WO2026030053A2 - Heart valve repair devices and delivery devices therefor - Google Patents

Abstract

An implantable device or implant is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal. The implantable device or implant can include one or more paddle frames that are expandable and collapsable for delivery through a catheter and/or adjustable in width during implantation of the device. The implantable device or implant can include paddle frames that cross.

Description

HEART VALVE REPAIR DEVICES AND DELIVERY DEVICES THEREFOR

RELATED APPLICATIONS

[0001] The present application claims the benefit of US Provisional Patent Application No. 63/677,402, filed on luly 30, 2024, titled “Heart Valve Repair Devices and Delivery Devices Therefor”, which is incorporated herein by reference in its entirety.

BACKGROUND

[0002] The native heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves may be damaged, and thus rendered less effective, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc. Such damage to the valves may result in serious cardiovascular compromise or death. Damaged valves may be surgically repaired or replaced during open heart surgery. However, open heart surgeries are highly invasive, and complications may occur. Transvascular techniques can be used to introduce and implant devices to treat a heart in a manner that is much less invasive than open heart surgery. As one example, a transvascular technique useable for accessing the native mitral and aortic valves is the trans-septal technique. The trans-septal technique comprises advancing a catheter into the right atrium (e.g., inserting a catheter into the right femoral vein, up the inferior vena cava and into the right atrium). The septum is then punctured, and the catheter passed into the left atrium. A similar transvascular technique can be used to implant a device within the tricuspid valve that begins similarly to the trans-septal technique but stops short of puncturing the septum and instead turns the delivery catheter toward the tricuspid valve in the right atrium.

[0003] A healthy heart has a generally conical shape that tapers to a lower apex. The heart is four-chambered and comprises the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair of cusps, or leaflets, extending downward from the annulus into the left ventricle. The mitral valve annulus may form a “D”-shaped, oval, or otherwise out- of-round cross-sectional shape having major and minor axes. The anterior leaflet may be larger than the posterior leaflet, forming a generally “C”-shaped boundary between the abutting sides of the leaflets when they are closed together.

[0004] When operating properly, the anterior leaflet and the posterior leaflet function 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 dilates (also referred to as “ventricular diastole” or “diastole”), the oxygenated blood that is 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 referred to as “ventricular systole” or “systole”), the increased blood pressure in the left ventricle urges the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle.

[0005] Valvular regurgitation involves the valve improperly allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium from the left ventricle during the systolic phase of heart contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation may have many different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral valve annulus resulting from dilation of the left ventricle, more than one of these, etc. Mitral regurgitation at a central portion of the leaflets can be referred to as central jet mitral regurgitation and mitral regurgitation nearer to one commissure (i.e., location where the leaflets meet) of the leaflets can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle and thus the valve does not close, and regurgitation is present. Tricuspid regurgitation may be similar, but on the right side of the heart. SUMMARY

[0006] This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the feature. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized here.

[0007] In some implementations, there is provided an implantable device or implant (e.g., implantable device, etc.) that is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal.

[0008] In some implementations, an implantable device or implant includes an anchor portion. Each anchor includes a plurality of paddles that are each moveable between an open position and a closed position.

[0009] In some implementations, an implantable device or implant is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal. The implantable device or implant can include a paddle frame that includes an inner frame portion and an outer frame portion. A cover is configured to prevent or inhibit regurgitant blood flow between the inner frame portion and the outer frame portion.

[0010] In some implementations, the implantable device or implant includes a first anchor and a second anchor, where each of the first and second anchors have a paddle frame that includes an inner frame portion and an outer frame portion. The anchors are configured to be move to a closed position in which the inner frame portions and the outer frame portions compress one or more leaflets (e.g., leaflets of a heart valve, such as the mitral valve, tricuspid valve, etc.) within inner and outer pinch points (e.g., pinch regions or regions where the frame members press the leaflet(s)) to secure the implantable device to a native valve of a patient. The implantable device or implant further includes a cover that is attached to the paddle frames of the anchors. The cover is configured block or inhibit blood flow between the anchors. [0011] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device. In some implementations, the implantable device or implant includes a bushing, at least one paddle, and a paddle frame connected to the paddle.

[0012] In some implementations the at least one paddle includes an outer paddle portion, inner paddle portion and a paddle mounting portion connected to the bushing.

[0013] In some implementations, the paddle frame connected to the paddle includes a first portion and a second portion.

[0014] In some implementations, the first and second portions spaced apart and connected by a third portion. In some implementations, the third portion includes a brace portion at least partially contacting the bushing.

[0015] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddle frame portions each include a plurality of struts arranged in a loop shape.

[0016] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the brace portion of the third portion includes a curved strut. In some implementations, a section of the brace portion includes the curved strut.

[0017] In some implementations, a section of the brace portion can include substantially straight portions.

[0018] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the third portion further includes spaced apart struts and the bushing is at least partially disposed in the space.

[0019] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddle frame portions each include a plurality of curved struts. In some implementations, one or more sections of the first and second paddle frame portions include the plurality of curved struts.

[0020] In some implementations, one or more other sections of the first and second paddle frame portions can include substantially straight portions. [0021] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddle frame portions each include an upper loop region and the third portion includes a loop region below the upper loop regions.

[0022] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddle frame portions are configured to contact a plurality of portions of a native leaflet of a heart valve.

[0023] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device wherein the first and second paddle frame portions include a saddle-shaped body.

[0024] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device wherein the first and second paddle frame portions include first and second loop regions disposed on opposite sides of the bushing.

[0025] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device. In some implementations, the implantable device or implant includes a bushing, at least one paddle, and a paddle frame connected to the paddle.

[0026] In some implementations the at least one paddle includes an inner paddle portion and an outer paddle portion.

[0027] In some implementations, a paddle frame includes a first portion and a second portion. In some implementations, the first and second portions are spaced apart and connected by a first brace strut.

[0028] In some implementations, the paddle frame further includes a third portion at least partially disposed between the inner paddle portion and the outer paddle portion. The third portion can be connected to the first and second portions by at least a second brace strut.

[0029] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddle frame portions each include a plurality of struts arranged in a loop shape.

[0030] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second brace struts include at least one curved strut. In some implementations, a section of one or more the first and second brace struts includes the at least one curved strut.

[0031] In some implementations, a section of the brace portion can include substantially straight portions.

[0032] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the third portion further includes spaced apart struts and the bushing is at least partially disposed in the space.

[0033] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddle frame portions each include a plurality of curved struts. In some implementations, one or more sections of the first and second paddle frame portions include the plurality of curved struts.

[0034] In some implementations, one or more other sections of the first and second paddle frame portions can include substantially straight portions.

[0035] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddle frame portions each include an upper loop region and the third portion includes a loop region below the upper loop regions.

[0036] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddle frame portions are configured to contact a plurality of portions of a native leaflet of a heart valve.

[0037] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddle frame portions include a saddle-shaped body.

[0038] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device wherein the first and second paddle frame portions include first and second loop regions disposed on opposite sides of the bushing.

[0039] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device wherein each of the first and second paddle frame portions include a collapsible upper loop region. [0040] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device. In some implementations, the implantable device or implant includes a bushing, first and second paddles disposed on opposite sides of the bushing, and first and second paddle frames.

[0041] In some implementations, the first and second paddles include a plurality of struts. The first and second paddles and/or the plurality of struts may include a crossover region having at least one strut portion of the first paddle frame and one strut of the second paddle frame crossing over each other. For instance, a first strut portion of the first paddle frame can cross over a first strut portion of the second paddle frame.

[0042] In some implementations, the first and second paddles can further include a clamp region. In some implementations, the clamp region can include at least one other strut portion of the first paddle frame in contact with at least one other strut portion of the second paddle frame. For instance, a second strut portion of the first paddle frame can cross over a second strut portion of the second paddle frame.

[0043] In some implementations, the first and second paddles can further include a base region having at least one curved strut. In some implementations, a section of the base region includes the at least one curved strut.

[0044] In some implementations, the base region can include one or more substantially straight portions.

[0045] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddles are configured to contact a native leaflet of a heart valve.

[0046] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the at least one strut portion of the first paddle frame in the crossover region includes an offset strut.

[0047] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the at least one curved strut of the base region is connected to a second curved strut of the base region. [0048] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddle frames include a saddle- shaped body.

[0049] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the plurality of struts of the first and second paddle frames include a plurality of curved struts. In some implementations, one or more sections of the first and second paddle frame portions include the plurality of curved struts.

[0050] In some implementations, one or more other sections of the first and second paddle frame portions can include substantially straight portions.

[0051] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the brace region exerts a clamping force on the first and second paddle frames.

[0052] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddle frames include a hinge portion disposed opposite the base region.

[0053] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the crossover region includes crossing struts.

[0054] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the crossover region includes a plurality of struts of the first paddle frame crossing over a plurality of struts of the second paddle frame.

[0055] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where a curvature of the at least one curved strut of the base exerts a clamping force.

[0056] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device. In some implementations, the implantable device or implant includes a bushing, first and second paddles disposed on opposite sides of the bushing, and first and second paddle frames. [0057] In some implementations, the first and second paddle frames include a plurality of struts and a clamp region. The clamp region may include at least one strut portion of the first paddle frame in contact with at least one strut portion of the second paddle frame.

[0058] In some implementations, the first and second paddle frames include a base region. The base region may include at least one curved strut connecting the first and paddle frames. In some implementations, the curved strut is configured to generate a clamping force between the first and second paddle frames.

[0059] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddles are configured to contact a native heart valve leaflet.

[0060] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device that further includes a hinge between the paddle frames and the paddles. For instance the hinge can couple the first paddle frame and the first paddle.

[0061] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the bushing includes an extended state where the paddle frames are collapsed against the bushing.

[0062] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the bushing includes a retracted state where the paddle frames extend away from the bushing.

[0063] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddle frames contact each other in a clamped state.

[0064] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the clamp region includes a plurality of clamp regions.

[0065] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the clamp region includes a plurality of curved struts. [0066] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the clamp region includes first and second clamp regions separated by at least one non-clamp region.

[0067] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the clamp region includes the at least one strut portion of the first paddle frame having a curved portion in contact with a curved portion of the at least one strut portion of the second paddle frame.

[0068] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable medical device. In some implementations, the implantable device or implant includes a bushing, first and second paddles disposed on opposite sides of the bushing, and first and second paddle frames.

[0069] In some implementations, the first and second paddle frames include a tab portion and first and second strut portions disposed laterally of each side of the central hinge portion.

[0070] In some implementations, the first and second strut portions each including a plurality of flex struts and gaps between the each of the flex struts of the plurality of flex struts.

[0071] In some implementations, the first and second paddle frames include a base region having at least one curved strut connecting the first and paddle frames. In some implementations, the curved strut is configured to generate a clamping force between the first and second paddle frames.

[0072] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddles are configured to contact a native heart valve leaflet.

[0073] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the tab portion connects the first paddle to the first paddle frame.

[0074] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device, the implantable device further including a cap. In some implementations, the cap is disposed distal to the bushing. In some implementations, the cap includes an extended state where the paddle frames are collapsed toward the bushing.

[0075] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the cap includes a retracted state wherein the paddle frames extend away from the bushing, e.g., as compared to the extended state.

[0076] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device where the first and second paddle frames contact each other in a clamped state.

[0077] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device further including a clamp region wherein portions of the first and second paddle frames contact each other.

[0078] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device further including a clamp region having a plurality of curved struts.

[0079] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device further including a clamp region having first and second clamp regions separated by at least one non-clamp region.

[0080] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable device including a clamp region having at least one strut portion of the first paddle frame having a curved portion in contact with a curved portion of at least one strut portion of a second paddle frame.

[0081] In some implementations, the implantable device or implant includes anchors and/or paddle frames that are adjustable in width to a variety of different widths. In some implementations, the cover is configured to block blood flow between the anchors at any width of the anchors and/or paddle frames.

[0082] In some implementations, any of the implantable devices comprising a base region may further include a stiffener coupled to said base region. In some implementations, the stiffener can be coupled to a proximal surface of the base region. In some implementations, the stiffener can be coupled to a distal surface of the base region. In some implementations, the stiffener can comprise at least two stiffeners, the first stiffener coupled to a proximal surface of the stiffener and a second stiffener coupled to a distal surface of the base region.

[0083] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable medical device. In some implementations, the implantable device or implant includes a bushing, first and second paddles disposed on opposite sides of the bushing, and first and second paddle frames.

[0084] In some implementations, the first and second paddle frames include lateral struts that extend away from the bushing. In some implementations, the lateral struts are configured to be pulled toward the bushing to reduce a coaptation distance of the first and second paddles.

[0085] In some implementations, apparatuses, systems, and/or methods described herein relate to an implantable medical device. In some implementations, the implantable device or implant includes a bushing, first and second paddles disposed on opposite sides of the bushing, and first and second paddle frames.

[0086] In some implementations, the first and second paddle frames include beam portions that extend away from a remaining portion of the paddle frame in an extended configuration. For instance, in some implementations, the beam portions may extend laterally away from the remaining portion of the paddle frame.

[0087] In some implementations, the beam portions are configured to be folded toward the remaining portion of the paddle frame.

[0088] A further understanding of the nature and advantages of the present implementations are set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

[0089] To further clarify various aspects of implementations of the present disclosure, a more particular description of the certain examples and implementations will be made by reference to various aspects of the appended drawings. These drawings depict only example implementations of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the Figures, can be drawn to scale for some examples, the Figures, are not necessarily drawn to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0090] FIG. 1 illustrates a cutaway view of the human heart in a diastolic phase;

[0091] FIG. 2 illustrates a cutaway view of the human heart in a systolic phase;

[0092] FIG. 3 illustrates a cutaway view of the human heart in a systolic phase showing mitral regurgitation;

[0093] FIG. 4 is the cutaway view of FIG. 3 annotated to illustrate a natural shape of mitral valve leaflets in the systolic phase;

[0094] FIG. 5 illustrates a healthy mitral valve with the leaflets closed as viewed from an atrial side of the mitral valve;

[0095] FIG. 6 illustrates a dysfunctional mitral valve with a visible gap between the leaflets as viewed from an atrial side of the mitral valve;

[0096] FIG. 7 illustrates a tricuspid valve viewed from an atrial side of the tricuspid valve;

[0097] FIGS. 8-14 show an example of an implantable device or implant, in various stages of deployment;

[0098] FIG. 15 shows an example of an implantable device or implant that is similar to the device illustrated by FIGS. 8-14, but where the paddles are independently controllable;

[0099] FIGS. 16-21 show the example implantable device or implant of FIGS. 8-14 being delivered and implanted within a native valve;

[0100] FIG. 22 shows a perspective view of an example implantable device or implant in a closed position;

[0101] FIG. 23 shows a perspective view of an example implantable device or implant in a closed position; [0102] FIG. 24 illustrates an example valve repair device with paddles in an open position;

[0103] FIGS. 25A and 25B illustrate an example valve repair device that is similar to the valve repair device of FIG. 24, but includes a spacer;

[0104] FIG. 26 illustrates a perspective view of an example of an implantable device having paddles of adjustable widths;

[0105] Figure 27 is a cross-section of the implantable device of Figure 26 in which the implantable device is bisected;

[0106] Figure 28 is another cross-section of the implantable device of Figure 26 in which the implantable device is bisected along a plane perpendicular to the plane shown in Figure 27;

[0107] Figure 29 is a schematic illustration of an example implant catheter assembly coupled to an implantable device;

[0108] Figure 30 is an illustration of the assembly of Figure 29 with the implantable device rotated 90 degrees;

[0109] FIG. 31 shows a perspective view of an example implantable device or implant that includes an example paddle frame where the implantable device or implant is in an open position;

[0110] FIG. 32 shows a bottom view of the implantable device or implant of FIG. 31;

[0111] FIG. 33 shows a front view of the implantable device or implant of FIG. 31 where the implantable device or implant is in a closed position;

[0112] FIG. 34 shows a side view of the implantable device or implant of FIG. 31 attached to a native valve of a heart;

[0113] FIG. 35 shows a bottom view of the implantable device or implant of FIG. 31 attached to a native valve of a heart;

[0114] FIG. 36 shows a perspective view of an example implantable device or implant that includes an example paddle frame where the device includes an example means of moving the paddle frame from a normal position to a narrowed position; [0115] FIG. 37 shows the paddle frame of FIG. 37 in the narrowed position;

[0116] FIG. 38 shows a front view of an example paddle frame for an implantable device or implant;

[0117] FIG. 39 shows a pair of the example paddle frames of FIG. 38 positioned adjacent to each other;

[0118] FIG. 40 shows a side view of an example of an implantable device or implant that includes the paddle frame of FIG. 38, where the paddle frame is in a narrowed position;

[0119] FIG. 41 shows a side view of the implantable device or implant of FIG. 40 where the paddle frame is in an expanded position;

[0120] FIG. 42 shows a partial side view of the implantable device or implant of FIG. 40 where the paddle frame is in the narrowed position;

[0121] FIG. 43 shows a partial side view of the implantable device or implant of FIG. 40 where the paddle frame is in the expanded position;

[0122] FIG. 44 shows a perspective view of the implantable device or implant of FIG. 40 with the paddle frame of FIG. 38;

[0123] FIG. 45 shows a front view of the implantable device or implant of FIG. 40 with the paddle frame of FIG. 38;

[0124] FIG. 46 show a perspective view of an example of inner and outer paddles for the implantable device or implant of FIG. 40;

[0125] FIG. 47 shows a side view of the inner and outer paddles of FIG. 46;

[0126] FIG. 48 shows a top view of the inner and outer paddles of FIG. 46;

[0127] FIG. 49 shows a perspective view of an example connection between the paddles of FIG. 47 and the paddle frame of FIG. 38;

[0128] FIG. 50 shows a front view of an example paddle frame for an implantable device or implant;

[0129] FIG. 51 shows a left side view of the paddle frame of FIG. 50; [0130] FIG. 52 shows a top view of the paddle frame of FIG. 50;

[0131] FIG. 53 shows a perspective view of an example of an implantable device or implant that includes the paddle frame of FIG. 50;

[0132] FIG. 54 shows a front view of the implantable device or implant of FIG. 53 that includes the paddle frame of FIG. 50;

[0133] FIGS. 55-59 shows the implantable device or implant of FIG. 53 having an example means for moving the paddle frame of FIG. 50 between an expanded position and narrowed positions;

[0134] FIG. 64 illustrates an example of a width adjustment device or control device;

[0135] FIG. 61 illustrates an example of an adjustable paddle frame assembly;

[0136] FIG. 62 illustrates an example of an adjustable paddle frame assembly;

[0137] FIG. 63 illustrates an example of an adjustable paddle frame assembly;

[0138] FIG. 64 illustrates an example of an adjustment member of the adjustable paddle frame assemblies of FIGS. 62 and 63;

[0139] FIG. 65 illustrates an example of an adjustable paddle frame assembly;

[0140] FIG. 66 shows a front cross-section view of an implantable device or implant;

[0141] FIG. 67 shows a perspective cross section view of the device/implant of FIG. 66;

[0142] FIG. 68 shows a perspective view of the device/implant of FIG. 66;

[0143] FIG. 69 shows a side view of the device/implant of FIG. 66;

[0144] FIG. 70 shows a top view of the device/implant of FIG. 66;

[0145] FIGS. 71-76 show a partial view of the device/implant of FIG. 66 in various stages of assembly;

[0146] FIG. 77 shows a front view of the device/implant of 70 in an expanded position;

[0147] FIG. 78 shows a side view of the device/implant of 70 in an expanded position;

[0148] FIG. 79 shows a top view of the device/implant of 70 in an expanded position; [0149] FIG. 80 shows a front view of the device/implant of 70 in a narrowed position;

[0150] FIG. 81 shows a side view of the device/implant of 70 in a narrowed position;

[0151] FIG. 82 shows a top view of the device/implant of 70 in a narrowed position;

[0152] FIG. 83 shows a front cross-section view of an example of an implantable device or implant;

[0153] FIG. 84 shows a side view of the device/implant of FIG. 83;

[0154] FIGS. 85-88 shows front views of the device/implant of FIG. 83 at various positions moving from an expanded position to a narrowed position;

[0155] FIG. 89 shows a front sectional view of an example paddle frame for an implantable device or implant;

[0156] FIG. 90 shows a top view of the frame of FIG. 89;

[0157] FIG. 91 A shows an example of a paddle structure made from sheet material;

[0158] FIG. 91B is a side view of the paddle structure of FIG. 91A;

[0159] FIG. 91C is a top view the paddle structure of FIG. 91A;

[0160] FIG. 91D is a bottom the paddle structure of FIG. 91 A;

[0161] FIG. 91E is another side view the paddle structure of FIG. 91A;

[0162] FIG. 91F shows detail of an example of eyelets of the structure the paddle structure of FIG. 91 A;

[0163] FIG. 91G is a top view of the flat material used to make the paddle structure of FIG. 91 A;

[0164] FIG. 91H shows an example of a valve repair device or implant that includes the paddle structure of FIG. 91 A in a fully retracted position.

[0165] FIG. 911 shows the valve repair device or implant of FIG. 91H with the paddle structure in a partially open position; [0166] FIG. 91 J shows the valve repair device or implant of FIG. 91H with the paddle structure in a laterally extended or open position;

[0167] FIG. 92 shows a perspective view of an example of a paddle frame connector and a width adjustment device for an implantable device;

[0168] FIG. 93 shows a perspective cross-sectional view of the paddle frame connector and the width adjustment device of FIG. 92;

[0169] FIG. 94 shows a front cross-sectional view of the paddle frame connector and the width adjustment device of FIG. 92;

[0170] FIG. 95 shows a bottom view of the paddle frame connector and the width adjustment device of FIG. 92;

[0171] FIG. 96 shows a front cross-sectional view of an example of a paddle frame connector and a width adjustment device for an implantable device;

[0172] FIG. 97 shows an example of a coupler for connection with an example width adjustment element for the width adjustment device of FIG. 96;

[0173] FIG. 98 illustrates a cross-sectional view of an example of a receiver for the width adjustment device of FIG. 96 with the distal portion of the actuation shaft of FIG. 97 moving through the receiver;

[0174] FIG. 99 shows a perspective view of an example implantable device;

[0175] FIG. 100 shows a top view of the implantable device of FIG. 99;

[0176] FIG. 101 shows a side view of the implantable device of FIG. 99;

[0177] FIG. 102 shows a perspective view of a coaptation element of the implantable device of FIG. 99;

[0178] FIG. 103 shows a front view of the coaptation element of FIG. 102;

[0179] FIG. 104 shows a bottom view of the coaptation element of FIG. 102;

[0180] FIG. 105 shows a side view of the coaptation element of FIG. 102; [0181] FIG. 106 shows a front cross-sectional view of the coaptation element of FIG. 102 taken along the plane indicated by lines 177-177 shown in FIG. 105;

[0182] FIG. 107 shows a perspective view of example paddles connected to the coaptation element of FIG. 102;

[0183] FIG. 108 shows a front cross-sectional view of an example implantable device having an example coupler for connecting an example width adjustment element to adjustable width paddles of the implantable device;

[0184] FIG. 109 shows a partial perspective view of the coupler of FIG. 108 connecting the width adjustment element to the adjustable width paddles of the implantable device;

[0185] FIG. 110 shows a partial cross-sectional view of a connection between the width adjustment member and the coupler of the implantable device of FIG. 108;

[0186] FIG. Ill shows a partial cross-sectional view of the connection between the coupler and the width adjustment member of FIG. 108;

[0187] FIG. 112 shows a front perspective view of the connection between the coupler and the width adjustment member of FIG. 108;

[0188] FIG. 113 shows a side perspective view of the connection between the coupler and the width adjustment member of FIG. 108;

[0189] FIG. 115 shows a front cross-sectional view of an example implantable device having an example coupler for connecting an example width adjustment member to the adjustable width paddles of the implantable device;

[0190] FIG. 115 shows a perspective cross-sectional view of the implantable device and the width adjustment member of FIG. 115;

[0191] FIG. 116 shows a front cross-sectional view of the implantable device of FIG. 115 with the connection between the coupler and the width adjustment member;

[0192] FIG. 117 shows a cutaway front view of the coupler of FIG. 115 connected with a width adjustment member; [0193] FIG. 118 shows a cutaway perspective view of the coupler of FIG. 115 connected with the width adjustment member;

[0194] FIG. 119 shows a perspective cross-sectional view of the coupler of FIG. 115 connected with the width adjustment member;

[0195] FIG. 120 shows a cutaway front view of the coupler of FIG. 115 disconnected from the width adjustment member;

[0196] FIG. 121 shows a cutaway perspective view of the coupler of FIG. 115 disconnected from the width adjustment member;

[0197] FIG. 122 shows a perspective cross-sectional view of the coupler of FIG. 115 disconnected from the width adjustment member;

[0198] FIG. 123 is a front sectional view showing engagement between the coupler and a receiver of the implantable device of FIG. 115 when the width adjustment member is disconnected from the coupler;

[0199] FIG. 124 shows a perspective view of the engagement between the coupler and the receiver of the implantable device shown in FIG. 123;

[0200] FIG. 125 shows a perspective view of another example coupler, where the coupler is in a locking position;

[0201] FIG. 126 shows a perspective view of the coupler of FIG. 125, where the coupler is in an unlocked position;

[0202] FIG. 127 shows a left side view of the coupler of FIG. 125, where the coupler is in an unlocked position;

[0203] FIG. 128 shows a right-side view of the coupler of FIG. 125, where the coupler feature is in an unlocked position;

[0204] FIG. 129 shows a top view of the coupler of FIG. 125, where the coupler is in the locked position;

[0205] FIG. 130 shows front view of the coupler of FIG. 125, where the coupler is in the locked position; [0206] FIG. 131 shows a front cross-sectional view of an example implantable device having an example coupler for connecting an example width adjustment element to adjustable width paddles of the implantable device;

[0207] FIG. 132 is a front sectional view showing engagement between the coupler and a receiver of the implantable device of FIG. 131 when the width adjustment element is disconnected from the coupler;

[0208] FIG. 133 shows a front cross-sectional view of an example implementation of the implantable device of FIG. 131 where the receiver has a non-threaded portion that prevents or inhibits the coupler from attaching to the receiver when within the non-threaded portion;

[0209] FIG. 134 shows a front cross-sectional view of another example implementation of the implantable device of FIG. 131 where the receiver has a window or opening that prevents or inhibits the coupler from attaching to the receiver when within the window or opening;

[0210] FIG. 135 shows a cutaway front view of a portion of the implantable device of FIG. 133 where the coupler is connected with the width adjustment element and disposed within the non-threaded portion of the receiver;

[0211] FIG. 136 shows a cutaway front view of a portion of the implantable device of FIG. 133 where the coupler is disconnected from the width adjustment element and disposed within the non-threaded portion of the receiver;

[0212] FIG. 137 is a perspective view of one implementation of an implantable device having expandable paddles/frames.

[0213] FIG. 138 is a perspective view of the paddles/frames of the device of FIG. 137 shown in isolation from other components of the device.

[0214] FIG. 139 is a partial exploded perspective view of the device of FIG. 137 showing the expandable paddles/frames.

[0215] FIG. 140 is a top view of the device of FIG. 137.

[0216] FIG. 141 is a side elevational view of the device of FIG. 137. [0217] FIG. 142 is a front elevational view of the device of FIG. 137.

[0218] FIG. 143 is a perspective view of another implementation of an implantable device having expandable paddles/frames.

[0219] FIG. 144 is a side elevational view of certain components of the device of FIG. 143.

[0220] FIG. 145 is a perspective view of the paddles/frames of the device of FIG. 143 shown in isolation from other components of the device.

[0221] FIG. 146 is a perspective view of an implementation of an implantable device having a clamping arrangement for the paddles/frames.

[0222] FIG. 147 is a perspective view of the paddles/frames of the device of FIG. 146 shown in isolation from other components of the device.

[0223] FIG. 148 is a perspective view of an implementation of paddle bodies which are split into separate components and in isolation from other device components.

[0224] FIG. 149 is a perspective view of an implementation of an implantable device having a scissors or crossover region generating an association (or clamping) force for the paddles/frames.

[0225] FIG. 150 is a perspective view of the paddles/frames of the device of FIG. 149 shown in isolation from other device components.

[0226] FIG. 151 is a side elevational view of the paddles/frames of the device of FIG. 149 shown in isolation from other device components.

[0227] FIG. 152 is a top view of the paddles/frames of the device of FIG. 149 shown in isolation from the other device components.

[0228] FIG. 153 is a perspective view of the paddles/frames of the device of FIG. 149 shown in one shape-set implementation.

[0229] FIG. 154 is a perspective view of an implementation of an implantable device having a scissors or crossover region and expandable paddles/frames.

[0230] FIG. 155 is a side elevational view of the device of FIG. 154. [0231] FIG. 156 is a perspective view of the paddles/frames of the device of FIG. 154 shown in isolation from other device components.

[0232] FIG. 157 is a bottom view of the paddles/frames of the device of FIG. 154 shown in isolation from other device components.

[0233] FIG. 158 is a front elevational view of the paddles/frames of the device of FIG. 154 shown in isolation from other device components.

[0234] FIG. 159 is a perspective view of an implementation of an implantable device having a scissors or crossover region and expandable paddles/frames.

[0235] FIG. 160 is a perspective view of the paddles/frames of the device of FIG. 159 shown in isolation from other device components.

[0236] FIG. 161 is a top view of the paddles/frames of the device of FIG. 159 shown in isolation from other device components.

[0237] FIG. 162 is a perspective view of an implementation of an implantable device having a scissors or crossover region and expandable paddles/frames.

[0238] FIG. 163 is a perspective view of the paddles/frames of the device of FIG. 162 shown in isolation from other device components.

[0239] FIG. 164 is a bottom view of the paddles/frames of the device of FIG. 162 shown in isolation from other device components.

[0240] FIG. 165 is a top view of the device of FIG. 162 with the paddles/frames collapsed.

[0241] FIG. 166 is a perspective view of the device of FIG. 162 with the paddles/frames collapsed.

[0242] FIG. 167 is a perspective view of another implementation of an implantable device having a scissors or crossover region and expandable paddles/frames.

[0243] FIG. 168 is a perspective view of the paddles/frames of the device of FIG. 167 shown in isolation from other device components. [0244] FIG. 169 is a perspective view of an implementation of expandable paddles/frames having a scissors or crossover region.

[0245] FIG. 170 is a perspective view of an implementation of an implantable device having expandable paddles/frames.

[0246] FIG. 171 is a front elevational view of the device of FIG. 170.

[0247] FIG. 172 is a side elevational view of the device of FIG. 170.

[0248] FIG. 173 is a bottom view of the paddles/frames of the device of FIG. 170 shown in isolation from other device components.

[0249] FIG. 174 is a perspective view of the paddles/frames of the device of FIG. 170 shown in isolation from other device components.

[0250] FIG. 175 is a perspective view of the device of FIG. 170 shown with the expandable paddles/frames further collapsed inward.

[0251] FIG. 176 is a front elevational view of the device of FIG. 175.

[0252] FIG. 177 is a side elevational view of the device of FIG. 175.

[0253] FIG. 178 is a top view of the device of FIG. 175.

[0254] FIG. 179 is a perspective view of the collapsed paddles/frames of the device of

FIG. 175 and shown in isolation from other device components.

[0255] FIG. 180 is a perspective view of one implementation of a stiffener.

[0256] FIG. 181 is a perspective view of the stiffener of FIG. 180 in its shape-set configuration.

[0257] FIG. 182 is a side elevation view of the stiffener of FIG. 181 incorporated into a paddle frame base portion.

[0258] FIG. 183 is a side elevation view of the stiffener of FIG. 181 incorporated into a paddle frame base portion having a scissors or crossover portion. DETAILED DESCRIPTION

[0259] The following description refers to the accompanying drawings, which illustrate example implementations of the present disclosure. Other implementations having different structures and operation do not depart from the scope of the present disclosure.

[0260] Example implementations of the present disclosure are directed to systems, devices, methods, etc. for repairing a defective heart valve. For example, some implementations of implantable devices, valve repair devices, implants, and systems (including systems for delivery thereof) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible. Further, the treatment techniques and methods herein can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g. with the body parts, heart, tissue, etc. being simulated), etc.

[0261] As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection can be direct as between the components or can be indirect such as through the use of one or more intermediary components. Also as described herein, reference to a "member," “component,” or “portion” shall not be limited to a single structural member, component, or element but can include an assembly of components, members, or elements. Also as described herein, the terms “substantially” and “about” are defined as at least close to (and includes) a given value or state (preferably within 10% of, more preferably within 1% of, and most preferably within 0.1% of).

[0262] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc. The device described or suggested herein or in references incorporated herein can be used on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc. [0263] FIGS. 1 and 2 are cutaway views of the human heart H in diastolic and systolic phases, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV; i.e., the atrioventricular valves. Additionally, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in FIGS. 3-6 and leaflets 30, 32, 34 shown in Fig. 7) extending inward across the respective orifices that come together or “coapf ’ in the flow stream to form the one-way, fluid-occluding surfaces. The native valve repair systems of the present application are frequently described and/or illustrated with respect to the mitral valve MV. Therefore, anatomical structures of the left atrium LA and left ventricle LV will be explained in greater detail. However, the devices described herein can also be used in repairing other native valves, e.g., the devices can be used in repairing the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0264] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase, or diastole, seen in FIG. 1, the blood that was previously collected in the left atrium LA (during the systolic phase) moves through the mitral valve MV and into the left ventricle LV by expansion of the left ventricle LV. In the systolic phase, or systole, seen in FIG. 2, the left ventricle LV contracts to force the blood through the aortic valve AV and ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close to prevent or inhibit the blood from regurgitating from the left ventricle LV and back into the left atrium LA and blood is collected in the left atrium from the pulmonary vein. In some implementations, the devices described by the present application are used to repair the function of a defective mitral valve MV. That is, the devices are configured to help close the leaflets of the mitral valve to prevent, inhibit, or reduce blood from regurgitating from the left ventricle LV and back into the left atrium LA. Many of the devices described in the present application are designed to easily grasp and secure the native leaflets around a coaptation element or spacer that beneficially acts as a filler in the regurgitant orifice to prevent or inhibit back flow or regurgitation during systole, though this is not necessary.

[0265] Referring now to FIGS. 1-7, the mitral valve MV includes two leaflets, the anterior leaflet 20 and the posterior leaflet 22. The mitral valve MV also includes an annulus 24 (see Fig. 5), which is a variably dense fibrous ring of tissues that encircles the leaflets 20, 22. Referring to FIGS. 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., the muscles located at the base of the chordae tendineae CT and within the walls of the left ventricle LV) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM serve to limit the movements of leaflets 20, 22 of the mitral valve MV and prevent the mitral valve MV from being reverted. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Rather, the papillary muscles PM support or brace the leaflets 20, 22 against the high pressure needed to circulate blood throughout the body. Together the papillary muscles PM and the chordae tendineae CT are known as the subvalvular apparatus, which functions to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As seen from a Left Ventricular Outflow Tract (LVOT) view shown in FIG. 3, the anatomy of the leaflets 20, 22 is such that the inner sides of the leaflets coapt at the free end portions and the leaflets 20, 22 start receding or spreading apart from each other. The leaflets 20, 22 spread apart in the atrial direction, until each leaflet meets with the mitral annulus.

[0266] Various disease processes can impair proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow’s Disease, 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 the right ventricle RV from prior heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy, etc.) may distort a native valve’s geometry, which may cause the native valve to dysfunction. However, the majority of patients undergoing valve surgery, such as surgery to the mitral valve MV, suffer from a degenerative disease that causes a malfunction in a leaflet (e.g., leaflets 20, 22) of a native valve (e.g., the mitral valve MV), which results in prolapse and regurgitation.

[0267] Generally, a native valve may malfunction in different ways: including (1) valve stenosis; and (2) valve regurgitation. Valve stenosis occurs when a native valve does not open completely and thereby causes an obstruction of blood flow. Typically, valve stenosis results from the buildup of calcified material on the leaflets of a valve, which causes the leaflets to thicken and impairs the ability of the valve to fully open to permit forward blood flow. Valve regurgitation occurs when the leaflets of the valve do not close completely thereby causing blood to leak back into the prior chamber (e.g., causing blood to leak from the left ventricle to the left atrium).

[0268] There are three main mechanisms by which a native valve becomes regurgitant — or incompetent — which include Carpentier’s type I, type II, and type III malfunctions. A Carpentier type I malfunction involves the dilation of the annulus such that normally functioning leaflets are distracted from each other and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in a type I mechanism malfunction are perforations of the leaflets, as are present in endocarditis. A Carpentier’s type II malfunction involves prolapse of one or more leaflets of a native valve above a plane of coaptation. A Carpentier’s type III malfunction involves restriction of the motion of one or more leaflets of a native valve such that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction may be caused by rheumatic disease or dilation of a ventricle.

[0269] Referring to FIG. 5, when a healthy mitral valve MV is in a closed position, the anterior leaflet 20 and the posterior leaflet 22 coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Referring to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflet 20 and/or the posterior leaflet 22 of the mitral valve MV is displaced into the left atrium LA during systole so that the edges of the leaflets 20, 22 are not in contact with 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 into the left atrium LA from the left ventricle LV during systole, as illustrated by the mitral regurgitation MR flow path shown in FIG. 3. Referring to FIG. 6, the gap 26 can have a width W 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 situations, the gap 26 can have a width W greater than 15 mm or even 17.5 mm. As set forth above, there are several different ways that a leaflet (e.g. leaflets 20, 22 of mitral valve MV) may malfunction which can thereby lead to valvular regurgitation.

[0270] In any of the above-mentioned situations, a valve repair device or implant is desired that is capable of engaging the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent or inhibit regurgitation of blood through the mitral valve MV. As can be seen in FIG. 4, an abstract representation of an implantable device, valve repair device, or implant 10 is shown implanted between the leaflets 20, 22 such that regurgitation does not occur during systole (compare FIG. 3 with FIG. 4). In some implementations, the coaptation element (e.g., spacer, coaptation element, gap filler, etc.) of the device 10 has a generally tapered or triangular shape that naturally adapts to the native valve geometry and to its expanding leaflet nature (toward the annulus). In this application, the terms spacer, coaptation element, coaptation element, and gap filler are used interchangeably and refer to an element that fills a portion of the space between native valve leaflets and/or that is configured such that the native valve leaflets engage or “coapt” against (e.g., such that the native leaflets coapt against the coaptation element, coaptation element, spacer, etc. instead of only against one another).

[0271] Although stenosis or regurgitation may affect any valve, stenosis is predominantly found to affect either the aortic valve AV or the pulmonary valve PV, and regurgitation is predominantly found to affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the workload of the heart H and may lead to very serious conditions if left un-treated; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Because the left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) are primarily responsible for circulating the flow of blood throughout the body. Accordingly, because of the substantially higher pressures on the left side heart dysfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life threatening.

[0272] Malfunctioning native heart valves can either be repaired or replaced. Repair typically involves the preservation and correction of the patient’s native valve. Replacement typically involves replacing the patient’s native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Because stenotic damage sustained by the leaflets is irreversible, treatments for a stenotic aortic valve or stenotic pulmonary valve can be removal and replacement of the valve with a surgically implanted heart valve, or displacement of the valve with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more prone to deformation of leaflets and/or surrounding tissue, which, as described above, may prevent the mitral valve MV or tricuspid valve TV from closing properly and allows for regurgitation or back flow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow for regurgitation or back flow from the left ventricle LV to the left atrium LA as shown in FIG. 3). The regurgitation or back flow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or the tricuspid valve TV are often repairable. In addition, 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 be reverted such that blood is regurgitated into the left atrium LA. The problems occurring due to dysfunctional chordae tendineae CT can be repaired by repairing the chordae tendineae CT or the structure of the mitral valve MV (e.g., by securing the leaflets 20, 22 at the affected portion of the mitral valve).

[0273] The devices and procedures disclosed herein can make reference to repairing the structure of a mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve, as well as any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit regurgitation of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts herein can be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or inhibit regurgitation of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein can be used on all three of the leaflets 30, 32, 34 together to prevent or inhibit regurgitation of blood from the right ventricle to the right atrium. That is, the valve repair devices or implants provided herein can be centrally located between the three leaflets 30, 32, 34.

[0274] An example implantable device or implant can optionally have a coaptation element (e.g., spacer, coaptation element, gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, an implantable device or implant can have any combination or sub-combination of the features disclosed herein without a coaptation element. When included, the coaptation element (e.g., coaptation element, spacer, etc.) is configured to be positioned within the native heart valve orifice to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting regurgitation described above. The coaptation element can have a structure that is impervious to blood (or that resists blood flow therethrough) and that allows the native leaflets to close around the coaptation element during ventricular systole to block blood from flowing from the left or right ventricle back into the left or right atrium, respectively. The device or implant can be configured to seal against two or three native valve leaflets; that is, the device can be used in the native mitral (bicuspid) and tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element can fill a space between improperly functioning native leaflets (e.g., mitral leaflets 20, 22 or tricuspid leaflets 30, 32, 34) that do not close completely.

[0275] The optional coaptation element (e.g., spacer, coaptation element, gap filler, etc.) can have various shapes. In some implementations, the coaptation element can have an elongated cylindrical shape having a round cross-sectional shape. In some implementations, the coaptation element can have an oval cross-sectional shape, an ovoid cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non- cylindrical shapes. In some implementations, the coaptation element can have an atrial portion positioned in or adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a side surface that extends between the native leaflets. In some implementations configured for use in the tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, and the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the side surfaces extend between the native tricuspid leaflets.

[0276] In some implementations, the anchor can be configured to secure the device to one or both of the native leaflets such that the coaptation element is positioned between the two native leaflets. In some implementations configured for use in the tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between the three native leaflets. In some implementations, the anchor can attach to the coaptation element at a location adjacent the ventricular portion of the coaptation element. In some implementations, the anchor can attach to an actuation element, such as a shaft or actuation wire, to which the coaptation element is also attached. In some implementations, the anchor and the coaptation element can be positioned independently with respect to each other by separately moving each of the anchor and the coaptation element along the longitudinal axis of the actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.). In some implementations, the anchor and the coaptation element can be positioned simultaneously by moving the anchor and the coaptation element together along the longitudinal axis of the actuation element, e.g., shaft, actuation wire, etc.). The anchor can be configured to be positioned behind a native leaflet when implanted such that the leaflet is grasped by the anchor.

[0277] The device or implant can be configured to be implanted via a delivery system or other means for delivery. The delivery system can comprise one or more of a guide/delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, tube, combinations of these, etc. The coaptation element and the anchor can be compressible to a radially compressed state and can be self-expandable to a radially expanded state when compressive pressure is released. The device can be configured for the anchor to be expanded radially away from the still- compressed coaptation element initially in order to create a gap between the coaptation element and the anchor. A native leaflet can then be positioned in the gap. The coaptation element can be expanded radially, closing the gap between the coaptation element and the anchor and capturing the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to self-expand. The implantation methods for some implementations can be different and are more fully discussed below with respect to each implementation. Additional information regarding these and other 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 Nos. W02020/076898, each of which is incorporated herein by reference in its entirety for all purposes. These method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g. with the body parts, heart, tissue, etc. being simulated), etc. mutatis mutandis.

[0278] The disclosed devices or implants can be configured such that the anchor is connected to a leaflet, taking advantage of the tension from native chordae tendineae to resist high systolic pressure urging the device toward the left atrium. During diastole, the devices can rely on the compressive and retention forces exerted on the leaflet that is grasped by the anchor. [0279] Referring now to FIGS. 8-15, a schematically illustrated implantable device or implant 100 (e.g., an implantable prosthetic device, a prosthetic spacer device, a valve repair device, etc.) is shown in various stages of deployment. The device or implant 100 and other similar devices/implants are described in more detail in PCT patent application publication Nos. WO2018/195215, W02020/076898, and WO 2019/139904, which are incorporated herein by reference in their entirety. The device 100 can include any other features for an implantable device or implant discussed in the present application or the applications cited above, and the device 100 can 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 applications cited above).

[0280] The device or implant 100 is deployed from a delivery system 102. The delivery system 102 can comprise one or more of a catheter, a sheath, a guide catheter/sheath, a delivery catheter/sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations of these, etc. The device or implant 100 includes a coaptation portion/coaptation region 104 and an anchor portion/ anchor region 106.

[0281] In some implementations, the coaptation portion 104 of the device or implant 100 includes a coaptation element or means for coapting 110 (e.g., spacer, plug, filler, foam, sheet, membrane, coaptation element, etc.) that is adapted to be implanted between leaflets of a native valve (e.g., a native mitral valve, native tricuspid valve, etc.) and is slidably attached to an actuation element 112 (e.g., actuation wire, actuation shaft, actuation tube, etc.). The anchor portion 106 includes one or more anchors 108 that are actuatable between open and closed conditions and can take a wide variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element 112 opens and closes the anchor portion 106 of the device 100 to grasp the native valve leaflets during implantation. The actuation element 112 (as well as other means for actuating and actuation elements disclosed herein) can take a wide variety of different forms (e.g., as a wire, rod, shaft, tube, screw, suture, line, strip, combination of these, etc.), be made of a variety of different materials, and have a variety of configurations. As one example, the actuation element can be threaded such that rotation of the actuation element moves the anchor portion 106 relative to the coaptation portion 104. Or, the actuation element can be unthreaded, such that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the coaptation portion 104.

[0282] The anchor portion 106 and/or anchors of the device 100 include outer paddles 120 and inner paddles 122 that are, in some implementations, connected between a cap 114 and coaptation element 110 by portions 124, 126, 128. The portions 124, 126, 128 can be jointed and/or flexible to move between all of the positions described below. The interconnection of the outer paddles 120, the inner paddles 122, the coaptation element 110, and the cap 114 by the portions 124, 126, and 128 can constrain the device to the positions and movements illustrated herein.

[0283] In some implementations, the delivery system 102 includes a steerable catheter, implant catheter, and the actuation element 112 (e.g., actuation wire, actuation shaft, etc.). These can be configured to extend through a guide catheter/sheath (e g., a transseptal sheath, etc.). In some implementations, the actuation element 112 extends through a delivery catheter and the coaptation element 110 to the distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuation element 112 increases and decreases the spacing between the coaptation element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), respectively. In some implementations, a collar or other attachment element removably attaches the coaptation element 110 to the delivery system 102, either directly or indirectly, so that the actuation element 112 slides through the collar or other attachment element and, in some implementations, through a coaptation element 110 during actuation to open and close the paddles 120, 122 of the anchor portion 106 and/or anchors 108.

[0284] In some implementations, the anchor portion 106 and/or anchors 108 can include attachment portions or gripping members. The illustrated gripping members can comprise clasps 130 that include a base or fixed arm 132, a moveable arm 134, optional frictionenhancing elements or other means for securing 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesive, etc.), and ajoint portion 138. The fixed arms 132 are attached to the inner paddles 122. In some implementations, the fixed arms 132 are attached to the inner paddles 122 with the joint portion 138 disposed proximate the coaptation element 110. The joint portion 138 provides a spring force between the fixed and moveable arms 132, 134 of the clasp 130. The joint portion 138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the joint portion 138 is a flexible piece of material integrally formed with the fixed and moveable arms 132, 134. The fixed arms 132 are attached to the inner paddles 122 and remain stationary or substantially stationary relative to the inner paddles 122 when the moveable arms 134 are opened to open the clasps 130 and expose the barbs or other friction-enhancing elements 136.

[0285] In some implementations, the clasps 130 are opened by applying tension to actuation lines 116 attached to the moveable arms 134, thereby causing the moveable arms 134 to articulate, flex, or pivot on the joint portions 138. The actuation lines 116 extend through the delivery system 102 (e.g., through a steerable catheter and/or an implant catheter). Other actuation mechanisms are also possible.

[0286] The actuation line 116 can take a wide variety of forms, such as, for example, a line, a suture, a wire, a rod, a catheter, or the like. The clasps 130 can be spring loaded so that in the closed position the clasps 130 continue to provide a pinching force on the grasped native leaflet. Optional barbs or other friction-enhancing elements 136 of the clasps 130 can grab, pinch, and/or pierce the native leaflets to further secure the native leaflets.

[0287] During implantation, the paddles 120, 122 can be opened and closed, for example, to grasp the native leaflets (e.g., native mitral valve leaflets, etc.) between the paddles 120, 122 and/or between the paddles 120, 122 and a coaptation element 110 (e.g., a spacer, plug, membrane, gap filler, etc.). The clasps 130 can be used to grasp and/or further secure the native leaflets by engaging the leaflets with barbs or other friction-enhancing elements 136 and pinching the leaflets between the moveable and fixed arms 134, 132. The barbs or other friction-enhancing elements 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesive, etc.) of the clasps or barbed clasps 130 increase friction with the leaflets or can partially or completely puncture the leaflets. The actuation lines 116 can be actuated separately so that each clasp 130 can be opened and closed separately. Separate operation allows one leaflet to be grasped at a time, or for the repositioning of a clasp 130 on a leaflet that was insufficiently grasped, without altering a successful grasp on the other leaflet. The clasps 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing leaflets to be grasped in a variety of positions as the particular situation requires.

[0288] Referring now to FIG. 8, the device 100 is shown in an elongated or fully open condition for deployment from an implant delivery catheter of the delivery system 102. The device 100 is disposed at the end of the catheter of the delivery system 102 in the fully open position. In the elongated condition the cap 114 is spaced apart from the coaptation element 110 such that the paddles 120, 122 are fully extended. In some implementations, an angle formed between the interior of the outer and inner paddles 120, 122 is approximately 180 degrees. The clasps 130 can be kept in a closed condition during deployment through the delivery system. The actuation lines 116 can extend and attach to the moveable arms 134.

[0289] Referring now to FIG. 9, the device 100 is shown in an elongated condition, similar to FIG. 8, but with the clasps 130 in a fully open position, ranging from about 140 degrees to about 200 degrees, from about 170 degrees to about 190 degrees, or about 180 degrees between fixed and moveable portions 132, 134 of the clasps 130.

[0290] Referring now to FIG. 10, the device 100 is shown in a shortened or fully closed condition. To move the device 100 from the elongated condition to the shortened condition, the actuation element 112 is retracted to pull the cap 114 towards the coaptation element 110 (e.g., towards a spacer). The connection portion(s) 126 (e.g., joint(s), flexible connection(s), etc.) between the outer paddle 120 and inner paddle 122 are constrained in movement such that compression forces acting on the outer paddle 120 from the cap 114 being retracted towards the coaptation element 110 cause the paddles or gripping elements to move radially outward.

During movement from the open position to the closed position, the outer paddles 120 maintain an acute angle with the actuation element 112. The outer paddles 120 can optionally be biased toward a closed position. The inner paddles 122 during the same motion move through a considerably larger angle as they are oriented away from the coaptation element 110 in the open condition and collapse along the sides of the coaptation element 110 in the closed condition.

[0291] Referring now to FIGS. 11-13, the device 100 is shown in a partially open, graspready condition. To transition from the fully closed to the partially open condition, the actuation element (e.g., actuation wire, actuation shaft, etc.) is extended to push the cap 114 away from the coaptation element 110, thereby pulling on the outer paddles 120, which in turn pull on the inner paddles 122, causing the anchors or anchor portion 106 to partially unfold. The actuation lines 116 are also retracted to open the clasps 130 so that the leaflets can be grasped. In some implementations, the pair of inner and outer paddles 122, 120 are moved in unison, rather than independently, by a single actuation element 112. Also, the positions of the clasps 130 are dependent on the positions of the paddles 122, 120. For example, referring to FIG. 10 closing the paddles 122, 120 also closes the clasps. In some implementations, the paddles 120, 122 can be independently controllable. In the example illustrated by Figure 15, the device 100 can have two actuation elements 111, 113 and two independent caps 115, 117 (or other attachment portions), such that one independent actuation element (e.g., wire, shaft, etc.) and cap (or other attachment portion) are used to control one paddle, and the other independent actuation element and cap (or other attachment portion) are used to control the other paddle.

[0292] Referring now to FIG. 12, one of the actuation lines 116 is extended to allow one of the clasps 130 to close. Referring now to FIG. 13, the other actuation line 116 is extended to allow the other clasp 130 to close. Either or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0293] Referring now to FIG. 14, the device 100 is shown in a fully closed and deployed condition. The delivery system 102 and actuation element 112 are retracted and the paddles 120, 122 and clasps 130 remain in a 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 through the use of spring materials, such as steel, other metals, plastics, composites, etc. or shape-memory alloys such as Nitinol. For example, the connection portions 124, 126, 128, the joint portions 138, and/or the inner and outer paddles 122, and/or an additional biasing component (not shown) can be formed of metals such as steel or shape-memory alloy, such as Nitinol — produced in a wire, sheet, tubing, or laser sintered powder — and are biased to hold the outer paddles 120 closed around the coaptation element 110 and the clasps 130 pinched around native leaflets. Similarly, the fixed and moveable arms 132, 134 of the clasps 130 are biased to pinch the leaflets. In some implementations, the attachment or connection portions 124, 126, 128, joint portions 138, and/or the inner and outer paddles 122, and/or an additional biasing component (not shown) can be formed of any other suitably elastic material, such as a metal or polymer material, to maintain the device 100 in the closed condition after implantation.

[0294] FIG. 15 illustrates an example where the paddles 120, 122 are independently controllable. The device 101 illustrated by FIG. 15 is similar to the device illustrated by FIG. 11, except the device 100 of FIG. 15 includes an actuation element that is configured as two independent actuation elements or actuation wires 111, 113 that are coupled to two independent caps 115, 117. To transition a first inner paddle 122 and a first outer paddle 120 from the fully closed to the partially open condition, the actuation element 111 is extended to push the cap 115 away from the coaptation element 110, thereby pulling on the outer paddle 120, which in turn pulls on the inner paddle 122, causing the first anchor 108 to partially unfold. To transition a second inner paddle 122 and a second outer paddle 120 from the fully closed to the partially open condition, the actuation element 113 is extended to push the cap 115 away from the coaptation element 110, thereby pulling on the outer paddle 120, which in turn pulls on the inner paddle 122, causing the second anchor 108 to partially unfold. The independent paddle control illustrated by FIG. 15 can be implemented on any of the devices disclosed by the present application. For comparison, in the example illustrated by FIG. 11, the pair of inner and outer paddles 122, 120 are moved in unison, rather than independently, by a single actuation element 112.

[0295] Referring now to FIGS. 16-21, the implantable device 100 of FIGS. 8-14 is shown being delivered and implanted within the native mitral valve MV of the heart H. Referring to FIG. 16, a delivery sheath/catheter is inserted into the left atrium LA through the septum and the implant/device 100 is deployed from the delivery catheter/ sheath in the fully open condition as illustrated in FIG. 16. The actuation element 112 is then retracted to move the implant/device into the fully closed condition shown in FIG. 17.

[0296] As can be seen in FIG. 18, the implant/device is moved into position within the mitral valve MV into the ventricle LV and partially opened so that the leaflets 20, 22 can be grasped. For example, a steerable catheter can be advanced and steered or flexed to position the steerable catheter as illustrated by FIG. 18. The implant catheter connected to the implant/device can be advanced from inside the steerable catheter to position the implant as illustrated by FIG. 18. [0297] Referring now to FIG. 19, the implant catheter can be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 in the clasps 130. An actuation line 116 is extended to close one of the clasps 130, capturing a leaflet 20. FIG. 20 shows the other actuation line 116 being then extended to close the other clasp 130, capturing the remaining leaflet 22. Lastly, as can be seen in FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), actuation element 112 and actuation lines 116 are then retracted and the device or implant 100 is fully closed and deployed in the native mitral valve MV.

[0298] Any of the features disclosed by the present application can be used in a wide variety of different valve repair devices. Figures 22-24 illustrate examples of valve repair devices that can be modified to include any of the features disclosed by the present application. Any combination or sub-combination of the features disclosed by the present application can be combined with, substituted for, and/or added to any combination or sub-combination of the features of the valve repair devices illustrated by Figures 8-24.

[0299] Referring now to FIG. 22, an example of an implantable device or implant 200 is shown. The implantable device 200 is one of the many different configurations that the device 100 that is schematically illustrated in FIGS. 8-14 can take. The device 200 can include any other features for an implantable device or implant discussed in the present application, and the device 200 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 the present application). The device/implant 200 can be a prosthetic spacer device, valve repair device, or another type of implant that attaches to leaflets of a native valve.

[0300] In some implementations, the implantable device or implant 200 includes a coaptation portion/region 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some implementations, the coaptation portion 204 of the device optionally includes a coaptation element 210 (e.g., a spacer, coaptation element, plug, membrane, sheet, gap filler, etc.) for implantation between leaflets of a native valve. In some implementations, the anchor portion 206 includes a plurality of anchors 208. The anchors can be configured in a variety of ways. In some implementations, each anchor 208 includes outer paddles 220, inner paddles 222, paddle extension members or paddle frames 224, and clasps 230. In some implementations, the attachment portion 205 includes a first or proximal collar 211 (or other attachment element) for engaging with a capture mechanism of a delivery system. A delivery system for the device 200 can be the same as or similar to delivery system 102 described above and can comprise one or more of a catheter, a sheath, a guide catheter/sheath, a delivery catheter/sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations of these, etc.

[0301] In some implementations, the coaptation element 210 and paddles 220, 222 are formed from a flexible material that can be a metal fabric, such as a mesh, woven, braided, or formed in any other suitable way or a laser cut or otherwise cut flexible material. The material can be cloth, shape-memory alloy wire — such as Nitinol — to provide shape-setting capability, or any other flexible material suitable for implantation in the human body.

[0302] An actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, actuation line, etc.) can extend from a delivery system (not shown) to engage and enable actuation of the implantable device or implant 200. In some implementations, the actuation element extends through the proximal collar 211, and spacer or coaptation element 210 to engage a cap 214 of the distal portion 207. The actuation element can be configured to removably engage the cap 214 with a threaded connection, or the like, so that the actuation element can be disengaged and removed from the device 200 after implantation.

[0303] The coaptation element 210 extends from the proximal collar 211 (or other attachment element) to the inner paddles 222. In some implementations, the coaptation element 210 has a generally elongated and round shape, though other shapes and configurations are possible. In some implementations, the coaptation element 210 has an elliptical shape or crosssection when viewed from above and has a tapered shape or cross-section when seen from a front view and a round shape or cross-section when seen from a side view. A blend of these three geometries can result in the three-dimensional shape of the illustrated coaptation element 210 that achieves the benefits described herein. The round shape of the coaptation element 210 can also be seen, when viewed from above, to substantially follow or be close to the shape of the paddle frames 224.

[0304] The size and/or shape of the coaptation element 210 can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In some implementations, the anterior-posterior distance at the top of the coaptation element is about 5 mm, and the medial-lateral distance of the coaptation element at its widest is about 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and the overall shape strategy described above. It should be readily apparent that the use of other anterior-posterior distance anterior-posterior distance and medial -lateral distance as starting points for the device will result in a device having different dimensions. Further, using other dimensions and the shape strategy described above will also result in a device having different dimensions.

[0305] In some implementations, the outer paddles 220 are jointably attached to the cap 214 of the distal portion 207 by connection portions 221 and to the inner paddles 222 by connection portions 223. The inner paddles 222 are jointably attached to the coaptation element by connection portions 225. In this manner, the anchors 208 are configured similar to legs in that the inner paddles 222 are like upper portions of the legs, the outer paddles 220 are like lower portions of the legs, and the connection portions 223 are like knee portions of the legs.

[0306] In some implementations, the inner paddles 222 are stiff, relatively stiff, rigid, have rigid portions and/or are stiffened by a stiffening member or a fixed portion of the clasps 230. The inner paddle 222, the outer paddle 220, and the coaptation element can all be interconnected as described herein.

[0307] In some implementations, the paddle frames 224 are attached to the cap 214 at the distal portion 207 and extend to the connection portions 223 between the inner and outer paddles 222, 220. In some implementations, the paddle frames 224 are formed of a material that is more rigid and stiff than the material forming the paddles 222, 220 so that the paddle frames 224 provide support for the paddles 222, 220.

[0308] The paddle frames 224 can provide additional pinching force between the inner paddles 222 and the coaptation element 210 and assist in wrapping the leaflets around the sides of the coaptation element 210. That is, the paddle frames 224 can be configured with a round three-dimensional shape extending from the cap 214 to the connection portions 223 of the anchors 208. The connections between the paddle frames 224, the outer and inner paddles 220, 222, the cap 214, and the coaptation element 210 can constrain each of these parts to the movements and positions described herein. In particular the connection portion 223 is constrained by its connection between the outer and inner paddles 220, 222 and by its connection to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connection portion 223 (and thus the inner and outer paddles 222, 220) and to the cap 214.

[0309] The wide configuration of the paddle frames 224 provides increased surface area compared to the inner paddles 222 alone. The increased surface area can distribute the clamping force of the paddles 220 and paddle frames 224 against the native leaflets over a relatively larger surface of the native leaflets in order to further protect the native leaflet tissue.

[0310] Additional features of the device 200, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2018/028189 (International Publication No. WO 2018/195215) and U.S. Provisional Patent App. No. 63/217,622, filed on July 1, 2021. Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2018/028189 (International Publication No. WO 2018/195215) and/or U.S. Provisional Patent App. No. 63/217,622. Patent Cooperation Treaty International Application No. PCT/US2018/028189 (International Publication No. WO 2018/195215) and U.S. Provisional Patent App. No. 63/217,622 are incorporated herein by reference in their entirety for all purposes.

[0311] Referring now to FIG. 23, an example of an implantable device or implant 300 is shown. The implantable device 300 is one of the many different configurations that the device 100 that is schematically illustrated in FIGS. 8-14 can take. The device 300 can include any other features for an implantable device or implant discussed in the present application, and the device 300 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 the present application).

[0312] The implantable device or implant 300 includes a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device/implant 300 includes a coaptation portion/region 304, and the coaptation portion/region 304 can optionally include a coaptation element 310 (e.g., spacer, plug, membrane, sheet, gap filler, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 can include one or more paddles, e.g., outer paddles 320, inner paddles 322, paddle extension members or paddle frames 324. The anchors can also include and/or be coupled to clasps 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging with a capture mechanism of a delivery system.

[0313] The anchors 308 can be attached to the other portions of the device and/or to each other in a variety of different ways (e.g., directly, indirectly, welding, sutures, adhesive, links, latches, integrally formed, a combination of some or all of these, etc.). In some implementations, the anchors 308 are attached to a coaptation element 310 by connection portions 325 and to a cap 314 by connection portions 321.

[0314] The anchors 308 can comprise first portions or outer paddles 320 and second portions or inner paddles 322 separated by connection portions 323. The connection portions 323 can be attached to paddle frames 324 that are hingeably attached to a cap 314 or other attachment portion. In this manner, the anchors 308 are configured similar to legs in that the inner paddles 322 are like upper portions of the legs, the outer paddles 320 are like lower portions of the legs, and the connection portions 323 are like knee portions of the legs.

[0315] In implementations with a coaptation member or coaptation element 310, the coaptation member or coaptation element 310 and the anchors 308 can be coupled together in various ways. As shown in the illustrated example, the coaptation element 310 and the anchors 308 can be coupled together by integrally forming the coaptation element 310 and the anchors 308 as a single, unitary component. This can be accomplished, for example, by forming the coaptation element 310 and the anchors 308 from a continuous strip 301 of a braided or woven material, such as braided or woven nitinol wire. In the illustrated example, the coaptation element 310, the outer paddle portions 320, the inner paddle portions 322, and the connection portions 321, 323, 325 are formed from a continuous strip of fabric 301.

[0316] Like the anchors 208 of the implantable device or implant 200 described above, the anchors 308 can be configured to move between various configurations by axially moving the distal end of the device (e.g., cap 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311 or other attachment element, etc ). This movement can be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device.

[0317] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some implementations, the connection portions 323 of the anchors 308 are adjacent the longitudinal axis of the coaptation element 310 (e.g., similar to the configuration of device 200 shown in FIG. 36). From the straight configuration, the anchors 308 can be moved to a fully folded configuration (e.g., FIG. 23), e.g., by moving the proximal end and distal end toward each other and/or toward a midpoint or center of the device.

[0318] In some implementations, the clasps comprise a moveable arm coupled to an anchor. In some implementations, the clasps 330 include a base or fixed arm 332, a moveable arm 334, optional barbs/friction-enhancing elements 336, and a joint portion 338. The fixed arms 332 are attached to the inner paddles 322, with the joint portion 338 disposed proximate the coaptation element 310. The joint portion 338 is spring-loaded so that the fixed and moveable arms 332, 334 are biased toward each other when the clasp 330 is in a closed condition.

[0319] The fixed arms 332 are attached to the inner paddles 322 through holes or slots with sutures. The fixed arms 332 can be attached to the inner paddles 322 with any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesive, or the like. The fixed arms 332 remain substantially stationary relative to the inner paddles 322 when the moveable arms 334 are opened to open the clasps 330 and expose the barbs 336. The clasps 330 are opened by applying tension to actuation lines attached to the moveable arms 334, thereby causing the moveable arms 334 to articulate, pivot, and/or flex on the joint portions 338.

[0320] In short, the implantable device or implant 300 is similar in configuration and operation to the implantable device or implant 200 described above, except that the coaptation element 310, outer paddles 320, inner paddles 322, and connection portions 321, 323, 325 are formed from the single strip of material 301. In some implementations, the strip of material 301 is attached to the proximal collar 311, cap 314, and paddle frames 324 by being woven or inserted through openings in the proximal collar 311, cap 314, and paddle frames 324 that are 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 implementations, portions of the device 300 have a single layer of the strip of material 301 and other portions are formed from multiple overlapping or overlying layers of the strip of material 301.

[0321] For example, FIG. 23 shows a coaptation element 310 and inner paddles 322 formed from multiple overlapping layers of the strip of material 301. The single continuous strip of material 301 can start and end in various locations of the device 300. The ends of the strip of material 301 can be in the same location or different locations of the device 300. For example, in the illustrated example of FIG. 23, the strip of material 301 begins and ends in the location of the inner paddles 322.

[0322] As with the implantable device or implant 200 described above, the size of the coaptation element 310 can be selected to minimize the number of implants that a single patient will require (preferably one), while at the same time maintaining low transvalvular gradients. In particular, forming many components of the device 300 from the strip of material 301 allows the device 300 to be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance of the device 300 (i.e., the width of the paddle frames 324 which are wider than the coaptation element 310) at its widest is about 5 mm.

[0323] Additional features of the device 300, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/055320 (International Publication No. WO 2020/076898) and U.S. Provisional Patent App. No. 63/217,622. Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/055320 (International Publication No. WO 2020/076898) and/or U.S. Provisional Patent App. No. 63/217,622. Patent Cooperation Treaty International Application No. PCT/US2019/055320 (International Publication No. WO 2020/076898) and U.S. Provisional Patent App. No. 63/217,622 are incorporated herein by reference in their entirety for all purposes. [0324] FIG 24 illustrates another example of one of the many valve repair systems 40056 for repairing a native valve of a patient that the concepts of the present application can be applied to. The valve repair system 40056 includes a delivery device 40156 and a valve repair device 40256.

[0325] The valve repair device 40256 includes a base assembly 40456, a pair of paddles 40656, and a pair of gripping members 40856. In one example, the paddles 40656 can be integrally formed with the base assembly. For example, the paddles 40656 can be formed as extensions of links of the base assembly. In the illustrated example, the base assembly 40456 of the valve repair device 40256 has a shaft 40356, a coupler 40556 configured to move along the shaft, and a lock 40756 configured to lock the coupler in a stationary position on the shaft. The coupler 40556 is mechanically connected to the paddles 40656, such that movement of the coupler 40556 along the shaft 40356 causes the paddles to move between an open position and a closed position. In this way, the coupler 40556 serves as a means for mechanically coupling the paddles 40656 to the shaft 40356 and, when moving along the shaft 40356, for causing the paddles 40656 to move between their open and closed positions.

[0326] In some implementations, the gripping members 40856 are pivotally connected to the base assembly 40456 (e.g., the gripping members 40856 can be pivotally connected to the shaft 40356, or any other suitable member of the base assembly), such that the gripping members can be moved to adjust the width of the opening 41456 between the paddles 40656 and the gripping members 40856. The gripping member 40856 can include a barbed portion 40956 for attaching the gripping members to valve tissue when the valve repair device 40256 is attached to the valve tissue. When the paddles 40656 are in the closed position, the paddles engage the gripping members 40856, such that, when valve tissue is attached to the barbed portion 40956 of the gripping members, the paddles secure the valve repair device 40256 to the valve tissue. In some implementations, the gripping members 40856 are configured to engage the paddles 40656 such that the barbed portion 40956 engages the valve tissue member and the paddles 40656 to secure the valve repair device 40256 to the valve tissue member. For example, in certain situations, it can be advantageous to have the paddles 40656 maintain an open position and have the gripping members 40856 move outward toward the paddles 40656 to engage valve tissue and the paddles 40656. [0327] While the example shown in FIG. 24 illustrates a pair of paddles 40656 and a pair of gripping members 40856, it should be understood that the valve repair device 40256 can include any suitable number of paddles and gripping members.

[0328] In some implementations, the valve repair system 40056 includes a placement shaft 41356 that is 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 valve tissue, the placement shaft 41356 is removed from the shaft 40356 to remove the valve repair device 40256 from the remainder of the valve repair system 40056, such that the valve repair device 40256 can remain attached to the valve tissue, and the delivery device 40156 can be removed from a patient’s body.

[0329] The valve repair system 40056 can also include a paddle control mechanism 41056, a gripper control mechanism 41156, and a lock control mechanism 41256. The paddle control mechanism 41056 is mechanically attached to the coupler 40556 to move the coupler along the shaft, which causes the paddles 40656 to move between the open and closed positions. The paddle control mechanism 41056 can take any suitable form, such as, for example, a shaft or rod. For example, the paddle control mechanism can comprise a hollow shaft, a catheter tube or a sleeve that fits over the placement shaft 41356 and the shaft 40356 and is connected to the coupler 40556.

[0330] The gripper control mechanism 41156 is configured to move the gripping members 40856 such that the width of the opening 41456 between the gripping members and the paddles 40656 can be altered. The gripper control mechanism 41156 can take any suitable form, such as, for example, a line, a suture or wire, a rod, a catheter, etc.

[0331] The lock control mechanism 41256 is configured to lock and unlock the lock. The lock 40756 locks the coupler 40556 in a stationary position with respect to the shaft 40356 and can take a wide variety of different forms and the type of lock control mechanism 41256 can be dictated by the type of lock used. In examples in which the lock 40756 includes a pivotable plate, the lock control mechanism 41256 is configured to engage the pivotable plate to move the plate between the tilted and substantially non-tilted positions. The lock control mechanism 41256 can be, for example, a rod, a suture, a wire, or any other member that is capable of moving a pivotable plate of the lock 40756 between a tilted and substantially nontilted position. [0332] The valve repair device 40256 is movable from an open position to a closed position. The base assembly 40456 includes links that are moved by the coupler 40556. The coupler 40556 is movably attached to the shaft 40356. In order to move the valve repair device from the open position to the closed position, the coupler 40556 is moved along the shaft 40356, which moves the links.

[0333] The gripper control mechanism 41156 is moves the gripping members 40856 to provide a wider or a narrower gap at the opening 41456 between the gripping members and the paddles 40656. In the illustrated example, the gripper control mechanism 41156 includes a line, such as a suture, a wire, etc. that is connected to an opening in an end of the gripper members 40856. When the line(s) is pulled, the gripping members 40856 move inward, which causes the opening 41456 between the gripping members and the paddles 40656 to become wider.

[0334] In order to move the valve repair device 40256 from the open position to the closed position, the lock 40756 is moved to an unlocked condition by the lock control mechanism 41256. Once the lock 40756 is in the unlocked condition, the coupler 40556 can be moved along the shaft 40356 by the paddle control mechanism 41056.

[0335] After the paddles 40656 are moved to the closed position, the lock 40756 is moved to the locked condition by the lock control mechanism 41256 to maintain the valve repair device 40256 in the closed position. After the valve repair device 40256 is maintained in the locked condition by the lock 40756, the valve repair device 40256 is removed from the delivery device 40156 by disconnecting the shaft 40356 from the placement shaft 41356. In addition, the valve repair device 40256 is disengaged from the paddle control mechanism 41056, the gripper control mechanism 41156, and the lock control mechanism 41256.

[0336] Additional features of the device 40256, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904) and U.S. Provisional Patent App. No. 63/217,622. Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904) and/or U.S. Provisional Patent App. No. 63/217,622. Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904) and U.S. Provisional Patent App. No. 63/217,622 are incorporated herein by reference in their entirety for all purposes.

[0337] Clasps or leaflet gripping devices disclosed herein can take a wide variety of different forms. Examples of clasps are disclosed by Patent Cooperation Treaty International Application No. PCT/US2018/028171 (International Publication No. WO 2018195201). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2018/028171 (International Publication No. WO 2018195201). Patent Cooperation Treaty International Application No. PCT/US2018/028171 (International Publication No. WO 2018195201) is incorporated herein by reference in its entirety.

[0338] Referring to Figures 25A-25B, an example implementation of a valve repair device 40256 has a spacer or coaptation element 3800. The valve repair device 40256 can have the same configuration as the valve repair device illustrated by Figure 24 with the addition of the spacer or coaptation element. The spacer or coaptation element 3800 can take a wide variety of different forms. The spacer or coaptation element 3800 can be compressible and/or expandable. For example, the spacer can be compressed to fit inside one or more catheters of a delivery system, can expand when moved out of the one or more catheters, and/or can be compressed by the paddles 40656 to adjust the size of the spacer or coaptation element. In the example illustrated by Figures 25 A and 25B, the size of the spacer or coaptation element 3800 can be reduced by squeezing the spacer or coaptation element with the paddles 40656 and can be increased by moving the paddles 40656 away from one another. The spacer element 3800 can extend past outer edges 4001 of the gripping members or clasps 40856 as illustrated for providing additional surface area for closing the gap of a mitral valve.

[0339] The spacer or coaptation element 3800 can be coupled to the valve repair device 40256 in a variety of different ways. For example, the spacer or coaptation element 3800 can be fixed to the shaft 40356, can be slidably disposed around the shaft, can be connected to the coupler 40556, can be connected to the lock 40756, and/or can be connected to a central portion of the clasps or gripping members 40856. In some implementations, the coupler 40556 can take the form of the spacer element 3800. That is, a single element can be used as the coupler 40556 that causes the paddles 40656 to move between the open and closed positions and the spacer element 3800 that closes the gap between the leaflets 20, 22 when the valve repair device 40256 is attached to the leaflets.

[0340] The spacer or coaptation element 3800 can be disposed around one or more of the shafts or other control elements of the valve repair system 40056. For example, the spacer or coaptation element 3800 can be disposed around the shaft 40356, the shaft 41356, the paddle control mechanism 41056, and/or the lock control mechanism 41256.

[0341] The valve repair device 40256 can include any other features for a valve repair device discussed in the present application, and the valve repair device 40256 can be positioned to engage valve tissue as part of any suitable valve repair system (e.g., any valve repair system disclosed in the present application). Additional features of the device 40256, modified versions of the device, delivery systems for the device, and methods for using the device and delivery system are disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904).

[0342] FIGS. 26-30 illustrate another example of one of the many valve repair systems for repairing a native valve of a patient that the concepts of the present application can be applied to. Referring to FIGS. 29 and 30, the valve repair system includes a delivery device 1611 and an implantable valve repair device 8200. Referring to FIGS. 26-28, the implantable device 8200 includes a proximal or attachment portion 8205, outer paddle portions 8120, inner paddle portions 8122, paddle frames 8224, and a distal portion 8207. The proximal portion 8205, the distal portion 8207, and the paddle frames 8224 can be configured in a variety of ways.

[0343] In the example illustrated in FIG. 26, the paddle frames 8224 can be symmetric along longitudinal axis YY. However, in some implementations, the paddle frames 8224 are not symmetric about the axis YY. Moreover, referring to FIG. 26, the paddle frames 8224 can include outer frame portions 8256 and inner frame portions 8260.

[0344] In some implementations, the connector 8266 (e.g., shaped metal component, shaped plastic component, tether, wire, strut, line, cord, suture, etc.) attaches to the outer frame portions 8256 at outer ends of the connector 8266 and to a coupler 8972 at an inner end 8968 of the connector 8266 (see FIG. 28). Between the connector 8266 and the proximal portion 8205, the outer frame portions 8256 form a curved shape. For example, in the illustrated example, the shape of the outer frame portions 8256 resembles an apple shape in which the outer frame portions 8256 are wider toward the proximal portion 8205 and narrower toward the distal portion 8207. In some implementations, however, the outer frame portions 8256 can be otherwise shaped.

[0345] The inner frame portions 8260 extend from the proximal portion 8205 toward the distal portion 8207. The inner frame portions 8260 then extend inward to form retaining portions 8272 that are attached to the actuation cap 8214. The retaining portions 8272 and the actuation cap 8214 can be configured to attach in any suitable manner.

[0346] In some implementations, the inner frame portions 8260 are rigid frame portions, while the outer frame portions 8256 are flexible frame portions. The proximal end of the outer frame portions 8256 connect to the proximal end of the inner frame portions 8260, as illustrated in Figure 26.

[0347] A width adjustment element 8211 (e.g. width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment screw or bolt etc.) is configured to move the outer frame portions 8256 from the expanded position to the narrowed position by pulling the inner end 8968 (Figure 28) and portions of the connector 8266 into the actuation cap 8214. The actuation element 8102 (e.g., actuation wire, actuation shaft, actuation tube, etc.), is configured to move the inner paddle frame portions 8260 to open and close the paddles in accordance with some implementations disclosed herein.

[0348] As shown in Figures 27 and 28, the connector 8266 has an inner end 8968 that engages with the width adjustment element 8211 such that a user can move the inner end 8968 inside the receiver 8912 (e.g., a internally threaded element, a column, a conduit, a hollow member, a notched receiving portion, a tube, a shaft, a sleeve, a post, a housing, tracks, a cylinder, etc.) to move the outer frame portions 8256 between a narrowed position and an expanded position. In the illustrated example, the inner end 8968 comprises a post 8970 that attaches to the outer frame portions 8256 and a coupler 8972 that extends from the post 8970. The coupler 8972 is configured to attach and detach from both the width adjustment element 8211 and the receiver 8912. The coupler 8972 can take a wide variety of different forms. For example, the coupler 8972 can include one or more of a threaded connection, features that mate with threads, detent connections, such as outwardly biased arms, walls or other portions. When the coupler 8972 is attached to the width adjustment element 8211, the coupler is released from the tube. When the coupler 8972 is detached from the width adjustment element 8211, the coupler is secured to the tube. The inner end 8968 of the connector can, however, be configured in a variety of ways. Any configuration that can suitably attach the outer frame portions 8256 to the coupler to allow the width adjustment element 8211 to move the outer frame portions 8256 between the narrowed position and the expanded position can be used.

The coupler can be configured in a variety of ways as well and can be a separate component or be integral with another portion of the device, e.g., of the connector or inner end of the connector.

[0349] The width adjustment element 8211 allows a user to expand or contract the outer frame portions 8256 of the implantable device 8200. In the example illustrated in Figures 27 and 28, the width adjustment element 8211 includes an externally threaded end that is threaded into the coupler 8972. The width adjustment element 8211 moves the coupler in the receiver 8912 to adjust the width of the outer frame portions 8256. When the width adjustment element 8211 is unscrewed from the coupler 8972, the coupler engages the inner surface of the receiver 8912 to set the width of the outer frame portions 8256.

[0350] In some implementations, the receiver 8912 can be integrally formed with a distal cap 8214. Moving the cap 8214 relative to a body of the attachment portion 8205 opens and closes the paddles. In the illustrated example, the receiver 8912 slides inside the body of the attachment portion. When the coupler 8972 is detached from the width adjustment element 8211, the width of the outer frame portions 8256 is fixed while the actuation element 8102 moves the receiver 8912 and cap 8214 relative to a body of the attachment portion 8205.

Movement of the cap can open and close the device in the same manner as some implementations disclosed above.

[0351] In the illustrated example, a driver head 8916 is disposed at a proximal end of the actuation element 8102. The driver head 8916 releasably couples the opening/closing actuation element 8102 to the receiver 8912. In the illustrated example, the width adjustment element 8211 extends through the actuation element 8102. The actuation tube is axially advanced in the direction opposite to direction Y to move the distal cap 8214. Movement of the distal cap 8214 relative to the attachment portion 8205 is effective to open and close the paddles, as indicated by the arrows in Figure 27. That is movement of the distal cap 8214 in the direction Y closes the device and movement of the distal cap in the direction opposite to direction Y opens the device.

[0352] Also illustrated in Figures 27 and 28, the width adjustment element 8211 extends through the actuation element 8102, the driver head 8916, and the receiver 8912 to engage the coupler 8972 attached to the inner end 8968. The movement of the outer frame portions 8256 to the narrowed position can allow the device or implant 8200 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart — e.g., chordae — and the device 8200. The movement of the outer frame portions 8256 to the expanded position provides the anchor portion of the device or implant 8200 with a larger surface area to engage and capture leaflet(s) of a native heart valve.

[0353] Referring to FIGS. 29 and 30, an implementation of an implant catheter assembly 1611 in which clasp actuation lines 624 extend through a handle 1616, the actuation element 8102 is coupled to a paddle actuation control 1626, and the width adjustment element 8211 is coupled to a paddle width control 1628. A proximal end portion 1622a of the shaft or catheter of the catheter assembly 1611 can be coupled to the handle 1616, and a distal end portion 1622b of the shaft or catheter can be coupled to the implantable device 8200. The actuation element 8102 can extend distally from the paddle actuation control 1626, through the handle 1616, through the delivery shaft or catheter of the delivery device 1611, and through the proximal end of the device 8200, where it couples with the driver head 8916. The actuation element 8102 can be axially movable relative to the outer shaft of the catheter assembly 1611 and the handle 1616 to open and close the device.

[0354] The width adjustment element 8211 can extend distally from the paddle width control 1628, through the paddle actuation control 1626 and through the actuation element 8102 (and, consequently, through the handle 1616, the outer shaft of the implant catheter assembly 1611, and through the device 8200), where it couples with the coupler 8972. The width adjustment element 8211 can be axially movable relative to the actuation element 8102, the outer shaft of the catheter assembly 1611, and the handle 1616. The clasp actuation lines 624 can extend through and be axially movable relative to the handle 1616 and the outer shaft of the catheter assembly 1611. The clasp actuation lines 624 can also be axially movable relative to the actuation element 8102.

[0355] Referring to Figures 29 and 30, the width adjustment element 8211 can be releasably coupled to the coupler 8972 of the device 8200. Advancing and retracting the width adjustment element 8211 with the control 1628 widens and narrows the paddles. Advancing and retracting the actuation element 8102 with the control 1626 opens and closes the paddles of the device.

[0356] In the examples of Figures 29 and 30, the catheter or shaft of the implant catheter assembly 1611 is an elongate shaft extending axially between the proximal end portion 1622a, which is coupled to the handle 1616, and the distal end portion 1622b, which is coupled to the device 8200. The outer shaft of the catheter assembly 1611 can also include an intermediate portion 1622c disposed between the proximal and distal end portions 1622a, 1622b.

[0357] AReferring to FIGS. 31-35, an example of an implantable device or implant 1500 includes an anchor portion 1506 having one or more paddle frames 1524. The paddle frames 1524 are configured to allow the device 1500 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart — e.g., chordae — and the device 1500. That is, the 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 can include a flexible outer portion that flexes inward to reduce the width of the paddles when the flexible outer portion contacts a native heart structure - e.g., chordae. [0358] When the paddle frames 1524 are in the narrowed position, the friction between the native structures of the heart and the device 1500 is reduced. The device 1500 can include any other features for an implantable device or implant discussed in the present application or in the applications and patents incorporated by reference herein, and the device 1500 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 the present application). In addition, any of the devices described herein can incorporate the features of the device 1500.

[0359] The implantable device or implant 1500 includes a coaptation portion 1504, a proximal or attachment portion 1505, an anchor portion 1506, and a distal portion 1507. The coaptation portion 1504, attachment portion 1505, and distal portion 1507 can take any suitable form, such as, for example, the form for these portions of the device 200 shown in FIG. 22, or any other form described in the present application. In some implementations, the coaptation portion 1504 optionally includes a coaptation element 1510 (e.g., a spacer, coaptation element, gap filler, etc.) that can be used, for example, for implantation between the leaflets 20, 22 of the native mitral valve MV. The coaptation element, etc. 1510 can take any suitable form, such as, for example, any form described in the present application. In the illustrated example, the coaptation element is made from woven wires.

[0360] The attachment portion 1505 includes a first or proximal collar 1511 for engaging with a capture mechanism of a delivery system. The proximal collar 1511 can take any suitable form, such as, for example, any form described in the present application. The capture mechanism 1513 can take any suitable form, such as, for example, any form described in the present application.

[0361] The distal portion 1507 includes a cap 1514 that is attached to anchors 1508 of the anchor portion 1506 such that movement of the cap 1514 causes the anchors 1508 to move between open and closed positions. The cap 1514 can take any suitable form, such as, for example, any form described in the present application. In the illustrated example, an actuation element 1512 (e.g., an actuation wire, actuation shaft, etc.) extends from a delivery system (e.g., any delivery system described in the present application) and engages the cap 1514 to move the cap 1514 relative to the coaptation element or spacer 1510 to enable actuations of the device 1500. The actuation element 1512 can engage and move the cap by any suitable means, such as, for example, any means provided in the present application.

[0362] The anchor portion 1506 of the device 1500 can take any suitable form, such as, for example, the form of the anchor portion 206 of the device 200 shown in FIG. 22 (except that the paddle frame 224 is replaced with the paddle frame 1524 shown in FIGS. 87-88 and described in more detail below), or any other form described in the present application that can incorporate paddle frame 1524. The anchor portion 1506 can include a plurality of anchors 1508, each anchor 1508 including outer paddles 1520, inner paddles 1522, paddle extension members or paddle frames 1524, and clasps 1530.

[0363] The paddle frame 1524 includes a main support section 1585, first connection members for attaching to a cap of the implantable device or implant, and second connection members for attaching to anchors of the device. The connection members can be the same as or similar to other connection members described elsewhere herein. The paddle frame 1524 can attach to the connection portion of the anchors and the cap by any suitable means, such as, for example, any means described in the present application. The thickness and width of the paddle frame can take any suitable form, such as, for example, the thickness can be substantially identical to the width, the thickness can be greater than the width (as shown in FIGS. 87-90), or the width can be greater than the thickness.

[0364] 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 that connects to the cap 1514 and a second end 1583 that connects to the anchors 1508. Referring to FIGS. 34 and 35, the rigid inner portion is configured to support the paddles 1520, 1522 of the anchors and provide a sufficient force to facilitate coaptation of the native leaflets 20, 22 against the coaptation element 1510 when the anchors 1508 are in the closed position. The rigid inner portion 1572 can be made of, for example, metals, plastics, etc.

[0365] Referring again to FIGS. 31-35, the flexible outer portion 1574 is connected to the rigid inner portion and defines the total width of the paddle frame 1524. That is, the flexible outer portion 1574 has a greater total width than the rigid inner portion 1572. The flexible outer portion 1574 is configured such that forces (e.g., forces from the flexible outer portion 1574 contacting the chordae during implantation of the device 1500) cause the flexible outer portion 1574 to flex and allow the device 1500 to maneuver more easily into position for implantation in the heart. Referring to FIGS. 34 and 35, when the anchors 1508 are in the closed position and causing leaflets to coapt against the coaptation element 1510, the flexible outer portion 1574 maintains its normal total width to provide for a larger surface area (relative to the rigid inner portion 1572) contacting the leaflets to hold the leaflets against the coaptation element 1510. The flexible outer portion 1574 can be made of, for example, metals, and plastics.

[0366] The total width of the flexible outer portion 1574 can be 5mm and 15mm, such as between 7mm and 12 mm, such as between 9mm and 11mm, such as about 10mm. The width of the inner portion 1572 can be between 2mm and 8mm, such as between 4mm and 6 mm, such as about 5mm.

[0367] In some implementations, the flexible outer portion 1574 are shaped set inward such that the total width of the outer portion 1574 narrows when the anchors 1508 are in the open position, and such that the outer portion moves back to its normal total width when the anchors 1508 are moved to the closed position.

[0368] While the illustrated example, shows rigid inner portion 1572 and the flexible inner portion 1574 having rounded shapes, it should be understood that the inner and outer portions 1572, 1574 can take any form that allows the device 1500 to more easily maneuver into position for implantation in the heart while providing sufficient support for facilitating coaptation of the leaflets of a native heart valve against the coaptation element 1510.

[0369] Referring to FIGS. 36-37, an example implementation 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 maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart — e.g., chordae — and the device 1800. That is, width adjustment lines 1890 are controlled by a user to create a compression force C (FIG. 37) on the paddle frames 1824 to move the paddle frames 1824 to a narrowed position as the device 1800 is being positioned for implantation on the native leaflets of a native valve such that the contact and/or friction between the native structures of the heart and the device 1800 is reduced. The device 1800 can include any other features for an implantable device or implant discussed in the present application or in the applications and patents incorporated by reference herein, and the device 1800 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 the present application). In addition, any of the devices described herein can incorporate the features of the device 1800.

[0370] The implantable device or implant 1800 includes a coaptation portion 1804, a proximal or attachment portion 1805, an anchor portion 1806, and a distal portion 1807. The coaptation portion 1804, attachment portion 1805, and distal portion 1807 can take any suitable form, such as, for example, the form for these portions of the device 200 shown in FIG. 22, or any other form described in the present application. In some implementations, the coaptation portion 1804 includes coaptation element 1810 (e.g., a spacer, coaptation element, gap filler, etc.) that can be used, for example, for implantation between the leaflets 20, 22 of the native mitral valve MV The coaptation element 1810 can take any suitable form, such as, for example, any form described in the present application.

[0371] The attachment portion 1805 includes a first or proximal collar 1811 for engaging with a capture mechanism of a delivery system. The capture mechanism and delivery system can be the same as or similar to other capture mechanisms and delivery systems described elsewhere herein. The proximal collar 1811 can take any suitable form, such as, for example, any form described in the present application.

[0372] The distal portion 1807 includes a cap 1814 that is attached to anchors 1808 of the anchor portion 1806 such that movement of the cap 1814 causes the anchors 1508 to move between open and closed positions. The cap 1814 can take any suitable form, such as, for example, any form described in the present application. In the illustrated example, 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 the present application) and engages the cap 1814 to move the cap 1814 relative to the coaptation element or spacer 1810 to enable actuations of the device 1800. The actuation element 1812 can engage and move the cap by any suitable means, such as, for example, any means provided in the present application.

[0373] The anchor portion 1806 can take any suitable form, such as, for example, the form of the anchor portion 206 of the device 200 shown in FIG. 22 or any other form described in the present application. The anchor portion 1806 can include a plurality of anchors 1808, each anchor 1808 including outer paddles 1820, inner paddles 1822, paddle extension members or paddle frames 1824, and clasps 1830. The paddle frames 1824 can include a main support section 1885, first connection members for attaching to the cap 1814, and second connection members for attaching to a connection portion 1823 of the anchors 1808. The paddle frame 1824 can attach to the connection portion of the anchors and the cap by any suitable means, such as, for example, any means described in the present application. The thickness and width of the paddle frame 1824 can take any suitable form, such as, for example, the thickness can be substantially identical to the width, the thickness can be greater than the width (as shown in FIGS. 87-90), or the width can be greater than the thickness.

[0374] The paddle frame 1824 includes an end 1801 that is 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 width adjustment lines 1890 of the delivery system. Referring to FIGS. 36-37, in some examples, a single width adjustment line 1890 extends through the first and second openings 1891, 1892 of each paddle frame 1824 and into the delivery system such that a user can pull the width adjustment lines 1890 to cause the paddle frame 1824 to move to the narrowed position. In some implementations, the width adjustment lines 1890 can also extend through an opening of the clasp 1830 of each paddle before extending into the delivery system. Referring to FIG. 37, when a user pulls the width adjustment line 1890, a force is created on each end of the width adjustment line 1890 in the direction Y, which causes a compression force C on the paddle frame 1824 due to the width adjustment line extending through the openings 1891, 1892. The compression force C causes the paddle frame 1824 to move to the narrowed position.

[0375] Referring to FIG. 37, the paddle frames 1824 have a length L2 and a total width W2 when in the narrowed position. The width of the paddle frame 1824 when in the normal, expanded position can be between 5mm and 15mm, such as between 7mm and 12 mm, such as between 9mm and 11mm, such as about 10mm. The narrowed width W2 of the paddle frame 1824 can be between 3mm and 12mm, such as between 5mm and 10 mm, such as between 7mm and 9mm, such as about 8mm. A 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. [0376] Referring to FIGS. 40-49, an example implementation of an implantable device or implant 2000 (FIGS. 40-45) includes an anchor portion 2006 having one or more paddle frames 2024. The paddle frames 2024 are configured to allow the device 2000 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart — e.g., chordae — and the device 2000. For example, width adjustment lines are controlled by a user to create a compression force (e.g., compression force C shown in FIG. 37) on the paddle frames 2024 to move the paddle frames 2024 from a normal, expanded position (FIGS. 41 and 43) to a narrowed position (FIGS. 40 and 42) as the device 2000 is being positioned for implantation on the leaflets of a native valve such that the contact between the native structures of the heart and the device 2000 is reduced. The device 2000 can include any other features for an implantable device or implant discussed in the present application or in the applications and patents incorporated by reference herein, and the 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 the present application). In addition, any of the devices described herein can incorporate the features of the device 2000.

[0377] Referring to FIGS. 44-45, the implantable device or implant 2000 includes a coaptation portion 2004, a proximal or attachment portion 2005, an anchor portion 2006, and a distal portion 2007. The coaptation portion 2004, attachment portion 2005, and distal portion 2007 can take any suitable form, such as, for example, the form for these portions of the device 200 shown in FIG. 22, or any other form described in the present application. In some implementations, the coaptation portion 2004 optionally includes a coaptation element 2010 (e.g., a spacer, coaptation element, gap filler, etc.) that can be used, for example, for implantation between the leaflets 20, 22 of the native mitral valve MV. The coaptation element, etc. 2010 can take any suitable form, such as, for example, any form described in the present application.

[0378] The attachment portion 2005 includes a first or proximal collar 2011 for engaging with a capture mechanism of a delivery system. The capture mechanism and delivery system can be the same as or similar to other capture mechanisms and delivery systems described elsewhere herein. The proximal collar 2011 can take any suitable form, such as, for example, any form described in the present application. [0379] The distal portion 2007 includes a cap 2014 that is attached to anchors 2008 of the anchor portion 2006 such that movement of the cap 2014 causes the anchors 2008 to move between open and closed positions. The cap 2014 can take any suitable form, such as, for example, any form described in the present application. An actuation element (e.g., the same as or similar to actuation element 112 shown in FIGS. 8-20 or actuation element 8102 shown in FIGS. 26-30) extends from a delivery system (e.g., any delivery system described in the present application), through the coaptation element 2010 via opening 2009 (FIG. 44), and engages the cap 2014 to move the cap 2014 relative to the coaptation element 2010 to enable actuations of the device 2000. The actuation element can engage and move the cap by any suitable means, such as, for example, any means provided in the present application.

[0380] The anchor portion 2006 can take any suitable form, such as, for example, the form of the anchor portion 206 of the device 200 shown in FIGS. 22 or any other form described in the present application. The anchor portion 2006 can include a plurality of anchors 2008, each anchor 2008 including outer paddles 2020, inner paddles 2022, paddle extension members or paddle frames 2024, and clasps (e.g., clasps 230 shown in FIG. 22). Referring to FIGS. 38 and 39, the paddle frames 2024 can include a main support section 2085 and connection members 2003 for attaching to the cap 2014. The paddle frame 2024 can attach to the cap 2014 by any suitable means, such as, for example, any means described in the present application. Referring to FIGS. 46-49, in the illustrated example both of the anchors 2008 include are defined by a paddle ribbon 2001 that includes the inner paddle 2022 and the outer paddle 2020 of each anchor 2008. The inner paddles 2022 of each anchor 2008 are attached by a connection portion 2025 that is configured to connect the inner paddles 2022 to the coaptation element 2010 (as shown in FIG. 49). In the illustrated example, the connection portion 2025 includes an opening 2094 for receiving a distal portion of the coaptation element 2010. The outer paddles 2020 of each anchor 2008 are attached by a connection portion 2021 that is configured to connect the outer paddles 2020 to the cap 214 (as shown in FIG. 49). In the illustrated example, the connection portion 2021 includes an opening 2096 for receiving a portion of the cap 2014. Each inner paddle 2022 is attached to the corresponding outer paddle 2020 by connection portion 2023. [0381] Referring to FIGS. 38 and 39, the paddle frame 2024 includes two or more arms 2080 that define the total width TW of the anchors 2008, in which the at least some of the arms 2080 are connected at a distal portion of the paddle frame 2024 (e.g., a portion of the paddle frame 2024 proximate the connection members 2003). Each of the arms 2080 includes one or more openings 2091, 2092 for receiving one or more width adjustment lines (e.g., width adjustment lines 1890 shown in FIGS. 36-37) such that a user can pull on the width adjustment lines to cause the paddle frame 2024 to move to the narrowed position. The illustrated example includes two arms 2080 that each include a proximal opening 2091 and a distal opening 2092. In some implementations, a single width adjustment line can extend through each opening 2091, 2092 such that the single width adjustment line can cause the paddle frame 2024 to move to the narrowed position. It should be understood, however, that any suitable number of width adjustment lines can extend through the openings 2091, 2092 to cause the paddle frame 2024 to move to the narrowed position.

[0382] Referring to FIG. 38, the arms 2080 are connected to each other at the distal portion of the paddle frame 2024 by a connection link 2083. This connection between the two arms 2080 causes the arms 2080 to pivot, flex, and/or articulate about the connection link 2083 in an inward direction Z when a user causes a tensioning force F on the paddle frame 2024 by pulling the one or more width adjustment lines that extend through the openings 2091, 2092. 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 such that the paddle frame 2024 is in the narrowed position. In the illustrated example, the connection 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 that connects the first member 2087 to the second member 2089. The connection link 2083 can, however, take any suitable form that allows the arms to pivot, flex, and/or articulate in the inward direction Z when a tensioning force F is applied to the paddle frame 2024. In some implementations, the connection link 2083 is integral to the arms 2080 of the paddle frame 2024.

[0383] Still referring to FIGS. 38, the total width TW of the paddle frame 1824 when in the normal, expanded position can be between 5mm and 15mm, such as between 7mm and 12 mm, such as between 9mm and 11mm, such as about 10mm. The narrowed width of the paddle frame 1824 can be between 3mm and 12mm, such as between 5mm and 10 mm, such as between 7mm and 9mm, such as about 8mm. A 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.

[0384] Referring to FIGS. 50-59, an example implementation of an implantable device or implant 2800 (FIGS. 53-59) includes an anchor portion 2806 having one or more paddle frames 2824 that are movable to a narrowed position to allow the device 2800 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart — e.g., chordae — and the device 2800. That is, one or more width adjustment elements, such as the illustrated width adjustment lines 2890 (FIGS. 55-59) are controlled by a user to create a compression force on the paddle frames 2824 to move the paddle frames 2824 to a narrowed position as the device 2800 is being positioned for implantation on the leaflets of a native valve such that the contact between the native structures of the heart and the device 1800 is reduced. In some implementations, the width adjustment elements can be width adjustment wires, width adjustment cords, width adjustment sutures, etc.) The device 2800 can include any other features for an implantable device or implant discussed in the present application or in the applications and patents incorporated by reference herein, and the device 2800 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 the present application). In addition, any of the devices described herein can incorporate the features of the device 2800.

[0385] Referring to FIGS. 53-54, the implantable device or implant 2800 includes a coaptation portion 2804, a proximal or attachment portion 2805, an anchor portion 2806, and a distal portion 2807. The coaptation portion 2804, attachment portion 2805, and distal portion 2807 can take any suitable form, such as, for example, the form for these portions of the device 200 shown in FIG. 22, or any other form described in the present application. In some implementations, the coaptation portion 2804 optionally includes a coaptation element 2810 (e.g., a spacer, coaptation element, gap filler, etc.) that can be used, for example, for implantation between the leaflets 20, 22 of the native mitral valve MV. The coaptation element, etc. 2810 can take any suitable form, such as, for example, any form described in the present application. [0386] The attachment portion 2805 includes a first or proximal collar 2811 for engaging with a capture mechanism of a delivery s system 2802. The capture mechanism and the delivery system 2802 can take any suitable form, such as, for example, any form described in the present application. The delivery system 2802 can be the same as or similar to other delivery systems herein, e.g., 102, 402, 502, etc. and can comprise one or more of a catheter, a sheath, a guide catheter/sheath, a delivery catheter/sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations of these, etc. The proximal collar 2811 can take any suitable form, such as, for example, any form described in the present application.

[0387] The distal portion 2807 includes a cap 2814 that is attached to anchors 2808 of the anchor portion 1806 such that movement of the cap 2814 causes the anchors 2808 to move between open and closed positions. The cap 2814 can take any suitable form, such as, for example, any form described in the present application. In the illustrated example, an actuation element (e.g., the same as or similar to actuation element 112 shown in FIGS. 8-20 or actuation element 8102 shown in FIGS. 26-30) extends from a delivery system (e.g., any delivery system described in the present application) and engages the cap 2814 to move the cap 2814 relative to the coaptation element 2810 to enable actuations of the device 2800. The actuation element can engage and move the cap by any suitable means, such as, for example, any means provided in the present application.

[0388] The anchor portion 2806 can take any suitable form, such as, for example, the form of the anchor portion 206 of the device 200 shown in FIG. 22 or any other form described in the present application. The anchor portion 2806 can include a plurality of anchors 2808, each anchor 2808 including outer paddles 2820, inner paddles 2822, paddle extension members or paddle frames 2824, and clasps (e.g., clasps 230 shown in FIG. 22). Referring to FIGS. SO- 52, the paddle frames 2824 can include a main support section 2885, first connection members 2801 for attaching to the cap 1814, and second connection members 2803 for attaching to a connection portion 2823 of the anchors 2808. The paddle frame 2824 can attach to the connection portion of the anchors and the cap by any suitable means, such as, for example, any means described in the present application. The thickness and width of the paddle frame 2824 can take any suitable form, such as, for example, the thickness can be substantially identical to the width, the thickness can be greater than the width (as shown in FIGS. 87-95), or the width can be greater than the thickness.

[0389] The paddle frame 2824 includes an inner portion 2872 and an outer portion 2874. The inner portion 2872 has arms 2880 that extend from the connection members 2801 to a proximal portion of the paddle frame 2824. The outer portion 2874 includes arms 2882 that are connected to arms 2880 at connection point 2871 and extend outward from arms 2880. The arms 2882 define a total width TW of the anchors 2808. The arms 2882 can have one or more openings for receiving one or more width adjustment lines 2890 such that the width adjustment lines 2890 can be engaged by a user to move the paddle frame 2824 to the narrowed position by moving the arms 2882 in the inward direction X. In the illustrated example, each of the arms 2882 have a first opening 2892 and a second opening 2891 that is positioned distally from the first opening 2892. The inner portion 2872 can include one or more openings 2893 that can be used for connecting to the connection portion 2823 of the anchors 2808 and/or for receiving one or more width adjustment lines 2890.

[0390] Referring to FIGS. 51-55, the arms 2882 of the outer portion 2874 can be biased in the direction X (FIGS. 51-52) such that the arms 2882 are configured to extend beyond a center line CL (FIG. 54) of the device 2800 when the anchors 2808 are in the closed position. Referring to FIGS. 53-54, for illustrative purposes, the arms 2882 of the paddle frames 2824 are shown crossing each other to show that the arms 2882 are configured to extend beyond the center line CL of the device 2800. It should be understood, however, that the arms 2882 can be positioned to engage the arms 2882 of the other paddle frame 2824 (rather than cross each other) to create a pinching force between the two anchors 2808. In these examples, when the anchors 2808 have captured the leaflets 20, 22 of the mitral valve MV the biased arms 2882 of each paddle frame 2824 pinch the leaflet tissue between them to better secure the device 2800 to the mitral valve MV.

[0391] Referring to FIG. 52, the paddle frame 2824 can have a rounded shape that corresponds to the shape of the coaptation element 2810 such that the anchors 2808 conform around the coaptation element to better secure the leaflet tissue between the anchors 2808 and the coaptation element 2810. The paddle frames 2824 can be formed by shape setting a material such that the arms 2882 are biased away from the arms 2880. For example, the paddle frames 2824 can be made of metals, such as steel, nitinol, etc., plastics, etc.

[0392] Referring to FIGS. 55-59, in some implementations, each paddle frame 2824 has a corresponding width adjustment line 2890 that is used to move the paddle frame 2824 from the normal, expanded position (FIGS. 55 and 58) to a narrowed position (FIGS. 56-57 and 59). Each width adjustment line 2890 can include two ends 2894, 2895 that extend from the delivery system 2802 such that a user can engage the ends 2894, 2895 to cause the paddle frame 2824 to move to the narrowed position. The width adjustment line 2890 can extend through the cap 2814 before extending through one or more openings (e.g., openings 2891, 2892, 2893) of the paddle frame 2824 and then extending back into the delivery system 2802.

[0393] Referring to FIG. 55, in the illustrated example, a first end 2894 of the width adjustment line 2890 extends from the delivery system 2802 and through an opening 2897a (FIGS. 57-59) of the cap 2814 at point A. Then the width adjustment line 2890 extends through the opening 2892 of one arm 2882 at point B and then through the opening 2892 of the other arm 2882 at point C. The width adjustment line 2890 extends back through an opening 2897b (FIGS. 57-59) the cap at point D, and then the second end 2895 of the width adjustment line 2890 extends back through the delivery system 2802.

[0394] Referring to FIG. 56, when a user pulls the ends 2894, 2895, of the width adjustment line 2890 in the direction Y, the width adjustment line 2890 causes a tensioning force F on the arms 2882 due to the width adjustment line extending through the openings 2892. This tensioning force F then causes the arms 2882 to move in the inward direction X such that the paddle frame 2824 is in a narrowed position. Referring to FIG. 57, if the user provides additional force to the ends 2894, 2895 of the width adjustment line 2890 in the direction Y, the tensioning force F (FIG. 56) continues on the arms 2882 such that the arms 2882 continue to move in the direction X, which can cause the arms 2882 to cross each other (as shown in FIG. 57) such that the paddle frame 2824 is in a more narrowed position. Referring to FIGS. 58 and 59, the paddle frames 2824 can be independently controllable between the normal and narrowed positions. For example, FIG. 58 shows both paddle frames 2824 in the normal position, and FIG. 59 shows one paddle frame 2824 moved to the narrowed position and the other paddle frame 2824 in the normal position. [0395] Referring to FIG. 50, the total width TW of the paddle frame 2824 when in the normal, expanded position can be between 5mm and 15mm, such as between 7mm and 12 mm, such as between 9mm and 11mm, such as about 10mm. The narrowed width of the paddle frame 2824 can be between 3mm and 12mm, such as between 5mm and 10mm, such as between 7mm and 9mm, such as about 8mm. A 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.

[0396] FIG. 60 illustrates an example of a width adjustment device 8900 that is configured to expand or contract the paddle frames of an implantable device or implant. The width adjustment device 8900 can take any suitable form, such as, for example, any form described in the present application. Moreover, any of the implantable device or implants and width adjustment devices described herein can incorporate features of the width adjustment device 8900. In the illustrated example, the width adjustment device 8900 includes a coupler, such as the illustrated shaft 8908 and a receiver, such as the illustrated housing 8902. In some implementations, the housing 8902 can be an integral part of an implantable device or implant. For example, the housing 8902 can be integrally formed with the distal cap or any other suitable member described herein. The shaft 8908 includes an external thread pattern that is configured to threadedly engage a female thread pattern 8904 formed in the housing 8902. A driver head 8910 is integrally formed at a proximal end of the shaft 8908 and is configured to enable rotation of the shaft 8908 by a variety of tools or drive types (e.g., Torx, slotted, Philips, etc.).

[0397] Still referring to FIG. 60, a fork-shaped carriage 8812 is disposed around the shaft 8908 and the driver head 8910. In the illustrated example, the carriage 8812 features proximal tines 8914 and a distal end 8918 which are formed as a single, unitary component. However, it is understood that the carriage 8812 can take any suitable form, such as, for example, any form described in the present application.

[0398] Still referring to FIG. 60, the driver head 8910 features mating surfaces 8911 that are configured to be complementary with surfaces 8915 of the proximal tines 8914, respectfully, for harnessing the carriage 8812 to the driver head 8910. Torque prevention cutaways 8913 formed in the housing 8902 are configured to receive and constrain the carriage 8812 to longitudinal movement in the direction L and prevent or inhibit the carriage 8812 from rotating when torque is applied to the driver head 8910. Therefore, when the driver head 8910 is rotated, the driver head 8910 will pull the carriage 8812 such that the carriage 8812 is confined to move in an upward or downward direction along a longitudinal axis of the shaft 8908 as indicated by arrows L.

[0399] Still referring to FIG. 60, the distal end 8918 of the carriage 8812 is formed with an aperture 8919 that is configured to permit a width adjustment line 1890 to pass therethrough. Opposite ends of the width adjustment line 1890 can be secured to various attachment points on the paddle frames, the paddles, the distal cap, or to any other suitable attachment point described herein. When the driver head 8910 is rotatably driven to move the carriage 8812, the distal end 8918 of the carriage 8812 will pull on the width adjustment line 1890, thereby causing the paddle frames (not shown) to contract. In the illustrated example, rotating the driver head 8910 clockwise (right-handed thread configuration) will cause the carriage 8812 to move downwards along the longitudinal axis of the shaft 8908 in the direction illustrated by arrows L. In this way, the distal end 8918 of the carriage 8812 will pull on the width adjustment line 1890 causing the paddle frames to contract. However, it is understood that other configurations are also contemplated. For example, rotating the driver head 8910 in a counterclockwise direction could apply tension to the width adjustment line 1890 for causing the paddle frames to contract. Moreover, it is appreciated that in other configurations, applying tension to the width adjustment line 1890 could cause the paddle frames to expand, rather than contract.

[0400] Referring to FIG. 61, an example of a width adjustment device 8900 and a retractable/expandable paddle frame is shown. In the illustrated example, the width adjustment device 8900 of FIG. 61 is substantially the same as that of the example shown in FIG. 60, except that the distal end 8918 of the carriage 8812 is integrally formed with a distal portion 81002 of paddle frames 81000 of an implantable device or implant. However, it should be understood that in some implementations, the carriage 8812 can be integrally formed with the distal cap, or with any other suitable member described herein.

[0401] Still referring to FIG. 61, when the driver head 8910 is rotatably driven to convey the carriage 8812, the carriage 8812 will cause a distal portion 81002 to move upward or downward. Upward movement of the distal portion 81002 causes the paddle frames 81000 to flex outward or expand and downward movement of the distal portion 81002 causes the paddle frames 81000 to flex inward or retract. For example, when rotating the driver head 8910 clockwise (right-handed thread configuration), the carriage 8812 will move in a downward direction along the longitudinal axis causing the distal portion 81002 of the paddle frames 81000 to move downward, and lateral portions 81004 of the paddle frames 81000 to contract inward, thereby reducing the overall width of the paddle frames 81000. When rotating the driver head 8910 counterclockwise (right-handed thread configuration), the carriage 8812 will move in an upward direction along the longitudinal axis causing the distal portion 81002 of the paddle frames 81000 to move upward, and lateral portions 81004 of the paddle frames 81000 to expand outward, thereby increasing the overall width of the paddle frames 81000.

[0402] FIG. 62 illustrates an example of a width adjustment device 81100 that is configured to expand or contract the paddle frames of an implantable device or implant 81200. The width adjustment device 81100 can take any suitable form, such as, for example, any form described in the present application. Moreover, any of the implantable device or implants and width adjustment devices described herein can incorporate features of the width adjustment device 81100. In the illustrated example, the width adjustment device 81100 includes a coupler, such as the illustrated externally threaded shaft 81102 (Fig. 64) that is rotatably engaged with a receiver, such as the illustrated internally threaded element 81104 (illustrated and often referred to as a “column” or herein, but can be or comprise other types of threaded elements or threaded lumens and have a variety of different sizes and shapes as well) that is integrally formed with or connected to a distal portion of an implantable device or implant. For example, the threaded element or column 81104 can be integrally formed with the distal cap, a distal portion of the paddle assembly, or with any other suitable member described in the present application.

[0403] A driver head 81106 is disposed at a proximal end of the shaft 81102 and is configured to rotatably drive the shaft 81102 into or out of the threaded element or column 81104. The driver head 81106 can take any form, such as for example, any form described in the present application. Referring to FIG. 64, a coupler 81108 is attached to a distal end of the shaft 81102 and is configured to be retained by a receiver 81110 (Fig. 62) that is formed on an inner end or post 81302. The inner end or post member 81302 is configured to mechanically couple the expandable/retractable paddle frames 81300 to the coupler 81108. In this way, when the driver head 81106 is driven to rotate the shaft 81102 counterclockwise (e.g., right- handed thread configuration), the shaft 81102 will rotate and move toward a proximal end of the width adjustment device 81100 causing the coupler 81108 to pull on the receiver 81110 of the paddle frames 81300. As the receiver 81110 is pulled by the coupler 81108, the paddle frames 81300 will begin to contract inward and reduce the overall width of the paddle frames 81300. Conversely, rotating the shaft 81102 clockwise (e.g., into the threaded element or column 81104) will cause the paddle frames 81300 to expand outwards. However, it should be understood that other configurations are also contemplated. For instance, in some implementations, rotating the shaft 81102 clockwise will cause the paddle frames 81300 to contract inwards. Therefore, it is appreciated that a wide variety of configurations are contemplated for expanding or contracting the paddle frames.

[0404] FIG. 63 illustrates an example of a width adjustment device 81100 that is configured to expand or contract the paddle frames of an implantable device or implant is shown. The width adjustment device 81100 can take any suitable form, such as, for example, any form described in the present application. Moreover, any of the implantable device or implants and width adjustment devices described herein can incorporate features of the width adjustment device 81100. In the illustrated example, the width adjustment device 81100 of FIG. 63 is substantially the same as the example shown in FIG. 62, except that the inner end or post 81302 is partially split along partition line 81304. The split inner end or post 81302 connects the coupler 81108 to the paddle frames 81300. The paddle frames 81300 are partially retractable into a distal portion 81305 (e.g., distal cap) of an implantable device or implant. In particular, sheathable portions 81300a and 81300b of the paddle frames 81300 can be drawn in and through the distal portion 81305 and into the cavity that is formed by the internally threaded column 81104. In this way, when the driver head 81106 causes the coupler to pull on the receiver 81110 for contracting the paddle frames 81300 and drawing the sheathable portions 81300a 81300b in through the distal portion 81305. The contracting paddle frames are particularly advantageous when having to navigate an implantable device or implant through tight spaces, such as through the chordae tendineae (e.g., such as, when deploying the device). [0405] Referring to FIG. 65, an example implementation of a width adjustment device is shown. Any of the implantable devices or implants and width adjustment devices described herein can incorporate features of width adjustment device 81500. In the illustrated example, the width adjustment device 81500 includes an engagement member or actuator 81502 that is couplable to a width adjustment element (e.g. width adjustment wire, width adjustment shaft, width adjustment tube, etc.), a receiver, such as the illustrated parallel racks 81504, and a coupler 81506. Each rack 81504 includes teeth 81505 that are configured to limit the motion of the coupler 81506 to a single direction (e.g., a ratchet mechanism) when the coupler is in an engaged state. In the illustrated example, the coupler 81506 is coupled to paddle frames 81530 by a connection portion 81520. In some implementations, the coupler 81506, the connection portion 81520, and the paddle frames 81530 can be formed as a single, unitary component.

[0406] Still referring to FIG. 65, arms 81508 are formed on the coupler 81506 and are configured to engage projections 81510 of the actuator 81502 (e.g., see sectional view of FIG. 65). Resilient fingers 81512 are also formed on the coupler 81506 and are configured to engage the teeth 81505 of the rack 81504 for preventing the coupler 81506 from moving along the path L in a downward or distal direction of the racks 81504.

[0407] Still referring to FIG. 65, the actuator 81502 can be driven in the directions indicated by arrows L. When the actuator 81502 is driven upwards, the projections 81510 of the actuator 81502 will pull the coupler 81506 via the arms 81508 of the coupler 81506. As a result, the resilient fingers 81512 will ratchet along the teeth 81505 of the rack 81504, thereby permitting the coupler 81506 to move upwards when the actuator 81502 moves upwards. Simultaneously, the coupler 81506 will cause the connection portion 81520 to pull on the paddle frames 81530 and cause the paddle frames 81530 to contract. In such implementations, the position of the resilient fingers 81512 relative to each of the plurality of discrete positions (i.e., the teeth) on the rack 81504 can correspond to a particular width of the paddle frames, respectively.

[0408] Conversely, when the actuator 81502 is driven downwards, the proj ections 81510 of the actuator 81502 push against resilient, sloped surfaces 81514 of the coupler 81506. As such, the projections 81510 cause the resilient fingers 81512 to disengage from the rack 81504. As such, the coupler 81506 is disengaged from the rack 81504 when the actuator is moved in a downward or distal direction to expand the paddle frames 81530.

[0409] Referring to FIGS. 66-80, an example implementation of an implantable device or implant 91000 is shown. The implantable device or implant 91000 includes a proximal or attachment portion 91005, anchor portions 91006 that include paddle frames 91024, an actuation portion 91050, and a distal portion 91007. The paddle frames 91024 have a height H (FIG. 69) between the proximal portion 91005 and the distal portion 91007. The anchor portion 91006 includes inner paddles 91022 and outer paddles 91020. The attachment portion 91005, the distal portion 91007, the anchor portion 91006, and the actuation portion 91050 can be configured in a variety of ways.

[0410] The paddle frames 91024 are configured to allow the device 91000 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart — e.g., chordae — and the device. That is, the paddle frames 91024 are configured to move between an expanded condition and a narrowed condition. When the paddle frames 91024 are in the narrowed condition, the contact between the native structures of the heart and the device 91000 is reduced. The device 91000 can include any other features for an implantable device or implant discussed in the present application or in the applications and patents incorporated by reference herein, and the device 91000 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 the present application). In addition, any of the devices described herein can incorporate the features of the device 91000.

[0411] In the illustrated example of FIGS. 66-82, the paddle frames 1024 are symmetric along longitudinal plane Y (FIG. 69) and are symmetric along longitudinal plane Z (FIG. 66).

In some implementations of the device or implant 91000, however, the paddle frames 91024 are not symmetric about one or both of the planes Y and Z. The paddle frames 91024 include a first frame side 91052 and a second frame side 91054 that is a mirror image of the first frame side 91052 (FIGS. 68-82).

[0412] In the illustrated example in FIGS. 66-70, the paddle frames 91024 includes outer frame portions 91056, intermediate frame members 91058, and inner frame portions 91060. In FIG. 66, the outer frame portions 91056 are shown in an expanded state such that the outer frame portions 91056 define a paddle frame width WE in the expanded state and a paddle frame depth DE in the expanded state (FIG. 70). The outer frame portions 91056 are attached to the intermediate frame members 91058 at the proximal portion 91005 and include terminal distal ends 91062. The outer frame portions 91056 are curved and can form a semicircle or U- shape. In some implementations, however, the outer frame portions 91056 can be otherwise shaped.

[0413] The intermediate frame members 91058 extend from a connection portion 91064 with the outer frame portions 91056 near or at the proximal portion 91005 and are attached at the distal portion 91007 via connection portions 91066. The intermediate frame members 91058 also include an inner end, which in the illustrated example is configured as a projection or post 91068 (FIGS. 66 and 67) extending axially along axis Z from the distal portion 91007 toward the proximal portion 91005. The post 91068 can be configured in a variety of ways. In the illustrated example, the post 91068 has a cylindrical outer side surface 91069 and an end surface 91071 perpendicular to the outer side surface (see FIG. 71).

[0414] The inner frame portions 91060 extend from a connection portion 91070 with the outer frame portions 91056 near or at the proximal portion 91005 and include retaining portions 91072 near or adjacent the distal portion 91007 for engaging the post 91068. The retaining portions 91072 are described below in more detail with regard to FIGS. 71-76.

[0415] The first frame side 91052 and a second frame side 91054 can optionally be in contact with each other along axis Y toward the distal portion 91007 and are separated toward the proximal end 91005 to form a V-shape, as shown, for example, in FIG. 68.

[0416] Referring to FIGS. 67-69, the outer paddles 91020 are connected to the retaining portions 91072 at the distal portion 91007 via connection portions 91021 and to the inner paddles 91022 by connection portions 91023. The inner paddles 91022 are connected to a coaptation portion or inner member (not shown) by connection portions 91025. Referring to FIGS. 67-69, the inner paddles 91022 are not connected to the retaining portions 91072. Instead, the inner paddles 91022 form an aperture or gap 91080 through which the retaining portions 91072 extend. [0417] Referring to FIGS. 71-76, the method of assembling the retaining portions 91072 to the post 91068 is illustrated. The retaining portions 91072 include a first retaining portion 91082 and a second retaining portion 91084 spaced apart from, and a mirror image of, the first retaining portion 91082. Each of the inner frame portions 91060 and retaining portions 91072 includes an inner side surface 91086, an outer side surface 91088 opposite the inner side surface 91086, and a distal end 91087.

[0418] The inner side surfaces 91086 of the inner frame portions 91060 include inward transition portions 91090 that form a seat. In the illustrated example, the inward transition portions 91090 are formed as inward curved surfaces. In some implementations, however, the inward transition portions 91090 can be formed in any suitable manner, such as for example, as angled or tapered surfaces, stepped surfaces, or any other suitable inward transition. The inner side surfaces 91086 extend axially from the inward transition portion 91090 toward the distal portion 1007 to form a gap 91092 configured to receive the post 91068.

[0419] Each of the outer side surfaces 91088 of the inner frame portions 91060 includes a first recessed portion 91094. In the illustrated example, the first recessed portion 91094 is formed axially nearer to the distal portion 91007 than the inward transition portion 91090 is located. Each of the first recessed portions 91094 include a second recessed portion 91096 that is recessed relative to the first recessed portion 91094. In the illustrated example, the second recessed portion 91096 is located at a portion of the first recessed portion 91094 that is closest to the distal portion 91007. The second recessed portions 91096 are configured to receive the connecting portions 91021 of the outer paddles 91020.

[0420] The first recessed portions 91094 are configured to receive an annular retainer 91098. The annular retainer 91098 can be a ring, a washer, a nut, or the like. The annular retainer 91098 includes an inner passage 91100 configured to receive the post 91068 therethrough. The inner passage 91100 has a diameter DI which is less than the combined width Wil of the distal ends 91087 and gap 91092 in an uncompressed state as shown in FIG. 71.

[0421] FIG. 66 illustrates an assembled state for the device 91000 in which the post 91068 is received through the gap 91092 in the retaining portion 91072. To assemble the device 91000, as shown in FIG. 71, the post 91068 and connecting portion 91066 of the intermediate frame members 91058 and the retaining portion 91072 of the inner frame portions 91060 are pulled away from each other along the plane X, as shown by arrow G.

[0422] The paddle frames 91024 can be made from or comprise a material that allows the post 91068 and connecting portion 91066 of the intermediate frame members 91058 and the retaining portion 91072 of the inner frame portions 91060 to be pulled away from each other. For example, the paddle frames 91024, or a portion thereof, can be made of a metal fabric, such as a mesh, woven, braided, or formed in any other suitable way or a laser cut or otherwise cut flexible material. The material can be cloth, shape-memory alloy wire — such as Nitinol — to provide shape-setting capability, or any other flexible material suitable for implantation in the human body.

[0423] In some implementations, some portions of the paddle frames 91024 can be stiffer or more rigid than other portions. For example, in the illustrated example of the paddle frames 91024, the inner frame portions 91060 can be configured to be stiffer than the outer frame portions 91056. The inner frame portions 91060 can be configured in a variety of ways to be stiffer or more rigid. For example, the thickness of the inner frame portions 91060 and/or the material used for the inner frame portions 91060 can provide more rigidity. In some implementations, the thickness of the inner frame portions 91060 can be greater than the outer frame portions 91056 to provide more rigidity. Further, in some implementations, the material used in the inner frame portions 91060 can be a more rigid material to provide more rigidity.

[0424] Once the post 91068 and the connecting portion 91066 are separated from the retaining portion 91072, the annular retainer 91098 and the connecting portions 91021 of the outer paddles 91020 can be placed therebetween. As shown by arrows H in FIG. 72, the distal ends 91087 of the first retaining portion 91082 and a second retaining portion 91084 can be compressed toward each other such that the gap 91092 is reduced or closed. The distal ends 91087 can be compressed such that the combined width of the distal ends 91087 and the gap 91092 is less than the diameter DI of the passage 91100 of the annular retainer 91098. As such, the distal ends 91087 can be received through the passage 91100 and between the connection portions 91021 of the outer paddles 91020, as shown by arrow I in FIG. 72.

[0425] As shown in FIG. 73, once the distal ends 91087 are received through the passage 91100 and between the connection portions 91021 of the outer paddles 91020, the annular retainer 91098 can be aligned with the first recessed portions 91094 and the connecting portion 91021 of the outer paddles 91020 can be aligned with the second recessed portions 91096. The distal ends 91087 can then be released to return toward the uncompressed state, as shown by arrows J, while the annular retainer 91098 is received in the first recessed portions 91094 and the connecting portions 91021 of the outer paddles 91020 are received with the second recessed portions 91096.

[0426] The distal ends 91087 can be configured to provide an outward bias on the annular retainer and/or the connecting portions 91021 of the outer paddles 91020 to provide a secure attachment between the annular retainer and/or the connecting portions 91021 of the outer paddles 91020. As shown in FIG. 74, once the annular retainer 91098 is received in the first recessed portions 91094 and the connecting portions 91021 of the outer paddles 91020 are received with the second recessed portions 91096, the post 91068 and the connecting portions 91066 of the intermediate frame members 91058 can be released, which allows the post 91068 to be received through the gap 91092 and the end surface 91071 extends past the inward transition portions 91090.

[0427] FIGS. 71-76 illustrate two connecting portions 91021 of the outer paddles 91020. For example, the outer paddles 91020 can be jointably attached at a distal portion 91007.

FIGS. 66-67, however, show an implementation with the connecting portions 91021 of the outer paddles 91020 as not be jointly attached and being offset. Thus, the retaining portions 91072 can include an additional recessed portion (not shown) to receive one of the offset retaining portions 91072. The additional recessed portion (not shown) can be provided on the inner side surface 91086 or on the outer side surface 91088 of the retaining portion 91072.

[0428] Referring to FIG. 75, the actuation portion 91050 of device or implant 91000 is configured to both facilitate moving the paddle frames 91024 between an expanded position and a narrowed position and move the paddles of the device 91000 between a closed position and an open position. The actuation portion 91050 can be configured in a variety of ways. Any structure capable of selectively moving the paddle frames 91024 between an expanded position and a narrowed position and moving the paddles of the device between a closed position and a closed position can be used. In some implementations, the actuation portion is configured such that advancing and retracting the actuation portion itself opens and closes the device and advancing and retracting the inner end or post inside the receiver narrows and widens the paddles. For example, the stiffer inner paddle frame portions are moved by the actuation portion to open and close the paddles in the same or a similar manner to that shown in FIGS. 8- 15.

[0429] In the illustrated example, the actuation portion 91050 includes a receiver, such as the illustrated sleeve 91102, configured to receive a portion of the post 91068 and a coupler, such as the illustrated plug 91103 configured to move the post axially within the sleeve 91102. During assembly, the sleeve 91102 can be received onto the post 91068 as shown by arrow K. The receiver and coupler can be the same as or similar to other implementations of these described herein.

[0430] The sleeve 91102 can be configured in a variety of ways. In the illustrated example, the sleeve 91102 includes a cylindrical sidewall 91104 extending between a proximal end 91106 to a distal end 91108 of the annular retainer 91098. The sleeve 91102 can optionally be integrally formed with the annular retainer 91098. The sleeve 91102 defines an internal passage 91110.

[0431 ] The sleeve 91102 has a length L 1 and the internal passage 91110 extends through the entire length LI of the sleeve 91102 from the proximal end 91106 and a distal end 91108. The passage 91110 has a diameter D2 that is sufficient to allow the post 91068 to be received into the passage 91110 and includes an internal threaded portion 91112.

[0432] As shown by arrow L in FIG. 75, the distal end 91108 of the sleeve 91102 is fixedly attached to the retaining portion 91072. The sleeve 91102 can be attached to the retaining portion 91072 in any suitable manner. In the illustrated example, annular retainer 91098 at the distal end 91108 is attached to the second recessed portion 91096 of the retaining portion 91072. The passage 91110 is aligned with the gap 91092 such that the post 91068 extends through the gap 91092 and into the passage 91110.

[0433] As shown FIG. 76, the plug 91103 is received within the passage 91110. The plug 91103 is configured to move axially within the sleeve 91102, as shown by arrow M. In the illustrated example, the plug 91103 is cylindrical and includes a proximal end 91114, a distal end 91116 opposite the proximal end, and an external threaded portion 91118. The external threaded portion 91118 is configured to threadedly engage with the internal threaded portion 91112 of the sleeve 91102.

[0434] The proximal end 91114 includes a drive interface 91120 configured to engage a drive member capable of rotating the plug 91103 to axially move the plug 91103 relative to the sleeve 91102. The drive interface 91120 can be any suitable interface. For example, the drive interface 91120 can be a drive recess, such as a slotted, hexagonal, Torx, Frearson, Phillips, square, or other suitable interface. The distal end 91116 forms an engagement surface configured to engage the proximal end 91071 of the post 91068.

[0435] As shown in FIGS. 77-79, in the expanded state, the majority of, or most of, the post 91068 is received within the receiver 91102 and the device 91000 has the width WE defined by the positions of the outer frame portions 91056 and the depth DE. The plug 91103 is illustrated as extending out of the receiver 91102 toward the proximal portion 91005 of the device 91000. However, in some implementations, the plug does not extend past the proximal end of the receiver 91102 and an actuation rod is coupled to the plug 91103 in the receiver

91102 or at the end of the receiver 91102.

[0436] As shown in FIG. 79, for the illustrated example, in the expanded state, the top view of the device 91000 has the shape of a lens (i.e., a convex region bounded by two circular arcs that intersect at, or near, their endpoints).

[0437] Referring to FIGS. 75-76, in operation, to move the device 91000 from the expanded position to the narrowed position, a coupler, such as the illustrated plug 91103 can be moved axially relative to a receiver, such as the illustrated sleeve 91102. For example, the plug

91103 can be rotated via the drive interface 91120 to move the plug 91103 axially relative to the sleeve 91102. Movement of the plug toward the distal end 91108 of the sleeve 91102 causes the distal end 91116 of the plug 91103 to engage the proximal end 91071 of the post 91068 and move the post 91068 in the same direction (i.e., away from the proximal portion 91005 of the device).

[0438] As shown in FIGS. 80-82, movement of the post 91068 away from the proximal portion 91005 pulls the intermediate frame members 91058 in the same direction, as shown by arrow N in FIGS. 80 and 81. Due to the connection of the intermediate frame members 91058 to the outer frame portions 91056 at the connection portions 91064, movement of the intermediate frame members 91058 away from the proximal portion 91005 pulls the outer frame portions 91056 inward (z.e., to the narrowed position), as shown by arrows O in FIGS. 80 and 82, such that the device 91000 has a width WN in the narrowed position that is narrower than the width WE in the expanded position.

[0439] When the device 91000 narrows in width to the narrowed position, the device 91000 can also widen in the depth dimension, as shown by arrows P in FIG. 81 and 86. As shown in FIG. 82, in the narrowed position, the device 91000 has a depth DN which is greater than the depth DE in the expanded position. In addition, the top view of the device 91000 changes from a lens shape, in the expanded position, to a circular or oval shape in the narrowed position, as shown in FIG. 82. Thus, the paddle frames 91024 can be moved between an expanded position and a narrowed position by rotating the plug 91103 within the sleeve 91102.

[0440] Referring to FIGS. 83-88, an example implementation of an implantable device or implant 91200 is shown. The implantable device or implant 91200 includes a proximal or attachment portion 91205, an anchor portion 91206 (FIG. 84), paddle frames 91224, an actuation portion 91050, and a distal portion 91207. The paddle frames 91224 have a height H2 (FIG. 84) between the proximal portion 91205 and the distal portion 91207. Referring to FIG. 84, the anchor portion 91206 includes inner members 91209, inner paddles 91222, and outer paddles 91220. The attachment portion 91205, the distal portion 91207, the anchor portion 91206, the actuation portion 91050, and the paddle frames 91224 can be configured in a variety of ways.

[0441] In the illustrated example of FIGS. 83-84, the paddle frames 91224 are symmetric along longitudinal axis T (FIG. 84) and are symmetric along longitudinal axis V (FIG. 83). In some implementations of the device or implant 91200, however, the paddle frames 91224 are not symmetric about one or both of the axes T and V. The paddle frames 91224 include a first frame side 91252 and a second frame side 91254 that is a mirror image of the first frame side 91252 (FIG. 84).

[0442] In the illustrated example, the paddle frames 91224 include outer frame portions 91256 and inner frame portions 91260. In FIG. 83, the outer frame portions 91256 are shown in an expanded state such that the outer frame portions 91256 define a paddle frame expanded width WE2 (FIG. 85).

[0443] The outer frame portions 91256 are flexibly attached at the proximal portion 91205 and are flexibly attached at the distal portion 91207. The outer frame portions 91256 are attached at the distal portion 91207 by connecting portions 91266. The outer frame portions 91256 are curved and form a generally circular or oval shape. In some implementations, however, the outer frame portions 91256 can be otherwise shaped.

[0444] The outer frame portions 91256 also include an inner end, which can be configured as a projection or post 91268 extending axially along axis V from the distal portion 91207 toward the proximal portion 91205. The inner end or post 91268 can be configured in a variety of ways. In the illustrated example, the inner end is configured as post 91268, which has an outer surface 91269 that can be formed by a plurality of side walls forming a polygonal cross section or the outer surface 91269 can have one flat side and a-half cylindrical surface. The post 91268 can have an end surface 91271 that is perpendicular to the side walls.

[0445] The inner frame portions 91260 extend from first connection portions 91270 with the outer frame portions 91256 near or at the proximal portion 91205 and include second connection portions 91272 near or adjacent the distal portion 91207 that connect to the post 91268. The first frame side 91252 and a second frame side 91254 can be in contact with each other along axis T toward the distal end 91207 and are separated toward the proximal end 91205 to form a V-shape, as shown, for example, in FIG. 84.

[0446] The inner members 91209 can be a portion of a coaptation element, such as coaptation element 210 of FIG. 22, or be attached to a coaptation element by any suitable means. As shown in FIG. 84, the outer paddles 91220 are jointably attached at the distal portion 91207 by connection portions 91221 and to the inner paddles 91222 by connection portions 91223. The inner paddles 91222 are flexibly attached to the inner members 91209 by connection portions 91225. The inner paddles 91222 and the inner members 91209 are not connected to the connection portions 91272, as shown in FIG. 84. [0447] In this manner, the anchors are configured similar to legs in that the inner paddles 91222 are like upper portions of the legs, the outer paddles 91220 are like lower portions of the legs, and the connection portions 91223 are like knee portions of the legs.

[0448] Referring to FIG. 83, the connection portions 91272 include a first retaining portion 91282 and a second retaining portion 91284, spaced apart from, and a mirror image of, the first retaining portion 91282. The inner frame portions 91260 include inward transition portions 91290. In the illustrated example, the inward transition portions 91290 are formed as inward curved surfaces. In some implementations, however, the inward transition portions 91290 can be formed in any suitable manner, such as for example, as angled or tapered surfaces, stepped surfaces, or any other suitable inward transition.

[0449] The retaining portions 91282, 91284 extend axially from the inward transition portions 91290 toward the distal end 91207 to form a gap 91292 configured to receive the post 91268. Each of the retaining portions 91282, 91284 includes an outer recessed portion 91294. In the illustrated example, the recessed portions 91294 are formed axially nearer to the distal end 91207 than the inward transition portion 91290 is located.

[0450] The recessed portions 91294 are configured to receive an annular retainer 91098 of the post 91268 and the connecting portions 91221 of the outer paddles 91220. The annular retainer 91098 can be configured similar to the annular retainer 91098; thus, the description of the annular retainer 91098 applies equally to the annular retainer 91098. The annular retainer 91098 can be a ring, a washer, a nut, or that like that is connected to the post 91268. In the illustrated example, the annular retainer 91098 is integrally formed with the post 91268.

[0451] FIG. 83 illustrates an assembled state for the device 91200 in which the post 91268 is received through the gap 91292 in the connection portion 91272 and the retainer 91098 and the connecting portions 91221 of the outer paddles 91220 are received in the recessed portions 91294. The device 91200 is assembled in the same manner as the device 91000. For example, the post 91268 and connecting portion 91266 of the outer frame portions 91256 and the connection portion 91272 of the inner frame portions 91260 are pulled away from each other along the axis V. [0452] The paddle frames 91224 can be made from or comprise a material that allows the post 91268 and connecting portion 91266 of the outer frame portions 91256 and the connection portion 91272 of the inner frame portions 91260 to be pulled away from each other. For example, the paddle frames 91224, or a portion thereof, can be made of a laser cut or otherwise formed flexible material, such as metal, plastic, etc.

[0453] In the illustrated example of FIGS. 83-88, the connecting portions 91266 are more rigid, such that the outer frame portions 91256 and will retain their general shape more when the post 91268 is extended to narrow the outer frame portions. The connecting portions 91266 can be configured in a variety of ways to be more rigid. For example, the thickness of the connecting portions 91266 and/or the material used in the connecting portions can provide more rigidity. In some implementations, the thickness of the connecting portion 91266 can be greater than the outer frame portions 91256 to provide more rigidity. Further, in some implementations, the material used in the connecting portions 91266 can be a more rigid material to provide more rigidity.

[0454] Once the post 91268 and the connecting portion 91266 are separated from the connection portion 91272, the annular retainer 91098 and the connecting portions 91221 of the outer paddles 91220 can be placed therebetween and the distal ends of the first retaining portion 91282 and a second retaining portion 91284 can be compressed toward each other. In the compressed state, the annular retainer 91098 can be received over the first retaining portion 91282 and a second retaining portion 91284.

[0455] The annular retainer 91098 and the connecting portion 91221 of the outer paddles 91220 can be aligned with the recessed portions 91294 and the retaining portions 91282, 91284 can then be released to return toward the uncompressed state to capture the annular retainer 91098 and the connecting portion 91221 of the outer paddles 91220 in the recessed portions 91294.

[0456] Once the annular retainer 91098 and the connecting portions 91221 of the outer paddles 91220 are received in the recessed portions 91294, the post 91268 and the connecting portions 91266 of the outer frame portions 91256 can be released, which allows the post 91268 to be received through the gap 91292 and the end surface 91271 extends past the inward transition portions 91290. [0457] The actuation portion 91050 of the device or implant 91200 is configured to both move the paddle frames 91224 between an expanded position and a narrowed position and to move the paddles between the closed position and the open position. The actuation portion 91050 can be configured in a variety of ways. Any structure capable of selectively moving the paddle frames 91224 between an expanded position and a narrowed position and opening and closing the device can be used, such as for example, the actuation portion 91050 of FIGS. 75-76. In some implementations, the actuation portion is configured such that advancing and retracting the actuation portion itself opens and closes the device and advancing and retracting a post inside the actuation portion narrows and widens the paddles. For example, the inner paddle frame portions are moved by the actuation portion to open and close the paddles in the same or a similar manner to that shown in FIGS. 23, 27, and 30-37.

[0458] Referring to FIG. 83, in the illustrated example the actuation portion 91050 includes a receiver, such as the illustrated sleeve 91202 configured to receive a portion of the post 91268 and a plug (not shown) configured to move the post axially within the sleeve 91202 to narrow and widen the paddles. The sleeve 91202 and the plug (not shown) can be configured the same or similar to the sleeve 91102 and the plug 91103 of the device 91000 of FIGS. 75-76, thus the description of the sleeve 91102 and the plug 91103 applies equally to the sleeve 91202 and the plug (not shown) of the example of FIGS. 83-88.

[0459] As shown in FIG. 83, the sleeve 91202 is fixedly attached to the connection portion 91272 such that the post 91268 can be received within a passage 91210 that extends through the sleeve 91202.

[0460] Referring to FIGS. 85-88, in operation, to move the device 91200 from the expanded position to the narrowed position, the plug (not shown) can be moved axially relative to the sleeve 91202. Movement of the plug toward the distal end 91207 causes the plug to engage the distal end 91271 of the post 91268 and move the post 91268 in the same direction (z.e., away from the proximal portion 91205 of the device).

[0461] Movement of the post 91268 away from the proximal portion 91205, as shown by arrow Q in FIG. 87, pulls the distal end portions of the outer frame portions downward while the more rigid inner frame portions maintain the positions of the proximal end portions of the outer frame portions. As a result, the outer frame portions 91256 are drawn inward (z.e., to the narrowed position), as shown by arrows R in FIG. 87. The device 91200 has a width WN2 (FIG. 88) in the narrowed position that is narrower than the width WE2 in the expanded position.

[0462] As shown in FIGS. 85-88, when the device 91200 moves between the expanded position and the narrowed position, the more rigid connecting portions 91266 tend to retain the shape, or deform only slightly, while the outer frame portions 91256 move inward. As shown in FIG. 88, in the narrowed position, each of the outer frame portions 91256 can optionally be configured to form a recessed or concave portion 91299 proximate the mid-point between the proximal portion 91205 and the distal portion 91207 when the outer frame portions are contracted.

[0463] Referring to FIGS. 89-90, an example implementation of an implantable device or implant 92100 is shown. The implantable device or implant 92100 includes a proximal or attachment portion 92105, paddle frames 92124, an anchor portion 92106 attached to the paddle frames 92124, a width adjustment device 81500, and a distal portion 92107. The proximal portion 92105, the distal portion 92107, the width adjustment device 81500, and the paddle frames 92124 can be configured in a variety of ways.

[0464] In the illustrated example of FIGS. 89-90, the paddle frames 92124 are symmetric along longitudinal axis XX (FIG. 90). In some implementations of the device or implant 92100, however, the paddle frames 92124 are not symmetric about the axis WW.

[0465] In the illustrated example, the paddle frames 92124 include outer frame portions 92156 and inner frame portions 92160. In FIGS. 89-90, the outer frame portions 92156 are shown in an expanded state such that the outer frame portions 92156 define a paddle frame expanded width WE 10 (FIG. 89).

[0466] The outer frame portions 92156 are flexibly attached to an attachment portion 92168 at the distal portion 92107 via connection portions 92166 and are coupled to the inner frame portions 92160 at the proximal portion 92105 via connection portions 92167. Between the connection portions 92166 and the connection portions 92167, the outer frame portions 92156 form a curved, convex shape. For example, in the illustrated example, the shape of the outer frame portions 92156 resembles an apple shape in which the outer frame portions are wider toward the proximal portion 92105 and narrower toward the distal portion 92107. In some implementations, however, the outer frame portions 92156 can be otherwise shaped.

[0467] The attachment portion 92168 is configured to attach to the width adjustment device 81500 to the outer frame portions 92156. The attachment portion 92168 can be configured in a variety of ways. Any configuration that can suitably attach the outer frame portions 92156 to the width adjustment device 81500 to allow the width adjustment device 81500 to move the outer frame portions 92156 between a narrowed position and an expanded position can be used.

[0468] The inner frame portions 92160 are jointly attached to the outer frame portions 92156 at the proximal portion 92105 via connection portions 92170 and extend from the connection portions 92170 to the distal portion 92107. The inner frame portions 92160 include retaining portions 92172 near or adjacent the distal portion 92107 for attaching to the width adjustment device 81500. The retaining portions 92172 and the width adjustment device 81500 can be configured to attach in any suitable manner.

[0469] The width adjustment device 81500 is configured to move the outer frame portions 92156 from the expanded position to the narrowed position by pulling the attachment portion 92168 and portions of the connecting portions 92166 into the width adjustment device 81500. The width adjustment device 81500 is configured to move the inner paddle frame portions 92160 to open and close the paddles in the same or a similar manner to that shown in FIGS. 23, 27, and 30-37.

[0470] The width adjustment device 81500 includes a width adjustment connection or actuator 81502, a receiver (which can be configured the as parallel racks 81504), and a coupler 81506. Each rack 81504 includes teeth 81505 that are configured to limit the motion of the coupler 81506 to a single direction (e.g., a ratchet mechanism) when the coupler is in an engaged state. In the illustrated example, the coupler 81506 is coupled to outer paddle frames 92156 by a connection portion 92168.

[0471] Still referring to FIG. 89, arms 81508 are formed on the coupler 81506 and are configured to engage proj ections 81510 of the actuator 81502. Resilient fingers 81512 are also formed on the coupler 81506 and are configured to engage the teeth 81505 of the rack 81504 for preventing the coupler 81506 from moving along the path L in a downward or distal direction of the racks 81504.

[0472] Still referring to FIG. 89, the actuator 81502 can be driven in either direction along the axis XX. When the actuator 81502 is driven upwards, the proj ections 81510 of the actuator 81502 will pull the coupler 81506 via the arms 81508 of the coupler 81506. As a result, the resilient fingers 81512 will ratchet along the teeth 81505 of the rack 81504, thereby permitting the coupler 81506 to move upwards when the actuator 81502 moves upwards. Simultaneously, the coupler 81506 will cause the connection portion 92168 to pull on the outer paddle frame portions 92156 and cause the outer frame portions 92156 to contract. In such examples, the position of the resilient fingers 81512 relative to each of the plurality of discrete positions (i.e., the teeth) on the rack 81504 can correspond to a particular width of the outer paddle frame portions.

[0473] Conversely, when the actuator 81502 is driven downwards, the proj ections 81510 of the actuator 81502 push against resilient, sloped surfaces 81514 of the coupler 81506. As such, the projections 81510 cause the resilient fingers 81512 to disengage from the rack 81504. As such, the coupler 81506 is disengaged from the rack 81504 when the actuator is moved in a downward or distal direction to expand the outer paddle frame portions 92156.

[0474] The paddle frames 92124 can be made from or comprise a material that allows the attachment portion 92168 and portions of the connecting portions 92166 to be pulled into the width adjustment device 81500. For example, the paddle frames 92124, or a portion thereof, can be made of a flexible metal, plastic, fabric, suture, etc. The paddle frames can be formed using a variety of different manufacturing processes, such as cutting, such as laser cutting, molding, forging, stamping, casting, bending, heat treating, shape setting, etc.

[0475] As discussed above, there are advantages to fabricating portions of the disclosed the devices (e.g., implantable device/implant 200) out of bulk materials, such a sheet material, such as a sheet of metal or plastic, rather than from a braided or woven networks of wire. Braided or woven networks can facilitate flexibility of design by which the device can elongate and compress into a tracking condition to enable delivery through a delivery system and intraprocedural maneuvering and expand into the shape of the implantable device or implant. However, devices made from or comprise a braided or woven network of wires can be expensive to manufacture. In some implementations, portions of the valve repair device or implant can be made from a flat sheet of material. For example, coaptation element supports, inner paddle portions, outer paddle portions, and/or a paddle frame connection portion can be made from a flat sheet of material.

[0476] FIGS. 91H-91 J show a device 100400 having a paddle structure 100450 illustrated by FIGS. 91A-91G. FIGS. 91A-91G depict a paddle structure 100450 in which a braided or wire paddle structure is replaced by a structure 100450 fabricated from a sheet of material. In the illustrated example, the paddle structure 100450 is made from a single, contiguous piece of material (e.g., a nitinol flat sheet or strip of material that can be laser cut, photo etched, or stamped as a flat part and subsequently shaped). The precise material and manufacturing method can vary.

[0477] Comparison of FIG. 91 A with FIG. 22 shows that the paddle structure 100450 takes a similar form as the paddle structure 220. Table 1 below compares components in the paddle structure 100450 with functionally similar components in braided or woven variation shown in FIG. 22. The components in the paddle structure 100450 are shown in a perspective view in FIG. 91A, side view in FIG. 91B, top view in FIG. 91C, bottom view in FIG. 91D, and another side view in FIG. 9 IE.

Table 1 : Correspondence between components in FIGS. 22 and 111A-111E.

[0478] The components of the paddle structure 100450 operate substantially similarly to their functional equivalents identified in Table 1. That is, the descriptions of the functional equivalents in the context of FIG. 22 apply equally well to the corresponding components in the paddle structure 100450.

[0479] As shown in FIGS. 91A-91E, inner/outer the paddle connection portion 100456 can be implemented by a cutout and series of perforations 100456a. Perforations 100456a allow connection portion 100456 to flex through a range of movement for opening and closing of the paddle structure 100450 shown in more detail below with respect to FIGS. 91H-91J. Joint portion 100460 can have a similar structure, though it is shown in FIGS. 91A-91E without perforations. More generally, either connection portion 100456 or joint portion 100460 can be fabricated in any suitable manner that creates flexibility to allow opening and closing of the paddle structure 100450. Abase connection portion 100458 extends from the joint portion 100460. The base connection portion 100458 is configured to connect the paddle structure to a base, such as a central post or a coaptation element.

[0480] A cap/paddle frame connection portion 100462 in FIG. 91 A connect the paddle structure 100450 to a distal the cap, such as the cap 214 and the paddle frames 224. The cap/paddle connection portion 100462 can take on a number of suitable forms. The connection portion 100462 is illustrated from above in FIG. 91C and from below in FIG. 91D. The connection portion 100462 can have any suitable configuration that fixes the paddle structure 100450 to the cap and/or the paddle frames. In the illustrated example, the connection portion includes a cutout that facilitates a snap fit connection of the paddle frames and/or the cap.

[0481] Turning back to FIG. 91A, each the paddle structure 100450 can contain eyelets 100464 that can be used to attach a cover and/or other components to the paddle structure 100450. Eyelet structure 100464 is shown in more detail in FIG. 9 IF. One of the purposes of the eyelets 100464 is to anchor sutures that connect the cover and/or other component sufficiently so that the suture does not pull out of the eyelet as stitching of the cover or other component to the paddle structure is started. In particular, the suture that is used to stitch the cover or other component to the paddle structure can be inserted into a wider portion 100464a of the eyelet 100464 that is wide enough to accommodate the entire diameter of suture. Then the suture can be anchored to the eyelet 100464 by moving suture from the wider portion 100464a to the narrower portion 100464b. The narrower portion 100464b has a width that is considerably less than the width of the wider portion 100464a. As a result, the narrower portion 100464b squeezes and fixes the suture into place. That is, the suture is wedged in the narrower portion 100464b.

[0482] FIG. 91G shows is a plan view of one-half of the flat, cut sheet material 100451 that is used to make the paddle structure 100450. FIG. 91G illustrates the location of the eyelets 100464 with respect to the inner/outer the paddle connection portion 100456 and other portions of the paddle structure 100450.

[0483] FIGS. 91H-91 J show an example opening and closing motion of the paddle structure 100450 when used in an implementation of a valve repair device or implant. The paddle structure 100450 can have the range of motion of any of the paddle structured disclosed herein. For example, the paddle structure can also be moved to an extended position and can have the same or similar range of motion as the paddle structure of the device illustrated by FIG. 22. The valve repair device or implant that includes the paddle structure 100450 can take a variety of different forms and can include any of the features of any of the devices or implants disclosed herein.

[0484] The position of the valve repair device or implant shown in FIG. 91H is a fully retracted position that corresponds to the fully retracted position shown for the example illustrated in FIG. 22. Referring to FIG. 911, the actuation element 212 extends the cap 214 away from the coaptation element 210 to partially open the paddle assembly. The position shown in FIG. 911 corresponds to the partially open position shown in either FIG. 30 or FIG. 31. Referring to FIG. 91 J, the actuation element 212 further extends the cap 214 further away from the coaptation element 210 to further open the paddle assembly. The position shown in FIG. 91 J corresponds to the laterally extended or open position shown in FIG. 32.

[0485] Referring to FIGS. 92-95, components of another example implementation of an implantable device or implant width adjustment assembly 100900 having paddle frame connectors is shown. The implantable device width adjustment assembly 100900 can include a proximal or attachment portion 100905, an anchor portion (e.g., any anchor portion described in the present application), paddle frame connector 100924 (e.g., shaped metal component, shaped plastic component, tether, wire, strut, line, cord, suture, etc.), an actuation portion 100910, an optional coaptation element (e.g., any spacer or coaptation element described in the present application), and a distal portion 100907. The connector 100924 forms a lower or distal portion of the paddle frames. The attachment portion 100905, the anchor portion, the distal portion 100907, the actuation portion 100910, and the connector 100924 can be configured in a variety of ways.

[0486] In the illustrated example, the connector 100924 is symmetric along longitudinal axis ZZ (FIG. 94). In some implementations of the implantable device width adjustment assembly 100900, however, the connector 100924 are not symmetric about the axis ZZ.

[0487] Referring to FIG. 94, in the illustrated example, the paddle frame connector 100924 comprises a W-shaped frame that has proximal ends 100967 and distal ends 100966. The connector 100924 has a width W12. The connector 100924 can be made of any suitable material that allows the connector 100924 to be moved between an expanded position and a narrowed position, such as, for example, any flexible material for paddle frames disclosed in the present application. While the connector 100924 is shown as having a W-shape, it should be understood that the connector 100924 can take any suitable form, such as, for example, any form described in the present application.

[0488] The connector 100924 has an inner end 100968 that engages with the actuation portion 100910 such that a user can move the inner end 100968 relative to the actuation portion 100910 to move the connector 100924 between a narrowed position and an expanded position, as described in more detail below. In the illustrated example, the inner end 100968 includes a post 100970 that attaches to the connector 100924 and a threaded receiving portion 100972 that extends from the post 100970. The inner end 100968 can, however, be configured in a variety of ways. Any configuration that can suitably attach the connector 100924 to the actuation portion 100910 to allow the actuation portion 100910 to move the connector 100924 between the narrowed position and the expanded position can be used.

[0489] The actuation portion 100910 allows a user to expand or contract the connector 100924 of the implantable device width adjustment assembly 100900. In the illustrated example, the actuation portion 100910 includes a coupler, such as the illustrated externally threaded shaft 100912 that is disposed within a receiver 100914 (e.g., an internally threaded element, a notched receiving portion, column, lumen, tube, shaft, sleeve, post, housing, tracks, cylinder etc.) and rotatably engaged with the threaded receiving portion 100972 of the inner end 100968 of the connector 100924. In some implementations, the receiver 100914 can be integrally formed with a distal cap 100915 of the distal portion 100907.

[0490] A driver head 100916 is disposed at a proximal end of the shaft 100912. The driver head 100916 is configured to receive a width adjustment element (e.g., an actuation wire, actuation shaft, actuation tube, actuation lumen, etc.) such that a user can rotate the width adjustment element to rotatably drive the shaft 100912 within the receiver 100914 in a direction R. The shaft 100912 extends through an opening of the receiving portion 100972 such that the external threads of the shaft 100912 engage internal threads of the opening of the receiving portion 100972. When the driver head 100916 is driven to rotate the shaft 100912, the engagement between the internal threads of the receiving portion 100972 and the external threads of the shaft 100912 causes the receiving portion 100972 (and, consequently, the post 100970) to move in a direction Y within the receiver 100914 and relative to the shaft 100912. The offset positioning between the shaft 100912 and the post 100970 of the inner end 100968 allows the post 100970 to move alongside the shaft 100912. In some implementations, rotation of the shaft 100912 in a counterclockwise direction causes the inner end 100968 to move toward the proximal end of the actuation portion 100910, and rotation of the shaft 100912 in a clockwise direction causes the inner end 100968 to move toward the distal end of the actuation portion 100910. However, it should be understood that other configurations are also contemplated.

[0491] In the illustrated example, the connection between the connector 100924 and the post 100970 of the inner end 100968 causes distal ends 100966 of the connector 100924 to move in the direction X (FIGS. 92-94) when the post 100970 moves in the direction Y, which causes the proximal ends 100967 of the connector to move in a direction Z (FIG. 95) to adjust the width W12 of the connector 100924. In the illustrated example, movement of the post 100970 toward a proximal end of the actuation portion 100910 causes the proximal ends 100967 of the connector 100924 to move in the direction Z toward the actuation portion 100910 such that the connector 100924 move to a narrowed position. Conversely, movement of the post 100970 toward a distal end of the actuation portion 100910 causes the proximal ends 100967 of the connector 100924 to move in the direction Z away from the actuation portion 100910 such that the connector 100924 moves to an expanded position. In some implementations, the distal ends 100966 of the connector 100924 can move into the receiver 100914 when the connector 100924 is moved to the narrowed position, and the distal ends 100966 can move out of the receiver 100914 when the connector 100924 is moved to the expanded position.

[0492] The movement of the connector 100924 to the narrowed position allows the device or implant to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart — e.g., chordae — and the device. The movement of the connector 100924 to the expanded position provides the anchor portion of the device or implant with a larger surface area to engage and capture leaflet(s) of a native heart valve.

[0493] In some implementations, the connector 100924 can be made from or comprise a material that allows the inner end 100968 and portions of the connector 100924 (e.g., the distal ends 100966) to be pulled into the actuation portion 100910. For example, the connector 100924, or a portion thereof, can be made of any flexible material, including but not limited to, metal, plastic, fabric, suture, etc. The connector 100924 can be made using a variety of processes, including, but not limited to, cutting, such as laser cutting, stamping, casting, molding, heat treating, shape setting, etc. The connector 100924 can be made from or comprise a shape memory material, — such as Nitinol — to provide shape-setting capability.

[0494] Referring to FIGS. 96-98, another example implementation of an implantable device or implant 101400 having paddle frames is shown. The implantable device 101400 includes a proximal or attachment portion 101405, an anchor portion (e.g., any anchor portion described in the present application), connector 101424 (e.g., shaped metal component, shaped plastic component, tether, wire, strut, line, cord, suture, etc.), an actuation portion 101410, an optional coaptation element (e.g., any coaptation element described in the present application), and a distal portion 101407. The attachment portion 101405, the anchor portion, the distal portion 101407, the actuation portion 101410, and the connector 101424 can be configured in a variety of ways.

[0495] In the illustrated example, the connector 101424 is symmetric along longitudinal axis BBB (FIG. 96). In some implementations of the implantable device 101400, however, the connector 101424 are not symmetric about the axis BBB. [0496] In the illustrated example, the connector 101424 are W-shaped frames that have proximal ends 101467 and distal ends 101466. The connector 101424 can have a width W14 (FIG. 96). The connector 101424 can be made of any suitable material that allows the connector 101424 to be moved between an expanded position and a narrowed position, such as, for example, any flexible material for paddle frames disclosed in the present application. While the connector 101424 is shown as having a W-shape, it should be understood that the connector 101424 can take any suitable form, such as, for example, any form described in the present application.

[0497] The connector 101424 have an inner end (not shown) that engages with the actuation portion 101410 such that a user can move the inner end relative to the actuation portion 101410 to move the connector 101424 between a narrowed position and an expanded position, as described in more detail below. The inner end can take any suitable form described in the present application. The inner end can, however, be configured in a variety of ways. Any configuration that can suitably couple the connector 101424 to the actuation portion 101410 to allow the actuation portion 101410 to open and close the paddle frames and to move the connector 101424 between the narrowed position and the expanded position can be used.

[0498] The actuation portion 101410 allows a user to open and close the paddle frames of the device by moving the actuation portion 101410 relative to the proximal portion of the device. The actuation portion 101410 also allows a user to expand or contract the connector 101424 of the implantable device 101400 by moving the connector 101424 into or out of the actuation portion 101410. In the illustrated example, the actuation portion 101410 includes a receiver 101414 (e.g., an internally threaded element, a notched receiving portion, column, lumen, tube, shaft, sleeve, post, housing, tracks, cylinder etc.) and a coupler 101411 that is configured to extend through the receiver 101414 and be moved by a user relative to the receiver 101414. For example, the coupler 101411 can include one or more of a threaded connection, features that mate with threads, detent connections, such as outwardly biased arms or portions, flexible projections etc. The coupler 101411 attaches to the connector 101424 such that movement of the width adjustment element relative to the receiver 101414 causes the connector 101424 between the narrowed and expanded positions. In some implementations, the receiver 101414 can be integrally formed with a distal cap 101415 of the distal portion 101407 of the implantable device 101400. While described here as a receiver, other structures or openings in structures of a variety of shapes and sizes that can accomplish the same purpose can be used as well.

[0499] The coupler 101411 can be connected to or can include, for example, an actuation wire, actuation shaft, or any other suitable element that a user can engage to move the connector 101424 between the narrowed and expanded positions. For example, a distal end, a proximal end, or another portion of the coupler 101411 can include a connection feature 101413 for receiving and connecting to a retention feature of the connector 101424 (e.g., the retention feature 101372 of the connector 101324 shown in FIG. 95). The connector or connection feature 101413 can include openings 101444 for receiving the retention feature of the connector 101324. For example, the openings 101444 can be configured to receive arms of the connector 101424. In the illustrated example, the connector or connection feature 101413 is a separate component from the remainder of the coupler 101411. For example, a proximal end of the connector or connection feature 101413 can be configured to attach to the remainder of the coupler 101411. In the illustrated example, the connector or connection feature 101413 includes a connection opening 101455 for receiving another portion of the coupler 101411. The connection between the remainder of the coupler 101411 and the connection opening 101455 can take any suitable form, such as, for example, any form described in the present application. In some implementations, the connector or connection feature 101413 is integral to another component of the coupler 101411.

[0500] The connection feature 101413 can have one or more protruding side wall portions 101461 (FIGS. 97-98) that are movable between a normal, expanded position (as shown in FIGS. 97 and 98) and a compressed position (as shown in FIG. 98), and the receiver 101414 can have a plurality of holes or openings 101465 (shown for example in FIGS. 96 and 98; however, other similar elements like indentations, protrusions, notches, etc. could be used as well) for receiving the protruding side wall portions 101461 when the side wall portions 101461 are in the normal, expanded position. The connection between the protruding side wall portions 101461 of the connector or connection feature 101413 and the openings 101465 of the receiver 101414 secures the connection feature 101413 (and, consequently, the inner end of the connector 101424) at a desired location within the receiver 101414, which allows a user to maintain the connector 101424 at a desired width. The protruding side wall portions 101461 can be made of a flexible and/or shape set material, such as, for example, the arms 101263 can be made of metal, plastic, composite material, shape memory material, etc.

[0501] Referring to FIG. 98, a user can move the connector or connection feature 101413 in a proximal direction P or a distal direction D relative to the receiver 101414. When the connection feature 101413 is aligned with an opening 101465 of the receiver 101414, the protruding side wall portions 101461 can move to their normal, expanded position such that the protruding side wall portions 101461 extend into the aligned opening 101465, which allows a user to maintain the connection feature 101413 and, consequently, the connector 101424 (FIG. 96) in a desired position. When a user provides a force to the connection feature 101413 in either the proximal direction P or the distal direction D, the protruding side wall portions 101461 are engaged by the interior surface of the receiver 101414 such that the protruding side wall portions 101461 move to the compressed position, which allows the user to move the connection feature 101413 and, consequently, the connector 101424 relative to the receiver 101414.

[0502] While the protruding side wall portions 101461 are described as being a component of the coupler 101411, in some implementations, it should be understood that the protruding side wall portions 101461 that engage the openings 101465 of the receiver 101414 can be a component of the connector 101424. For example, the protruding side wall portions can be attached to or integral to the inner end of the connector 101424.

[0503] In some implementations, movement of the connection feature 101413 in the proximal direction P causes the connector 101424 to move such that the width W14 (FIG. 96) moves to the narrowed position, and movement of the connection feature 101413 in the distal direction D causes the connector 101424 to move such that the width W14 of the connector 101424 move to the expanded position. However, it should be understood that other configurations are also contemplated. In some implementations, the distal ends 101466 of the connector 101424 can move into the receiver 101414 when the connector 101424 is moved to the narrowed position, and the distal ends 101466 can move out of the receiver 101414 when the connector 101424 are moved to the expanded position. However, it should be understood that other configurations are also contemplated. [0504] The movement of the connector 101424 to the narrowed position allows the device or implant 101400 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart — e.g., chordae — and the device 101400. The movement of the connector 101424 to the expanded position provides the anchor portion of the device or implant 101400 with a larger surface area to engage and capture leaflet(s) of a native heart valve.

[0505] In some implementations, the connector 101424 can be made from or comprise a material that allows the inner end and portions of the connector 101424 (e.g., the distal ends 101066) to be pulled into the actuation portion 101410. For example, the connector 101424, or a portion thereof, can be made of any flexible material, including but not limited to, metal, plastic, fabric, suture, etc. The connector 101424 can be made using a variety of processes, including, but not limited to, cutting, such as laser cutting, stamping, casting, molding, heat treating, shape setting, etc. The connector 101424 can be made from or comprise a shape memory material, — such as Nitinol — to provide shape-setting capability.

[0506] Referring to Figure 96, a connection feature 101416 is disposed at a proximal end of the implantable device 101400 for receiving an actuation element (not shown) of a delivery device (not shown). The connection between the connection feature 101416 and the actuation element of the delivery device can take any suitable form described in the present application. In the illustrated example, the connection feature 101416 is threadably attached to the receiver 101414. The connection feature 101416 can, however, be attached to the receiver 101414 or any other portion of the implantable device 101400 by any suitable means. In some implementations, the connection feature 101416 can be integral to the receiver 101414.

[0507] Referring now to FIGS. 99-107, an example of an implantable device or implant 102200 is shown that includes coaptation element that is smaller than the coaptation element shown in other implementations. For example, the coaptation element can be smaller compared to the coaptation elements shown in FIG. 22 with more space between the paddle frames and the spacer in the example of FIGS. 99-107 than in the FIG. 22 example. The implantable device or implant 102200 is one of the many different configurations that the device 100, schematically illustrated in FIGS. 8-14, can take. [0508] For example, in some implementations, the device/implant 102200 includes a coaptation portion 102204, a proximal or attachment portion 102205, an anchor portion 102206, and a distal portion 102207. The device 102200 can include any other features for an implantable device or implant discussed in the present application and/or in U.S. Provisional Patent Application No. 63/217,622 filed on July 1, 2021, which is incorporated herein by reference in its entirety. In some implementations, the device 102200 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 the present application and/or U.S. Provisional Patent Application No. 63/217,622). The device/implant 102200 can be a prosthetic spacer device, valve repair device, or another type of implant that attaches to leaflets of a native valve.

[0509] In some implementations, the anchor portion 102206 includes a plurality of anchors 102208. The anchors 102208 can be configured in a variety of ways, such as, for example, any of the ways described in the present application. In the illustrated example, the anchor portion 102206 includes two anchors 102208. In some implementations, each anchor 102208 can have outer paddles 102220, inner paddles 102222, paddle extension members or paddle frames 102224, and clasps 102230. The outer paddles 102220, inner paddles 102222, paddle frames 102224, and clasps 102230 can take any suitable form, such as, for example, any form described in the present application.

[0510] In some implementations, the paddle frames 102224 can have an inner frame portion 102272 and an outer frame portion 102274, such as, for example, similar to any other paddle frame disclosed in the present application that includes an inner frame portion and an outer frame portion. The anchors 102208 can include an optional cover, such as, for example, any of the covers disclosed in the present application, where the cover can be configured to assist in coapting the leaflets and preventing or inhibiting regurgitation of blood through the native valve. The cover can be attached to the anchors 102208 in any suitable manner and by any suitable means, such as, for example, any manner and/or means described in the present application.

[0511] The attachment portion 102205 and distal portion 102207 can take any suitable form, such as, for example, any form described in the present application. In the illustrated example, the attachment portion 102205 includes a first or proximal collar 102211 (or other attachment element) for engaging with a coupler of a delivery system. In the illustrated example, the distal portion 102207 includes a cap 102214 that is operatively connected to the anchor portion 102206 of the device 102200 such that movement of the cap 102214 relative to a spacer or coaptation element 102210 of the coaptation portion 102204 causes the anchors 102208 to move between open and closed positions.

[0512] The coaptation portion 102204 of the device can include a coaptation element 102210 (e.g., a spacer, coaptation element, bushing, etc.) for implantation between leaflets of a native valve. The coaptation element 102210 extends from the proximal collar 102211 (or other attachment element) to a distal end 102251 and includes a lumen 102253 for receiving the actuation element (e.g., actuation shafts, actuation rods, actuation tubes, actuation wires, actuation lines, etc.) and the width adjustment element (e.g. width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, etc.) of the implantable device 102200. In the illustrated example, the proximal collar 102211 of the attachment portion 102205 is integral with the coaptation element 102210.

[0513] The coaptation element 102210 can have attachment openings 102240 (FIGS. 102-103 and 106) such that the anchors 102208 can be attached to the coaptation element 102210. In the illustrated example, the inner paddles 102222 of the anchors 102208 are coupled to the coaptation element 102210 at the attachment openings 102240. Referring to FIG. 107, mounting posts 102261 are connected to the inner paddles 102222 by transition portions or curved segments 102263. The mounting posts 102261 can have attachment openings 102252 (FIG. 107) that are configured to align with the attachment openings 102240 of the coaptation element 102210 such that a connection component (e.g., a suture, fastener, etc.) can be inserted through the attachment openings 102240, 102252 to secure the mounting posts 102261 to the coaptation element 102210. The inner paddles 102222 can, however, be coupled to the coaptation element 102210 by any other suitable means.

[0514] The proximal end of the coaptation element 102210 has a proximal opening 102255 that allows an actuation element and/or a width adjustment element to move relative to the lumen 102253. The proximal opening 102255 allows the actuation element and/or the width adjustment element to engage one or more controllable components of the device or implant 102200. The distal end 102251 of the coaptation element 102210 can include a distal opening 102257. An actuation element and/or one or more components that couple the cap to the actuation element can extend through the distal opening 102257 and attach to the cap. In some implementations, an actuation element extends from the delivery system to engage and enable actuation of the device 102200 between the open and closed positions and/or a width adjustment element extends from the delivery system to adjust widths of the paddles. Movement of the cap 102214 away from the coaptation element 102210 can cause the anchors 102208 to move to the open position, and movement of the cap 102214 toward the coaptation element 102210 can cause the anchors 102208 to move to the closed position. The actuation element, the cap, and any components that couple the cap to the actuation element can be configured to removably engage the cap 102214 in any suitable manner that allows the actuation element to be disengaged and removed from the device 102200 after implantation, such as, for example, any manner described in the present application.

[0515] In some implementations, one or more width adjustment elements extend through the lumen 102253 of the coaptation element 102210 and engage the paddle frames 102224 to move the paddle frames 102224 between a narrowed position and an expanded position. For example, a connector 102266 or other component that is coupled to the paddle frames 102224 can extend through the cap 102214, through the distal opening 102257 and into the lumen 102253 of the coaptation element 102210. The width adjustment s) can be configured to engage and move the connector 102266 or other component of the paddle frames 102224 relative to the cap 102214. In some implementations, movement of the connector 102266 or other component of the paddle frames 102224 in a distal direction relative to the cap 102214 can cause the paddle frames 102224 to move to an expanded position, and movement of the connector 102266 or other component of the paddle frames 102224 in a proximal direction relative to the cap 102214 can cause the paddle frames 102224 to move to a narrowed position. The width adjustment element can be configured to removably engage the paddle frames 102224 in any suitable manner that allows the width adjustment element to be disengaged and removed from the device 102200 after implantation, such as, for example, any manner described in the present application. [0516] In some implementations, when viewed from above (as shown in FIG. 100), the coaptation element 102210 has a smaller size relative to the outer periphery of the device 102200, such as, for example, relative to the outer periphery of the paddle frames 102224 of the device 102200. For example, a ratio of an area defined by the outer periphery of the paddle frames 102224 when view from above relative to the outer periphery of the coaptation element 102210 when view from above can be greater than or equal to 2 to 1, such as greater than or equal to 3 to 1, such as greater than or equal to 4 to 1, such as greater than equal to 5 to 1, such as greater than or equal to 6 to 1, such as greater than or equal to 10 to 1. In implementations with a smaller coaptation element, the optional cover described above can be attached to the paddle frames 102224 to cover any open portions between the paddle frames 102224 and the coaptation element 102210 to block regurgitative blood flow between the paddle frames 102224 and the coaptation element 102210.

[0517] The smaller size of the coaptation element 102210 can allow for easier movement of the various components of the anchors 102208 as the anchors 102208 are moved between the open and closed positions. For example, the coaptation element 102210 can include planar surfaces 102244 (FIGS. 102-103) for allowing the clasps 102230 to rest on when the device 102200 is in the closed position. In some implementations, the coaptation element 102210 can have tapered walls 102246 (FIGS. 101 and 105) that extend inward from the proximal end to the distal end of the coaptation element 102210 to create additional space for the anchors 102208 to move when the device is moved to the opened position. That is, as the device 102200 is moved to the opened position, one or more components of the anchors 102208 (e.g., the paddle frames 102224) pivot downward, and the tapered walls provide for additional space for the components of the anchors to move.

[0518] Referring to FIGS. 102-104, in the illustrated example, the coaptation element 102210 has a proximal portion 102241 (FIG. 102) having a generally rectangular shape and a distal portion 102243 (FIG. 102) having a generally rounded shape. However, it should be understood that other configurations are also contemplated. In some implementations, the coaptation element 102210 can be made by injection molding. However, it should be understood that other configurations are also contemplated. In some implementations, the coaptation element can be made from or comprise any known polymer material or other non- polymer material(s). In some implementations, the coaptation element 102210 can be made from or comprise a metal material or any other suitable material.

[0519] Referring to FIGS. 108-113, components of another example implementation of an implantable device or implant 102300 having paddle frames is shown, where a coupler or connection feature 102313 is used to allow a width adjustment element to engage the paddle frames and move the paddle frames between narrowed and expanded positions. The implantable device 102300 can include a proximal or attachment portion 102305, an anchor portion 102306 (e.g., any anchor portion described in the present application), a coaptation portion 102304, and a distal portion 102307. The coaptation portion 102304, proximal portion 102305, the anchor portion 102306, and the distal portion 102307 can be configured in a variety of ways, such as, for example, any of the ways described in the present application.

[0520] In some implementations, for example, in the illustrated example, the coaptation portion 102304 includes a coaptation element 102310 that takes the form of the coaptation element 102210 shown in FIGS. 99-107. The coaptation element 102310 includes a column or lumen 102353 that accepts a receiver 102302 (e.g., an internally threaded element, a notched receiving portion, column, lumen, tube, shaft, post, housing, tracks, cylinder etc.). The receiver 102302 is connected to the cap and is moveable inside the lumen 102353 to open and close the paddles. For example, the receiver 102302 can be coupled to the actuation element 8102 shown in FIGS. 26-30. Movement of the actuation element can open and close the paddles in the manner described in FIGS. 26-30. The actuation element 8102 can be coupled and decoupled from the receiver in any manner described herein. The coupler 102313 is moveable inside the receiver 102302. The coupler 102313 is connected to a width adjustment element 102311 (e.g. width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, etc.) and to a connector 102366 that is connected to the paddle frames 102324. As such, movement of the width adjustment element 102311, moves the coupler 102313 and the connector 102366 inside the receiver 102302 to move the paddle frames 102324 between the narrowed and expanded positions. The paddle frames 102324 can include outer frame portions and inner frame portions that are the same as or similar to other outer frame portions and inner frame portions described elsewhere herein. [0521] In the illustrated example, the paddle frames 102324 are symmetric along longitudinal axis CCC (FIG. 108). In some implementations of the implantable device 102300, however, the paddle frames 102324 are not symmetric about the axis CCC. In the illustrated example, the two paddle frames 102324 are connected to the single connector 102366 at the sides of the paddle frame portions. As a result, the single movement of the connector 102366 uniformly controls the width of the two paddle frames 102324. In some implementations, more than one, such as two or four, connectors 102366 can be used to non-uniformly adjust the paddle frames 102324 (differently between the two paddle frame portions and/or differently between the two sides of a single paddle frame portion.

[0522] Referring to FIG. 108, in the illustrated example, the connector 102366 is W- shaped. The connector 102366 is configured to be drawn/flexed into the cap 102314 to pull the paddle frames 102324 to the narrowed configuration. The connector 102366 is configured to be advanced out of the cap 102314 to allow the paddle frames 102324 to widen. The connector 102366 can take a wide variety of different forms. The connector 102366 can be made from or comprise a flexible material. In the illustrated example, the connector 102366 includes arms 102367 with optional slits or cutouts 102369. The cutouts 102369 allow the sides 102371 to move or flex toward one another as the arms 102367 are drawn into the cap 102314. This increases the flexibility of the arms 102367. The connector 102366 can be made from or comprise any material that can be drawn into and pushed out of the cap 102314 to move the paddle frames 102324 between an expanded position and a narrowed position. While the connector 102366 is shown as having a W-shape, it should be understood that the connector 102366 can take any suitable form that can move the paddle frames 102324 between an expanded position and a narrowed position.

[0523] In the illustrated example, a connector 102366 (e.g., shaped metal component, shaped plastic component, tether, wire, strut, line, cord, suture, etc.) includes an inner end or post 102368 that is engaged by a paddle width adjustment element 102311 (e.g., an adjustment shaft, adjustment rod, adjustment tube, or any other suitable type of adjustment element) such that a user can move the inner end or post 102368 relative to the receiver 102302 and the cap 102314. Movement of the paddle width adjustment element 102311 relative to the receiver 102302 and the cap 102314 moves the paddle frames 102324 between the narrowed and expanded positions, as described in more detail below. In the illustrated example, the inner end or post 102368 includes prongs 102370 that attach to a coupler 102313 that is releasably attachable to the paddle width adjustment element 102311. The inner end or post 102368 of the connector 102366 can take any suitable form, such as, for example, the form of the inner end 101368 of the connector 101324 shown in FIG. 95, or any other form described in the present application. The slit 101374 illustrated in Figure 95 is optional.

[0524] The width adjustment element 102311 can be releasably connected to the coupler or connection feature 102313, and thus, the prongs 102370. For example, the width adjustment element 102311 can be releasably connected to the coupler 102313 by a threaded connection. When connected to the coupler 102313, the width adjustment element can move the coupler 102313 to move relative to the receiver 102302.

[0525] In some implementations, referring to FIGS. 110-113, the coupler 102313 has a body 102381 that includes a proximal opening 102382, a distal opening 102384, a lumen 102386 (FIG. Ill) that extends from the proximal to distal opening, a first attachment projection 102388, and a second attachment projection 102390. The first and second attachment projections 102388, 102390 extend from cutouts 102394 of the body 102381 such that the attachment projections 102388, 102390 extend at an inward angle relative to the body 102381. The first attachment projection 102388 is offset from the second attachment projection 102390 by a height H (FIG. Ill) such that the attachment projections 102388, 102390 are configured to connect the width adjustment element 102311 to the coupler 102313 by a threaded connection. That is, the attachment projections 102388, 102390 are configured to align with the pitch of external threads 102395 of the width adjustment element 102311. Accordingly, the width adjustment element 102311 can be connected to the coupler 102313 by rotating the width adjustment element 102311 relative to the coupler 102313 in a first direction, and the width adjustment element 102311 can be disconnected from the coupler 102313 by rotating the width adjustment element 102311 relative to the coupler 102313 in an opposite direction. In the illustrated example, the attachment projections 102388, 102390 are configured to connect to square threads of the width adjustment element 102311. However, the attachment projections 102388, 102390 can be configured to connect to any type of threads. However, it should be understood that other configurations are also contemplated. For example, the proximal end of the coupler can include traditional female threads instead of the projections 102388, 102390.

[0526] The prongs 102370 of the paddle frames 102324 can connect to the coupler 102313 by any suitable means, such as, for example, any means described in the present application. In the illustrated example, the prongs 102370 connect to the coupler 102313. That is, the coupler 102313 includes openings for receiving the prongs 102370 of paddle frames 102324. However, it should be understood that other configurations are also contemplated.

[0527] The coupler 102313 can be made of any suitable material that allows for the attachment projections 102388, 102390 to be positioned to engage the external threads of the width adjustment element 102311. For example, the coupler 102313 can be made from or comprise metal or polymer materials. In some implementations, the coupler can be made from or comprise a sheet metal material that includes the attachment projections 102388, 102390, such as, for example, a sheet metal material.

[0528] Referring to FIG. 108, in in some implementations, the connector 102366 (e.g., shaped metal component, shaped plastic component, tether, wire, strut, line, cord, suture, etc.) attaches to the paddle frames 102324 at outer ends of the connector 102366 and to a coupler 102313 at an inner end of the connector 102366 (See FIG. 108). Prongs 102370 of the inner end 102368 are connected to the coupler 102313. Movement of the coupler 102313 and prongs 102370 in direction Y causes the arms 102367 of the connector 102366 to move in the directions X. This movement causes the paddle frames 102324 to move between the narrowed and expanded positions. In the illustrated example, movement of the prongs 102370 away from the cap 102314 causes the paddle frames 102324 to move to a narrowed position. Conversely, movement of the prongs 102370 toward the cap 102314 causes the paddle frames 102324 to move to an expanded position. In some implementations, the arms 102367 of the connector 102366 move into the receiver 102302 when the paddle frames 102324 are moved to the narrowed position, and the distal ends of the connector 102366 move out of the receiver 102302 when the paddle frames 102324 are moved to the expanded position.

[0529] The movement of the paddle frames 102324 to the narrowed position allows the device or implant 102300 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart — e.g., chordae — and the device 102300. The movement of the paddle frames 102324 to the expanded position provides the anchor portion of the device or implant 102300 with the flexibility to select a range of surface areas to engage and capture leaflet(s) that best suits the individual native heart valve.

[0530] In some implementations, the paddle frames 102324 can be made from or comprise a material that allows the paddle frames 102324 to be pulled and flexed between narrow and wide configurations. For example, the paddle frames 102324, or a portion thereof, can be made of any flexible material, including but not limited to, metal, plastic, fabric, suture, etc. The paddle frames 102324 can be made using a variety of processes, including, but not limited to, cutting, such as laser cutting, stamping, casting, molding, heat treating, shape setting, etc. The paddle frames 102324 can be made from or comprise a shape memory material, — such as Nitinol — to provide shape-setting capability.

[0531] In some implementations, the adjustable width paddle frames can be adjusted to a selected width and be set or fixed at the selected width to remain at the selected width. The adjustable width paddle frames can be adjusted to a selected width and be set or fixed at the selected width to remain at the selected width in a variety of different ways. Any configuration that allows the width of the paddle frames to be adjusted between a narrow configuration and a wide configuration and then set or fixed at the selected configuration can be used. In some implementations, connecting a paddle width adjustment element to a coupler allows the coupler to move to adjust the width of the adjustable width paddle frame(s) and disconnecting the paddle width adjustment element from the coupler fixes the position of the coupler relative to one or more components of the valve repair device to set the width of the adjustable width paddle frame(s). For example, connecting a paddle width adjustment element to a coupler can allow the coupler to move relative to the cap and/or receiver to adjust the width of the adjustable width paddle frame(s) and disconnecting the paddle width adjustment element from the coupler fixes the position of the coupler relative to the cap and/or receiver to set the width of the adjustable width paddle frame(s).

[0532] Referring to FIGS. 115-130, components of an example implementation of an implantable device or implant 102400 where a connector 102466 and connected adjustable width paddle frames (See FIGS. 99, 100, and 108) can be adjusted to a selected width and be set or fixed at the selected width to remain at the selected width are illustrated. A coupler or connection feature 102413 is used to allow a width adjustment element to engage the paddle frames and move the paddle frames between narrowed and expanded positions and to set the position of the paddle frames relative to a cap 102414 and/or receiver 102402 (e.g., an internally threaded element, a notched receiving portion, column, lumen, tube, shaft, post, housing, tracks, cylinder etc.). The implantable device 102400 can include a proximal or attachment portion (not shown), an anchor portion 102406 (e.g., any anchor portion described in the present application), paddle frames (attached to the connector - See FIGS. 99, 100, and 108), a coaptation or spacer portion 102404, and a distal portion 102407. The coaptation portion 102404, the proximal portion, the anchor portion 102406, and the distal portion 102407 can be configured in a variety of ways, such as, for example, any of the ways described in the present application. In the illustrated example, the coaptation portion 102404 includes a coaptation element 102410 that takes the form of the coaptation element 102210 shown in FIGS. 99-107.

[0533] In the illustrated example, the connector 102466 is symmetric along longitudinal axis DDD (FIG. 115). In some implementations of the implantable device 102400, however, the connector 102466 is not symmetric about the axis DDD. In the illustrated example, the connector 102466 has an inner end or post 102468 that is engaged by n width adjustment element 102411 (e.g., an actuation shaft, actuation rod, actuation tube, or any other suitable type of actuation element) such that a user can move the inner end 102468 relative to the receiver 102402 to move the connector 102466 and attached paddle frame portions between the narrowed and expanded positions. In the illustrated example, the inner end 102468 includes prongs 102470 or other connecting structure that attaches to the coupler 102413. The inner end or post 102468 of the connector 102466 can take any suitable form, such as, for example, the form of the inner end 101368 of the connector 101324 shown in FIG. 95 with or without the optional slit 101374, or any other form described in the present application.

[0534] The width adjustment element 102411 can be releasably connected to the coupler 102413, and the inner end 102468 is connected to the coupler 102413. When the width adjustment element 102411 is connected to the coupler 102413, the coupler disengages from the receiver 102402. When the coupler 102413 is disengaged from the receiver 102402, movement of the width adjustment element causes the coupler 102413 and, consequently, the prongs 102470 to move relative to the receiver 102402 to widen and narrow the paddle frames. When the width adjustment element 102411 is disconnected from the coupler 102413, the coupler engages the receiver 102402, When the coupler 102413 is engaged with the receiver 102402, movement of the width adjustment element 102411, the coupler 102413, and the prongs 102470 is prevented, setting or fixing the width of the paddle frame.

[0535] In the illustrated example, referring to FIGS. 125-130, the coupler 102413 has a body 102481 that includes a proximal opening 102482, a distal opening 102484, a lumen 102486 that extends from the proximal to distal opening. The proximal end of the coupler 102413 has a connection portion 102453 for connecting to the width adjustment element 102411 (FIGS. 115-123). The connection portion 102453 can take any suitable form that allows for a connection between the width adjustment element 102411 and the coupler 102413, such as, for example, a threaded connection, a snap-fit connection, or any other suitable type of connection described in the present application. In the illustrated example, the connection portion 102453 takes the form for connecting the width adjustment element 102311 and coupler 102313 shown in FIGS. 108-113. However, it should be understood that other configurations are also contemplated.

[0536] The post or inner end 102468 of the paddle frame connector 102466 can connect to the coupler 102413 by any suitable means, such as, for example, any means described in the present application. In the illustrated example, the prongs 102470 on the inner end 102468 connect to the coupler 102413 in any manner described in the present application. That is, the coupler 102413 can includes opening 102415 for receiving the prongs 102470 (FIG. 115). In the illustrated example, arms 102473 connect the prongs 102470 to the inner end 102468 and allow the prongs 102470 to be pressed toward one another to enter the openings 102415.

[0537] The coupler 102413 can also include a first arm 102494 and a second arm 102496 for engaging internal threads 102491 or other recesses or cutouts (FIGS. 117-124) of the receiver 102402 to maintain the coupler 102413 in a selected position. Setting the position of the coupler 102413 sets the position of the connector 102466 in a desired position, which maintains the paddle frame portions (See FIGS. 99, 100, and 108) at a desired width. Since the position of the coupler 102413 is set relative to the receiver 102402 and attached cap 102414, the width of the paddle frame portions is fixed as the paddles moved between closed, open, and extended positions by the receiver 102402 and the cap 102414.

[0538] The first and second arms 102494, 102496 extend from cutouts of the body 102481. Referring to FIGS. 125 and 129-130, when the coupler 102413 is in the normal position (i.e., disconnected from the width adjustment element 102411), the arms 102494, 102496 extend at an angle relative to the body 102481, where a portion of the arms 102494, 102496 extend within the lumen 102486 of the coupler 102413 and another portion of the arms 102494, 102496 extend away from an exterior of the body 102481. In the illustrated example, the proximal ends of the arms 102494, 102496 extend into the lumen 102486 of the coupler 102413, and the distal ends of the arms 102494, 102496 extend away from the body 102481. Alternatively, the proximal ends of the arms 102494, 102496 can extend away from the exterior of the body 102481, and the distal ends of the arms 102494, 102496 can extend into the lumen 102486.

[0539] Referring to FIGS. 125-130, the first arm 102494 is offset from the second arm 102496 by a height H (FIG. 128) such that the arms 102494, 102496 are configured to connect to the internal threads 102491 (FIGS. 117-124) of the receiver 102402 when in the normal position (as shown in FIGS. 123-124). That is, the arms 102494, 102496 are configured to align with the pitch of internal threads 102491 of the receiver 102402. Accordingly, when the arms 102494, 102496 are in the normal position, the portion of the arms 102494, 102496 that extend away from the exterior of the body 102481 engage the internal threads 102491 of the receiver 102402 to prevent or inhibit movement of the coupler 102413 relative to the receiver 102402. In the illustrated example, the arms 102494, 102496 are configured to connect to square threads of the receiver 102402. However, it should be understood that other configurations are also contemplated, such as traditional internal threads, recesses, cutouts, etc. Referring to FIG. 130, in some implementations, the arms 102494, 102496 extend away from the body 102481 by an angle a when the arms 102494, 102496 are in the normal position. The angle a can be between about 10 degrees and about 45 degrees, such as between 15 degrees and about 30 degrees.

[0540] Referring to FIG. 115, in the illustrated example, the connection between the width adjustment element or shaft 102411 and the connector 102466 causes the connector 102466 to move in the direction X when the width adjustment element 102411 moves in the direction Y. This causes the connector 102466 and attached paddle frames to move between the narrowed and expanded positions. In the illustrated example, movement of the width adjustment element or shaft 102411 proximally causes the paddle frame portions to narrow. Conversely, movement of the width adjustment element or shaft 102411 distally causes the paddle frame portions to expand or widen. Once the connector 102466 and paddle frames are in the desired position, the user can disconnect the width adjustment element 102411 from the coupler 102413, which will cause the arms 102494, 102496 of the coupler 102413 to move to the normal position and engage the internal threads 102491 of the receiver 102402 such that the paddle frame portions are set or maintained in the desired position.

[0541] The movement of the paddle frame portions to the narrowed position allows the device or implant 102400 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart — e.g., chordae — and the device 102400. The movement of the connector 102466 and paddle frames to the expanded position provides the anchor portion of the device or implant 102400 with a larger surface area to engage and capture leaflet(s) of a native heart valve.

[0542] In some implementations, the connector 102466 can be made from or comprise a material that allows arms of the connector 102466 to be pulled into the receiver 102402. For example, the connector 102466, or a portion thereof, can be made of any flexible material, including but not limited to, metal, plastic, fabric, suture, etc. The connector 102466 can be made using a variety of processes, including, but not limited to, cutting, such as laser cutting, stamping, casting, molding, heat treating, shape setting, etc. The connector 102466 and paddle frames can be made from or comprise a shape memory material, — such as Nitinol — to provide shape-setting capability.

[0543] Referring to FIGS. 131-136, components of an example implementation of an implantable device or implant 102500 where a connector 102566 (e.g., shaped metal component, shaped plastic component, tether, wire, strut, line, cord, suture, etc.) and connected adjustable width paddle frames 102524 can be adjusted to a selected width and be set or fixed at the selected width to remain at the selected width are illustrated (See also FIGS. 99, 100, and 108). A coupler or connection feature 102513 is used to allow a width adjustment element to engage the connector 102566 and move the paddle frames 102524 between narrowed and expanded positions and to set the position of the paddle frames 102524 relative to a cap 102514 and/or receiver 102502 (e.g., an internally threaded element, a notched receiving portion, column, lumen, tube, shaft, post, housing, tracks, cylinder etc.). The implantable device 102500 and coupler 102513 can take the form of the implantable device 102400 and coupler 102413 shown in FIGS. 115-130. However, it should be understood that other configurations are also contemplated.

[0544] The implantable device 102500 can include a proximal or attachment portion 102505, an anchor portion 102506 (e.g., any anchor portion described in the present application) having paddle frames 102524 (attached to the connector - See FIGS. 99, 100, and 108), a coaptation or spacer portion 102504, and a distal portion 102507. The coaptation portion 102504, the proximal portion 102505, the anchor portion 102506, and the distal portion 102507 can be configured in a variety of ways, such as, for example, any of the ways described in the present application. In the illustrated example, the coaptation portion 102504 includes a coaptation element 102510 that takes the form of the coaptation element 102210 shown in FIGS. 99-107. However, it should be understood that other configurations are also contemplated.

[0545] In the illustrated example, the connector 102566 is symmetric along longitudinal axis EEE (FIG. 131). In other implementations of the implantable device 102500, however, the connector 102566 is not symmetric about the axis EEE. In the illustrated example, an inner end 102568 of the connector 102566 is engaged by a width adjustment element 102511 (e.g., an actuation shaft, actuation rod, actuation tube, or any other suitable type of actuation element) such that a user can move the inner end 102568 relative to the receiver 102502 to move the connector 102566 and attached paddle frames 102524 between the narrowed and expanded positions. In the illustrated example, the inner end 102568 of the connector 102566 includes prongs 102570 or other connecting structure that attaches to the coupler 102513. The inner end or post 102568 of the connector 102566 can take any suitable form, such as, for example, the form of the inner end 101368 of the connector 101324 shown in FIG. 95 with or without the optional slit 101374, or any other form described in the present application. [0546] Referring to FIG. 131, the width adjustment element 102511 can be releasably connected to the coupler 102513, and the inner end 102568 of the connector 102566 can be connected to the coupler 102513. When the width adjustment element 102511 is connected to the coupler 102513, the coupler disengages from the receiver 102502. When the coupler 102513 is disengaged from the receiver 102502, movement of the width adjustment element 102511 causes the coupler 102513 and, consequently, the connector 102566 to move relative to the receiver 102502 to widen and narrow the paddle frames 102524.

[0547] The coupler 102513 has a body 102581 that includes a proximal opening 102582, a distal opening 102584, and a lumen 102586 that extends from the proximal to distal opening. The proximal end of the coupler 102513 has a connection portion 102515 for removably connecting to the width adjustment element 102511 (FIGS. 115-123). The connection portion 102515 can take any suitable form that allows for a connection between the width adjustment element 102511 and the coupler 102513, such as, for example, a threaded connection, a snap-fit connection, or any other suitable type of connection described in the present application. The connection portion 515 can be an internally threaded portion or can take the form for connecting the width adjustment element 102311 and coupler 102313 shown in FIGS. 108-113. However, it should be understood that other configurations are also contemplated and usable. The inner end 102568 of the connector 102566 can connect to the coupler 102513 by any suitable means, such as, for example, any means described in the present application. In the illustrated example, the prongs 102570 on the connector 102566 connect to the coupler 102513 in any manner described in the present application. However, it should be understood that other configurations are also contemplated.

[0548] Referring to FIG. 132, in some implementations, when the width adjustment element 102511 is disconnected from the coupler 102513, the coupler engages the receiver 102502. When the coupler 102513 is engaged with the receiver 102502, movement of the coupler 102513 and the inner end 102568 of the connector 102566 is prevented, setting or fixing the width of the paddle frame 102524. In the illustrated example, the coupler 102513 includes a first arm 102594 and a second arm 102596 for engaging internal threads 102591 or other recesses or cutouts (FIGS. 117-124) of the receiver 102502 to maintain the coupler 102513 in a selected position. Setting the position of the coupler 102413 sets the connector m 102566 in a desired position, which maintains the paddle frame 102524 at a desired width (See FIGS. 99, 100, and 108). Since the position of the coupler 102513 is set relative to the receiver 102502 and attached cap 102514, the width of the paddle frame 102524 is fixed as the paddles move between closed, open, and extended positions by a user engaging an actuation element (e.g., actuation element 8102 shown in FIGS. 26-30) to cause the receiver 102502 and the cap 102514 to move relative to the coaptation element 102514. In some implementations, the arms 102594, 102596 can also have one or more tabs 102593 and the body 102581 can have one or more slots 102597 for receiving the tabs 102593 when the arms 102594, 102596 are in the normal position, which prevents the arms 102594, 102596 from disengaging from the internal threads 102591 of the receiver 102502 due to forces provided on the arms 102594, 102596 resulting from the engagement with the internal threads 102591. In some implementations, the coupler 102513 can take the form of the coupler 102413 shown in FIGS. 115-130. However, it should be understood that other configurations for the coupler are also contemplated that allows the coupler to be removably engaged with the receiver 102502.

[0549] Referring to FIGS. 131 and 132, connection of the width adjustment element 102511 to the coupler 102513 can cause the width adjustment element 102511 to engage and move the arms 102594, 102596 such that the arms pivot to a substantially aligned position with the body 102581 of the coupler 102513. This movement of the arms 102594, 102596 to the substantially aligned position with the body 102581 causes the arms to disengage with the internal threads 102591 of the receiver 102502, which allows the coupler 102513 to move relative to the receiver 102502 and cap 102514. This movement of the coupler 102513 relative to the receiver 102502 and cap 102514 allows a user to move the width adjustment element 102511 within the receiver 102502 to move the paddle frames 102524 between the narrowed and expanded positions.

[0550] In the illustrated example, movement of the width adjustment element 102511 proximally causes the paddle frame 102524 to narrow. Conversely, movement of the width adjustment element 102511 distally causes the paddle frame 102524 to expand or widen. Once the paddle frame 102524 is in the desired position, the user can disconnect the width adjustment element 102511 from the coupler 102513, which will cause the arms 102594, 102596 of the coupler 102513 to move to the normal position and engage the internal threads 102591 of the receiver 102502 such that the paddle frame 102524 is set or maintained at the desired width.

[0551] The movement of the paddle frames 102524 to the narrowed position allows the device or implant 102500 to maneuver more easily into position for implantation in the heart by reducing the contact and/or friction between the native structures of the heart — e.g., chordae — and the device 102500. The movement of the paddle frames 102524 to the expanded position provides the anchor portion of the device or implant 102500 with a larger surface area to engage and capture leaflet(s) of a native heart valve and/or to block a larger area of regurgitant flow through the native heart valve.

[0552] In some implementations, the connector 102566 can be made from a material that allows the connector 102566 to be pulled into the receiver 102502. For example, the connector 102566, or a portion thereof, can be made of any flexible material, including but not limited to, metal, plastic, fabric, suture, etc. The connector 102566 can be made using a variety of processes, including, but not limited to, cutting, such as laser cutting, stamping, casting, molding, heat treating, shape setting, etc. The paddle frame 102524 (attached to the connector) can be made from a shape memory material, — such as Nitinol — to provide shape-setting capability.

[0553] Referring to FIGS. 131-134, in some implementations, the receiver 102502 can have an unattachable portion 102541 that does not allow the coupler 102513 to engage or couple to the receiver 102502 when the width adjustment element 102511 is disengaged from the coupler 102513. The unattachable portion 102541 can take a wide variety of different forms. For example, the unattachable portion 102541 can be a filled or plugged portion of the receiver, a portion of the receiver without threads, and/or a portion of the receiver with windows or cutouts, any combination of these etc. Any configuration that prevents the coupler 102513 from engaging the receiver 102502 in the unattachable portion can be used. FIG. 131 illustrates an example where the unattachable portion comprises an extended plug. The length of the plug can be selected to limit the travel of the coupler. FIG. 133 illustrates an example where a portion of the internal threads of the receiver are removed or not included. The coupler 102513 can temporarily move in the receiver 102513 but will not latch in the unthreaded portion of the receiver. FIG. 133 illustrates an example where the receiver includes windows or cutouts. The coupler 102513 can temporarily move in the portion of the receiver 102513 with the windows or cutouts but will not latch in the portion of the receiver with the windows or cutouts.

[0554] In the illustrated examples, the unattachable portion 102541 is located at a proximal end 102509 of the receiver 102502. For example, a distance Y between a bottom 102543 of the receiver 102502 and a bottom 102545 of the unattachable portion 102541 can be between about 4 mm and about 10 mm or any subrange between 3 mm and 10 mm. In s implementations, a height H of the unattachable portion 102541 can be between about 0.5 mm and about 5 mm or any subrange between 0.5 mm and 5 mm. The unattachable portion 102541 prevents the paddle frames 102524 from being locked in a position that may cause a sustained stress or strain on the paddle frames 102524 that exceeds a maximum allowable permanent or set level of stress or strain, while also allowing the paddle frames 102524 to be temporarily moved to a fully narrowed position by moving the coupler 102513 through the unattachable portion 102541 of the receiver 102502. That is, the paddle frames 102524 can be moved to a narrower width during positioning of the device than the final width that the paddle frames can be set at.

[0555] Referring to FIG. 133, in some implementations, the unattachable portion 102541 includes a non-threaded portion such that the receiver 102502 does not have threads for the coupler 102513 to engage with when the coupler is in the unattachable portion 102541. For example, the unattachable portion 102541 of the receiver 102502 can be made by boring such that at least a portion of the unattachable portion 102541 does not include threads. In the illustrated example, an entirety of the unattachable portion 102541 does not include threads. In other implementations, only the portion of the unattachable portion 102541 that aligns with the arms 102594, 102596 (or other connection elements) of the coupler 102513 does not include threads.

[0556] Referring to FIG. 134, in some implementations, the unattachable portion 102541 includes windows or openings 102531 in the receiver 102502 such that the arms 102594, 102596 (or other connection elements) of the coupler 102513 extend through the opening 102531 if disengaged by the width adjustment element 102511 rather than engaging the receiver 102502. In the illustrated example, the openings 102531 are bisected by the cross- section of the view. However, it should be understood that other configurations and orientations are also contemplated. For example, the openings 102531 can be located along the outer surface of the receiver 102502 at a position that is 90 degrees from the illustrated position (i.e. extend into and out of the page) along the outer surface of the receiver 102502. In some implementations, unattachable portion 102541 can include more than one opening 102531 (e.g., two openings) to prevent or inhibit attachment of the coupler 102513 in the unattachable portion 102541.

[0557] FIGS. 135-136 show the coupler 102513 moving through the unattachable portion 102541 of the receiver 102502. In the illustrated example, the coupler 102513 is shown moving through an unattachable portion 102541 that includes a non-threaded portion (as shown in FIG. 133), but it should be understood that the same principles apply to the unattachable portion 102541 having an opening 102531 shown in FIG. 134. Referring to FIG. 135, when the width adjustment element 102511 is connected to the coupler 102513, the arms 102594, 102596 are substantially aligned with the body 102581 of the coupler 102513, which allows a user to move the coupler 102513 relative to the receiver 102502 to move the paddle frames 102524 between narrowed and expanded positions. Referring to FIG. 136, when the width adjustment element 102511 is disconnected from the coupler 102513 and the coupler 102513 is positioned within the unattachable portion 102541, the arms 102594, 102596 pivot outward, but the unattachable portion 102541 does not have internal threads for the arms 102594, 102596 to engage with. Consequently, the coupler 102513 continues moving downward within the receiver 102502 until the arms 102594, 102596 engage the internal threads 102591 positioned below the unattachable portion 102541. Once the arms engage the internal threads 102591, the coupler 102513 is set relative to the receiver 102502, which sets the connector 102566 in a desired position and maintains the paddle frame 102524 at a desired width (See FIGS. 99, 100, and 108).

[0558] In some implementations, the receiver 102502 can include a window (not shown) at its distal end that allows a user to view the connection between coupler 102513 and width adjustment element 102511. In these implementations, the window can take a form similar to the window 102531 shown in FIG. 134, but rather than being positioned to prevent attachment between the width adjustment element 102511 and the coupler 102513, the window is positioned to allow a user to view a connection between the width adjustment element 102511 and the coupler 102513 when the width adjustment element 102511 is moved through the receiver 102502 to engage the coupler 102513. This window for viewing the connection between the coupler 102513 and width adjustment element 102511 can be included on either of the receivers 102502 shown in FIGS. 133-134, or the viewing window can be included on any other receiver described in the present application and can be used to view the connection between any coupler and any width adjustment element described in the present application.

[0559] Referring now to Figures 137-179, implementations of valve repair devices are described that provide for points or regions of contact or coaptation with a native leaflet of a heart valve. In some situations, it has been desirable to use more than one implantable heart valve device to manage valve regurgitation. For example, two or more such implants can be used on a single heart valve to provide increased coaptation of the leaflets. In some implementations, implantable heart valve devices having, for example, expanded and/or expandable paddles and/or paddle frames can be used in place of multiple valve repair devices. For example, these implementations provide for a wider (expanded or edge-to-edge) and/or multiple regions of contact on a valve leaflet so that a single device can be used instead of more than one device. The width of these expanded contact or coaptation regions can be, for example, approximately 6 to 20 mm (or more). In this way a single device can provide the expanded coaptation region.

[0560] In some implementations, an increased approximation (or clamping) force is provided for the expanded/expandable paddles/frames. In some implementations, the increased approximation/clamping force is provided by a scissors or crossover region or configuration of the paddles/frames. In other implementations, the increased approximation/clamping force can be provided by a base portion of the paddles/frames having a resilient or bias member in the form of a curved or arched strut or beam member or portion. In general, the amount of curvature or arc can be used to increase or decrease the amount of approximation/clamping force in the base and/or other regions of the paddles/frames. The approximation/clamping force can be a tension/pressure force applied by a spring-like arrangement via, for example, the base portion of the paddles/frames. These arrangements can be provided by, for example, coil, leaf, arc (beam, strut, etc.), kerf cut arcuate sections, etc.) Any arrangement capable of providing the association/clamping force can be used to provide the tension/pressure force.

[0561] Referring now to Figures 137-142, an example of an implantable device 13700 having expanded/ expandable paddles/frames is provided. The implementation includes a central assembly 13702 which can be a bushing assembly and/or width adjustment element 8211 (as previously described) or similar assembly. On both sides of the central assembly 13702 are paddle frames having extension (e.g., 13704). Only one side is shown for clarity in the Figures hereinafter with the understanding that the description and arrangements illustrated apply equally to a (mirrored) second side oppositely disposed around central assembly 13702.

[0562] Paddle frame extension portions 13704 include a first paddle frame portion 13706 and a second paddle frame portion 13708. First paddle frame portion 13706 and second paddle frame portion 13708 are spaced apart and disposed on the side regions/portion of central assembly 13702. As described in previous implementations herein, a paddle portion 13710 is connected to central assembly 13702 to provide at least first and second paddles/portions.

[0563] In some implementations, a paddle frame portion 13712 is connected (via a hinge or pivot) to the paddle portion 13710 (as previously described herein). In some implementations, paddle frame portion 13712 may be a discrete paddle frame portion from the first paddle frame portion 13706 and second paddle frame portion 13708. For instance, paddle frame portion 13712 may not be integrally formed with first paddle frame portion 13706 and second paddle frame portion 13708. A collar 13714 is provided for fixating or connecting a base region of the paddle frame portions to central assembly 13702 (as also previously described herein in other implementations). A cap 13716 is further provided, which can extend and retract as also previously described and further described hereinafter.

[0564] Referring to Figure 138, one side/half of the paddle frame portions are shown in isolation. First paddle frame portion 13706 and second paddle frame portion 13708 are spaced apart by a space 13804. A central paddle frame portion 13800 is also provided between first paddle frame portion 13706 and second paddle frame portion 13708. The paddle frame portion 13800 can include a brace portion 13802, which connects first paddle frame portion 13706 and second paddle frame portion 13708. In some implementations, the paddle frame portion 13800 does not extend out or away from central assembly 13702 and generally does not extend out in beyond the ends of first paddle frame portion 13706 and second paddle frame portion 13708.

As shown in Figure 141, central assembly 13702 is disposed in space 13804.

[0565] Figure 139 illustrates an exploded view of the implementation of the valve repair device 13700. Central assembly 13702 includes a receiver portion 13900 having moving elements for extending and retracting cap 13716 (as previously described herein). Also shown are outer paddle portion 13902, inner paddle portion 13904, and paddle mounting portion 13906 that mounts the paddles to central assembly 13702. In some implementations, the paddle mounting portion 13906 can include one or more recesses and/or tabs for receiving the paddles. Also shown in this view are the various curved struts of paddle frame extension portions 13704 that form, for example, upper loop region 13908, upper loop region 13910, and lower loop region 13912. The struts or beams of upper loop region 13908 and upper loop region 13910 are flexible and/or collapsible (e.g., can bend inwards on itself) to facilitate an undeployed (or narrow) state for passage through a delivery catheter.

[0566] FIG. 140 shows a top view of the valve repair device 13700. As previously described, paddle frame extension portions 13704 can have a plurality of flexible or bending struts or beams which range from curved to linear portions (as shown). This includes flex strut portions 14000, 14002, 14004, 14006. Also, distances DI, D2, and D3 are schematically illustrated showing the range of coaptation or contact with a native leaflet of a heart valve. Distance DI shows the entire range and distances D2 and D3 shown individual distances associated with each paddle frame extension portion (e.g., first paddle frame portion 13706 and second paddle frame portion 13708). As previously described, the distance DI can range anywhere from approximately 6 to 20 mm or more.

[0567] Figure 141 illustrates a side view of the implementation of the valve repair device 13700. In this view, it can be seen that paddle frame extension portions 13704 include a generally curved or sinuous shape, which can be, for example, a saddle-shape 14100 (or other undulating shape). Also shown in this view is that paddle frame portion 13800 can contact central assembly 13702, which can optionally include at least a partial recess for receiving and holding paddle frame portion 13800.

[0568] In some implementations, during operation, paddle portions 13710 are swung out or extended from central assembly 13702, first paddle frame portion 13706 and second paddle frame portion 13708 correspondingly swing or pivot out. During such movement, paddle frame portion 13800 begins to press against central assembly 13702 with increasing pressure. This provides an association (or clamping) force wanting to return first paddle frame portion 13706 and second paddle frame portion 13708 back to their original position. This association or (clamping) force is helpful during leaflet capture and fixation because it helps to maintain the leaflet in its captured (and coaptation) state as the clasps (e.g., 130) engage and press against the leaflet.

[0569] By biasing the first and second paddle frame extension portions 13706 and 13708 past (i.e. to the right in Figures 140 and 141) paddle frame portion 13712, an increased association (or clamping) force can be generated compared to if paddle frame portions 13706 and 13708 were biased to a position in line with paddle frame portion 13712 in Figure 141. In the example illustrated by Figures 140 and 141, only one paddle frame portion 13704 is shown to illustrate the biased position of the paddle frame portion 13704. However, two paddle frame portions 13704 are typically included and engage/hold one another at a center line or plane of the device 13700. That is, a pinching force exists between the two paddle frame portions 13704 when the paddle frame portions 13704 engage one another at the center line or plane of the device 13700.

[0570] Figure 142 illustrates a front view of the implementation of the valve repair device 13700. As previously described, implementation of the valve repair device 13700 includes a plurality of flexible or bendable struts or beams associated with first paddle frame portion 13706, second paddle frame portion 13708, and paddle frame portion 13800. This includes struts 14200, 14202, 14204 and 14206. These struts are configured to collapse inwards (as indicated by arrows 14216 and 14218) when flex strut portions 14000 and 14002 are pulled upward (as indicated by arrows 14212 and 14214.

[0571] In some implementations, struts 14200 and 14202 include notched connecting portions 14208 and 14210 into which collar 13714 is at least partially received to fixate the lower portion of first paddle frame portion 13706 and second paddle frame portion 13708 from movement. The collapsed state provides a narrow width configuration for implementation of the valve repair device 13700 allowing it to fit inside and through a delivery catheter. In some implementations, paddle frame extension portions 13704 can be made from a shape set material such as nitinol (or other similar shape settable material). In such implementations, the paddle frame extension portions 13704 can return to their uncompressed state for the capture ready position (as shown in Figure 142).

[0572] Figures 143-145 illustrate another implementation of an implantable heart valve device 14300 having expandable paddles/frames. In some implementations, the valve repair device includes a paddle frame portion 14302 having a first paddle frame portion 14304 and a second paddle frame portion 14306. A third paddle frame portion 14308 is also provided and connected to the first paddle frame portion 14304 and second paddle frame portion 14306. First and second paddle frame portions 14304 and 14306 include curved flexible strut or beam portions forming coaptation loops/portions 14310 and 14312. Coaptation loops/portions 14310 and 14312 are connected to beam or strut portions 14314 and 14316, which can also be curved and flexible. Abrace/strut portion 14318 connects strut portions 14314 and 14316. A beam/strut portion 14320 connects to another brace/strut portion 14322, which connects to beam strut portion 14324 of the third paddle frame portion 14308.

[0573] In the example illustrated by Figures 143-145, only one paddle frame portion 14302 is shown to illustrate the biased position of the paddle frame portion 13704. However, two paddle frame portions 14302 are typically included and engage/hold one another at a center line or plane of the device 14300. That is, a pinching force exists between the two paddle frame portions 14302 when the paddle frame portions 14302 engage one another at the center line or plane of the device 14300.

[0574] Similar to the paddle frames of the device 13700, the paddle frames of the device 14300 can bend and/or compress to a narrow configuration for ease of passage through a delivery catheter. As indicated by arrows 14326 and 14328, upward movement of loop portions 14310 and 14312 cause the loops to collapse or narrow and, as indicated by arrows 14330 and 14332, beam or strut portions 14314 and 14316 will flex in towards central assembly 13702. This collapsed configuration provides a narrower arrangement for the valve repair device 14300.

[0575] Referring now to Figure 144, a side view of the implementation of the valve repair device 14300 is illustrated. A space 14400 is provided between outer paddle portion 13902 and inner paddle portion 13904. In some implementations, one or more portions of third paddle frame portion 14308 are positioned in space 14400 such as, for example, beam/strut portion 14324 and the upper loop portion 14410 thereof So arranged, one or more regions of contact between third paddle frame portion 14308 and paddles 13710 can be established. In some implementations, only the upper loop portion 14410 of the paddle frame portion 14308 engages the paddle 13710 at region 14402. In some implementations, the paddle frame portion 14308 can engage the paddle 13710 at one or more location, such as, for example, at one or more of regions 14402, 14404, and 14406. While three such regions are shown more or less than three can be implemented, such as only at region 14402. As shown in this view, a saddle- shaped body 14408 is formed by the curved beams or struts of the first paddle frame portion 14304 (and the second paddle frame portion 14306).

[0576] Figure 145 illustrates the paddle frame portions and extensions in perspective view and in isolation from the other components of the device. The first and second paddle frame portions 14304 and 14306 include upper loop regions 14502 and 14506 and lower loop regions 14504 and 14508. Paddle frame portion 14308 includes upper loop portion 14410. In some implementations, the upper loop portion 14410 may be located at a position axially below the upper loop regions 14502 and 14506 of the first and second paddle frame portions. A space 14500 is provided between the beams or struts of first and second paddle frame portions 14304 and 14306, which is arranged to include central assembly 13702 at least partially, as shown in Figures 143 and 144.

[0577] In operation, when paddles 13710 are swung out from central assembly 13702, first and second paddle frame portions 14304 and 14306 correspondingly swing or pivot outward. During such movement, paddle frame portion 14308, which resides in space 14400 between in the outer and inner paddle portions 13902 and 13904, is biased to be displaced from its initial position but either cannot or is very limited by virtue of being captured with space 14400. This restriction on movement provides an association (or clamping) force wanting to return first and second paddle frame portion 14304 and 14306 back to their original position. As previously described, this association or (clamping) force is helpful during leaflet capture and fixation because it helps to maintain the leaflet in its captured (and coaptation) state as the clasps (e g., 130) engage and press against the leaflet. [0578] Referring now to Figures 146-148, another implementation of an implantable medical device 14600, such as a valve repair device, is shown. In some implementations, the device 14600 includes paddle frame portions 14602 and 14604 having a plurality of beams or struts in various configurations including curved and linear. The valve repair device 14600 also includes a modified paddle structure having first paddle portion 14606 and second paddle portion 14608. In some implementations, the first paddle portion 14606 and the second paddle frame portion are not directly connected. In some implementations, the valve repair device includes a base portion (14750 (Fig. 147)). The base portion 14750 can be arranged to provide an association (or clamping) force for paddle frame portions 14602 and 14604.

[0579] Referring to Figure 147, the paddle frames are shown in perspective view and isolated from other structures of the device. Paddle frame portion 14602 includes a plurality of beams or struts including brace strut portion 14700, which is shown having a linear section with curved end portions. In other implementations, the brace strut portion 14700 can be entirely curved. Brace strut portion 14700 is connected to extension strut portions 14704 and 14706, respectively, which can be generally linear, but also curved in other implementations. Extension strut portions 14704 and 14706 are connected to curved or arched beams or struts 14708 and 14710, respectively. In some implementations, the arched beams or struts 14708 and 14710 can be oriented in a generally longitudinal direction. Beams or struts 14708 and 14710 are connected to a base portion 14750 having a brace strut portion 14712, which is curved, radiused, or arched.

[0580] Second paddle frame portion 14604 is similarly arranged and includes brace struct 14702 connected to struts 14714 and 14716, which are connected to struts 14718 and 14720, which are connected to base portion 14750 having a brace strut 14722, which is curved, radiused, or arched. Abase mount portion 14724 having a mounting aperture is positioned between brace struts 14712 and 14722.

[0581] As shown in Figure 147, the paddle frame portions include a plurality of strut contact portions formed by the association (or clamping) force. These include strut contact portions 14726, 14728, 14730, 14732, 14734, 14736, 14738, and 14740. In these portions, opposition beams or struts press against each other due to the association (or clamping) force(s) generated by the struts in base portion 14750. In some implementations, these portions can provide contact between all or some of the struts. So arranged a plurality of clamping regions are provided including 14742, 14744, 14746, and 14748.

[0582] The amount of association (or clamping) force generated is based on the curvature, arc, or radius of brace struts 14712 and 14722. In one implementation, the radius extends over a length of approximately 110 degrees or more. In other implementations, more or less than 110 degrees can be used such as, for example, 90 or more degrees. As described in the previous implementations, the association (or clamping) force is helpful during leaflet capture and fixation.

[0583] One or more non-clamping regions can also be provided such as in the space between struts 14708 and 14718, for example. During leaflet capture, the leaflets may extend as far down as clamping regions 14746 and 14748. In some implementations, the leaflets extend past the clamping regions 14742, 14744, but not as far as regions 14746 and 14748. In other implementations, the leaflet can extend anywhere along the lengths of the paddle(s)/frame(s) portions.

[0584] In some implementations, a gap or space 14752 is provided between curved struts 14708 and 14718, for example, to accommodate portions of a leaflet body during and after capture and reduce the likelihood of a leaflet being improperly seated when captured. For example, end portions and/or ventricular edges of the native heart valve leaflets can sit in the space 14752. In some implementations, these end portions and/or ventricular ends of the native heart valve leaflets are not clamped together and/or can move in the space 14752, which can inhibit the clamped leaflets from bunching, wrinkling, curling, etc. This curved arrangement has the same effect in other implementations described herein.

[0585] Referring now to Figure 148, a perspective view of a paddle portion implementation is shown in isolation from other device components. The paddle portion includes first paddle portion 14606 and second paddle portion 14608. Second paddle portion 14608 will be described in detail with the understanding the same description applies to first paddle portion 14606 (which is a mirror copy in this implementation). In the examples illustrated by Figures. 22 and 23, the outer paddle portions 220, 320 and the paddle frames 224, 324 are both connected to the cap 214, 314 and to one another at the connection portion 223, 323. As a result, the outer paddle portions 220, 330 and the paddle frames 224, 324 are constrained to have substantially the same length or the same length throughout the range of motion of the device. In some implementations, the lengths of the paddle portions 14606 and 14608 are decoupled from the lengths of the paddle frame portions 14602 and 14604.

[0586] The lengths of the paddle portions 14606 and 14608 can be decoupled from the lengths of the paddle frame portions 14602 and 14604 in a variety of different ways. For example, as is shown in Figure 149 the outer paddle portions 220, 320 of the examples of Figures 22 and 23 are eliminated and/or not connected to the cap. As a result, the lengths of the paddle portions 14606 and 14608 can be different from the lengths of the paddle frame portions 14602 and 14604 as the device moves through its range of motion. That is, the lengths of the paddle portions 14606 and 14608 can be changed for example, elongated and/or narrowed independent of the length of the paddle portions 14606 and 14608. This allows the paddle portions and the paddle frame portions to be of different lengths during movement of the device between the various configurations/positions (e.g., between closed, open/capture ready, and elongated/delivery /bailout positions). Referring back to Figure 146, in the example shown, outer paddle portions are not included the paddle frame portions 14602 and 14604 are longer than the paddle portions 14606 and 14608 that are included.

[0587] Second paddle portion 14608 includes a paddle body 14800 having a loop portion 14802, a fastening extension 14804, and hinge opening 14806. Paddle body 14800 also includes extension beams or members 14808 and 14810 and mounting extensions 14812 and 14814, which are used to mount paddle body 14800 to, for example, central assembly 13702. A plurality of apertures are provided in paddle body 14800 using any of a variety of fasteners/techniques for mounting paddle body 14800 to central assembly 13702 including sutures, friction/interference fit(s), rivets, screws, adhesives, welds, etc. By having the paddle structure split into two portions (compared to the singular structure shown in, for example, Figure 141), an elongated central assembly 13702 can be used. An elongated central assembly 13702 allows for uncrimping (or straightening) of longer/ elongate paddles and frames from their crimped (bent or curved) configuration used for passage through delivery catheters.

[0588] Figures 149-153 show various views of another example of a valve repair device 14900. In this implementation, the paddle frame portions include a scissors or crossover configuration. The crossover configuration of the paddle frame portions are configured to generate an association (or clamping) force for the paddles and frames.

[0589] As shown in Figure 149, the valve repair device 14900 includes first and second paddle frame portions 14902 and 14904, which are similar to first and second paddle portion 14606 and 14608 but include a scissors or strut crossover region 14912. The scissors or crossover region 14912 can provide an increased association (or clamping) force for the paddles/frames and, hence, on the leaflets, to keep them closed at the coaptation region. In some implementations, the crossover region 14912 can provide a constant association (or clamping) force for the paddles/frames and, hence, on the leaflets, to keep them closed at the coaptation region.

[0590] In some implementations, the first and second paddle frame portions 14902 and 14904 include curved beams or struts 14906 and 14908, which crossover each other at the scissors or strut crossover region 14912. In some implementations, curved beams or struts 14906 and 14908 can also form a clamp region 14910. In order to provide scissors or strut crossover region 14912, a lateral or offset strut 14914 is provided which offsets strut 14908 so that it can crossover strut 14906. And, in order to provide clamp region 14910, strut 14908 then curves or bends gradually to reduce or eliminate the offset and approximately align with strut 14906 in the clamp region 14910.

[0591] In implementations where the first and second paddle frame portions 14902 and 14904 are each symmetrical, the same description and arrangement applies to the other side of each paddle frame portion (as shown in, for example, Figure 150). Abase region 14916 is provided having a curved base strut 14918, which is similar to brace strut portion 14712 and provides the amount/degree of association (or clamping) force as previously described. In some implementations, the first and second paddle frame portions 14902 and 14904 can be connected by the base strut portion 14712. As also described, one or more non-clamping regions can also be provided such as in the space between struts 14906 and 14908, for example.

[0592] Referring now to Figure 150 specifically, further views of strut contact or clamping regions and strut crossover regions, including strut contact/clamp region 15000 and strut crossover region 15002 are shown. Also shown in this view is the saddle-shaped body 15004 of the paddle frame portions. Further shown in this view is a hinge portion 15006, which pivotably connects to the paddle portions (e.g., 14606 and 14608) for allowing movement of the paddles/frames away and towards central assembly 13702 for deployment and capture of leaflets. In some implementations, the hinge portion 15006 can comprise an opening or aperture for receiving a paddle portion (e.g., 14606 and 14608).

[0593] Figure 153 illustrates one example of valve repair device 14900 in its shape-set configuration. As previously described, the paddle/frames disclosed herein can be made of a shape-settable material such as, for example, nitinol (or other similar metallic or non-metallic material). This allows the material to bend or flex under load and then return to its shape-set configuration. In Figure 153, arrows 15300 and 15302 indicate the direction of positional displacement (e.g., flexing, bending, curving, etc.) of first and second paddle frame portions 14902 and 14904 from their original shape-set configuration to their configuration shown in Figures 149-152. This same general arrangement applies to the paddle frames and extensions described throughout herein with respect to being shape-set and then converted configurations including the crimped and uncrimped configurations shown and described herein.

[0594] Referring now to Figures 154-158, another implementation of a heart valve repair device 15400 is illustrated. This implementation provides, for example, a scissor or crossover region 15406 and a strut contact or clamping region 15408 similar to that already described (e.g., device 14900). The valve repair device 15400 also includes a base region having a kerfcut arcuate beam or strut arrangement 15420. The valve repair device 15400 can also include paddle frames that provide a wide/wider line or region of coaptation (e.g., compared to valve repair device 14900).

[0595] The heart valve repair device 15400 can include first and second paddle frame portions 15402 and 15404. In order to provide scissors or strut crossover region 15406, a lateral or offset strut 15014 (see Figures 154 and 156) is provided which offsets the crossing struts. The lateral or offset strut 15014 can be configured as described in connection with other scissor implementations to allow for the beam or strut crossover arrangement 15406. The first and second paddle frames/portions 15402 and 15404 are similarly constructed and only one will be described in detail with the understanding the same description applies to the other paddle frame portion (e.g., the paddle frame portions 14902 and 14904). [0596] In some implementations, first paddle frame portion 15402 includes a wide lateral beam or strut portion 15410. Lateral beam or strut portion 15410 connects to a curved strut portion 15412, which connects to an extension strut portion 15414. Extension strut portion 15414 includes a distal end having an aperture 15418. Aperture 15418 can be used to attach sutures or other actuation elements (e.g., a wire, rod, shaft, tube, screw, suture, line, strip, combination of these, etc.) to facilitate opening and/or closing of the paddles/frames during the heart valve coaptation or repair process. The other side of first paddle frame portion 15402 is similarly arranged and thus the same description applies.

[0597] Figure 157 is a bottom view of the paddle frame portions isolated from other device components and shows an example coaptation distance DI for the device. In this implementation, the coaptation distance can be continuous and can range from approximately 6 to 20 mm (more or less). In some implementations, the lateral struts are configured to be pulled toward the bushing to adjust the coaptation distance DI of the device. As previously described, the scissor or crossover strut arrangement provides an association (or clamping) force that assists in the capture and holding of leaflets. The kerf cut pattern can be any suitable pattern for providing the amount of bias or spring to produce the desired association (or clamping) force.

[0598] Figure 158 is a side elevational view of the paddle frames in isolation from other device components. Arrows are illustrated showing the direction of movement used to collapse the paddle frames to a narrow configuration suitable for passing the repair device through a catheter. Arrows 15800 and 15802 indicate movement inwards (i.e., towards where central assembly 13702) resides. Arrows 15804 and 15806 indicate movement downwards as the paddle frames collapse inwards. As previously described one or more actuation elements can be used to collapse and/or expand the paddle frames from their positions during the repair process.

[0599] Figures 159-161 illustrate another implementation of an implantable repair device 15900. The valve repair device 15900 is similar to those previously described having a scissor or crossover region 15406 and clamping region 15408 (and 15416) and, hence, these regions will not be described again in detail. [0600] The device 15900 includes first and second paddle frame portions 15902 and 15904. As in previous implementations, only one paddle frame portion will be described in detail with the understanding such description also applies to the other paddle (which is a mirrored arrangement). First paddle frame portion 15902 includes a beam or strut portion 15906 that branches from a top brace strut 15922. In some implementations, beam or strut portion 15906 can branch from one or both of the top brace strut 15922 and a vertical strut 15923. Beam or strut portion 15906 connects to an extension strut portion 15908, which forms a portion of the leaflet contact or coaptation line/region. Extension strut portion 15908 connects to a curved strut portion 15910 having an aperture 15914. And, curved strut portion 15910 connects to a further extension strut portion 15912. A suture or other actuation element 15920 can be connected to or through apertures 15914 and 15918 to control the movement of the paddle frame portions to, for example, collapse or expand them during the repair process. Aperture 15918 can be located in a projection or tab portion 15916 of the paddle frame, which can also include additional apertures for sutures and hinge or pivot connection(s) to the paddles.

[0601] Referring now to Figures 160-161, the paddle frames are shown in isolation from other device components. First and second paddle frame portions 15902 and 15904 form lines of contact or coaptation as represented by contact regions 16100. Distances DI, D2 and D3 are also shown. As previously described, distance DI indicates a general range of coaptation. Distances D2 and D3 indicate a specific range of coaptation formed by the extension strut portions 15908 of each paddle frame portion.

[0602] Figures 162-166 illustrate another implementation of an implantable repair device 16200. The valve repair device 16200 can be similar to those previously described having a scissor or crossover region 15406 and clamping region 15408 and, hence, these regions will not be described again in detail. The device 16200 can include first and second paddle frame portions 16202 and 16204. As in previous implementations, one paddle frame portion will be described in detail with the understanding such description also applies to the other paddle (which is a mirrored arrangement).

[0603] First paddle frame portion 16202 includes a beam or strut portion 16206 that branches from a vertical strut 16210. The beam portions extend away from a remaining portion of the paddle frame in an extended configuration. The beam portions are configured to be folded toward the remaining portion of the paddle frame (See Figures 165 and 166). The beam or strut portion 15906 can branch from a top brace strut 16216. Beam or strut portion 16206 extends to a distal end having an aperture 16208. In this implementation, beam or strut portion 16206 forms a portion of the leaflet contact or coaptation line/region. A suture or other actuation element 16218 can be connected to or through apertures 16208 and 16212 to control the movement of the paddle frame portions to, for example, collapse or expand them during the repair process. Aperture 16212 can be located in a projection or tab portion of the top brace strut 16216, which can also include additional apertures for sutures and hinge or pivot connect! on(s) to the paddles. An arrow 16214 shows the direction that the actuation element(s) 16218 can be pulled to cause the paddle frame portions 16202 and 16204 to move from their expanded state or configuration to their collapsed state or configuration. For example, the actuation element(s) 16218 can be pulled through the apertures 16212 and into the opening of the distal cap, such as in the same or similar manner as the connector 8266 shown in Figures 26-30.

[0604] Figure 164 shows a bottom view of the paddle frames in isolation from other device components. First and second paddle frame portions 16202 and 16204 form lines of contact or coaptation as represented by contact regions 16400. Distances DI, D2 and D3 are also shown. As previously described, distance DI indicates a general range of coaptation. Distances D2 and D3 indicate a specific range of coaptation formed by the extension strut portions 16206 of each paddle frame portion.

[0605] Figures 165-166 show top and perspective views of the valve repair device 16200, respectively, with the paddle frame portions in the collapsed configuration. Arrows 16600 and 16602 show the direction that the actuation element(s) 16218 can be pulled to cause the paddle frame portions 16202 and 16204 to move from their expanded state or configuration to the illustrated collapsed state or configuration. For example, the actuation element(s) 16218 can be pulled through the apertures 16212 and into the opening of the distal cap, such as in the same or similar manner as the connector 8266 shown in Figures 26-30.

[0606] Referring now to Figures 167-168, another implementation of a heart valve repair device 16700 is shown. The valve repair device 16700 can be similar to those previously described having a scissor or crossover region 15406 and clamping region 15408 and, hence, these regions will not be described again in detail. The valve repair device 16700 can include first and second paddle frame portions 16702 and 16704. As in previous implementations, only one paddle frame portion will be described in detail with the understanding such description also applies to the other paddle (which is a mirrored arrangement).

[0607] First paddle frame portion 16702 includes a beam or strut portion 16706 that branches from a vertical strut similar to the arrangement shown for the device 16200. Beam or strut portion 16706 connects to extension strut portion 16708, which extends and curves slightly upward as shown in the figures. Extension strut portion 16708 includes a distal end having an aperture 16710. In this implementation, beam or strut portion 16706 forms a portion of the leaflet contact or coaptation line/region. A suture or other actuation element can be connected to or through aperture 16710 (as in previously described examples) to control the movement of the paddle frame portions to, for example, collapse or expand them during the repair process. Aperture 16212 can be located in a projection or tab portion of the top brace strut 16216, which can also include additional apertures for sutures and hinge or pivot connection(s) to the paddles. An arrow 16714 shows the direction of paddle/frame movement when the paddles (e.g., 14608) are moved from the illustrated expanded state or configuration to their collapsed state or configuration.

[0608] Figure 168 shows a bottom view of the paddle frames in isolation from other device components. First and second paddle frame portions 16702 and 16704 form lines of contact or coaptation as represented by contact regions having distances DI, D2 and D3. As previously described, distance DI indicates a general range of coaptation. Distances D2 and D3 indicate a specific range of coaptation formed by the extension strut portions 16706 of each paddle frame portion. First and second paddle frame portions 16702 and 16704 can be collapsed inward by any arrangement described herein including, for example, use of sutures or actuation elements connected to aperture 16710 to thereby draw the paddle frame portions inward.

[0609] Figure 169 shows a perspective view of another implementation of a paddle/frame arrangement 16900. The paddle/frame arrangement 16900 can be similar to those previously described having a scissor or crossover region 15406 and clamping region 15408 and, hence, these regions will not be described again in detail.

[0610] The paddle/frame arrangement 16900 includes first and second paddle frame portions 16902 and 16904. Each paddle frame portion further includes paddle extension portions 16906 and 16908, which are laterally disposed. As in previous examples, only one paddle frame portion will be described in detail with the understanding such description also applies to the other paddle (which is a mirrored arrangement). First paddle frame portion 16902 includes a beam or strut portion 16910 that branches from a vertical strut similar to the arrangement shown for the device 16200. Beam or strut portion 16910 connects to a loop brace portion 16912, which can include an aperture 16914. Loop brace portion 16912 is connected to strut portion 16916, which extends downwards as shown. Strut portion 16916 is connected to a curved inward strut portion 16918, which is connected to end strut portion 16920. So arranged, additional strut contact or clamping regions 16922 and 16924 are formed. In the implementation shown, additional clamping regions 16922 and 16924 are positioned parallel to clamping regions 15408. In some implementations, the additional clamping regions 16922 and 16924 can be positioned offset from clamping regions 15408.

[0611] As described with other examples, sutures or other actuation elements can be connected to or through the shown apertures to control the movement of the paddle frame portions to, for example, collapse or expand them during the repair process. The paddle frame portions 16902, 16904, 16906 and 16908 form lines or regions of contact or coaptation as represented by contact regions having distances DI, D2 and D3. As previously described, distance DI indicates a general range of coaptation. Distances D2 and D3 indicate a specific range of coaptation formed by the paddle extension portions 16906 and 16908.

[0612] Referring now to Figures 170-179, an implementation of a valve repair device 17000 is shown having paddle frame portion with an optional plurality of narrow flex strut portions separated by gaps or spaces, instead of a singular or solid strut portion. The narrow flex strut portions can better accommodate (i.e., experience relatively less) stress and strain when bending, curving, and/or flexing to form various configurations (e.g., collapsed versus expanded configurations). The valve repair device 17000 can be similar to those previously described having a clamping region 14746, etc. and, hence, these regions will not be described again in detail.

[0613] The valve repair device 17000 can include first and second paddle frame portions 17002 and 17004. As in previous examples, one paddle frame portion will be described in detail with the understanding such description also applies to the other paddle (which is a mirrored arrangement). Paddle frame portion 17002 includes a central coupling tab 17030 and a plurality of flexible beams or struts positioned in each side thereof. This includes beams or struts 17006, 17008, and 17010. Spaces or gaps are located between each of these struts.

While three struts are shown, more or less than three can be used (with associated gaps therebetween). Each strut includes extension strut portion 17012 that connects to inward curved strut portion 17014. Inward curved strut portion 17014 is connected to curved strut portion 17016, which is connected to a clamping strut portion 17038. Clamping strut portion 17038 is connected to the base region 17026 via a curved base strut 17040. Curved or radiused base strut 17040 provides the association (or clamping) force in the same manner as, for example, that described for curved brace strut portion 14712.

[0614] Paddle frame portion 17002 includes a central coupling tab 17030. Central coupling tab 17030 includes an aperture 17032 for receiving a pivot or hinge portion 17022 of paddle portion 14608. In some implementations, a brace strut portion 17034 can also be provided as shown in the central region of the paddle. The brace strut portion 17034 can connect the central coupling tab 17030 to extension strut portion 17012.

[0615] In some implementations, an optional suture or other actuation element 17020 can be provided between pivot or hinge portion 17022 and cap 13716 to open and close the paddles/frames. In some implementations, the optional suture or other actuation element 17020 is omitted and movement of the cap both moves the paddles/frame between the wide and narrow configurations and also opens and closes the paddles/frames, as will be described in more detail below. As previously described, paddle portion 14608 includes a pivot region or portion 17024, which can bend or flex through a range of degrees to allow the paddles/frames to expand outward from (and inward to) central assembly 13702. In this regard, arrow 17036 illustrates that a push direction movement on cap 13716 can cause pivot or hinge portion 17022 to pivot inward as shown by arrow 17028. Alternatively, the association (or clamping) force can generate the upward movement indicated by arrow 17036 and the pivot inward shown by arrow 17028 of the pivot or hinge portion 17022. Such motion expands and/or collapses the paddles/frames relative to central assembly 13702.

[0616] Figure 173 shows a bottom view of the paddle frames in isolation from other device components. First and second paddle frame portions 17002 and 17004 form lines of contact or coaptation as represented by contact regions 17300 and 17302. Distances DI, D2 and D3 are also shown. As previously described, distance DI indicates a general range of coaptation. Distances D2 and D3 indicate a specific range of coaptation formed by the extension strut portions 17006, 17008, and 17010 of each paddle frame portion.

[0617] Figures 175-179 illustrate the valve repair device 17000 in its more fully collapsed configuration including, for example, strut portions 17006, 17008, and 17010 are collapsed inward toward central assembly 13702 (compared to Figures 170-174 where they are not collapsed and are positioned outward from 13702). In some implementations, the valve repair device 17000 is configured such that downward or distal movement of the cap 13716 first narrows the paddle frame portions 17002, 17004 to a narrowest configuration. In the narrow configuration, the cap may be in an extended state and the paddle frames may be collapsed against the central assembly 17012. Continued downward or distal movement of the cap 13716 can open the paddles/frames.

[0618] Conversely, upward or proximal movement of the cap 13716 from an open position first closes the paddles/frames and, once in the closed position, continued upward or proximal movement of the cap widens the paddle frame portions 17002, 17004. In this manner, the paddle frame portions 17002, 17004 can be narrowed and then opened, making navigation through chordae tendinea and/or leaflet capture easier.

[0619] During operation, once the leaflets are captured with the paddle frame portions 17002, 17004 in the narrowed position, the cap can be further moved upward or proximally to move the paddle frame portions 17002, 17004 to a desired widened position (e.g., any position between the fully narrowed position to the fully widened position). The position of the cap can then be fixed to set the width of the paddle frame portions 17002, 17004 with the device attached to the native heart valve leaflets. The position of the cap can be set in a variety of different ways, such as with a lock, a connector, etc. In some implementations, the position of the cap 13716 can be set by including the coupler or connection feature 102513 (see Figure 133) in the central assembly 13702.

[0620] As mentioned above, the central assembly 13702 can include the ability to extend cap 13716 downward or further way, as indicated by arrow 17502. This extension draws strut portions 17006, 17008, and 17010 inward and collapses them into the narrow device configuration shown by direction arrows 17600 and 17602. The reverse motion expands these struts back to the positions illustrated in Figures 170-174. The range of extension/motion is illustrated by region or distance 17500. Further, by shape-setting the first and second paddle frame portions 17002 and 17004 to the collapsed configuration shown in Figures 175-179, additional association (or clamping) force be provided. This is because when first and second paddle frame portions 17002 and 17004 expand to the configuration shown in Figures 170-174, they have a bias towards to the collapse (or crimped) configuration. This can increase the association (or clamping) force in contact/cl amping regions 17300 and 17302 (e.g., see FIG. 173). Thus, expanding the first and second paddle frame portions 17002 and 17004 can provide additional association (or clamping) force(s).

[0621] Figures 180-183 show various views of an implementation of a stiffener 18000 for the paddle frame portions. Stiffener 18000 can be used to provide additional bias, resistance, and/or spring force to the paddles/frames. This can be done to increase, maintain, and/or otherwise adjust the association (or clamping) force provided by the paddles/frames. Stiffener 18000 can be used with any of the devices disclosed herein. For instance, the stiffener 18000 can be used with any of the devices 14600, 14900, 15400, 15900, 16200, 16700, 16900, and 17000 having a base region.

[0622] Stiffener 18000 or additional biasing element (e.g., spring, flexing plate, etc.) can have a body 18002 that includes, for example, an opening 18004 and optional end extensions 18006 and 18008. Aperture 18004 is a mounting aperture for allowing stiffener 18000 or additional biasing element to be attached or connected to the base region of an implantable device between, for example, the cap 13716 and bushing 13702. Body 18002 can be either singular or be made of one or more discrete or continuous pieces of material. This can include, for example, ribs with or without spaces or gaps therebetween, cutouts in the body (longitudinal or otherwise), etc. [0623] Figure 181 shows one implementation of stiffener 18000 in a shape-set configuration that is arcuate or curved. In some implementations, stiffener 18000 can remain in its flat configuration (e.g., FIG. 180). Figure 182 shows stiffener 18000 incorporated into a base region 18200 of paddles/frames. In this implementation, the stiffener 18000 is positioned on the outer curved side of the base region 18200 to provide additional force or bias against tensile bending/flexing of the base region 18200. Figure 182 shows stiffener 18000 incorporated into a base region 18300 having a scissors or crossover portion. In this implementation, stiffener 18000 is position on the inner curved side of base region 18300 to provide additional force or bias against compressive bending/flexing of the base region 18300. Alternatively, the position of stiffener 18000 in Figures 182 and 183 can be reversed (e.g., placed inside base region 18200 and outside base region 18300) and provide the same additional force or bias against bending/flexing.

[0624] Examples

[0625] Example 1. An implantable device comprising: a bushing; at least one paddle comprising an outer paddle portion, inner paddle portion, and a paddle mounting portion connected to the bushing; a paddle frame connected to the paddle and comprising: a first portion and a second portion, the first and second portions spaced apart and connected by a third portion; and the third portion comprising a brace portion at least partially contacting the bushing.

[0626] Example 2. The implantable device of example 1 wherein the first and second paddle frame portions each comprise a plurality of struts arranged in a loop shape.

[0627] Example 3. The implantable device of any of examples 1 to 2 wherein the brace portion of the third portion comprises a curved strut.

[0628] Example 4. The implantable device of any of examples 1 to 3 wherein the third portion further comprises spaced apart struts and the bushing is at least partially disposed in the space. [0629] Example 5. The implantable device of any of examples 1 to 4 wherein the first and second paddle frame portions each comprise a plurality of curved struts.

[0630] Example 6. The implantable device of any of examples 1 to 5 wherein the first and second paddle frame portions each comprise an upper loop region and the third portion comprises a loop region below the upper loop regions.

[0631] Example 7. The implantable device of any of examples 1 to 6 wherein the first and second paddle frame portions are configured to contact a plurality of portions of a native leaflet of a heart valve.

[0632] Example 8. The implantable device of any of examples 1 to 7 wherein the first and second paddle frame portions comprise a saddle-shaped body.

[0633] Example 9. The implantable device of any of examples 1 to 8 wherein the first and second paddle frame portions comprise first and second loop regions disposed on opposite sides of the bushing.

[0634] Example 10. An implantable device comprising: a bushing; at least one paddle having an inner paddle portion and an outer paddle portion; a paddle frame comprising: a first portion and a second portion, the first and second portions spaced apart and connected by a first brace strut; and a third portion at least partially disposed between the inner paddle portion and the outer paddle portion and connected to the first and second portions by at least a second brace strut.

[0635] Example 11. The implantable device of example 10 wherein the first and second paddle frame portions each comprise a plurality of struts arranged in a loop shape.

[0636] Example 12. The implantable device of any one of examples 10 to 11 wherein the first and second brace struts comprise at least one curved strut. [0637] Example 13. The implantable device of any one of examples 10 to 12 wherein the third portion further comprises spaced apart struts and the bushing is at least partially disposed in the space.

[0638] Example 14. The implantable device of any one of examples 10 to 13 wherein the first and second paddle frame portions each comprise a plurality of curved struts.

[0639] Example 15. The implantable device of any of examples 10 to 14 wherein the first and second paddle frame portions each comprise an upper loop region and the third portion comprises a loop region below the upper loop regions.

[0640] Example 16. The implantable device of any one of examples 10 to 15 wherein the first and second paddle frame portions are configured to contact a plurality of portions of a native leaflet of a heart valve.

[0641] Example 17. The implantable device of any one of examples 10 to 16 wherein the first and second paddle frame portions comprise a saddle-shaped body.

[0642] Example 18. The implantable device of any one of examples 10 to 17 wherein the first and second paddle frame portions comprise first and second loop regions disposed on opposite sides of the bushing.

[0643] Example 19. The implantable device of any one of examples 10 to 18 wherein each of the first and second paddle frame portions comprise a collapsible upper loop region.

[0644] Example 20. An implantable device comprising: a bushing; first and second paddles disposed on opposite sides of the bushing; first and second paddle frames comprising: a plurality of struts; a crossover region having at least a first strut portion of the first paddle frame cross over a first strut portion of the second paddle frame; a clamp region having at least a second strut portion of the first paddle frame in contact with at least a second strut portion of the second paddle frame; and a base region having at least one curved strut.

[0645] Example 21. The implantable device of example 20 wherein the first and second paddles are configured to contact a native leaflet of a heart valve.

[0646] Example 22. The implantable device of any one of examples 20 to 21 wherein the first strut portion of the first paddle frame in the crossover region comprises an offset strut.

[0647] Example 23. The implantable device of any one of examples 20 to 22 wherein the first and second paddle frames comprise a saddle-shaped body.

[0648] Example 24. The implantable device of any one of examples 20 to 23 wherein the plurality of struts of the first and second paddle frames comprise a plurality of curved struts.

[0649] Example 25. The implantable device of any one of examples 20 to 24 wherein the base region exerts a clamping force on the first and second paddle frames.

[0650] Example 26. The implantable device of any one of examples 20 to 25 wherein the first and second paddle frames comprise a hinge portion disposed opposite the base region.

[0651] Example 27. The implantable device of any one of examples 20 to 26 wherein the crossover region comprises crossing struts.

[0652] Example 28. The implantable device of any one of examples 20 to 27 wherein the crossover region comprises a plurality of struts of the first paddle frame crossing over a plurality of struts of the second paddle frame.

[0653] Example 29. The implantable device of any one of examples 20 to 28 wherein a curvature of the at least one curved strut of the base exerts a clamping force.

[0654] Example 30. An implantable device comprising: a bushing; first and second paddles disposed on opposite sides of the bushing; first and second paddle frames comprising: a plurality of struts; a clamp region having a first strut portion of the first paddle frame in contact with a first strut portion of the second paddle frame; and a base region having a curved strut connecting the first and paddle frames, the curved strut configured to generate a clamping force between the first and second paddle frames.

[0655] Example 31. The implantable device of example 30 wherein the first and second paddles are configured to contact a native heart valve leaflet.

[0656] Example 32. The implantable device of any one of examples 30 to 31 further comprising a hinge coupling the first paddle frame and the first paddle.

[0657] Example 33. The implantable device of any one of examples 30 to 32 wherein the bushing comprises an extended state wherein the paddle frames are collapsed against the bushing.

[0658] Example 34. The implantable device of any one of examples 30 to 33 wherein the bushing comprises a retracted state wherein the paddle frames extend away from the bushing.

[0659] Example 35. The implantable device of any one of examples 30 to 34 wherein the first and second paddle frames contact each other in a clamped state.

[0660] Example 36. The implantable device of any one of examples 30 to 35 wherein the clamp region comprises a plurality of clamp regions.

[0661] Example 37. The implantable device of any one of examples 30 to 36 wherein the clamp region comprises a plurality of curved struts.

[0662] Example 38. The implantable device of any one of examples 30 to 37 wherein the clamp region comprises first and second clamp regions separated by at least one non-clamp region. [0663] Example 39. The implantable device of any one of examples 30 to 38 wherein the clamp region comprises the at least one strut portion of the first paddle frame having a curved portion in contact with a curved portion of the at least one strut portion of the second paddle frame.

[0664] Example 40. An implantable medical device comprising: a bushing; first and second paddles disposed on opposite sides of the bushing; first and second paddle frames comprising: a tab portion; first and second strut portions disposed laterally of each side of the central hinge portion, the first and second strut portions each comprising a plurality of flex struts and gaps between the each of the flex struts of the plurality of flex struts; and a base region having at least one curved strut connecting the first and paddle frames, the curved strut configured to generate a clamping force between the first and second paddle frames.

[0665] Example 41. The implantable device of example 40 wherein the first and second paddles are configured to contact a native heart valve leaflet.

[0666] Example 42. The implantable device of any one of examples 40 to 41 wherein the tab portion connects the first paddle to the first paddle frame.

[0667] Example 43. The implantable device of any one of examples 40 to 42 further comprising a cap, the cap disposed distal to the bushing, wherein the cap comprises an extended state wherein the paddle frames are collapsed toward the bushing.

[0668] Example 44. The implantable device of example 43, wherein the cap comprises a retracted state wherein the paddle frames extend away from the bushing as compared to the extended state.

[0669] Example 45. The implantable device of any one of examples 40 to 44 wherein the first and second paddle frames contact each other in a clamped state. [0670] Example 46. The implantable device of any one of examples 40 to 45 further comprising a clamp region wherein portions of the first and second paddle frames contact each other.

[0671] Example 47. The implantable device of any one of examples 40 to 46 further comprising a clamp region having a plurality of curved struts.

[0672] Example 48. The implantable device of any one of examples 40 to 47 further comprising a clamp region having first and second clamp regions separated by at least one nonclamp region.

[0673] Example 49. The implantable device of any one of examples 40 to 48 comprising a clamp region having at least one strut portion of the first paddle frame having a curved portion in contact with a curved portion of at least one strut portion of a second paddle frame.

[0674] Example 50. The device of any of the preceding examples wherein the device is sterilized.

[0675] Example 51. The device of any of the preceding examples 20-50 further comprising a stiffener coupled to the base region of the device.

[0676] Example 52. An implantable medical device comprising: a bushing; first and second paddle frames disposed on opposite sides of the bushing; wherein the first and second paddle frames include lateral struts that extend away from the bushing; wherein the lateral struts are configured to be pulled toward the bushing to reduce a coaptation distance of the first and second paddles.

[0677] Example 53. An implantable medical device comprising: a bushing; first and second paddle frames disposed on opposite sides of the bushing; wherein the first and second paddle frames include beam portions that extend away from a remaining portion of the paddle frame in an extended configuration; wherein the beam portions are configured to be folded toward the remaining portion of the paddle frame.

[0678] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc. The device described or suggested herein or in references incorporated herein can be used on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc.

[0679] Any of the various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use with patients, and the methods herein can comprise sterilization of the associated system, device, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0680] While various inventive aspects, concepts and features of the disclosures can be described and illustrated herein as embodied in combination in the examples herein, these various aspects, concepts, and features can be used in many alternative examples, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the present application. Still further, while various alternative examples as to the various aspects, concepts, and features of the disclosures — such as alternative materials, structures, configurations, methods, devices, and components, alternatives as to form, fit, and function, and so on — may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative examples, whether presently known or later developed. Those skilled in the art can readily adopt one or more of the inventive aspects, concepts, or features into additional examples and uses within the scope of the present application even if such examples are not expressly disclosed herein. [0626] Additionally, even though some features, concepts, or aspects of the disclosures may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, example or representative values and ranges may be included to assist in understanding the present application, however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated.

[0627] Moreover, while various aspects, features and concepts may be expressly identified herein as being inventive or forming part of a disclosure, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a specific disclosure, the disclosures instead being set forth in the appended claims. Descriptions of example methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated. The words used in the claims have their full ordinary meanings and are not limited in any way by the description of the examples in the specification.

Claims

CLAIMS What is claimed is:

1. An implantable device comprising: a bushing; at least one paddle comprising an outer paddle portion, inner paddle portion, and a paddle mounting portion connected to the bushing; a paddle frame connected to the paddle and comprising: a first portion and a second portion, the first and second portions spaced apart and connected by a third portion; and the third portion comprising a brace portion at least partially contacting the bushing.

2. The implantable device of claim 1 wherein the first and second paddle frame portions each comprise a plurality of struts arranged in a loop shape.

3. The implantable device of any of claims 1 to 2 wherein the brace portion of the third portion comprises a curved strut.

4. The implantable device of any of claims 1 to 3 wherein the third portion further comprises spaced apart struts and the bushing is at least partially disposed in the space.

5. The implantable device of any of claims 1 to 4 wherein the first and second paddle frame portions each comprise a plurality of curved struts.

6. The implantable device of any of claims 1 to 5 wherein the first and second paddle frame portions each comprise an upper loop region and the third portion comprises a loop region below the upper loop regions.

7. The implantable device of any of claims 1 to 6 wherein the first and second paddle frame portions are configured to contact a plurality of portions of a native leaflet of a heart valve.

8. The implantable device of any of claims 1 to 7 wherein the first and second paddle frame portions comprise a saddle-shaped body.

9. The implantable device of any of claims 1 to 8 wherein the first and second paddle frame portions comprise first and second loop regions disposed on opposite sides of the bushing.

10. An implantable device comprising: a bushing; at least one paddle having an inner paddle portion and an outer paddle portion; a paddle frame comprising: a first portion and a second portion, the first and second portions spaced apart and connected by a first brace strut; and a third portion at least partially disposed between the inner paddle portion and the outer paddle portion and connected to the first and second portions by at least a second brace strut.

11. The implantable device of claim 10 wherein the first and second paddle frame portions each comprise a plurality of struts arranged in a loop shape.

12. The implantable device of any one of claims 10 to 11 wherein the first and second brace struts comprise at least one curved strut.

13. The implantable device of any one of claims 10 to 12 wherein the third portion further comprises spaced apart struts and the bushing is at least partially disposed in the space.

14. The implantable device of any one of claims 10 to 13 wherein the first and second paddle frame portions each comprise a plurality of curved struts.

15. The implantable device of any of claims 10 to 14 wherein the first and second paddle frame portions each comprise an upper loop region and the third portion comprises a loop region below the upper loop regions.

16. The implantable device of any one of claims 10 to 15 wherein the first and second paddle frame portions are configured to contact a plurality of portions of a native leaflet of a heart valve.

17. The implantable device of any one of claims 10 to 16 wherein the first and second paddle frame portions comprise a saddle-shaped body.

18. The implantable device of any one of claims 10 to 17 wherein the first and second paddle frame portions comprise first and second loop regions disposed on opposite sides of the bushing.

19. The implantable device of any one of claims 10 to 18 wherein each of the first and second paddle frame portions comprise a collapsible upper loop region.

20. An implantable device comprising: a bushing; first and second paddles disposed on opposite sides of the bushing; first and second paddle frames comprising: a plurality of struts; a crossover region having at least a first strut portion of the first paddle frame cross over a first strut portion of the second paddle frame; a clamp region having at least a second strut portion of the first paddle frame in contact with at least a second strut portion of the second paddle frame; and a base region having at least one curved strut.

21. The implantable device of claim 20 wherein the first and second paddles are configured to contact a native leaflet of a heart valve.

22. The implantable device of any one of claims 20 to 21 wherein the first strut portion of the first paddle frame in the crossover region comprises an offset strut.

23. The implantable device of any one of claims 20 to 22 wherein the first and second paddle frames comprise a saddle-shaped body.

24. The implantable device of any one of claims 20 to 23 wherein the plurality of struts of the first and second paddle frames comprise a plurality of curved struts.

25. The implantable device of any one of claims 20 to 24 wherein the base region exerts a clamping force on the first and second paddle frames.

26. The implantable device of any one of claims 20 to 25 wherein the first and second paddle frames comprise a hinge portion disposed opposite the base region.

27. The implantable device of any one of claims 20 to 26 wherein the crossover region comprises crossing struts.

28. The implantable device of any one of claims 20 to 27 wherein the crossover region comprises a plurality of struts of the first paddle frame crossing over a plurality of struts of the second paddle frame.

29. The implantable device of any one of claims 20 to 28 wherein a curvature of the at least one curved strut of the base exerts a clamping force.

30. An implantable device comprising: a bushing; first and second paddles disposed on opposite sides of the bushing; first and second paddle frames comprising: a plurality of struts; a clamp region having a first strut portion of the first paddle frame in contact with a first strut portion of the second paddle frame; and a base region having a curved strut connecting the first and paddle frames, the curved strut configured to generate a clamping force between the first and second paddle frames.

31. The implantable device of claim 30 wherein the first and second paddles are configured to contact a native heart valve leaflet.

32. The implantable device of any one of claims 30 to 31 further comprising a hinge coupling the first paddle frame and the first paddle.

33. The implantable device of any one of claims 30 to 32 wherein the bushing comprises an extended state wherein the paddle frames are collapsed against the bushing.

34. The implantable device of any one of claims 30 to 33 wherein the bushing comprises a retracted state wherein the paddle frames extend away from the bushing.

35. The implantable device of any one of claims 30 to 34 wherein the first and second paddle frames contact each other in a clamped state.

36. The implantable device of any one of claims 30 to 35 wherein the clamp region comprises a plurality of clamp regions.

37. The implantable device of any one of claims 30 to 36 wherein the clamp region comprises a plurality of curved struts.

38. The implantable device of any one of claims 30 to 37 wherein the clamp region comprises first and second clamp regions separated by at least one non-clamp region.

39. The implantable device of any one of claims 30 to 38 wherein the clamp region comprises the at least one strut portion of the first paddle frame having a curved portion in contact with a curved portion of the at least one strut portion of the second paddle frame.

40. An implantable medical device comprising: a bushing; first and second paddles disposed on opposite sides of the bushing; first and second paddle frames comprising: a tab portion; first and second strut portions disposed laterally of each side of the central hinge portion, the first and second strut portions each comprising a plurality of flex struts and gaps between the each of the flex struts of the plurality of flex struts; and a base region having at least one curved strut connecting the first and paddle frames, the curved strut configured to generate a clamping force between the first and second paddle frames.

41. The implantable device of claim 40 wherein the first and second paddles are configured to contact a native heart valve leaflet.

42. The implantable device of any one of claims 40 to 41 wherein the tab portion connects the first paddle to the first paddle frame.

43. The implantable device of any one of claims 40 to 42 further comprising a cap, the cap disposed distal to the bushing, wherein the cap comprises an extended state wherein the paddle frames are collapsed toward the bushing.

44. The implantable device of claim 43, wherein the cap comprises a retracted state wherein the paddle frames extend away from the bushing as compared to the extended state.

45. The implantable device of any one of claims 40 to 44 further comprising a clamp region having first and second clamp regions separated by at least one non-clamp region.

46. The implantable device of any one of claims 40 to 45 comprising a clamp region having at least one strut portion of the first paddle frame having a curved portion in contact with a curved portion of at least one strut portion of a second paddle frame.

47. The device of any of the preceding claims wherein the device is sterilized.

48. The device of any of the preceding claims 20-47 further comprising a stiffener coupled to the base region of the device.

49. An implantable medical device comprising: a bushing; first and second paddle frames disposed on opposite sides of the bushing; wherein the first and second paddle frames include lateral struts that extend away from the bushing; wherein the lateral struts are configured to be pulled toward the bushing to reduce a coaptation distance of the first and second paddles.

50. An implantable medical device comprising: a bushing; first and second paddle frames disposed on opposite sides of the bushing; wherein the first and second paddle frames include beam portions that extend away from a remaining portion of the paddle frame in an extended configuration; wherein the beam portions are configured to be folded toward the remaining portion of the paddle frame.