HEART VALVE REPAIR DEVICE AND DELIVERY DEVICE THEREFOR - Patent application

Abstract

The implantable device or implant is configured to be positioned inside the native heart valve so that the native heart valve may form a more effective seal. The implantable device or implant may include a paddle frame with an adjustable width. The coupler may be configured to allow width adjustment of the paddle frame and to set or fix the width of the paddle frame. The cover may be configured to prevent or inhibit backflow of blood regardless of the selected width of the paddle frame.

Description

[Technical field]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 308,940, filed February 10, 2022, U.S. Provisional Patent Application No. 63 / 278,037, filed November 10, 2021, and U.S. Provisional Patent Application No. 63 / 217,622, filed July 1, 2021, all of which are incorporated by reference in their entirety and for all purposes. [Background technology]

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

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

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

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

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

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

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

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

[0010] In some implementations, the implantable device or implant includes a first anchor and a second anchor, each of the first and second anchors having a paddle frame including an inner frame portion and an outer frame portion. The anchors are configured to move to a closed position in which the inner and outer frame portions compress one or more leaflets (e.g., leaflets of a heart valve such as a mitral valve, tricuspid valve, etc.) within inner and outer pinch points (e.g., pinch areas or areas where the frame members press against the leaflets) to secure the implantable device to the patient's native valve. The implantable device or implant further includes a cover attached to the paddle frame of the anchor. The cover is configured to block or inhibit blood flow between the anchors.

[0011] 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, and the cover is configured to block blood flow between the anchors at any width of the anchors and / or paddle frames.

[0012] In some implementations, the paddle frame of the implantable device includes an outer frame portion movable between a constricted position and an expanded position, wherein a proximal width of a proximal end of the outer frame portion is greater than a distal width of a distal end of the outer frame portion when the outer frame portion is in the expanded position.

[0013] In some implementations, the paddle frame of the implantable device includes an outer frame portion movable between a constricted position and an expanded position, the distal width of the distal end of the outer frame portion being greater than the proximal width of the proximal end of the outer frame portion when the outer frame portion is in the expanded position.

[0014] In some implementations, an implantable device or implant is provided with a first anchor and a second anchor, the first anchor and the second anchor configured to be moved to a closed position in which the first anchor and the second anchor compress one or more leaflets of the native valve within the first pinch point and the second pinch point such that the implantable device is secured to the native valve. The first pinch point and the second pinch point can be between portions of the first anchor and the second anchor. A cover is attached to the first anchor and the second anchor and extends between the first anchor and the second anchor.

[0015] In some implementations, a first pinch point is formed between a first frame member of the first and second anchors, and in some implementations, a second pinch point is formed between a second frame portion (e.g., an outer frame portion) of the first and second anchors.

[0016] In some implementations, the first frame member is separate and distinct from the second frame member, hi some implementations, the first frame member is integrally formed with the second frame member for each of the first and second anchors.

[0017] In some implementations, the first frame member is a protrusion or protruding portion of the first and second anchors, e.g., protruding or extending from a surface of the first and second anchors. In some implementations, the second frame member is a protrusion or protruding portion of the first and second anchors, e.g., protruding or extending from a surface of the first and second anchors.

[0018] In some implementations, the first anchor includes a rigid inner frame portion and a flexible outer frame portion member.

[0019] In some implementations, the covering extends over an inner surface of the first anchor.In some implementations, the covering extends over an outer surface of the first anchor.

[0020] In some implementations, the cover is positioned between at least a portion of an area defined by an inner surface of the first anchor, hi some implementations, the cover extends across the entire area defined by the inner surface of the first anchor.

[0021] In some implementations, the cover encapsulates at least a portion of the outer paddle of each of the first and second anchors, hi some implementations, the cover encapsulates the entire outer paddle of each of the first and second anchors.

[0022] In some implementations, the cover includes a first membrane attached to the paddle frame of the first anchor and a second membrane attached to the paddle frame of the second anchor.

[0023] In some implementations, the first and second membranes are connected together to block blood flow between the first and second anchors.

[0024] In some implementations, the cover comprises a single membrane that is attached to the paddle frames of both the first and second anchors.

[0025] In some implementations, the covering (e.g., a single membrane, multiple membranes, etc.) is configured to form a canopy extending between the first anchor and the second anchor.

[0026] In some implementations, the cover is made of a porous material that becomes impermeable to blood flow over time.

[0027] In some implementations, the cover is configured to provide a compressive force against one or more leaflets in a region between the first pinch point and the second pinch point.

[0028] In some implementations, the first anchor and the second anchor are configured to be moved between a constricted position having a first width and an expanded position having a second width greater than the first width.

[0029] In some implementations, the cover is configured to be in tension when the outer frame portion is in a constricted position, and the cover is configured to be stretched when the outer frame portion is in an expanded position.

[0030] In some implementations, the cover is configured to be in tension when the outer frame portion is in a constricted position, and the cover includes one or more stretchable portions that allow the cover to stretch when the outer frame is in an expanded position.

[0031] In some implementations, an implantable device or implant is provided that includes a first anchor and a second anchor, the first anchor and the second anchor configured to be moved between a constricted configuration having a first width and an expanded configuration having a second width greater than the first width, and the first anchor and the second anchor configured to be moved to a closed position in which the first anchor and the second anchor compress one or more leaflets of the native valve between themselves. The device or implant includes a flexible cover attached to the first anchor and the second anchor.

[0032] In some implementations, the covering is configured to provide a compressive force against one or more leaflets in an area between the portions that compress the one or more leaflets when the implantable device is secured to the native valve.

[0033] In some implementations, the first anchor and the second anchor are configured to move to a closed position in which the first anchor and the second anchor compress one or more leaflets of the native valve between the first pinch point and the second pinch point such that the implantable device is secured to the native valve. In some implementations, the cover is configured to provide a compressive force to the one or more leaflets in a region between the first pinch point and the second pinch point when the implantable device is secured to the native valve.

[0034] In some implementations, the cover is configured to be in tension when the first anchor and the second anchor are in the constricted configuration, and the cover is configured to be stretched when the first anchor and the second anchor are in the expanded configuration (e.g., remain in tension in the constricted configuration, the expanded configuration, and positions between the constricted configuration and the expanded configuration).

[0035] In some implementations, the implantable device is anchored to the native valve and the first anchor comprises a rigid inner frame portion and a flexible outer frame portion.

[0036] In some implementations, the cover is connected to the first anchor by one or more stitches.

[0037] In some implementations, the covering extends over an inner surface of the first anchor.In some implementations, the covering extends over an outer surface of the first anchor.

[0038] In some implementations, the cover is positioned between at least a portion of an area defined by an inner surface of the first anchor, hi some implementations, the cover extends across the entire area defined by the inner surface of the first anchor.

[0039] In some implementations, the cover encapsulates at least a portion of the outer paddle of each of the first and second anchors, hi some implementations, the cover encapsulates the entire outer paddle of each of the first and second anchors.

[0040] In some implementations, the cover includes a first membrane attached to the first anchor and a second membrane attached to the second anchor.

[0041] In some implementations, the first membrane and the second membrane are not connected such that a gap exists between the bottom ends of the first membrane and the second membrane.

[0042] In some implementations, the cover includes a single membrane that is attached to both the first anchor and the second anchor.

[0043] In some implementations, the single membrane creates or forms a canopy that extends between the first anchor and the second anchor.

[0044] In some implementations, the cover is made of a porous material. In some implementations, the cover is made of an impermeable material.

[0045] In some implementations, the implantable device or implant includes a coaptation element (e.g., a spacer, plug, filler, foam, sheet, membrane, coaptation element, wedge, barrier, balloon, etc.) and one or more anchors. The coaptation element defines a first region when viewed from above. The one or more anchors are coupled to the coaptation element. The anchors are movable between an open position and a closed position. The one or more anchors are configured to attach to one or more leaflets of the native heart valve. Each of the anchors includes a paddle frame.

[0046] In some implementations, the paddle frame defines an outer portion of the implantable device when viewed from above and the anchor is in a closed position. In some implementations, the outer portion of the device when viewed from above has a second region. In some implementations, the ratio of the second region to the first region is 2:1 or greater.

[0047] In some implementations, the ratio of the second region to the first region can be 3:1, 4:1, 5:1, or 6:1 or more.

[0048] In some implementations, the interface element may include one or more flat and / or tapered sides. The interface element may include a rectangular first portion and a rounded second portion.

[0049] In some implementations, the interface element may be injection molded. The interface element may include a polymer material.

[0050] In some implementations, the implantable device can include an attachment portion having a collar configured to be attached to a delivery device. The collar of the attachment portion can be integrated into the interface element.

[0051] In some implementations, the interface element includes one or more attachment openings for aligning with one or more openings in the anchor component such that the anchor component can be attached to the interface element.

[0052] In some implementations, the anchor may include an inner paddle and an outer paddle and / or clasp. Each paddle frame of the anchor may include an inner paddle frame and an outer paddle frame.

[0053] In some implementations, the outer paddle frame defines an outer portion of the implantable device when viewed from above and the anchors are in a closed position.

[0054] In some implementations, the implantable device or implant described above is incorporated into a system, such as a valve repair system that includes a delivery system and the implantable device or implant.

[0055] In some implementations, a valve repair system for repairing a native heart valve includes a delivery device, an implantable device, and a coupler. The delivery device has a width adjustment element (e.g., a width adjustment control, a line, a shaft, a wire, a tether, etc.) that includes an external threaded portion. The implantable device is configured to be implanted onto the native valve. The anchor portion has one or more anchors. The one or more anchors are configured to be attached to one or more leaflets of the native valve.

[0056] In some implementations, each of the anchors can have a paddle frame including an inner end.

[0057] In some implementations, the coupler removably connects a width adjustment element of the delivery device to an inner end of the anchor. In some implementations, the coupler comprises one or more attachment protrusions extending inwardly from a body of the coupler. In some implementations, the attachment protrusions are configured to be removably attached to an externally threaded portion of the width adjustment element. The width adjustment element is configured to move the inner end of the anchor to move the paddle frame between a constricted position and an expanded position.

[0058] In some implementations, the one or more mounting protrusions can include a first mounting protrusion and a second mounting protrusion, and the first mounting protrusion can be offset from the second mounting protrusion along a height of the body of the coupler.

[0059] In some implementations, the coupler can have an arm that is movable between a normal position and an engaged position, where when the coupler is disconnected from the implantable device, the arm is in the normal position and when the coupler is connected to the width adjustment element, the arm is in the engaged position.

[0060] In some implementations, a valve repair system for repairing a patient's native valve includes a delivery device, an implantable device, and a coupler. The delivery device can have a width adjustment element (e.g., a width adjustment control, a line, a shaft, a wire, a tether, etc.). The implantable device can be configured to be implanted onto the patient's native valve. The implantable device includes an anchor portion having one or more anchors. The one or more anchors are configured to be attached to one or more leaflets of the native valve.

[0061] In some implementations, the implantable device has a receiver (e.g., a female threaded element, a column, a conduit, a hollow member, a notched receiving portion, a tube, a shaft, a sleeve, a post, a housing, a raceway, a cylinder, etc.) that defines an internal lumen containing female threads.

[0062] In some implementations, the receiver has a non-attachable portion that prevents the coupler from connecting to the receiver when the coupler is placed within the non-attachable portion.

[0063] In some implementations, each of the anchors has a paddle frame including an inner end.

[0064] In some implementations, the coupler releasably connects a width adjustment element of the delivery device to an inner end of the anchor.

[0065] In some implementations, the coupler comprises at least two arms movable between a normal position and an engaged position, hi some implementations, the arms are in the normal position when the coupler is separated from the width adjustment element, and the arms are in the engaged position when the coupler is connected to the width adjustment element.

[0066] In some implementations, the arm is configured to attach to the internal threads of the receiver bore when the arm is in a normal position.

[0067] In some implementations, the arm can include one or more tabs configured to be inserted into one or more slots in the body of the coupler when the arm is in a normal position.

[0068] In some implementations, the arms are configured such that when in the engaged position, the coupler is movable within the lumen of the receiver.

[0069] In some implementations, a first of the arms is offset from a second of the arms along a height of the body of the coupler.

[0070] In some implementations, a first portion of each arm extends into an inner lumen of the coupler when the arms are in their normal position, and a second portion of each arm extends away from the exterior of the body of the coupler when the arms are in their normal position.

[0071] In some implementations, the arms can extend from about 20 degrees to about 45 degrees away from the outer surface of the body of the coupler when the arms are in a normal position.

[0072] In some implementations, the coupler includes an upper body, a lower body, and a number of struts connected to the upper body and the lower body, the coupler being movable between a first position in which the number of struts is in a straight configuration and a second position in which the number of struts is in a helical configuration.

[0073] In some implementations, the coupler is configured to attach to the female threads of the receiver when the multiple posts are in a helical configuration.

[0074] In some implementations, the multiple struts are generally in a helical configuration.

[0075] In some implementations, the coupler includes at least two arms movable between a normal position and an engaged position, each of the arms having a central portion, a first connecting member connecting the central portion to a proximal end of the coupler, and a second connecting member connecting the central portion to a distal end of the coupler.

[0076] In some implementations, the arm is configured to attach to the female threads of the receiver when the arm is in a normal position.

[0077] In some implementations, the first and second connecting members are generally twisted such that a first portion of the central portion is disposed within the lumen of the coupler and a second portion of the central portion extends away from the exterior of the coupler.

[0078] In some implementations, the arms of the coupler have a T-shape.

[0079] In some implementations, the implantable device or implant includes an interface element (e.g., a spacer, plug, filler, foam, sheet, membrane, interface element, wedge, barrier, balloon, etc.), an anchor portion, a cap, and a distal cover element (e.g., a cover, covering, fabric, polymer, weave, braid, portion thereof, etc.). The interface element has an internal lumen for receiving one or more actuating elements of a delivery device. Each anchor is movable between an open position and a closed position.

[0080] In some implementations, the cap is operatively connected to the anchor such that movement of the cap relative to the coaptation element by one or more actuation elements of the delivery device moves the anchor between an open position and a closed position, hi some implementations, the cap has a distal opening in communication with the lumen of the coaptation element.

[0081] In some implementations, the distal cover element is positioned to prevent or inhibit blood from migrating through the distal opening of the cap and into the interior of the implantable device.

[0082] In some implementations, each anchor has a paddle frame with an inner end that is movable relative to the cap such that at least a portion of the paddle frame can move through a distal opening in the cap.

[0083] In some implementations, an implantable device is provided having an anchor portion with a first anchor and a second anchor (which may, for example, be similar or identical to any anchor shown or described herein), each of the first and second anchors comprising a paddle frame, the paddle frame configured to move between a stenotic configuration and an expanded configuration, and the first and second anchors configured to move to a closed position in which the first and second anchors compress one or more native valve leaflets such that the implantable device is secured to the native valve.

[0084] In some implementations, the implantable device further comprises a flexible covering attached to the paddle frame (e.g., which may be similar or identical to any covering shown or described anywhere herein), the flexible covering configured to be in tension when the paddle frame is in a constricted configuration, and the flexible covering configured to stretch when the paddle frame is in an expanded configuration.

[0085] In some implementations, the paddle frame includes an inner frame portion and an outer frame portion, the inner frame portion being rigid and the outer frame portion being flexible.

[0086] In some implementations, the flexible cover includes a first membrane attached to the paddle frame of the first anchor and a second membrane attached to the paddle frame of the second anchor.

[0087] In some implementations, the flexible cover comprises a single membrane that is attached to the paddle frames of both the first and second anchors.

[0088] In some implementations, the paddle frame of each of the first and second anchors includes an inner frame portion and an outer frame portion, and the paddle frame is configured such that the outer frame portion of the paddle frame changes shape as the paddle frame moves between the constricted configuration and the expanded configuration.

[0089] In some implementations, the paddle frame of each of the first and second anchors includes an inner frame portion and an outer frame portion, and the first and second anchors are configured such that, in a closed position, the inner frame portion of each of the first and second anchors can compress the native valve leaflets between an inner pinch point and the outer frame portion of each of the first and second anchors can compress one or more native valve leaflets between an outer pinch point, such that the one or more implantable devices are secured to the native valve.

[0090] In some implementations, an implantable device is provided having an anchor portion including an anchor (which may, for example, be similar or identical to any anchor shown or described herein), the anchor having a paddle frame, the paddle frame configured to be moved between a stenotic configuration and an expanded configuration, and the anchor configured to be moved to a closed position in which the anchor compresses at least one native valve leaflet such that the implantable device is secured to the native valve.

[0091] In some implementations, the implantable device further comprises a cover (e.g., which may be similar or identical to any cover described or illustrated in relevant sections of this specification) attached to the paddle frame, the cover configured to be in tension when the paddle frame is in a constricted configuration and the cover configured to be stretched when the paddle frame is in an expanded configuration.

[0092] In some implementations, the paddle frame includes an inner frame portion and an outer frame portion, the inner frame portion being rigid and the outer frame portion being flexible.

[0093] In some implementations, the cover extends over at least a portion of the inner surface of the paddle frame.

[0094] In some implementations, the cover extends across the entire area defined by the inner surface of the paddle frame.

[0095] In some implementations, the anchor is a first anchor, the implantable device also includes a second anchor, and the covering comprises a single membrane attached to the paddle frames of the first anchor and the second anchor, hi some implementations, the single membrane creates or forms a canopy extending between the first anchor and the second anchor.

[0096] In some implementations, the anchor is a first anchor and the implantable device includes a second anchor that also includes a paddle frame, the paddle frames of both the first anchor and the second anchor include inner and outer frame portions, and the cover is attached to the inner and outer frame portions of the first and second anchors, and the cover extends between the first anchor and the second anchor.

[0097] In some implementations, the paddle frame includes an inner frame portion and an outer frame portion, and the paddle frame is configured such that when the paddle frame is moved between the constricted configuration and the expanded configuration, the outer frame portion of the paddle frame changes shape between the constricted configuration and the expanded configuration.

[0098] In some implementations, the paddle frame includes an inner frame portion and an outer frame portion, and the anchors are configured such that, in a closed position, the inner frame portion of the anchors can compress the inner pinch point and at least one of the native valve leaflets, and the outer frame portion of each of the anchors can compress the outer pinch point and at least one of the native valve leaflets, such that the implantable device is secured to the native valve.

[0099] In some implementations, a valve repair system for repairing a patient's native valve is provided, the valve repair system comprising: (A) a delivery device having a width adjustment element (e.g., which may be similar or identical to any width adjustment element shown or described elsewhere herein); and (B) an implantable device configured to be implanted into the patient's native valve, the implantable device having: (i) an anchor portion having one or more anchors (e.g., which may be similar or identical to any anchor shown or described elsewhere herein), each of the one or more anchors having a paddle frame, the one or more anchors being configured to be attached to one or more leaflets of the native valve; and (ii) a coupler (e.g., which may be similar or identical to any coupler shown or described elsewhere herein) for releasably connecting the width adjustment element of the delivery device to an end of the one or more anchors, the coupler being configured to allow an end of the one or more anchors to be secured to one of a plurality of potential positions within the implantable device such that the anchors are held in one of a plurality of potential configurations selected from the group consisting of a stenotic configuration, an expanded configuration, and an intermediate configuration between the stenotic configuration and the expanded configuration.

[0100] In some implementations, the coupler includes at least two arms movable between a normal position and an engaged position, the arms being in the normal position when the coupler is separated from the width adjustment element, and the arms being in the engaged position when the coupler is connected to the width adjustment element.

[0101] In some implementations, the coupler includes an upper body, a lower body, and a number of posts connected to the upper body and the lower body.

[0102] In some implementations, the joint element defines a first region when viewed from above, the paddle frame of the one or more anchors defines an outer region of the implantable device when viewed from above, and when the one or more anchors are in a closed position, the outer region of the implantable device has a second region when viewed from above, and the ratio of the second region to the first region is about 2:1 or greater.

[0103] In some implementations, the paddle frame includes a connector that includes an end portion.

[0104] In some implementations, the implantable device further comprises a cover attached to the paddle frame.

[0105] In some implementations, the cover is configured to be in tension when the paddle frame is in a constricted configuration, and the cover is configured to stretch when the paddle frame transitions from the constricted configuration to the expanded configuration.

[0106] In some implementations, the paddle frame includes an inner frame portion and an outer frame portion, and the paddle frame is configured such that when the paddle frame is moved between the constricted configuration and the expanded configuration, the outer frame portion of the paddle frame changes shape between the constricted configuration and the expanded configuration.

[0107] In some implementations, the paddle frame includes an inner frame portion and an outer frame portion, and the anchors are configured such that the inner frame portion of the anchor can compress the inner pinch point of the anchor and one or more native valve leaflets, and the outer frame portion of each of the anchors can compress the outer pinch point and one or more native valve leaflets.

[0108] In some implementations, the width adjustment element includes an externally threaded portion.

[0109] In some implementations, the coupler includes one or more mounting protrusions extending inwardly from a body of the coupler, hi some implementations, the one or more mounting protrusions are configured to be removably attached to an externally threaded portion of the width adjustment element.

[0110] In some implementations, the system (e.g., a delivery device and / or a portion of the implantable device) includes a receiver (which may, for example, be similar or identical to any receiver shown or described herein). In some implementations, the receiver defines an internal lumen including an internal thread.

[0111] In some implementations, the coupler includes at least two arms movable between a normal position and an engaged position, the arms are in the normal position when the coupler is separated from the width adjustment element, the arms are in the engaged position when the coupler is connected to the width adjustment element, and the arms are configured to attach to the female threads of the receiver bore when the arms are in the normal position.

[0112] In some implementations, the receiver comprises a non-attachable portion. In some implementations, the coupler is configured to be removably coupled to the receiver (e.g., internal threads of the receiver, etc.) to secure an inner end of one or more anchors in a desired position relative to the receiver. In some implementations, the non-attachable portion of the receiver prevents the coupler from connecting to the receiver when the coupler is disposed within the non-attachable portion.

[0113] In some implementations, the implantable device further comprises a joint element.

[0114] In some implementations, the implantable device further comprises a cap operably connected to one or more anchors such that, when one or more actuating elements of the delivery device move the cap relative to another portion of the implantable device (e.g., relative to a joint element, a collar, a proximal end, a distal end, etc.), the one or more anchors move between an open position and a closed position.

[0115] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like elements bear like reference characters and in which: [Brief description of the drawings]

[0116] To further clarify various aspects of the implementations of the present disclosure, certain embodiments and implementations will be described in more detail by reference to various aspects of the accompanying drawings. These drawings depict only exemplary implementations of the present disclosure and therefore should not be considered as limiting the scope of the present disclosure. Furthermore, the drawings may be drawn to scale for some embodiments, but not necessarily to scale for all embodiments. The embodiments and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Figure 1] FIG. 1 shows a cross-section of a human heart in diastole. [Diagram 2] FIG. 2 shows a cross-section of a human heart during systole. [Diagram 3] FIG. 3 shows a cross-section of a human heart during systole, showing mitral valve regurgitation. [Figure 4] FIG. 4 is a cross-sectional view of FIG. 3, annotated to show the natural shape of the mitral valve leaflets during systole. [Diagram 5] FIG. 5 shows a healthy mitral valve with the leaflets closed as viewed from the atrial side of the mitral valve. [Figure 6] FIG. 6 shows an incompetent mitral valve with visible gaps between the leaflets when viewed from the atrial side of the mitral valve. [Figure 7] FIG. 7 shows the tricuspid valve as viewed from the atrial side of the tricuspid valve. [Figure 8] 8-14 show one embodiment of an implantable device or implant in various stages of deployment. [Figure 9] Same as above. [Figure 10] Same as above. [Figure 11] Same as above. [Figure 12] Same as above. [Figure 13] Same as above. [Figure 14] Same as above. [Figure 15]FIG. 15 shows one embodiment of an implantable device or implant similar to the device shown in FIGS. 8-14, but in which the paddles are independently controllable. [Figure 16] 16-21 show the exemplary implantable device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 17] Same as above. [Figure 18] Same as above. [Figure 19] Same as above. [Figure 20] Same as above. [Figure 21] Same as above. [Figure 22] FIG. 22 shows a perspective view of an exemplary implantable device or implant in a closed position. [Diagram 23] FIG. 23 shows a perspective view of an exemplary implantable device or implant in a closed position. [Figure 24] FIG. 24 illustrates an exemplary valve repair device with the paddle in an open position. [Figure 25A] 25A and 25B show an exemplary valve repair device similar to that of FIG. 24, but including a spacer. [Figure 25B] Same as above. [Figure 26] FIG. 26 shows a perspective view of one embodiment of an implantable device having paddles with adjustable width. [Figure 27] FIG. 27 is a cross-section of the implantable device of FIG. 26 where the implantable device is bisected. [Figure 28] 28 is another cross-section of the implantable device of FIG. 26, where the implantable device is bisected along a plane perpendicular to the plane shown in FIG. [Figure 29] FIG. 29 shows a schematic diagram of an exemplary implant catheter assembly coupled to an implantable device. [Diagram 30] FIG. 30 is a view of the assembly of FIG. 29 with the implantable device rotated 90 degrees. [Diagram 31]FIG. 31 shows a perspective view of an exemplary implantable device or implant including an exemplary paddle frame, with the implantable device or implant in an open position. [Diagram 32] FIG. 32 shows a bottom view of the implantable device or implant of FIG. [Diagram 33] FIG. 33 shows a front view of the implantable device or implant of FIG. 31 with the implantable device or implant in a closed position. [Diagram 34] FIG. 34 shows a side view of the implantable device or implant of FIG. 31 attached to a native valve of the heart. [Diagram 35] FIG. 35 shows a bottom view of the implantable device or implant of FIG. 31 attached to a native valve of the heart. [Diagram 36] FIG. 36 shows a perspective view of an exemplary implantable device or implant including an exemplary paddle frame, the device including an exemplary means for moving the paddle frame from a normal position to a stenosed position. [Figure 37] FIG. 37 shows the paddle frame of FIG. 37 in a constricted position. [Figure 38] FIG. 38 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 39] FIG. 39 illustrates a pair of the exemplary paddle frames of FIG. 38 positioned adjacent to one another. [Diagram 40] FIG. 40 shows a side view of an embodiment of an implantable device or implant including the paddle frame of FIG. 38, with the paddle frame in a constricted position. [Diagram 41] FIG. 41 shows a side view of the implantable device or implant of FIG. 40 with the paddle frame in an extended position. [Diagram 42] FIG. 42 shows a partial side view of the implantable device or implant of FIG. 40 with the paddle frame in a constricted position. [Diagram 43] FIG. 43 shows a partial side view of the implantable device or implant of FIG. 40 with the paddle frame in an extended position. [Diagram 44]FIG. 44 shows a perspective view of the implantable device or implant of FIG. 40 with the paddle frame of FIG. [Diagram 45] FIG. 45 shows a front view of the implantable device or implant of FIG. 40 with the paddle frame of FIG. [Figure 46] FIG. 46 shows a perspective view of one embodiment of inner and outer paddles for the implantable device or implant of FIG. [Figure 47] FIG. 47 shows a side view of the inner and outer paddles of FIG. [Figure 48] FIG. 48 shows a top view of the inner and outer paddles of FIG. [Figure 49] FIG. 49 illustrates a perspective view of an exemplary connection between the paddle of FIG. 47 and the paddle frame of FIG. [Figure 50] FIG. 50 shows a front view of an exemplary paddle frame for an implantable device or implant. [Figure 51] FIG. 51 shows a left side view of the paddle frame of FIG. [Figure 52] FIG. 52 shows a top view of the paddle frame of FIG. [Figure 53] FIG. 53 shows a perspective view of one embodiment of an implantable device or implant including the paddle frame of FIG. [Figure 54] 54 shows a front view of the implantable device or implant of FIG. 53 including the paddle frame of FIG. [Figure 55] 55-59 show the implantable device or implant of FIG. 53 having exemplary means for moving the paddle frame of FIG. 50 between an expanded position and a constricted position. [Figure 56] Same as above. [Figure 57] Same as above. [Figure 58] Same as above. [Figure 59] Same as above. [Figure 60] FIG. 60 shows a perspective view of a pair of exemplary paddle frames for a pair of anchors of an implantable device or implant. [Figure 61] FIG. 61 shows a front view of the paddle frame of FIG. [Figure 62] FIG. 62 shows a top view of the paddle frame of FIG. [Figure 63] FIG. 63 shows a side view of the paddle frame of FIG. [Figure 64] FIG. 64 shows one embodiment of a width adjustment or control device. [Figure 65] FIG. 65 illustrates one embodiment of an adjustable paddle frame assembly. [Figure 66] FIG. 66 illustrates one embodiment of an adjustable paddle frame assembly. [Figure 67] FIG. 67 illustrates one embodiment of an adjustable paddle frame assembly. [Figure 68] FIG. 68 illustrates one embodiment of the adjustment members of the adjustable paddle frame assembly of FIGS. [Figure 69] FIG. 69 illustrates one embodiment of an adjustable paddle frame assembly. [Figure 70] FIG. 70 shows a front cross-sectional view of an implantable device or implant. [Figure 71] FIG. 71 shows a perspective cross-sectional view of the device / implant of FIG. [Figure 72] FIG. 72 shows a perspective view of the device / implant of FIG. [Figure 73] FIG. 73 shows a side view of the device / implant of FIG. [Figure 74] FIG. 74 shows a top view of the device / implant of FIG. [Figure 75] 75-80 show partial views of the device / implant of FIG. 70 at various stages of assembly. [Figure 76] Same as above. [Figure 77] Same as above. [Figure 78] Same as above. [Figure 79] Same as above. [Figure 80] Same as above. [Figure 81]FIG. 81 shows a front view of the device / implant 70 in the expanded position. [Figure 82] FIG. 82 shows a side view of the device / implant 70 in the expanded position. [Figure 83] FIG. 83 shows a top view of the device / implant 70 in the expanded position. [Figure 84] FIG. 84 shows a front view of the device / implant of 70 in the stenotic position. [Figure 85] FIG. 85 shows a side view of the device / implant of 70 in the stenotic position. [Figure 86] FIG. 86 shows a top view of the device / implant 70 in the stenotic position. [Figure 87] FIG. 87 shows a front cross-sectional view of one embodiment of an implantable device or implant. [Figure 88] FIG. 88 shows a side view of the device / implant of FIG. [Figure 89] 89-92 show front views of the device / implant of FIG. 87 in various positions moving from an expanded position to a constricted position. [Figure 90] Same as above. [Figure 91] Same as above. [Figure 92] Same as above. [Figure 93] FIG. 93 shows a front cross-sectional view of an exemplary paddle frame for an implantable device or implant. [Figure 94] FIG. 94 shows a top view of the frame of FIG. [Figure 95] FIG. 95 is a front view of one embodiment of a connection mechanism between a rigid inner portion and a flexible outer portion of a paddle frame. [Figure 96] FIG. 96 is a perspective view of the paddle frame assembly of FIG. 95. [Figure 97] FIG. 97 is a top view of the paddle frame assembly of FIG. [Figure 98] FIG. 98 is a side view of the paddle frame assembly of FIG. [Figure 99] FIG. 99 is a rear view of the paddle frame assembly of FIG. [Figure 100] FIG. 100 is a front view of one embodiment of a connection mechanism between a rigid inner portion and a flexible outer portion of a paddle frame. [Figure 101] FIG. 101 is a side view of the paddle frame assembly of FIG. [Figure 102] FIG. 102 is a rear view of the paddle frame assembly of FIG. [Figure 103] FIG. 103 is a front view of an embodiment of a connection between a rigid inner portion and a flexible outer portion of a paddle frame. [Figure 104] FIG. 104 is a side view of the paddle frame of FIG. [Figure 105] FIG. 105 is a perspective view of the paddle frame of FIG. [Fig. 106] FIG. 106 is a front view of an embodiment of a connection between a rigid inner portion and a flexible outer portion of a paddle frame. [Figure 107] FIG. 107 is a perspective view of the paddle frame assembly of FIG. [Figure 108A] FIG. 108A shows an embodiment of a cap engaged with a paddle. [Figure 108B] FIG. 108B shows a close-up of the cap of FIG. 108A without the paddle. [Figure 108C] FIG. 108C is a perspective view of the cap and paddle shown in FIG. 108A. [Fig. 108D] FIG. 108D is a cross-sectional view showing deflection of the paddle caused by various degrees of containment of the paddle within the cap. [Figure 108E] FIG. 108E is a perspective view showing the degree of deflection of FIG. 108D. [Fig. 108F] FIG. 108F is a schematic diagram showing a configuration in which the paddles are simultaneously biased by a housing coupled within the cap. [Figure 108G] FIG. 108G is a perspective view of the cap and paddle assembly. [Figure 109A] FIG. 109A is a partial cross-sectional view of the adjustable paddle assembly. [Figure 109B] FIG. 109B is a perspective view of the adjustable paddle assembly of FIG. 109A. [Figure 109C] FIG. 109C is a cross-sectional view of the adjustable paddle assembly of FIG. 109B. [Fig. 109D] FIG. 109D is a cross-sectional view of the adjustable paddle assembly of FIG. 109B. [Figure 109E] FIG. 109E is a side view of the adjustable paddle assembly of FIG. 109B. [Fig. 109F] FIG. 109F is a side view of the adjustable paddle assembly showing the paddle in a first actuated position. [Figure 109G] FIG. 109G is a side view of the adjustable paddle assembly showing the paddle in a second actuated position. [Fig. 109H] FIG. 109H is a side view of the adjustable paddle assembly showing the paddle in a third actuated position. [Figure 110A] FIG. 110A is a side perspective view of the adjustable paddle assembly. [Figure 110B] FIG. 110B is a side view of the adjustable paddle assembly of FIG. 110A. [Figure 110C] FIG. 110C is a front view of the adjustable paddle assembly of FIG. 110A. [Figure 110D] 110D and 110E show the use of the adjustable paddle assembly of FIG. 110A within a valve repair device or implant. [Figure 110E] Same as above. [Fig. 111A] FIG. 111A shows one embodiment of a paddle structure made from sheet material. [Fig. 111B] FIG. 111B is a side view of the paddle structure of FIG. 111A. [Figure 111C] FIG. 111C is a top view of the paddle structure of FIG. 111A. [Fig. 111D] FIG. 111D is a bottom view of the paddle structure of FIG. 111A. [Figure 111E] FIG. 111E is another side view of the paddle structure of FIG. 111A. [Fig. 111F] FIG. 111F shows details of an embodiment of the paddle structure of FIG. 111A with lacing holes. [Figure 111G] FIG. 111G is a top view of the flat material used to create the paddle structure of FIG. 111A. [Fig. 111H] FIG. 111H illustrates one embodiment of a valve repair device or implant including the paddle structure of FIG. 111A in a fully retracted position. [Fig. 111I] FIG. 111I shows the valve repair device or implant of FIG. 111H with the paddle structure in a partially open position. [Fig. 111J] FIG. 111J shows the valve repair device or implant of FIG. 111H with the paddle structures in a laterally extended or laterally open position. [Fig. 112A] FIG. 112A is a perspective view of one embodiment of a valve repair device or implant with a compressible outer paddle portion. [Fig. 112B] FIG. 112B is a perspective view of a paddle of the valve repair device or implant shown in FIG. 112A. [Figure 113] FIG. 113 shows a perspective view of one embodiment of a paddle frame connector and width adjustment device for an implantable device. [Fig. 114] 114 shows a perspective cross-sectional view of the paddle frame connector and width adjustment device of FIG. 113. FIG. [Figure 115] 115 shows a front cross-sectional view of the paddle frame connector and width adjustment device of FIG. 113. FIG. [Fig. 116] 116 shows a bottom view of the paddle frame connector and width adjuster of FIG. 113. FIG. [Figure 117] FIG. 117 shows a front cross-sectional view of one embodiment of a paddle frame connector and width adjustment device for an implantable device. [Figure 118] FIG. 118 shows a front cross-sectional view of the paddle frame connector and width adjustment device of FIG. 117 with the delivery device actuation element attached to the receiver of the width adjustment device and the width adjustment element attached to the paddle frame coupler. [Figure 119]FIG. 119 illustrates a perspective cross-sectional view of the paddle frame connector of FIG. [Figure 120] FIG. 120 shows a top view of the receiver of the width adjustment device of FIG. [Figure 121] 121 shows a front cross-sectional view of the paddle frame connector and width adjustment device of FIG. 117 without the width adjustment and actuation elements of FIG. [Figure 122] 122 shows a front cross-sectional view of the paddle frame connector and width adjustment device of FIG. 117 with the width adjustment element and actuation element of FIG. [Figure 123] 123-125 show various views of one embodiment of a connection between an actuating element of an implantable device and a component of the implantable device. [Figure 124] Same as above. [Fig. 125] Same as above. [Fig. 126] 126-128 show various views of the connection between the working element and a component of the implantable device of FIGS. 123-125, where the working element has been moved proximally relative to the implantable device. [Figure 127] Same as above. [Figure 128] Same as above. [Figure 129] 129-131 show various views of the coupling between the working elements and components of the implantable device of FIGS. 123-125, where the working elements are decoupled from the implantable device. [Fig. 130] Same as above. [Fig. 131] Same as above. [Fig. 132] FIG. 132 is a front view of an exemplary coupling between an actuating element of an implantable device and a component of the implantable device, with a width adjustment element extending through the actuating element and into the implantable device. [Fig. 133] FIG. 133 illustrates the coupling between the actuating element of FIG. 132 and a component of the implantable device, where the width adjustment element has been moved proximally relative to the actuating element. [Fig. 134]FIG. 134 illustrates the coupling between the actuating element of FIG. 132 and a component of the implantable device, where the width adjustment element has been moved proximally relative to the actuating element. [Fig. 135] FIG. 135 illustrates the coupling between the working element of FIG. 132 and a component of the implantable device, with the working element being decoupled from the implantable device. [Fig. 136] FIG. 136 shows a perspective view of one embodiment of a coupler between a paddle frame connector and a width adjustment element of an implantable device. [Fig. 137] FIG. 137 shows a front cross-sectional view of one embodiment of the coupler of FIG. [Figure 138] FIG. 138 shows a side view of the coupler of FIG. [Figure 139] FIG. 139 shows a partial front view of the paddle frame connector of FIG. [Fig. 140] FIG. 140 shows a front cross-sectional view of one embodiment of a paddle frame connector and width adjustment device for an implantable device. [Fig. 141] FIG. 141 illustrates one embodiment of a coupler for connecting with an exemplary width adjustment element for the width adjustment device of FIG. [Fig. 142] 142 is a cross-sectional view of one embodiment of a receiver for the width adjustment device of FIG. 140 with a distal portion of the actuation shaft of FIG. 141 moving through the receiver. [Fig. 143] FIG. 143 shows a front perspective view of one embodiment of an implantable device having a cover. [Fig. 144] FIG. 144 shows a bottom perspective view of the implantable device of FIG. [Fig. 145] FIG. 145 is a partial schematic cross-sectional view of the implantable device of FIG. 143 taken along the plane indicated by line 145A-145A shown in FIG. 143, illustrating an exemplary paddle frame and cover of the implantable device. [Fig. 146] FIG. 146 is a partial schematic cross-sectional view of the implantable device of FIG. 143 taken along the plane indicated by line 146B-146B shown in FIG. 143, illustrating an exemplary paddle frame and cover of the implantable device. [Fig. 147] FIG. 147 shows a front view of one embodiment of an implantable device having a cover. [Fig. 148] FIG. 148 shows a side view of the implantable device of FIG. [Figure 149] FIG. 149 is a partial cross-sectional view of the implantable device of FIG. 147 taken along the plane indicated by line 149A-149A shown in FIG. 147, illustrating an exemplary paddle frame and cover of the implantable device. [Fig. 150] FIG. 150 is a partial schematic cross-sectional view of the implantable device of FIG. 147 taken along the plane indicated by line 150B-150B shown in FIG. 147, illustrating an exemplary paddle frame and cover of the implantable device. [Fig. 151] FIG. 151 shows a front view of one embodiment of an implantable device having a cover. [Fig. 152] FIG. 152 is a partial schematic cross-sectional view of the implantable device of FIG. 151 taken along the plane indicated by line 152A-152A shown in FIG. 151, illustrating an exemplary paddle frame and cover of the implantable device. [Fig. 153] FIG. 153 is a partial schematic cross-sectional view of the implantable device of FIG. 151 taken along the plane indicated by line 153B-153B shown in FIG. 151, illustrating an exemplary paddle frame and cover of the implantable device. [Fig. 154] FIG. 154 shows a front perspective view of one embodiment of an implantable device having a cover. [Fig. 155] FIG. 155 is a partial schematic cross-sectional view of the implantable device of FIG. 154 taken along the plane indicated by line 155A-155A shown in FIG. 154, illustrating an exemplary paddle frame and cover of the implantable device. [Fig. 156] FIG. 156 is a partial schematic cross-sectional view of the implantable device of FIG. 154 taken along the plane indicated by line 156B-156B shown in FIG. 154, illustrating an exemplary paddle frame and cover of the implantable device. [Fig. 157] FIG. 157 shows a front cross-sectional view of one embodiment of an implantable device having a cover. [Fig. 158] FIG. 158 shows a side view of the implantable device of FIG. [Fig. 159] FIG. 159 shows a bottom view of the implantable device of FIG. [Fig. 160] FIG. 160 is a partial schematic cross-sectional view of the implantable device of FIG. 157 taken along the plane indicated by line 160A-160A shown in FIG. 157, illustrating an exemplary paddle frame and cover of the implantable device. [Fig. 161] FIG. 161 is a partial schematic cross-sectional view of the implantable device of FIG. 157 taken along the plane indicated by line 161B-161B shown in FIG. 157, illustrating an exemplary paddle frame and cover of the implantable device. [Fig. 162] FIG. 162 shows a front cross-sectional view of one embodiment of an implantable device having a cover. [Fig. 163] FIG. 163 shows a side perspective view of the implantable device of FIG. [Fig. 164] FIG. 164 is a partial schematic cross-sectional view of the implantable device of FIG. 162 taken along the plane indicated by line 164A-164A shown in FIG. 162, illustrating an exemplary paddle frame and cover of the implantable device. [Fig. 165] FIG. 165 is a partial schematic cross-sectional view of the implantable device of FIG. 162 taken along the plane indicated by line 165B-165B shown in FIG. 162, illustrating an exemplary paddle frame and cover of the implantable device. [Fig. 166] FIG. 166 shows a front view of one embodiment of an implantable device having a cover. [Fig. 167] FIG. 167 shows a side perspective view of the implantable device of FIG. [Fig. 168] FIG. 168 is a partial cross-sectional view of the implantable device of FIG. 166 taken along the plane indicated by line 168A-168A shown in FIG. 166, illustrating an exemplary paddle frame and cover of the implantable device. [Fig. 169]FIG. 169 is a partial schematic cross-sectional view of the implantable device of FIG. 166 taken along the plane indicated by line 169B-169B shown in FIG. 166, illustrating an exemplary paddle frame and cover of the implantable device. [Fig. 170] FIG. 170 shows a perspective view of an exemplary implantable device. [Fig. 171] FIG. 171 shows a top view of the implantable device of FIG. [Fig. 172] FIG. 172 shows a side view of the implantable device of FIG. [Fig. 173] 173 shows a side view of the coaptation element of the implantable device of FIG. [Fig. 174] FIG. 174 shows a front view of the interface element of FIG. [Fig. 175] FIG. 175 shows a bottom view of the interface element of FIG. [Fig. 176] FIG. 176 shows a side view of the interface element of FIG. [Fig. 177] 177 shows a front cross-sectional view of the interface element of FIG. 173 taken along the plane indicated by line 177-177 shown in FIG. [Fig. 178] FIG. 178 illustrates a perspective view of an exemplary paddle connected to the interface element of FIG. [Fig. 179] FIG. 179 shows a front cross-sectional view of an exemplary implantable device having an exemplary coupler for connecting an exemplary width adjustment element to an adjustable width paddle of the implantable device. [Fig. 180] FIG. 180 shows a partial perspective view of the coupler of FIG. 179 connecting a width adjustment element to an adjustable width paddle of an implantable device. [Fig. 181] 181 shows a partial cross-sectional view of the connection between the width adjustment member and the coupler of the implantable device of FIG. [Fig. 182] FIG. 182 shows a partial cross-sectional view of the connection between the coupler and width adjustment member of FIG. [Fig. 183] FIG. 183 shows a front perspective view of the connection between the coupler and width adjustment member of FIG. [Fig. 184]FIG. 184 shows a side perspective view of the connection between the coupler and width adjustment member of FIG. [Fig. 185] FIG. 185 shows a front cross-sectional view of an exemplary implantable device having an exemplary coupler for connecting an exemplary width adjustment member to an adjustable width paddle of the implantable device. [Fig. 186] FIG. 186 shows a perspective cross-sectional view of the implantable device and width adjustment member of FIG. [Fig. 187] FIG. 187 shows a front cross-sectional view of the implantable device of FIG. 185 with a connection between the coupler and the width adjustment member. [Fig. 188] FIG. 188 shows a cutaway front view of the coupler of FIG. 185 connected with a width adjustment member. [Fig. 189] FIG. 189 shows a cutaway perspective view of the coupler of FIG. 185 connected to a width adjustment member. [Fig. 190] FIG. 190 shows a perspective cross-sectional view of the coupler of FIG. 185 connected to a width adjustment member. [Fig. 191] FIG. 191 shows a cutaway front view of the coupler of FIG. 185 separated from the width adjustment members. [Fig. 192] FIG. 192 shows a cutaway perspective view of the coupler of FIG. 185 separated from the width adjustment members. [Fig. 193] FIG. 193 shows a perspective cross-sectional view of the coupler of FIG. 185 separated from the width adjustment member. [Fig. 194] FIG. 194 is a front cross-sectional view showing the engagement between the coupler and receiver of the implantable device of FIG. 185 when the width adjustment member is separated from the coupler. [Fig. 195] FIG. 195 shows a perspective view of the engagement between the coupler and receiver of the implantable device shown in FIG. [Fig. 196] FIG. 196 illustrates a perspective view of another exemplary coupler, with the coupler in a locked position. [Figure 197] FIG. 197 shows a perspective view of the coupler of FIG. 196, the coupler being in an unlocked position. [Figure 198] FIG. 198 shows a left side view of the coupler of FIG. 196, with the coupler in the unlocked position. [Figure 199] FIG. 199 illustrates a right side view of the coupler of FIG. 196 with the coupler mechanism in the unlocked position. [Figure 200] FIG. 200 shows a top view of the coupler of FIG. 196, with the coupler in a locked position. [Figure 201] FIG. 201 shows a front view of the coupler of FIG. 196, with the coupler in a locked position. [Fig. 202] FIG. 202 illustrates an exemplary sheet material for manufacturing the coupler of FIG. [Fig. 203] FIG. 203 shows a front cross-sectional view of an exemplary implantable device having an exemplary coupler for connecting an exemplary width adjustment element to an adjustable width paddle of the implantable device. [Fig. 204] FIG. 204 is a front cross-sectional view showing the engagement between the coupler and receiver of the implantable device of FIG. 203 when the width adjustment element is separated from the coupler. [Fig. 205] FIG. 205 shows a front cross-sectional view of an exemplary implementation of the implantable device of FIG. 203, where the receiver has a non-threaded portion that, when within the non-threaded portion, prevents or inhibits the coupler from being attached to the receiver. [Fig. 206] FIG. 206 shows a front cross-sectional view of another exemplary implementation of the implantable device of FIG. 203, in which the receiver has a window or opening that, when within the window or opening, prevents or inhibits the coupler from being attached to the receiver. [Fig. 207] FIG. 207 shows a cutaway front view of a portion of the implantable device of FIG. 205, where the coupler is connected to a width adjustment element and disposed within the non-threaded portion of the receiver. [Fig. 208] FIG. 208 shows a cutaway front view of a portion of the implantable device of FIG. 205 with the coupler disconnected from the width adjustment element and placed within the non-threaded portion of the receiver. [Fig. 209] 209 and 210 show an exemplary coupler with the exemplary posts of the coupler in a substantially straight configuration and the coupler in an unlocked position. [Fig. 210] Same as above. [Figure 209A]209A and 210A show the coupler of FIGS. 209 and 210 with the coupler posts in a fully straight configuration and the coupler in an unlocked position. [Figure 210A] Same as above. [Fig. 211] 211 and 212 show the coupler of FIGS. 209 and 210 with the struts in a helical or rotationally offset configuration and the coupler in a locked position. [Fig. 212] Same as above. [Fig. 213] FIG. 213 illustrates a perspective view of an exemplary coupler, with the coupler in an unlocked position. [Fig. 214] FIG. 214 shows a top view of the coupler of FIG. 213, with the coupler in a locked position. [Fig. 215] FIG. 215 shows a perspective view of an exemplary implantable device. [Fig. 216] FIG. 216 shows a bottom view of the implantable device of FIG. [Fig. 217] FIG. 217 shows a perspective view of the implantable device of FIG. 215 with a covering element attached to a distal portion of the implantable device. [Fig. 218] FIG. 218 shows a front view of an implantable device with the cover element of FIG. [Fig. 219] FIG. 219 shows a bottom view of the implantable device with the cover element of FIG. [Fig. 220] FIG. 220 shows a top view of an exemplary covering for attachment to an implantable device, the exemplary covering including a stretchable portion. [Fig. 221] FIG. 221 shows a plan view of a portion of the stretchable portion for the cover of FIG. [Fig. 222] FIG. 222 shows a plan view of an exemplary plain weave of the cover of FIG. [Fig. 223] FIG. 223 shows a plan view of a portion of the cover of FIG. 220, with the expandable portion in a preheated state. [Fig. 224] FIG. 224 shows a plan view of a portion of the cover of FIG. 220 with the expandable portion in a post-heated state. [Fig. 225] FIG. 225 shows a top view of an exemplary cover having an extendable portion attached to a paddle frame of an implantable device, with the paddle frame in an extended position and the cover in an extended position. [Fig. 226] FIG. 226 shows the cover attached to the paddle frame of FIG. 225 with the paddle frame in the constricted position and the cover in the normal position. [Fig. 227] FIG. 227 illustrates an exemplary cover attached to a paddle frame of an implantable device, with the paddle frame in a stenosed position. [Fig. 228] FIG. 228 illustrates an exemplary cover attached to a paddle frame of an implantable device, with the paddle frame in a stenosed position. [Fig. 229] FIG. 229 illustrates a front view of an exemplary implantable device, with the paddle frame of the implantable device in a fully expanded position. [Fig. 230] FIG. 230 shows a front view of the implantable device of FIG. 229 with the paddle frame in a first position between the fully expanded position and the fully constricted position. [Fig. 231] FIG. 231 shows a front view of the implantable device of FIG. 229 with the paddle frame in a second position between the fully expanded and fully constricted positions. [Fig. 232] FIG. 232 is a front view of the implantable device of FIG. 229, with the paddle frame in the full stenosis position. [Fig. 233] FIG. 233 shows a top view of the native valve with the implantable device of FIG. 229 attached, with the paddle frame in the fully expanded position shown in FIG. [Fig. 234] FIG. 234 shows a front view of an exemplary implantable device with the paddle frame in a fully extended position. [Fig. 235] FIG. 235 shows a top view of the implantable device of FIG. 234, with the paddle frame in a constricted position. [Fig. 236] FIG. 236 shows a top view of a native valve with the implantable device of FIG. 234 attached thereto, with the paddle frame in the fully expanded position shown in FIG. [Fig. 237] FIG. 237 shows a perspective view of an exemplary paddle frame for the implantable device of FIG. [Fig. 238] FIG. 238 shows a top view of the paddle frame of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0117] In the following description, reference is made to the accompanying drawings which illustrate exemplary implementations of the present disclosure. Other implementations having different structure and operation do not depart from the scope of the present disclosure.

[0118] Exemplary implementations of the present disclosure are directed to systems, devices, methods, etc., for repairing defective heart valves. For example, some implementations of implantable devices, valve repair devices, implants, and systems (including systems for delivering them) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or physically impossible. Furthermore, the techniques and methods herein can be performed on live animals or can be performed on simulations, such as cadavers, cadaver hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0119] As described herein, when one or more components are described as being connected, joined, fastened, coupled, attached, or otherwise interconnected, such interconnection may be direct, such as between the components, or may be indirect, such as through the use of one or more intermediate components. Also, references to a "member," "component," or "portion" described herein are not limited to a single structural member, component, or element, but may include an assembly of components, members, or elements. Also, as used herein, the terms "substantially" and "about" are defined as at least close to (and including) a given value or condition (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0120] 1 and 2 are cross-sectional views of a human heart H during diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, i.e., atrioventricular valves, respectively. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in Figs. 3-6 and leaflets 30, 32, 34 shown in Fig. 7) that extend inwardly across their respective valve openings, which come together or "coapt" in flow to form a unidirectional fluid occlusion surface. The native valve repair system of the present application is frequently described and / or illustrated with respect to the mitral valve MV. Accordingly, the anatomy of the left atrium LA and the left ventricle LV will be described in more detail. However, the devices described herein may also be used in the repair of other native valves, for example, the devices may be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0121] The left atrium LA receives oxygen-rich blood from the lungs. During the expansion phase, or diastole, seen in FIG. 1, blood already collected in the left atrium LA (during the contraction phase) moves through the mitral valve MV into the left ventricle LV due to the expansion of the left ventricle LV. During the contraction phase, or systole, seen in FIG. 2, the left ventricle LV contracts to pump blood into the body through the aortic valve AV and the ascending aorta AA. During systole, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV into the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In some implementations, the device described in this application is used to restore the function of a defective mitral valve MV. That is, the device is configured to assist in the closing of the leaflets of the mitral valve to prevent or inhibit blood from flowing back from the left ventricle LV into the left atrium LA. Many of the devices described in this application are designed to easily grasp and secure the native valve leaflets around a coaptation element or spacer that beneficially acts as a filler in the regurgitant opening to prevent or reduce backflow or regurgitation during systole, although this is not required.

[0122] Now, referring to Figures 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24 (see Figure 5), which is a variably dense fibrous ring of tissue that surrounds the leaflets 20, 22. Referring to Figures 3 and 4, the mitral valve MV is fixed to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., muscles located in the wall of the left ventricle LV at the base of the chordae tendineae CT) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM function to limit the movement of the leaflets 20, 22 of the mitral valve MV and to prevent the mitral valve MV from everting. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Rather, the papillary muscles PM support or brace the leaflets 20, 22 against the high pressures required to circulate blood throughout the body. Together, the papillary muscles PM and chordae tendineae CT are known as the subvalvular tissue, which function to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As can be seen from the left ventricular outflow tract (LVOT) diagram shown in Figure 3, the anatomy of the leaflets 20, 22 is such that the inner surfaces of the leaflets coapt at their free ends and the leaflets 20, 22 begin to retract or spread apart from one another. The leaflets 20, 22 spread apart toward the atrium until each leaflet contacts the mitral valve annulus.

[0123] Various disease processes can impair the proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's disease, elastic fiber deficiency, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or right ventricle RV from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathies, etc.) can distort the shape of the native valve, which can cause the native valve to malfunction. However, the majority of patients who undergo valve surgery, such as mitral valve MV surgery, suffer from a degenerative disease that causes the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV) to malfunction, resulting in prolapse and regurgitation.

[0124] In general, native valves can malfunction in different ways, including (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when a native valve does not open completely, thereby causing impaired blood flow. Typically, valve stenosis is due to the accumulation of calcified material on the leaflets of the valve, which thickens the leaflets and impairs the ability of the valve to open completely to allow forward blood flow. Valve regurgitation occurs when the leaflets of the valve do not close completely, thereby causing blood to leak back into the previous heart chamber (e.g., blood leaks from the left ventricle into the left atrium).

[0125] There are three main mechanisms by which native valves become regurgitant or incompetent, including Carpentier's Type I, II, and III insufficiencies. Carpentier's Type I insufficiency involves dilatation of the valve annulus, so that normally functioning leaflets move apart and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in the insufficiency of the Type I mechanism is leaflet perforation, as occurs in endocarditis. Carpentier's Type II insufficiency involves prolapse of one or more leaflets of the native valve above the plane of coaptation. Carpentier's Type III insufficiency involves restriction of the movement of one or more leaflets of the native valve, so that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease or ventricular dilatation.

[0126] With reference to FIG. 5, when a healthy mitral valve MV is in a closed position, the anterior leaflets 20 and posterior leaflets 22 coapt, thereby preventing blood from leaking from the left ventricle LV into the left atrium LA. With reference to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflets 20 and / or posterior leaflets 22 of the mitral valve MV are displaced into the left atrium LA during systole, such that the edges of the leaflets 20, 22 do not contact one another. This failure to coapt creates a gap 26 between the anterior leaflets 20 and posterior leaflets 22, which allows blood to flow regurgitantly from the left ventricle LV into the left atrium LA during systole, as shown by the mitral regurgitation MR flow path in FIG. 3. With reference to FIG. 6, the gap 26 may have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some circumstances, the gap 26 may have a width W of greater than 15 mm or even greater than 17.5 mm. As discussed above, there are several different ways in which a valve leaflet (e.g., the leaflets 20, 22 of the mitral valve MV) may become incompetent, causing valve regurgitation.

[0127] In any of the above situations, a valve repair device or implant that can engage the anterior leaflets 20 and posterior leaflets 22 and close the gap 26 to prevent or inhibit backflow of blood through the mitral valve MV is desirable. As can be seen from FIG. 4, an abstract representation of an implantable device, valve repair device, or implant 10 is shown implanted between the leaflets 20, 22 such that no backflow occurs during systole (compare FIG. 3 with FIG. 4). In some implementations, the coaptation elements (e.g., spacers, plugs, fillers, foams, sheets, membranes, coaptation elements, wedges, barriers, balloons, etc.) of the device 10 have a generally tapered or triangular shape that naturally matches the shape of the native valve and its tendency to expand (towards the annulus). In this application, terms such as spacer, coaptation element, and gap filler are used interchangeably and refer to elements that are configured to fill a portion of the space between the leaflets of the native valve and / or to cause the leaflets of the native valve to engage or "coapt" (e.g., so that the native leaflets coapt not only to each other but also to the coaptation element, spacer, etc.).

[0128] Although stenosis or regurgitation can affect any valve, stenosis has been found to primarily affect either the aortic valve AV or the pulmonary valve PV, and regurgitation has been found to primarily affect either the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the burden on the heart H and, if left untreated, can lead to very serious conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. The left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) is primarily responsible for circulating blood flow throughout the body. Therefore, since pressures are substantially higher in the left side of the heart, insufficiency of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening.

[0129] Dysfunctional native heart valves can be either repaired or replaced. Repair typically involves maintaining and correcting the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Since the stenotic damage sustained by the valve leaflets is irreversible, treatment for a stenotic aortic valve or pulmonary valve can be removal of the valve and replacing it with a surgically implanted heart valve, or replacing it with a transcatheter heart valve. The mitral valve MV and tricuspid valve TV are more prone to deformation of the leaflets and / or surrounding tissue, which, as described above, prevents the mitral valve MV or tricuspid valve TV from closing properly and allows regurgitation or backflow of blood from the ventricle into the atrium (e.g., deformation of the mitral valve MV can allow regurgitation or backflow from the left ventricle LV into the left atrium LA, as shown in FIG. 3). Regurgitation or backflow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. In addition, regurgitation can occur due to incompetence of the chordae tendineae CT (e.g., the chordae tendineae CT can stretch or rupture), allowing the anterior leaflet 20 and the posterior leaflet 22 to evertate, resulting in blood flowing back into the left atrium LA. Problems caused by incompetent chordae tendineae CT can be repaired by repairing the structure of the chordae tendineae CT or the mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0130] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it is understood that the devices and concepts provided herein can be used to repair any native valve, as well as to repair any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit backflow of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts provided herein can be used between any two of the anterior leaflet 30, the septal leaflet 32, and the posterior leaflet 34 to prevent or inhibit backflow 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 backflow of blood from the right ventricle into the right atrium. That is, the valve repair device or implant provided herein can be centrally located between the three leaflets 30, 32, 34.

[0131] An exemplary implantable device or implant may optionally have a coaptation element (e.g., a spacer, plug, filler, foam, sheet, membrane, coaptation element, wedge, barrier, balloon, etc.) and at least one anchor (e.g., one, two, three or more). In some implementations, an implantable device or implant may have any combination or subcombination of the features disclosed herein without a coaptation element. The coaptation element, if included, is configured to be positioned within the native heart valve opening to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting the above-mentioned backflow. The coaptation element may be impermeable to blood (or resist blood flow therethrough) and may have a structure that allows the native leaflets to close around the coaptation element during ventricular systole, thereby blocking backflow of blood from the left or right ventricle into the left or right atrium, respectively. The device or implant may be configured to seal against two or three native valve leaflets, i.e., the device may be used with native mitral (bicuspid) and native tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element may fill the space between native valve leaflets (e.g., mitral leaflets 20, 22 or tricuspid leaflets 30, 32, 34) that do not close completely or function properly.

[0132] The optional coaptation elements (e.g., spacers, coaptation elements, etc.) may have a variety of shapes. In some implementations, the coaptation elements may have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the coaptation elements may have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some implementations, the coaptation elements may have an atrial portion positioned in or adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a lateral surface extending between the native leaflets. In some implementations configured for use with a tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the lateral surface extends between the native tricuspid leaflets.

[0133] In some implementations, the anchors can be configured to secure the device to one or both of the native leaflets such that the coaptation element is positioned between two native leaflets. In some implementations configured for use with a tricuspid valve, the anchors can be configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between three native leaflets. In some implementations, the anchors can be attached to the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some implementations, the anchors can be attached to an actuating element, such as a shaft or actuation wire, to which the coaptation element is also attached. In some implementations, the anchors and coaptation elements can be positioned independently relative to one another by separately moving each of the anchors and coaptation elements along a longitudinal axis of the actuating element (e.g., actuating shaft, actuating rod, actuating tube, actuating wire, etc.). In some implementations, the anchors and coaptation elements can be positioned simultaneously by moving the anchors and coaptation elements together along a longitudinal axis of the actuating element, such as a shaft, actuating wire, etc. The anchors can be configured to be positioned behind the native leaflets when implanted such that the leaflets are gripped by the anchors.

[0134] The device or implant may be configured to be implanted via a delivery system or other delivery means. The delivery system may include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, and the like. The coaptation element and anchor may be compressible to a radially compressed state and may be self-expandable to a radially expanded state when the compressive pressure is released. The device may be configured such that the anchor is expanded radially away from the initially still compressed coaptation element to create a gap between the coaptation element and the anchor. The native leaflet may then be positioned within the gap. The coaptation element may be expanded radially to close the gap between the coaptation element and the anchor to capture the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to be self-expanding. The implantation methods for various implementations may vary and are described more fully below for each implementation. Additional information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599, U.S. Patent Application Publication No. 2014 / 0222136, U.S. Patent Application Publication No. 2014 / 0067052, U.S. Patent Application Publication No. 2016 / 0331523, and PCT Patent Application Publication No. WO2020 / 076898, which are incorporated by reference in their entirety for all purposes. These methods can be performed, mutatis mutandis, on live animals or can be performed on simulations, such as cadavers, cadaver hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0135] The disclosed device or implant may be configured such that anchors are connected to the leaflets and utilize tension from the natural chordae tendineae to resist the large systolic pressures that urge the device toward the left atrium. During diastole, the device may rely on compressive and retaining forces exerted against the leaflets that are gripped by the anchors.

[0136] 8-15, a schematic representation of an implantable device or implant 100 (e.g., an implantable prosthetic device, an artificial spacer device, a valve repair device, etc.) is shown in various stages of deployment. The device or implant 100, as well as other similar devices / implants, are described in more detail in PCT Patent Application Publication Nos. WO2018 / 195215, WO2020 / 076898, and WO2019 / 139904, which are incorporated by reference in their entireties. The device 100 may include any other features of another implantable device or implant described in this application or the applications cited above, and the device 100 may be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the applications cited above).

[0137] The device or implant 100 is deployed from a delivery system or other delivery means 102. The delivery system 102 may include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a passageway, combinations thereof, etc. The device or implant 100 includes an interface portion / region 104 and an anchor portion / region 106.

[0138] In some implementations, the interface portion 104 of the device or implant 100 is adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and includes an interface element or interface means 110 (e.g., spacer, plug, filler, foam, sheet, membrane, interface element, wedge, barrier, etc.) 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 actuable between an open state and a closed state and can take a wide variety of forms, such as, for example, paddles, gripping members, or the like. Actuation of the actuation element 112 causes the anchor portion 106 of the device 100 to open and close and grip the leaflets of the native valve during implantation. The actuation element 112 (as well as other actuation means and elements disclosed herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, threads, sutures, lines, strips, combinations thereof, etc.), can be made from a variety of different materials, and can have a variety of configurations. As one example, the actuation element can be threaded such that rotational actuation of the actuation element moves the anchor portion 106 relative to the interface portion 104. Alternatively, the actuation element can be unthreaded such that pushing or pulling actuation of the actuation element 112 moves the anchor portion 106 relative to the interface portion 104.

[0139] The anchor portion 106 and / or anchor of the device 100, in some implementations, includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the interface element 110 by portions 124, 126, 128. The portions 124, 126, 128 may be articulated and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 120, inner paddle 122, interface element 110, and cap 114 by portions 124, 126, 128 may constrain the device to the positions and movements shown herein.

[0140] In some implementations, the delivery system 102 includes a steerable catheter, an implant catheter, and an actuation means or element 112 (e.g., actuation wire, actuation shaft, etc.), which may be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuation means or element 112 extends through the delivery catheter and the interface element 110 to a distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuation element 112 increases and decreases the spacing between the interface element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), respectively. In some implementations, a collar or other attachment element removably attaches, either directly or indirectly, the interface element 110 to the delivery system 102 such that an actuation means or element 112 slides through the collar or other attachment member, and in some implementations, through the interface element 110 during actuation, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0141] In some implementations, the anchor portion 106 and / or the anchor 108 may include an attachment portion or gripping member. In some implementations, as shown, the gripping member may include a catch 130 including a base or fixed arm 132, a movable arm 134, optional barbs, friction enhancing elements or other fastening means 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and an interface portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 with the interface portion 138 disposed proximate to the interface element 110. The interface portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the catch 130. The interface portion 138 may be any suitable interface, such as a flexible interface, a spring interface, a pivot interface, or the like. In some implementations, interface 138 is a flexible piece of material integrally formed with fixed arm 132 and movable arm 134. Fixed arm 132 is attached to inner paddle 122 and remains stationary or substantially stationary relative to inner paddle 122 when movable arm 134 is in an open state, opening clasp 130 and exposing optional barbs, friction enhancing members or fastening means 136.

[0142] In some implementations, the clasp 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, thereby causing the movable arm 134 to articulate, bend or pivot on a joint 138. The actuation line 116 extends through the delivery system 102 (e.g., through the steerable catheter and / or the implant catheter). Other actuation mechanisms are also possible.

[0143] The actuation line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The clasp 130 can be spring loaded so that the clasp 130 continues to provide a clamping force against the grasped native leaflet in the closed position. Optional barbs, friction enhancing members, or other securing means 136 of the clasp 130 can grasp, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0144] The paddles 120, 122 may be opened and closed during implantation, for example, to grip the native leaflets (such as the leaflets of a native mitral valve) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation element 110 (spacer, plug, filler, foam, sheet, membrane, coaptation element, wedge, barrier, etc.). The clasps 130 may be used to grip 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 movable arm 134 and the fixed arm 132. The barbs or other friction enhancing elements 136 (e.g., projections, ridges, grooves, textured surfaces, adhesives, etc.) of the clasps 130 may increase friction with the leaflets or partially or completely puncture the leaflets. The actuation lines 116 may be actuated separately such that each clasp 130 may be opened and closed separately. Acting separately allows one leaflet to be grasped at a time, or the clasp 130 to be repositioned on a leaflet that was not adequately grasped without changing the good grip on the other leaflets. The clasp 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), allowing the leaflets to be grasped in various positions as the particular situation requires.

[0145] 8, the device 100 is shown in an extended or fully open state for deployment from an implant delivery catheter of a delivery system 102. The device 100 is placed at the end of the catheter of the delivery system 102 in the fully open position. In the extended state, the cap 114 is spaced from the interface element 110 such that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the interior of the outer paddle 120 and the inner paddle 122 is about 180 degrees. The clasp 130 can be held in a closed state during deployment through the delivery system. The actuation line 116 can extend to and be attached to a movable arm 134.

[0146] 9, device 100 is shown in an extended state similar to FIG. 8, but with clasp 130 in a range of about 140 degrees to about 200 degrees, in a range of about 170 degrees to about 190 degrees, or in a fully open position of about 180 degrees between fixed portion 132 and movable portion 134 of clasp 130.

[0147] 10, the device 100 is shown in a contracted or fully closed state. To move the device 100 from the extended state to the contracted state, the actuation means or element 112 is retracted, pulling the cap 114 towards the interface element 110. The connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained from moving, so that the compressive force acting on the outer paddle 120 from the cap 114 retracted towards the interface element 110 moves the paddle or gripping member radially outward. The outer paddle 120 maintains an acute angle with the actuation means or element 112 during movement from the open position to the closed position. The outer paddle 120 can optionally be biased towards the closed position. The inner paddle 122 moves over a very large angle and crushes along the side of the closed interface element 110, as it is oriented away from the open interface element 110 during the same movement.

[0148] 11-13, the device 100 is shown in a partially open, ready to grasp state. To move from the fully closed state to the partially open state, an actuation means or element (e.g., actuation wire, actuation shaft, etc.) is extended to push the cap 114 away from the coaptation element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor or anchor portion 106 to partially unfold. The actuation line 116 is also retracted to open the clasp 130, which allows the leaflets to be grasped. In some implementations, the pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation means or single actuation element 112. Also, the position of the clasp 130 depends on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 will close the clasp. In some implementations, the paddles 120, 122 may be independently controllable. For example, in the embodiment shown in FIG. 15, the device 100 may have two actuation elements 111, 113 and two independent caps 115, 117 (or other mounting parts), such that one independent actuation element (e.g., wire, shaft, etc.) and cap (or other mounting part) is used to control one paddle, and the other independent actuation element and cap (or other mounting part) is used to control the other paddle.

[0149] 12, one of the actuation lines 116 can be extended to close one of the clasps 130. Now, referring to FIGURE 13, the other actuation line 116 can be extended to close the other clasp 130. One or both of the actuation lines 116 can be repeatedly actuated to repeatedly open and close the clasps 130.

[0150] 14, the device 100 is shown in a fully closed and deployed state. The delivery system or delivery means 102 and actuation means or actuation element 112 are retracted and the paddles 120, 122 and clasp 130 remain in a fully closed position. Once deployed, the device 100 may be maintained in the fully closed position by a mechanical latch or may be biased to remain closed by the use of a spring material such as steel, other metals, plastics, composites, or a shape memory alloy such as Nitinol. For example, the connecting portions 124, 126, 128, the interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from a metal such as steel or from a shape memory alloy such as Nitinol that is fabricated into a wire, sheet, tube, or laser sintered powder and biased to hold the outer paddle 120 closed around the interface element 110 and the clasp 130 in a clamped state around the native leaflets. Similarly, the fixed and movable arms 132, 134 of the clasp 130 are biased to clamp the valve leaflets. In some implementations, the attachment or connecting portions 124, 126, 128, the interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be made from metal or any other suitable resilient material, such as a polymeric material, to maintain the device 100 in a closed state after implantation.

[0151] Figure 15 shows an embodiment in which the paddles 120, 122 are independently controllable. The device 101 shown in Figure 15 is similar to the device shown in Figure 11, except that the device 100 of Figure 15 includes an actuation element configured as two independent actuation elements or actuation wires 111, 113 coupled to two independent caps 115, 117. The actuation element 111 is extended to push the cap 115 away from the interface element 110 to transition the first inner paddle 122 and the first outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the first anchor 108 to partially expand. The actuation element 113 is extended to push the cap 115 away from the interface element 110 to transition the second inner paddle 122 and the second outer paddle 120 from a fully closed state to a partially open state, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the second anchor 108 to partially expand. The independent paddle control shown in Figure 15 can be implemented in any of the devices disclosed in this application. For comparison, in the embodiment shown in Figure 11, the pair of inner and outer paddles 122, 120 are moved together, rather than independently, by a single actuation element 112.

[0152] 16-21, the implantable apparatus 100 of FIGS. 8-14 is shown delivered and deployed within the native mitral valve MV of the heart H. With reference to FIG. 16, a delivery sheath / catheter is inserted through the septum into the left atrium LA and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state as shown in FIG. 16. The actuating element 112 is then retracted, moving the implant / apparatus to a fully closed state as shown in FIG. 17.

[0153] As can be seen from Figure 18, the implant / device is moved into a position within the mitral valve MV and into the ventricle LV in a partially open state so as to grasp the leaflets 20, 22. For example, a steerable catheter may be advanced to steer or bend the steerable catheter to position it as shown in Figure 18. An implant catheter connected to the implant / device may be advanced from within the steerable catheter to position the implant as shown in Figure 18.

[0154] 19, the implant catheter may be retracted into the steerable catheter to position the mitral valve leaflets 20, 22 within the clasps 130. The actuating line 116 is extended to close one of the clasps 130, capturing the leaflet 20. FIG. 20 shows the other actuating line 116 then being extended to close the other clasp 130, capturing the remaining leaflet 22. Finally, as can be seen from FIG. 21, the delivery system 102 (e.g., steerable catheter, implant catheter, etc.), actuating means or element 112, and actuating line 116 are then retracted and the device or implant 100 is fully closed and deployed within the native mitral valve MV.

[0155] Any of the features disclosed herein may be used in a wide variety of different valve repair devices. Figures 22-24 show examples of valve repair devices that may be modified to include any of the features disclosed herein. Any combination or subcombination of the features disclosed herein may be combined with, substituted for, and / or added to any combination or subcombination of the features of the valve repair devices shown in Figures 8-24.

[0156] 22, an embodiment of an implantable device or implant 200 is shown. The implantable device 200 is one of many different configurations that the device 100, shown generally in FIGS. 8-14, may take. The device 200 may include any of the other features of an implantable device or implant described herein, and the device 200 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system, such as any of the valve repair systems disclosed herein. The device / implant 200 may be an artificial spacer device, a valve repair device, or another type of implant that is attached to the leaflets of a native valve.

[0157] In some implementations, the implantable device or implant 200 includes an interface portion / region 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some implementations, the interface portion 204 of the device optionally includes an interface element 210 (e.g., a spacer, interface element, plug, membrane, sheet, etc.) for implantation between the leaflets of a native valve. In some implementations, the anchor portion 206 includes multiple anchors 208. The anchors may be configured in a variety of ways. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clasp 230. In some implementations, the attachment portion 205 includes a first or proximal collar 211 (or other attachment element) for engaging a capture mechanism of a delivery system. The delivery system for device 200 may be the same as or similar to delivery system 102 described above and may comprise one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, and the like.

[0158] In some implementations, the joint elements 210 and paddles 220, 222 are made from a flexible material, which may be a metal fabric formed as a mesh, woven fabric, braided fabric, or in any other suitable manner, or a flexible material that is laser cut or otherwise cut. The material may be a fabric, a shape memory alloy wire, such as Nitinol, to provide shape setting capabilities, or any other flexible material suitable for implantation within the human body.

[0159] An actuating element (e.g., an actuating shaft, actuating rod, actuating tube, actuating wire, actuating line, etc.) extends from the delivery system to engage and enable actuation of the implantable device or implant 200. In some implementations, the actuating element extends through the proximal collar 211 and the spacer or interface element 210 and engages a cap 214 on the distal portion 207. The actuating element may be configured to releasably engage the cap 214, such as with a threaded connection, such that the actuating element may be disengaged and removed from the device 200 after implantation.

[0160] The coaptation element 210 extends from a proximal collar 211 (or other attachment member) to an inner paddle 222. In some implementations, the coaptation element 210 has a generally elongated, circular shape, although other shapes and configurations are possible. In some implementations, the coaptation element 210 has an elliptical shape or cross-section when viewed from above, a tapered shape or cross-section when viewed from the front, and a circular shape or cross-section when viewed from the side. A mixture of these three geometries may result in the illustrated three-dimensional shape of the coaptation element 210 that achieves the benefits described herein. It may be seen that the circular shape of the coaptation element 210 also substantially follows or approximates the shape of the paddle frame 224 when viewed from above.

[0161] The size and / or shape of the coaptation element 210 may be selected to minimize the number of implants required per patient (preferably one) while maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the apex of the coaptation element is about 5 mm, and the medial-lateral distance at the widest point of the coaptation element is about 10 mm. In some implementations, the overall geometry of the device 200 may be based on these two dimensions and the overall shape plan described above. Using other anterior-posterior and medial-lateral distances as a starting point for the device, it will be readily apparent that the device will have different dimensions. Additionally, using other dimensions and the shape plan described above will also result in the device having different dimensions.

[0162] In some implementations, the outer paddle 220 is joinably attached to the cap 214 of the distal portion 207 by connecting portion 221 and to the inner paddle 222 by connecting portion 223. The inner paddle 222 is joinably attached to the joint element by connecting portion 225. In this manner, the anchor 208 is configured similar to a leg, in that the inner paddle 222 is like an upper portion of a leg, the outer paddle 220 is like a lower portion of a leg, and the connecting portion 223 is like a knee portion of a leg.

[0163] In some implementations, the inner paddle 222 is hard, relatively hard, rigid, has a rigid portion, and / or is rigidified by a reinforcing member or fastening portion of the clasp 230. The inner paddle 222, the outer paddle 220, and the interface elements may all be interconnected as described herein.

[0164] In some implementations, the paddle frame 224 is attached to the cap 214 of the distal portion 207 and extends to a connection 223 between the inner paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is made from a material that is stiffer and harder than the material that forms the paddles 222, 220, such that the paddle frame 224 provides support for the paddles 222, 220.

[0165] The paddle frame 224 may provide additional clamping force between the inner paddle 222 and the coaptation element 210 and may help wrap the leaflets around the sides of the coaptation element 210. That is, the paddle frame 224 may be configured with a rounded three-dimensional shape that extends from the cap 214 to the connecting portion 223 of the anchor 208. The connections between the paddle frame 224, the outer and inner paddles 220 and 222, the cap 214, and the coaptation element 210 may constrain each of these members to the movements and positions described herein. In particular, the connecting portion 223 is constrained by its connections between the outer and inner paddles 220 and 222, and by its connections to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connecting portion 223 (and thus the inner and outer paddles 222 and 220) and by its attachment to the cap 214.

[0166] Such a wide configuration of the paddle frame 224 provides an increased surface area as compared to just the inner paddle 222. The increased surface area also allows the clamping force of the paddles 220 and paddle frame 224 against the native leaflets to be distributed over a larger area of ​​the native leaflets to further protect the native leaflet tissue.

[0167] Additional features of the device 200, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) and U.S. Provisional Patent Application No. 63 / 217,622, filed July 1, 2021. Any combination or subcombination of features disclosed by this application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) and / or U.S. Provisional Patent Application No. 63 / 217,622. Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) and U.S. Provisional Patent Application No. 63 / 217,622 are hereby incorporated by reference in their entireties for all purposes.

[0168] 23, there is shown one embodiment of an implantable device or implant 300. The implantable device 300 is one of many different configurations that the device 100, shown generally in Figures 8-14, may take. The device 300 may include any of the other features of an implantable device or implant described herein, and the device 300 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0169] 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, which optionally includes a coaptation element 310 (e.g., a spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 can include one or more paddles, for example, an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchors can also include and / or be coupled to a clasp 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment member) for engaging a capture mechanism of a delivery system.

[0170] The anchors 308 may be attached to other portions of the device and / or to each other in a variety of different manners (e.g., directly, indirectly, by welding, by sutures, by adhesive, by links, by latches, by integral formation, by combinations of any or all of these, etc.) In some implementations, the anchors 308 are attached to the interface element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0171] The anchor 308 may include a first portion or outer paddle 320 and a second portion or inner paddle 322 separated by a connecting portion 323. The connecting portion 323 may be attached to a paddle frame 324 that is hingedly attached to the cap 314 or to another mounting portion. In this manner, the anchor 308 is configured similar to a leg, in that the inner paddle 322 is like an upper portion of a leg, the outer paddle 320 is like a lower portion of a leg, and the connecting portion 323 is like a knee portion of a leg.

[0172] In implementations that include the interface element 310, the interface element 310 and the anchors 308 may be coupled together in a variety of ways. For example, as shown in the illustrated embodiment, the interface element 310 and the anchors 308 may be coupled together by integrally forming the interface element 310 and the anchors 308 as a single, unitary component. This may be accomplished, for example, by forming the interface element 310 and the anchors 308 from a continuous piece 301 of braided or woven material, such as braided or interwoven Nitinol wire. In the illustrated embodiment, the interface element 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, 325 are formed from a continuous piece of fabric 301.

[0173] Similar to the anchor 208 of the implantable device or implant 200 described above, the anchor 308 may be configured to transition between various configurations by axially moving a distal end of the device (e.g., cap 314, etc.) relative to a proximal end of the device (e.g., proximal collar 311 or other attachment member, etc.). This movement may occur along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device.

[0174] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some implementations, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the coaptation element 310 (e.g., similar to the configuration of the device 200 shown in FIG. 36). From the straight configuration, the anchor 308 can be moved to a fully collapsed configuration (e.g., FIG. 23), for example, by moving the proximal and distal ends toward each other and / or toward the midpoint or center of the device.

[0175] In some implementations, the clasp comprises a movable arm coupled to the anchor. In some implementations, the clasp 330 includes a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancing member 336, and an interface portion 338. The fixed arm 332 is attached to the inner paddle 322 with the interface portion 338 disposed proximate to the interface element 310. The interface portion 338 is spring loaded such that the fixed arm 332 and the movable arm 334 are biased toward each other when the clasp 330 is in a closed state.

[0176] The fixed arm 332 is attached to the inner paddle 322 by sutures (not shown) through holes or slots. The fixed arm 332 may be attached to the inner paddle 322 by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, welding, adhesive, or the like. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the clasp 330 is opened by opening the movable arm 334 to expose the barb 336. The clasp 330 is opened by applying tension to an actuation line attached to the movable arm 334, thereby allowing the movable arm 334 to articulate, pivot, and / or bend on the interface 338.

[0177] In summary, the implantable device or implant 300 is similar in construction and operation to the implantable device or implant 200 described above, except that the joint element 310, the outer paddle 320, the inner paddle 322, and the connecting portions 321, 323, 325 are formed from a single piece of material 301. In some implementations, the piece of material 301 is attached to the proximal collar 311, the cap 314, and the paddle frame 324 by weaving or inserting through openings in the proximal collar 311, in the cap 314, and in the paddle frame 324 that are configured to receive the continuous piece of material 301. The continuous piece 301 can be a single layer of material or can include two or more layers. In some implementations, portions of the device 300 have a single layer of material 301, and other portions are formed from multiple overlapping or overlapping layers of the piece of material 301.

[0178] For example, Figure 23 shows a joining element 310 and inner paddle 322 formed from multiple overlapping layers of the piece of material 301. The single, continuous piece of material 301 may begin and end at various locations on the apparatus 300. The ends of the piece of material 301 may be at the same location or at different locations on the apparatus 300. For example, in the illustrated embodiment of Figure 23, the piece of material 301 begins and ends at the location of the inner paddle 322.

[0179] As with the implantable device or implant 200 described above, the size of the coaptation element 310 may be selected to minimize the number of implants required per patient (preferably one), while at the same time maintaining a low transvalvular gradient. Notably, by forming many of the components of the device 300 from a single piece of material 301, the device 300 may be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance at the widest point of the device 300 (i.e., the width of the paddle frame 324, which is wider than the coaptation element 310) is about 5 mm.

[0180] Additional features of the device 300, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) and U.S. Provisional Patent Application No. 63 / 217,622. Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) and / or U.S. Provisional Patent Application No. 63 / 217,622. Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) and U.S. Provisional Patent Application No. 63 / 217,622 are hereby incorporated by reference in their entireties for all purposes.

[0181] 24 illustrates another example of one of many valve repair systems 40056 for repairing a patient's native valve to which the concepts of the present application may be applied. The valve repair system 40056 includes a delivery device 40156 and a valve repair device 40256.

[0182] The valve repair device 40256 includes a base assembly 40456, a pair of paddles 40656, and a pair of gripping members 40856. In one embodiment, the paddles 40656 can be formed integrally with the base assembly. For example, the paddles 40656 can be formed as an extension of a link of the base assembly. In the illustrated embodiment, the base assembly 40456 of the valve repair device 40256 includes 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 moving the coupler 40556 along the shaft 40356 moves the paddles between an open position and a closed position. In this manner, the couplers 40556 function as a means for mechanically coupling the paddles 40656 to the shaft 40356 and for moving the paddles 40656 between their open and closed positions as they move along the shaft 40356.

[0183] In some implementations, the gripping member 40856 can be pivotally connected to the base assembly 40456 (e.g., the gripping member 40856 can be pivotally connected to the shaft 40356, or any other suitable member of the base assembly) such that the gripping member can be moved to adjust the width of the opening 41456 between the paddle 40656 and the gripping member 40856. The gripping member 40856 can include a barbed portion 40956 for attaching the gripping member to the valve tissue when the valve repair device 40256 is attached to the valve tissue. When the paddle 40656 is in a closed position, the paddle engages the gripping member 40856 such that when the valve tissue is attached to the barbed portion 40956 of the gripping member, the paddle secures the valve repair device 40256 to the valve tissue. In some implementations, the gripping member 40856 is configured to engage the paddle 40656 such that the barbed portion 40956 engages the valve tissue member and the paddle 40656 to secure the valve repair device 40256 to the valve tissue member. For example, in certain circumstances it may be advantageous to have the paddle 40656 maintain an open position and have the gripping member 40856 move outwardly toward the paddle 40656 to engage the valve tissue and the paddle 40656.

[0184] Although the embodiment depicted in FIG. 24 shows a pair of paddles 40656 and a pair of gripping members 40856, it will be understood that the valve repair device 40256 can include any suitable number of paddles and gripping members.

[0185] In some implementations, the valve repair system 40056 includes a deployment shaft 41356 that is removably attached to the shaft 40356 of the base assembly 40456 of the valve repair device 40256. The deployment shaft 41356 is detached from the shaft 40356 after the valve repair device 40256 is secured to the valve tissue, removing 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 the patient's body.

[0186] The valve repair system 40056 may also include a paddle control mechanism 41056, a gripper control mechanism 41156, and a lock control mechanism 41256. In some implementations, the paddle control mechanism 41056 is mechanically attached to the coupler 40556 to move the coupler along the shaft, thereby moving the paddle 40656 between an open position and a closed position. The paddle control mechanism 41056 may take any suitable form and may include, for example, a shaft, wires, tubes, rods, lines, etc. For example, the paddle control mechanism may include a hollow shaft and a catheter tube or sleeve that fits over the deployment shaft 41356 and the shaft 40356 and connects to the coupler 40556.

[0187] The gripper control mechanism 41156 is configured to move the gripping member 40856 such that the width of the opening 41456 between the gripping member and the paddle 40656 can be altered. The gripper control mechanism 41156 can take any suitable form and can include, for example, a line, a suture or wire, a rod, a catheter, or the like.

[0188] The lock control mechanism 41256 is configured to lock and unlock the lock. The lock 40756 serves as a locking means for locking the coupler 40556 in a stationary position relative 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 embodiments 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 a tilted position and a substantially non-tilted position. The lock control mechanism 41256 can be, for example, a rod, suture, wire, or any other member that can move the pivotable plate of the lock 40756 between a tilted position and a substantially non-tilted position.

[0189] The valve restoration device 40256 is movable from an open position to a closed position. The base assembly 40456 includes a link that is moved by a coupler 40556. The coupler 40556 is movably attached to a shaft 40356. To move the valve restoration device from the open position to the closed position, the coupler 40556 moves along the shaft 40356, thereby moving the link.

[0190] The gripper control mechanism 41156 moves the gripping members 40856 to provide a wider or narrower gap at the opening 41456 between the gripping members and the paddle 40656. In the illustrated embodiment, the gripper control mechanism 41156 includes a line, such as a suture, wire, or the like, that is connected to an opening in the end of the gripper member 40856. When the line is pulled, the gripping members 40856 move inward, causing the opening 41456 between the gripping members and the paddle 40656 to become wider.

[0191] To move the valve restoration device 40256 from an open position to a closed position, the lock 40756 is moved to an unlocked state by the lock control mechanism 41256. Once the lock 40756 is in the unlocked state, the coupler 40556 can be moved along the shaft 40356 by the paddle control mechanism 41056.

[0192] After the paddle 40656 is moved to the closed position, the lock 40756 is moved to a locked state 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 state by the lock 40756, the valve repair device 40256 is removed from the delivery device 40156 by decoupling the shaft 40356 from the deployment shaft 41356. Additionally, the valve repair device 40256 is removed from the paddle control mechanism 41056, the gripper control mechanism 41156, and the lock control mechanism 41256.

[0193] Additional features of device 40256, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) and U.S. Provisional Patent Application No. 63 / 217,622. Any combination or subcombination of features disclosed by this application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) and / or U.S. Provisional Patent Application No. 63 / 217,622. Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904) and U.S. Provisional Patent Application No. 63 / 217,622 are hereby incorporated by reference in their entireties for all purposes.

[0194] The clasp or leaflet grasping device disclosed herein can take a wide variety of different forms. An example of a clasp is disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Any combination or subcombination of the features disclosed by this application can be combined with any combination or subcombination of the features disclosed by Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201). Patent Cooperation Treaty International Application No. PCT / US2018 / 028171 (International Publication No. WO2018195201) is incorporated herein by reference in its entirety.

[0195] 25A and 25B, an exemplary implementation of the valve repair device 40256 includes a spacer or coaptation element 3800. The valve repair device 40256 may have the same configuration as the valve repair device shown in FIG. 24 with the addition of a spacer or coaptation element. The spacer or coaptation element 3800 may take a wide variety of different shapes. The spacer or coaptation element 3800 may be compressible and / or expandable. For example, the spacer may be compressed to fit within one or more catheters of a delivery system, may expand when moved out of the one or more catheters, and / or may be compressed by paddles 40656 to adjust the size of the spacer or coaptation element. In the embodiment shown in FIG. 25A and 25B, the size of the spacer or coaptation element 3800 may be decreased by compressing the spacer or coaptation element with the paddles 40656 and increased by moving the paddles 40656 away from each other. The spacer element 3800 may extend beyond the outer edge 4001 of the gripping member or clasp 40856 as illustrated to provide additional surface area for closing the mitral valve gap.

[0196] The spacer or coaptation element 3800 may be coupled to the valve repair device 40256 in a variety of different ways. For example, the spacer or coaptation element 3800 may be fixed to the shaft 40356, slidably disposed about the shaft, connected to the coupler 40556, connected to the lock 40756, and / or connected to a central portion of the catch or gripping member 40856. In some implementations, the coupler 40556 may take the form of a spacer element 3800. That is, a single element may be used as both the coupler 40556, which moves the paddle 40656 between the open and closed positions, and the spacer element 3800, which closes the gap between the leaflets 20, 22 when the valve repair device 40256 is attached to the leaflets.

[0197] The spacer or interface element 3800 can be disposed about one or more of the shafts or other control elements of the valve repair system 40056. For example, the spacer or interface element 3800 can be disposed about the shaft 40356, the shaft 41356, the paddle control mechanism 41056, and / or the lock control mechanism 41256.

[0198] The valve repair device 40256 may include any other features for the valve repair device discussed in this application, and the valve repair device 40256 may be positioned to engage valve tissue as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additional features of the device 40256, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Any combination or subcombination of the features disclosed by this application may be combined with any combination or subcombination of the features disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. 2019139904).

[0199] 26-30 show another example of one of many valve repair systems for repairing a patient's native valve to which the concepts of the present application may be applied. With reference to FIGS. 29 and 30, the valve repair system includes a delivery device 1611 and an implantable valve repair device 8200. With reference to FIGS. 26-28, the implantable device 8200 includes a proximal or attachment portion 8205, an outer paddle portion 8120, an inner paddle portion 8122, a paddle frame 8224, and a distal portion 8207. The proximal portion 8205, the distal portion 8207, and the paddle frame 8224 may be configured in a variety of ways.

[0200] 26, the paddle frame 8224 may be symmetrical along the longitudinal axis YY. However, in some implementations, the paddle frame 8224 is not symmetrical about the axis YY. Further, with reference to FIG. 26, the paddle frame 8224 may include an outer frame portion 8256 and an inner frame portion 8260.

[0201] In some implementations, the connector 8266 (e.g., a shaped metal component, a shaped plastic component, a tether, wire, post, line, cord, suture, etc.) is attached to the outer frame portion 8256 at an outer end of the connector 8266 and to a coupler 8972 at an inner end 8968 of the connector 8266 (FIG. 28). Between the connector 8266 and the proximal portion 8205, the outer frame portion 8256 forms a curved shape. For example, in the illustrated embodiment, the shape of the outer frame portion 8256 resembles an apple shape, with the outer frame portion 8256 being wider toward the proximal portion 8205 and narrower toward the distal portion 8207. However, in some implementations, the outer frame portion 8256 may be shaped in other ways.

[0202] The inner frame portion 8260 extends from the proximal portion 8205 towards the distal portion 8207. The inner frame portion 8260 then extends inwardly to form a retaining portion 8272 that is attached to the actuation cap 8214. The retaining portion 8272 and the actuation cap 8214 can be configured to be attached in any suitable manner.

[0203] In some implementations, the inner frame portion 8260 is a rigid frame portion while the outer frame portion 8256 is a flexible frame portion. As shown in FIG. 26 , a proximal end of the outer frame portion 8256 connects to a proximal end of the inner frame portion 8260.

[0204] The width adjustment element 8211 (e.g., a width adjustment control, a width adjustment wire, a width adjustment shaft, a width adjustment tube, a width adjustment line, a width adjustment cord, a width adjustment suture, a width adjustment screw or bolt, a width adjustment tether, etc.) is configured to move the outer frame portion 8256 from an expanded position to a narrowed position by pulling the inner end 8968 ( FIG. 28 ) and a portion of the connector 8266 into the actuation cap 8214. The actuation element 8102 (e.g., an actuation wire, an actuation shaft, an actuation tube, etc.), according to some implementations disclosed herein, is configured to move the inner paddle frame portion 8260 to open and close the paddle.

[0205] As shown in FIGS. 27 and 28 , the connector 8266 has an inner end 8968 that engages with the width adjustment element 8211 such that a user can move the inner end 8968 inside the receiver 8912 (e.g., an internally threaded element, a column, a conduit, a hollow member, a notched receiving portion, a tube, a shaft, a sleeve, a post, a housing, a raceway, a cylinder, etc.) to move the outer frame portion 8256 between a constricted position and an expanded position. In the illustrated embodiment, the inner end 8968 comprises a post 8970 that is attached to the outer frame portion 8256 and a coupler 8972 that extends from the post 8970. The coupler 8972 is configured to be attached to and detached from both the width adjustment element 8211 and the receiver 8912. The coupler 8972 can take a wide variety of different forms. For example, the coupler 8972 may include one or more of a threaded connection, a mechanism that mates with the threads, an outwardly biased arm, a detent connection such as a wall, or other portion. When the coupler 8972 is attached to the width adjustment element 8211, the coupler is released from the tube. When the coupler 8972 is removed from the width adjustment element 8211, the coupler is secured to the tube. However, the inner end 8968 of the connector may be configured in a variety of ways. Any configuration may be used that can adequately attach the outer frame portion 8256 to the coupler so that the width adjustment element 8211 can move the outer frame portion 8256 between the constricted and expanded positions. The coupler may be similarly configured in a variety of ways and may be a separate component or may be integrated with another portion of the device, such as the connector or another portion of the inner end of the connector.

[0206] The width adjustment element 8211 allows a user to expand or contract the outer frame portion 8256 of the implantable device 8200. In the embodiment shown in FIGS. 27 and 28, the width adjustment element 8211 includes a male threaded end that screws into the coupler 8972. The width adjustment element 8211 moves the coupler into the receiver 8912 to adjust the width of the outer frame portion 8256. When the width adjustment element 8211 is unscrewed from the coupler 8972, the coupler engages the inner surface of the receiver 8912 to set the width of the outer frame portion 8256.

[0207] In some implementations, the receiver 8912 may be integrally formed with the distal cap 8214. Moving the cap 8214 relative to the body of the mounting portion 8205 opens and closes the paddle. In the illustrated embodiment, the receiver 8912 slides inside the body of the mounting portion. When the coupler 8972 is removed from the width adjustment element 8211, the width of the outer frame portion 8256 is fixed while the actuation element 8102 moves the receiver 8912 and cap 8214 relative to the body of the mounting portion 8205. Moving the cap may open and close the device in the same manner as some implementations disclosed above.

[0208] In the illustrated embodiment, the driver head 8916 is disposed at a proximal end of the actuation element 8102. The driver head 8916 removably couples the opening and closing actuation element 8102 to the receiver 8912. In the illustrated embodiment, the width adjustment element 8211 extends through the actuation element 8102. The actuation tube is advanced axially in the opposite direction to the Y direction to move the distal cap 8214. As shown by the arrows in FIG. 27, movement of the distal cap 8214 relative to the mounting portion 8205 is effective to open and close the paddle. That is, when the distal cap 8214 is moved in the Y direction, the device is closed, and when the distal cap is moved in the opposite direction to the Y direction, the device is opened.

[0209] 27 and 28, the width adjustment element 8211 extends through the actuation element 8102, the driver head 8916, and the receiver 8912 and engages a coupler 8972 attached to the inner end 8968. When the outer frame portion 8256 is moved to the stenotic position, the device or implant 8200 may be easily maneuvered into position for implantation into the heart by reducing contact and / or friction between the native structures of the heart (e.g., chordae tendineae) and the device 8200. When the outer frame portion 8256 is moved to the expanded position, the anchor portions of the device or implant 8200 are provided with a larger surface area to engage and capture the leaflets of the native heart valve.

[0210] 29 and 30, an implementation of an implant catheter assembly 1611 is shown in which the clasp actuation line 624 extends through the handle 1616, the actuation element 8102 is coupled to a paddle actuation control 1626, and the width adjustment element 8211 is coupled to a paddle width control 1628. A proximal end portion 1622a of the shaft or catheter of the catheter assembly 1611 may be coupled to the handle 1616, and a distal end portion 1622b of the shaft or catheter may be coupled to the implantable device 8200. The actuation element 8102 may 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 a proximal end of the device 8200 that couples with the driver head 8916. The actuation element 8102 may be axially movable relative to the outer shaft of the catheter assembly 1611 and the handle 1616 to open and close the device.

[0211] The width adjustment element 8211 may extend distally from the paddle width control 1628, through the paddle actuation control 1626, through the actuation element 8102 (and consequently through the handle 1616, the outer shaft of the implant catheter assembly 1611, and the device 8200), where it couples with the coupler 8972. The width adjustment element 8211 may be axially movable relative to the actuation element 8102, the outer shaft of the catheter assembly 1611, and the handle 1616. The clasp actuation line 624 may extend through and be axially movable relative to the handle 1616 and the outer shaft of the catheter assembly 1611. The clasp actuation line 624 may also be axially movable relative to the actuation element 8102.

[0212] 29 and 30, the width adjustment element 8211 can be removably coupled to the coupler 8972 of the device 8200. The width adjustment element 8211 is advanced and retracted via control 1628 to increase or decrease the width of the paddle. The actuation element 8102 is advanced and retracted via control 1626 to open and close the paddle of the device.

[0213] 29 and 30, the catheter or shaft of the implant catheter assembly 1611 is an elongate shaft extending axially between a proximal end portion 1622a that is coupled to the handle 1616 and a distal end portion 1622b that is coupled to the device 8200. The outer shaft of the catheter assembly 1611 may also include an intermediate portion 1622c disposed between the proximal end portion 1622a and the distal end portion 1622b.

[0214] 31-35, one embodiment 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 be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device 1500 and natural structures of the heart, such as, for example, tethers. 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 constricted position (when the device 1500 is in an open position), and / or the paddle frames may include flexible outer portions that bend inwardly to reduce the width of the paddles when the flexible outer portions contact natural structures of the heart, such as, for example, tethers.

[0215] When the paddle frame 1524 is in the stenosis position, friction between the natural structure of the heart and the device 1500 is reduced. The device 1500 may include any other features of an implantable device or implant described in this application or in the applications or patent documents incorporated herein by reference, and the device 1500 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed in this application). Additionally, any of the devices described herein may incorporate the features of the device 1500.

[0216] 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, the attachment portion 1505, and the distal portion 1507 can take any suitable form, such as, for example, that for these portions of the device 200 shown in FIG. 22, or any other form described herein. 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, to implant 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 herein. In the illustrated example, the coaptation element is made from a woven wire.

[0217] The attachment portion 1505 includes a first or proximal collar 1511 for engaging a capture mechanism of a delivery system. The proximal collar 1511 can take any suitable form, such as, for example, any of the forms described herein. The capture mechanism 1513 can take any suitable form, such as, for example, any of the forms described herein.

[0218] The distal portion 1507 includes a cap 1514 that is attached to the anchor 1508 of the anchor portion 1506 such that moving the cap 1514 moves the anchor 1508 between an open position and a closed position. The cap 1514 can take any suitable form, such as, for example, any form described herein. In the illustrated embodiment, an actuation element 1512 (e.g., an actuation wire, an actuation shaft, etc.) extends from a delivery system (e.g., any delivery system described herein) and engages the cap 1514 to move the cap 1514 relative to the joint element or spacer 1510, thereby enabling actuation 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 herein.

[0219] The anchor portion 1506 of the device 1500 may take any suitable form, such as, for example, that of the anchor portion 206 of the device 200 shown in FIG. 22 (except that the paddle frame 224 is replaced by a paddle frame 1524 as shown in FIGS. 91-95 and described in more detail below), or any other form described herein that may incorporate a paddle frame 1524. The anchor portion 1506 may include a plurality of anchors 1508, each anchor 1508 including an outer paddle 1520, an inner paddle 1522, a paddle extension or frame 1524, and a clasp 1530.

[0220] The paddle frame 1524 includes a main support section 1585, a first connecting member for attachment to the cap of an implantable device or implant, and a second connecting member for attachment to an anchor of the device. The connecting members may be the same or similar to other connecting members described elsewhere herein. The paddle frame 1524 may be attached to the connecting portion of the anchor and the cap by any suitable means, such as, for example, any of the means described herein. The thickness and width of the paddle frame may take any suitable form, for example, the thickness may be substantially the same as the width, the thickness may be greater than the width (as shown in FIGS. 91-95), or the width may be greater than the thickness.

[0221] 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 is connected to the cap 1514 and a second end 1583 that is connected to the anchor 1508. With reference to FIGS. 34 and 35 , the rigid inner portion is configured to provide sufficient force to support the anchor paddles 1520, 1522 and facilitate coaptation of the native leaflets 20, 22 to the coaptation element 1510 when the anchor 1508 is in a closed position. The rigid inner portion 1572 may be made of, for example, metal, plastic, or the like.

[0222] 31-35, the flexible outer portion 1574 is connected to the rigid inner portion and defines the overall width of the paddle frame 1524. That is, the flexible outer portion 1574 has a greater overall width than the rigid inner portion 1572. The flexible outer portion 1574 is configured such that a force (e.g., a force from the flexible outer portion 1574 contacting the chordae during implantation of the device 1500) causes the flexible outer portion 1574 to bend and more easily maneuver the device 1500 into position for implantation in the heart. With reference to FIGS. 34 and 35, when the anchor 1508 is in the closed position to coapt the leaflets to the coaptation element 1510, the flexible outer portion 1574 maintains its normal overall width to provide a larger surface area (relative to the rigid inner portion 1572) to contact the leaflets to hold them against the coaptation element 1510. The flexible outer portion 1574 may be made from, for example, metal and plastic.

[0223] The overall width of the flexible outer portion 1574 can be, for example, 5 mm to 15 mm, such as, for example, about 10 mm, such as, for example, 7 mm to 12 mm, such as, for example, 9 mm to 11 mm, etc. The width of the inner portion 1572 can be, for example, 2 mm to 8 mm, such as, for example, about 5 mm, such as, for example, 4 mm to 6 mm.

[0224] In some implementations, the flexible outer portion 1574 is shaped inwardly such that when the anchor 1508 is in the open position, the overall width of the outer portion 1574 is narrowed, and when the anchor 1508 is moved to the closed position, the outer portion moves back to its normal overall width.

[0225] While the illustrated embodiment shows rigid inner portion 1572 and flexible inner portion 1574 having a rounded shape, it will be understood that inner portion 1572 and outer portion 1574 may take any form that allows device 1500 to be more easily maneuvered into position for implantation within the heart while providing sufficient support to facilitate coaptation of the leaflets of the native heart valve to coaptation element 1510.

[0226] 36 and 37, an exemplary 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 stenosis position so that the device 1800 may be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device 1800 and the natural structures of the heart, such as, for example, cords. That is, the width adjustment lines 1890 are controlled by a user when the device 1800 is positioned for implantation over the native leaflets of a native valve to generate a compressive force C (FIG. 37) on the paddle frames 1824, moving the paddle frames 1824 to a stenosis position so that contact and / or friction between the device 1800 and the natural structures of the heart is reduced. Device 1800 may include any other features of an implantable device or implant described in this application or in the applications or patent documents incorporated herein by reference, and device 1800 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed in this application). In addition, any of the devices described herein may incorporate the features of device 1800.

[0227] 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, the attachment portion 1805, and the 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 herein. In some implementations, the coaptation portion 1804 includes a coaptation element 1810 (e.g., a spacer, coaptation element, gap filler, etc.) that can be used, for example, to implant 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 herein.

[0228] The attachment portion 1805 includes a first or proximal collar 1811 for engaging a capture mechanism of a delivery system. The capture mechanism and delivery system may be the same as or similar to other capture mechanisms and delivery systems described elsewhere herein. The proximal collar 1811 may take any suitable form, such as, for example, any of the forms described in this application.

[0229] Distal portion 1807 includes a cap 1814 that is attached to anchor 1808 of anchor portion 1806 such that movement of cap 1814 moves anchor 1508 between an open position and a closed position. Cap 1814 can take any suitable form, such as, for example, any form described herein. In the illustrated embodiment, actuation element 1812 (e.g., a movement wire, actuation shaft, etc.) extends from a delivery system (e.g., any delivery system described herein) and engages cap 1814 to move cap 1814 relative to joint element or spacer 1810 to enable actuation of device 1800. Actuation element 1812 may engage and move cap by any suitable means, such as, for example, any means provided herein.

[0230] The anchor portion 1806 can take any suitable form, such as, for example, that of the anchor portion 206 of the device 200 shown in FIG. 22, or any other form described herein. The anchor portion 1806 can include a plurality of anchors 1808, each anchor 1808 including an outer paddle 1820, an inner paddle 1822, a paddle extension member or paddle frame 1824, and a clasp 1830. The paddle frame 1824 can include a main support section 1885, a first connecting member for attachment to the cap 1814, and a second connecting member for attachment to a connecting portion 1823 of the anchor 1808. The paddle frame 1824 can be attached to the connecting portion of the anchor and the cap by any suitable means, such as, for example, any means described herein. The thickness and width of the paddle frame 1824 may take any suitable form, for example, the thickness may be substantially the same as the width, the thickness may be greater than the width (as shown in FIGS. 91-95), or the width may be greater than the thickness.

[0231] The paddle frame 1824 includes an end 1801 configured to be attached to the cap 1814 and a free end 1803. The paddle frame 1824 includes a first opening 1891 and a second opening 1892 for receiving one or more width adjustment lines 1890 of a delivery system. With reference to FIGS. 36 and 37 , in some embodiments, a single width adjustment line 1890 extends through the first opening 1891 and the second opening 1892 of each paddle frame 1824 into the delivery system such that a user can pull the width adjustment line 1890 to move the paddle frame 1824 to a constricted position. In some implementations, the width adjustment line 1890 can also extend through an opening in the clasp 1830 of each paddle before extending into the delivery system. 37, when a user pulls on the width adjustment line 1890, a force is generated in the Y direction at each end of the width adjustment line 1890 based on the width adjustment line extending through the openings 1891, 1892, generating a compressive force C on the paddle frame 1824. The compressive force C causes the paddle frame 1824 to move to a constricted position.

[0232] 37, the paddle frame 1824 has a length L2 and an overall width W2 when in a constricted position. The width of the paddle frame 1824 when in a normal expanded position can be 5 mm to 15 mm, such as, for example, about 10 mm, such as, for example, 9 mm to 11 mm, such as, for example, 7 mm to 12 mm. The constricted width W2 of the paddle frame 1824 can be 3 mm to 12 mm, such as, for example, about 8 mm, such as, for example, 7 mm to 9 mm, such as, for example, 5 mm to 10 mm. The ratio of the normal width to the constricted width W2 can be 10 / 9 to 3 / 1, such as, for example, 4 / 3 to 3 / 2, such as, for example, 5 / 4 to 2 / 1.

[0233] 40-49, an exemplary implementation of the 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 be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device 2000 and the natural structures of the heart, such as cords. For example, the width adjustment lines are controlled by a user to cause the paddle frames 2024 to generate a compressive force (e.g., compressive force C shown in FIG. 37) to move the paddle frames 2024 from a normal expanded position (FIGS. 41 and 43) to a stenotic position (FIGS. 40 and 42) when the device 2000 is positioned for implantation over the leaflets of a native valve such that friction between the natural structures of the heart and the device 2000 is reduced. Device 2000 may include any other features of an implantable device or implant described in this application or in the applications or patent documents incorporated herein by reference, and device 2000 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed in this application). In addition, any of the devices described herein may incorporate the features of device 2000.

[0234] 44 and 45, an 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, the attachment portion 2005, and the distal portion 2007 can take any suitable form, such as, for example, that for these portions of the device 200 shown in FIG. 22, or any other form described herein. 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 2010 can take any suitable form, such as, for example, any form described herein.

[0235] The attachment portion 2005 includes a first or proximal collar 2011 for engaging a capture mechanism of a delivery system. The capture mechanism and delivery system may be the same as or similar to other capture mechanisms and delivery systems described elsewhere herein. The proximal collar 2011 may take any suitable form, such as, for example, any of the forms described in this application.

[0236] Distal portion 2007 includes a cap 2014 that is attached to anchor 2008 of anchor portion 2006 such that movement of cap 2014 moves anchor 2008 between open and closed positions. Cap 2014 can take any suitable form, such as, for example, any form described herein. 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 herein) through opening 2009 (FIG. 44) and through interface element 2010 to engage cap 2014 and move cap 2014 relative to interface element 2010 to enable actuation of device 2000. The actuation element may engage and move cap by any suitable means, such as, for example, any means provided herein.

[0237] The anchor portion 2006 can take any suitable form, such as, for example, that of the anchor portion 206 of the device 200 shown in FIG. 22, or any other form described herein. The anchor portion 2006 can include a plurality of anchors 2008, each anchor 2008 including an outer paddle 2020, an inner paddle 2022, a paddle extension member or paddle frame 2024, and a clasp (e.g., clasp 230 shown in FIG. 22). With reference to FIGS. 38 and 39, the paddle frame 2024 can include a main support section 2085 and a connecting member 2003 for attachment to the cap 2014. The paddle frame 2024 can be attached to the cap 2014 by any suitable means, such as, for example, any of the means described herein. 46-49, in the illustrated embodiment, both of the anchors 2008 are defined by a paddle ribbon 2001 including an inner paddle 2022 and an outer paddle 2020 of each anchor 2008. The inner paddle 2022 of each anchor 2008 is attached by a connecting portion 2025 configured to connect the inner paddle 2022 to the interface element 2010 (as shown in FIG. 49). In the illustrated embodiment, the connecting portion 2025 includes an opening 2094 for receiving a distal portion of the interface element 2010. The outer paddle 2020 of each anchor 2008 is attached by a connecting portion 2021 configured to connect the outer paddle 2020 to the cap 214 (as shown in FIG. 49). In the illustrated embodiment, the connecting portion 2021 includes an opening 2096 for receiving a portion of the cap 2014. Each inner paddle 2022 is attached to a corresponding outer paddle 2020 by a connecting portion 2023.

[0238] 38 and 39, the paddle frame 2024 includes two or more arms 2080 that define an overall width TW of the anchor 2008, with at least a portion of the arms 2080 connected at a distal portion of the paddle frame 2024 (e.g., a portion of the paddle frame 2024 proximate the connecting member 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 and 37) such that a user can pull on the width adjustment lines to move the paddle frame 2024 to a constricted position. The illustrated embodiment includes two arms 2080, each including a proximal opening 2091 and a distal opening 2092. In some implementations, a single width adjustment line may extend through each opening 2091, 2092 such that a single width adjustment line may move the paddle frame 2024 to the constricted position. However, it will be understood that any suitable number of width adjustment lines may extend through the openings 2091, 2092 to move the paddle frame 2024 to the constricted position.

[0239] 38, the arms 2080 are connected to one another at a distal portion of the paddle frame 2024 by a connecting link 2083. With this connection between the two arms 2080, when a user creates tension F in the paddle frame 2024 by pulling on one or more width adjustment lines extending through the openings 2091, 2092, the arms 2080 pivot, bend, and / or articulate in an inward Z direction about the connecting link 2083. This pivoting, bending, and / or articulation of the arms 2080 causes the main support section 2085 of the arms 2080 to move in an inward X direction such that the paddle frame 2024 is in a constricted position. In the illustrated example, the connecting link 2083 has a first member 2087 attached to one arm 2080, a second member 2089 attached to the other arm 2080, and a thin arched member 2086 connecting the first member 2087 to the second member 2089. However, the connecting link 2083 can take any suitable form that allows the arm to pivot, bend, and / or articulate in the medial Z direction when a tension force F is applied to the paddle frame 2024. In some implementations, the connecting link 2083 is integral to the arm 2080 of the paddle frame 2024.

[0240] 38, the overall width TW of the paddle frame 1824 when in the normal expanded position can be 5 mm to 15 mm, such as, for example, about 10 mm, such as, for example, 7 mm to 12 mm, such as, for example, 9 mm to 11 mm. The constriction width of the paddle frame 1824 can be 3 mm to 12 mm, such as, for example, about 8 mm, such as, for example, 7 mm to 9 mm, such as, for example, 5 mm to 10 mm. The ratio of the normal width to the constriction width W2 can be 10 / 9 to 3 / 1, such as, for example, 4 / 3 to 3 / 2, such as, for example, 5 / 4 to 2 / 1.

[0241] 50-59, an exemplary 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 stenosis position so that the device 2800 may be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device 2800 and the natural structures of the heart, such as cords. 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 generate a compressive force on the paddle frame 2824 when the device 2800 is positioned for implantation over the leaflets of a native valve, thereby moving the paddle frame 2824 to the stenosis position, thereby reducing contact and / or friction between the natural structures of the heart and the device 1800. In some implementations, the width adjustment elements may be width adjustment wires, width adjustment cords, width adjustment sutures, other width adjustment elements described herein, etc. ) Device 2800 may include any other features of an implantable device or implant described in this application or in the applications or patent documents incorporated herein by reference, and device 2800 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed in this application). In addition, any of the devices described herein may incorporate the features of device 2800.

[0242] 53 and 54, an 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, the attachment portion 2805, and the distal portion 2807 can take any suitable form, such as, for example, that for these portions of the device 200 shown in FIG. 22, or any other form described herein. 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, to implant 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 herein.

[0243] The attachment portion 2805 includes a first or proximal collar 2811 for engaging a capture mechanism of a delivery system 2802. The capture mechanism and delivery system 2802 can take any suitable form, such as, for example, any of the forms described herein. The delivery system 2802 can be the same as or similar to other delivery systems herein, such as, for example, 102, 402, 502, and can further include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, and the like. The proximal collar 2811 can take any suitable form, such as, for example, any of the forms described herein.

[0244] The distal portion 2807 includes a cap 2814 that is attached to the anchor 2808 of the anchor portion 1806 such that movement of the cap 2814 moves the anchor 2808 between an open position and a closed position. The cap 2814 can take any suitable form, such as, for example, any of the forms described herein. In the illustrated embodiment, an actuation element (e.g., the same as or similar to the actuation element 112 shown in FIGS. 8-20 or the actuation element 8102 shown in FIGS. 26-30) extends from a delivery system (e.g., any of the delivery systems described herein) and engages the cap 2814 to move the cap 2814 relative to the interface element 2810, thereby enabling actuation of the device 2800. The actuation element may engage and move the cap by any suitable means, such as, for example, any of the means provided herein.

[0245] The anchor portion 2806 can take any suitable form, such as, for example, that of the anchor portion 206 of the device 200 shown in FIG. 22, or any other form described herein. The anchor portion 2806 can include a plurality of anchors 2808, each anchor 2808 including an outer paddle 2820, an inner paddle 2822, a paddle extension member or paddle frame 2824, and a clasp (e.g., clasp 230 shown in FIG. 22). With reference to FIGS. 50-52, the paddle frame 2824 can include a main support section 2885, a first connecting member 2801 for attachment to the cap 1814, and a second connecting member 2803 for attachment to a connecting portion 2823 of the anchor 2808. The paddle frame 2824 can be attached to the connecting portion of the anchor and the cap by any suitable means, such as, for example, any means described herein. The thickness and width of the paddle frame 2824 may take any suitable form, for example, the thickness may be substantially the same as the width, the thickness may be greater than the width (as shown in FIGS. 91-95), or the width may be greater than the thickness.

[0246] The paddle frame 2824 includes an inner portion 2872 and an outer portion 2874. The inner portion 2872 has an arm 2880 extending from the connecting member 2801 to a proximal portion of the paddle frame 2824. The outer portion 2874 includes an arm 2882 connected to the arm 2880 at a connection point 2871 and extending outwardly from the arm 2880. The arm 2882 defines an overall width TW of the anchor 2808. The arm 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 arm 2882 in the X-inner direction to move the paddle frame 2824 to a constricted position. In the illustrated embodiment, each of the arms 2882 has a first opening 2892 and a second opening 2891 positioned distally from the first opening 2892. The inner portion 2872 can include one or more openings 2893 that can be used to connect to the connecting portion 2823 of the anchor 2808 and / or to receive one or more width adjustment lines 2890.

[0247] 51-55, the arms 2882 of the outer portion 2874 may be biased in an X direction (FIGS. 51 and 52) such that the arms 2882 are configured to extend beyond the centerline CL (FIG. 54) of the device 2800 when the anchors 2808 are in the closed position. With reference to FIGS. 53 and 54, for purposes of illustration, the arms 2882 of the paddle frame 2824 are shown crossing one another to indicate that the arms 2882 are configured to extend beyond the centerline CL of the device 2800. However, it will be understood that the arms 2882 may be positioned to engage the arms 2882 of the other paddle frame 2824 (rather than crossing one another) to generate a clamping force between the two anchors 2808. In these embodiments, when the anchor 2808 captures the leaflets 20, 22 of the mitral valve MV, the biased arms 2882 of each paddle frame 2824 clamp the leaflet tissue between them, thereby better securing the device 2800 to the mitral valve MV.

[0248] 52, the paddle frame 2824 can have a rounded shape that corresponds to the shape of the coaptation element 2810 such that the anchor 2808 fits around the coaptation element to better secure the leaflet tissue between the anchor 2808 and the coaptation element 2810. The paddle frame 2824 can be formed by shaping a material such that the arms 2882 are biased away from the arms 2880. For example, the paddle frame 2824 can be made from steel, a metal such as Nitinol, plastic, or the like.

[0249] 55-59, in some implementations, each paddle frame 2824 has a corresponding width adjustment line 2890 that moves the paddle frame 2824 from a normal expanded position (FIGS. 55 and 58) to a constricted position (FIGS. 56 and 57, and FIG. 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 move the paddle frame 2824 to the constricted 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.

[0250] 55, in the illustrated embodiment, a first end 2894 of the width adjustment line 2890 extends from the delivery system 2802 through an opening 2897a in the cap 2814 (FIGS. 57-59) at point A. The width adjustment line 2890 then extends through an opening 2892 in one arm 2882 at point B, and then through an opening 2892 in the other arm 2882 at point C. The width adjustment line 2890 extends back through an opening 2897b in the cap (FIGS. 57-59) at point D, and then a second end 2895 of the width adjustment line 2890 extends back through the delivery system 2802.

[0251] 56, if a user pulls the ends 2894, 2895 of the width adjustment line 2890 in the Y direction, the width adjustment line 2890 creates a tension F on the arm 2882 due to the width adjustment line extending through the opening 2892. This tension F then causes the arm 2882 to move in the X inward direction, so that the paddle frame 2824 is in a narrowed position. With reference to FIG. 57, if a user applies additional force to the ends 2894, 2895 of the width adjustment line 2890 in the Y direction, the tension F (FIG. 56) continues on the arm 2882, so that the arm 2882 continues to move in the X direction, which may cause the arms 2882 to cross over each other (as shown in FIG. 57), so that the paddle frame 2824 is in a narrower position. 58 and 59, the paddle frames 2824 can be independently controllable between a normal position and a constricted position. For example, FIG. 58 shows both paddle frames 2824 in the normal position, and FIG. 59 shows one paddle frame 2824 moved to the constricted position and the other paddle frame 2824 in the normal position.

[0252] 50, the overall width TW of the paddle frame 2824 when in the normal expanded position can be 5 mm to 15 mm, such as, for example, about 10 mm, such as, for example, 7 mm to 12 mm, such as, for example, 9 mm to 11 mm. The constriction width of the paddle frame 2824 can be 3 mm to 12 mm, such as, for example, about 8 mm, such as, for example, 7 mm to 9 mm, such as, for example, 5 mm to 10 mm. The ratio of the normal width TW to the constriction width can be 10 / 9 to 3 / 1, such as, for example, 4 / 3 to 3 / 2, such as, for example, 5 / 4 to 2 / 1.

[0253] 60-63 show an example implementation of a paddle frame 3024 for an implantable device or implant, such as any of the implantable devices or implants disclosed herein. The paddle frame 3024 is configured to allow the device to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device and the natural structures of the heart, such as, for example, cords.

[0254] 60-63, each of the paddle frames 3024 can include an inner portion 3072 and an outer portion 3074. The inner portion 3072 includes one or more arms 3080 having a proximal end 3090 and a distal end 3091. The proximal end 3090 can be connected and can have an opening 3092 for receiving the paddles (e.g., inner and outer paddles) of the anchor. The distal end 3091 can include a connecting member for attaching to a cap used to open and close the paddles. Although the illustrated embodiment shows the inner portion 3072 having two arms 3080, it will be understood that the inner portion 3072 can have any suitable number of arms.

[0255] The outer portion 3074 of each paddle frame 3024 has a pair of arms 3082 having a proximal end 3093 and a distal end 3094. The proximal end 3093 can be configured to be attached to the proximal end 3090 of the inner portion 3072. For example, the proximal ends 3090, 3093 of both the inner portion 3072 and the outer portion 3074 can include openings 3095, 3096 for receiving fasteners that connect the inner portion 3072 and the outer portion 3074 together. The distal ends 3094 are connected together at a connection point 3083 or inner end. The arms 3082 can be curved such that the distal ends 3094 extend over at least a portion of the remainder of the arms 3082. For example, in the illustrated embodiment, the arms 3082 include a curved portion 3084. In some implementations, a connection point or inner end 3083 at the distal end of the arm 3082 is connected to the distal end 3091 of the arm 3080 of the inner portion 3072, such that when the distal ends 3091, 3094 are moved in the proximal direction PD or the distal direction DD, they can move in the proximal direction PD or the distal direction DD along with the connection point or inner end 3083.

[0256] In some implementations, the arm 3082 is more flexible than the arm 3080. This increased flexibility may cause the arm 3082 to bend when the connecting portion or inner end 3083 is pulled into the arm 3080. This bending may cause the arm 3082 to narrow. The stiffer arm 3080 may cause the paddles of the device to open and close in the same or similar manner as shown in FIGS. 23, 27, and 30-37.

[0257] 61, when the connection point or inner end 3083 connecting the distal end 3094 of the arm 3082 in the distal direction DD is moved, the arm 3082 moves in the outward direction OD (FIG. 61), so that the paddle frame 3024 is in an extended position. That is, when the connection point or inner end 3083 is moved in the distal direction DD, the curved portion 3084 of the arm 3082 bends outward, which causes the arm 3082 to move in the outward direction OD, with reference to FIG.

[0258] 61, when the connection point or inner end 3083 connecting the distal end 3094 of the arm 3082 in the proximal direction PD moves, the arm 3082 moves in the inner direction ID, so that the paddle frame 3024 is in a constricted position. That is, with reference to FIG. 61, when the connection point or inner end 3083 moves in the proximal direction PD, the curved portion 3084 of the arm 3082 bends inward, which causes the arm 3082 to move in the inner direction ID.

[0259] The connection point or inner end 3083 can be moved in the distal direction DD or the proximal direction PD by a user using a width adjustment element (e.g., the width adjustment element 8211 shown in FIGS. 26-30 or another width adjustment element shown or described herein). For example, the connection point or inner end 3083 can be coupled to a width adjustment element such that an actuation element can move the connection wire in the proximal direction PD and in the distal direction DD. A wide variety of mechanisms can be used to move the connection point or inner end 3083 proximally and distally to adjust the width of the paddle frame. Several examples of mechanisms that can be used to move the connection point or inner end 3083 proximally and distally to adjust the width of the paddle frame are disclosed below.

[0260] In some implementations, the paddle frame 3024 shown in Figures 60-63 may have a normal expansion width of 5 mm to 15 mm, such as, for example, about 10 mm, such as, for example, 7 mm to 12 mm, such as, for example, 9 mm to 11 mm. The constriction width of the paddle frame 3024 may be 3 mm to 12 mm, such as, for example, about 8 mm, such as, for example, 7 mm to 9 mm, such as, for example, 5 mm to 10 mm. The ratio of the normal expansion width to the constriction width may be 10 / 9 to 3 / 1, such as, for example, 4 / 3 to 3 / 2, such as, for example, 5 / 4 to 2 / 1.

[0261] FIG. 64 illustrates an embodiment of a width adjustment device 8900 configured to expand or contract a paddle frame of an implantable device or implant. The width adjustment device 8900 can take any suitable form, such as, for example, any form described in this application. Moreover, any implantable device or implant described herein, and any width adjustment device described herein, can incorporate the features of the width adjustment device 8900. In the illustrated embodiment, 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 the 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 configured to threadingly engage an internal thread pattern 8904 formed in the housing 8902. A driver head 8910 is integrally formed at the proximal end of the shaft 8908 and is configured to allow rotation of the shaft 8908 with a variety of tools or driver types (eg, Torx, slotted, Phillips, etc.).

[0262] 64 , a fork-shaped carriage 8812 is disposed about the shaft 8908 and the driver head 8910. In the illustrated embodiment, the carriage 8812 features proximal tines 8914 and a distal end 8918 that are formed as a single, integral component. However, it will be understood that the carriage 8812 may take any suitable form, such as, for example, any of the forms described in this application.

[0263] 64, the driver head 8910 features an engagement surface 8911 that is configured to be complimentary to a surface 8915 of the proximal teeth 8914, in order to attach the carriage 8812 to the driver head 8910. An anti-torque notch 8913 formed in the housing 8902 is configured to receive and restrain the carriage 8812 from longitudinal movement in the L direction, and to prevent or inhibit the carriage 8812 from rotating, when a torque is applied to the driver head 8910. Thus, when the driver head 8910 is rotated, the driver head 8910 pulls the carriage 8812, such that the carriage 8812 is constrained to move upwards or downwards along the longitudinal axis of the shaft 8908, as indicated by the arrow L.

[0264] Still referring to FIG. 64 , the distal end 8918 of the carriage 8812 is formed with an opening 8919 configured to allow the width adjustment line 1890 to pass therethrough. The opposing ends of the width adjustment line 1890 may be secured to various attachment points on the paddle frame, the paddle, the distal cap, or any other suitable attachment points described herein. When the driver head 8910 is rotationally driven to move the carriage 8812, the distal end 8918 of the carriage 8812 pulls on the width adjustment line 1890, thereby causing the paddle frame (not shown) to retract. In the illustrated embodiment, rotating the driver head 8910 clockwise (right-hand thread configuration) causes the carriage 8812 to move downward along the longitudinal axis of the shaft 8908 in the direction indicated by arrow L. In this manner, the distal end 8918 of the carriage 8812 pulls on the width adjustment line 1890, causing the paddle frame to retract. However, it is understood that other configurations are also contemplated. For example, rotating the driver head 8910 in a counterclockwise direction can tension the width adjustment lines 1890 to contract the paddle frame. Moreover, it will be understood that in other configurations, tensioning the width adjustment lines 1890 can cause the paddle frame to expand rather than contract.

[0265] Referring to Fig. 65, one embodiment of a width adjustment device 8900 and retractable / expandable paddle frame is shown. In the illustrated embodiment, the width adjustment device 8900 of Fig. 65 is substantially identical to the embodiment shown in Fig. 64, except that the distal end 8918 of the carriage 8812 is integrally formed with the distal portion 81002 of the paddle frame 81000 of the implantable device or implant. However, it will be appreciated that in some implementations, the carriage 8812 may be integrally formed with the distal cap or any other suitable member described herein.

[0266] 65, when the driver head 8910 is rotationally driven to carry the carriage 8812, the carriage 8812 moves the distal portion 81002 upwards or downwards. When the distal portion 81002 moves upwards, the paddle frame 81000 flexes or expands outward, and when the distal portion 81002 moves downwards, the paddle frame 81000 flexes or retracts inward. For example, when the driver head 8910 is rotated clockwise (right-hand thread configuration), the carriage 8812 moves downwards along the longitudinal axis, which causes the distal portion 81002 of the paddle frame 81000 to move downwards and the side portions 81004 of the paddle frame 81000 to contract inwardly, thereby reducing the overall width of the paddle frame 81000. When the driver head 8910 is rotated counterclockwise (right-hand thread configuration), the carriage 8812 moves upward along the longitudinal axis, causing the distal portion 81002 of the paddle frame 81000 to move upward and the lateral portions 81004 of the paddle frame 81000 to expand outward, thereby increasing the overall width of the paddle frame 81000.

[0267] FIG. 66 shows an embodiment of a width adjustment device 81100 configured to expand or contract a paddle frame of an implantable device or implant 81200. The width adjustment device 81100 can take any suitable form, such as, for example, any of the forms described in this application. Moreover, any of the implantable devices or implants and width adjustment devices described herein may incorporate the features of the width adjustment device 81100. In the illustrated embodiment, the width adjustment device 81100 includes a coupler, such as the illustrated male threaded shaft 81102 (FIG. 68) rotatably engaged with a receiver, such as the illustrated female threaded element 81104 (as shown and often referred to herein as a "post", although it can be or include other types of threaded elements or threaded bores, and can have a variety of different sizes and shapes as well), that is integrally formed with or connected to a distal portion of the implantable device or implant. For example, the threaded element or post 81104 may be integrally formed with the distal cap, the distal portion of the paddle assembly, or any other suitable member described herein.

[0268] The driver head 81106 is disposed at the proximal end of the shaft 81102 and configured to rotatably drive the shaft 81102 into and out of the threaded element or post 81104. The driver head 81106 can take any suitable form, such as, for example, any of the forms described in this application. With reference to FIG. 68, the coupler 81108 is attached to the distal end of the shaft 81102 and configured to be retained by a receiver 81110 ( FIG. 66 ) formed on an inner end or post 81302. The inner end or post member 81302 is configured to mechanically couple the expandable / retractable paddle frame 81300 to the coupler 81108. In this manner, when the driver head 81106 is driven to rotate the shaft 81102 clockwise (e.g., a right-hand thread configuration), the shaft 81102 rotates toward the proximal end of the width adjustment device 81100, which causes the coupler 81108 to pull on the receiver 81110 of the paddle frame 81300. As the receiver 81110 is pulled by the coupler 81108, the paddle frame 81300 begins to contract inwardly and the overall width of the paddle frame 81300 begins to decrease. Conversely, rotating the shaft 81102 clockwise (e.g., into the threaded element or post 81104) causes the paddle frame 81300 to expand outwardly. However, it will be appreciated that other configurations are also contemplated. For example, in some implementations, rotating the shaft 81102 clockwise causes the paddle frame 81300 to contract inwardly. It will therefore be appreciated that a wide variety of configurations are contemplated for expanding or contracting the paddle frame.

[0269] FIG. 67 illustrates an embodiment of a width adjustment device 81100 configured to expand or contract a paddle frame of an implantable device or implant. The width adjustment device 81100 can take any suitable form, such as, for example, any of the forms described in this application. Moreover, any of the implantable devices or implants and width adjustment devices described herein may incorporate the features of the width adjustment device 81100. In the illustrated embodiment, the width adjustment device 81100 of FIG. 67 is substantially identical to the embodiment shown in FIG. 66, except that the inner end or post 81302 is partially split along a parting line 81304. The split inner end or post 81302 connects the coupler 81108 to the paddle frame 81300. The paddle frame 81300 can be partially housed within a distal portion 81305 (e.g., a distal cap) of the implantable device or implant. In particular, the sheathable portions 81300a and 81300b of the paddle frame 81300 can be drawn into and through the distal portion 81305 into the cavity formed by the female threaded post 81104. In this manner, the driver head 81106 causes the coupler to retract the paddle frame 81300 and pull the receiver 81110 to draw the sheathable portions 81300a, 81300b through the distal portion 81305. A retracting paddle frame is particularly advantageous when an implantable device or implant must be maneuvered through a tight space, such as, for example, through chordae tendineae (e.g., when deploying a device).

[0270] 69, an exemplary implementation of a width adjustment device is shown. Any of the implantable devices or implants and width adjustment devices described herein may incorporate the mechanism of the width adjustment device 81500. In the illustrated embodiment, the width adjustment device 81500 includes an engagement member or actuator 81502 that can be coupled to a width adjustment element (e.g., a width adjustment control, a width adjustment wire, a width adjustment shaft, a width adjustment tube, a width adjustment line, a width adjustment cord, a width adjustment suture, a width adjustment tether, etc.), a receiver such as the illustrated parallel racks 81504, and a coupler 81506. Each rack 81504 includes teeth 81505 (e.g., a ratchet mechanism) configured to limit the movement of the coupler 81506 to a single direction when the coupler is in an engaged state. In the illustrated embodiment, the coupler 81506 is coupled to the paddle frame 81530 by a connecting portion 81520. In some implementations, the coupler 81506, the connecting portion 81520, and the paddle frame 81530 can be formed as a single integral component.

[0271] 69, an arm 81508 is formed on the coupler 81506 and configured to engage a protrusion 81510 of the actuator 81502 (see, e.g., the cross-sectional view of FIG. 69). A resilient finger 81512 is also formed on the coupler 81506 and configured to engage a tooth 81505 of the rack 81504 to prevent the coupler 81506 from moving downwardly or distally along path L of the rack 81504.

[0272] Still referring to FIG. 69, the actuator 81502 may be driven in the direction indicated by the arrow L. When the actuator 81502 is driven upward, the protrusion 81510 of the actuator 81502 pulls the coupler 81506 via the arm 81508 of the coupler 81506. As a result, the resilient finger 81512 ratchet along the teeth 81505 of the rack 81504, thereby allowing the coupler 81506 to move upward when the actuator 81502 moves upward. At the same time, the coupler 81506 causes the connecting portion 81520 to pull the paddle frame 81530, causing the paddle frame 81530 to contract. In such an implementation, the position of the resilient finger 81512 relative to each of a plurality of separate positions (i.e., teeth) on the rack 81504 may each correspond to a particular width of the paddle frame.

[0273] Conversely, when the actuator 81502 is driven downward, the protrusion 81510 of the actuator 81502 presses against the resilient angled surface 81514 of the coupler 81506. As such, the protrusion 81510 causes 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 downward or distally to expand the paddle frame 81530.

[0274] 70-84, an exemplary implementation of an implantable device or implant 91000 is shown. The implantable device or implant 91000 includes a proximal or mounting portion 91005, an anchor portion 91006 including a paddle frame 91024, an actuating portion 91050, and a distal portion 91007. The paddle frame 91024 has a height H (FIG. 73) between the proximal portion 91005 and the distal portion 91007. The anchor portion 91006 includes an inner paddle 91022 and an outer paddle 91020. The mounting portion 91005, the distal portion 91007, the anchor portion 91006, and the actuating portion 91050 may be configured in a variety of ways.

[0275] The paddle frame 91024 is configured to reduce contact and / or friction between the natural structures of the heart, such as, for example, ligaments, and the device 91000, so that the device can be more easily maneuvered into position for implantation within the heart. That is, the paddle frame 91024 is configured to move between an expanded state and a stenotic state. When the paddle frame 91024 is in a stenotic state, contact between the natural structures of the heart and the device 91000 is reduced. The device 91000 may include any other features of an implantable device or implant described in this application or in the applications or patent documents incorporated herein by reference, and the device 91000 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). In addition, any of the devices described herein may incorporate the features of the device 91000.

[0276] In the illustrated embodiment of FIGS. 70-86, the paddle frame 91024 is symmetrical along longitudinal plane Y (FIG. 73) and symmetrical along longitudinal plane Z (FIG. 70). However, in some implementations of the device or implant 91000, the paddle frame 91024 is not symmetrical about one or both of plane Y and plane Z. The paddle frame 91024 includes a first frame side 91052 and a second frame side 91054 that is a mirror image of the first side 91052 (FIGS. 72-86).

[0277] In the illustrated embodiment of FIGS. 70-74, the paddle frame 91024 includes an outer frame portion 91056, an intermediate frame member 91058, and an inner frame portion 91060. In FIG. 70, the outer frame portion 91056 is shown in an expanded state such that the outer frame portion 91056 defines an expanded state paddle frame width WE and an expanded state paddle frame depth DE (FIG. 74). The outer frame portion 91056 is attached to the intermediate frame member 91058 at a proximal portion 91005 and includes a distal end 91062. The outer frame portion 91056 may be curved and form a semicircular or U-shape. However, in some implementations, the outer frame portion 91056 may be shaped in other manners.

[0278] The intermediate frame member 91058 extends from a connecting portion 91064 with the outer frame portion 91056 near or at the proximal portion 91005 and is attached at the distal portion 91007 via a connecting portion 91066. The intermediate frame member 91058 also includes an inner end, which in the illustrated embodiment is configured as a protrusion or post 91068 (FIGS. 70 and 71) that extends 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 embodiment, the post 91068 has a cylindrical outer side 91069 and an end surface 91071 perpendicular to the outer side (see FIG. 75).

[0279] The inner frame portion 91060 extends from a connecting portion 91070 with the outer frame portion 91056 near or at the proximal portion 91005 and includes a retaining portion 91072 near or adjacent the distal portion 91007 for engaging a post 91068. The retaining portion 91072 is described in more detail below with respect to Figures 75-80.

[0280] The first frame side 91052 and the second frame side 91054 can optionally contact each other along the axis Y toward the distal portion 91007 and separate toward the proximal end 91005, thereby forming a V-shape, as shown, for example, in FIG. 72.

[0281] 71-73, the outer paddle 91020 is connected to the retaining portion 91072 at the distal portion 91007 via a connecting portion 91021, and to the inner paddle 91022 by a connecting portion 91023. The inner paddle 91022 is connected to an interface portion or inner member (not shown) by a connecting portion 91025. With reference to FIGS. 71-73, the inner paddle 91022 is not connected to the retaining portion 91072. Instead, the inner paddle 91022 forms an opening or gap 91080 through which the retaining portion 91072 extends.

[0282] 75-80, there is illustrated a method of assembling the retention portion 91072 to the post 91068. The retention portion 91072 includes a first retention portion 91082 and a second retention portion 91084 that is spaced apart from and is a mirror image of the first retention portion 91082. Each of the inner frame portion 91060 and the retention portion 91072 includes an inner side 91086, an outer side 91088 opposite the inner side 91086, and a distal end 91087.

[0283] The inner side 91086 of the inner frame portion 91060 includes an inner transition portion 91090 that forms a seat. In the illustrated example, the inner transition portion 91090 is formed as an inner curved surface. However, in some implementations, the inner transition portion 91090 may be formed in any suitable manner, such as, for example, an inclined or tapered surface, a stepped surface, or any other suitable inner transition portion. The inner side 91086 extends axially from the inner transition portion 91090 toward the distal portion 91007 to form a gap 91092 configured to receive the post 91068.

[0284] Each of the outer sides 91088 of the inner frame portion 91060 includes a first recessed portion 91094. In the illustrated embodiment, the first recessed portion 91094 is formed axially closer to the distal portion 91007 than the location where the inner transition portion 91090 is disposed. Each of the first recessed portions 91094 includes a second recessed portion 91096 that is recessed relative to the first recessed portion 91094. In the illustrated embodiment, the second recessed portion 91096 is located at a portion of the first recessed portion 91094 closest to the distal portion 91007. The second recessed portion 91096 is configured to receive the connecting portion 91021 of the outer paddle 91020.

[0285] The first recessed portion 91094 is configured to receive an annular retaining member 91098. The annular retaining member 91098 can be a ring, a washer, a nut, or the like. The annular retaining member 91098 includes an inner passage 91100 configured to receive the post 91068 therethrough. The inner passage 91100 has a diameter D1 that is less than a combined width W11 of the distal end 91087 and the gap 91092 in an uncompressed state, as shown in FIG.

[0286] Figure 70 illustrates an assembled state for the device 91000, where the post 91068 is received through the gap 91092 in the retaining portion 91072. To assemble the device 91000, the post 91068, the connecting portion 91066 of the middle frame member 91058, and the retaining portion 91072 of the inner frame portion 91060 are pulled away from one another along the plane X, as indicated by arrow G, as shown in Figure 75.

[0287] The paddle frame 91024 may be made of or include a material that allows the posts 91068, the connecting portions 91066 of the middle frame member 91058, and the retaining portions 91072 of the inner frame portion 91060 to be pulled apart from one another. For example, the paddle frame 91024, or portions thereof, may be made of a metal fabric such as a mesh, woven fabric, braid, or any other suitable method or flexible material that is laser cut or otherwise cut. The material may be a fabric, a shape memory alloy wire such as, for example, Nitinol, to provide shape setting capabilities, or any other flexible material suitable for implantation within the human body.

[0288] In some implementations, some portions of the paddle frame 91024 can be harder or stiffer than other portions. For example, in the illustrated embodiment of the paddle frame 91024, the inner frame portion 91060 can be configured to be stiffer than the outer frame portion 91056. The inner frame portion 91060 can be configured in a variety of ways to be stiffer or stiffer. For example, the thickness of the inner frame portion 91060 and / or the material used for the inner frame portion 91060 can provide greater stiffness. In some implementations, the thickness of the inner frame portion 91060 can be greater than the outer frame portion 91056 to provide greater stiffness. Additionally, in some implementations, the material used for the inner frame portion 91060 can be a stiffer material to provide greater stiffness.

[0289] Once the post 91068 and connecting portion 91066 are separated from the retaining portion 91072, the annular retaining member 91098 and the connecting portion 91021 of the outer paddle 91020 can be disposed therebetween. As shown by arrow H in FIG. 76, the distal ends 91087 of the first retaining portion 91082 and the second retaining portion 91084 can be compressed toward one another 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 D1 of the passage 91100 of the annular retaining member 91098. Thus, the distal ends 91087 can be received through the passage 91100 and between the connecting portion 91021 of the outer paddle 91020, as shown by arrow I in FIG.

[0290] 77 , once the distal end 91087 is received through the passage 91100 and between the connecting portion 91021 of the outer paddle 91020, the annular retaining member 91098 can be aligned with the first concave portion 91094 and the connecting portion 91021 of the outer paddle 91020 can be aligned with the second concave portion 91096. The distal end 91087 can then be released, as indicated by arrow J, to return toward a non-compressed state while the annular retaining member 91098 is received within the first concave portion 91094 and the connecting portion 91021 of the outer paddle 91020 is received within the second concave portion 91096.

[0291] The distal end 91087 can be configured to apply an outward biasing force to the annular retaining member and / or the connecting portion 91021 of the outer paddle 91020 to provide a secure attachment between the annular retaining member and / or the connecting portion 91021 of the outer paddle 91020. As shown in FIG. 78 , once the annular retaining member 91098 is received within the first recessed portion 91094 and the connecting portion 91021 of the outer paddle 91020 is received with the second recessed portion 91096, the post 91068 and the connecting portion 91066 of the intermediate frame member 91058 can be released such that the post 91068 can be received through the gap 91092 and the end face 91071 extends beyond the inner transition portion 91090.

[0292] 75-80 show two connecting portions 91021 of the outer paddle 91020. For example, the outer paddle 91020 can be articulatedly attached to the distal portion 91007. However, FIGS. 70 and 71 show an implementation in which the connecting portions 91021 of the outer paddle 91020 are not articulatedly attached and are offset. Thus, the retaining portion 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 located on the inner surface 91086 or on the outer surface 91088 of the retaining portion 91072.

[0293] Referring to FIG. 79, the actuating portion 91050 of the device or implant 91000 is configured to both facilitate moving the paddle frame 91024 between the expanded and constricted positions and to move the paddles of the device 91000 between the closed and open positions. The actuating portion 91050 can be configured in a variety of ways. Any structure that can selectively move the paddle frame 91024 between the expanded and constricted positions and move the paddles of the device between the closed and closed positions can be used. In some implementations, the actuating portion is configured such that advancing and retracting the actuating portion itself opens and closes the device, and advancing and retracting the inner ends or posts within the receiver narrows and widens the paddles. For example, the actuating portion moves a stiffer inner paddle frame portion to open and close the paddles in the same or similar manner as shown in FIGS. 8-15.

[0294] In the illustrated embodiment, 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 over the post 91068, as indicated by arrow K. The receiver and coupler can be the same or similar to these other implementations described herein.

[0295] The sleeve 91102 may be configured in a variety of ways. In the illustrated embodiment, the sleeve 91102 includes a cylindrical sidewall 91104 that extends from a proximal end 91106 to a distal end 91108 of the annular retention member 91098. The sleeve 91102 may optionally be integrally formed with the annular retention member 91098. The sleeve 91102 defines an internal passageway 91110.

[0296] The sleeve 91102 has a length L1, and the internal passageway 91110 extends through the entire length L1 of the sleeve 91102 from the proximal end 91106 to the distal end 91108. The passageway 91110 has a diameter D2 sufficient to allow the post 91068 to be received into the passageway 91110 and includes an internally threaded portion 91112.

[0297] As shown by arrow L in FIG. 79 , the distal end 91108 of the sleeve 91102 is fixedly attached to the retention portion 91072. The sleeve 91102 may be attached to the retention portion 91072 in any suitable manner. In the illustrated embodiment, the annular retention member 91098 at the distal end 91108 is attached to the second recess 91096 of the retention portion 91072. The passageway 91110 is aligned with the gap 91092 such that the post 91068 extends through the gap 91092 and into the passageway 91110.

[0298] 80 , the plug 91103 is received within the passage 91110. The plug 91103 is configured to move axially within the sleeve 91102, as indicated by arrow M. In the illustrated embodiment, the plug 91103 is cylindrical and includes a proximal end 91114, an opposing distal end 91116, and an externally threaded portion 91118. The externally threaded portion 91118 is configured to threadingly engage the internally threaded portion 91112 of the sleeve 91102.

[0299] The proximal end 91114 includes a drive interface 91120 configured to engage a drive member that may rotate the plug 91103 to axially move the plug 91103 relative to the sleeve 91102. The drive interface 91120 may be any suitable interface. For example, the drive interface 91120 may be a drive recess, such as a slotted, hex, 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.

[0300] 81-83, in the expanded state, most or a majority of the posts 91068 are received within the receiver 91102 and the device 91000 has a width WE and a depth DE defined by the position of the outer frame portion 91056. The plug 91103 is shown extending from the receiver 91102 toward a proximal portion 91005 of the device 91000. However, in some implementations, the plug does not extend beyond the proximal end of the receiver 91102 and the actuation rod is coupled to the plug 91103 within or at the end of the receiver 91102.

[0301] As shown in FIG. 83, for the illustrated embodiment, in the expanded state, a 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).

[0302] 79 and 80, in operation, to move the device 91000 from an expanded position to a constricted position, a coupler, such as the illustrated plug 91103, may be moved axially relative to a receiver, such as the illustrated sleeve 91102. For example, the plug 91103 may be rotated via the drive interface 91120 to move the plug 91103 axially relative to the sleeve 91102. As the plug moves toward the distal end 91108 of the sleeve 91102, the distal end 91116 of the plug 91103 engages the proximal end 91071 of the post 91068, moving the post 91068 in the same direction (i.e., away from the proximal portion 91005 of the device).

[0303] As shown in Figures 84-86, movement of the post 91068 away from the proximal portion 91005 pulls the middle frame member 91058 in the same direction, as shown by arrow N in Figures 84 and 85. Due to the connection of the middle frame member 91058 to the outer frame portion 91056 at the connection portion 91064, movement of the middle frame member 91058 in a direction away from the proximal portion 91005 pulls the outer frame portion 91056 inward (i.e., to a constricted position), as shown by arrow O in Figures 84 and 86, such that the device 91000 has a constricted position width WN that is narrower than the expanded position width WE.

[0304] When the device 91000 is narrowed in width to a constricted position, the device 91000 may also widen in depth, as shown by arrow P in Figs. 85 and 86. As shown in Fig. 86, in the constricted position, the device 91000 has a depth DN that is greater than the depth DE in the expanded position. In addition, the top view of the device 91000 changes from a lenticular shape in the expanded position to a circular or elliptical shape in the constricted position, as shown in Fig. 86. Thus, the paddle frame 91024 may be moved between the expanded and constricted positions by rotating the plug 91103 within the sleeve 91102.

[0305] 87-92, an exemplary implementation of an implantable device or implant 91200 is shown. The implantable device or implant 91200 includes a proximal or mounting portion 91205, an anchor portion 91206 (FIG. 88), a paddle frame 91224, an actuating portion 91050, and a distal portion 91207. The paddle frame 91224 has a height H2 (FIG. 88) between the proximal portion 91205 and the distal portion 91207. With reference to FIG. 88, the anchor portion 91206 includes an inner member 91209, an inner paddle 91222, and an outer paddle 91220. The mounting portion 91205, the distal portion 91207, the anchor portion 91206, the actuating portion 91050, and the paddle frame 91224 may be configured in a variety of ways.

[0306] In the illustrated embodiment of FIGS. 87 and 88, the paddle frame 91224 is symmetrical along longitudinal axis T (FIG. 88) and symmetrical along longitudinal axis V (FIG. 87). However, in some implementations of the device or implant 91200, the paddle frame 91224 is not symmetrical about one or both of axes T and V. The paddle frame 91224 includes a first frame side 91252 and a second frame side 91254 that is a mirror image of the first side 91252 (FIG. 88).

[0307] In the illustrated implementation, the paddle frame 91224 includes an outer frame portion 91256 and an inner frame portion 91260. In FIG. 87, the outer frame portion 91256 is shown in an expanded state such that the outer frame portion 91256 defines a paddle frame expanded width WE2 (FIG. 89).

[0308] The outer frame portion 91256 is flexibly attached at a proximal portion 91205 and flexibly attached at a distal portion 91207. The outer frame portion 91256 is attached at the distal portion 91207 by a connecting portion 91266. The outer frame portion 91256 is curved and forms a generally circular or elliptical shape. However, in some implementations, the outer frame portion 91256 can be shaped in other manners.

[0309] The outer frame portion 91256 also includes an inner end that may be configured as a protrusion or post 91268 that extends axially along the axis V from the distal portion 91207 toward the proximal portion 91205. The inner end or post 91268 may be configured in a variety of ways. In the illustrated embodiment, the inner end is configured as a post 91268 having an outer surface 91269 that may be formed by multiple sidewalls that form a polygonal cross-section, or the outer surface 91269 may have one flat side and a semi-cylindrical surface. The post 91268 may have an end surface 91271 that is perpendicular to the sidewalls.

[0310] The inner frame portion 91260 extends from a first connecting portion 91270 with the outer frame portion 91256 near or at the proximal portion 91205 and includes a second connecting portion 91272 near or adjacent the distal portion 91207 that connects to the post 91268. The first frame side 91252 and the second frame side 91254 can contact one another along the axis T toward the distal end 91207 and separate toward the proximal end 91205, forming a V-shape, for example, as shown in FIG.

[0311] The inner member 91209 may be part of an interface element, such as interface element 210 of FIG. 22, or may be attached to the interface element by any suitable means. As shown in FIG. 88, the outer paddle 91220 is joinably attached at a distal portion 91207 by a connecting portion 91221 and to the inner paddle 91222 by a connecting portion 91223. The inner paddle 91222 is flexibly attached to the inner member 91209 by a connecting portion 91225. The inner paddle 91222 and the inner member 91209 are not connected to the connecting portion 91272 as shown in FIG.

[0312] In this manner, the anchor is configured similarly to a leg, in that the inner paddle 91222 is like an upper portion of a leg, the outer paddle 91220 is like a lower portion of a leg, and the connecting portion 91223 is like a knee portion of a leg.

[0313] 87, the connecting portion 91272 includes a first retaining portion 91282 and a second retaining portion 91284 that is spaced apart from and is a mirror image of the first retaining portion 91282. The inner frame portion 91260 includes an inner transition portion 91290. In the illustrated embodiment, the inner transition portion 91290 is formed as an inner curved surface. However, in some implementations, the inner transition portion 91290 can be formed in any suitable manner, such as, for example, an inclined or tapered surface, a stepped surface, or any other suitable inner transition portion.

[0314] The retention portions 91282, 91284 extend axially from the inner transition portion 91290 toward the distal end 91207 and form a gap 91292 configured to receive the post 91268. Each of the retention portions 91282, 91284 includes an outer concave portion 91294. In the illustrated embodiment, the concave portion 91294 is formed axially closer to the distal end 91207 than the inner transition portion 91290 is disposed at.

[0315] The recessed portion 91294 is configured to receive the annular retaining member 91098 of the post 91268 and the connecting portion 91221 of the outer paddle 91220. The annular retaining member 91098 may be configured similarly to the annular retaining member 91098, and thus the descriptions relating to the annular retaining member 91098 apply equally to the annular retaining member 91098. The annular retaining member 91098 may be a ring, washer, nut, or the like that is connected to the post 91268. In the illustrated embodiment, the annular retaining member 91098 is integrally formed with the post 91268.

[0316] 87 illustrates an assembled state for device 91200, where post 91268 is received through gap 91292 in connecting portion 91272, and retaining member 91098 and connecting portion 91221 of outer paddle 91220 are received within recessed portion 91294. Device 91200 is assembled in the same manner as device 91000. For example, post 91268 and connecting portion 91266 of outer frame portion 91256 and connecting portion 91272 of inner frame portion 91260 are pulled away from one another along axis V.

[0317] The paddle frame 91224 can be made of or can include a material that can separate the posts 91268 and the connecting portion 91266 of the outer frame portion 91256 from the connecting portion 91272 of the inner frame portion 91260. For example, the paddle frame 91224, or portions thereof, can be made of a laser cut or otherwise cut flexible material, such as metal, plastic, or the like.

[0318] In the illustrated embodiment of FIGS. 87-92, the connecting portion 91266 is stiffer such that the outer frame portion 91256 is more likely to retain its overall shape when the post 91268 is extended to constrict the outer frame portion. The connecting portion 91266 can be configured in various ways to be stiffer. For example, the thickness of the connecting portion 91266 and / or the material used for the connecting portion can provide the stiffer stiffness. In some implementations, the thickness of the connecting portion 91266 can be greater than the outer frame portion 91256 to provide the stiffer stiffness. Additionally, in some implementations, the material used for the connecting portion 91266 can be a stiffer material to provide the stiffer stiffness.

[0319] Once the post 91268 and connecting portion 91266 are separated from the connecting portion 91272, the annular retention member 91098 and the connecting portion 91221 of the outer paddle 91220 can be disposed therebetween and the distal ends of the first retaining portion 91282 and the second retaining portion 91284 can be compressed toward one another. The annular retention member 91098 can be received over the first retaining portion 91282 and the second retaining portion 91284 in the compressed state.

[0320] The connection portion 91221 of the annular retaining member 91098 and the outer paddle 91220 can be aligned in the concave portion 91294, after which the retaining portions 91282, 91284 can be released and return toward an uncompressed state, capturing the connection portion 91221 of the annular retaining member 91098 and the outer paddle 91220 within the concave portion 91294.

[0321] Once the connection portion 91221 of the annular retaining member 91098 and the outer paddle 91220 is received within the recessed portion 91294, the post 91268 and the connection portion 91266 of the outer frame portion 91256 can be released such that the post 91268 can be received through the gap 91292 and the end face 91271 extends beyond the inner transition portion 91290.

[0322] The actuating portion 91050 of the device or implant 91200 is configured to both move the paddle frame 91224 between the expanded and constricted positions and to move the paddle between the closed and open positions. The actuating portion 91050 can be configured in a variety of ways. For example, any structure that can selectively move the paddle frame 91224 between the expanded and constricted positions and move the device between the open and closed positions can be used, such as the actuating portion 91050 of FIGS. 79 and 80. In some implementations, the actuating portion is configured such that advancing and retracting the actuating portion itself opens and closes the device, and advancing and retracting the posts within the actuating portion narrows and widens the paddle. For example, the inner paddle frame portion is moved by the actuating portion to open and close the paddle in the same or similar manner as shown in FIGS. 23, 27, and 30-37.

[0323] 87, in the illustrated embodiment, 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 or widen the paddle. The sleeve 91202 and plug (not shown) may be configured the same as or similar to the sleeve 91102 and plug 91103 of the device 91000 of FIGS. 79 and 80, and thus the discussion regarding the sleeve 91102 and plug 91103 applies equally to the sleeve 91202 and plug (not shown) of the embodiment of FIGS. 87-92.

[0324] As shown in FIG. 87, the sleeve 91202 is fixedly attached to the connecting portion 91272 such that the post 91268 can be received within the passageway 91210 extending through the sleeve 91202 .

[0325] 89-92, in operation, to move the device 91200 from an expanded position to a constricted position, a plug (not shown) can be moved axially relative to the sleeve 91202. As the plug moves toward the distal end 91207, it engages the distal end 91271 of the post 91268, moving the post 91268 in the same direction (i.e., away from the proximal portion 91205 of the device).

[0326] Movement of the post 91268 away from the proximal portion 91205 pulls the distal end of the outer frame portion downward, as shown by arrow Q in Fig. 91, while the stiffer inner frame portion maintains the position of the proximal end of the outer frame portion. As a result, the outer frame portion 91256 is pulled inward (i.e., to the constricted position), as shown by arrow R in Fig. 91. The device 91200 has a width WN2 in the constricted position (Fig. 92) that is narrower than the width WE2 in the expanded position.

[0327] 89-92, when the device 91200 moves between the expanded and constricted positions, the outer frame portions 91256 move inwardly while the stiffer connecting portions 91266 tend to retain their shape or deform only slightly, as shown in FIG. 92. In the constricted position, each of the outer frame portions 91256 can optionally be configured to form a concave portion or recess 91299 proximate a midpoint between the proximal portion 91205 and the distal portion 91207 when the outer frame portions are contracted.

[0328] 93 and 94, an exemplary implementation of an implantable device or implant 92100 is shown. The implantable device or implant 92100 includes a proximal or mounting portion 92105, a paddle frame 92124, an anchor portion 92106 attached to the paddle frame 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 frame 92124 may be configured in a variety of ways.

[0329] 93 and 94, the paddle frame 92124 is symmetrical along a longitudinal axis XX (FIG. 94). However, in some implementations of the device or implant 92100, the paddle frame 92124 is not symmetrical about the axis WW.

[0330] In the illustrated implementation, the paddle frame 92124 includes an outer frame portion 92156 and an inner frame portion 92160. In Figures 93 and 94, the outer frame portion 92156 is shown in an expanded state such that the outer frame portion 92156 defines a paddle frame expanded width WE10 (Figure 93).

[0331] The outer frame portion 92156 is flexibly attached to the attachment portion 92168 at the distal portion 92107 via a connecting portion 92166 and is coupled to the inner frame portion 92160 at the proximal portion 92105 via a connecting portion 92167. Between the connecting portion 92166 and the connecting portion 92167, the outer frame portion 92156 forms a curved convex shape. For example, in the illustrated embodiment, the shape of the outer frame portion 92156 resembles an apple shape, with the outer frame portion being wider toward the proximal portion 92105 and narrower toward the distal portion 92107. However, in some implementations, the outer frame portion 92156 may be shaped in other manners.

[0332] The mounting portion 92168 is configured to mount the width adjustment device 81500 to the outer frame portion 92156. The mounting portion 92168 may be configured in a variety of ways. Any configuration that suitably mounts the outer frame portion 92156 to the width adjustment device 81500 such that the width adjustment device 81500 can move the outer frame portion 92156 between a constricted position and an expanded position may be used.

[0333] The inner frame portion 92160 is articulatedly attached to the outer frame portion 92156 at a proximal portion 92105 via a connecting portion 92170 and extends from the connecting portion 92170 to a distal portion 92107. The inner frame portion 92160 includes a retaining portion 92172 near or adjacent the distal portion 92107 for attachment to a width adjustment device 81500. The retaining portion 92172 and the width adjustment device 81500 may be configured to be attached in any suitable manner.

[0334] The width adjustment device 81500 is configured to move the outer frame portion 92156 from an expanded position to a constricted position by retracting a portion of the mounting portion 92168 and the connecting portion 92166 into the width adjustment device 81500. The width adjustment device 81500 is configured to move the inner paddle frame portion 92160 to open and close the paddle in a manner the same as or similar to that shown in Figures 23, 27, and 30-37.

[0335] The width adjustment device 81500 includes a width adjustment connection or actuator 81502, a receiver (which may be configured as parallel racks 81504), and a coupler 81506. Each rack 81504 includes teeth 81505 (e.g., a ratchet mechanism) configured to limit movement of the coupler 81506 to a single direction when the coupler is in an engaged state. In the illustrated embodiment, the coupler 81506 is coupled to the outer paddle frame 92156 by a connecting portion 92168.

[0336] 93 , an arm 81508 is formed on the coupler 81506 and configured to engage a protrusion 81510 of the actuator 81502. A resilient finger 81512 is also formed on the coupler 81506 and configured to engage a tooth 81505 of the rack 81504 to prevent the coupler 81506 from moving downwardly or distally along path L of the rack 81504.

[0337] 93, the actuator 81502 can be driven in either direction along the axis XX. When the actuator 81502 is driven upward, the protrusion 81510 of the actuator 81502 pulls the coupler 81506 via the arm 81508 of the coupler 81506. As a result, the resilient finger 81512 ratchet along the teeth 81505 of the rack 81504, thereby allowing the coupler 81506 to move upward when the actuator 81502 moves upward. At the same time, the coupler 81506 causes the connecting portion 92168 to pull the outer paddle frame portion 92156, causing the outer frame portion 92156 to contract. In such an embodiment, the position of the resilient finger 81512 relative to each of a plurality of distinct positions (i.e., teeth) on the rack 81504 can correspond to a particular width of the outer paddle frame portion.

[0338] Conversely, when the actuator 81502 is driven downward, the protrusion 81510 of the actuator 81502 presses against the resilient angled surface 81514 of the coupler 81506. As such, the protrusion 81510 disengages the resilient fingers 81512 from the rack 81504. Thus, when the actuator is moved downward or distally to expand the outer paddle frame portion 92156, the coupler 81506 disengages from the rack 81504.

[0339] The paddle frame 92124 can be made of or include a material that can retract a portion of the mounting portion 92168 and the connecting portion 92166 into the width adjustment device 81500. For example, the paddle frame 92124 or portions thereof can be made of flexible metal, plastic, fabric, suture, etc. The paddle frame 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.

[0340] 95-99, an exemplary implementation of a connection mechanism between the rigid inner frame portion 7672 and the flexible outer frame portion 7675 of the paddle frame 7670 is shown. As shown in FIGS. 95 and 96, the proximal end of the flexible outer portion 7675 connects to the proximal end of the rigid inner portion 7672 via a pivot connection. The pivot connection may be achieved via pins, stitches, adhesives, or any other similar means for allowing the flexible outer portion 7675 to move relative to the rigid inner portion 7672. The proximal ends of the rigid inner portion 7672 and the flexible outer portion 7675 may connect via at least one pin connection. In an exemplary implementation, the proximal end of the rigid inner portion 7672 has a first opening 7673A and a second opening 7674B for receiving a pin, stitch, or pin portion of the flexible outer frame 7675.

[0341] The flexible outer frame 7675 comprises a first portion 7671A and a second portion 7671B. A proximal end 7674A of the first portion 7671A is configured to connect to the rigid inner portion 7672 via a first opening 7673A. A proximal end 7674B of the second portion 7671B is configured to connect to the rigid inner portion 7672 via a second opening 7673B. These connections may include pin connections such that a pin (not shown) extends through the first opening 7673A and through the proximal end 7674A of the first portion 7671A of the flexible outer portion 7675, and a pin extends through the second opening 7673B and through the proximal end 7674B of the second portion 7671B of the flexible outer portion 7675. The pins may also be stitches, connector elements, or integral extensions of the proximal end 7674A of the first portion 7671A and the proximal end 7674B of the second portion 7671B of the flexible outer frame 7675.

[0342] 97 shows a rigid inner portion 7672 having a first opening 7673A and a second opening 7673B. A first portion 7671A of a flexible outer portion 7675 is connected to the rigid inner portion 7672 by attaching a proximal end 7674A of the flexible outer portion 7675 to the first opening 7673A of the rigid inner portion 7672. A second portion 7671B of the flexible outer portion 7675 is connected to the rigid inner portion 7672 by attaching a proximal end 7674B of the flexible outer portion 7675 to the second opening 7673B of the rigid inner portion 7672. The proximal ends 7674A, 7674B may be attached to the first portion 7671A and the second portion 7671B of the flexible outer portion 7675 via a pin connection, a pivot connection, lamination, or any other means. The flexible outer portion 7675 of the paddle frame 7670 can be above the rigid inner portion 7672, as shown in Fig. 97. Alternatively, the flexible outer portion 7675 can be below the rigid inner portion 7672, as shown in Fig. 99. Fig. 98 is a partial side view of this embodiment of the paddle frame 7670.

[0343] 100-102, one embodiment of a connection mechanism between the rigid inner portion 7672 and the flexible outer portion 7675 of the paddle frame 7670 is shown. As shown in FIGS. 100 and 102, the proximal end 7676 of the flexible outer portion 7675 may be laminated or otherwise attached to the proximal end of the rigid inner portion 7672. The inner portion 7672 and the outer portion 7675 may additionally or alternatively be pivotally connected via a first pivot point 7677A and a second pivot point 7677B. The pivotal connection allows the flexible outer portion 7675 to bend relative to the rigid inner portion 7672. The pivotal connection may be achieved via pins, stitches, connecting elements, adhesives, or any other similar means by which the flexible outer portion 7675 may move relative to the rigid inner portion 7672. In this embodiment, the pivot connection is such that the flexible outer portion 7675 is located outside of the rigid inner portion 7672. However, as shown in FIG. 102, the flexible outer portion 7675 can also be located inside the rigid inner portion 7672.

[0344] The proximal ends of the rigid inner portion 7672 and the flexible outer portion 7675 may connect via at least one pivot. In some implementations, the proximal end of the rigid inner portion 7672 has a first opening 7673A and a second opening 7673B for receiving a pin, stitch, connecting element, or pin portion of the flexible outer frame 7675. The flexible outer frame 7675 includes a first portion 7671A and a second portion 7671B. A first pivot point 7677A of the first portion 7671A is configured to connect to the rigid inner portion 7672 via the first opening 7673A. A second pivot point 7677B of the second portion 7671B is configured to connect to the rigid inner portion 7672 via the second opening 7673B. These connections may include pin connections such that a pin (not shown) extends through a first opening 7673A and through a proximal end 7674A of a first portion 7671A of the flexible outer portion 7675, and a pin extends through a second opening 7673B and through a proximal end 7674B of a second portion 7671B of the flexible outer portion 7675. The pin may also be an integral extension of the proximal end 7674A of the first portion 7671A and the proximal end 7674B of the second portion 7671B of the flexible outer frame 7675. FIG. 101 shows a partial side view of this embodiment of a paddle frame 7670.

[0345] 103-105, one embodiment of a connection mechanism between the rigid inner portion 7672 and the flexible outer portion 7675 of the paddle frame 7670 is shown. The proximal ends of the inner portion 7672 and the outer portion 7675 of the paddle frame 7670 are integrally joined together. This connection may be formed from one unitary member having a first pivot point 7678A and a second pivot point 7678B. The first pivot point 7678A is located at the integration point between the first portion 7671A of the flexible outer portion 7675 and the rigid inner portion 7672. The second pivot point 7678B is formed from the integration point between the second portion 7671B of the flexible outer portion 7675 and the rigid inner portion 7672. Although the flexible outer portion 7675 and the rigid inner portion 7672 are formed by a single member, the flexible outer portion 7675 can bend relative to the rigid inner portion 7672 via a first pivot point 7678A and a second pivot point 7678B.

[0346] 106 and 107, one embodiment of a connection mechanism between a rigid inner portion 7672 and a flexible outer portion 7675 of a paddle frame 7670 is shown. In this embodiment, the proximal ends of the outer portion 7672 and the inner portion 7675 of the paddle frame 7670 are nested together. The flexible outer portion 7675 can have an opening 7679 within the proximal end of the rigid inner portion 7672 and proximate to the first opening 7673A and the second opening 7673B. The inner portion 7672 and outer portion 7675 of the paddle frame 7670 may be connected by any means, including, but not limited to, nesting together inside the cover, sewing together through openings 7679, 7673A, 7673B, or connecting via a connector (not shown) extending between the first opening 7673A and the second opening 7673B and the opening 7679 on the flexible outer portion 7675.

[0347] 108A-108G show an example cap 100100 that reduces the stress applied to the portion of the paddle frame 224 that is drawn in by the cap by providing a rounded lead-in point or rounded hole in the cap 100100. This rounded lead-in point increases the radius of curvature of the portion of the paddle frame that is drawn into the cap, thus reducing the stress introduced to the paddle frame. The rounded hole or rounded lead-in point 100110 in the cap 100100 can guide the paddle frame 224 through a series of deflections.

[0348] FIG. 108A shows the cap 100100 engaged with the paddle frame 224. FIG. 108B shows an enlarged view of the cap 100100 with the paddle frame 224 omitted for clarity. Both FIG. 108A and FIG. 108B show the cap 100100 in cross section. FIG. 108C shows an exterior side view of the cap 100100 and paddle frame 224 arrangement shown in FIG. 108A. As shown in FIG. 108A and FIG. 108B, the cap 100100 includes a rounded hole or lead-in point 100110 that receives at least the inner end 224a of the paddle frame 224.

[0349] The rounded holes or lead-in points 100110 provide a mechanism by which the cap 100100 may control the deflection of the paddle frame 224 in a manner that introduces less stress into the paddle frame 224. In particular, the rounded holes 100110 have a radius 100112a at the distal end 100100a of the cap 100100 that is greater than the radius 100112b at the proximal end 100100b (FIGS. 108A and 108B). (Note--"proximal" and "distal" are used herein to refer to distances relative to the user.) The difference in radius between the radius 100112b and the radius 100112a is bridged by the slope S of the portion of the hole 100110 that contacts the paddle frame portion 224b. Because of the tilt S, relative movement of the cap 100100 with respect to the paddle frame 224 can apply a force F (see, e.g., FIG. 108A) to portion 224b. This force F is much smaller than if the hole 100110 were cylindrical, and the inner surface of the hole and the distal end of the cap form a right angle. Because the paddle frame 224 is generally made from a material that can substantially retain its shape without plastic deformation, force F tends to deflect the paddle frame 224 upwards / downwards along its entire length.

[0350] The paddle frame 224 may include a mounting portion 224c that allows the paddle frame 224 to be directly attached to another piece of equipment for mechanical communication. For example, the mounting portion 224c may be attached to a mechanism for drawing the paddle frame 224 into the cap to reduce the width of the paddle frame, or for pushing the paddle frame 224 out of the cap to increase the width of the paddle frame.

[0351] Deflection of the paddle frame 224 through the cap 100100 is shown in more detail in Figs. 108D and 108E. Fig. 108D shows the movement in cross section, while Fig. 108E shows the same movement in a perspective exterior side view. Figs. 108D and 108E show the deflection ranges DF1-DF4 facilitated by moving the paddle frame 224 into the cap 100100 along the D1 direction (i.e., as the paddle frame 224 is retracted into the cap). The D1 direction extends from the distal end 100100a to the proximal end 100100b of the cap 100100. The hole 100110 extends from the proximal end 100100b to the distal end 100100a of the cap 100100 to accommodate the inner end 224a of the paddle frame 224. In this manner, moving the paddle frame 224 into the cap 100100 in direction D1 causes the paddle frame 224 to deflect towards the cap 100100 (e.g., deflects the paddle frame 224 from DF4 to DF1). Pushing the paddle frame 224 out of the cap 100100 in a direction opposite to direction D1 causes the paddle frame 224 to deflect in the other outward direction (e.g., deflects the paddle frame 224 from DF1 to DF4).

[0352] FIG. 108F illustrates how the cap 100100 may be used to both deflect (expand and contract) the paddle frame 224 (as shown in FIGS. 108D and 108E) (either simultaneously or separately) and open and close the paddle frame 224 via an actuation element (e.g., the same as or similar to the actuation element 112 shown in FIGS. 8-20 or the actuation element 8102 shown in FIGS. 26-30). FIG. 108F is a cross-sectional view of the cap 100100 perpendicular to the cross-sectional view shown in FIGS. 108A and 108D. The differences in the views become apparent by comparing the relative orientation of the force F applied by the cap 100100 to deflect the paddle frame 224 in FIG. 108F with the orientation of the force F in FIGS. 108A and 108D. In FIG. 108F, the force F is directed into the plane of the paper. On the other hand, the force F is parallel to the plane of the paper in FIGS. 108A and 108D.

[0353] As shown in FIG. 108F, movement of the width adjustment element 100003 (e.g., width adjustment control, width adjustment wire, width adjustment shaft, width adjustment tube, width adjustment line, width adjustment cord, width adjustment suture, width adjustment tether, etc.) along the D1 direction results in the same movement of the paddle frame 224 into the cap 100100 discussed in view of FIGS. 108D and 108E above. On the other hand, movement along D2 represents actuation or relative movement of an actuation element (e.g., the same as or similar to the actuation element 112 shown in FIGS. 8-20 or the actuation element 8102 shown in FIGS. 26-30) and the concomitant movement of the cap 100100 to open or close the paddle frame 224. FIG. 108F illustrates how movement of the paddle frame in the D1 direction into the cap can occur independently of movement of the cap 100100 in the D1 direction, and vice versa. Movement of the paddle frame 224 in the D1 direction into the cap and movement of the cap in the D2 direction can also occur simultaneously. That is, movement of the actuation element and cap 100100 in the D2 direction can open the paddle frame 220 (as shown in FIGS. 30-36), while movement of the paddle frame in the D1 direction into the cap 100100 causes the paddle to be deflected inward (as shown in FIGS. 108D and 108E). FIG. 108G illustrates the difference in paddle motion between 1) a deflection caused by retracting the paddle into the cap 100100 in the D1 direction, and 2) the opening and closing (into and out of the page) of both the rigid and flexible portions of the paddle frame caused by moving the cap in the D2 direction by the actuation element.

[0354] As mentioned above, in some implementations, the paddle frame 224 can be narrowed / widened, stopped, locked, and held in a fully expanded, fully narrowed, and intermediate position. Locking can also be particularly useful prior to capturing the leaflets in keeping the paddle frame 224 narrow to cross potential obstacles such as chordae tendineae (CT, FIGS. 3 and 5).

[0355] In some implementations, the paddle narrowing and widening adjustment mechanism automatically holds the paddle frame 224 in the adjusted position when the mechanism is released. A wide variety of different mechanisms may be used to narrow and widen the paddle frame and automatically hold the paddle frame 224 in any adjusted position. For example, screw mechanisms, ratchet mechanisms, cam mechanisms, etc. may be used. Such mechanisms allow the user to set and maintain the paddle frame 224 at any width such that a particular paddle width is maintained without the action of active tensioning by the user. Additionally, such mechanisms may facilitate more precise control of narrowing / widening.

[0356] 109A-109E show an exemplary implementation of a paddle narrowing and widening adjustment mechanism 100299 that automatically holds the paddle frame 224 in an adjusted position when the mechanism is released. The mechanism includes a coupler, such as the rotating member 100300 shown. In addition to adjusting the width of the paddle, linear movement of the entire mechanism 100299 may be used to open and close the paddle frame with an actuating element (e.g., the same as or similar to the actuating element 112 shown in FIGS. 8-20 or the actuating element 8102 shown in FIGS. 26-30). One advantage of the rotating member 100300 is that the member may hold the paddle width without using a separate locking mechanism. Another advantage is that the rotating member 100300 may precisely control the width of the paddle frame 224. Another advantage is that a single element may be used to both open and close the paddle frame and adjust the width of the paddle frame.

[0357] In some implementations, the paddle narrowing and widening adjustment mechanism 100299 is a helical screw system that extends the paddle frame 224 by moving the inner end 224a along the axis A2. Details of this mechanism are described below. The movement of the rotating member 100300 may be driven by components located in the proximal portion 100300d of the device. It will be understood that the configurations shown in FIGS. 109A-109E are merely examples. Variations in the location of components and specific structures are possible within the scope of this disclosure. In addition, the cap 100100 is shown in FIGS. 109A-109E for illustrative purposes. It will be understood that in other variations, different caps and / or other components may be used. For example, the cap 100100 shown in FIG. 109A may be the cap 100100 shown in FIGS. 108A and 108B with one or more of the optional stress reduction features. In some implementations, the cap 100100 shown in FIG. 109A does not include the optional stress reduction feature. For example, in some implementations, the cap 100100 shown in FIG. 109A can have a cylindrical bore with an inner surface that meets the distal end of the cap at a right angle (i.e., the opening of the cap is not rounded).

[0358] 109A and 109C are cutaway cross-sectional views of the paddle narrowing and widening adjustment mechanism 100299 and how it moves the paddle frame 224. As shown in FIG. 109A and 109C, the member 100300 includes a helical portion 100300a. The cross-sectional views of the helical portion 100300a in FIG. 109A and 109C show six sections (the helical portion 100300a can have any number of sections). This is a product of the cross-sectional view. In effect, each of the six sections that make up the helical portion 100300a are joined as a ribbon of solid continuous material that forms a helix shape. The formation of the helix creates a slot 100300c between each of the six sections. The helical portion 100300a is surrounded by a receiver, such as the illustrated case 100300b. The helical portion 100300a is rotatable about axis A2, as shown in Figures 109A-109C, while the case 100300b remains fixed. The helical portion 100300a, slot 100300c, and case 100300b are shown in an external view (as opposed to a cross-sectional view) in Figure 109B.

[0359] FIG. 109A shows that the inner end 224a of the paddle frame 224 interacts with the helical portion 100300a via a protrusion 224d, such as a post. In FIG. 109A and FIG. 109C, the protrusion 224d is oriented into / out of the page from the portion 224c. FIG. 109B shows the protrusion 224d extending away from the inner end 224a of the paddle frame 224 to which it is attached. As shown in FIG. 109B, the protrusion 224d fits into a helical slot 100300c in the helical portion 100300a and into a linear slot 100300e in the case 100300b. The case 100300b is fixed against rotation of the helical portion 100300a. Thus, as the helical portion 100300a rotates about the axis A2, the protrusion 224d moves in a manner that is guided by both the slot 100300c and the slot 100300e. In particular, when the helical portion 100300a is rotated about the axis A2, the slot 100300c presses the protrusion 224d (and thus the inner end 224a) along the 100300e and thus along the axis A2. The direction in which the protrusion 224d moves along the axis A2 (i.e., either toward the cap 100100 or in the reverse direction toward the proximal portion 100300d) depends on the direction of rotation of the helical portion 100300a. As described above, as the protrusion 224d moves, the paddle frame 224 can be pulled into or pushed out of the cap 100100 depending on the direction of rotational movement. In some implementations, whenever the helical portion 100300a is stopped from rotating, the paddle narrowing and widening adjustment mechanism 100299 holds the paddle frame 224 at a corresponding width.

[0360] The mechanism for actuating the rotation of the helical portion 100300a may include, for example, a rod, handle, or other fixed member rotated by a user. The rotation may be manually actuated, electronically actuated, and / or controlled via a software / computer interface. Other implementations may include using a remotely or locally controlled stepper motor and / or any other suitable actuator. Such mechanisms may be coupled to the proximal portion 100300d in a wide variety of different ways, such as any coupling configuration disclosed herein. In some implementations, the coupling to the proximal portion 100300d facilitates both rotation of the helical portion 100300a to adjust the width of the paddle frame, and linear extension of the entire paddle narrowing and widening adjustment mechanism 100299 relative to the delivery catheter and / or relative to the joint element to open and close the paddles of the device.

[0361] Figures 109D and 109E show the rotation of the helical portion 100300a from the side of the device. In both Figures 109D and 109E, the paddle frame 224 is in its widest position. Figure 109D shows a cross-sectional view of the helical portion 100300a. Figure 109E shows this with the paddle frame configuration, but with an external view of the housing 100300b. As shown in Figure 109D, the protrusion 224d extends through the inner end 224a, through the helical slot 100300c of the helical portion 100300c, and through the elongated slot 100300e of the housing 100300b.

[0362] Figures 109F, 109G, and 109H show a portion of the paddle frame 224 in three different width positions (i.e., three different amounts of the paddle frame pulled into the paddle narrowing and widening adjustment mechanism 100299). The different positions are created sequentially by rotating the helical portion 100300a about axis A2 to move the protrusion 224d from a distal position (Figure 109F) to a more proximal position (Figure 109H).

[0363] FIG 109F illustrates the start of the movement, with the protrusion 224d proximate the cap 100100 at the distal end of the member 100300. As shown in FIG 109F, in this position, both sets of paddle frames 224 are at their widest position. The two paddle frame portions 224 are at a distance d1 from each other. As the helical portion 100300a is rotated about the axis A2, the slot 100300c presses the protrusion 224d towards the proximal end of the rotating member 100300 (e.g., towards the end 100300d).

[0364] Continuing this rotation reduces the amount of paddle frame 224 extending from cap 100100 shown in FIG. 109G, where protrusion 224d has now been moved to an intermediate position between the proximal and distal portions of rotating member 100300. Correspondingly, paddle frame 224 is now partially constricted. In this partially extended position, two paddle frames 224 have a distance d2 between each other. Paddle frames 224 may be configured such that distance d2 is greater than distance d1 (i.e., paddle frame portions move apart as they are constricted by inclusion within the mechanism) or such that distance d2 is less than distance d1 (i.e., paddle frame portions move toward each other as they are constricted by inclusion within the mechanism).

[0365] Continuing to rotate the helical portion 100300a about axis A2 presses the protrusion 224d further toward the proximal end of the member 100300 (i.e., toward 100300d). The result is shown in FIG. 109H. The paddle frame 224 is further constricted by being accommodated within the paddle constriction and widening adjustment mechanism 100299. In this position, the two paddle frames 224 have a distance d3 between them. The paddle frames 224 can be configured such that the distance d3 is greater than the distance d2 (i.e., the paddle frame portions move apart as they are constricted by being further accommodated within the mechanism) or such that the distance d3 is less than the distance d2 (i.e., the paddle frame portions move toward each other as they are constricted by being further accommodated within the mechanism).

[0366] In some implementations, the paddle frame 224 is actively constricted and passively expanded. Thus, the expanded state can be the natural or substantially stress-free shape of the paddle frame. To move the paddle frame to the constricted state, the paddle frame is stressed, causing it to bend from the expanded state to the constricted state. This stress can be localized in certain areas of the paddle frame 224, such as at the area where the paddle is introduced into the cap. As mentioned above, one way to reduce this stress is to provide a rounded or tapered introduction for the paddle to enter the cap.

[0367] In some implementations, the paddle frame is structurally modified to reduce stress in the area where the paddle frame is introduced into the cap. The paddle frame can be structurally modified to reduce stress in the area where the paddle frame is introduced into the cap in a variety of different ways. For example, the area where the paddle frame is introduced into the cap can be movably connected to the remainder of the paddle frame, the area where the paddle frame is introduced into the cap can be decoupled from the remainder of the paddle frame, or the area where the paddle frame is introduced into the cap can be connected to the remainder of the paddle frame via a flexible component.

[0368] 110A-110E show a paddle system 100350 that partially solves the problem of stress concentrations at the portion of the paddle frame 224 that is pulled into the cap by segmenting the paddle structure. The paddle system 100350 includes a connector or lower portion 224e (e.g., a shaped metal component, a shaped plastic component, a tether, wire, post, line, cord, suture, etc.) and an upper portion 224g joined by a pivot point 224f. Although FIGS. 110A-110E show the system 100350 being used in combination with the cap 100100, it will be understood that this is merely exemplary. The system 100350 may be used in combination with other components, for example, as disclosed and / or suggested herein.

[0369] Figures 110A-110C show different views of system 100350. Figures 110A-110C show pivot point 224f in the form of a hinge that allows a user to actively increase the width of paddle frame 224 by pushing inner end 224a in direction D2 (Figure 110C) and decrease the paddle width by pulling inner end 224a in the opposite direction. More specifically, pushing the inner end 224a in a direction (e.g., moving the protrusion 224d) pushes the lower portion 224e along the D3 direction while the lower portion 224e and the upper portion 224g are free to pivot relative to each other about the pivot point 224f. This then causes the upper portion 224g to curve along the D4 direction, and therefore the paddle frame 224 to expand. Pulling the inner end 224a in the opposite direction pulls the lower portion 224e into the cap 100100 while the lower portion 224e and the upper portion 224g are free to pivot relative to each other about the pivot point 224f. This then causes the upper portion 224g to curve inward (in the opposite direction D4), and therefore the paddle frame 224 to narrow.

[0370] In some implementations, the bending of the upper portion 224g is resisted and / or a counter restoring force is provided by the elastic member 224h. The elastic member 224h may automatically or passively reverse the active narrowing or widening of the paddle frame 224. The elastic member 224h may include a spring, as shown in FIGS. 110A-110C. However, it will be understood that other variations may include other types of biasing mechanisms (e.g., leaf springs, coil springs, etc.) or any other restoring mechanism described herein may be used.

[0371] As shown in FIGS. 110A and 110B, positioning the lower portion 224e between the upper portions 224g at the pivot point 224f of the system 100350 creates a spacing 100352 between adjacent upper portions 224g of the paddle frame 224. The spacing 100352 may prevent or inhibit the upper portions 224g from pinching or restricting the leaflets of the valve being repaired. That is, the spacing 100352 may reduce pinching of the free ends of the leaflets between the upper portions 224g. The spacing 100352 may be adjusted based on the selection and fabrication of the lower portion 224e of the pivot point 224f (e.g., the thickness of the lower portion 224e).

[0372] The use of pivot points 224f to connect the segmented upper and lower portions 224g, 224e of the paddle frame 224 may facilitate certain manufacturing advantages. By segmenting the upper and lower portions 224g, 224e, the portions may be manufactured from different materials and / or via different methods. For example, the lower frame portion 224e may be manufactured by stamping or laser cutting a ribbon of a more flexible and / or stronger material capable of withstanding the application of large strains, while the upper portion 224g may be manufactured using a less flexible and / or weaker material. The upper portion 224g may be made from a less expensive material, such as bent wire.

[0373] 110D and 110E show an example implementation of an implantable device or valve repair device or implant including a hinged paddle system 100350. The valve repair device or implant may include any of the features of any of the other devices or implants disclosed in this application. Comparing FIG. 110D and FIG. 110E, the user moves the end of the paddle portion in the D2 direction, for example, by the paddle narrowing and widening adjustment mechanism 100299, out of the cap 100100. This causes the lower portion 224e to be pushed along the D3 direction. Then, as the lower portion 224e is so moved, the upper portion 224g is actuated to move along D4 via the pivot point 224f.

[0374] FIG. 110E shows the result of this movement. As shown in FIG. 110E, both the lower portion 224e and the upper portion 224g are extended, widening the paddle frame. As described above, this movement extends the paddle frame 224 with reduced stress concentrations on the system 100350. Note that an optional restoring member 224h is not shown in FIG. 110D and FIG. 110E, but it can be understood that a restoring member 224h can be included. If so, the restoring member 224h can create a mechanical bias in a direction that returns the expansion of the paddle frame 224 to its original fully widened or narrowed position.

[0375] As mentioned above, there are advantages to fabricating portions of the disclosed devices (e.g., implantable device / implant 200) from bulk materials, such as sheet materials, such as metal or plastic sheets, rather than from a braided or woven network of wires. A braided or woven network can facilitate flexibility in the design, whereby the device can expand and contract into a tracked state, allowing for delivery and intraoperative steering via a delivery system, and can expand into the shape of the implantable device or implant. However, devices made from or including 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 fabricated from flat sheets of material. For example, the coaptation element support, inner paddle portion, outer paddle portion, and / or paddle frame connecting portion can be fabricated from flat sheets of material.

[0376] Figures 111H-111J show a device 100400 having a paddle structure 100450 as shown in Figures 111A-111G. Figures 111A-111G show a paddle structure 100450 in which the braided or wire paddle structure is replaced by a structure 100450 fabricated from a sheet of material. In the illustrated embodiment, the paddle structure 100450 is made from a single continuous piece of material (e.g., a Nitinol flat sheet or piece of material that may be laser cut, photo etched, or stamped as a flat section and then shaped). The specific materials and manufacturing methods may vary.

[0377] Comparing Fig. 111A with Fig. 22 shows that paddle structure 100450 takes a similar form as paddle structure 220. Table 1 below compares the components in paddle structure 100450 to functionally similar components in the braided or woven variation shown in Fig. 22. The components in paddle structure 100450 are shown in a perspective view in Fig. 111A, a side view in Fig. 111B, a top view in Fig. 111C, a bottom view in Fig. 111D, and another side view in Fig. 111E. [Table 1] Table 1: Correspondence between the components of FIG. 22 and the components of FIGS. 111A to 111E

[0378] The components within paddle structure 100450 operate substantially similarly to the functional equivalents identified in Table 1. That is, the discussion of functional equivalents in view of FIG. 22 applies equally to the corresponding components of paddle structure 100450.

[0379] As shown in FIGS. 111A-111E, the inner / outer paddle connecting portion 100456 may be implemented with a notch and a series of perforations 100456a. The perforations 100456a allow the connecting portion 100456 to bend over a range of motion for opening and closing the paddle structure 100450, as shown in more detail below with respect to FIGS. 111H-111J. The interface portion 100460 is shown in FIGS. 111A-111E without perforations, but may have a similar structure. More generally, either the connecting portion 100456 or the interface portion 100460 may be manufactured in any suitable manner that creates flexibility that allows the paddle structure 100450 to be opened and closed. A base connecting portion 100458 extends from the interface portion 100460. The base connecting portion 100458 is configured to connect the paddle structure to a base, such as a central post or interface element.

[0380] The cap / paddle frame connecting portion 100462 in FIG. 111A connects the paddle structure 100450 to a cap, such as cap 214, and to the paddle frame 224. The cap / paddle connecting portion 100462 can take many suitable forms. The connecting portion 100462 is shown from above in FIG. 111C and from below in FIG. 111D. The connecting portion 100462 can have any suitable configuration that secures the paddle structure 100450 to the cap and / or paddle frame. In the illustrated embodiment, the connecting portion includes a notch that facilitates a snap-fit ​​connection of the paddle frame and / or cap.

[0381] Returning to FIG. 111A, each of the paddle structures 100450 may contain lacing holes 100464 that may be used to attach a cover and / or other component to the paddle structure 100450. The lacing hole structures 100464 are shown in more detail in FIG. 111F. One purpose of the lacing holes 100464 is to sufficiently secure a suture such that the suture connecting the cover and / or other component is pulled through the lacing hole when suturing of the cover or other component to the paddle structure begins. In particular, the suture used to suturing the cover or other component to the paddle structure may be inserted into the wider portion 100464a of the lacing hole 100464, which has a width sufficient to accommodate the entire diameter of the suture. The suture may then be secured in the lacing hole 100464 by moving the suture from the wider portion 100464a to the narrower portion 100464b. The narrower portion 100464b has a width that is significantly less than the width of the wider portion 100464a such that the narrower portion 100464b pinches the suture and secures it in place, i.e., the suture is wedged within the narrower portion 100464b.

[0382] FIG. 111G shows a plan view of one half of the flat cut sheet material 100451 used to form the paddle structure 100450. FIG. 111G shows the location of the lacing holes 100464 relative to the inner paddle / outer paddle connection portion 100456 and other portions of the paddle structure 100450.

[0383] 111H-111J show an exemplary opening and closing motion for the paddle structure 100450 when used in an implementation of a valve repair device or implant. The paddle structure 100450 may have a range of motion for any of the paddle structures disclosed herein. For example, the paddle structure may also be moved to an extended position and may have the same or similar range of motion as the paddle structure of the device shown in FIG. 22. A valve repair device or implant including the paddle structure 100450 may take a variety of different forms and may include any of the features of any of the devices or implants disclosed herein.

[0384] The position of the valve repair device or implant shown in FIG. 111H is a fully retracted position that corresponds to the fully retracted position shown for the embodiment shown in FIG. 22. With reference to FIG. 111I, the actuating element 212 extends the cap 214 away from the coaptation element 210 to partially open the paddle assembly. The position shown in FIG. 111I corresponds to the partially open position shown in either FIG. 30 or FIG. 31. With reference to FIG. 111J, the actuating element 212 extends the cap 214 further away from the coaptation element 210 to further open the paddle assembly. The position shown in FIG. 111J corresponds to the laterally extended or laterally open position shown in FIG. 32.

[0385] 112A and 112B show another device 100700 with an outer paddle frame portion 100752 that is passively constricted by compression and passively expands back to its original state when the paddle frame is no longer compressed. Referring to FIG. 112B, the outer paddle frame portion 100752 includes a restoring component 100754, such as a spring portion, that can passively help the outer paddle frame portion 100752 (shown in FIGS. 112A and 112B) to restore to its full width after the outer paddle frame portion 100752 bends inwardly along the D5 direction (FIG. 112B). In addition, the outer paddle frame portion 100752 can be formed from a flexible material (e.g., shape memory alloys, Nitinol, CuAlNi, NiTi, and various alloys such as Zn, Cu, Au, and Fe) that does not substantially plastically deform the outer paddle frame portion 100752 during constriction.

[0386] More specifically, referring to FIG. 112B, the outer paddle frame portion 100752 can be passively constricted by engaging an obstacle, such as a tendon, that applies a force to the outer portion 100752a of the paddle frame portion 100752 in the D5 direction, pressing the outside of the paddle frame portion 100752 along the D5 direction.

[0387] In any case, the force may be transmitted to the restoring component 100754 along the D6 direction through the length of the outer paddle frame portion 100752 and the joint mechanism 100754a. The transmitted force then causes the paddle frame portion 100752 to rotate about the joint mechanism 100754a, compressing and / or displacing the central portion 100754b of the restoring component 100754 along the D7 direction. The compression and / or displacement of the central portion 100754b stores energy as a restoring force that may be used to eventually move the outer paddle frame portion 100752 back to its original shape and configuration. Once the force causing the displacement along D5 is resolved (e.g., the device 100700 is moved without interference with biological material), the outer paddle frame portion 100752 may tend to return to its original shape. The central portion 100754b of the restoring component 100754 aids in this process by applying a restoring force in the opposite direction of D7, which is then transferred to the outer paddle frame portion 100752, bending the outer paddle frame portion 100752 in the opposite direction of D5, which then returns to its original shape as shown in FIGS. 112A and 112B.

[0388] Another advantageous aspect of the paddle configuration 100750 is that the outer paddle frame portion 100752 can still be opened and closed even upon deflection of the ends along the D5 direction. That is, the outer paddle frame portion 100752 can be made of a substantially rigid material such that deflection along D5 does not impede the user from opening and closing the paddle. For example, the paddle can still be opened and closed even in the presence of substantial obstructions or interference with biological material.

[0389] Although the restoring member 100754 shown in FIGS. 112A and 112B is shown as an integral spring, it will be understood that any suitable restoring force mechanism may be used. Examples include coiled wire such as compression springs, or other similar devices, shape memory alloys, pneumatic devices, and other elastic devices may all be used as the restoring component 100754. The restoring component 100754 may further include materials cut with patterned geometries that reduce strain upon extension, or may include polymers (e.g., rubber, or elastomeric polymers). Rings or bands of polymers or other elastic materials may be used. Still other examples of materials that may be used in the restoring component 100754 include superelastic nitinol, other nitinol, and / or stainless steel. Preferably, the materials are biologically inert. In the illustrated example, the restoring component 100754 may be mounted in a stacked configuration on the narrow inner paddle frame 100756.

[0390] The outer paddle frame portion 100752, the inner paddle frame 100756, and the restoration components 100754 may be constructed using laser cutting, casting, 3D printing, or other advanced manufacturing techniques. These components may be manufactured separately and assembled at the time of finishing. Such manufacturing techniques may be simple, scalable, and amenable to mass production.

[0391] 113-116, components of another exemplary implementation of an implantable device or implant width adjustment assembly 100900 with a paddle frame connector are shown. The implantable device width adjustment assembly 100900 may include a proximal or attachment portion 100905, an anchor portion (e.g., any anchor portion described herein), a paddle frame connector 100924 (e.g., a shaped metal component, a shaped plastic component, a tether, wire, strut, line, cord, suture, etc.), an actuation portion 100910, an optional interface element (e.g., any spacer or interface element described herein), and a distal portion 100907. The connector 100924 forms the lower or distal portion of the paddle frame (see FIGS. 110A-110E). The mounting portion 100905, anchor portion, distal portion 100907, actuation portion 100910, and connector 100924 may be configured in a variety of ways.

[0392] In the illustrated embodiment, the connectors 100924 are symmetrical along the longitudinal axis ZZ (FIG. 115). However, in some implementations of the implantable device width adjustment assembly 100900, the connectors 100924 are not symmetrical about the axis ZZ.

[0393] 115, in the illustrated embodiment, the paddle frame connector 100924 comprises a W-shaped frame having a proximal end 100967 and a distal end 100966. The connector 100924 has a width W12. The connector 100924 may be made from any suitable material that allows the connector 100924 to move between an expanded position and a constricted position, such as, for example, any of the flexible materials for the paddle frames disclosed herein. Although the connector 100924 is shown as having a W-shape, it will be understood that the connector 100924 may take any suitable form, such as, for example, any of the forms described herein.

[0394] 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 constricted position and an expanded position, as described in more detail below. In the illustrated embodiment, the inner end 100968 includes a post 100970 that is attached to the connector 100924 and a threaded receiving portion 100972 that extends from the post 100970. However, the inner end 100968 can be configured in a variety of ways. Any configuration can be used that can suitably attach the connector 100924 to the actuation portion 100910 and that allows the actuation portion 100910 to move the connector 100924 between a constricted position and an expanded position.

[0395] The actuation portion 100910 allows a user to expand or contract the connector 100924 of the width adjustment assembly 100900 of the implantable device. In the illustrated embodiment, the actuation portion 100910 includes a coupler, such as the illustrated male threaded shaft 100912, disposed within the receiver 100914 (e.g., female threaded element, notched receiving portion, column, lumen, tube, shaft, sleeve, post, housing, raceway, cylinder, etc.) and rotatably engaged with a threaded receiving portion 100972 on an 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.

[0396] The 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., a width adjustment control, a width adjustment wire, a width adjustment shaft, a width adjustment tube, a width adjustment line, a width adjustment cord, a width adjustment suture, a width adjustment tether, etc.) such that a user can rotate the width adjustment element to rotatably drive the shaft 100912 in the receiver 100914 in the R direction. The shaft 100912 extends through an opening in the receiving portion 100972 such that the male threads of the shaft 100912 engage the female threads of the opening in the receiving portion 100972. When the driver head 100916 is driven to rotate the shaft 100912, engagement between the female threads of the receiving portion 100972 and the male threads of the shaft 100912 causes the receiving portion 100972 (and thus the post 100970) to move in the Y direction within the receiver 100914 relative to the shaft 100912. The offset positioning of the inner end 100968 between the shaft 100912 and the post 100970 allows the post 100970 to move alongside the shaft 100912. In some implementations, counterclockwise rotation of the shaft 100912 causes the inner end 100968 to move towards the proximal end of the actuating portion 100910 and clockwise rotation of the shaft 100912 causes the inner end 100968 to move towards the distal end of the actuating portion 100910. However, it will be appreciated that other configurations are also contemplated.

[0397] In the illustrated embodiment, the connection between the connector 100924 and the post 100970 at the inner end 100968 causes the distal end 100966 of the connector 100924 to move in the X direction (FIGS. 113-115) when the post 100970 moves in the Y direction, which causes the proximal end 100967 of the connector to move in the Z direction (FIG. 116) to adjust the width W12 of the connector 100924. In the illustrated embodiment, movement of the post 100970 toward the proximal end of the actuation portion 100910 causes the proximal end 100967 of the connector 100924 to move in the Z direction toward the actuation portion 100910, which causes the connector 100924 to move to the constricted position. Conversely, movement of the post 100970 toward the distal end of the actuation portion 100910 causes the proximal end 100967 of the connector 100924 to move in the Z direction away from the actuation portion 100910, resulting in the connector 100924 moving to the expanded position. In some implementations, the distal end 100966 of the connector 100924 can move into the receiver 100914 when the connector 100924 is moved to the constricted position, and the distal end 100966 can move out of the receiver 100914 when the connector 100924 is moved to the expanded position.

[0398] Movement of the connectors 100924 to the constricted position may allow the device or implant to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device and the natural structures of the heart, such as cords, etc. When the connectors 100924 are moved to the expanded position, the anchor portions of the device or implant are provided with a larger surface area to engage and capture the leaflets of the native heart valve.

[0399] In some implementations, the connector 100924 may be made from or include a material that allows the inner end 100968 and a portion of the connector 100924 (e.g., the distal end 100966) to be retracted into the actuation portion 100910. For example, the connector 100924 or a portion thereof may be made from any flexible material, including, but not limited to, metal, plastic, fabric, suture, and the like. The connector 100924 may be made using a variety of processes, including, but not limited to, cutting, laser cutting, stamping, casting, molding, heat treating, shape setting, and the like. The connector 100924 may be made from or include a shape memory material, such as Nitinol, to provide shape setting capabilities.

[0400] 117-122, another exemplary implementation of a portion of an implantable device 101000 having a connector 101024 (e.g., a shaped metal component, a shaped plastic component, a tether, a wire, a post, a line, a cord, a suture, etc.) is shown. The implantable device 101000 includes a proximal or attachment portion 101005, an anchor portion (e.g., any anchor portion described herein), a connector 101024, a width adjustment device 101010, an optional interface element (e.g., any spacer or interface element described herein), and a distal portion 101007. The connector 101024 forms the lower or distal portion of the paddle frame (see FIGS. 110A-110E). The attachment portion 101005, the anchor portion, the distal portion 101007, the width adjustment device 101010, and the connector 101024 may be configured in a variety of ways.

[0401] In the illustrated embodiment, the connector 101024 is symmetrical along the longitudinal axis AAA (FIG. 117). However, in some implementations of the implantable device 101000, the connector 101024 is not symmetrical about the axis AAA.

[0402] In the illustrated embodiment, the connector 101024 is a W-shaped frame having a proximal end 101067 and a distal end 101066. The connector 101024 can have a width W13 (FIG. 117). The connector 101024 can be made from any suitable material that can move the connector 101024 between an expanded position and a constricted position, such as, for example, any of the flexible materials for paddle frames disclosed herein. Although the connector 101024 is shown as having a W-shape, it will be understood that the connector 101024 can take any suitable form, such as, for example, any of the forms described herein.

[0403] The connector 101024 has a coupler 101068 that engages with the width adjustment element 101011 (e.g., a width adjustment control, a width adjustment wire, a width adjustment shaft, a width adjustment tube, a width adjustment line, a width adjustment cord, a width adjustment suture, a width adjustment tether, etc.). The coupler 101068 may be configured in a variety of different ways. For example, the coupler 8972 may include one or more of a threaded connection, a thread mating mechanism, a detent connection such as an outwardly biased arm or portion, a flexible protrusion, etc. The coupling between the width adjustment element 101011 and the coupler 101068 allows a user to move the coupler 101068 of the width adjustment device 101010 to move the connector 101024 between a constricted position and an expanded position, as described in more detail below. In the illustrated embodiment, the coupler 101068 includes a post 101070 that is attached to the connector 101024 and a flexible protrusion 101072 extending from the post 101070. The coupler 101068 can be configured to receive a width adjustment element 101011 (e.g., an actuation wire, an actuation shaft, etc.) that allows a user to move the coupler 101068 in the Y direction. For example, the post 101070 can have a coupler such as the illustrated threaded receiving portion 101073 (FIG. 119) that is configured to engage threads of the width adjustment element 101011. The coupler 101068 can include any configuration that appropriately attaches the connector 101024 to the width adjustment device 101010 to allow the width adjustment device 101010 to move the connector 101024 between a constricted position and an expanded position. The coupler may be a separate component or may be integrally formed as part of another component of the device (eg, as part of a connector).

[0404] The width adjustment device 101010 allows a user to expand or contract the connector 101024 of the implantable device 101000. In the illustrated embodiment, the width adjustment device 101010 includes a receiver 101014 (e.g., an internally threaded element, a notched receiving portion, a pillar, a lumen, a tube, a shaft, a post, a housing, a raceway, a cylinder, etc.) having a number of slots 101015 (FIGS. 117 and 120) for receiving the flexible protrusions 101072 of the coupler 101068. That is, the post 101070 of the coupler 101068 is sized to fit within the receiver 101014 and move in the Y direction, and the flexible protrusions 101072 are sized to fit within the slots 101015 of the receiver 101014 to secure the coupler 101068 in a desired position within the receiver 101014. In some implementations, the receiver 101014 includes channels 101017 ( FIG. 120 ) that connect to each of the slots 101015 and are positioned to align with the flexible protrusions 101072 of the coupler 101068, such that the flexible protrusions 101072 can move through the channels 101017 when a user moves the coupler 101068 to various positions within the receiver 101014. The channels 101017 guide the flexible protrusions 101072 of the coupler 101068 along the receiver 101014. In some implementations, the receiver 101014 can be integrally formed with the distal cap 101019 of the distal portion 101007.

[0405] The connection mechanism 101016 is disposed at a proximal end of the implantable device 101000 for receiving an actuating element 101002 (e.g., an actuating shaft, actuating tube, actuating lumen, conduit, etc.) of the delivery device. In the illustrated embodiment, the connection mechanism 100916, such as the illustrated driver head, includes female threads for connecting to male threads of the actuating element 101002. However, the connection mechanism 101016 may have any configuration capable of receiving and attaching to the actuating element 101002.

[0406] The width adjustment element 101011 extends through the actuation element 101002 of the delivery device and into the receiver 101014 of the width adjustment device 101010 of the implantable device 101000. The width adjustment element 101011 removably connects to the post 101070 of the coupler 101068 such that a user can move the width adjustment element 101011 in the Y direction, which moves the coupler 101068 in the Y direction. In the illustrated embodiment, the width adjustment element 101011 includes male threads for connecting to the female threads of the post 101070. However, the width adjustment element 101011 can have any configuration that can be attached to the coupler 101068 and allows a user to move the coupler 101068.

[0407] 121 and 122, in some implementations, the connection mechanism 101016 at the proximal end of the device 101000 and the threaded receiving portion 101073 of the coupler 101068 of the connector 101024 are threaded in opposite directions. That is, referring to FIG. 121, the threads of the connection mechanism 101016 are disposed in the M direction and the threads of the receiving portion 101073 are disposed in the N direction. As a result, referring to FIG. 122, rotation of the actuation element 101002 in the R direction causes the male threads of the actuation element 101002 to engage with the connection mechanism 101016 and attach to the device 101000, and rotation of the width adjustment element 101011 in the T direction causes the male threads of the width adjustment element 101011 to engage with the threaded receiving portion 101073 of the coupler 101068 and attach to the coupler 101068. In this example, the actuating element 101002 can be disengaged from the device 101000 by rotating the actuating element 101002 in the T direction, and the width adjustment element 101011 can be disengaged from the coupler 101068 by rotating the width adjustment element 101011 in the R direction. The reversed threading direction of the connection mechanism 101016 and the threaded receiving portion 101073 prevents or inhibits accidental disengagement of the actuating element 101002 and the width adjustment element 101011 when a user attempts to disengage one of the actuating element 101002 and the width adjustment element 101011. That is, when a user attempts to disengage one of the actuating element 101002 and the width adjustment element 101011, the other of the actuating element and the width adjustment element will be clamped (or will not move at all) due to the direction of rotation caused by the user. However, it will be understood that other configurations are also envisioned.

[0408] 117 and 118, after the width adjustment element 101011 is attached to the coupler 101068, the user moves the width adjustment element 101011 in the Y direction to move the connector 101024 between the constricted and expanded positions. That is, the movement of the width adjustment element 101011 in the Y direction causes the post 101070 of the coupler 101068 to move in the Y direction, and the distal end 101066 of the connector 101024 to move in the X direction when the post 100970 moves in the Y direction due to the connection between the connector 101024 and the post 101070. This movement of the distal end 101066 in the X direction causes the proximal end 101067 of the connector 101024 to move, adjusting the width W13 of the connector 101024.

[0409] In the illustrated embodiment, as the post 101070 moves toward the proximal end of the width adjustment device 101010, the proximal end 101067 of the connector 101024 moves toward the width adjustment device 101010, resulting in the connector 101024 moving to the constricted position. Conversely, as the post 101070 moves toward the distal end of the width adjustment device 101010, the proximal end 100967 of the connector 100924 moves away from the width adjustment device 101010, resulting in the connector 101024 moving to the expanded position. However, it will be understood that other configurations are also contemplated. In some implementations, the distal end 101066 of the connector 101024 may move into the receiver 101014 when the connector 101024 is moved to a constricted position, and the distal end 101066 may move out of the receiver 101014 when the connector 101024 is moved to an expanded position, however, it will be understood that other configurations are also contemplated.

[0410] As the coupler 101068 moves in the Y direction within the receiver 101014, the flexible protrusion 101072 bends in the direction F, which allows the flexible protrusion 101072 to move between a bent position in which the flexible protrusion engages the inner surface of the receiver 101014 and an extended position in which the flexible protrusion 101072 is disposed within the receiver's slot 101015. When the flexible protrusion 101072 is in the extended position and disposed within the slot 101015, the width W13 of the connector 101024 is maintained at a position relative to the position of the coupler 101068 relative to the receiver 101014. A user can adjust the width W13 of the connector 101024 by moving the width adjustment element 101011 in the Y direction, which can cause the flexible protrusion 101072 to bend and move the coupler 101068 inside the receiver 101014. In some implementations, the inner surface of the receiver includes a channel 101017 (FIG. 120) that allows the flexible protrusion 101072 to move through the receiver 101014. The flexible protrusion 101072 of the coupler 101068 can be made from a flexible material, including but not limited to metal, plastic, fabric, suture, etc. Although described here as a receiver, other structures or openings in structures of different shapes and different sizes that can achieve the same purpose can be used as well.

[0411] Movement of the connector 101024 to the constricted position may allow the device or implant 101000 to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the natural structures of the heart, such as cords, and the device 101000. When the connector 101024 is moved to the expanded position, the anchor portions of the device or implant 101000 are provided with a larger surface area to engage and capture the leaflets of the native heart valve.

[0412] In some implementations, the connector 101024 may be made from or include a material that allows the coupler 101068 and a portion of the connector 101024 (e.g., the distal end 101066) to be retracted into the actuation portion 100910. For example, the connector 101024 or a portion thereof may be made from any flexible material, including but not limited to metal, plastic, fabric, suture, and the like. The connector 101024 may be made using a variety of processes, including but not limited to cutting, laser cutting, stamping, casting, molding, heat treating, shape setting, and the like. The connector 101024 may be made from or include a shape memory material, such as Nitinol, to provide shape setting capabilities.

[0413] 123-131 show exemplary couplings between an actuating element 101102 (e.g., an actuating shaft, an actuating tube, an actuating lumen, a conduit, etc.) of a delivery device and a component of an implantable device or implant 101100. For example, the coupling can be located between the actuating element and a proximal end of the implantable device 101100. In some implementations, the coupling is between the actuating element 101102 and a receiver of the implantable device 101100 (e.g., any receiver of an implantable device described herein) such that a width adjustment element (e.g., a width adjustment control, a width adjustment wire, a width adjustment shaft, a width adjustment tube, a width adjustment line, a width adjustment cord, a width adjustment suture, a width adjustment tether, etc.) can extend through the actuating element 101102 and engage a connector or paddle frame of the implantable device (e.g., any connector or paddle frame of an implantable device described herein).

[0414] The distal end 101131 of the actuating element 101102 has a connection mechanism 101161 including a pair of arms 101163 that is movable between a normal extended position (e.g., as shown in FIGS. 123 and 129) and a compressed position (e.g., as shown in FIG. 126). Although the illustrated embodiment shows the connection mechanism 101161 having a pair of arms 101163, it will be understood that the connection mechanism 101161 may have any suitable number of arms. In some implementations, the arms 101163 include an opening 101165 for maintaining a secure connection between the actuating element 101102 and the implantable device 101100. That is, the opening 101165 may be sized and configured to receive an inner extension portion 101170 (see FIG. 131) of the connection mechanism 101160 of the implantable device 101100, preventing the arms 101163 from disengaging from the implantable device 101100. The distal end 101131 may have an arched or curved opening 101181 positioned at the connection between the arm 101163 and the remainder of the actuating element 101102 that facilitates movement of the arm 101163 between a normal position and a compressed position. That is, the curved opening 101181 allows the arm 101163 to bend more easily relative to the remainder of the actuating element 101102.

[0415] The proximal end 101130 of the implantable device 101100 has a connection mechanism 101160 including an opening 101162 for receiving an arm 101163 of the actuation element 101102. Referring to FIG. 129, the opening 101162 can include a distal portion 101164 and a proximal portion 101166, the distal portion 101164 being wider than the proximal portion 101166. The interior of the opening 101162 can include a tapered wall 101168 extending between the distal portion 101164 and the proximal portion 101166. In the illustrated embodiment, the connection mechanism 101160 includes an inner extension portion 101170 ( FIG. 131 ) that defines the proximal portion 101166 of the opening 101162. The connecting mechanism 101160 may also have another connecting element 101180 for attachment to the implantable device 101100. For example, the connecting element 101180 may include a threaded portion that is threadably attached to the implantable device 101100. In some implementations, the connecting element 101180 is attached to an actuating portion of the implantable device 101100. In some implementations, the connecting mechanism 101160 may be integral with a component of the implantable device 101100, or the connecting mechanism 101160 may be attached to the implantable device 101100 by any other suitable means.

[0416] 123-125, when the implantable device 101100 is delivered to the patient's native valve by a delivery device, the actuating element 101102 is attached to the implantable device 101100. That is, the arm 101163 of the actuating element 101102 extends into the distal portion 101164 of the opening 101162 of the implantable device 101100. When the arm 101163 is in a normal position, the width W of the arm 101163 (FIG. 129) is greater than the width X of the proximal portion 101166 of the opening 101162 (FIG. 129), thereby preventing or inhibiting the arm 101163 from moving through the proximal portion 101166 of the opening 101162 and disengaging from the implantable device 101100. Additionally, an inner extension portion 101170 (FIG. 131) of the connection mechanism 101160 may extend into an opening 101165 of the arm 101163 of the actuating element 101102, further securing the actuating element 101102 to the implantable device 101100. When the actuating element 101102 is attached to the implantable device 101100, an open pathway may extend from the actuating element through the implantable device 101100 such that a width adjustment element (e.g., a movement wire, a movement shaft, a width adjustment tube, etc.) may extend through the actuating element 101102 and the implantable device 101100 to engage one or more portions of the implantable device 101100, move a paddle frame of the implantable device between an expanded position and a stenotic position, or engage the implantable device in any other desired manner when the device is implanted onto the patient's native valve and / or released from the delivery system.

[0417] 126-128, when a force is applied to the actuating element 101102 in the Y direction (FIG. 126), the arm 101163 engages with the tape...

Claims

**Claim 1** A transplantable device, a joining element that defines a first region when viewed from above, one or more anchors coupled to the joining element, the one or more anchors being movable between an open position and a closed position and configured to be attached to one or more valve leaflets of a native heart valve, each of the one or more anchors comprising a paddle frame, one or more anchors; comprising the paddle frame defines an outer portion of the implantable device when viewed from above, the one or more anchors are in the closed position, the outer portion of the implantable device has a second region when viewed from above, A transplantable device, wherein a ratio of the second region to the first region is 2:1 or more. **Claim 2** The transplantable device according to claim 1, wherein a ratio of the second region to the first region is 3:1 or more. **Claim 3** The transplantable device according to claim 1 or 2, wherein the joining element is injection molded. **Claim 4** The transplantable device according to claim 1, wherein the joining element comprises a polymeric material. **Claim 5** The transplantable device according to claim 1, wherein the paddle frame comprises an inner frame portion and an outer frame portion. **Claim 6** The one or more anchors comprise a first anchor and a second anchor, the first anchor and the second anchor are configured to be moved to the closed position, and an inner frame portion of each of the first anchor and the second anchor compresses a valve leaflet of the native valve at an inner pinch point, and an outer frame portion of each of the first anchor and the second anchor compresses a valve leaflet of the native valve at an outer pinch point, whereby the implantable device is fixed to the valve leaflet of the native valve. The implantable device according to claim 5. **Claim 7** The implantable device according to claim 6, further comprising a cover attached to at least one of the inner frame portion and the outer frame portion of the first and second anchors to provide a compressive force against the valve leaflet of the native valve in a region between the inner pinch point and the outer pinch point when the implantable device is fixed to the valve leaflet of the native valve. **Claim 8** The implantable device according to claim 7, wherein the cover forms a canopy extending between the first anchor and the second anchor. **Claim 9** The paddle frame is A paddle frame including an inner frame portion and an outer frame portion, wherein the outer frame portion is configured to move between a narrowed position and an expanded position, the paddle frame; A flexible cover configured to be in a tensioned state when the outer frame portion is in the narrowed position, the flexible cover being configured to stretch when the outer frame portion is in the expanded position; The implantable device according to claim 1, comprising:

10. The implantable device according to claim 9, wherein the flexible cover comprises one or more stretchable portions that allow the cover to stretch when the paddle frame is in the expanded position.

11. Further comprising a cap operably connected to the one or more anchors, wherein when the cap is moved relative to the engagement element by one or more actuating elements of a delivery device, the one or more anchors move between an open position and a closed position, and the cap comprises: A distal opening in communication with the lumen of the engagement element; A distal cover element disposed to prevent blood from moving into the interior of the implantable device through the distal opening of the cap; The implantable device according to claim 1, comprising:

12. A valve repair system for repairing a patient's native valve, the valve repair system comprising: A delivery device; An implantable device coupled to the delivery device; Comprising, the implantable device comprising: An engagement element defining a first region when viewed from above; One or more anchors coupled to the engagement element, the one or more anchors being movable between an open position and a closed position and configured to be attached to one or more leaflets of a native heart valve, each of the one or more anchors comprising a paddle frame; Comprising: The paddle frame defines an outer portion of the implantable device when viewed from above, the one or more anchors are in the closed position, The outer portion of the implantable device has a second region when viewed from above, A valve repair system, wherein a ratio of the second region to the first region is 2:1 or more.

13. The valve repair system according to claim 12, wherein a ratio of the second region to the first region is 3:1 or more.

14. The valve repair system according to any one of claims 12 to 13, wherein the engagement element is injection molded.

15. The valve repair system according to claim 12, wherein the joining element comprises a polymeric material.

16. The delivery device has a width adjustment element including a male threaded portion, The implantable device includes a coupler for removably connecting the width adjustment element of the delivery device to an inner end of the one or more anchors, The coupler includes one or more mounting protrusions extending inwardly from a body of the coupler, The one or more mounting protrusions are configured to be removably attached to the male threaded portion of the width adjustment element, The valve repair system according to claim 12, wherein the width adjustment element is configured to move the paddle frame between a narrowed position and an expanded position.

17. The coupler includes at least two arms movable between a first position and a second position, and when the coupler is separated from the implantable device, the arms are in the first position, and when the coupler is connected to the width adjustment element, the arms are in the second position. The valve repair system according to claim 16.

18. The delivery device includes a receiver, The coupler is removably coupled to an internal thread of the receiver and is configured to fix an inner end of the one or more anchors to a desired position relative to the receiver, The non - attachable portion of the receiver prevents the coupler from connecting to the receiver when the coupler is disposed within the non - attachable portion. The valve repair system according to claim 16.

19. The coupler includes at least two arms movable between a first position and a second position, and each of the arms has a central portion, a first connecting member connecting the central portion to a proximal end of the coupler, a second connecting member connecting the central portion to a distal end of the coupler, and is provided with, The valve repair system according to claim 18, wherein the arms are configured to be attached to an internal thread of a lumen of the receiver when in the first position.

20. The valve repair system according to claim 12, wherein the one or more anchors are coupled to the joining element by mounting posts attached to the joining element.

Images