces faces the same direction Z ( Fig.104 ).

[0611] refer to Fig.98 , the paddle frame 724 is shown in a closed position relative to the apposition element or spacer 710 of the implantable device or implant. Fig.101 and 104 , the blade frame is shown in an open position relative to the engagement element 710. The engagement element 710 may take any suitable form, such as any of the forms described in this application.

[0612] refer to Fig.99 and 102 and 105, an implantable device or implant (e.g., Figure 22-37 The device 200 shown, Fig.94 An example of a paddle frame 824 of the device 600 shown in FIG. 6 or any other suitable device) includes a main support section 885, a first connecting member 801 for attachment to an implantable device or a cover of an implant, a second connecting member (e.g., Fig.91 803 as shown), and a transition portion 871 extending between the first connecting member 801 and the main support section 885. The blade frame 824 can be attached to the connecting portion and cover of the anchor member by any suitable means, such as any means described in this application. The thickness and width of the blade frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (such as Figures 91-95 as shown), or the width may be greater than the thickness.

[0613] Connecting member 801 of paddle frame 824 includes extension portion 873 configured to extend into the cap of an implantable device or implant to connect paddle frame 824 to the cap. In this example, outer surface 879 of connecting member 801 is disposed at an angle of approximately 45 degrees to outer surface 875 of main support section 885, such that transition portion 871 is twisted about its axis.

[0614] The blade frame can be used Fig.99 and 102 In some embodiments, the blade frame can be shaped as Fig.96 , 98 and 101, the connecting member 801 can be twisted to Fig.99 and 102 In some embodiments, the blade frame 824 can be shaped such that the connecting member 801 is set at Fig.99 and 102 position shown, but twisted back by connecting to the cover Fig.96 , 98 and the location shown in 101.

[0615] refer to Fig.99 , the paddle frame 724 is shown in a closed position relative to the apposition element or spacer 810 of the implantable device or implant. Fig.102 and 105 , the blade frame is shown in an open position relative to the engagement element 810. The engagement element 810 may take any suitable form, such as any form described in this application.

[0616] The angle between the outer surface 879 of the connecting member 801 and the outer surface 875 of the main support section 885 (and the corresponding twisted transition portion 871) is such that when the paddle frame moves from the closed position to the open position, the torque and resulting stress in the material of the paddle frame 824 increases. This torque and resulting stress increase in the material of the paddle frame is due to the paddle frame being fixedly connected to the inner and outer paddles (at the transition between the two) and the cover of the implantable device or implant. As the cover pulls the outer paddle, the twist of the transition portion 871 stretches along the length of the paddle frame. Therefore, when the cover pulls the paddle to the open position, the paddle frame 824 is narrower than a paddle frame that does not include the twisted translation portion 871. This additional reduction in the width of the paddle frame allows the implantable device or implant to be more easily moved to an implantation position in the heart by reducing contact and / or friction between native heart structures such as chordae tendineae and the device.

[0617] Although the illustrated example shows outer surface 879 being disposed at an angle of approximately 45 degrees relative to outer surface 875, it should be understood that outer surface 879 can be disposed at any other suitable angle relative to outer surface 875 such that when the blade frame moves from a closed position to an open position, the blade frame twists and moves to a narrower position (compared to a blade frame without a twisting translation portion).

[0618] Generally speaking, more twist results in more torque, stress, and blade narrowing. Fig.100 , 103 In 106, the example of blade frame 924 has a 90 degree twist. Fig.100 , 103 In the example shown in 106, an implantable device or implant (e.g., Figure 22-37The device 200 shown, Fig.94 The device 600 shown, or any other suitable device, comprises a main support section 985, a first connecting member 901 for attachment to an implantable device or a cover of an implant, a second connecting member (e.g., Fig.91 903) and a transition portion 971 extending between the first connecting member 901 and the main support section 985. The blade frame 924 can be attached to the connecting portion and cover of the anchor member by any suitable means, such as any means described in this application. The thickness and width of the blade frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (such as Figures 91-95 as shown), or the width may be greater than the thickness.

[0619] Connecting member 901 of paddle frame 924 includes extension portion 973 configured to extend into the cap of an implantable device or implant to connect paddle frame 924 to the cap. In this example, outer surface 979 of connecting member 901 is disposed at an angle of approximately 90 degrees to outer surface 975 of main support section 985, such that transition portion 971 is twisted about its axis.

[0620] The blade frame can be used Fig.100 and 103 In some embodiments, the blade frame can be shaped as Fig.96 , 98 and 101, the connecting member 901 can be twisted to Fig.100 and 103 In some embodiments, the blade frame 924 can be shaped such that the connecting member 901 is set at Fig.100 and 103 position shown, but twisted back by connecting to the cover Fig.96 , 98 and the location shown in 101.

[0621] refer to Fig.100 , the paddle frame 924 is shown in a closed position relative to the apposition element or spacer 910 of the implantable device or implant. Fig.103 and 106 , the blade frame is shown in an open position relative to the engagement element 910. The engagement element 910 may take any suitable form, such as any of the forms described in this application.

[0622] The angle between the outer surface 979 of the connecting member 901 and the outer surface 975 of the main support section 985 (and the corresponding twisted transition portion 971) is such that when the paddle frame moves from the closed position to the open position, the torque and resulting stress in the material of the paddle frame 924 increases. This torque and resulting stress increase in the material of the paddle frame is due to the paddle frame being fixedly connected to the inner and outer paddles (at the transition between the two) and the cover of the implantable device or implant. As the cover pulls the outer paddle, the twist of the transition portion 971 stretches along the length of the paddle frame. Therefore, when the cover pulls the paddle to the open position, the paddle frame 924 is narrower than a paddle frame that does not include the twisted translation portion 971. This additional reduction in the width of the paddle frame allows the implantable device or implant to be more easily moved to an implantation position in the heart by reducing contact and / or friction between native heart structures such as chordae tendineae and the device.

[0623] refer to Fig.107 and 108 , an implantable device or implant (e.g., Figure 22-37 The device 200 shown, Fig.94 An example of a paddle frame 1024 of the device 600 shown in the figure or any other suitable device) includes a main support section 1085, a first connecting member 1001 for attaching to a cover of an implantable device or implant, and a second connecting member 1003 for attaching to an anchor of the device. The paddle frame 1024 can be attached to the connecting portion and cover of the anchor by any suitable means, such as any of the means described in this application. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (such as Figures 91-95 as shown), or the width may be greater than the thickness.

[0624] Main support section 1085 includes inner portion 1072 and outer portion 1074. Inner portion 1072 is connected to connecting members 1001, 1003 at connection points 1076, 1078, respectively. Inner portion 1072 is configured to allow paddle frame 1024 to be moved from a normal deployed position ( Fig.107 ) moves to a narrowed position when the anchor of the device moves to an open position ( Fig.108 ). Outer portion 1074 is connected to inner portion at connection point 1080, and outer portion 104 defines the overall width of blade frame 1024 (eg, Fig.107 The expanded width EW and Fig.108 The narrowed width NW is shown).

[0625] In the example shown, the inner portion 1072 of the main support section 1085 is diamond-shaped. Fig.108, when the anchor of the implantable device or implant is moved to the open position, paddle frame 1024 experiences a tension force F because paddle frame 1024 is fixedly connected to the cover and the transition between the inner and outer paddles of the device. This tension force F on paddle frame 1024 causes connection points 1076, 1078 to move in the outward direction OD, which causes connection point 1080 to move in the inward direction ID. The movement of connection point 1080 in the inward direction ID causes outer portion 1074 to move in the inward direction ID, such that the overall width of paddle frame 1024 increases from the deployed width EW ( Fig.107 ) moves to the narrow width NW( Fig.108 ). Movement of paddle frame 1024 to the narrowed position allows an implantable device or implant to be more easily moved to an implantation site in the heart by reducing contact and / or friction between native heart structures, such as chordae tendineae, and the device.

[0626] The expanded width EW of the blade frame 1024 may be between 5 mm and 15 mm, for example, between 7 mm and 12 mm, for example, between 9 mm and 11 mm, for example, about 10 mm. The narrowed width NW of the blade frame 1024 may be between 3 mm and 12 mm, for example, between 5 mm and 10 mm, for example, between 7 mm and 9 mm, for example, about 8 mm. The ratio of the expanded width EW to the narrowed width NW may be between 10 / 9 and 3 / 1, for example, between 5 / 4 and 2 / 1, for example, between 4 / 3 and 3 / 2.

[0627] Although the illustrated example shows the inner portion 1072 of the main support section 1085 as being diamond-shaped, it should be understood that the inner portion 1072 can take any form that allows the paddle frame 1024 to move to a narrowed position when a tension F is applied to the paddle frame 1024 so that the paddle frame can allow the implantable device or implant to be more easily moved to an implantation position in the heart.

[0628] refer to Fig.109 and 110 , an implantable device or implant (e.g., Figure 22-37 The device 200 shown, Fig.94 An example of a paddle frame 1124 of the device 600 shown in the figure or any other suitable device) includes a main support section 1185, a first connecting member 1101 for attaching to a cover of an implantable device or implant, and a second connecting member 1103 for attaching to an anchor of the device. The paddle frame 1124 can be attached to the connecting portion and cover of the anchor by any suitable means, such as any of the means described in the present application. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (such as Figures 91-95 as shown), or the width may be greater than the thickness.

[0629] Main support section 1185 includes inner portion 1172 and outer portion 1174. Inner portion 1172 is connected to connection member 1103 at connection point 1178. Outer portion 1174 is connected to inner portion 1172 at connection point 1180, and outer portion 1174 extends to connection member 1101. Outer portion 1174 defines the overall width of blade frame 1124 (e.g., Fig.109 The expanded width EW and Fig.110 The inner portion 1172 is configured to allow the paddle frame 1124 to be extended from a normal expanded position (NW) when the implantable device or implant anchor is in a closed position. Fig.109 ) moves to a narrowed position when the anchor of the device moves to an open position ( Fig.110 ).

[0630] In the example shown, the inner portion 1172 of the main support section 1185 includes arms 1182 that extend inwardly from the connection point 1180 and meet at the connection point 1178, so that the inner portion 1172 has a triangular shape. Fig.110 , when the anchor of the implantable device or implant is moved to the open position, paddle frame 1124 experiences a tension force F because paddle frame 1124 is fixedly connected to the cover and the transition between the inner and outer paddles of the device. This tension force F on paddle frame 1124 causes connection point 1178 and connecting member 1101 to move in the outward direction OD, which causes connection point 1080 to move in the inward direction ID. The movement of connection point 1080 in the inward direction ID causes outer portion 1174 to move in the inward direction ID, such that the overall width of paddle frame 1124 increases from the deployed width EW ( Fig.109 ) moves to the narrow width NW( Fig.110 ). Movement of paddle frame 1124 to the narrowed position allows an implantable device or implant to be more easily moved to an implantation site in the heart by reducing contact and / or friction between native heart structures, such as chordae tendineae, and the device.

[0631] The expanded width EW of blade frame 1124 blade frame 1024 may be between 5 mm and 15 mm, for example between 7 mm and 12 mm, for example between 9 mm and 11 mm, for example about 10 mm. The narrowed width NW of blade frame 1124 may be between 3 mm and 12 mm, for example between 5 mm and 10 mm, for example between 7 mm and 9 mm, for example about 8 mm. The ratio of the expanded width EW to the narrowed width NW may be between 10 / 9 and 3 / 1, for example between 5 / 4 and 2 / 1, for example between 4 / 3 and 3 / 2.

[0632] Although the illustrated example shows the inner portion 1172 of the main support section 1185 having arms 1182 extending inwardly from connection point 1180 and connecting at connection point 1178 so that the inner portion 1172 has a triangular shape, it should be understood that the inner portion 1072 can take any form that allows the paddle frame 1124 to move to a narrowed position when tension F is applied to the paddle frame 1124 so that the paddle frame can allow the implantable device or implant to be more easily moved to an implantation position in the heart.

[0633] In the example shown, the inner portion 1172 of the main support section 1185 includes arms 1182 that extend inwardly from the connection point 1180 and meet at the connection point 1178, so that the inner portion 1172 has a triangular shape. Fig.110 , when the anchor of the implantable device or implant is moved to the open position, paddle frame 1124 experiences a tension F because paddle frame 1124 is fixedly connected to the cover and anchor of the device. This tension F on paddle frame 1124 causes connection point 1178 and connecting member 1101 to move in the outward direction OD, which causes connection point 1180 to move in the inward direction ID. The movement of connection point 1180 in the inward direction ID causes outer portion 1174 to move in the inward direction ID, such that the overall width of paddle frame 1124 increases from the deployed width EW ( Fig.109 ) moves to the narrow width NW( Fig.110 ). Movement of paddle frame 1124 to the narrowed position allows an implantable device or implant to be more easily moved to an implantation site in the heart by reducing contact and / or friction between native heart structures, such as chordae tendineae, and the device.

[0634] Although the illustrated example shows the inner portion 1172 of the main support section 1185 having arms 1182 extending inwardly from connection point 1180 and connecting at connection point 1178 so that the inner portion 1172 has a triangular shape, it should be understood that the inner portion 1172 can take any form that allows the paddle frame 1124 to move to a narrowed position when tension F is applied to the paddle frame 1124 so that the paddle frame can allow the implantable device or implant to be more easily moved to an implantation position in the heart.

[0635] refer to Fig.111 , an implantable device or implant (e.g., Figure 22-37 The device 200 shown, Fig.94An example of a paddle frame 1224 of the device 600 shown in the figure or any other suitable device) includes a main support section 1285, a first connecting member 1201 for attaching to a cover of an implantable device or implant, and a second connecting member 1203 for attaching to an anchor of the device. The paddle frame 1224 can be attached to the connecting portion and cover of the anchor by any suitable means, such as any of the means described in this application. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (such as Figures 91-95 as shown), or the width may be greater than the thickness.

[0636] Main support section 1285 includes inner portion 1272 and outer portion 1274. Inner portion 1272 is connected to connection member 1203 at connection point 1278. Outer portion 1274 is connected to inner portion 1272 at connection point 1280, and outer portion 1274 extends to connection member 1201. Outer portion 1274 defines an overall width TW of paddle frame 1224. Inner portion 1272 is configured so that paddle frame 1224 can be extended from a normal deployed position (TW) when the anchor of the implantable device or implant is in a closed position. Fig.111 ) moves to a narrowed position when the anchor of the device moves to an open position.

[0637] In the example shown, inner portion 1272 of main support section 1185 includes arms 1282 and rounded members 1284. Arms 1282 extend inwardly from connection point 1280, and rounded members 1284 are connected to each arm 1282 and to connection point 1278. When the anchor of the implantable device or implant is moved to the open position, paddle frame 1224 experiences tension (e.g., Fig.108 and 110 1200. The present invention relates to a device that is implanted in the heart and has a plurality of implants that are implanted in the heart. The present invention relates to a device that is implanted in the heart and has a plurality of implants that are implanted in the heart and have ...

[0638] When in the normal deployed position, the total width TW of blade frame 1224 can be between 5 mm and 15 mm, such as between 7 mm and 12 mm, such as between 9 mm and 11 mm, such as about 10 mm. The narrowed width of blade frame 1124 can be between 3 mm and 12 mm, such as between 5 mm and 10 mm, such as between 7 mm and 9 mm, such as about 8 mm. The ratio of the total width TW to the narrowed width can be between 10 / 9 and 3 / 1, such as between 5 / 4 and 2 / 1, such as between 4 / 3 and 3 / 2.

[0639] While the illustrated example shows inner portion 1272 of main support section 1285 having arms 1282 extending inward from connection point 1280 and connected to rounded member 1284 connected to connection point 1278, it will be understood that inner portion 1272 may take any form that allows paddle frame 1224 to move to a narrowed position when tension F is applied to paddle frame 1224 so that the paddle frame may allow an implantable device or implant to be more easily moved to an implantation position in the heart.

[0640] refer to Figures 112-114 , an implantable device or implant (e.g., Figure 22-37 The device 200 shown, Fig.94 An example of a paddle frame 1324 of the device 600 shown in the figure or any other suitable device) includes a main support section 1385, a first connecting member 1301 for attaching to a cover of an implantable device or implant, and a second connecting member 1303 for attaching to an anchor of the device. The paddle frame 1324 can be attached to the connecting portion and cover of the anchor by any suitable means, such as any of the means described in the present application. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (such as Figures 91-95 as shown), or the width may be greater than the thickness.

[0641] Main support section 1385 includes inner portion 1372 and outer portion 1374. Inner portion 1372 is connected to connecting member 1303 at connection point 1378. Outer portion 1374 is connected to inner portion 1372 at connection point 1380, and outer portion 1374 extends to connecting member 1301. Outer portion 1374 defines an overall width TW of paddle frame 1324. Inner portion 1372 is configured so that paddle frame 1324 can be extended from a normal deployed position (TW) when the anchor of the implantable device or implant is in a closed position. Figures 112-114 ) moves to a narrowed position when the anchor of the device moves to an open position.

[0642] In the example shown, the inner portion 1372 of the main support section 1385 includes arms 1382 and rounded members 1384. The arms 1382 extend inwardly from the connection point 1380, and the rounded members 1384 are connected to each arm 1382 and to the connection point 1378. Figures 112-114 The configuration of the blade frame 1324 shown is similar, except that the connection point 1380 between the inner portion 1372 and the outer portion 1374 of the blade frame 1324 is disposed at a different location than the connection member 1301 in each of these configurations. Fig.112 The connection point 1380 of the structure of the blade frame 1324 is shown as Fig.113 The blade frame is shown in a configuration further away from the connecting member 1301, and Fig.113 The connection point 1380 of the structure of the blade frame 1324 is shown as Fig.114 The blade frame configuration shown is further away from the connecting member 1301. For each of these configurations, these different configurations cause the width Z between the connection points 1380 to be different. For example, Fig.112 The blade 1324 is shown in a configuration where the width Z is greater than Fig.113 The blade 1324 is shown as having a width Z, and Fig.113 The blade 1324 is shown in a configuration where the width Z is greater than Fig.114 The blade 1324 is shown having a width Z of the configuration.

[0643] When the anchor of the implantable device or implant is moved to the open position, the paddle frame 1324 experiences tension (e.g., Fig.108 and 110 1301. The present invention relates to a device that is implanted in the heart and has a plurality of implants that are implanted in the heart. The present invention relates to a device that is implanted in the heart and has a plurality of implants that are implanted in the heart and have ...

[0644] When in the normal deployed position, the total width TW of blade frame 1324 can be between 5 mm and 15 mm, such as between 7 mm and 12 mm, such as between 9 mm and 11 mm, such as about 10 mm. The narrowed width of blade frame 1124 can be between 3 mm and 12 mm, such as between 5 mm and 10 mm, such as between 7 mm and 9 mm, such as about 8 mm. The ratio of the total width TW to the narrowed width can be between 10 / 9 and 3 / 1, such as between 5 / 4 and 2 / 1, such as between 4 / 3 and 3 / 2.

[0645] While the illustrated example shows the inner portion 1372 of the main support section 1385 having an arm 1382 extending inwardly from the connection point 1380 and connected to a rounded member 1384 connected to the connection point 1378, it will be understood that the inner portion 1372 can take any form that allows the paddle frame 1324 to move to a narrowed position when a tension force F is applied to the paddle frame 1324 so that the paddle frame can allow an implantable device or implant to be more easily moved to an implantation position in the heart.

[0646] refer to Figures 115-116 , an implantable device or implant (e.g., Figure 22-37 The device 200 shown, Fig.94 An example of a paddle frame 1424 of the device 600 shown in the figure or any other suitable device) includes a main support section 1485, a first connecting member 1401 for attaching to a cover of an implantable device or implant, and a second connecting member 1403 for attaching to an anchor of the device. The paddle frame 1424 can be attached to the connecting portion and cover of the anchor by any suitable means, such as any of the means described in this application. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (such as Figures 91-95 as shown), or the width may be greater than the thickness.

[0647] Main support section 1485 includes inner portion 1472 and outer portion 1474. Inner portion 1472 of main support section 1485 includes arm 1482 extending inwardly from connection point 1480 and connected to connection point 1478. Outer portion 1474 is connected to inner portion 1472 at connection point 1480 and is connected to connection point 1478 by biasing member 1484, and outer portion 1474 extends to connection member 1401. Biasing member 1484 bends at least a portion of outer portion 1474 so that the blade has curved side edge 1486 ( Fig.16). Curved side edge 1486 can be configured to be formed against the outer shape of a spacer or mate element (e.g., any mate element described in the present application) of an implantable device or implant. Biasing member 1484 can be, for example, a spring member, or any other member that enables paddle frame 1424 to have curved side edge 1486.

[0648] Outer portion 1474 defines an overall width TW of paddle frame 1424. Inner portion 1472 and biasing member 1484 are configured to allow paddle frame 1424 to be extended from a normally deployed position (TW) when the anchor of the implantable device or implant is in a closed position. Figures 115-116 ) moves to a narrowed position when the anchor of the device moves to an open position.

[0649] When the anchor of the implantable device or implant is moved to the open position, the paddle frame 1424 experiences tension (e.g., Fig.108 and 110 1402 is a substantially parallel relationship between the outer and inner blades of the device. The outer and inner blades of the device are substantially parallel to each other in the direction of the outer blades of the device. The outer and inner blades of the device are substantially parallel to each other in the direction of the outer blades of the device. The outer and inner blades of the device are substantially parallel to each other in the direction of the outer blades of the device. The outer and inner blades of the device are substantially parallel to each other in the direction of the outer blades of the device. The outer and inner blades of the device are substantially parallel to each other in the direction of the outer blades of the device. The outer and inner blades of the device are substantially parallel to each other in the direction of the outer blades of the device. The outer and inner blades of the device are substantially parallel to each other in the direction of the outer blades of the device. Fig.116 ) so that the overall width TW of paddle frame 1424 moves to a narrowed position. Movement of paddle frame 1424 to a narrowed position allows an implantable device or implant to be more easily moved to an implantation position in the heart by reducing contact and / or friction between native heart structures, such as chordae tendineae, and the device.

[0650] When in the normal deployed position, the total width TW of blade frame 1424 can be between 5 mm and 15 mm, such as between 7 mm and 12 mm, such as between 9 mm and 11 mm, such as about 10 mm. The narrowed width of blade frame 1124 can be between 3 mm and 12 mm, such as between 5 mm and 10 mm, such as between 7 mm and 9 mm, such as about 8 mm. The ratio of the deployed width TW to the narrowed width can be between 10 / 9 and 3 / 1, such as between 5 / 4 and 2 / 1, such as between 4 / 3 and 3 / 2.

[0651] In some embodiments, the biasing member 1484 can be passive to allow the anchors of the implantable device or implant to open more when needed, as well as to work with the movement of the leaflets and aid in coaptation when the implantable device or implant is attached to the native heart valve leaflets.

[0652] While the illustrated example shows inner portion 1472 of main support section 1485 having arms 1482 extending inwardly from connection point 1480 and connected to connection point 1478, it should be understood that inner portion 1472 can take any form that allows paddle frame 1424 to move to a narrowed position when tension F is applied to paddle frame 1424 so that the paddle frame can allow an implantable device or implant to be more easily moved to an implantation position in the heart.

[0653] refer to Figures 117-121 , an example of an implantable device or implant 1500 includes an anchoring portion 1506 having one or more paddle frames 1524. Paddle frames 1524 are configured to allow the device 1500 to be more easily moved to an implantation location in the heart by reducing contact and / or friction between native heart structures, such as chordae tendineae, and the device 1500. That is, paddle frames 1524 are configured to move between an expanded position (when the device 1500 is in a closed position) and a narrowed position (when the device 1500 is in an open position), and / or the paddle frames may include a flexible outer portion that flexes inwardly to reduce the width of the paddles when the flexible outer portion contacts native heart structures, such as chordae tendineae.

[0654] When the paddle frame 1524 is in the narrowed position, friction between the native heart structure and the device 1500 is reduced. The device 1500 can include any other features of the implantable devices or implants discussed in this application or in the applications and patents incorporated herein by reference, and the device 1500 can be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). In addition, any device described herein can incorporate the features of the device 1500.

[0655] The implantable device or implant 1500 includes a commissure portion 1504, a proximal or attachment portion 1505, an anchoring portion 1506, and a distal portion 1507. The commissure portion 1504, the attachment portion 1505, and the distal portion 1507 may take any suitable form, such as Figure 22-37The forms of these parts of the device 200 shown, or any other forms described in this application. In some embodiments, the apposition portion 1504 optionally includes an apposition element 1510 (e.g., a spacer, a coupling element, a gap filler, etc.) that can be used, for example, to implant between the leaflets 20, 22 of the native mitral valve MV. The apposition element 1510, etc. can take any suitable form, such as any form described in this application. In the example shown, the apposition element is made of a woven wire.

[0656] Attachment portion 1505 includes a connector for use with a delivery system (e.g., Fig.86A , 87A , 88 and 89 of the delivery system 502) capture mechanism 1513 ( Fig.119 ) is engaged with a first or proximal collar 1511. The proximal collar 1511 can take any suitable form, such as any form described in this application. The capture mechanism 1513 can take any suitable form, such as any form described in this application.

[0657] The distal portion 1507 includes a cover 1514 that is attached to the anchor 1508 of the anchor portion 1506 so that movement of the cover 1514 causes the anchor 1508 to move between an open position and a closed position. The cover 1514 can take any suitable form, such as any form described in this application. In the example shown, an actuation element 1512 (e.g., an actuation wire, an actuation shaft, etc.) extends from a delivery system (e.g., any delivery system described in this application) and engages the cover 1514 to move the cover 1514 relative to the apposition element or spacer 1510 to enable actuation of the device 1500. The actuation element 1512 can engage and move the cover by any suitable means, such as any means provided in this application.

[0658] The anchoring portion 1506 of the device 1500 may take any suitable form, such as Figure 22-37 The anchor portion 206 of the device 200 shown is of a form (except that the blade frame 224 is Figures 91-95 1524, or any other form described herein that may incorporate blade frame 1524. Anchor portion 1506 may include a plurality of anchors 1508, each anchor 1508 including an outer blade 1520, an inner blade 1522, a blade extension member or blade frame 1524, and a fastener 1530.

[0659] Paddle frame 1524 includes a main support section 1585, a first connection member for attachment to an implantable device or a cover of an implant (eg, Figures 91-95The connecting member 601 shown or any other connecting member described in this application), and a second connecting member ( Figures 91-95 The blade frame 1524 can be attached to the connecting portion and cover of the anchor member by any suitable means, such as any means described in this application. The thickness and width of the blade frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (such as Figures 91-95 as shown), or the width may be greater than the thickness.

[0660] The main support section 1585 includes a rigid inner portion 1572 and a flexible outer portion 1574. The rigid inner portion 1572 has a first end 1581 connected to the cover 1514 and a second end 1583 connected to the anchor 1508. Fig.120 and 121 The rigid inner portion is configured to support the paddles 1520, 1522 of the anchor and provide sufficient force to promote the apposition of the native leaflets 20, 22 to the apposition element 1510 when the anchor 1508 is in the closed position. The rigid inner portion 1572 can be made of, for example, metal, plastic, etc.

[0661] Reference again Figures 117-121 , flexible outer portion 1574 is connected to the rigid inner portion and defines the overall width of paddle frame 1524. That is, flexible outer portion 1574 has a greater overall width than rigid inner portion 1572. Flexible outer portion 1574 is configured so that forces (e.g., forces from flexible outer portion 1574 contacting chordae tendineae during implantation of device 1500) cause flexible outer portion 1574 to flex and allow device 1500 to be more easily moved to an implantation position in the heart. Reference Fig.120 and 121 When anchor 1508 is in the closed position and the leaflets are in coaptation with coaptation element 1510, flexible outer portion 1574 maintains its normal overall width to provide a greater surface area for contacting the leaflets (relative to rigid inner portion 1572), thereby holding the leaflets against coaptation element 1510. Flexible outer portion 1574 can be made of, for example, metal and plastic.

[0662] The total width of the flexible outer portion 1574 can be between 5 mm and 15 mm, such as between 7 mm and 12 mm, such as between 9 mm and 11 mm, such as about 10 mm. The width of the inner portion 1572 can be between 2 mm and 8 mm, such as between 4 mm and 6 mm, such as about 5 mm.

[0663] In some embodiments, the flexible outer portion 1574 is shaped inwardly so that the overall width of the outer portion 1574 is narrowed when the anchor 1508 is in the open position, and so that the outer portion moves back to its normal overall width when the anchor 1508 is moved to the closed position.

[0664] Although the illustrated example shows a rigid inner portion 1572 and a flexible outer portion 1574 having a rounded shape, it should be understood that the inner portion 1572 and the outer portion 1574 can take any form that allows the device 1500 to be more easily moved to an implantation location in the heart while providing sufficient support to promote apposition of the leaflets of the native heart valve against the apposition element 1510.

[0665] refer to Figures 122-124 , an exemplary embodiment of an implantable device or implant 1600 includes an apposition portion 1604, a proximal or attachment portion 1605, an anchoring portion 1606, and a distal portion 1607. The implantable device or implant 1600 is configured such that the paddle frame 1624 of the anchoring portion 1606 moves to a narrowed position ( Fig.124 ) to allow the device 1600 to be more easily moved to an implantation position in the heart by reducing contact and / or friction between native cardiac structures such as chordae tendineae and the device 1600. That is, the paddle frame 1624 is configured to move the device 1600 to an implantation position in the heart when the device 1600 is in the closed position ( Fig.122 ) and the device 1600 is in the open position ( Fig.123 ), and when paddle frame 1624 is in the narrowed position, contact between native heart structure and device 1600 is reduced. Device 1600 can include any other features of implantable devices or implants discussed in this application or in the applications and patents incorporated herein by reference, and device 1600 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). In addition, any device described herein can incorporate features of device 1600.

[0666] Attachment portion 1605 includes a connector for use with a delivery system (e.g., Figure 38-49 The delivery system 202 shown) has a capture mechanism (e.g., Figure 44-49 1608) is engaged with a first or proximal collar 1611 of the anchor 1608 (shown as a capture mechanism 213). The proximal collar 1611 can take any suitable form, such as any form described in this application. The distal portion 1607 includes a cover 1614 that is attached to the outer paddle 1620 of the anchor 1608 so that movement of the cover 1614 causes the anchor 1608 to move between an open position and a closed position. The cover 1614 can take any suitable form, such as any form described in this application.

[0667] The anchoring portion 1606 may take any suitable form, such as Figure 22-37 16. The form of anchoring portion 206 of device 200 shown, or any other form described herein that may incorporate paddle frame 1524. Anchoring portion 1606 may include a plurality of anchors 1608, each anchor 1608 including an outer paddle 1620, an inner paddle 1622, a paddle extension member or paddle frame 1624, and a fastener 1630. In the example shown, inner paddle 1622 is made of a material having a greater hardness than the material of outer paddle 1620.

[0668] refer to Fig.124 , paddle frame 1624 includes a main support section 1685, a first connecting member 1601 for attaching to cover 1614 of device 1600, and a second connecting member 1603 for attaching to a connecting portion 1623 between inner paddle 1622 and outer paddle 1620 of anchor 1608. Paddle frame 1624 can be attached to the connecting portion and cover of the anchor by any suitable means, such as any means described in this application. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (such as Figures 91-95 As shown), or the width may be greater than the thickness. However, the blade frame 1624 may take any suitable form, such as any form described in this application.

[0669] In some embodiments, the apposition portion 1604 includes an apposition element 1610 (e.g., an apposition element 1610 that can be used, for example, to be implanted between the leaflets 20, 22 of a native mitral valve MV). The apposition element 1610 and the like can take any suitable form, such as any of the forms described in the present application. The apposition element 1610 is connected to the connection portion 1623 of the inner paddle 1622 of the anchor 1608. In the example shown, the apposition element 1610 includes one or more flexible portions 1687 connected to the inner paddle 1622. The flexible portion 1687 can be formed of a woven material having a looser weave than the inner paddle portion and / or the rest of the apposition element 1610, can be formed of an elastic material that is more elastic than the inner paddle portion and / or the rest of the apposition element 1610, or can be formed in any other way that makes the flexible portion 1687 more flexible and / or stretchable than the inner paddle portion and / or the rest of the apposition element 1610.

[0670] During implantation, the paddles 1620, 1622 of the anchor 1608 are opened and closed to grasp the native valve leaflets between the paddles 1620, 1622 and the coaptation element 1610. The anchor 1608 is moved in a closed position ( Fig.122 ) and various open positions (e.g. Fig.123 Extending and retracting the actuation element 1612 increases and decreases the spacing between the abutment element 1610 and the cap 1614, respectively. During actuation, the proximal collar 1611 and the abutment element 1610 slide along the actuation element 1612, so that the change in spacing between the abutment element 1610 and the cap 1614 causes the paddles 1620, 1622 to move between different positions during implantation to grasp the native valve leaflets.

[0671] In the example shown, actuating element 1612 includes a wide portion 1689 for facilitating movement of blade frame 1624 to the narrowed position. Fig.123 , when actuating element 612 moves downwardly through mating element 610 in direction Y to move anchor 1608 from the closed position to the open position, wide portion 1689 of actuating element 1612 engages flexible portion 1687 of mating element 1610, which causes flexible portion 1687 to move in outward direction Z. This movement of flexible portion 1687 in outward direction Z causes connecting portion 1625 of inner paddle 1622 to move in outward direction D relative to cover 1614, which causes connecting portion 1623 of anchor 1608 (to which paddle frame 1624 is connected) to also move in direction D. The stiffness of inner paddle 1622 helps facilitate movement of connecting portion 1623. Because paddle frame 1624 is connected to cover 1614 and connecting portion 1623 of anchor 1608, this movement of connecting portion 1623 in direction D creates a tension F on paddle frame 1624 ( Fig.124 ), which causes the blade frame 1624 to move to a narrowed position ( Fig.124 ). In the example shown, wide portion 1689 of actuating element 1612 has a tapered shape for engaging flexible portion 1687 of engaging element 1610 to facilitate movement of paddle frame 1624 to the narrowed position. In some embodiments, wide portion 1689 may have a spherical shape or any other suitable shape.

[0672] In some embodiments, wide portion 1689 is configured to widen transition portion 1625 for only a small portion of the travel of the actuating element. For example, the path of travel of the actuating element may have a starting point corresponding to the device being fully closed and an end point corresponding to the path of travel being fully closed. Wide portion 1689 may be configured to maintain transition portion 1625 at its original width along the beginning of the path of travel, move transition portion 1625 to a wider width during the middle of the path of travel, and allow transition portion 1625 to move back to its original width along the end portion of the path of travel.

[0673] refer to Fig.124 , when in the narrowed position, paddle frame 1624 has a length L2 and an overall width W2. When in the normal deployed position, the width of paddle frame 1424 can be between 5 mm and 15 mm, such as between 7 mm and 12 mm, such as between 9 mm and 11 mm, such as about 10 mm. The narrowed width W2 of paddle frame 1124 can be between 3 mm and 12 mm, such as between 5 mm and 10 mm, such as between 7 mm and 9 mm, such as about 8 mm. The ratio of the normal width to the narrowed width W2 can be between 10 / 9 and 3 / 1, such as between 5 / 4 and 2 / 1, such as between 4 / 3 and 3 / 2.

[0674] refer to Fig.125 and 126 , an implantable device or implant (e.g., Figure 22-37 The device 200 shown, Fig.94 1700 or any other suitable device) includes a main support section 1785, a first connecting member 1701 for attachment to an implantable device or a cover of an implant, and a second connecting member (e.g., Figures 91-95 The blade frame 1724 can be attached to the connecting portion and cover of the anchor member by any suitable means, such as any means described in this application. The thickness and width of the blade frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (such as Figures 91-95 as shown), or the width may be greater than the thickness.

[0675] Main support section 1785 includes inner portion 1772 and outer portion 1774. Inner portion 1772 is connected to outer portion 1774 at connection points 1780, and outer portion 1774 extends to connecting member 1701. In the example shown, inner portion 1772 includes arms 1782 extending inwardly from each connection point 1780 and meeting at connection portion 1778, so that when blade frame 1724 is in the deployed position, arms 1782 have a V-shape ( Fig.126 The connection portion 1780 between the inner portion 1772 and the outer portion 1774 may include an opening 1773 for receiving a retaining device (e.g., a suture, a pin, or other suitable device) for connecting the openings 1773 together to retain the paddle frame 1724 in a narrow position ( Fig.125 ). When the retaining device is removed from opening 1773 so that opening 1773 is no longer connected, blade frame 1724 is configured to move outward in direction Z to its normal deployed position. That is, blade frame 1724 can be made of a material pre-formed to the deployed position (such as Fig.126 17). A retaining device may be used to connect opening 1773 at connection point 1780 so that paddle frame 1724 is retained in a folded narrow position (eg, Fig.125 ). Removal of the retaining device then causes the blade frame 1724 to spring back to the normal deployed position.

[0676] During movement of the implantable device or implant to a position to be implanted on the patient's native valve leaflets (e.g., mitral valve leaflets 20, 22, tricuspid valve leaflets 30, 32, 34, or other valve leaflets), the paddle frame 1724 is maintained in a narrowed position to allow the implantable device or implant to be more easily moved to the implantation position in the heart by reducing contact and / or friction between native heart structures such as chordae tendineae and the device. Once the device is positioned for implantation, the retaining device is removed from the opening 1773, allowing the paddle frame 1724 to be moved to the deployed position so that the anchors of the device have a larger surface area for capturing the native valve leaflets.

[0677] Outer portion 1774 defines the overall width of blade frame 1724 (eg, Fig.126 The expanded width EW and Fig.125When in the normal deployed position, the deployed width EW of the paddle frame 1424 can be between 5 mm and 15 mm, for example, between 7 mm and 12 mm, for example, between 9 mm and 11 mm, for example, about 10 mm. The narrowed width NW of the paddle frame 1124 can be between 3 mm and 12 mm, for example, between 5 mm and 10 mm, for example, between 7 mm and 9 mm, for example, about 8 mm. The ratio of the normal width to the narrowed width W2 can be between 10 / 9 and 3 / 1, for example, between 5 / 4 and 2 / 1, for example, between 4 / 3 and 3 / 2.

[0678] Although the illustrated example shows the inner portion 1772 of the main support section 1785 having V-shaped arms 1782, it should be understood that the inner portion 1772 can take any form that allows the blade frame 1724 to be folded into and retained in a narrow position when engaged by the retaining device and also allows the blade frame 1724 to move to an expanded position when the retaining device is disengaged from the blade frame 1724.

[0679] refer to Figures 127-130 , an example embodiment of an implantable device or implant 1800 includes an anchor portion 1806 having one or more paddle frames 1824 that are movable to a narrowed position to allow the device 1800 to be more easily moved to an implantation position in the heart by reducing contact and / or friction between native heart structures such as chordae tendineae and the device 1800. That is, the actuation line 1890 is controlled by a user to generate a compressive force C( Fig.128 ), so that when the device 1800 is positioned for implantation on the native leaflets of the native valve, the paddle frame 1824 is moved to a narrowed position, thereby reducing contact and / or friction between the native heart structure and the device 1800. The device 1800 can include any other features of the implantable devices or implants discussed in this application or in the applications and patents incorporated herein by reference, and the device 1800 can be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). In addition, any device described herein can incorporate the features of the device 1800.

[0680] The implantable device or implant 1800 includes a commissure portion 1804, a proximal or attachment portion 1805, an anchoring portion 1806, and a distal portion 1807. The commissure portion 1804, the attachment portion 1805, and the distal portion 1807 may take any suitable form, such as Figure 22-37The forms of these parts of the device 200 shown, or any other forms described in this application. In some embodiments, the apposition portion 1804 includes an apposition element 1810 (e.g., a spacer, a coaptation element, a gap filler, etc.) that can be implanted, for example, between the leaflets 20, 22 of a native mitral valve MV. The apposition element 1810 can take any suitable form, such as any form described in this application.

[0681] Attachment portion 1805 includes a connector for use with a delivery system (e.g., Figure 38-49 The delivery system 202 shown) has a capture mechanism (e.g., Figure 44-49 213) is engaged with a first or proximal collar 1811. The proximal collar 1811 can take any suitable form, such as any form described in this application.

[0682] The distal portion 1807 includes a cover 1814 that is attached to the anchor 1808 of the anchor portion 1806 so that movement of the cover 1814 causes the anchor 1508 to move between the open position and the closed position. The cover 1814 can take any suitable form, such as any form described in this application. In the example shown, an actuation element 1812 (e.g., an actuation wire, an actuation shaft, etc.) extends from a delivery system (e.g., any delivery system described in this application) and engages the cover 1814 to move the cover 1814 relative to the apposition element or spacer 1810 to enable actuation of the device 1800. The actuation element 1812 can engage and move the cover by any suitable means, such as any means provided in this application.

[0683] The anchoring portion 1806 may take any suitable form, such as Figure 22-37 The anchor portion 206 of the device 200 shown or any other form described in this application. The anchor portion 1806 can include a plurality of anchors 1808, each anchor 1808 including an outer blade 1820, an inner blade 1822, a blade extension member or blade frame 1824, and a fastener 1830. The blade frame 1824 can include a main support section 1885, a first connecting member for attaching to the cover 1814, and a second connecting member for attaching to the connecting portion 1823 of the anchor 1808. The blade frame 1824 can be attached to the connecting portion and the cover of the anchor by any suitable means, such as any means described in this application. The thickness and width of the blade frame 1824 can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (such as Figures 91-95 as shown), or the width may be greater than the thickness.

[0684] The paddle frame 1824 includes one end 1801 configured to be attached to the cap 1814 and a free end 1803. The paddle frame 1824 includes a first opening 1891 and a second opening 1892 for receiving one or more actuation lines 1890 of the delivery system. Figures 127-129 In some examples, a single actuation line 1890 extends through first opening 1891 and second opening 1892 of each paddle frame 1824 and into the delivery system so that a user can pull actuation line 1890 to move paddle frame 1824 to a narrowed position. Fig.129 , the actuation line 1890 may also extend through the opening 1893 of each paddle's fastener 1830 before extending into the delivery system. Fig.128 When the user pulls actuation line 1890, a force is generated on each end of actuation line 1890 in direction Y, which generates a compression force C on paddle frame 1824 due to the actuation line extending through openings 1891, 1892. Compression force C causes paddle frame 1824 to move to a narrowed position.

[0685] refer to Fig.129 , actuation line 1890 may also extend through opening 1893 of buckle 1830 of each paddle before extending into the delivery system. When the user pulls actuation line 1890, buckles 1830 open and paddle frame 1824 moves to a narrowed position.

[0686] refer to Fig.130 In some examples, connecting actuation line 1889 extends in a closed loop between first opening 1891 and second opening 1892 of each paddle frame 1824, and a single actuation line 1890 extends through the closed loop of each connecting line 1889, so that a user only needs to pull a single actuation line 1890 to move both paddle frames 1824 to the narrowed position. That is, pulling a single actuation line 1890 simultaneously generates a compressive force on each paddle frame 1824 (e.g., similar to Fig.128 The compression force C shown in FIG. 18A ) causes the paddle frame 1824 to move to a narrowed position. In the example shown, a single actuation line 1890 extends through the engaging element 1810 before extending into the delivery system. Figures 127-130 , the actuation lines 1889, 1890 may be, for example, sutures.

[0687] refer to Fig.128, when in the narrowed position, blade frame 1824 has a length L2 and an overall width W2. When in the normal deployed position, the width of blade frame 1424 can be between 5 mm and 15 mm, for example, between 7 mm and 12 mm, for example, between 9 mm and 11 mm, for example, about 10 mm. The narrowed width W2 of blade frame 1124 can be between 3 mm and 12 mm, for example, between 5 mm and 10 mm, for example, between 7 mm and 9 mm, for example, about 8 mm. The ratio of the normal width to the narrowed width W2 can be between 10 / 9 and 3 / 1, for example, between 5 / 4 and 2 / 1, for example, between 4 / 3 and 3 / 2. Although the dimensions described above for blade frame 1824 in the narrowed and deployed positions refer to Figures 127-129 examples shown, but it should be understood that the same dimensions may apply to Fig.130 Example shown.

[0688] refer to Figures 131-136 , an example embodiment of an implantable device or implant 1900 includes an anchor portion 1906 having one or more paddle frames 1924 that are movable to a narrowed position to allow the device 1900 to be more easily moved to an implantation position in the heart by reducing contact and / or friction between native heart structures, such as chordae tendineae, and the device 1900. That is, the actuation line 1990 is controlled by a user to generate a compressive force C (e.g., similar to a force C) on the paddle frames 1924. Fig.128 The invention also provides a compressive force C in the valve stem 1924, thereby moving the paddle frame 1924 to a narrowed position when the device 1900 is positioned for implantation on the leaflets of a native valve, thereby reducing contact between the native heart structure and the device 1900. The device 1900 may include any other features of the implantable devices or implants discussed in this application or in the applications and patents incorporated herein by reference, and the device 1900 may be positioned to engage valve tissue (e.g., leaflets 20, 22, etc.) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). In addition, any device described herein may incorporate features of the device 1900.

[0689] The implantable device or implant 1900 includes a commissure portion 1904, a proximal or attachment portion 1905, an anchoring portion 1906, and a distal portion 1907. The commissure portion 1904, the attachment portion 1905, and the distal portion 1907 may take any suitable form, such as Figure 22-37The forms of these parts of the device 200 shown, or any other forms described in this application. In some embodiments, the apposition portion 1904 includes an apposition element 1910 (e.g., a spacer, a coaptation element, a gap filler, etc.) that can be implanted, for example, between the leaflets 20, 22 of the native mitral valve MV. The apposition element 1910 and the like can take any suitable form, such as any form described in this application.

[0690] Attachment portion 1905 includes a connector for use with a delivery system (e.g., Figure 38-49 The delivery system 202 shown) has a capture mechanism (e.g., Figure 44-49 213) is engaged with a first or proximal collar 1911. The proximal collar 1911 can take any suitable form, such as any form described in this application.

[0691] The distal portion 1907 includes a cover 1914 that is attached to the anchor 1908 of the anchor portion 1906 such that movement of the cover 1914 causes the anchor 1908 to move between an open position and a closed position. The cover 1914 can take any suitable form, such as any form described in this application. In the example shown, an actuation element 1912 (e.g., an actuation wire, an actuation shaft, etc.) extends from a delivery system (e.g., any delivery system described in this application) and engages the cover 1914 to move the cover 1914 relative to the apposition element 1910 to enable actuation of the device 1900. The actuation element 1912 can engage and move the cover by any suitable means, such as any means provided in this application.

[0692] The anchoring portion 1906 may take any suitable form, such as Figure 22-37 The anchor portion 206 of the device 200 shown or any other form described in this application. The anchor portion 1906 can include a plurality of anchors 1908, each anchor 1908 including an outer blade 1920, an inner blade 1922, a blade extension member or blade frame 1924, and a fastener 1930. The blade frame 1924 can include a main support section 1985, a first connecting member 1901 for attaching to the cover 1914, and a second connecting member 1903 for attaching to the connecting portion 1923 of the anchor 1908. The blade frame 1924 can be attached to the connecting portion and the cover of the anchor by any suitable means, such as any means described in this application. The thickness and width of the blade frame 1924 can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (such as Figures 91-95 as shown), or the width may be greater than the thickness.

[0693] Main support section 1985 includes an inner portion 1972 and an outer portion 1974 connected to connecting member 1901. In the example shown, inner portion 1972 has a pair of arms 1982 extending from connecting member 1901 to connecting member 1903, wherein arms 1982 provide support for anchor 1908. Outer portion 1974 has a pair of arms 1980 extending from connecting member 1901 in an outward direction relative to arms 1982 of inner portion 1972, such that arms 1980 define the overall width of blade frame 1924 (e.g., Fig.128 Total width W2 shown). Fig.131 , arms 1980 each include one or more actuation lines 1990 ( Figures 132-136 ). The arm 1982 may also include an opening 1991 for receiving one or more actuation lines 1990. The opening 1991 may be an opening of the connection member 1903 for connecting to the connection portion 1923 of the anchor 1908 (as shown in the illustrated example), or the opening 1991 may be separate from the connection member 1903.

[0694] refer to Fig.132 and 133 In some examples, a single actuation line 1990 corresponds to each paddle frame 1924 to move paddle frame 1924 to a narrowed position. In the example shown, actuation line 1990 extends through openings 1991, 1992 of paddle frame 1924 so that a user can generate a pulling force on actuation line 1990 to move paddle frame 1924 to a narrowed position. Each actuation line 1990 has a first end 1993 and a second end 1994. First end 1993 extends from the delivery system, through an opening 1991 of one arm 1982 of inner portion 1972, through an opening 1992 of one arm 1980 of outer portion 1974, through an opening 1992 of another arm 1980 of outer portion 1974, through an opening 1991 of another arm 1982 of inner portion 1972, and second end 1994 of actuation line 1990 extends into the delivery system. In Fig.132 In the example shown, the tension on the two ends 1993, 1994 of the actuation line 1990 is actuated by the arms 1980 ( Fig.131 ) creates a compressive force on the blade frame 1924, causing the blade frame to move to a narrowed position, thereby moving the arm 1980 toward the inner portion 1972 of the blade frame 1924.

[0695] refer to Fig.133 , the actuation line 1990 may also extend through the opening 1931 of the fastener 1930 of each paddle before extending into the delivery system. Fig.132In the example shown, tension on both ends 1993, 1994 of the actuation line 1990 causes the blade frame to move to the narrowed position and open the buckle.

[0696] refer to Fig.134 , a single actuation line 1990 corresponds to each paddle frame 1924 to move paddle frame 1924 to the narrowed position. Each actuation line 1990 has a first end (not shown) that extends from the delivery system, through the coupling element 1910, through an opening 1992 of one arm 1980 of the outer portion 1974, through an opening 1991 of one arm 1982 of the inner portion 1972, through an opening 1991 of the other arm 1982 of the inner portion 1972, through an opening 1992 of the other arm 1980 of the outer portion 1974, and a second end (not shown) of the actuation line 1990 extends through the coupling element 1910 and into the delivery system. The tension on both ends of the actuation line 1990 is exerted by the tension on the arms 1980 ( Fig.131 ) creates a compressive force on the blade frame 1924 that moves the blade frame 1924 to a narrowed position, thereby moving the arm 1980 toward the inner portion 1972 of the blade frame 1924.

[0697] refer to Fig.135 and 136 In some embodiments, connecting actuation line 1989 is connected to each paddle frame 1924, and actuation line 1990 is connected to connecting actuation line 1989 so that a user can pull actuation line 1990 to move paddle frame 1924 to a narrowed position. Fig.135 In some embodiments, the connecting actuation line 1989 extends in a closed loop between the openings 1991 , 1992 of the inner portion 1972 and the outer portion 1974 of the blade frame 1924 . Fig.136 In some embodiments, connecting actuation line 1989 extends in a closed loop between openings 1992 of outer portion 1974 of blade frame 1924 , but connecting actuation line 1989 does not extend through opening 1991 of inner portion 1972 .

[0698] exist Fig.135 and 136 In both examples shown, the tension on the actuation line 1990 is actuated by the arm 1980 ( Fig.131 ) creates a compressive force on the blade frame 1924 to move the blade frame to a narrowed position, thereby moving the arm 1980 toward the inner portion 1972 of the blade frame 1924. Fig.135 and 136The illustrated example shows a separate actuation line 1990 attached to the actuation connection line 1989 of each blade frame 1924, but in some embodiments, a single actuation line (e.g., similar to Fig.130 The pipeline 1890 shown) can be attached to the connecting actuation pipeline 1989 of each blade frame 1924, so that pulling the end of a single actuation pipeline causes both blade frames 1924 to move to the narrowed position. Figures 131-136 , the actuation lines 1989, 1990 may be, for example, sutures.

[0699] Still refer to Figures 131-136 , when in the normal deployed position, the total width of blade frame 1924 (defined by outer portion 1974 of blade frame 1924) can be between 5 mm and 15 mm, such as between 7 mm and 12 mm, such as between 9 mm and 11 mm, such as about 10 mm. The narrowed width of blade frame 1124 can be between 3 mm and 12 mm, such as between 5 mm and 10 mm, such as between 7 mm and 9 mm, such as about 8 mm. The ratio of the normal width to the narrowed width can be between 10 / 9 and 3 / 1, such as between 5 / 4 and 2 / 1, such as between 4 / 3 and 3 / 2.

[0700] refer to Figures 137-148 , implantable device or implant 2000( Figures 139-144 ) includes an anchoring portion 2006 having one or more paddle frames 2024. The paddle frames 2024 are configured to allow the device 2000 to be more easily moved to an implantation location in the heart by reducing contact and / or friction between native heart structures, such as chordae tendineae, and the device 2000. For example, the actuation line is controlled by a user to generate a compressive force on the paddle frames 2024 (e.g., Fig.128 The compressive force C shown in FIG. 2000 is thereby applied to the paddle frame 2024 from the normally deployed position ( Fig.140 and 142 ) moves to a narrowed position ( Fig.139 and 141 ), thereby reducing contact between native heart structures and device 2000. Device 2000 can include any other features of implantable devices or implants discussed in this application or in the applications and patents incorporated herein by reference, and device 2000 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). In addition, any device described herein can incorporate features of device 2000.

[0701] refer to Figures 143-144, the implantable device or implant 2000 includes a mate portion 2004, a proximal or attachment portion 2005, an anchoring portion 2006, and a distal portion 2007. The mate portion 2004, the attachment portion 2005, and the distal portion 2007 can take any suitable form, such as Figure 22-37 The forms of these parts of the device 200 shown, or any other forms described in this application. In some embodiments, the apposition portion 2004 optionally includes an apposition element 2010 (e.g., a spacer, a coaptation element, a gap filler, etc.) that can be implanted, for example, between the leaflets 20, 22 of the native mitral valve MV. The apposition element 2010 and the like can take any suitable form, such as any form described in this application.

[0702] Attachment portion 2005 includes a connector for use with a delivery system (e.g., Figure 38-49 The delivery system 202 shown) has a capture mechanism (e.g., Figure 44-49 The proximal collar 2011 may be provided with a first or proximal collar 2011 that is engaged with a capture mechanism 213 as shown. The proximal collar 2011 may take any suitable form, such as any form described in this application.

[0703] The distal portion 2007 includes a cover 2014 that is attached to the anchor 2008 of the anchor portion 2006 such that movement of the cover 2014 causes the anchor 2008 to move between an open position and a closed position. The cover 2014 can take any suitable form, such as any of the forms described in this application. Figure 22-37 The actuator element 212 shown is the same or similar) through the opening 2009 ( Fig.143 ) extends from a delivery system (e.g., any of the delivery systems described herein) through the engagement element 2010 and engages the cover 2014 to move the cover 2014 relative to the engagement element 2010 to enable actuation of the device 2000. The actuation element can engage and move the cover by any suitable means, such as any of the means provided herein.

[0704] The anchoring portion 2006 may take any suitable form, such as Figure 22-37 The anchor portion 206 of the device 200 shown in the figure or any other form described in the present application. The anchor portion 2006 can include a plurality of anchors 2008, each anchor 2008 including an outer blade 2020, an inner blade 2022, a blade extension member or blade frame 2024, and a fastener (e.g., Figure 22-37 Referring to the fastener 230 shown in FIG. Fig.137 and 138, the blade frame 2024 can include a main support section 2085 and a connecting member 2003 for attaching to the cover 2014. The blade frame 2024 can be attached to the cover 2014 by any suitable means, such as any of the means provided in this application. Figures 145-148 In the example shown, two anchors 2008 are defined by a blade band 2001, which includes an inner blade 2022 and an outer blade 2020 of each anchor 2008. The inner blade 2022 of each anchor 2008 is attached by a connecting portion 2025, which is configured to connect the inner blade 2022 to the coaptation element 2010 (such as Fig.148 In the example shown, the connecting portion 2025 includes an opening 2094 for receiving the distal portion of the apposition element 2010. The outer paddle 2020 of each anchor 2008 is attached by a connecting portion 2021, which is configured to connect the outer paddle 2020 to the cover 214 (e.g., Fig.148 ). In the example shown, the connecting portion 2021 includes an opening 2096 for receiving a portion of the cover 2014. Each inner blade 2022 is attached to a corresponding outer blade 2020 by a connecting portion 2023.

[0705] refer to Fig.137 and 138 , blade frame 2024 includes two or more arms 2080 that define the overall width TW of anchor 2008, wherein at least some of arms 2080 are connected at a distal portion of blade frame 2024 (e.g., a portion of blade frame 2024 that is proximal to connection member 2003). Each arm 2080 includes one or more openings 2091, 2092 for receiving one or more actuation lines (e.g., Figures 127-130 2090) so that a user can pull the actuation line to move paddle frame 2024 to the narrowed position. The illustrated example includes two arms 2080, each of which includes a proximal opening 2091 and a distal opening 2092. In some embodiments, a single actuation line can extend through each opening 2091, 2092 so that a single actuation line can move paddle frame 2024 to the narrowed position. However, it should be understood that any suitable number of actuation lines can extend through openings 2091, 2092 to move paddle frame 2024 to the narrowed position.

[0706] refer to Fig.137, the arms 2080 are connected to each other at the distal portion of the blade frame 2024 by a connecting link 2083. When a user generates a tension F on the blade frame 2024 by pulling one or more actuation lines extending through the openings 2091, 2092, this connection between the two arms 2080 causes the arms 2080 to pivot, flex, and / or articulate in the inward direction Z about the connecting link 2083. This pivoting, flexing, and / or articulating of the arms 2080 causes the main support section 2085 of the arms 2080 to move in the inward direction X, so that the blade frame 2024 is in a narrowed position. In the example shown, the connecting link 2083 has a first member 2087 attached to one arm 2080, a second member 2089 attached to the other arm 2080, and a thin arched member 2086 connecting the first member 2087 to the second member 2089. However, connecting link 2083 may take any suitable form that allows the arm to pivot, flex, and / or articulate in the inward direction Z when tension F is applied to blade frame 2024. In some embodiments, connecting link 2083 is integral with arm 2080 of blade frame 2024.

[0707] Still reference Fig.137 , when in the normal deployed position, the total width TW of blade frame 1924 can be between 5 mm and 15 mm, such as between 7 mm and 12 mm, such as between 9 mm and 11 mm, such as about 10 mm. The narrowed width of blade frame 1124 can be between 3 mm and 12 mm, such as between 5 mm and 10 mm, such as between 7 mm and 9 mm, such as about 8 mm. The ratio of the normal width to the narrowed width W2 can be between 10 / 9 and 3 / 1, such as between 5 / 4 and 2 / 1, such as between 4 / 3 and 3 / 2.

[0708] Figures 149-156 Shows that it can be Figures 139-144 An example of a paddle frame 2024 for use with an implantable device or implant 2000 is shown. Fig.149 , the device 2000 can include a blade frame 2124 having an inner portion 2172 and an outer portion 2174. The outer portion 2174 has two arms 2180 each including an opening 2192 for receiving one or more actuation lines (e.g., Figure 27-30 2000 ) so that a user can pull the actuation line to move the paddle frame to the narrowed position. Arm 2180 defines the overall width TW of the anchor of device 2000 .

[0709] The arms 2180 are connected to each other at the distal portion of the paddle frame 2124 by a connecting link 2183. When a user creates a tension F on the paddle frame 2024 by pulling one or more actuation lines extending through the opening 2192, this connection between the two arms 2180 causes the arms 2180 to pivot, flex, and / or articulate in the inward direction Z about the connecting link 2183. This pivoting, flexing, and / or articulating of the arms 2180 causes the main support section 2185 of the arms 2180 to move in the inward direction X, so that the paddle frame 2124 is in a narrowed position. In the example shown, the connecting link 2183 has a first member 2187 attached to one arm 2180, a second member 2189 attached to the other arm 2180, and a thin arched member 2186 connecting the first member 2187 to the second member 2189. The connecting link 2183 can take any suitable form, such as for Fig.137 The connecting link 2083 shown may be of any form described.

[0710] The inner portion 2172 of the paddle frame 2124 has two arms 2182 that extend inwardly and downwardly from the proximal portion of the arm 2180 and help facilitate movement of the paddle frame 2124 to the narrowed position. The arms 2182 are connected to the arm 2180 at a connection point 2197. In some embodiments, the connection point 2197 includes a thin arcuate portion that helps facilitate movement of the arms 2180, 2182 in the inward direction X. The arms 2182 are connected to each other at a connection point 2198. The connection point 2198 can include a thin rounded portion that further helps facilitate movement of the arms 2180, 2182 in the inward direction X.

[0711] refer to Fig.150 In some embodiments, the device 2000 can include a paddle frame 2224 having an inner portion 2272 and an outer portion 2274. The outer portion 2274 has two arms 2280 each including an opening 2292 for receiving one or more actuation lines (e.g., Figure 27-30 2000 ) so that a user can pull the actuation line to move the paddle frame to the narrowed position. Arm 2280 defines the overall width TW of the anchor of device 2000 .

[0712] The arms 2280 are connected to each other at the distal portion of the paddle frame 2224 by a connecting link 2283. When a user creates a tension F on the paddle frame 2224 by pulling one or more actuation lines extending through the opening 2292, this connection between the two arms 2280 causes the arms 2280 to pivot, flex, and / or articulate in the inward direction Z about the connecting link 2283. This pivoting, flexing, and / or articulating of the arms 2280 causes the main support section 2285 of the arms 2280 to move in the inward direction X, so that the paddle frame 2224 is in a narrowed position. In the example shown, the connecting link 2283 has a first member 2287 attached to one arm 2280, a second member 2289 attached to the other arm 2280, and a thin arched member 2286 connecting the first member 2287 to the second member 2289. The connecting link 2283 can take any suitable form, such as for Fig.137 The connecting link 2083 shown may be of any form described.

[0713] The inner portion 2272 of the paddle frame 224 has two arms 2282 that extend inwardly and downwardly from the proximal portion of the arm 2280 and help facilitate movement of the paddle frame 2224 to the narrowed position. The arms 2282 are connected to the arm 2280 at a connection point 2297. In some embodiments, the connection point 2297 includes a thin arcuate portion that helps facilitate movement of the arms 2280, 2282 in the inward direction X. The arms 2282 are connected to each other at a connection point 2298. The connection point 2298 can include a thin arcuate portion that further helps facilitate movement of the arms 2280, 2282 in the inward direction X. In the example shown, each arm 2282 has a concave portion that is attached to each other at the thin arcuate portion of the connection point 2298 to help facilitate flexion of the arms 2282 in the inward direction X.

[0714] refer to Fig.151 In some embodiments, the device 2000 can include a paddle frame 2324 having an inner portion 2372 and an outer portion 2374. The outer portion 2374 has two arms 2380 each including an opening 2392 for receiving one or more actuation lines (e.g., Figure 27-30 2000 ) so that a user can pull the actuation line to move the paddle frame to the narrowed position. Arm 2380 defines the overall width TW of the anchor of device 2000 .

[0715] The arms 2380 are connected to each other at the proximal portion of the paddle frame 2324 by a connecting link 2383. When a user creates a tension F on the paddle frame 2324 by pulling one or more actuation lines extending through the opening 2392, this connection between the two arms 2380 causes the arms 2380 to pivot, flex, and / or articulate in the inward direction Z about the connecting link 2383. This pivoting, flexing, and / or articulating of the arms 2380 causes the main support section 2385 of the arms 2280 to move in the inward direction X, so that the paddle frame 2324 is in a narrowed position. In the example shown, the connecting link 2283 has a first member 2387 attached to one arm 2380, a second member 2389 attached to the other arm 2380, and a thin arched member 2386 connecting the first member 2387 to the second member 2389. The connecting link 2383 can take any suitable form, such as for Fig.137 The connecting link 2083 shown may be of any form described.

[0716] The inner portion 2372 of the paddle frame 2324 has two arms 2382 that extend inwardly and upwardly from the arms 2380 and help facilitate movement of the paddle frame 2324 to the narrowed position. The arms 2382 are connected to the arms 2380 at connection points 2397. In some embodiments, the connection points 2397 include thin arched portions that help facilitate movement of the arms 2380, 2382 in the inward direction X. The arms 2282 are connected to each other at connection points 2398. The connection points 2398 can include thin rounded portions that further help facilitate movement of the arms 2380, 2382 in the inward direction X. The arms 2382 each include a distal opening 2391 and a proximal opening 2393 that can receive one or more actuation lines. In some embodiments, the openings 2393 can be connected to the connection portion 2023 ( Fig.145 ) such that movement of the anchor member to the open position provides additional tension F on the paddle frame 2324 to facilitate movement of the paddle frame 2324 to the narrowed position.

[0717] refer to Fig.152 , the device 2000 can include a paddle frame 2424 having an inner portion 2472 and an outer portion 2474. The outer portion 2474 has two arms 2480 each including a distal opening 2492 and a proximal opening 2491 for receiving one or more actuation lines (e.g., Figure 27-30 2000 ) so that a user can pull the actuation line to move the paddle frame to the narrowed position. Arm 2480 defines the overall width TW of the anchor of device 2000 .

[0718] The arms 2480 are connected to each other at the distal portion of the paddle frame 2424 by a connecting link 2483. When a user creates a tension F on the paddle frame 2424 by pulling one or more actuation lines extending through the opening 2492, this connection between the two arms 2480 causes the arms 2480 to pivot, flex, and / or articulate in an inward direction Z about the connecting link 2483. This pivoting, flexing, and / or articulating of the arms 2480 causes the main support section 2485 of the arms 2480 to move in an inward direction X, so that the paddle frame 2424 is in a narrowed position. In the example shown, the connecting link 2483 has a first member 2487 attached to one arm 2480, a second member 2489 attached to the other arm 2480, and a thin arched member 2486 connecting the first member 2487 to the second member 2489. The connecting link 2483 can take any suitable form, such as for Fig.137 The connecting link 2083 shown may be of any form described.

[0719] The inner portion 2472 of the paddle frame 2424 has two arms 2482 that extend inwardly and downwardly from the proximal portion of the arm 2480 and help facilitate movement of the paddle frame 2424 to the narrowed position. The arms 2482 are connected to the arm 2480 at a connection point 2497. In some embodiments, the connection point 2497 includes a thin arcuate portion that helps facilitate movement of the arms 2480, 2482 in the inward direction X. The arms 2482 are connected to each other at a connection point 2498. The connection point 2498 may include a thin rounded portion that further helps facilitate movement of the arms 2480, 2482 in the inward direction X. The arms 2482 each include an opening 2493 that can receive one or more actuation lines.

[0720] refer to Figure 153-155 In some embodiments, the device 2000 can include a paddle frame 2524 having an inner portion 2572 and an outer portion 2574. The outer portion 2574 has two arms 2580 each including a proximal opening 2592 and a distal opening 2591 for receiving one or more actuation lines (e.g., Figure 27-30 2500 ) so that a user can pull the actuation line to move the paddle frame to the narrowed position. Arm 2580 defines the overall width TW of the anchor of device 2000 .

[0721] The arms 2580 are connected to each other at the proximal portion of the paddle frame 2524 by a connecting link 2583. When a user creates a tension F on the paddle frame 2524 by pulling one or more actuation lines extending through the openings 2591, 2592, this connection between the two arms 2580 causes the arms 2580 to pivot, flex, and / or articulate in the inward direction Z about the connecting link 2583. This pivoting, flexing, and / or articulating of the arms 2580 causes the main support section 2585 of the arms 2580 to move in the inward direction X, so that the paddle frame 2524 is in a narrowed position. In the example shown, the connecting link 2583 has a first member 2587 attached to one arm 2580, a second member 2589 attached to the other arm 2580, and a thin arched member 2586 connecting the first member 2587 to the second member 2589. The connecting link 2583 can take any suitable form, such as for Fig.137 The connecting link 2083 shown may be of any form described.

[0722] Inner portion 2572 of paddle frame 2524 has two arms 2582 that extend inwardly and upwardly from arm 2580 and help facilitate movement of paddle frame 2524 to the narrowed position. Arm 2582 is connected to arm 2580 at connection point 2597. In some embodiments, connection point 2597 includes a thin arched portion that helps facilitate movement of arms 2580, 2582 in the inward direction X. Arms 2582 are connected to each other at connection point 2598. Connection point 2598 can include a thin rounded portion that further helps facilitate movement of arms 2580, 2582 in the inward direction X. Connection point 2598 includes an opening 2593 that can receive one or more actuation lines. In some embodiments, opening 2593 can be connected to connection portion 2023 ( Fig.145 ) such that movement of the anchor member to the open position provides additional tension F on the paddle frame 2524 to facilitate movement of the paddle frame 2524 to the narrowed position.

[0723] In some embodiments, there is an angle α between each arm 2582 of inner portion 2372 of blade frame 2524 and axis A that bisects blade frame 2524. Fig.153 , the angle α may be about 60 degrees. Fig.154 , the angle α may be about 65 degrees. Fig.155 , angle α can be about 70 degrees. Although the angle is shown as 60, 65, or 70 degrees, it should be understood that angle α can take any suitable form that allows blade frame 2524 to move to a narrowed position when force F is applied to the blade frame, such as between 50 degrees and about 80 degrees.

[0724] refer to Fig.156, the device 2000 can include a paddle frame 2624 having two arms 2680 each including an opening 2692 for receiving one or more actuation lines (e.g., Figure 27-30 2690) so that a user can pull the actuation line to move the paddle frame to the narrowed position. Arms 2680 define an overall width TW of the anchor of device 2000. Proximal portions 2670 of arms 2680 are offset from one another so that when arms 2680 move in the inward direction X, one of arms 2680 can extend over the other arm 2680 and proximal portions 2670 of arms 2680 can move away from one another to move back to the normally deployed position.

[0725] The arms 2680 are connected to each other at the distal portion of the paddle frame 2624 by a connecting link 2683. When a user creates a tension F on the paddle frame 2624 by pulling one or more actuation lines extending through the opening 2692, this connection between the two arms 2680 causes the arms 2680 to pivot, flex, and / or articulate in the inward direction Z about the connecting link 2683. This pivoting, flexing, and / or articulating of the arms 2680 causes the main support section 2685 of the arms 2680 to move in the inward direction X so that the paddle frame 2624 is in a narrowed position. In the example shown, the connecting link 2683 has a first member 2687 attached to one arm 2680, a second member 2689 attached to the other arm 2680, and a thin arched member 2686 connecting the first member 2687 to the second member 2689. The connecting link 2683 can take any suitable form, such as for Fig.137 The connecting link 2083 shown may be of any form described.

[0726] refer to Figures 149-156 , when in the normal deployed position, the total width TW of the paddle frames 2024-2524 can be between 5 mm and 15 mm, such as between 7 mm and 12 mm, such as between 9 mm and 11 mm, such as about 10 mm. The narrowed width of the paddle frame 1124 can be between 3 mm and 12 mm, such as between 5 mm and 10 mm, such as between 7 mm and 9 mm, such as about 8 mm. The ratio of the normal width TW to the narrowed width can be between 10 / 9 and 3 / 1, such as between 5 / 4 and 2 / 1, such as between 4 / 3 and 3 / 2.

[0727] refer to Fig.157 and 158 , an implantable device or implant (e.g., Figure 22-37 The device 200 shown, Fig.94The example of a paddle frame 2724 of the device 600 shown in the figure or any other suitable device described in the present application includes a main support section 2785 and a connecting member 2701 for attaching to a cover of an implantable device or implant. The paddle frame 2724 is configured to allow the device to be more easily moved to an implantation position in the heart by reducing contact and / or friction between native heart structures such as chordae tendineae and the device. For example, an actuation line (e.g., Figures 127-130 The actuation line 1890 shown is controlled by the user to generate a compressive force on the paddle frame 2724, thereby moving the paddle frame 2724 from the normally deployed position ( Fig.157 ) moves to a narrowed position ( Fig.158 ), thereby reducing contact between the native cardiac structure and the device.

[0728] The connecting member 2701 can take any suitable form, such as any form described in this application. The blade frame 2724 can be attached to the cover by any suitable means, such as any means provided in this application. The thickness and width of the blade frame 2724 can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (such as Figures 91-95 as shown), or the width may be greater than the thickness.

[0729] Paddle frame 2724 includes arms 2780 that each extend from a distal portion 2771 to a proximal portion 2770. Arms 2780 define an overall width TW of an anchor of an implantable device or implant. Proximal portion 2770 of arm 2780 includes opening 2792 for receiving suture 2789 that is connected to the implantable device or implant (e.g., to a cover of the device) such that suture 2789 controls the overall width of paddle frame 2724.

[0730] The proximal portions 2770 of the arms 2780 are loosely connected by sleeve members 2773, which allow the proximal portions 2770 of the arms 2780 to move relative to each other. That is, the proximal portions 2770 can be offset from each other (e.g., similar to Fig.156 2724) such that when arms 2780 move in inward direction X, one of arms 2780 can extend over the other arm 2780 and proximal portions 2770 of arms 2680 can move away from each other to move back to a normally deployed position. When paddle frame 2724 is in narrowed position W2, at least a portion of proximal portions 2770 of arms 2780 is disposed within sleeve 2773.

[0731] The user can pull the actuation line to generate tension F on the blade frame 2724 to move the blade frame to the normal deployed position ( Fig.157) and narrowing position ( Fig.158 ) between. Actuation lines may be connected to blade frame (e.g., to opening 2792) or to suture 2789 such that pulling on the actuation lines creates tension F on blade frame 2724. Fig.158 , when tension F is applied to the paddle frame, proximal portions 2770 of arms 2780 move toward each other in direction X, causing paddle frame 2724 to move to a narrowed position. Movement of paddle frame 2724 to a narrowed position allows an implantable device or implant to be more easily moved to an implantation position in the heart by reducing contact and / or friction between native heart structures, such as chordae tendineae, and the device.

[0732] When in the normal deployed position, the total width TW of the paddle frame 2724 can be between 5 mm and 15 mm, such as between 7 mm and 12 mm, such as between 9 mm and 11 mm, such as about 10 mm. The narrowed width W2 of the paddle frame 1124 can be between 3 mm and 12 mm, such as between 5 mm and 10 mm, such as between 7 mm and 9 mm, such as about 8 mm. The ratio of the normal width to the narrowed width W2 can be between 10 / 9 and 3 / 1, such as between 5 / 4 and 2 / 1, such as between 4 / 3 and 3 / 2.

[0733] refer to Figures 159-168 , implantable device or implant 2800( Figures 162-168 ) includes an anchoring portion 2806 having one or more paddle frames 2824 that can be moved to a narrowed position to allow the device 2800 to be more easily moved to an implantation position in the heart by reducing contact and / or friction between native heart structures such as chordae tendineae and the device 2800. That is, one or more actuation lines 2890 ( Figures 164-168 ) is controlled by the user to generate a compressive force on the paddle frame 2824, thereby moving the paddle frame 2824 to a narrowed position when the device 2800 is positioned for implantation on the native valve leaflets, thereby reducing contact between the native heart structure and the device 1800. The device 2800 can include any other features of the implantable devices or implants discussed in this application or in the applications and patents incorporated herein by reference, and the device 2800 can be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). In addition, any device described herein can incorporate the features of the device 2800.

[0734] refer to Figures 162-163, the implantable device or implant 2800 includes a mate portion 2804, a proximal or attachment portion 2805, an anchoring portion 2806, and a distal portion 2807. The mate portion 2804, the attachment portion 2805, and the distal portion 2807 can take any suitable form, such as Figure 22-37 The forms of these parts of the device 200 shown, or any other forms described in this application. In some embodiments, the apposition portion 2804 optionally includes an apposition element 2810 (e.g., a spacer, a coaptation element, a gap filler, etc.) that can be implanted, for example, between the leaflets 20, 22 of the native mitral valve MV. The apposition element 2810 and the like can take any suitable form, such as any form described in this application.

[0735] Attachment portion 2805 includes a capture mechanism for coupling with delivery system 2802 (e.g., Figure 44-49 The first or proximal collar 2811 that is engaged with the capture mechanism 213 shown in the figure. The capture mechanism and delivery system 2802 can take any suitable form, such as any form described in this application. The delivery system 2802 can be the same or similar to other delivery systems described herein, such as 102, 202, 402, 502, etc., and can include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a path, a combination of these, etc. The proximal collar 2811 can take any suitable form, such as any form described in this ...

Claims

1. An implantable device comprising: an anchoring portion comprising one or more anchors configured to attach to one or more leaflets of a native heart valve; wherein each of the one or more anchors comprises a plurality of blades and a blade frame; wherein the paddle frame has an inner frame member and at least two outer arms, each of the outer arms being connected to the inner frame member at a distal connection point and extending proximally to a proximal portion of the implantable device; one or more actuation lines connected to the paddle frame so that a user can provide tension to the one or more actuation lines to cause the paddle frame to move from an expanded position having an expanded width to a narrowed position having a narrowed width, wherein the expanded width is greater than the narrowed width; wherein the one or more actuation lines extend from the proximal portion to the distal portion, from the distal portion along each of the outer arms to the proximal portion, and radially inwardly from the proximal portion to connect to a fixed location on the implantable device relative to the outer arms; and Wherein the one or more anchors are configured to move between an open position and a closed position.

2. The implantable device of claim 1, wherein the fixed location is on the inner frame member.

3. The implantable device of claim 2, wherein the fixed location is an opening on the inner frame member at the proximal portion of the implantable device, and wherein the opening connects the inner frame member to a paddle of the plurality of paddles.

4. The implantable device of claim 1, wherein the fixed location is on a paddle clip.

5. An implantable device according to any one of claims 1 to 4, wherein providing the tension to the one or more actuation lines causes each of the outer arms to pivot or flex inwardly about the distal connection point.

6. An implantable device according to any one of claims 1 to 5, wherein each outer arm has a first portion extending distally from the distal connection point, a second portion extending proximally toward the proximal portion, and a bend connecting the first portion to the second portion.

7. The implantable device of claim 6, wherein providing the tension to the one or more actuation lines causes each of the outer arms to articulate at the bend and at the distal connection point.

8. The implantable device of claim 7, wherein a first distance between the first portion and the inner frame member and a second distance between the second portion and the first portion decrease when the paddle frame moves from the expanded position to the narrowed position.

9. The implantable device of claim 6, wherein in the narrowed position, the second portion overlaps the inner frame member.

10. The implantable device of any one of claims 1 to 9, wherein each of the outer arms has a proximal tip, and wherein in the narrowed position, the proximal tip is adjacent the fixed position.

11. An implantable device according to any one of claims 1 to 10, wherein each of the outer arms has a certain length and a plurality of openings are spaced along the length for receiving one of the one or more actuation lines.

12. The implantable device of claim 11, wherein each of the outer arms has a proximal tip, one of the plurality of openings being located at the proximal tip.

13. The implantable device of any one of claims 1 to 12, further comprising a biasing member associated with each of the outer arms, wherein the biasing member is configured to bias the outer arms outwardly.

14. The implantable device of claim 13, wherein the biasing member is positioned around the one or more actuation lines.

15. An implantable device according to claim 13 or 14, wherein the biasing member comprises a coil.

16. The implantable device of claim 13 or 14, wherein the biasing member comprises a cloth material.

17. An implantable device according to claim 13 or 14, wherein the biasing member comprises a cellular design.

18. The implantable device of any one of claims 13 to 17, wherein the biasing member is integrally formed with the paddle frame.

19. The implantable device of any one of claims 1 to 18, further comprising a strain relief feature incorporated into the paddle frame.

20. The implantable device of claim 19, wherein the strain relief feature comprises one or more cutouts in the paddle frame.

21. The implantable device of any one of claims 1 to 20, wherein the paddle frame comprises a shape memory alloy.

22. An implantable device according to any one of claims 1 to 21, wherein each of the plurality of blades comprises an inner blade and an outer blade, and each of the one or more anchors comprises at least one fastener corresponding to at least one of the plurality of blades.

23. A valve repair system for repairing a patient's native valve, the valve repair system comprising: a delivery device having an inner lumen; an implantable device configured to be delivered through the lumen, the implantable device comprising: an anchoring portion including one or more anchors coupled to the mate element and the cover; the one or more anchors configured to attach to one or more leaflets of a native heart valve; wherein each of the anchors comprises a plurality of blades and a blade frame; wherein the paddle frame has an inner frame portion and at least two outer arms, each of the outer arms being connected to the inner frame member at a respective distal connection point and extending proximally to a proximal portion of the device; one or more actuation lines connected to the paddle frame such that a user can provide tension to the actuation lines to cause each of the at least two outer arms of the paddle frame to pivot, articulate, or flex inwardly at or near their respective distal connection points such that the paddle frame moves from an expanded position having an expanded width to a narrowed position having a narrowed width, wherein The expanded width is greater than the narrowed width; wherein the one or more actuation lines extend from the proximal portion through the coaptation element to the distal portion, from the distal portion along each of the outer arms to the proximal portion, and radially inwardly from the proximal portion to connect to a fixed location on the device relative to the outer arms; and Wherein the anchor is configured to move between an open position and a closed position.

24. A valve repair system according to claim 23, wherein the fixing location is on the inner frame portion.

25. The valve repair system of claim 24, wherein the fixed location is an opening on the inner frame portion at the proximal portion of the device, and wherein the opening connects the inner frame member to a paddle of the plurality of paddles.

26. The valve repair system of claim 23, wherein the fixed location is on a paddle clip.

27. The implantable device of claim 23, wherein providing tension to the actuation wire causes each of the outer arms to pivot or flex inwardly about the respective distal connection point.

28. A valve repair system according to any one of claims 23 to 27, wherein each outer arm has a first portion extending distally from the corresponding distal connection point, a second portion extending proximally toward the proximal portion, and a bend connecting the first portion to the second portion.

29. The valve repair system of claim 28, wherein providing tension to the actuation line causes each of the outer arms to articulate at the bend and at the respective distal connection point.

30. The valve repair system of claim 29, wherein a first distance between the first portion and the inner frame member and a second distance between the second portion and the first portion decrease when the paddle frame moves from the deployed position to the narrowed position.

31. The valve repair system of claim 28, wherein in the narrowed position, the second portion overlaps the inner frame member.

32. The valve repair system of any one of claims 23 to 31, wherein each of the outer arms has a proximal tip, and wherein in the narrowed position, the proximal tip is adjacent the fixed position.

33. The valve repair system of any one of claims 23 to 32, wherein each outer arm has a length and a plurality of openings spaced along the length for receiving one of the one or more actuation lines.

34. The valve repair system of claim 33, wherein each of the outer arms has a proximal tip, and one of the plurality of openings is located at the proximal tip.

35. The valve repair system of any one of claims 23 to 34, further comprising a biasing member associated with each of the outer arms, wherein the biasing member is configured to bias the outer arms outwardly.

36. The valve repair system of claim 35, wherein the biasing member is positioned around the actuation line.

37. A valve repair system according to claim 35 or 36, wherein the biasing member comprises a coil.

38. A valve repair system according to claim 35 or 36, wherein the biasing member comprises a cloth material.

39. A valve repair system according to claim 35 or 36, wherein the biasing member comprises a unitary structure.

40. The valve repair system of any one of claims 35 to 39, wherein the biasing member is integrally formed with the paddle frame.

41. The valve repair system of any one of claims 23 to 40, further comprising a strain relief feature incorporated into the paddle frame.

42. The valve repair system of claim 41, wherein the strain relief feature comprises one or more cutouts in the paddle frame.

43. The valve repair system of any one of claims 23 to 42, wherein the paddle frame comprises a shape memory alloy.

44. A valve repair system according to any one of claims 23 to 43, wherein each of the plurality of paddles comprises an inner paddle and an outer paddle, and each of the anchors comprises at least one fastener corresponding to at least one of the paddles.

45. A method of repairing a patient's native valve, the method comprising: delivering an implantable prosthetic device to the native valve, the implantable prosthetic device comprising: An anchor portion comprising one or more anchors coupled to the mate element and the cover, wherein Each of the anchors comprises an inner blade, an outer blade and a blade frame, wherein the paddle frame has an inner frame portion and at least two outer arms, each of the outer arms being connected to the inner frame member at a respective distal connection point and extending proximally to a proximal portion of the device; one or more actuation lines connected to the blade frame; wherein the one or more actuation lines extend from the proximal portion through the coaptation element to the distal portion, from the distal portion along each of the outer arms to the proximal portion, and radially inwardly from the proximal portion to connect to a fixed location on the device relative to the outer arms; moving the anchor from an open position to a closed position to capture the native valve leaflets, and Tension is applied to the actuation line to move the blade frame from an expanded position having an expanded width to a narrowed position having a narrowed width.

46. ​​The method of claim 45, wherein providing tension to the actuation line causes each of the outer arms to pivot, hinge or flex inwardly about the respective distal connection point.

47. A method according to claim 45 or 46, wherein each outer arm has a first portion extending distally from its respective distal connection point, a second portion extending proximally toward the proximal portion, and a bend connecting the first portion to the second portion, and wherein applying tension to the actuation line causes each of the outer arms to articulate at the bend and at its respective distal connection point.

48. The method of claim 47, further comprising decreasing a first distance between the first portion and the inner frame member and decreasing a second distance between the second portion and the first portion when the blade frame moves from the deployed position to the narrowed position.

49. The method of claim 47, further comprising overlapping the inner frame member with the second portion in the narrowed position.

50. The method of any one of claims 45 to 49, wherein each of the outer arms has a proximal tip, and wherein moving the paddle frame from the deployed position to the narrowed position further comprises positioning the proximal tip proximate the fixed position.

51. A method according to any one of claims 45 to 50, wherein the fixing location is on the inner frame member.

52. The method of any one of claims 45 to 51 , wherein applying tension to the actuation line applies tension along the length of each of the outer arms.

53. The method of any one of claims 45 to 52, further comprising biasing the outer arm outwardly.

54. The method of claim 53, further comprising biasing the outer arm outwardly at a proximal tip of the outer arm.

55. The method of any one of claims 45 to 54, further comprising relieving strain from the blade frame via one or more cutouts in the blade frame.

56. A method according to any one of claims 45 to 55, wherein the method is performed as a simulation.

57. The method of claim 56, wherein the simulation is performed on a cadaver, a computer simulator, or a virtual human.

58. The device of any one of claims 1 to 22, wherein the device is sterilized.

59. The system of any one of claims 23 to 44, wherein one or more of the components of the system are sterilized.

60. The method of any one of claims 45 to 57, wherein one or more components of the system are sterilized.

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