HEART VALVE SEALING DEVICE AND DELIVERY APPARATUS THEREFOR - Patent application

Abstract

The device or implant is configured to be positioned within the native heart valve and to allow the native heart valve to form a more effective seal. One or more portions of the device or implant may expand and contract. For example, one or more portions of the device or implant may be constricted upon delivery and expanded upon implantation over the native heart valve. The delivery system is configured to constrict and expand one or more portions of the device or implant.

Description

[Technical field]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 287,907, filed December 9, 2021, entitled "Heart Valve Repair Device and Delivery Apparatus Therefor," which is incorporated by reference herein in its entirety. [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 surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and complications can occur. Transvascular techniques can be used to introduce and implant the implant device 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 a catheter into the right femoral vein, ascending the inferior vena cava, and into the right atrium). The septum is then punctured and the catheter passed into the left atrium. A similar transvascular technique may be used, beginning as the transseptal technique but not going as far as puncturing the septum, instead pivoting the delivery catheter toward the tricuspid valve in the right atrium to implant a 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 natural 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 natural heart valves. The mitral valve includes an annulus portion, which is an annular portion of natural valve tissue that surrounds the mitral valve orifice, 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 cusps from prolapsing under pressure and folding back through the mitral valve annulus toward the left atrium, multiple fibrous cords called chordae tendineae anchor the cusps to the papillary muscles within 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 prolapse of the leaflets, insufficient papillary muscles, stretching of the mitral annulus from dilation of the left ventricle, or a combination of these. Mitral regurgitation in the central portion of the cusps can be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one of the commissures of the cusps (i.e., where the cusps abut) can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the cusps do not abut 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 of the present invention is intended to provide some examples and is not intended to limit the scope of the present invention in any way. For example, any features included in the examples of this summary of the present invention are not required by the claims unless the claims explicitly recite those features. Also, the features, components, steps, concepts, etc. described in the examples of this summary of the present invention and elsewhere in this disclosure can be combined in various ways. Various features and steps described in relevant parts of this disclosure can be included in the examples summarized herein.

[0007] In some implementations, an exemplary heart valve repair system includes an apparatus (e.g., a repair apparatus, an implantable device, etc.) having a proximal head and an adjustable member attached to the proximal head. In some implementations, a delivery system for the apparatus includes a distal gripper and a coupling assembly for attaching the apparatus to the distal gripper.

[0008] In some implementations, the delivery system includes a retaining member that extends through the delivery system and into the coupling assembly to secure the distal gripper in the coupled state.

[0009] In some implementations, the coupling assembly is configured to transmit rotational movement of the distal gripper via the proximal head to the adjustable member when the coupling assembly is in a coupled state.

[0010] In some implementations, the retaining member extends or is extendable through the coupling assembly and, in some cases, engages with the adjustable member.

[0011] In some implementations, the proximal head is removably attached to the adjustable member.

[0012] In some implementations, the proximal head includes a plurality of engagement protrusions and the distal gripper includes a plurality of engagement protrusions for interlocking with the engagement protrusions of the proximal head.

[0013] In some implementations, the retention member includes a threaded distal end and the proximal head includes a threaded opening for receiving the threaded distal end. In some implementations, the system is configured such that threading the threaded distal end of the retention member into the threaded opening of the proximal head retains the coupling assembly in a coupled state.

[0014] In some implementations, the distal gripper has a plurality of flexible fingers, each flexible finger including an engagement portion, and the proximal head has an opening for receiving the flexible fingers and a window for receiving the engagement portion of the flexible fingers.

[0015] In some implementations, stretching the retaining member between the flexible fingers prevents the engaging portions of the flexible fingers from disengaging from the window.

[0016] In some implementations, the flexible fingers are biased inwardly such that removal of the retention member allows the flexible fingers to move inwardly such that the engagement portion disengages from the window.

[0017] In some implementations, the distal gripper has a pivoting engagement member and the proximal head includes a window for receiving the pivoting engagement member.

[0018] In some implementations, the system is configured such that extending the retaining member into the distal gripper engages the pivoting engagement member to pivot the pivoting engagement member outwardly into engagement with the window in the proximal head.

[0019] In some implementations, the pivot engagement members are biased to pivot in an inward direction to facilitate disengagement from the window in the proximal head.

[0020] In some implementations, the distal gripper includes a sliding engagement member and the proximal head has a window for receiving the sliding engagement member.

[0021] In some implementations, the system is configured such that extending the retaining member into the distal gripper engages the sliding engagement member and slides the sliding engagement member outwardly into engagement with the window in the proximal head.

[0022] In some implementations, the sliding engagement members are biased to slide in an inward direction to facilitate disengagement from the window in the proximal head.

[0023] In some implementations, the distal gripper has a deployable engagement member attached to the distal gripper via a linkage, and the proximal head includes a recess for receiving the deployable engagement member.

[0024] In some implementations, the system is configured such that distal movement of the distal gripper moves the deployable engagement member into a recess in the proximal head.

[0025] In some implementations, the system is configured such that extending a retaining member between the distal gripper and the deployable engagement member secures the deployable engagement member within a recess in the proximal head.

[0026] In some implementations, the distal gripper includes a slot and the proximal head has a laterally extending pin for engaging the slot of the distal gripper, hi some implementations, the system is configured such that extending the retention member into the distal gripper secures the laterally extending pin in the slot.

[0027] In some implementations, the distal gripper has a keyed end with an engagement member, and the proximal head includes an opening configured to receive the keyed end of the distal gripper only when the distal gripper is axially offset from the proximal head.

[0028] In some implementations, the system is configured such that extending the retaining member through the distal gripper and the proximal head secures the engagement member of the keyed end to the window in the proximal head.

[0029] In some implementations, the distal gripper includes a window and the proximal head includes an engagement protrusion configured to extend into and be received by the window of the distal gripper.

[0030] In some implementations, the system is configured such that extending the retention member through the distal gripper and the proximal head secures the engagement member of the proximal head within the window of the distal gripper.

[0031] In some implementations, the distal gripper includes a plurality of flexible fingers, each flexible finger having a window, and the proximal head has an opening for receiving the flexible fingers and an engagement portion for engaging the window of the flexible fingers.

[0032] In some implementations, the system is configured such that stretching the retaining member between the flexible fingers prevents the windows in the flexible fingers from disengaging from the engagement portion.

[0033] In some implementations, the flexible fingers are biased inwardly to allow removal of the retention member to cause the flexible fingers to move inwardly such that the window disengages from the engagement portion.

[0034] In some implementations, the distal gripper has a deployable engagement member attached to the distal gripper by a linkage, and the proximal head includes an opening for receiving the distal gripper and a recess in the opening for receiving the deployable engagement member.

[0035] In some implementations, when the deployable engagement members contact the bottom of the opening in the proximal head, the deployable engagement members move radially outward and into the recesses.

[0036] In some implementations, a retention member extends between the deployable engagement member and the distal gripper to inhibit the distal gripper from moving from the deployed state to the retracted state.

[0037] In some implementations, the proximal head includes a laterally oriented pin that is received in a slot of the distal gripper, and the axial opening of the distal gripper is configured to receive a retaining member such that the retaining member extends beyond the laterally oriented pin of the proximal head to retain the laterally oriented pin in the slot of the distal gripper.

[0038] In some implementations, the distal gripper includes a tapered opening for guiding the retaining member toward the open end of the slot.

[0039] In some implementations, the distal gripper and the proximal head are axially aligned when a laterally oriented pin is retained in the slot by a retaining member.

[0040] In some implementations, an actuation assembly or mechanism for an apparatus (e.g., a repair apparatus, an implantable device, etc.) includes an outer tube having a plurality of openings, a latch tube attached to an adjustable member, and a drive member having a threaded portion that can be threadably attached to the threaded opening and tapered distal end of the latch tube.

[0041] In some implementations, when the threaded portion of the drive member is screwed into the threaded opening of the latch tube, the tapered distal end engages the latch member and holds the latch member in an unlatched state so that the latch tube can be moved to a desired location within the outer tube.

[0042] In some implementations, the drive member can be unscrewed from a threaded opening in the latch tube to disengage the tapered distal end from the latch member to facilitate movement of the latch member to a latched state in which the latch member engages one of a plurality of openings in the outer tube.

[0043] In some implementations, the latch members are laser cut from the latch tube.

[0044] In some implementations, the latch member is biased toward the latched state.

[0045] In some implementations, the latch tube also has an orientation tab that extends through an orientation slot in the outer tube to prevent relative rotation of the latch tube and the outer tube.

[0046] In some implementations, an actuation assembly or mechanism for an apparatus (e.g., a repair apparatus, an implantable device, etc.) includes an outer tube having a plurality of openings, a latch tube attached to an adjustable member, and an actuation tube having a distal end that forms one half of a coupling connection and configured to removably couple to a proximal end of the latch tube that forms the other half of the coupling connection.

[0047] In some implementations, a locking member extends through the actuation tube and the latch tube and prevents decoupling of the mating connection when the actuation tube and the latch tube are in a mated state, the locking member having a tapered distal end.

[0048] In some implementations, when the fixation member is inserted into the latch tube, the tapered distal end engages the latch member and holds the latch member in an unlatched state so that the latch tube can be moved to a desired location within the outer tube.

[0049] In some implementations, the locking member can be withdrawn from the latch tube to disengage the tapered distal end from the latch member and facilitate movement of the latch member to a latched state in which the latch member engages one of the multiple openings in the outer tube. In some implementations, the locking member can also be withdrawn from the mating connection to allow the actuation tube to be disengaged from the latch tube.

[0050] In some implementations, the latch members are laser cut from the latch tube.

[0051] In some implementations, the latch member is biased toward the latched state.

[0052] In some implementations, the latch tube further includes an orientation pin that extends through an orientation slot in the outer tube to prevent relative rotation of the latch tube and the outer tube.

[0053] In some implementations, withdrawing the securing member from the mating connection allows the actuation tube to move laterally relative to the latch tube to disengage the mating connection.

[0054] In some implementations, an actuation assembly or mechanism for an apparatus (e.g., a repair apparatus, an implantable device, etc.) includes a drive member removably attached to an adjustable member having a plurality of notches, a latch tube, and a release tube disposed between the adjustable member and the latch tube.

[0055] In some implementations, the latch tube has a plurality of latch members spaced longitudinally along the latch tube that are biased to move inwardly toward a latched state.

[0056] In some implementations, the release tube inhibits the latch member from moving from the unlatched state to the latched state so that the adjustable member can be moved to a desired location.

[0057] In some implementations, withdrawing the release tube distally allows at least one of the latch members to move inwardly from an unlatched state to a latched state by engaging one of the notches in the adjustable member.

[0058] In some implementations, the latch members are laser cut from the latch tube.

[0059] In some implementations, the drive member is a suture.

[0060] In some implementations, a handle release assembly of a delivery system for the device has an actuating element extending from a distal end for engaging the device to a proximal end secured to an actuating element adapter, and a width adjustment element extending within the actuating element from the distal end for engaging the device to a proximal end secured to a width adjustment element adapter.

[0061] In some implementations, the handle release assembly also includes a connector body having a central lumen through which the actuation element and the width adjustment element extend.

[0062] In some implementations, the connector body has a mating portion that includes one, some, or all of the retention grooves, the inner body includes an attachment member for engaging the mating portion and the retention grooves of the connector body, a recess for accommodating the actuation element adapter, a catch, and a side slot, and the outer body includes a proximal locking portion, a latch arm having a protrusion for engaging the catch on the inner body to prohibit relative movement between the outer body and the inner body, and a side slot.

[0063] In some implementations, the width adjustment element adapter extends through a side slot of the inner body and a side slot of the outer body and a gripping portion slidably attached to the outer body. Sliding the gripping portion proximally exposes a latch arm of the outer body allowing the latch arm to disengage from a catch of the inner body.

[0064] In some implementations, the assembly is configured such that after disengaging the latch arm, the outer body moves proximally upon application of further proximal force to the gripping portion, causing the outer body to move proximally such that the side slots engage with the width adjustment element adapter and move the width adjustment element in a proximal direction.

[0065] In some implementations, further proximal movement of the gripping portion and outer body exposes the mounting member of the inner body and engages the width adjustment element adapter with a side slot on the inner body to disengage the mounting member from the retention groove of the coupling portion of the connector body and pull the actuation element in a proximal direction.

[0066] In some implementations, a handle release assembly of a delivery system for a device (e.g., a repair device, an implantable device, a delivery device, etc.) has an actuating element extending from a distal end for engaging the device to a proximal end secured to an actuating element adapter, and a width adjustment element extending from a distal end into the actuating element for engaging the device to a proximal end secured to a width adjustment element adapter.

[0067] In some implementations, the handle release assembly also includes a connector body having a central lumen through which the actuation element and the width adjustment element extend. In some implementations, the connector body includes a mating portion including one, some, or all of the retention grooves, a movable body including an attachment member for engaging the mating portion and the connector body retention grooves, a recess for receiving the actuation element adapter, and a side slot.

[0068] In some implementations, the width adjustment element adaptor is configured to extend through a side slot of the movable body and a gripping portion slidably attached to the movable body, hi some implementations, the assembly can be configured such that sliding the gripping portion proximally engages the width adjustment element adaptor to move the width adjustment element proximally.

[0069] In some implementations, further proximal movement of the gripping portion and outer body exposes the attachment member of the movable body and engages the width adjustment element adapter with a side slot of the inner body, disengaging the attachment member from the retention groove of the coupling portion of the connector body and pulling the actuation element in a proximal direction.

[0070] In some implementations, a clasp for a device includes a fixed arm having a curved shape, a movable arm having a curved shape complementary to the curved shape of the fixed arm, and an interface that hingeably connects the movable arm to the fixed arm.

[0071] In some implementations, the clasp also includes a gripping protrusion or member extending from at least one of the fixed arm and the movable arm. In some implementations, the gripping protrusion or member may have rounded ends. In some implementations, the gripping protrusion or member may have sharp ends.

[0072] In some implementations, the curved shape is sinusoidal, triangular, or sawtooth.

[0073] In some implementations, the curved shape has a peak located proximal to the interface and a trough located distal to the peak.

[0074] In some implementations, the curved shape has a trough located proximal to the interface and a peak located distal to the peak.

[0075] In some implementations, the curved shape has multiple peaks disposed between the interface and the distal ends of the fixed and movable arms.

[0076] In some implementations, the curved shape has a number of troughs disposed between the interface and the distal ends of the fixed and movable arms.

[0077] In some implementations, the clasp includes a gripping surface extending along at least a portion of one of the fixed and movable arms. The gripping surface may be formed by powder coating, laser printing, and / or an adhesive coating that removably adheres to the leaflet.

[0078] In some implementations, the gripping surface includes a plurality of teeth or a plurality of serrations.

[0079] In some implementations, a cover is included that covers at least one of the fixed arm and the movable arm. The gripping surface may also have surface features that extend through the cover.

[0080] In some implementations, an apparatus (e.g., a repair apparatus, an implantable device, an implant, etc.) includes a first collar and a second collar, an expandable coaptation element extending between the first collar and the second collar, the expandable coaptation element having a middle portion between two end portions, in some implementations, the middle portion is more flexible than the two end portions such that the second collar is moved proximally toward the first collar, contracting the expandable coaptation element.

[0081] In some implementations, the intermediate portion retracts more than the end portions when the second collar retracts proximally. An optional biasing member can extend between the first and second collars to bias the second collar distally toward or away from the first collar.

[0082] In some implementations, a drive member can be attached to the second collar, and moving the drive member in a proximal direction can extend or compress the biasing member.

[0083] In some implementations, the expandable joint element may be made from a tube of braided wire, which may be formed from a shape memory alloy, such as Nitinol, CuAlNi, NiTi, or another alloy containing one or more of Zn, Cu, Au, and Fe. In some implementations, the braided wire in the middle section of the expandable joint element may be thinner than the braided wire in the end sections. An optional cover may be used to cover the components of the expandable joint element.

[0084] In some implementations, an apparatus (e.g., a repair apparatus, an implantable device, etc.) includes a first nut and a second nut, at least one of the first nut and the second nut includes a threaded opening, In some implementations, a pair of flexible struts extend between the first nut and the second nut, each of the pair of flexible struts includes a first threaded end, a second threaded end, and a flexible intermediate portion.

[0085] In some implementations, a first threaded end of each flexible post engages with a threaded opening in a first nut and a second threaded end of each flexible post engages with a threaded opening in a second nut.

[0086] In some implementations, the device is configured such that rotation of a first nut relative to a first threaded end of the pair of flexible struts moves the first threaded end toward and away from the first nut, and rotation of a second nut relative to a second threaded end of the pair of flexible struts moves the second threaded end toward and away from the second nut.

[0087] In some implementations, the device is configured to cause the flexible intermediate portion of each flexible strut to expand laterally outward by moving at least one of the first threaded end away from the first nut or the second threaded end away from the second nut.

[0088] In some implementations, one or both of the first nut and the second nut may include an engagement portion for engaging the flexible intermediate portion to move the flexible intermediate portion laterally inward. The threaded openings of the first nut and the second nut may have opposite threads. One or both of the first nut and the second nut may be rotated to expand and contract the flexible intermediate portion of the flexible post. An optional cover may be used to cover the components of the expandable interface element.

[0089] In some implementations, an apparatus (e.g., a repair apparatus, an implantable device, etc.) includes a first drive member movably attached to a second drive member, In some implementations, the apparatus can be configured such that engagement with at least one of the first drive member and the second drive member moves the first drive member and the second drive member toward one another.

[0090] In some implementations, the device includes an expandable joint element including an expansion member and a spreader member both disposed between a first drive member and a second drive member, hi some implementations, the device can be configured such that movement of the first and second drive members toward one another causes the spreader member to engage and expand the expansion member.

[0091] In some implementations, the first drive member can include a distally extending threaded rod that extends through the expandable joint element and the second drive member includes a threaded opening for engaging the distally extending threaded rod of the first drive member.

[0092] In some implementations, the spreader member can have two expandable rings disposed between the spreader member and each of the first second member and the second drive member, hi some implementations, the spreader member includes a tapered end for engaging the spreader member, which can include a corresponding chamfered inner diameter.

[0093] In some implementations, the actuation assembly or mechanism can include a threaded rod having first and second threaded portions with counter-winding threads that engage first and second drive members, respectively. Rotating the threaded rod moves the drive members toward and away from each other to expand and contract the expandable interfacing element. An optional cover can be used to cover the components of the expandable interfacing element.

[0094] In some implementations, the apparatus includes a fixed drive member, a movable drive member, a threaded shaft extending through the movable drive member and rotatably attached to the first drive member, and a number of posts extending between the fixed drive member and the movable drive member.

[0095] In some implementations, each strut is made from multiple rigid sections connected together by multiple hinge sections.

[0096] In some implementations, the device is configured to move the movable drive member toward and away from the fixed drive member by rotating the threaded shaft to expand and contract the multiple struts, respectively. In some implementations, each of the struts can be made of three rigid sections, with the second, or middle, section including a mounting location for mounting other components of the device. Any number of struts can be used, for example, two struts or four struts.

[0097] In some implementations, where the device has four struts, the four struts may be arranged in two opposing pairs of struts. In some implementations, each strut of one of the two opposing pairs of struts may include an attachment location. The struts of different opposing pairs may expand at different rates.

[0098] In some implementations, an apparatus (e.g., a repair apparatus, an implantable device, etc.) includes a first drive member, a second drive member, and a threaded shaft having a first threaded portion for engagement with the first drive member and a second threaded portion for engagement with the second drive member, the first threaded portion and the second threaded portion including counter-winding threads.

[0099] In some implementations, a plurality of struts extend between the first drive member and the second drive member, each strut being made from a plurality of rigid sections connected together by a plurality of hinge sections.

[0100] In some implementations, the device is configured to move the first and second drive members toward and away from each other by rotating the threaded shaft to expand and contract the multiple struts, respectively. In some implementations, each of the struts can be made of three rigid sections, with the second, or middle, section including a mounting location for mounting other components of the device. Any number of struts can be used, for example, two struts or four struts.

[0101] In some implementations, where a device has four struts, the four struts may be arranged in two opposing pairs of struts. Each strut of one of the two opposing pairs of struts may include an attachment location. Different opposing pairs of struts may expand at different rates.

[0102] In some implementations, the apparatus (e.g., repair apparatus, implantable device, delivery apparatus, etc.) has an outer tube attached to a fixed drive member, the outer tube including a plurality of openings, In some implementations, a latch tube is attached to a movable drive member, the latch tube having a latch member.

[0103] In some implementations, the securing member extends through the latch tube and has a tapered end for engaging the latch member.

[0104] In some implementations, a plurality of struts extend between the fixed drive member and the movable drive member, each strut including a plurality of rigid portions connected together by a plurality of hinge portions.

[0105] In some implementations, when the fixation member is inserted into the latch tube, the tapered distal end engages the latch member and holds the latch member in an unlatched state so that the latch tube can be moved to a desired location within the outer tube.

[0106] In some implementations, the securing member can be withdrawn from the latch tube to disengage the securing member from the latch member and facilitate movement of the latch member to a latched state in which the latch member engages with one of a plurality of openings in the outer tube.

[0107] In some implementations, the device is configured to move the movable drive member toward and away from the fixed drive member by extending and retracting the latch tube to expand and contract the multiple struts, respectively.

[0108] The latch members may be laser cut from a latch tube and both may be formed from a shape memory alloy that the latch members are shape set in the latched state. In some implementations, each post has two rigid portions joined by a hinge portion. The posts may be joined in pairs at the proximal and distal ends or may be cut together from a sheet of material. The two pairs of posts may be connected to each other by a side plate that may optionally include a mounting portion.

[0109] In some implementations, the device has an actuation spool, a central frame extending from the actuation spool, a round pivot frame pivotally mounted to the central frame, and a drive member extending from the actuation spool to the pivot frame, hi some implementations, the device is configured such that rotation of the actuation spool retracts and releases the drive member to pivot the pivot frame.

[0110] In some implementations, the device may have multiple pivot frames, one or more of which may be smaller than the rest of the pivot frames such that the combination of the pivot frames provides a smooth three-dimensional shape, hi some implementations, the shape may be configured to fill in similarly shaped gaps between the natural cusps.

[0111] In some implementations, where the apparatus includes multiple pivot frames, at least one actuation element can be attached to an adjacent pivot frame such that pivoting the first pivot frame causes pivoting of the second pivot frame.

[0112] In some implementations, as the actuation spool rotates, a first half of the pivot frame moves toward the actuation spool and a second half of the pivot frame moves away from the actuation spool. In other implementations, as the actuation spool rotates, a first half of the pivot frame moves toward the actuation spool and a second half of the pivot frame also moves toward the actuation spool. The pivot frame may extend through or terminate at the central frame.

[0113] In some implementations, the drive member is released when the actuation spool rotates in a first direction, and the drive member is retracted when the spool rotates in a second direction.

[0114] In some implementations, when the actuation spool rotates in a first direction, the first drive member is released and the second drive member is retracted, and when the actuation spool rotates in a second direction, the first drive member is retracted and the second drive member is released.

[0115] In some implementations, when the actuation spool rotates in a first direction the first drive member is released and the second drive member is released, and when the actuation spool rotates in a second direction the first drive member retracts and the second drive member retracts.

[0116] In some implementations, the heart valve repair system includes an apparatus (e.g., a repair apparatus, an implantable device, etc.) having a proximal collar and a delivery system including a distal coupler and a drive member. In some implementations, the proximal collar has a pair of protrusions extending radially inward to engage openings in a pair of movable arms of the distal coupler.

[0117] In some implementations, the movable arm can move between engaged and disengaged positions to engage and disengage the protrusion.

[0118] In some implementations, a drive member extends through the distal coupler and between the pair of movable arms to hold the movable arms in the engaged position.

[0119] In some implementations, the system is configured to allow the pair of movable arms to disengage from the pair of protrusions by retracting the drive member through the distal coupler.

[0120] In some implementations, the movable arm may be biased inwardly or in a disengaging direction and may include an engagement portion for engaging with the drive member, which may have a rounded shape. In some implementations, the engagement portion is compressed between the drive member and the movable arm such that the movable arm is pressed against a pair of protrusions on the proximal collar.

[0121] In some implementations, the apparatus (e.g., repair apparatus, implantable device, etc.) includes an outer tube, an inner tube, and one or more expandable junction members. In some implementations, the outer tube includes an opening. In some implementations, the inner tube is concentrically disposed within the outer tube.

[0122] In some implementations, the one or more expandable joint members extend from the first end to the second end.

[0123] In some implementations, the first end is hinged to the outer tube and the second end is hinged to the inner tube through an opening in the outer tube.

[0124] In some implementations, the device can be configured to expand the expandable joint members radially outward by rotating the outer tube relative to the inner tube.

[0125] In some implementations, the one or more expandable joint members include a number of links connected together by a number of hinge portions.

[0126] In some implementations, the expandable joint member or members are severed from the outer tube.

[0127] In some implementations, the device includes three expandable junction members equally radially spaced from one another.

[0128] In some implementations, the hinge portion includes a plurality of notches.

[0129] In some implementations, the one or more expandable junction members vary in width between the first end and the second end.

[0130] In some implementations, one or more of the expandable joint members are formed from a shape memory alloy.

[0131] In some implementations, the one or more expandable joint members are biased in an expansion direction.

[0132] In some implementations, the heart valve repair system includes a device (e.g., a repair device, an implantable device, etc.) and a delivery system. In some implementations, the device includes an interface portion and an anchor portion.

[0133] In some implementations, the interface portion includes an outer tube including an opening, an inner tube concentrically disposed within the outer tube, and one or more expandable interface members extending from a first end to a second end.

[0134] In some implementations, the first end is hinged to the outer tube and the second end is hinged to the inner tube through an opening in the outer tube.

[0135] In some implementations, the delivery system includes a delivery sheath and a drive member.

[0136] In some implementations, the drive member engages one of the inner and outer tubes such that rotating the drive member causes the one or more expandable joint members to expand radially outward.

[0137] In some implementations, the expandable joint members are biased in an expansion direction.

[0138] In some implementations, the device further includes a cover over the one or more expandable joint members.

[0139] In some implementations, the device includes a flexible enclosure and an elongate filler element. In some implementations, the flexible enclosure forms an expandable cavity. In some implementations, the flexible enclosure is expandable from an unexpanded state to an expanded state.

[0140] In some implementations, the elongate filling element is configured to fill at least a portion of the expandable cavity when the flexible enclosure is in the expanded state.

[0141] In some implementations, the elongate filling element provides resistance to compression of the flexible enclosure in the expanded state.

[0142] In some implementations, the flexible enclosure is formed from a woven material. In some implementations, the flexible enclosure is formed from a molded polymeric material.

[0143] In some implementations, the elongate filling element comprises a metallic coil. In some implementations, the elongate filling element comprises a polymer coil. In some implementations, the elongate filling element comprises a radiopaque material.

[0144] In some implementations, the radiopaque material is formed into a plurality of markers attached to the elongate filler element.

[0145] In some implementations, a second elongate filler element disposed within the expandable cavity.

[0146] In some implementations, the second elongated packing element is formed from a different material than the elongated packing element.

[0147] In some implementations, the apparatus further includes multiple pieces of filler material.

[0148] In some implementations, at least one of the elongate packing element, the second elongate packing element, and the plurality of packing materials are coated with a hydrogel coating.

[0149] In some implementations, the flexible enclosure includes an expandable frame formed from a shape memory alloy.

[0150] In some implementations, the heart valve repair system includes a device (e.g., a repair device, an implantable device, etc.) and a delivery system. In some implementations, the device includes an interface portion and an anchor portion.

[0151] In some implementations, the interface includes a flexible enclosure expandable from an unexpanded state to an expanded state forming an expandable cavity, hi some implementations, the interface includes an elongate filling element configured to fill at least a portion of the expandable cavity when the flexible enclosure is in the expanded state.

[0152] In some implementations, the elongate filling element provides resistance to compression of the flexible enclosure in the expanded state.

[0153] In some implementations, the delivery system includes a delivery sheath and a drive member.

[0154] In some implementations, the actuation member facilitates expansion of the flexible enclosure.

[0155] In some implementations, the elongate filler element is configured to be delivered into the expandable cavity via a delivery sheath.

[0156] In some implementations, the drive member includes a tube for filling the expandable cavity with saline to expand the flexible enclosure.

[0157] In some implementations, the flexible enclosure is expanded by delivery of an elongated filler element.

[0158] Any of the above systems, devices, apparatus, components, etc. may be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for patient use, and the above methods may include (or additionally consist of) sterilization (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, apparatus, components, etc. described herein.

[0159] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like elements bear like reference numerals and in which: [Brief description of the drawings]

[0160] To further clarify various aspects of the implementation of the present disclosure, specific examples 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 are therefore not to be considered as limiting the scope of the present disclosure. Furthermore, the drawings may be drawn to scale for some embodiments, but not necessarily to scale for all embodiments. The embodiments and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings. [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 valvular 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 cusps 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 an embodiment of the 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 an embodiment of a 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 device or implant of FIGS. 8-14 delivered and implanted within the 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 device or implant in a closed position. [Figure 23] FIG. 23 shows a front view of the device or implant of FIG. [Figure 24] FIG. 24 shows a side view of the device or implant of FIG. [Diagram 25] FIG. 25 shows a front view of the device or implant of FIG. 22 with a cover over the paddle and the coaptation element or spacer. [Figure 26] FIG. 26 shows a perspective view from above of the device or implant of FIG. 22 in the open position. [Figure 27]FIG. 27 shows a perspective view from below of the device or implant of FIG. 22 in the open position. [Figure 28A] FIG. 28A shows a clasp for use with a device or implant. [Figure 28B] FIG. 28B illustrates a perspective view of an exemplary clasp in an exemplary device or implant in a closed position. [Figure 29] FIG. 29 shows a portion of the native valve tissue grasped by the clasp. [Diagram 30] FIG. 30 illustrates a side view of an exemplary device or implant in a partially open position with the clasp in a closed position. [Diagram 31] FIG. 31 illustrates a side view of an exemplary device or implant in a partially open position with the clasps in the open position. [Diagram 32] FIG. 32 shows a side view of an exemplary device or implant in a half-open position with the clasp in the closed position. [Diagram 33] FIG. 33 shows a side view of an exemplary device or implant in a half-open position with the clasp in the open position. [Diagram 34] FIG. 34 shows a side view of an exemplary device or implant in a three-quarters open position with the clasp in the closed position. [Diagram 35] FIG. 35 shows a side view of an exemplary device or implant in a three-quarters open position with the clasps in the open position. [Diagram 36] FIG. 36 illustrates a side view of an exemplary device in a fully open or fully evacuation position with the clasp in the closed position. [Figure 37] FIG. 37 illustrates a side view of an exemplary device in a fully open or fully evacuation position with the clasp in the open position. [Figure 38] 38-49 show the exemplary device or implant of FIGS. 30-38 including a cover and delivered and implanted within a native valve. [Figure 39] Same as above. [Diagram 40]Same as above. [Diagram 41] Same as above. [Diagram 42] Same as above. [Diagram 43] Same as above. [Diagram 44] Same as above. [Diagram 45] Same as above. [Figure 46] Same as above. [Figure 47] Same as above. [Figure 48] Same as above. [Figure 49] Same as above. [Figure 50] FIG. 50 is a schematic diagram illustrating the path of the native leaflets along each side of a coaptation element or spacer in an exemplary valve repair device or implant. [Figure 51] FIG. 51 is a schematic diagram from above illustrating the path of the native leaflets around the coaptation elements or spacers in an exemplary valve repair device or implant. [Figure 52] FIG. 52 illustrates a coaptation element or spacer positioned within the native valve gap when viewed from the atrial side of the native valve. [Diagram 53] FIG. 53 illustrates a valve repair device or implant attached to the native valve leaflets with a coaptation element or spacer positioned within the native valve gap when viewed from the ventricular side of the native valve. [Figure 54] FIG. 54 is a perspective view of a valve repair device or implant attached to the native valve leaflets with a coaptation element or spacer positioned within the native valve gap when viewed from the ventricular side of the native valve. [Figure 55] FIG. 55 illustrates a perspective view of an exemplary device or implant in a closed position. [Figure 56A] FIG. 56A illustrates an exemplary valve repair device with the paddles in the open position. [Figure 56B] FIG. 56B illustrates the valve repair device of FIG. 56A with the paddles in an open position and the gripping members moved to create a wider gap between the gripping members and the paddles. [Figure 56C] FIG. 56C illustrates the valve repair device of FIG. 56A in the position shown in FIG. 56A with the valve tissue disposed between the grasping members and the paddles. [Figure 56D] FIG. 56D illustrates the valve repair device of FIG. 56A where the gripping members have been moved to reduce the gap between the gripping members and the paddles. [Figure 56E] 56E-56F illustrate the paddles of the valve repair device of FIG. 56A moving from an open position to a closed position. [Fig. 56F] Same as above. [Figure 56G] FIG. 56G illustrates the valve repair device of FIG. 56A in a closed position with the gripping members engaged against the valve tissue. [Fig. 56H] FIG. 56H illustrates the valve repair device of FIG. 56A after being detached from the delivery device and attached to valve tissue, causing the valve repair device to be in an occluded and locked state. [Figure 57] FIG. 57 is a top view of an exemplary device or implant having multiple anchors, each anchor including multiple paddles and multiple clasps, such that each clasp corresponds to an associated paddle. [Figure 58] FIG. 58 shows a front view of the exemplary device or implant of FIG. [Figure 59] FIG. 59 shows a side view of the exemplary device or implant of FIG. [Figure 60] FIG. 60 shows a top view of an exemplary device or implant similar to the exemplary device of FIG. 57, except that only a portion of the paddles of each anchor include a corresponding clasp. [Figure 61] FIG. 61 shows a front view of the exemplary device or implant of FIG. [Figure 62] FIG. 62 shows a side view of the exemplary device or implant of FIG. [Figure 63]FIG. 63 shows a top view of an exemplary device or implant similar to the exemplary device of FIG. 60, except that the inner paddle of each anchor has a longer length compared to the outer paddle of the anchor. [Figure 64] FIG. 64 shows a front view of the exemplary device or implant of FIG. [Figure 65] FIG. 65 shows a side view of the exemplary device or implant of FIG. [Figure 66] FIG. 66 shows a top view of an exemplary device or implant similar to the exemplary device of FIG. 60, except that the inner paddle of each anchor has a shorter length compared to the outer paddle of the anchor. [Figure 67] FIG. 67 shows a front view of the exemplary device or implant of FIG. [Figure 68] FIG. 68 shows a side view of the exemplary device or implant of FIG. [Figure 69] 69-73 show the exemplary device or implant of FIG. 57 during various stages of deployment. [Figure 70] Same as above. [Figure 71] Same as above. [Figure 72] Same as above. [Figure 73] Same as above. [Figure 74] FIG. 74 is a top view of an exemplary device or implant having multiple anchors, each anchor including multiple paddle members and multiple clasps such that each clasp corresponds to an associated paddle member. [Figure 75] FIG. 75 shows a front view of the exemplary device or implant of FIG. [Figure 76] FIG. 76 shows a side view of the exemplary device or implant of FIG. [Figure 77] FIG. 77 illustrates a top view of an exemplary device or implant similar to the exemplary device of FIG. 74, except that only a portion of the paddle members of each anchor include a corresponding clasp. [Figure 78]FIG. 78 shows a front view of the exemplary device or implant of FIG. [Figure 79] FIG. 79 shows a side view of the exemplary device or implant of FIG. [Figure 80] FIG. 80 shows a top view of an exemplary device or implant similar to the exemplary device of FIG. 77, except that the inner paddle member of each anchor has a longer length compared to the outer paddle member of the anchor. [Figure 81] FIG. 81 shows a front view of the exemplary device or implant of FIG. [Figure 82] FIG. 82 shows a side view of the exemplary device or implant of FIG. [Figure 83] FIG. 83 shows a top view of an exemplary device or implant similar to the exemplary device of FIG. 77, except that the inner paddle member of each anchor has a shorter length compared to the outer paddle member of the anchor. [Figure 84] FIG. 84 shows a front view of the exemplary device or implant of FIG. [Figure 85] FIG. 85 shows a side view of the exemplary device or implant of FIG. [Figure 86A] FIG. 86A illustrates the exemplary device or implant of FIG. 57 during various stages of deployment. [Figure 86B] FIG. 86B illustrates an embodiment similar to that illustrated in FIGS. 86A and 87A with the paddle portion in an extended position. [Fig. 87A] FIG. 87A illustrates the exemplary device or implant of FIG. 57 during various stages of deployment. [Fig. 87B] FIG. 87B illustrates an embodiment similar to that illustrated in FIGS. 86A and 87A with the paddle portion in an extended position. [Figure 88] 88-90 show the exemplary device or implant of FIG. 57 during various stages of deployment. [Figure 89] Same as above. [Figure 90]Same as above. [Figure 91] FIG. 91 shows a perspective view of an exemplary paddle frame for a device or implant. [Figure 92] FIG. 92 shows a partial view of the paddle frame of FIG. 91 when the paddle frame is in a constricted position. [Figure 93] FIG. 93 shows the paddle frame of FIG. 91 positioned within a delivery system. [Figure 94] FIG. 94 illustrates an exemplary device or implant including the paddle frame of FIG. 91 when the device or implant is in an open position. [Figure 95] FIG. 95 shows the paddle frame of FIG. 91 when the paddle frame is in the constricted position. [Figure 96] FIG. 96 shows a perspective view of an exemplary paddle frame for a device or implant. [Figure 97] FIG. 97 shows a partial view of the paddle frame of FIG. [Figure 98] FIG. 98 shows a partial front view of an exemplary device including an exemplary paddle frame with the device or implant in a closed position. [Figure 99] FIG. 99 shows a partial front view of an exemplary device including an exemplary paddle frame with the device or implant in a closed position. [Figure 100] FIG. 100 shows a partial front view of an exemplary device including an exemplary paddle frame with the device or implant in a closed position. [Figure 101] FIG. 101 shows a partial front view of the device or implant of FIG. 98, with the device or implant in an open position. [Figure 102] FIG. 102 shows a partial front view of the device or implant of FIG. 99, with the device or implant in an open position. [Figure 103] FIG. 103 shows a partial front view of the device or implant of FIG. 100, with the device or implant in an open position. [Figure 104]FIG. 104 shows a partial side view of the device or implant of FIG. 98, with the device or implant in an open position. [Figure 105] FIG. 105 shows a partial side view of the device or implant of FIG. 99, with the device or implant in an open position. [Figure 106] FIG. 106 shows a partial side view of the device or implant of FIG. 100, with the device or implant in an open position. [Figure 107] FIG. 107 shows a front view of an exemplary paddle frame for a device or implant. [Figure 108] FIG. 108 illustrates a front view of the exemplary paddle frame of FIG. 107 when the paddle frame is in a constricted position. [Figure 109] FIG. 109 shows a front view of an exemplary paddle frame for a device or implant. [Figure 110] FIG. 110 illustrates a front view of the exemplary paddle frame of FIG. 109 when the paddle frame is in a constricted position. [Figure 111] FIG. 111 shows a front view of an exemplary paddle frame for a device or implant. [Figure 112] FIG. 112 shows a front view of an exemplary paddle frame for a device or implant. [Figure 113] FIG. 113 illustrates a front view of one exemplary configuration for the exemplary paddle frame of FIG. [Fig. 114] FIG. 114 illustrates a front view of one exemplary configuration for the exemplary paddle frame of FIG. [Figure 115] FIG. 115 shows a front view of an exemplary paddle frame for a device or implant. [Fig. 116] FIG. 116 illustrates a top view of the exemplary paddle frame of FIG. [Figure 117] FIG. 117 shows a perspective view of an exemplary device or implant including an exemplary paddle frame, with the device or implant in an open position. [Fig. 118]FIG. 118 shows a bottom view of the device or implant of FIG. [Figure 119] FIG. 119 shows a front view of the device or implant of FIG. 117 when the device or implant is in a closed position. [Figure 120] FIG. 120 shows a side view of the device or implant of FIG. 117 attached to a native valve of the heart. [Figure 121] FIG. 121 shows a bottom view of the device or implant of FIG. 117 attached to a native valve of the heart. [Figure 122] FIG. 122 illustrates a front view of an exemplary device or implant with the device or implant in a closed position. [Figure 123] FIG. 123 illustrates the exemplary device or implant of FIG. 122 with the device or implant in an open position. [Figure 124] FIG. 124 illustrates an exemplary paddle frame of the device or implant of FIG. 122 when the device or implant is in an open position. [Fig. 125] FIG. 125 shows a front view of an exemplary paddle frame of a device or implant, with the paddle frame in a constricted position. [Fig. 126] FIG. 126 illustrates the exemplary paddle frame of FIG. 125 with the paddle frame in an extended position. [Figure 127] FIG. 127 shows a perspective view of an exemplary device or implant including an exemplary paddle frame, where the device includes an exemplary means for moving the paddle frame from a normal position to a constricted position. [Figure 128] FIG. 128 shows the paddle frame of FIG. 127 in a constricted position. [Figure 129] FIG. 129 shows a perspective view of the exemplary device or implant of FIG. 127, except that the device includes an exemplary means for moving the paddles from a normal position to a constricted position. [Fig. 130]FIG. 130 shows a perspective view of the exemplary device or implant of FIG. 127, except that the device includes an exemplary means for moving the paddles from a normal position to a constricted position. [Fig. 131] FIG. 131 shows a perspective view of an exemplary device or implant including an exemplary paddle frame. [Fig. 132] FIG. 132 illustrates the device or implant of FIG. 131 with an exemplary means for moving the paddle frame from a normal position to a constricted position. [Fig. 133] FIG. 133 illustrates the device or implant of FIG. 131 with an exemplary means for moving the paddle frame from a normal position to a constricted position. [Fig. 134] FIG. 134 illustrates the device or implant of FIG. 131 with an exemplary means for moving the paddle frame from a normal position to a constricted position. [Fig. 135] FIG. 135 illustrates the device or implant of FIG. 131 with an exemplary means for moving the paddle frame from a normal position to a constricted position. [Fig. 136] FIG. 136 illustrates the device or implant of FIG. 131 with an exemplary means for moving the paddle frame from a normal position to a constricted position. [Fig. 137] FIG. 137 shows a front view of an exemplary paddle frame for a device or implant. [Figure 138] FIG. 138 illustrates a pair of the exemplary paddle frames of FIG. 137 positioned adjacent to one another. [Figure 139] FIG. 139 shows a side view of an embodiment of a device or implant including the paddle frame of FIG. 137, with the paddle frame in a constricted position. [Fig. 140] FIG. 140 shows a side view of the device or implant of FIG. 139 with the paddle frame in an extended position. [Fig. 141] FIG. 141 shows a partial side view of the device or implant of FIG. 139 with the paddle frame in the constricted position. [Fig. 142]FIG. 142 shows a partial side view of the device or implant of FIG. 139 with the paddle frame in an extended position. [Fig. 143] FIG. 143 shows a perspective view of the device or implant of FIG. 139 with the paddle frame of FIG. [Fig. 144] FIG. 144 shows a front view of the device or implant of FIG. 139 with the paddle frame of FIG. [Fig. 145] FIG. 145 shows a perspective view of an embodiment of an inner paddle and an outer paddle for the device or implant of FIG. [Fig. 146] FIG. 146 shows a side view of the inner and outer paddles of FIG. [Fig. 147] FIG. 147 shows a top view of the inner and outer paddles of FIG. [Fig. 148] FIG. 148 shows a perspective view of an exemplary connection between the paddle of FIG. 146 and the paddle frame of FIG. [Figure 149] FIG. 149 shows a front view of an exemplary paddle frame for a device or implant. [Fig. 150] FIG. 150 shows a front view of an exemplary paddle frame for a device or implant. [Fig. 151] FIG. 151 shows a front view of an exemplary paddle frame for a device or implant. [Fig. 152] FIG. 152 shows a front view of an exemplary paddle frame for a device or implant. [Fig. 153] 153-155 show front views of various configurations of an exemplary paddle frame for a device or implant. [Fig. 154] Same as above. [Fig. 155] Same as above. [Fig. 156] FIG. 156 shows a front view of an exemplary paddle frame for a device or implant. [Fig. 157]FIG. 157 illustrates a front view of an exemplary paddle frame for a device or implant, where the paddle frame is shown in an extended position. [Fig. 158] FIG. 158 is a front view of the exemplary paddle frame of FIG. 157, with the paddle frame shown in a constricted position. [Fig. 159] FIG. 159 shows a front view of an exemplary paddle frame for a device or implant. [Fig. 160] FIG. 160 shows a left side view of the paddle frame of FIG. [Fig. 161] FIG. 161 shows a top view of the paddle frame of FIG. [Fig. 162] FIG. 162 shows a perspective view of an embodiment of a device or implant including the paddle frame of FIG. [Fig. 163] FIG. 163 shows a front view of the device or implant of FIG. 162 including the paddle frame of FIG. [Fig. 164] 164-168 illustrate the device or implant of FIG. 162 having exemplary means for moving the paddle frame of FIG. 159 between expanded and constricted positions. [Fig. 165] Same as above. [Fig. 166] Same as above. [Fig. 167] Same as above. [Fig. 168] Same as above. [Fig. 169] FIG. 169 shows a perspective view of an embodiment of a paddle and interface element frame assembly for a device or implant. [Fig. 170] 170 illustrates a rear view of the paddle and interface element frame assembly of FIG. [Fig. 171] FIG. 171 illustrates a perspective view of an embodiment of a device or implant including the paddle and coaptation element frame assembly of FIG. 171 with the coaptation element frame in a constricted position. [Fig. 172] FIG. 172 shows a perspective view of the device or implant of FIG. 171 with the coaptation element frame in an extended position. [Fig. 173] FIG. 173 shows a top view of the device or implant of FIG. 171 with the coaptation element frame in the constricted position. [Fig. 174] FIG. 174 shows a top view of the device or implant of FIG. 172 with the coaptation element frame in an expanded position. [Fig. 175] FIG. 175 shows a rear view of the paddle and interface frame assembly of FIG. 169 when in a constricted position where the paddle and interface frame assembly is attached to the inner and outer paddles of the anchor portion of the device or implant. [Fig. 176] FIG. 176 shows a rear view of the paddle and interface frame assembly of FIG. 169 when in an extended position in which the paddle and interface frame assembly is attached to the inner and outer paddles of the anchor portion of the device or implant. [Fig. 177] FIG. 177 shows a perspective view of the paddle and interface frame assembly of FIG. 169 when in a constricted position where the paddle and interface frame assembly is attached to the inner and outer paddles of the anchor portion of the device or implant. [Fig. 178] FIG. 178 shows a top view of the paddle and interface frame assembly of FIG. 169 in an extended position in which the paddle and interface frame assembly is attached to the inner and outer paddles of the anchor portion of the device or implant. [Fig. 179] FIG. 179 illustrates a perspective view of the paddle and interface element frame assembly of FIG. 169 in an extended position. [Fig. 180] FIG. 180 shows a perspective view of the coaptation element frame of the paddle and coaptation element frame assembly of FIG. 169, where the coaptation element frame is attached to the inner paddle of the anchor portion of the device or implant. [Fig. 181] FIG. 181 shows a front view of the frame of the paddle and abutment element assembly of FIG. 169 when in the constricted position. [Fig. 182]FIG. 182 shows a side view of the interface element frame of FIG. [Fig. 183] FIG. 183 shows a top view of the interface element frame of FIG. [Fig. 184] FIG. 184 shows a perspective view of the interface element frame of FIG. [Fig. 185] FIG. 185 shows a front view of the coaptation element frame of FIG. 181 in an extended position. [Fig. 186] FIG. 186 shows a side view of the interface element frame of FIG. [Fig. 187] FIG. 187 shows a top view of the interface element frame of FIG. [Fig. 188] FIG. 188 shows a perspective view of the interface element frame of FIG. [Fig. 189] FIG. 189 shows a perspective view of an exemplary pair of paddle frames for a pair of anchors in a device or implant. [Fig. 190] FIG. 190 shows a front view of the paddle frame of FIG. [Fig. 191] FIG. 191 shows a top view of the paddle frame of FIG. [Fig. 192] FIG. 192 shows a side view of the paddle frame of FIG. [Fig. 193] FIG. 193 shows a top view of an embodiment of a device or implant including one of the paddle frames of FIG. 189, with the paddle frame in an extended position. [Fig. 194] FIG. 194 shows a top view of the device or implant of FIG. 193 with the paddle frame in the constricted position. [Fig. 195] FIG. 195 shows a ventricular view of the native valve with the device or implant of FIG. 193 positioned to connect against the native valve. [Fig. 196] FIG. 196 shows an atrial view of an exemplary device or implant attached to a native valve of the heart. [Figure 197]FIG. 197 shows an atrial view of the device or implant of FIG. 196 attached to a native valve with tissue graft covering the device. [Figure 198] FIG. 198 shows a front view of the device or implant of FIG. 196 attached to a native valve with tissue graft covering the device. [Figure 199] FIG. 199 shows an atrial view of an exemplary device or implant attached to a native valve of the heart, where the device includes an exemplary coaptation extension member. [Figure 200] FIG. 200 shows an atrial view of the device or implant of FIG. 199 attached to a native valve with tissue engraftment covering the device. [Figure 201] FIG. 201 shows an atrial view of an exemplary device or implant attached to a native valve of the heart, where the device includes an exemplary coaptation extension member. [Figure 202] FIG. 202 shows an atrial view of the device or implant of FIG. 201 attached to a native valve with tissue graft covering the device. [Fig. 203] FIG. 203 shows a front view of an exemplary device or implant attached to a native valve of the heart, where the device includes an exemplary coaptation extension member. [Fig. 204] FIG. 204 shows a front view of the device or implant of FIG. 203 attached to a native valve with tissue graft covering the device. [Fig. 205] FIG. 205 shows a front view of an exemplary device or implant attached to a native valve of the heart, where the device includes an exemplary coaptation extension member. [Fig. 206] FIG. 206 shows a front view of the device or implant of FIG. 205 attached to a native valve with tissue graft covering the device. [Fig. 207] FIG. 207 shows an atrial view of an exemplary device or implant attached to a native valve of the heart, where the device includes an exemplary coaptation extension member. [Fig. 208]FIG. 208 shows a front view of an exemplary device or implant attached to a native valve of the heart, the device including an exemplary coaptation extension member. [Fig. 209] FIG. 209 shows a front view of an exemplary device or implant attached to a native valve of the heart, where the device includes an exemplary coaptation extension member. [Fig. 210] 210-214 illustrate examples of connections between actuation elements and components of a device or implant. [Fig. 211] Same as above. [Fig. 212] Same as above. [Fig. 213] Same as above. [Fig. 214] Same as above. [Fig. 215] 215-218 illustrate examples of connections between working elements and components of a device or implant. [Fig. 216] Same as above. [Fig. 217] Same as above. [Fig. 218] Same as above. [Fig. 219] 219-222 illustrate examples of connections between working elements and components of a device or implant. [Fig. 220] Same as above. [Fig. 221] Same as above. [Fig. 222] Same as above. [Fig. 223] 223-224 illustrate examples of connections between working elements and components of a device or implant. [Fig. 224] Same as above. [Fig. 225] 225-227 illustrate examples of connections between working elements and components of a device or implant. [Fig. 226] Same as above. [Fig. 227] Same as above. [Fig. 228] 228-230 illustrate examples of connections between working elements and components of a device or implant. [Fig. 229] Same as above. [Fig. 230] Same as above. [Fig. 231] 231-232 illustrate examples of connections between working elements and components of a device or implant. [Fig. 232] Same as above. [Fig. 233] FIG. 233 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 234] FIG. 234 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 235] FIG. 235 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 236] FIG. 236 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 237] FIG. 237 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 238] FIG. 238 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 239] FIG. 239 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 240] FIG. 240 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 241] FIG. 241 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 242] FIG. 242 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 243] FIG. 243 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 244]FIG. 244 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 245] 245-250 illustrate examples of connections between working elements and components of a device or implant. [Fig. 246] Same as above. [Fig. 247] Same as above. [Fig. 248] Same as above. [Fig. 249] Same as above. [Fig. 250] Same as above. [Fig. 251] 251-252 illustrate examples of connections between working elements and components of a device or implant. [Fig. 252] Same as above. [Fig. 253] FIG. 253 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 254] 254-255 illustrate examples of connections between working elements and components of a device or implant. [Figure 255] Same as above. [Fig. 256] FIG. 256 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 257] FIG. 257 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 258] 258-259 illustrate examples of connections between working elements and components of a device or implant. [Fig. 259] Same as above. [Fig. 260] 260-261 illustrate examples of connections between working elements and components of a device or implant. [Fig. 261] Same as above. [Fig. 262] FIG. 262 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 263] 263-264 illustrate examples of connections between working elements and components of a device or implant. [Fig. 264] Same as above. [Fig. 265] 265-266 illustrate examples of connections between working elements and components of a device or implant. [Fig. 266] Same as above. [Fig. 267] 267-268 illustrate examples of connections between working elements and components of a device or implant. [Fig. 268] Same as above. [Fig. 269] 269-270 illustrate examples of connections between working elements and components of a device or implant. [Fig. 270] Same as above. [Fig. 271] FIG. 271 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 272] FIG. 272 ​​illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 273] FIG. 273 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 274] FIG. 274 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 275] FIG. 275 illustrates an example of a connection between an actuation element and a component of a device or implant. [Fig. 276] FIG. 276 shows an embodiment of a width adjustment or control device. [Fig. 277] FIG. 277 shows an embodiment of a width adjustment or control device. [Fig. 278] FIG. 278 illustrates an example of a pulley configuration. [Fig. 279] 279 is a top view of the width adjustment or control device shown in FIG. [Fig. 280] FIG. 280 is a bottom view of the width adjustment device or control device shown in FIG. [Fig. 281] 281 and 282 show an embodiment of a width adjustment or control device. [Fig. 282] Same as above. [Fig. 283] 283-285 show an embodiment of a width adjustment device or control device. [Fig. 284] Same as above. [Fig. 285] Same as above. [Fig. 286] FIG. 286 illustrates an embodiment of a paddle frame. [Fig. 287] FIG. 287 shows an embodiment of a width adjustment or control device that is coupled to the paddle frame. [Fig. 288] FIG. 288 shows an embodiment of a width adjustment or control device coupled to the paddle frame. [Fig. 289] FIG. 289 illustrates an embodiment of an adjustable paddle frame assembly. [Fig. 290] FIG. 290 illustrates an embodiment of an adjustment mechanism for the adjustable paddle assembly of FIG. [Fig. 291] FIG. 291 illustrates an embodiment of an adjustable paddle frame assembly. [Fig. 292] FIG. 292 shows an embodiment of a width adjustment or control device. [Fig. 293] FIG. 293 illustrates an embodiment of an adjustable paddle frame assembly. [Fig. 294] FIG. 294 illustrates an embodiment of an adjustable paddle frame assembly. [Fig. 295] FIG. 295 illustrates an embodiment of an adjustable paddle frame assembly. [Fig. 296] FIG. 296 illustrates an embodiment of an adjustment member in the adjustable paddle frame assembly of FIGS. 294 and 295. [Fig. 297] FIG. 297 illustrates an embodiment of an adjustable paddle frame assembly. [Fig. 298] 298-300 show an embodiment of a width adjustment device or control device. [Figure 299] Same as above. [Figure 300] Same as above. [Fig. 301] FIG. 301 shows a front cross-sectional view of the device or implant. [Fig. 302] FIG. 302 shows a perspective cross-sectional view of the device / implant of FIG. [Fig. 303] FIG. 303 shows a perspective view of the device / implant of FIG. [Fig. 304] FIG. 304 shows a side view of the device / implant of FIG. [Fig. 305] FIG. 305 shows a top view of the device / implant of FIG. [Fig. 306] 306-311 show partial views of the device / implant of FIG. 301 at various stages of assembly. [Fig. 307] Same as above. [Fig. 308] Same as above. [Fig. 309] Same as above. [Fig. 310] Same as above. [Fig. 311] Same as above. [Fig. 312] FIG. 312 shows a front view of the device / implant of 301 in the expanded position. [Fig. 313] FIG. 313 shows a side view of the device / implant of 301 in the expanded position. [Fig. 314] FIG. 314 shows a top view of the device / implant of 301 in the expanded position. [Fig. 315] FIG. 315 shows a front view of the device / implant of 301 in the constriction position. [Fig. 316] FIG. 316 shows a side view of the device / implant of 301 in the constriction position. [Fig. 317] FIG. 317 shows a top view of the device / implant of 301 in the constriction position. [Fig. 318]FIG. 318 shows a front cross-sectional view of an embodiment of a device or implant. [Fig. 319] FIG. 319 shows a side view of the device / implant of FIG. [Fig. 320] 320-323 show front views of the device / implant of FIG. 318 in various positions moving from an expanded position to a constricted position. [Fig. 321] Same as above. [Fig. 322] Same as above. [Figure 323] Same as above. [Fig. 324] FIG. 324 shows a front view of some embodiments of a paddle frame for a device or implant. [Fig. 325] FIG. 325 shows a perspective view of the frame of FIG. [Fig. 326] FIG. 326 shows a top view of the frame of FIG. [Fig. 327] FIG. 327 shows a side view of the frame of FIG. [Fig. 328] 328-331 show front views of the device / implant of FIG. 324 in various positions moving from an expanded position to a constricted position. [Fig. 329] Same as above. [Fig. 330] Same as above. [Fig. 331] Same as above. [Fig. 332] FIG. 332 shows a perspective view of some embodiments of a paddle frame for a device or implant. [Figure 333] FIG. 333 shows a front view of the frame of FIG. 332 attached to an anchor. [Fig. 334] FIG. 334 shows a front view with partial cross section of the frame of FIG. 332 as part of a device or implant. [Figure 335] FIG. 335 shows the frame of FIG. 332 attached to a width adjustment device of a device or implant. [Fig. 336]FIG. 336 shows a perspective view of a device or implant using the frame of FIG. [Figure 337] FIG. 337 shows a front view of the device of FIG. 332 in an extended position. [Figure 338] FIG. 338 shows a front view of the device of FIG. 332 in the constriction position. [Fig. 339] FIG. 339 shows a side view of the device of FIG. 332 in an expanded position. [Fig. 340] FIG. 340 shows a side view of the device of FIG. 332 in a constriction position. [Fig. 341] FIG. 341 shows a top view of the device of FIG. 332 in an expanded position. [Fig. 342] FIG. 342 shows a top view of the device of FIG. 332 in the constriction position. [Figure 343] FIG. 343 shows a front view of the device or implant illustrating two examples of paddle frames for the device. [Fig. 344] FIG. 344 shows a front view of an exemplary paddle frame for a device or implant. [Figure 345] 345-347 show front views of the frame of FIG. 332 in various positions from an expanded position to a constricted position. [Fig. 346] Same as above. [Figure 347] Same as above. [Fig. 348] FIG. 348 shows a front view of an exemplary paddle frame for a device or implant. [Fig. 349] FIG. 349 shows a perspective view of the frame of FIG. 348 as part of a device or implant. [Fig. 350] FIG. 350 shows a front view of an exemplary paddle frame for a device or implant. [Fig. 351] FIG. 351 shows a perspective view of the frame of FIG. [Fig. 352] FIG. 352 shows a top view of the frame of FIG. [Fig. 353] FIG. 353 shows a side view of the frame of FIG. [Fig. 354] FIG. 354 shows a front view of an exemplary paddle frame for a device or implant. [Figure 355] FIG. 355 shows a perspective view of the frame of FIG. [Figure 356] FIG. 356 shows a top view of the frame of FIG. [Figure 357] FIG. 357 shows a side view of the frame of FIG. [Figure 358] FIG. 358 shows a perspective view of an exemplary paddle frame for a device or implant. [Figure 359] FIG. 359 shows a cross-sectional front view of the frame of FIG. [Figure 360] FIG. 360 shows a front cross-sectional view of an exemplary paddle frame for a device or implant. [Fig. 361] FIG. 361 shows a top view of the frame of FIG. [Fig. 362] FIG. 362 shows a front cross-sectional view of an exemplary paddle frame for a device or implant. [Figure 363] FIG. 363 shows a perspective view of a paddle frame attached to an elongated cap. [Figure 364] FIG. 364 shows a partial front view of the frame and elongated cap in FIG. [Figure 365] FIG. 365 shows a front view of an embodiment of a connection mechanism between a rigid inner frame portion and a flexible outer frame portion of a paddle frame. [Fig. 366] FIG. 366 shows a perspective view of the paddle frame assembly of FIG. 365. [Figure 367] FIG. 367 shows a top view of the paddle frame assembly of FIG. [Figure 368] FIG. 368 shows a side view of the paddle frame assembly of FIG. [Figure 369] FIG. 369 shows a rear view of the paddle frame assembly of FIG. [Figure 370]FIG. 370 shows a front view of an embodiment of a connection mechanism between a rigid inner frame portion and a flexible outer frame portion of a paddle frame. [Fig. 371] FIG. 371 shows a side view of the paddle frame assembly of FIG. [Fig. 372] FIG. 372 shows a rear view of the paddle frame assembly of FIG. [Fig. 373] FIG. 373 shows a front view of an embodiment of a connection between a rigid inner frame portion and a flexible outer frame portion of a paddle frame. [Fig. 374] FIG. 374 shows a side view of the paddle frame of FIG. [Figure 375] FIG. 375 shows a perspective view of the paddle frame of FIG. [Figure 376] FIG. 376 shows a front view of an embodiment of a connection between a rigid inner frame portion and a flexible outer frame portion of a paddle frame. [Figure 377] FIG. 377 shows a perspective view of the paddle frame assembly of FIG. [Figure 378] FIG. 378 shows a schematic diagram of the anchor portion of the device or implant in the closed position. [Figure 379] FIG. 379 is a schematic diagram of the anchor portion of FIG. 378 in a closed position, illustrating how the native leaflets are secured by the anchor portion. [Figure 380] FIG. 380 shows a schematic diagram of an exemplary anchor portion for a device or implant in a closed position. [Figure 381] FIG. 381 is a schematic diagram of the anchor portion of FIG. 380, illustrating how the native leaflets are secured by the anchor portion. [Figure 382] FIG. 382 shows a schematic view of the anchor portion of FIG. 380 in a partially open position. [Figure 383] FIG. 383 shows a schematic view of the anchor portion of FIG. 380 in an open position. [Figure 384]FIG. 384 is a top view of the anchor in the anchor portion of FIG. 380, showing the anchor flattened out. [Figure 385] FIG. 385 is a schematic diagram of the anchor of the anchor portion of FIG. 380 with the anchor in a closed position and a clasp attached to the anchor. [Figure 386] FIG. 386 is a schematic diagram of the anchors and clasps of FIG. 385 in a closed position, showing how the native leaflets are secured by the anchors and clasps. [Figure 387] FIG. 387 is a schematic diagram of the anchor and clasp of FIG. 385 with the anchor in an open position and the clasp in a closed position. [Figure 388] FIG. 388 shows a schematic diagram of the anchor portion and clasp in a closed position of the device or implant showing the inward bias of the anchor portion relative to the outer paddle. [Figure 389] FIG. 389 is a schematic view of one side of the anchor portion of FIG. 388 in a closed position, showing the inward bias on the outer paddle. [Figure 390] FIG. 390 is a top view of an embodiment of a clasp for a device or implant, where the clasp is flattened. [Figure 391] FIG. 391 shows an embodiment of a clasp for a device or implant. [Figure 392] FIG. 392 is a top view of an embodiment of a clasp for a device or implant, with the clasp flattened. [Figure 393] FIG. 393 is a side view of an embodiment of a clasp for a device or implant, the clasp being in a closed position. [Figure 394] FIG. 394 shows the anchor portion of FIG. 388 positioned in a shape memory alloy fixture. [Figure 395] FIG. 395 shows a perspective view of an embodiment of an anchor portion for a device or implant. [Figure 396]396 illustrates a top view of an embodiment of the inner member and inner paddle portion of the anchor portion of FIG. 395. FIG. [Figure 397] FIG. 397 shows a left perspective view of an embodiment of a device or implant. [Figure 398] FIG. 398 shows a right-side perspective view of the device of FIG. [Figure 399] FIG. 399 shows a front view of the device of FIG. [Figure 400] FIG. 400 is a partial perspective view of the distal portion of the device of FIG. 397 showing the anchor portion attached to the cap at the distal end of the device. [Fig. 401] FIG. 401 shows a perspective view of an embodiment of a clasp for a device or implant. [Fig. 402] FIG. 402 shows a perspective view of an embodiment of a clasp for a device or implant. [Fig. 403] FIG. 403 shows a perspective view of an embodiment of a clasp for a device or implant. [Fig. 404] FIG. 404 shows a perspective view of an embodiment of a clasp for a device or implant. [Fig. 405] FIG. 405 shows a perspective view of an embodiment of a clasp for a device or implant. [Fig. 406] FIG. 406 shows a perspective view of an embodiment of a clasp for a device or implant. [Figure 407A] FIG. 407A shows an example of a retention or locking mechanism. [Figure 407B] FIG. 407B shows an embodiment of the retention or locking feature of FIG. 407A deployed within a housing. [Figure 407C] FIG. 407C is a cross-sectional view of FIG. 407B showing a retention or locking feature within the housing. [Figure 408A] FIG. 408A shows an embodiment of a cap engaged to a paddle. [Figure 408B]FIG. 408B shows a close-up view of the cap of FIG. 408A without the paddle. [Figure 408C] FIG. 408C is a perspective view of the cap and paddle shown in FIG. 408A. [Figure 408D] FIG. 408D is a cross-sectional view showing the deflection of the paddle caused by retracting the paddle into the cap to various degrees. [Figure 408E] FIG. 408E is a perspective view showing the degree of deflection of FIG. 408D. [Figure 408F] FIG. 408F is a schematic diagram showing a configuration in which the paddles are simultaneously deflected by coupled retraction into the cap. [Figure 408G] FIG. 408G is a perspective view of the cap and paddle assembly. [Figure 409A] FIG. 409A is a top perspective view of the assembly consisting of a cap and two independent adjustable paddles. [Figure 409B] FIG. 409B is a perspective view from below of the assembly of FIG. 409A. [Figure 409C] FIG. 409C is a cross-sectional view illustrating independent control for the paddles of FIGS. 409A and 409B. [Fig. 410A] FIG. 410A is a partial cross-sectional view of an adjustable paddle assembly. [Figure 410B] FIG. 410B is a perspective view of the adjustable paddle assembly of FIG. 410A. [Figure 410C] FIG. 410C is a cross-sectional view of the adjustable paddle assembly of FIG. 410B. [Fig. 410D] FIG. 410D is a cross-sectional view of the adjustable paddle assembly of FIG. 410B. [Figure 410E] FIG. 410E is a side view of the adjustable paddle assembly of FIG. 410B. [Fig. 410F] FIG. 410F is a side view of the adjustable paddle assembly showing the paddle in the first travel position. [Figure 410G]FIG. 410G is a side view of the adjustable paddle assembly showing the paddle in the second travel position. [Fig. 410H] FIG. 410H is a side view of the adjustable paddle assembly showing the paddle in a third travel position. [Fig. 411A] FIG. 411A is a side perspective view of the adjustable paddle assembly. [Fig. 411B] FIG. 411B is a side view of the adjustable paddle assembly of FIG. 411A. [Fig. 411C] FIG. 411C is a front view of the adjustable paddle assembly of FIG. 411A. [Fig. 411D] 411D and 411E show the use of the adjustable paddle assembly of FIG. 411A within a valve repair device or implant. [Figure 411E] Same as above. [Figure 412A] FIG. 412A shows an embodiment of a paddle structure formed from a sheet material. [Fig. 412B] FIG. 412B is a side view of the paddle structure of FIG. 412A. [Fig. 412C] FIG. 412C is a top view of the paddle structure of FIG. 412A. [Fig. 412D] FIG. 412D is a bottom view of the paddle structure of FIG. 412A. [Figure 412E] FIG. 412E is another side view of the paddle structure of FIG. 412A. [Fig. 412F] FIG. 412F shows details of an embodiment of an eyelet in the paddle structure of FIG. 412A. [Figure 412G] FIG. 412G is a top view of the flat material used to form the paddle structure of FIG. 412A. [Fig. 412H] FIG. 412H illustrates an embodiment of a valve repair device or implant including the paddle structure of FIG. 412A in a fully retracted position. [Fig. 412I] FIG. 412I shows the valve repair device or implant of FIG. 412H with the paddle structure in a partially open position. [Fig. 412J] FIG. 412J shows the valve repair device or implant of FIG. 412H with the paddle structures in a laterally extended or laterally open position. [Figure 412K] FIG. 412K is a perspective view of a die that may be used to form the paddle structure of FIG. 412A. [Fig. 412L] FIG. 412L is a perspective view of the die illustrated in FIG. 412K. [Fig. 413A] 413A and 413B show an embodiment of a valve repair device or implant having a compressible outer paddle portion. [Fig. 413B] Same as above. [Fig. 414A] FIG. 414A is an example of a perspective view of a valve repair device or implant having a compressible outer paddle portion. [Fig. 414B] FIG. 414B is a perspective view of the paddles of the valve repair device or implant shown in FIG. 414A. [Fig. 415A] FIG. 415A is a side view of an embodiment of a valve repair device or implant in an open position and with a gap filling material. [Fig. 415B] FIG. 415B is a view of the valve repair device or implant of FIG. 415A attached against the cusps of the native valve as viewed from the ventricular side of the native valve. [Fig. 415C] FIG. 415C is a side view of the valve repair device or implant of FIG. 415A in an occluded state. [Fig. 415D] FIG. 415D is a front view of the valve repair device or implant of FIG. 415A in an occluded state. [Fig. 416A] FIG. 416A is a side view of an embodiment of a valve repair device or implant in an open position and with a gap filling material. [Fig. 416B] FIG. 416B is a view of the valve repair device or implant of FIG. 416A attached to the cusps of the native valve as viewed from the ventricular side of the native valve. [Fig. 416C]FIG. 416C is a side view of the valve repair device or implant of FIG. 416A in an occluded state. [Fig. 416D] FIG. 416D is a front view of the valve repair device or implant of FIG. 416A in an occluded state. [Fig. 417] FIG. 417 is a perspective view of an exemplary coupling assembly for an exemplary device in a coupled state. [Fig. 418] FIG. 418 is a front view of the coupling assembly of FIG. [Fig. 419] FIG. 419 is a perspective cross-sectional view of the coupling assembly of FIGS. 417-418 taken along line 418-418 of FIG. [Fig. 420] FIG. 420 is a cross-sectional view of the coupling assembly of FIG. 418 taken along line 418-418 of FIG. [Fig. 421] FIG. 421 is a perspective view of the exemplary coupling assembly of FIG. 418 in an uncoupled state. [Fig. 422] FIG. 422 is a front view of the coupling assembly of FIG. [Fig. 423] FIG. 423 is a perspective cross-sectional view of the coupling assembly of FIGS. 423-424 taken along line 422-422 of FIG. [Fig. 424] FIG. 424 is a cross-sectional view of the coupling assembly of FIG. 418 taken along line 422-422 of FIG. [Fig. 425] FIG. 425 is a perspective view of an exemplary coupling assembly for an exemplary device in a coupled state. [Fig. 426] FIG. 426 is a front view of the coupling assembly of FIG. [Fig. 427] FIG. 427 is a perspective cross-sectional view of the coupling assembly of FIGS. 425-426 taken along line 426-426 of FIG. [Fig. 428] FIG. 428 is a cross-sectional view of the coupling assembly of FIGS. 425-426 taken along line 426-426 of FIG. [Fig. 429] FIG. 429 is a perspective view of the exemplary coupling assembly of FIG. 425 in an uncoupled state. [Fig. 430]FIG. 430 is a front view of the coupling assembly of FIG. [Fig. 431] FIG. 431 is a perspective cross-sectional view of the coupling assembly of FIGS. 429-430 taken along line 430-430 of FIG. [Fig. 432] FIG. 432 is a cross-sectional view of the coupling assembly of FIGS. 429-430 taken along line 430-430 of FIG. [Fig. 433] FIG. 433 is a perspective view of an exemplary coupling assembly for an exemplary device in a coupled state. [Fig. 434] FIG. 434 is a front view of the coupling assembly of FIG. [Fig. 435] FIG. 435 is a perspective cross-sectional view of the coupling assembly of FIGS. 433-434 taken along line 434-434 of FIG. [Fig. 436] FIG. 436 is a cross-sectional view of the coupling assembly of FIGS. 433-434 taken along line 434-434 of FIG. [Fig. 437] FIG. 437 is a perspective view of the exemplary coupling assembly of FIG. 433 in an uncoupled state. [Fig. 438] FIG. 438 is a front view of the coupling assembly of FIG. [Fig. 439] FIG. 439 is a perspective cross-sectional view of the coupling assembly of FIGS. 437-438 taken along line 438-438 of FIG. [Fig. 440] FIG. 440 is a cross-sectional view of the coupling assembly of FIGS. 437-438 taken along line 438-438 of FIG. [Fig. 441] FIG. 441 is a perspective view of an exemplary coupling assembly for an exemplary device in a coupled state. [Fig. 442] 442 is a front view of the coupling assembly of FIG. 441. FIG. [Figure 443] FIG. 443 is a perspective cross-sectional view of the coupling assembly of FIGS. 441-442 taken along line 442-442 of FIG. [Figure 444] FIG. 444 is a cross-sectional view of the coupling assembly of FIGS. 441-442 taken along line 442-442 of FIG. [Figure 445] FIG. 445 is a perspective view of the exemplary coupling assembly of FIG. 441 in an uncoupled state. [Fig. 446] FIG. 446 is a front view of the coupling assembly of FIG. [Figure 447] FIG. 447 is a perspective cross-sectional view of the coupling assembly of FIGS. 445-446 taken along line 446-446 of FIG. [Figure 448] FIG. 448 is a cross-sectional view of the coupling assembly of FIGS. 445-446 taken along line 446-446 of FIG. [Figure 449] FIG. 449 is a schematic diagram of an exemplary coupling assembly for an exemplary device in a coupled state. [Fig. 450] FIG. 450 is a schematic diagram of the exemplary bonded assembly of FIG. 449 in an unbonded state. [Fig. 451] FIG. 451 is a perspective view of an exemplary coupling assembly for an exemplary device in a coupled state. [Fig. 452] 452 is a front view of the coupling assembly of FIG. 451. FIG. [Fig. 453] FIG. 453 is a perspective cross-sectional view of the coupling assembly of FIGS. 451-452 taken along line 452-452 of FIG. [Fig. 454] FIG. 454 is a cross-sectional view of the coupling assembly of FIGS. 451-452 taken along line 452-452 of FIG. [Fig. 455] FIG. 455 is a perspective view of the exemplary coupling assembly of FIG. 451 in an uncoupled state. [Fig. 456] FIG. 456 is a front view of the coupling assembly of FIG. [Fig. 457] FIG. 457 is a perspective cross-sectional view of the coupling assembly of FIGS. 455-456 taken along line 456-456 of FIG. [Fig. 458] FIG. 458 is a cross-sectional view of the coupling assembly of FIGS. 455-456 taken along line 456-456 of FIG. [Fig. 459] FIG. 459 is a perspective view of an exemplary coupling assembly for an exemplary device in a coupled state. [Fig. 460] 460 is a front view of the coupling assembly of FIG. [Fig. 461] FIG. 461 is a perspective cross-sectional view of the coupling assembly of FIGS. 459-460 taken along line 460-460 of FIG. [Fig. 462] FIG. 462 is a cross-sectional view of the coupling assembly of FIGS. 459-460 taken along line 460-460 of FIG. [Fig. 463] FIG. 463 is a perspective view of the exemplary coupling assembly of FIG. 459 in an uncoupled state. [Fig. 464] FIG. 464 is a front view of the coupling assembly of FIG. [Fig. 465] FIG. 465 is a perspective cross-sectional view of the coupling assembly of FIGS. 463-464 taken along line 464-464 of FIG. [Fig. 466] FIG. 466 is a cross-sectional view of the coupling assembly of FIGS. 463-464 taken along line 464-464 of FIG. [Fig. 467] FIG. 467 is a perspective view of an exemplary coupling assembly for an exemplary device in a coupled state. [Fig. 468] FIG. 468 is a front view of the coupling assembly of FIG. [Fig. 469] FIG. 469 is a perspective cross-sectional view of the coupling assembly of FIGS. 467-468 taken along line 468-468 of FIG. [Fig. 470] FIG. 470 is a cross-sectional view of the coupling assembly of FIGS. 467-468 taken along line 468-468 of FIG. [Fig. 471] FIG. 471 is a perspective view of the exemplary coupling assembly of FIG. 467 in an uncoupled state. [Fig. 472] FIG. 472 is a front view of the coupling assembly of FIG. [Fig. 473] FIG. 473 is a perspective cross-sectional view of the coupling assembly of FIGS. 471-472 taken along line 472-472 of FIG. [Fig. 474] FIG. 474 is a cross-sectional view of the coupling assembly of FIGS. 471-472 taken along line 472-472 of FIG. [Fig. 475] FIG. 475 is a perspective view of an exemplary coupling assembly for an exemplary device in a coupled state. [Fig. 476] FIG. 476 is a front view of the coupling assembly of FIG. [Fig. 477] FIG. 477 is a perspective cross-sectional view of the coupling assembly of FIGS. 475-476 taken along line 476-476 of FIG. [Fig. 478] FIG. 478 is a cross-sectional view of the coupling assembly of FIGS. 475-476 taken along line 476-476 of FIG. [Fig. 479] FIG. 479 is a perspective view of the exemplary coupling assembly of FIG. 475 in an uncoupled state. [Fig. 480] FIG. 480 is a front view of the coupling assembly of FIG. [Figure 481] FIG. 481 is a perspective cross-sectional view of the coupling assembly of FIGS. 479-480 taken along line 480-480 of FIG. [Figure 482] FIG. 482 is a cross-sectional view of the coupling assembly of FIGS. 479-480 taken along line 480-480 of FIG. [Figure 483] FIG. 483 is a perspective view of an exemplary device. [Figure 484] FIG. 484 is a front view of the device of FIG. [Figure 485] FIG. 485 is a perspective cross-sectional view of the device of FIGS. 483-484, showing the exemplary actuation mechanism in a movable state taken along line 484-484 of FIG. [Figure 486] FIG. 486 is a cross-sectional view of the device of FIGS. 483-484 taken along line 484-484 of FIG. [Figure 487] FIG. 487 is an enlarged detail of area 485 of FIG. [Figure 488] FIG. 488 is an enlarged detail of area 486 of FIG. [Figure 489] FIG. 489 is a perspective cross-sectional view of the device of FIGS. 483-484 taken along line 484-484 of FIG. 484, showing the actuation mechanism in a latched state. [Fig. 490]FIG. 490 is a cross-sectional view of the device of FIGS. 483-484 taken along line 484-484 of FIG. [Figure 491] FIG. 491 is an enlarged detail of area 489 of FIG. [Fig. 492] FIG. 492 is an enlarged detail of area 490 of FIG. [Figure 493] FIG. 493 is a perspective view of an exemplary actuation mechanism for the device of FIGS. [Figure 494] FIG. 494 is a front view of the mechanism of FIG. [Fig. 495] FIG. 495 is a perspective cross-sectional view of the mechanism of FIG. 493 taken along line 494--494 of FIG. [Fig. 496] FIG. 496 is an enlarged detail of area 495 of FIG. [Figure 497] FIG. 497 is a perspective view of a latch tube of the device of FIGS. [Figure 498] FIG. 498 is a perspective view of an exemplary device. [Figure 499] FIG. 499 is a front view of the device of FIG. [Figure 500] FIG. 500 is a perspective cross-sectional view of the device of FIGS. 498-499 taken along line 499-499 of FIG. 499, showing the exemplary actuation mechanism in a movable state. [Fig. 501] FIG. 501 is a cross-sectional view of the device of FIGS. 498-499 taken along line 499-499 of FIG. [Figure 502] View 502 is an enlarged detail of area 500 of view 500. [Figure 503] View 503 is an enlarged detail of area 501 of view 501. [Figure 504] FIG. 504 is a perspective cross-sectional view of the device of FIGS. 498-499 taken along line 499-499 of FIG. 499, showing the actuation mechanism in a latched state. [Figure 505] FIG. 505 is a cross-sectional view of the device of FIGS. 498-499 taken along line 499-499 of FIG. [Figure 506] View 506 is an enlarged detail of area 504 of view 504. [Figure 507] View 507 is an enlarged detail of area 505 of view 505. [Figure 508] FIG. 508 is a perspective view of an exemplary actuation mechanism for the device of FIGS. [Figure 509] FIG. 509 is a front view of the mechanism of FIG. [Fig. 510] FIG. 510 is a perspective cross-sectional view of the arrangement of FIG. 508 taken along line 509-509 of FIG. [Figure 511] FIG. 511 is an enlarged detail of area 510 of FIG. [Figure 512] FIG. 512 is a perspective view of a latch tube of the device of FIGS. [Figure 513] FIG. 513 is a front view of the mounting portion of the actuation mechanism of FIG. 508 in a coupled state. [Figure 514] FIG. 514 is a front view of the mounting portion of FIG. 513 in a decoupled state. [Figure 515] FIG. 515 is a cross-sectional view of the mounting portion of FIG. [Fig. 516] FIG. 516 is a cross-sectional view of the mounting portion of FIG. [Figure 517] FIG. 517 is a perspective view of an exemplary device. [Figure 518] FIG. 518 is a front view of the device of FIG. [Figure 519] FIG. 519 is a perspective cross-sectional view of the device of FIGS. 517-518 taken along line 518-518 of FIG. 518, showing the exemplary actuation mechanism in a movable state. [Fig. 520] FIG. 520 is a cross-sectional view of the device of FIGS. 517-518 taken along line 518-518 of FIG. [Fig. 521] FIG. 521 is an enlarged detail of area 519 of FIG. [Figure 522] FIG. 522 is an enlarged detail of area 520 of FIG. [Figure 523]FIG. 523 is a perspective cross-sectional view of the device of FIGS. 517-518 taken along line 518-518 of FIG. 518, showing the actuation mechanism in a latched state. [Figure 524] FIG. 524 is a cross-sectional view of the device of FIGS. 517-518 taken along line 518-518 of FIG. [Figure 525] FIG. 525 is an enlarged detail of area 523 of FIG. [Fig. 526] FIG. 526 is an enlarged detail of area 524 of FIG. [Figure 527] FIG. 527 is a perspective view of an exemplary actuation mechanism of the device of FIGS. 517-518 in a movable state. [Figure 528] FIG. 528 is a front view of the actuation mechanism of FIG. [Figure 529] FIG. 529 is a cross-sectional view of the actuation mechanism of FIG. 527 taken along line 528-528 of FIG. [Fig. 530] FIG. 530 is an enlarged detail of area 529 of FIG. [Fig. 531] FIG. 531 is a perspective view of an exemplary actuation mechanism for the device of FIGS. 517-518 in a latched state. [Figure 532] FIG. 532 is a front view of the actuation mechanism of FIG. [Figure 533] FIG. 533 is a cross-sectional view of the actuation mechanism of FIG. 531 taken along line 532-532 of FIG. [Fig. 534] FIG. 534 is an enlarged detail of area 533 of FIG. [Fig. 535] FIG. 535 is a perspective view of an exemplary handle release mechanism of an exemplary delivery system for an exemplary device. [Fig. 536] FIG. 536 is a side view of the handle release mechanism of FIG. [Figure 537] FIG. 537 is a front view of the handle release mechanism of FIG. [Figure 538] FIG. 538 is a perspective cross-sectional view of the handle release mechanism of FIG. 535 taken along line 537-537 of FIG. [Figure 539]FIG. 539 is a cross-sectional view of the handle release mechanism of FIG. 535 taken along line 537-537 of FIG. [Fig. 540] FIG. 540 is a perspective view of the illustrative handle release mechanism of FIG. 535 with the slide in a retracted position. [Figure 541] FIG. 541 is a side view of the handle release mechanism of FIG. [Fig. 542] 542 is a front view of the handle release mechanism of FIG. [Figure 543] 543 is a perspective cross-sectional view of the handle release mechanism of FIG. 540 taken along line 542-542 of FIG. [Fig. 544] FIG. 544 is a cross-sectional view of the handle release mechanism of FIG. 540 taken along line 542-542 of FIG. [Figure 545] FIG. 545 is a perspective view of the illustrative handle release mechanism of FIG. 535 with the slide retracted and the latch member of the outer body disengaged from the inner body. [Figure 546] FIG. 546 is a side view of the handle release mechanism of FIG. [Figure 547] FIG. 547 is a front view of the handle release mechanism of FIG. [Figure 548] FIG. 548 is a perspective cross-sectional view of the handle release mechanism of FIG. 545 taken along line 547-547 of FIG. [Figure 549] FIG. 549 is a cross-sectional view of the handle release mechanism of FIG. 545 taken along line 547-547 of FIG. [Fig. 550] FIG. 550 is a perspective view of the exemplary handle release mechanism of FIG. 535 with the inner body slide retracted and the finger material disengaged from the connector body. [Fig. 551] FIG. 551 is a side view of the handle release mechanism of FIG. [Figure 552] 552 is a front view of the handle release mechanism of FIG. [Figure 553] 553 is a perspective cross-sectional view of the handle release mechanism of FIG. 550 taken along line 552-552 of FIG. [Fig. 554] FIG. 554 is a cross-sectional view of the handle release mechanism of FIG. 550 taken along line 552-552 of FIG. [Figure 555] FIG. 555 is a perspective view of the exemplary handle release mechanism of FIG. 535 with the inner and outer bodies disengaged from the connector body. [Fig. 556] FIG. 556 is a side view of the handle release mechanism of FIG. [Figure 557] FIG. 557 is a front view of the handle release mechanism of FIG. [Figure 558] FIG. 558 is a perspective cross-sectional view of the handle release mechanism of FIG. 555 taken along line 557-557 of FIG. [Figure 559] FIG. 559 is a cross-sectional view of the handle release mechanism of FIG. 555 taken along line 557-557 of FIG. [Fig. 560] FIG. 560 is a perspective view of an exemplary handle release mechanism of an exemplary delivery system for an exemplary device. [Fig. 561] FIG. 561 is a side view of the handle release mechanism of FIG. [Fig. 562] 562 is a front view of the handle release mechanism of FIG. 560. FIG. [Fig. 563] 563 is a perspective cross-sectional view of the handle release mechanism of FIG. 560 taken along line 562-562 of FIG. [Fig. 564] FIG. 564 is a cross-sectional view of the handle release mechanism of FIG. 560 taken along line 562-562 of FIG. [Fig. 565] FIG. 565 is a perspective view of the illustrative handle release mechanism of FIG. 560 with the slide in a retracted position. [Fig. 566] FIG. 566 is a side view of the handle release mechanism of FIG. [Figure 567] FIG. 567 is a front view of the handle release mechanism of FIG. [Figure 568] FIG. 568 is a perspective cross-sectional view of the handle release mechanism of FIG. 565 taken along line 567-567 of FIG. [Fig. 569]FIG. 569 is a cross-sectional view of the handle release mechanism of FIG. 565 taken along line 567-567 of FIG. [Fig. 570] FIG. 570 is a perspective view of the exemplary handle release mechanism of FIG. 560 with the slide in a retracted position and the outer body disengaged from the connector body. [Fig. 571] FIG. 571 is a side view of the handle release mechanism of FIG. [Fig. 572] FIG. 572 is a front view of the handle release mechanism of FIG. [Fig. 573] FIG. 573 is a perspective cross-sectional view of the handle release mechanism of FIG. 570 taken along line 572-572 of FIG. [Figure 574] FIG. 574 is a cross-sectional view of the handle release mechanism of FIG. 570 taken along line 572-572 of FIG. [Figure 575] FIG. 575 is a schematic diagram of an exemplary clasp for the device. [Fig. 576] FIG. 576 is a schematic diagram of the clasp of FIG. 575 including an optional retention surface. [Figure 577] FIG. 577 is a schematic diagram of an exemplary clasp for the device. [Figure 578] FIG. 578 is a schematic diagram of the clasp of FIG. 577 including an optional retention surface. [Fig. 579] FIG. 579 is a schematic diagram of an exemplary clasp for the device. [Fig. 580] FIG. 580 is a schematic diagram of the clasp of FIG. 579 including an optional retention surface. [Fig. 581] FIG. 581 is a schematic diagram of an exemplary clasp for the device. [Fig. 582] FIG. 582 is a schematic diagram of the clasp of FIG. 581 including an optional retention surface. [Fig. 583] FIG. 583 is a schematic diagram of an exemplary braided spacer in an unexpanded state. [Fig. 584] FIG. 584 is a schematic diagram of an exemplary braided spacer in an expanded state. [Figure 585]FIG. 585 illustrates a perspective view of an exemplary expandable coaptation element in an expanded state. [Fig. 586] FIG. 586 illustrates a front view of the exemplary expandable coaptation element of FIG. [Figure 587] FIG. 587 illustrates a perspective cross-sectional view of the exemplary expandable coaptation element of FIG. 585. [Figure 588] FIG. 588 illustrates a cross-sectional view of the exemplary expandable coaptation element of FIG. [Figure 589] FIG. 589 illustrates a perspective view of an exemplary expandable coaptation element in an unexpanded state. [Fig. 590] FIG. 590 illustrates a front view of the expandable coaptation element of FIG. [Fig. 591] FIG. 591 illustrates a perspective cross-sectional view of the exemplary expandable coaptation element of FIG. 589 taken along line 590-590 of FIG. [Fig. 592] FIG. 592 illustrates a cross-sectional view of the exemplary expandable coaptation element of FIG. 589 taken along line 590-590 of FIG. [Fig. 593] FIG. 593 illustrates a perspective view of the exemplary expandable coaptation element of FIG. 585 in an expanded state. [Figure 594] FIG. 594 illustrates a front view of the expandable coaptation element of FIG. [Fig. 595] FIG. 595 illustrates a perspective cross-sectional view of the exemplary expandable coaptation element of FIG. 593 taken along line 594-594 of FIG. [Fig. 596] FIG. 596 illustrates a cross-sectional view of the exemplary expandable coaptation element of FIG. 593 taken along line 594-594 of FIG. [Figure 597] FIG. 597 illustrates a perspective view of an exemplary expandable coaptation element in an expanded state. [Figure 598] FIG. 598 illustrates a front view of the expandable coaptation element of FIG. [Figure 599] FIG. 599 illustrates a perspective cross-sectional view of the exemplary expandable coaptation element of FIG. 597 taken along line 598-598 of FIG. [Figure 600]FIG. 600 illustrates a cross-sectional view of the exemplary expandable coaptation element of FIG. 597 taken along line 598-598 of FIG. [Fig. 601] FIG. 601 illustrates a perspective view of an exemplary expandable coaptation element in an expanded state. [Fig. 602] FIG. 602 shows a front view of the expandable coaptation element of FIG. [Figure 603] FIG. 603 illustrates a perspective cross-sectional view of the exemplary expandable coaptation element of FIG. 601 taken along line 602-602 of FIG. 602; [Figure 604] FIG. 604 illustrates a cross-sectional view of the exemplary expandable coaptation element of FIG. 601 taken along line 602-602 of FIG. 602; [Fig. 605] FIG. 605 illustrates a perspective view of an exemplary expandable coaptation element in an unexpanded state with the latch tube in an unlatched state. [Fig. 606] FIG. 606 shows a front view of the expandable coaptation element of FIG. [Fig. 607] FIG. 607 illustrates a perspective cross-sectional view of the exemplary expandable coaptation element of FIG. 605 taken along line 606-606 of FIG. 606; [Figure 608] FIG. 608 illustrates a cross-sectional view of the exemplary expandable coaptation element of FIG. 605 taken along line 606-606 of FIG. 606; [Figure 609] FIG. 609 illustrates a perspective view of the exemplary expandable coaptation element of FIG. 605 with the latch tube in a latched state. [Figure 610] FIG. 610 shows a front view of the expandable coaptation element of FIG. [Figure 611] FIG. 611 illustrates a perspective cross-sectional view of the exemplary expandable coaptation element of FIG. 609 taken along line 610-610 of FIG. [Figure 612] FIG. 612 illustrates a cross-sectional view of the exemplary expandable coaptation element of FIG. 609 taken along line 610-610 of FIG. [Figure 613] FIG. 613 shows an enlarged detail view of the exemplary expandable coaptation element of FIG. 605 in the region 607 of FIG. [Figure 614]FIG. 614 shows an enlarged detail view of the exemplary expandable coaptation element of FIG. 609 in the area 611 of FIG. [Fig. 615] FIG. 615 illustrates a perspective view of an exemplary expandable coaptation element in an unexpanded state with the latch tube in an unlatched state. [Fig. 616] FIG. 616 shows a front view of the expandable coaptation element of FIG. [Fig. 617] FIG. 617 illustrates a perspective cross-sectional view of the exemplary expandable coaptation element of FIG. 615 taken along line 616-616 of FIG. [Fig. 618] FIG. 618 illustrates a cross-sectional view of the exemplary expandable coaptation element of FIG. 615 taken along line 616-616 of FIG. [Fig. 619] FIG. 619 illustrates a perspective view of the exemplary expandable coaptation element of FIG. 615 with the latch tube in a latched state. [Fig. 620] FIG. 620 shows a front view of the expandable coaptation element of FIG. [Fig. 621] FIG. 621 illustrates a perspective cross-sectional view of the exemplary expandable coaptation element of FIG. 619 taken along line 620-620 of FIG. [Fig. 622] FIG. 622 illustrates a cross-sectional view of the exemplary expandable coaptation element of FIG. 619 taken along line 620-620 of FIG. [Fig. 623] FIG. 623 shows an enlarged detail view of the exemplary expandable coaptation element of FIG. 615 in the region 617 of FIG. [Fig. 624] FIG. 624 shows an enlarged detail view of the exemplary expandable coaptation element of FIG. 619 in the region 621 of FIG. [Fig. 625] FIG. 625 illustrates a perspective view of an exemplary expandable coaptation element in an unexpanded state. [Fig. 626] FIG. 626 illustrates a top view of the expandable coaptation element of FIG. [Figure 627] FIG. 627 illustrates a side view of the expandable coaptation element of FIG. [Fig. 628] FIG. 628 shows a front view of the expandable coaptation element of FIG. [Figure 629] FIG. 629 illustrates a perspective view of the exemplary expandable coaptation element of FIG. 625 in an expanded state. [Fig. 630] FIG. 630 illustrates a top view of the expandable coaptation element of FIG. [Fig. 631] FIG. 631 illustrates a side view of the expandable coaptation element of FIG. [Figure 632] FIG. 632 illustrates a front view of the expandable coaptation element of FIG. [Figure 633] FIG. 633 illustrates a perspective view of an exemplary expandable coaptation element in an unexpanded state. [Figure 634] FIG. 634 shows a top view of the expandable coaptation element of FIG. [Fig. 635] FIG. 635 shows a side view of the expandable coaptation element of FIG. [Fig. 636] FIG. 636 shows a front view of the expandable coaptation element of FIG. [Figure 637] FIG. 637 illustrates a perspective view of the exemplary expandable coaptation element of FIG. 633 in an expanded state. [Fig. 638] FIG. 638 illustrates a top view of the expandable coaptation element of FIG. [Figure 639] FIG. 639 shows a side view of the expandable coaptation element of FIG. [Fig. 640] FIG. 640 illustrates a front view of the expandable coaptation element of FIG. [Fig. 641] FIG. 641 illustrates a perspective view of an exemplary coupler for an exemplary device with the coupler in a coupled state. [Fig. 642] FIG. 642 illustrates a front view of the exemplary connector of FIG. [Fig. 643] FIG. 643 illustrates a perspective cross-sectional view of the exemplary coupler of FIG. 641 taken along line 642-642 of FIG. [Fig. 644] FIG. 644 illustrates a cross-sectional view of the exemplary expandable coaptation element of FIG. 641 taken along line 642-642 of FIG. [Fig. 645]FIG. 645 illustrates a perspective view of the exemplary coupler of FIG. 641 with the retention member retracted. [Fig. 646] FIG. 646 illustrates a front view of the exemplary connector of FIG. [Fig. 647] FIG. 647 illustrates a perspective cross-sectional view of the example coupler of FIG. 645 taken along line 646-646 of FIG. [Fig. 648] FIG. 648 illustrates a cross-sectional view of the exemplary expandable coaptation element of FIG. 645 taken along line 646-646 of FIG. [Fig. 649] FIG. 649 illustrates a perspective view of the exemplary coupler of FIG. 641 with the retention members retracted and the coupler in an uncoupled state. [Fig. 650] FIG. 650 illustrates a front view of the exemplary connector of FIG. [Fig. 651] FIG. 651 illustrates a perspective cross-sectional view of the exemplary coupler of FIG. 649 taken along line 650-650 of FIG. [Fig. 652] FIG. 652 illustrates a cross-sectional view of the exemplary expandable coaptation element of FIG. 649 taken along line 650-650 of FIG. [Fig. 653] FIG. 653 shows a cross-sectional view of an expandable coaptation element in an unexpanded state. [Fig. 654] FIG. 654 illustrates a cross-sectional view of the expandable coaptation element of FIG. 653 in an expanded state. [Fig. 655] FIG. 655 shows a schematic diagram of an expandable coaptation element having a single expandable member. [Fig. 656] FIG. 656 shows a schematic diagram of an expandable coaptation element having three expandable members. [Fig. 657] FIG. 657 shows a schematic diagram of an expandable coaptation element having four expandable members. [Fig. 658] FIG. 658 shows a schematic diagram of an expandable coaptation element having six expandable members arranged in two sets of three expandable members spaced longitudinally from each other. [Fig. 659]FIG. 659 illustrates a perspective view of an implantation of an expandable coaptation element having inner and outer tubes and an expandable coaptation member in an unexpanded state. [Fig. 660] FIG. 660 shows a top view of this. [Fig. 661] FIG. 661 illustrates a perspective view of the expandable coaptation element of FIG. 659 in an expanded state. [Fig. 662] FIG. 662 shows a top view of this. [Figure 663] FIG. 663 shows an exploded view of the expandable coaptation element of FIG. [Fig. 664] FIG. 664 shows a flattened view of a portion of the outer tube that is cut to form the expandable component. [Fig. 665] FIG. 665 shows a schematic diagram of a device in which an expandable coaptation element is implanted into a patient's heart. [Fig. 666] FIG. 666 shows a schematic diagram of a device in which an expandable coaptation element is implanted into a patient's heart. [Fig. 667] FIG. 667 shows the expandable coaptation element in an unexpanded state. [Fig. 668] FIG. 668 shows the expandable joint element of FIG. 667 in an expanded state. [Fig. 669] FIG. 669 illustrates the expandable joint element of FIG. 667 expanded by the introduction of an elongate filler element. [Fig. 670] FIG. 670 shows an elongate filling element filling an expandable coaptation element. [Fig. 671] FIG. 671 illustrates the expandable coaptation element of FIG. 670 with a second elongate filler element. [Fig. 672] FIG. 672 illustrates the expandable coaptation element of FIG. 670 having multiple filler materials. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0161] In the following description, reference is made to the accompanying drawings which illustrate example implementations of the present disclosure. Other implementations having different structure and operation do not depart from the scope of the present disclosure.

[0162] Some implementations of the present disclosure are directed to systems, apparatus, methods, etc., for repairing defective heart valves. For example, implementations of valve repair apparatus, implantable devices, implants, and systems (including systems for delivering them) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed apparatus and systems can be combined unless mutually exclusive or physically impossible. Furthermore, the treatment techniques, methods, processes, etc. described or suggested herein, or references incorporated herein, may be performed on live animals or on non-living simulations, such as cadavers, cadaver hearts, simulators (e.g., simulating body parts, tissues, etc.). As used herein, the term "simulation" encompasses simulations performed on cadavers, computer rooms, virtual people, open spaces, etc.

[0163] Various systems, devices, apparatus, etc. of the present disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can include sterilization (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of the associated systems, devices, apparatus, etc.

[0164] 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, the terms "substantially" and "about" described herein 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%). Although the terms "clasp" and "clasp arm" are often used herein with respect to specific embodiments, the terms "gripping member" and / or "gripping arm" may be substituted and function in the same or similar manner, even if not configured in the same manner as a typical clasp.

[0165] 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 cusps (e.g., cusps 20, 22 shown in Figs. 3-6 and cusps 30, 32, 34 shown in Fig. 7) that extend inwardly across their respective orifices, 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.

[0166] The left atrium LA receives oxygen-rich blood from the lungs. During the expansion phase or diastole, seen in FIG. 1, blood already collected in the left atrium LA (during systole) moves through the mitral valve MV into the left ventricle LV due to the expansion of the left ventricle LV. During the contraction phase or systole, seen in FIG. 2, the left ventricle LV contracts to pump blood through the aortic valve AV and the ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV are closed 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 closure of the leaflets of the mitral valve to prevent, inhibit, or reduce blood from flowing back from the left ventricle LV into the left atrium LA. Many of the devices described in this application are designed to easily grasp and secure the natural cusps around a coaptation element or spacer that beneficially acts as a filler in the reflux orifice to prevent or inhibit backflow during systole, although this is not required.

[0167] Referring now 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, which is a variably dense, fibrous ring of tissue surrounding the leaflets 20, 22. Referring to Figures 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., muscles located in the wall of the left ventricle LV at the base of the chordae tendineae CT) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM function to limit the movement of the leaflets 20, 22 of the mitral valve MV and prevent the mitral valve MV from everting. 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 cusps 20, 22 against the high pressure required to circulate blood throughout the body. Together, the papillary muscles PM and chordae tendineae CT are known as the subvalvular tissue, which functions 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 cusps 20, 22 is such that the medial surfaces of the cusps meet at their free ends and the cusps 20, 22 begin to retract or splay away from each other. The cusps 20, 22 splay away toward the atrium until each cusp contacts the annulus of the mitral valve.

[0168] 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 (e.g., 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.

[0169] In general, native valves can malfunction in different ways, including (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when the native valve does not open completely, thereby causing impaired blood flow. Typically, valve stenosis is due to the accumulation of calcified material on the valve cusps, which thicken the cusps and impair the valve's ability to open completely to allow forward blood flow. Valve regurgitation occurs when the valve cusps do not close completely, causing blood to leak back into the previous heart chamber (e.g., blood leaks from the left ventricle into the left atrium).

[0170] 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 cusps move apart and fail to form a tight seal (i.e., the cusps do not coapt properly). Included in the type I mechanism insufficiency is cusp perforation, as occurs in endocarditis. Carpentier's Type II insufficiency involves prolapse of one or more cusps of the native valve above the plane of coaptation. Carpentier's Type III insufficiency involves restricted movement of one or more cusps of the native valve so that they are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease or ventricular dilatation.

[0171] 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 back from the left ventricle LV into the left atrium LA during systole, as shown by the mitral regurgitation MR flow path in FIG. 3. With reference to FIG. 6, the gap 26 may have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some circumstances, the gap 26 may have a width W of greater than 15 mm or even greater than 17.5 mm. As discussed above, there are several different ways in which the leaflets (e.g., the leaflets 20, 22 of the mitral valve MV) may become incompetent, causing valvular regurgitation.

[0172] In any of the above situations, a valve repair device or implant that can engage the anterior 20 and posterior 22 leaflets 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 a valve repair device, implantable device, or implant 10 is shown implanted between the cusps 20, 22 such that no backflow occurs during systole (compare FIG. 3 with FIG. 4). In some implementations, the coaptation elements (e.g., spacers, coaptation elements, gap fillers, membranes, sheets, plugs, wedges, balloons, etc.) of the device 10 have a generally tapered or triangular shape that naturally matches the shape of the native valve and the propensity of the cusps to expand (towards the annulus). In this application, terms such as spacer, coaptation element, coaptation element, and gap filler are used interchangeably and refer to elements that are configured to fill a portion of the space between the native valve leaflets and / or to cause the native valve leaflets 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.).

[0173] 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. Thus, 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.

[0174] 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 cusps 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).

[0175] 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 cusps 20, 22 of the mitral valve MV to prevent or block the backflow of blood from the left ventricle into the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts provided herein can be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or block the backflow of blood from the right ventricle into the right atrium. In addition, any of the devices and concepts provided herein can be used on all three of the leaflets 30, 32, 34 together to prevent or block the backflow of blood from the right ventricle into the right atrium. That is, the valve repair device or implant provided herein can be centrally located between the three leaflets 30, 32, 34.

[0176] An exemplary device or implant may optionally include a coaptation element (e.g., a spacer, coaptation element, gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, the device or implant may have any combination or subcombination of the features disclosed herein without a coaptation element. The coaptation element (e.g., coaptation element, spacer, etc.), if included, is configured to be positioned within the native heart valve orifice to help fill the space between the cusps 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 cusps to close around the coaptation element during ventricular systole, thereby blocking backflow of blood from the left or right ventricle into the left or right atrium, respectively. The device or implant can be configured to seal against two or three native leaflets, i.e., the device can be used with native mitral (bicuspid) and native tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element can fill the space between native leaflets (e.g., mitral leaflets 20, 22 or tricuspid leaflets 30, 32, 34) that do not close completely or function properly.

[0177] The optional coaptation elements (spacers, coaptation elements, gap fillers, etc.) can have a variety of shapes. In some implementations, the coaptation elements can have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the coaptation elements can have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or a variety of other non-cylindrical shapes. In some implementations, the coaptation elements can have an atrial portion positioned in or adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a lateral surface extending between the native cusps. 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 valve cusps.

[0178] In some implementations, the anchors may be configured to secure the device to one or both of the native cusps such that the coaptation element is positioned between two native cusps. In some implementations configured for use with a tricuspid valve, the anchors are configured to secure the device to one, two, or three of the tricuspid valve cusps such that the coaptation element is positioned between three native cusps. In some implementations, the anchors may be attached to the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some implementations, the anchors may be attached to an actuating element, such as a shaft, rod, tube, wire, etc., to which the coaptation element is also attached. In some implementations, the anchors and coaptation elements may be independently positioned 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 may be simultaneously positioned by moving the anchors and coaptation elements together along a longitudinal axis of the actuating element (e.g., shaft, actuating wire, etc.). The anchor can be configured to be positioned behind the natural cusp when implanted such that the cusp is gripped by the anchor.

[0179] 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 allowed to self-expand 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 coaptation element, which is initially still compressed, to create a gap between the coaptation element and the anchor. The natural cusp may then be positioned within the gap. The coaptation element may be expanded radially, closing the gap between the coaptation element and the anchor to capture the cusp between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to self-expand. The implantation method for some implementations may vary and is 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 entireties for all purposes. These methods can be performed, mutatis mutandis, on a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., a body part, heart, tissue, etc. is simulated), etc.

[0180] 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 towards the left atrium. During diastole, the device may rely on compressive and retaining forces exerted against the leaflets that are gripped by the anchors.

[0181] 8-15, a generally depicted apparatus or implant 100 (e.g., an implantable prosthetic device, an artificial spacer device, a valve repair device, an implantable device, etc.) is shown in various stages of deployment. The apparatus 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 herein in their entireties. Device 100 may include any other features of devices or implants discussed elsewhere in this application or in the above-cited applications, and device 100 may be positioned to engage valve tissue (e.g., cusps 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed in this application or the above-cited applications).

[0182] 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 pathway, combinations thereof, etc. The device or implant 100 includes an interface portion / region 104 and an anchor portion / region 106.

[0183] In some implementations, the interface portion 104 of the device or implant 100 is adapted to be implanted between the cusps of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and includes an interface element 110 (e.g., a spacer, plug, filler, foam, sheet, membrane, interface element, etc.) slidably attached to an actuation element 112 (e.g., an actuation wire, shaft, tube, hypotube, line, suture, braid, etc.). The anchor portion 106 includes one or more anchors 108 that are actuable between an open state and a closed state and can take a wide variety of forms, such as, for example, a paddle, a gripping element, or the like. Actuation of the actuation element 112 causes the anchor portion 106 of the device 100 to open and close and grip the native valve leaflets during implantation. The actuation element 112 (as well as other actuation means and elements disclosed herein) may take a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), may be made from a variety of different materials, and may have a variety of configurations. As one example, the actuation element may 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 may be unthreaded such that pushing or pulling actuation of the actuation element 112 moves the anchor portion 106 relative to the interface portion 104.

[0184] 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.

[0185] In some implementations, the delivery system 102 includes a steerable catheter, an implant catheter, and an actuation means or element 112 (e.g., an actuation wire, an 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., a cap 114 or other attachment portion), respectively. In some implementations, a collar or other attachment element (e.g., clamp, clip, lock, suture, friction fit, buckle, snap fit, lasso) 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 element, 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.

[0186] In some implementations, the anchor portion 106 and / or the anchor 108 may include an attachment portion or gripping member (e.g., a gripping arm, a clasp arm, etc.). The illustrated gripping member may include a clasp 130 including a base or fixed arm 132, a movable arm 134, an optional friction enhancing element or other fastening structure 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.), and an interface portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122 with the interface portion 138 disposed proximate to the interface element 110. The interface portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the clasp 130. The interface portion 138 may be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, interface portion 138 is a flexible piece of material that is integrally formed with fixed arm 132 and movable arm 134. Fixed arm 132 is attached to inner paddle 122 and remains stationary or substantially stationary relative to inner paddle 122 when movable arm 134 is opened to open clasp 130 and expose optional friction enhancing elements or securing structures 136 (e.g., barbs, ridges, points, etc.).

[0187] 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.

[0188] 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 in the closed position, the clasp 130 continues to provide a clamping force against the grasped native cusp. Optional barbs, friction enhancing elements, or fixation structures 136 of the clasp 130 can grip, pinch, and / or pierce the native cusp to further secure the native cusp.

[0189] During implantation, the paddles 120, 122 can be opened and closed to grip a native cusp (e.g., a native mitral valve cusp, etc.) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation element 110 (e.g., a spacer, plug, membrane, gap filler, etc.). The clasps 130 can be used to grip and / or further secure the native cusp by engaging the cusp with optional barbs, friction enhancing elements, or fixation structures 136 and clamping the cusp between the movable arm 134 and the fixed arm 132. The optional barbs, friction enhancing elements, or other fixation structures 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) of the clasps 130 can increase friction with the cusp or partially or completely pierce the cusp. The actuation lines 116 can be actuated separately such that each clasp 130 can 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.

[0190] 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 joint element 110 such that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the interior of the outer paddle 120 and the inner paddle 122 is about 180 degrees. The clasp 130 can be held closed while being deployed through the delivery system 102 so that the optional barbs, friction enhancing elements, or other securing structures 136 (FIG. 9) do not catch on or damage the delivery system 102. The actuation line 116 can extend to and be attached to a movable arm 134.

[0191] 9, device 100 is shown in an extended state similar to that of FIG 8, but with clasp 130 in a fully open position at a range of about 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or about 180 degrees between fixed portion 132 and movable portion 134 of clasp 130. Full opening of paddles 120, 122 and clasp 130 has been found to improve ease of disengagement or detachment of device 100 from a patient's anatomical structures, such as chordae tendineae CT, upon implantation.

[0192] 10, the device 100 is shown in a retracted or fully closed state. To move the device 100 from the extended state to the retracted state, the actuation means or element 112 is retracted, pulling the cap 114 towards the interface element 110 (e.g., towards the spacer). The connection 126 (e.g., joint, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained from moving, such that the compressive force acting on the outer paddle 120 from the cap 114 retracting towards the interface element 110 moves the paddle or gripping element 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 may optionally be biased towards the closed position. As the inner paddle 122 is oriented away from the open interface element 110 during the same movement, it moves through a much larger angle and collapses along the side of the closed interface element 110 .

[0193] 11-13, the device 100 is shown in a partially open, ready to grip 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 mating 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 cusp to be gripped. 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.

[0194] 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.

[0195] 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, 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 natural cusp. Similarly, the fixed and movable arms 132, 134 of the clasp 130 are biased to pinch the tines. 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.

[0196] Figure 15 illustrates an embodiment in which the paddles 120, 122 are independently controllable. The device 101 illustrated in Figure 15 is similar to the device illustrated in Figure 11, except that the device 100 of Figure 15 includes actuation elements configured as two independent actuation elements (e.g., actuation shafts, actuation rods, actuation tubes, actuation wires, etc.) 111, 113 coupled to two independent caps 115, 117. The actuation elements 111 are extended to push the caps 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.

[0197] 16-21, the device 100 of Figures 8-14 is shown being delivered and deployed within the native mitral valve MV of the heart H. With reference to Figure 16, a delivery sheath / catheter is inserted through the septum into the left atrium LA and the implant / device 100 is deployed from the delivery catheter / sheath in a fully open state as shown in Figure 16. The actuating element 112 is then retracted, moving the implant / device to a fully closed state as shown in Figure 17.

[0198] 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 that it can grasp the cusps 20, 22. For example, the steerable catheter can be advanced to steer or bend it to position it as Figure 18 shows. An implant catheter connected to the implant / device can be advanced from within the steerable catheter to position the implant as Figure 18 shows.

[0199] 19, the implant catheter can 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.

[0200] Any of the features disclosed herein may be used in a wide variety of different valve repair devices. Figures 22-27 and 56A-56H 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 22-27 and 56A-56H.

[0201] 22, an embodiment of a device or implant 200 is shown. Device 200 is one of many different configurations that device 100, shown generally in FIGS. 8-14, may take. Device 200 may include any other features of devices or implants discussed herein, and 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. Device / implant 200 may be a valve repair device, an implantable device, or another type of implant that is attached to the cusps of the native valve.

[0202] In some implementations, the device or implant 200 includes an interface portion 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 cusps of the native valve. In some implementations, the anchor portion 206 includes multiple anchors 208. The anchors may be configured in a variety of ways. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension or 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 213 (FIGS. 43-49) of the delivery system 202 (see, e.g., FIGS. 38-42 and 49). The delivery system 202 may be the same as or similar to the delivery system 102 described elsewhere and 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 pathway, combinations thereof, etc. The capture mechanism may be configured in a variety of ways and in some implementations may include one or more of a clamp, clip, pin, suture, line, lasso, noose, snare, buckle, lock, latch, etc.

[0203] In some implementations, the joint elements 210 and paddles 220, 222 are formed from a flexible material, which may be a metal fabric formed as a mesh, woven fabric, braided fabric, or the like, or in any other suitable manner, or a flexible material that is laser cut or otherwise cut. The material may be a fabric, a shape memory alloy wire such as Nitinol to provide shape setting capabilities, or any other flexible material suitable for implantation in the human body.

[0204] An actuating element 212 (e.g., an actuating shaft, actuating rod, actuating tube, actuating wire, actuating line, etc.) extends from the delivery system 202 to engage and enable actuation of the device or implant 200. In some implementations, the actuating element 212 extends through the capture mechanism 213, the proximal collar 211, and the interface element 210 to engage a cap 214 on the distal portion 207. The actuating element 212 may be configured to releasably engage the cap 214, such as with a threaded connection, such that the actuating element 212 may be disengaged and removed from the device 200 after implantation.

[0205] The coaptation element 210 extends from a proximal collar 211 (or other attachment element) to an inner paddle 222. In some implementations, the coaptation element 210 has a generally elongated, round shape, although other shapes and configurations are possible. In some implementations, the coaptation element 210 has an oval shape or cross-section when viewed from above (e.g., FIG. 51), a tapered shape or cross-section when viewed from the front (e.g., FIG. 23), and a round shape or cross-section when viewed from the side (e.g., FIG. 24). A mixture of these three geometries can result in a three-dimensional shape for the illustrated coaptation element 210 that achieves the advantages described herein. It can be seen that the round shape of the coaptation element 210 also substantially follows or approximates the shape of the paddle frame 224 when viewed from above.

[0206] The size and / or shape of the coaptation element 210 may be selected to minimize the number of implants required per patient (preferably one) while maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance at the apex of the coaptation element is about 5 mm, and the medial-lateral distance at the widest point of the coaptation element is about 10 mm. In some implementations, the overall geometry of the device 200 may be based on these two dimensions and the overall shape plan described above. It will be readily apparent that using other anterior-posterior and medial-lateral distances as a starting point for the device will result in a device with different dimensions. Additionally, using other dimensions and the shape plan described above will also result in a device with different dimensions.

[0207] 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.

[0208] In some implementations, the inner paddle 222 is rigid, relatively rigid, stiff, has a stiff portion, and / or is stiffened by a stiffening member (e.g., rod, plate, etc.) or fixed portion 232 of the clasp 230. The stiffening of the inner paddle allows the device to move to a variety of different positions as described and illustrated herein. The inner paddle 222, outer paddle 220, and interface elements may all be interconnected as described herein such that the device 200 is constrained to the movements and positions as described and illustrated herein.

[0209] 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.

[0210] The paddle frame 224 provides additional clamping force between the inner paddle 222 and the interface element 210, as can be seen in FIG. 51, and helps wrap the cusps around the sides of the interface element 210 for a better seal between the interface element 210 and the cusps. That is, the paddle frame 224 may be configured with a rounded three-dimensional shape that extends from the cap 214 to the connection 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 interface element 210 may constrain each of these members to the movements and positions described herein. In particular, the connection 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 paddle 222 and the outer paddle 220 ) and by its attachment to the cap 214 .

[0211] Configuring the paddle frame 224 in this manner provides an increased surface area compared to the outer paddle 220 alone. This may, for example, allow easier grasping and fixation of the natural cusps. The increased surface area may also distribute the clamping force of the paddles 220 and paddle frame 224 on the natural cusps over a larger surface area of ​​the natural cusps to further protect the natural cusp tissue. Referring again to FIG. 51, the increased surface area of ​​the paddle frame 224 may also allow the natural cusps to be clamped against the device or implant 200 such that the natural cusps generally articulate against the periphery of the articulation element or member 210. This may, for example, improve sealing of the natural cusps 20, 22, thereby preventing or further reducing mitral regurgitation.

[0212] In some implementations, the clasp includes a movable arm coupled to the anchor. In some implementations, the clasp 230 includes a base or fixed arm 232, a movable arm 234, an optional barb, friction enhancing element, or securing structure 236, and an interface 238. The fixed arm 232 is attached to the inner paddle 222 with the interface 238 disposed proximate to the interface element 210. The interface 238 is spring loaded such that the fixed arm 232 and the movable arm 234 are biased toward each other when the clasp 230 is in a closed state. In some implementations, the clasp 230 includes friction enhancing elements or securing means such as barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.

[0213] In some implementations, the fixed arm 232 is attached to the inner paddle 222 through a hole or slot 231 using a suture (not shown). The fixed arm 232 may be attached to the inner paddle 222 by any suitable means, such as a screw or other fastener, a crimp sleeve, a mechanical latch or snap, a weld, an adhesive, a clamp, a latch, or the like. The fixed arm 232 remains substantially stationary relative to the inner paddle 222 when the movable arm 234 is opened to open the clasp 230 and expose the optional barb or other friction enhancing element or fixation structure 236. The clasp 230 is opened by applying tension to an actuation line 216 (e.g., as shown in FIGS. 43-48 ) attached to a hole 235 in the movable arm 234, thereby allowing the movable arm 234 to articulate, pivot, and / or bend over an interface 238.

[0214] 29, a close-up view of one of the cusps 20, 22 being gripped by a clasp, such as clasp 230, is shown. The cusps 20, 22 are gripped between a movable arm 234 and a fixed arm 232 of the clasp 230. The tissue of the cusps 20, 22 is not pierced by the optional barbs, friction enhancing elements, or fixation structures 236, although in some implementations the optional barbs 236 can partially or completely pierce the cusps 20, 22. The angle and height of the optional barbs, friction enhancing elements, or fixation structures 236 relative to the movable arms 234 helps to secure the cusps 20, 22 within the clasp 230. In particular, the force pulling the implant away from the native cusps 20, 22 encourages the optional barbs, friction enhancing elements, or fixation structures 236 to further engage the tissue, thereby ensuring a better hold. Retention of the cusps 20, 22 within the clasp 230 is further improved by the location of the fixation arms 232 near the optional barbs, frictional enhancement elements, or fixation structures 236 when the clasp 230 is closed. In this arrangement, the tissue is forced into an S-shaped, tortuous path by the fixation arms 232 and the movable arms 234 and the optional barbs, frictional enhancement elements, or fixation structures 236. Thus, the force pulling the cusps 20, 22 away from the clasp 230 encourages the tissue to further engage the optional barbs, frictional enhancement elements, or fixation structures 236 before the cusps 20, 22 can prolapse. For example, tension on the leaflets during diastole encourages the optional barbs, frictional enhancement elements, or fixation structures 236 to pull towards the end portions of the cusps 20, 22. The S-shaped pathway thus allows the leaflets 20, 22 to more firmly engage with the optional barbs, friction enhancing elements, or anchoring structures 236, taking advantage of the tension of the leaflets during diastole.

[0215] 25, the device or implant 200 may also include a cover 240. In some implementations, the cover 240 may be disposed on the interface elements 210, the outer and inner paddles 220 and 222, and / or the paddle frame 224. The cover 240 may be configured to prevent or reduce blood flow through the device or implant 200 and / or to promote native tissue engraftment. In some implementations, the cover 240 may be a cloth or fabric, such as PET, velour, or other suitable fabric. In some implementations, instead of or in addition to a fabric, the cover 240 may include a coating (e.g., a polymer) applied to the device or implant 200.

[0216] During implantation, the paddles 220, 222 of the anchor 208 can be opened and closed to grip the native leaflets 20, 22 between the paddles 220, 222 and the coaptation element 210. The anchor 208 is moved between a closed position (FIGS. 22-25) and various open positions (FIGS. 26-37) by extending and retracting the actuation element 212. Extending and retracting the actuation element 212 increases and decreases the spacing between the coaptation element 210 and the cap 214, respectively. The proximal collar 211 (or other attachment element) and coaptation element 210 slide along the actuation element 212 during actuation, thereby changing the spacing between the coaptation element 210 and the cap 214 to move the paddles 220, 222 between different positions to grip the mitral valve leaflets 20, 22 during implantation.

[0217] To open and close the device 200, the pair of inner and outer paddles 222, 220 are moved together, rather than independently, by a single actuation element 212. Additionally, the position of the clasp 230 depends on the position of the paddles 222, 220. For example, the clasp 230 is configured such that occlusion of the anchor 208 simultaneously occludes the clasp 230. In some implementations, the device 200 can be configured with the paddles 220, 222 independently controllable in the same manner (e.g., the device 100 depicted in FIG. 15).

[0218] In some implementations, the clasp 230 further secures the original cusps 20, 22 by engaging the cusps 20, 22 with optional barbs, friction enhancing elements, or locking structures 236 and / or sandwiching the cusps 20, 22 between the movable arm 234 and the fixed arm 232. In some implementations, the clasp 230 is a barbed clasp that includes barbs that can increase friction with the cusps 20, 22 and / or partially or fully pierce the cusps 20, 22. The actuation lines 216 (FIGS. 43-48) can be moved individually so that each clasp 230 can be opened and closed individually. Moving individually allows for gripping one cusp 20, 22 at a time, or allows for repositioning of the clasp 230 on a cusp 20, 22 that was not adequately gripped without altering the good grip on the other cusps 20, 22. The clasp 230 can be fully opened or closed when the inner paddle 222 is not occluded, thereby allowing the tines 20, 22 to be grasped in a variety of positions as a particular situation requires.

[0219] 22-25, the device 200 is shown in a closed position. When occluded, the inner paddle 222 is disposed between the outer paddle 220 and the coaptation element 210. The clasp 230 is disposed between the inner paddle 222 and the coaptation element 210. Upon successful capture of the native cusps 20, 22, the device 200 is moved and held in a closed position such that the cusps 20, 22 are secured within the device 200 by the clasp 230 and pressed against the coaptation element 210 by the paddles 220, 222. The outer paddle 220 can have a wider curved shape that fits around the curved shape of the coaptation element 210 (e.g., as can be seen in FIG. 51) to more securely grip the cusps 20, 22 when the device 200 is occluded. The curved shape and rounded ends of the outer paddle 220 also prevent or inhibit tearing of the cusp tissue.

[0220] 30-37, the device or implant 200 described above is shown in various positions and configurations ranging from partially open to fully open. The paddles 220, 222 of the device 200 transition between the positions shown in FIGS. 30-37 from the closed position shown in FIGS. 22-25 to the upward extension of the actuating element 212 from a fully retracted position to a fully extended position.

[0221] 30-31, the device 200 is shown in a partially open position. The device 200 is moved to the partially open position by extending the actuation element 212. The extension of the actuation element 212 pulls down the bottom of the outer paddle 220 and paddle frame 224. The outer paddle 220 and paddle frame 224 pull down the inner paddle 222, which is connected to the outer paddle 220 and paddle frame 224. As the proximal collar 211 (or other attachment element) and interface element 210 are held in place by the capture mechanism 213, the inner paddle 222 is caused to articulate, pivot, and / or bend toward the opening. The inner paddle 222, outer paddle 220, and paddle frame all bend to the positions shown in FIGS. 30-31. Releasing the paddles 222, 220 and frame 224 creates a gap between the interface element 210 and the inner paddle 222 that can receive and grip the native cusps 20, 22. This movement also exposes the catch 230, which can move between a closed position (FIG. 30) and an open position (FIG. 31) to create a second gap for gripping the native cusps 20, 22. The extent of the gap between the fixed arm 232 and the movable arm 234 of the catch 230 is limited to the extent that the inner paddle 222 extends away from the interface element 210.

[0222] 32-33, the device 200 is shown in a laterally extended or laterally open position. The device 200 is moved to the laterally extended or laterally open position by continuing the extension of the actuating element 212 as described above, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207. Continuing the extension of the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 down, thereby spreading the inner paddle 222 further away from the coaptation element 210. In the laterally extended or laterally open position, the inner paddle 222 extends more horizontally than in other positions of the device 200, forming an angle of approximately 90 degrees with the coaptation element 210. Similarly, the paddle frame 224 are in their maximum spread position when the device 200 is in the laterally extended or laterally open position. The increased gap formed between the interface element 210 and the inner paddle 222 in the laterally extended or laterally open position allows the clasp 230 to open further (FIG. 33) before engaging the interface element 210, thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0223] 34-35, the exemplary device 200 is shown in a three-quarters extended position. The device 200 is moved to the three-quarters extended position by continuing to extend the actuating element 212 as described above, thereby increasing the distance between the interface element 210 and the cap 214 of the distal portion 207. Continuing to extend the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 down, thereby spreading the inner paddle 222 further away from the interface element 210. In the three-quarters extended position, the inner paddle 222 opens to an angle of more than 90 degrees to about 135 degrees with the interface element 210. The paddle frame 224 spreads less than in the laterally extended or laterally open positions and begins to move inwardly toward the actuating element 212 as the actuating element 212 extends further. The outer paddle 220 also bends backwards toward the actuating element 212. Similar to the laterally extended or laterally open position, the increased gap formed between the joint element 210 and the inner paddle 222 in the laterally extended or laterally open position allows the clasp 230 to open even further (FIG. 35), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0224] 36-37, the exemplary device 200 is shown in a fully extended position. The device 200 is moved to the fully extended position by continuing the extension of the actuating element 212 as described above, thereby increasing the distance between the coaptation element 210 and the cap 214 of the distal portion 207 to the maximum distance allowable by the device 200. Continuing the extension of the actuating element 212 pulls the outer paddle 220 and the paddle frame 224 down, thereby spreading the inner paddle 222 further away from the coaptation element 210. The outer paddle 220 and the paddle frame 224 move to a position where they are closer to the actuating element. In the fully extended position, the inner paddle 222 is opened to an angle of about 180 degrees with the coaptation element 210. In the fully extended position, the inner and outer paddles 222, 220 are linearly extended to form an angle of about 180 degrees between the paddles 222, 220. The fully extended position of the device 200 provides the maximum size of the gap between the coaptation element 210 and the inner paddle 222, and in some implementations allows the clasp 230 to also be fully opened to about 180 degrees between the fixed arm 232 and the movable arm 234 of the clasp 230 (FIG. 37). The position of the device 200 is its longest and narrowest configuration. Thus, the fully extended position of the device 200 may be a desired location for extrication of the device 200 from an attempted implantation, or may be in a desired location for placement of the device into a delivery catheter or the like.

[0225] Configuring the device or implant 200 such that the anchors 208 may extend into a straight or near-straight configuration (e.g., about 120 degrees to 180 degrees relative to the coaptation element 210) may provide several advantages. For example, this configuration may reduce the radial crimp profile of the device or implant 200. The configuration may make it easier to grasp the native cusps 20, 22 by providing a larger opening between the coaptation element 210 and the inner paddle 222 for grasping the native cusps 20, 22. Additionally, the relatively narrow and straight configuration may prevent, inhibit, or reduce the possibility of the device or implant 200 becoming entangled in native anatomy (e.g., chordae tendineae CT shown in FIGS. 3 and 4) when positioning and / or retrieving the device or implant 200 within the delivery system 202.

[0226] 38-49, an exemplary device 200 is shown being delivered and deployed into the native mitral valve MV of the heart H. As mentioned above, the device 200 shown in FIGS. 38-49 includes an optional cover 240 (e.g., FIG. 25) over the coaptation element 210, the clasp 230, and the inner paddle 222 and / or the outer paddle 220. The device 200 is deployed from a delivery system 202 (which may include, for example, a steerable catheter and / or an implant catheter extendable from a guide sheath) and is held by a capture mechanism 213 (see, for example, FIGS. 43 and 48) and moved by extending and retracting the actuating element 212. Fingers of the capture mechanism 213 releasably attach the collar 211 to the delivery system 202. In some implementations, the capture mechanism 213 is held in a closed state around the collar 211 by the actuating element 212 such that after the device 200 is successfully implanted, the actuating element 212 can be removed to allow the fingers of the capture mechanism 213 to open the collar 211, thereby releasing the collar 211 and thereby detaching the capture mechanism 213 from the device 200.

[0227] 38, a delivery system 202 (e.g., its delivery catheter / sheath) is inserted through the septum into the left atrium LA and the device / implant 200 is deployed from the delivery system 202 in a fully open state for the reasons described above with respect to device 100 (e.g., an implant catheter holding the device / implant can be expanded to deploy the device / implant from the steerable catheter). The device 200 is then moved through a partially occluded state (FIG. 39) to a fully occluded state as shown in FIGS. 40-41 by retracting the actuating element 212. The delivery system or catheter then steers the device / implant 200 towards the mitral valve MV as shown in FIG. 41. 42, when the device 200 is aligned with the mitral valve MV, the actuating element 212 extends, releasing the paddles 220, 222 to a partially open position and the actuating line 216 (FIGS. 43-48) retracts, opening the clasp 230 ready to grasp the leaflets. The partially open device 200 is then inserted (e.g., by advancing an implant catheter from the steerable catheter) through the native valve until the leaflets 20, 22 are properly positioned between the inner paddle 222 and the coaptation element 210 and within the open clasp 230, as shown in FIGS. 43-44.

[0228] FIG. 45 shows the device 200 with both clasps 230 closed, but with the optional barb, friction enhancing element, or fixation structure 236 of one clasp 230 missing one leaflet 22. As can be seen from FIGS. 45-47, the misaligned clasp 230 is again opened and occluded to properly grasp the missed leaflet 22. When both leaflets 20, 22 are properly grasped, retracting the actuating element 212 moves the device 200 to a fully closed position shown in FIG. 48. When the device 200 is fully occluded and implanted within the native valve, the actuating element 212 can be disengaged and withdrawn from the cap 214 to release the capture mechanism 213 from the proximal collar 211 (or other attachment element), allowing the capture mechanism 213 to be withdrawn into the delivery system 202 (e.g., into a catheter / sheath) as shown in FIG. 49. Once deployed, the device 200 may be maintained in a fully closed position by mechanical means such as a latch, or may be biased to remain closed through the use of a spring material such as steel and / or a shape memory alloy such as Nitinol. For example, the outer paddles 220, 222 may be formed from steel or Nitinol shape memory alloy fabricated into a wire, sheet, tube, or laser sintered powder and biased to hold the outer paddle 220 closed around the inner paddle 222, the joint element 210, and / or to hold the clasp 230 in a clamping position around the native cusps 20, 22.

[0229] 50-54, after the device 200 is implanted in the native valve, the coaptation element 210 functions as a gap filler in a valve regurgitation orifice, such as the gap 26 in the mitral valve MV illustrated in FIG. 6 or in another native valve. In some implementations, when the device 200 is deployed between two opposing leaflets 20, 22, the leaflets 20, 22 no longer coapt against each other in the region of the coaptation element 210, but instead coapt against the coaptation element 210. This reduces the distance that the leaflets 20, 22 must approach to close the mitral valve MV during systole, thereby facilitating the repair of functional valve disease that may cause mitral regurgitation. The reduction in leaflet approach distance may provide several other benefits as well. For example, the stresses experienced by the native valve are reduced or minimized by the reduction in the approach distance required for the leaflets 20, 22. A closer approximation of the leaflets 20, 22 may require a reduced approximation force, which may result in less tension on the leaflets 20, 22 and less reduction in the diameter of the valve annulus. A lesser or no reduction in the valve annulus may result in a lesser reduction in the valve orifice area compared to a device without a coaptation element or spacer. In this manner, the coaptation element 210 may reduce transvalvular gradients.

[0230] In order to adequately fill the gaps 26 between the cusps 20, 22, the device 200 and its components can have a wide variety of different shapes and sizes. For example, the outer paddle 220 and paddle frame 224 can be configured to fit against the shape or geometry of the coaptation element 210, as shown in FIGS. 50-54. As a result, the outer paddle 220 and paddle frame 224 can mate with both the coaptation element 210 and the native leaflets 20, 22. In some implementations, when the cusps 20, 22 are coapted against the coaptation element 210, the cusps 20, 22 completely surround or "hugge" the coaptation element 210 in their entirety, and thus small leaks at the outer and inner surfaces 201, 203 of the coaptation element 210 can be prevented or reduced. The interaction of the cusps 20, 22 with the device 200 is made clear in Fig. 51, which shows a schematic atrial or surgeon's eye view showing a paddle frame 224 (which would not actually be visible from a true atrial view, e.g., Fig. 52) conforming to the geometry of the coaptation element 210. The opposing cusps 20, 22 (whose ends would also not be visible from a true atrial view, e.g., Fig. 52) are moved closer together by the paddle frame 224 to completely surround or "embrace" the coaptation element 210.

[0231] This coaptation of the cusps 20, 22 against the lateral and medial surfaces 201, 203 of the coaptation element 210 (shown from the atrial side in FIG. 52 and from the ventricular side in FIG. 53) would seem to contradict the statement above that the presence of the coaptation element 210 minimizes the distance the cusps must come together. However, the distance the cusps 20, 22 must come together is still minimized if the coaptation element 210 is placed exactly at the regurgitant gap 26, and further if the regurgitant gap 26 is smaller than the width (medial minus lateral) of the coaptation element 210.

[0232] FIG. 50 illustrates the geometry of the coaptation element 210 and paddle frame 224 from the perspective of the LVOT. As can be seen from this figure, the coaptation element 210 has a tapered shape with smaller dimensions in the area close to where the inner surfaces of the cusps 20, 22 are required to coapt and larger dimensions as the coaptation element 210 extends toward the atrium. Thus, the challenges of the native valve geometry shown are addressed by the tapered coaptation element shape. Still referring to FIG. 50, the tapered coaptation element geometry, in combination with the expanded paddle frame 224 shape (towards the annulus) as shown, can help achieve capture at the bottom of the leaflets, reduce stress, and minimize transvalvular gradients.

[0233] 54, the shapes of the coaptation element 210 and the paddle frame 224 can be defined based on the native valve and the inner commissure diagram of the device 200. The two factors for these shapes are the coaptation of the cusps to the coaptation element 210 and the reduction of stress on the cusps due to coaptation. With reference to FIG. 54 and FIG. 24, the coaptation element 210 can have a circular or round shape and the paddle frame 224 can have a full radius that spans almost the entirety of the paddle frame 224 to both coapt the cusps 20, 22 to the coaptation element 210 and to reduce the stress that the coaptation element 210 and / or paddle frame 224 apply to the cusps 20, 22. The round shape of the coaptation element 210 and / or the fully round shape of the paddle frame 224 shown distributes the stress on the cusps 20, 22 over a highly curved engagement region 209. For example, in FIG. 54, the force on the cusps 20, 22 by the paddle frame is spread along the entire rounded length of the paddle frame 224 as the cusps 20 attempt to open during diastole.

[0234] 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.

[0235] 55, there is shown an embodiment of a device or implant 300 (e.g., an implantable prosthetic device, a valve repair device, a valve repair device, etc.). Device 300 is one of many different configurations that device 100, shown generally in FIGS. 8-14, may take. Device 300 may include any other features of a device or implant discussed herein, and 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).

[0236] The 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 an interface portion / region 304 that optionally includes an interface element 310 (e.g., a spacer, plug, membrane, sheet, gap filler, etc.) for implantation between the native valve cusps 20, 22. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 may include one or more paddles, for example, an outer paddle 320, an inner paddle 322, a paddle extension member, or a paddle frame 324. The anchors may also include and / or be coupled to a clasp 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging with a capture mechanism (e.g., a capture mechanism such as capture mechanism 213 shown in Figures 43-49, or another capture mechanism described herein or otherwise known) of a delivery system (e.g., a delivery system such as the systems shown in Figures 38-42 and 49).

[0237] The anchors 308 can 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 any or all combinations thereof, etc.) In some implementations, the anchors 308 are attached to the joining member or joining element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0238] 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.

[0239] In some implementations having a joining member or element 310, the joining element 310 and the anchor 308 may be coupled together in a variety of ways. For example, as shown in the illustrated embodiment, the joining element 310 and the anchor 308 may be coupled together by integrally forming the joining element 310 and the anchor 308 as a single unitary component. This may be accomplished, for example, by forming the joining element 310 and the anchor 308 from a continuous strip 301 of braided or woven material, such as braided or woven Nitinol wire. In the illustrated embodiment, the joining element 310, the outer paddle portion 320, the inner paddle portion 322, and the connecting portions 321, 323, 325 are formed from a continuous strip of fabric 301.

[0240] Similar to the anchor 208 of the 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 element, etc.). The movement may be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device. For example, the anchor 308 may be positioned in a fully extended or straightened configuration (e.g., similar to the configuration of the device 200 shown in FIG. 36) by moving the distal end (e.g., cap 314, etc.) away from the proximal end of the device.

[0241] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight with respect to the orientation of the longitudinal axis of the device. In some implementations, the connecting portion 323 of the anchor 308 is adjacent with respect 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. 55), for example, by moving the proximal and distal ends toward each other and / or toward the midpoint or center of the device. Initially, as the distal end (e.g., cap 314, etc.) moves toward the proximal end and / or toward the midpoint or center of the device, anchor 308 bends at connecting portions 321, 323, 325 and connecting portion 323 moves radially outward relative to the longitudinal axis of device 300 and axially toward the midpoint and / or proximal end of the device (e.g., similar to the configuration of device 200 shown in FIG. 34). As cap 314 continues to move toward the midpoint and / or proximal end of the device, connecting portion 323 moves radially inward relative to the longitudinal axis of device 300 and axially toward the proximal end of the device (e.g., similar to the configuration of device 200 shown in FIG. 30).

[0242] In some implementations, the clasp includes a movable arm coupled to the anchor. In some implementations, the clasp 330 (shown in detail in FIG. 28B ) includes a base or fixed arm 332, a movable arm 334, an optional barb / friction enhancing element 336, and an interface portion 338. The fixed arm 332 is attached to the inner paddle 322 with the interface portion 338 disposed proximate to the interface element 310. The interface portion 338 is spring loaded such that the fixed arm 332 and the movable arm 334 are biased toward each other when the clasp 330 is in a closed state.

[0243] The fixed arm 332 is attached to the inner paddle 322 by sutures (not shown) through holes or slots 331. The fixed arm 332 may be attached to the inner paddle 322 by any suitable means, such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, or the like. The fixed arm 332 remains substantially stationary relative to the inner paddle 322 when the movable arm 334 is opened to open the clasp 330 and expose optional barbs, friction enhancing elements, or fixation structures. The clasp 330 is opened by applying tension to an actuation line (e.g., actuation line 216 shown in FIGS. 43-48 ) attached to a hole 335 in the movable arm 334, thereby allowing the movable arm 334 to articulate, pivot, and / or bend over an interface 338.

[0244] In summary, the device or implant 300 is similar in construction and operation to the 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 strip of material 301. The continuous strip 301 may be a single layer of material or may include two or more layers. In some implementations, portions of the device 300 have a single layer of the strip of material 301, and other portions are formed from multiple overlapping or overlapping layers of the strip of material 301.

[0245] For example, Figure 55 shows a joining element 310 and inner paddle 322 formed from multiple overlapping layers of strip of material 301. The single continuous strip of material 301 can begin and end at various locations on the device 300. The ends of the strip of material 301 can be located at the same or different locations on the device 300. For example, in the example illustrated in Figure 55, the strip of material 301 begins and ends at the location of the inner paddle 322.

[0246] As with the 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. In particular, 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 device 300's widest point (i.e., the width of the paddle frame 324, which is wider than the coaptation element 310) is about 5 mm.

[0247] 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 may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) and U.S. Provisional Patent Application No. 63 / 217,622. Any combination or subcombination of features disclosed by the present application may be combined with any combination or subcombination of features disclosed by Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. 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 incorporated herein by reference in their entirety for all purposes. The described therapeutic methods can be performed on a live animal or a simulation such as a cadaver, cadaver heart, simulator (e.g., where a body part, heart, tissue, etc. is simulated), mutatis mutandis, applying the concepts herein.

[0248] The concepts disclosed herein may be used in a wide variety of different valve repair devices. Figures 56A-56H show another example of one of many valve repair systems 40056 for repairing a patient's native valve to which the concepts disclosed herein may be applied. The valve repair system 40056 includes a delivery device 40156 and a valve repair device 40256.

[0249] The valve repair device 40256 includes a base assembly 40456, a pair of paddles 40656, and a pair of gripping members 40856 (e.g., clasps, arms, pliers, etc.). In some implementations, the paddles 40656 may be integrally formed with the base assembly. For example, the paddles 40656 may be formed as an extension of a link of the base assembly. In the illustrated example, the base assembly 40456 of the valve repair device 40256 has a shaft 40356, a coupler 40556 configured to move along the shaft, and a lock 40756 configured to lock the coupler in a stationary position on the shaft. The coupler 40556 is mechanically connected to the paddles 40656 such that 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 as a means for moving the paddles 40656 between their open and closed positions as they move along the shaft 40356.

[0250] In some implementations, the gripping member 40856 may be pivotally connected to the base assembly 40456 (e.g., the gripping member 40856 may be pivotally connected to the shaft 40356, or any other suitable member of the base assembly) such that the gripping member may be moved to adjust the width of the opening 41456 between the paddle 40656 and the gripping member 40856. The gripping member 40856 may include a gripping portion 40956 (e.g., barbs, projections, ridges, grooves, textured surfaces, adhesives, etc.) for attaching the gripping member to valve tissue when the valve repair device 40256 is attached to the valve tissue. The gripping member 40856 forms a means for gripping valve tissue (particularly tissue of the valve leaflets) using an anchoring means or portion such as a barbed portion 40956. When the paddle 40656 is in the closed position, the paddle engages the gripping member 40856 such that when the valve tissue is attached to the gripping portion 40956 of the gripping member, the paddle acts as a retention or fixation means to hold the valve tissue at the gripping member and fix 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 gripping portion 40956 engages the valve tissue member and the paddle 40656 to fix 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 with the paddle 40656.

[0251] In the implementation shown in FIGS. 56A-56H, a pair of paddles 40656 and a pair of gripping members 40856 are illustrated, however, it will be understood that the valve repair device 40256 can include any suitable number of paddles and gripping members.

[0252] 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.

[0253] The valve repair system 40056 can also include a paddle control mechanism 41056, a gripper control mechanism 41156, and a lock control mechanism 41256. The paddle control mechanism 41056 is mechanically attached to the coupler 40556 such that moving the coupler along the shaft moves the paddle 40656 between the open and closed positions. The paddle control mechanism 41056 can take any suitable form and can include, for example, a shaft, wires, tubes, hypotubes, rods, sutures, lines, etc. For example, the paddle control mechanism can 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.

[0254] 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, such as, for example, a line, suture, wire, rod, catheter, tube, hypotube, etc.

[0255] The lock control mechanism 41256 is configured to lock and unlock the lock. The lock 40756 functions 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 some implementations, the lock 40756 includes a pivotable plate having a hole, and the shaft 40356 of the valve restoration device 40256 is disposed within the hole of the pivotable plate. In this example, when the pivotable plate is in a tilted position, the pivotable plate engages the shaft 40356 to maintain its position on the shaft 40356, but when the pivotable plate is in a substantially non-tilted position, the pivotable plate can move along the shaft (thereby allowing the coupler 40556 to move along the shaft 40356). In other words, the coupler 40556 is prevented from moving in direction Y (as shown in FIG. 56E ) along the shaft 40356 when the pivotable plate of the lock 40756 is in a tilted position (or locked position), and the coupler is allowed to move in direction Y along the shaft 40356 when the pivotable plate is in a substantially non-tilted position (or unlocked position). In some implementations where the lock 40756 includes a pivotable plate, the lock control mechanism 41256 is configured to engage the pivotable plate to move the plate between the tilted position and the substantially non-tilted position. The lock control mechanism 41256 can be, for example, a rod, suture, wire, or any other member capable of moving the pivotable plate of the lock 40756 between the tilted position and the substantially non-tilted position. In some implementations, the rotatable plate of the lock 40756 is biased to a tilted position (or locked position) and the plate can be moved from the tilted position to a substantially non-tilted position (or unlocked position) using the lock control mechanism 41256.In some implementations, the rotatable plate of the lock 40756 is biased to a substantially non-tilted position (or unlocked position), and the lock control mechanism 41256 can be used to move the plate from the substantially non-tilted position to a tilted position (or locked position).

[0256] 56E-56F illustrate the movement of the valve repair device 40256 from an open position (shown in FIG. 56E) to a closed position (shown in FIG. 56F). The base assembly 40456 includes a first link 102156 extending from point A to point B, a second link 102256 extending from point A to point C, a third link 102356 extending from point B to point D, a fourth link 102456 extending from point C to point E, and a fifth link 102556 extending from point D to point E. The coupler 40556 is movably attached to the shaft 40356, which is fixed relative to the fifth link 102556. The first link 102156 and the second link 102256 are pivotally attached to the coupler 40556 at point A, such that movement of the coupler 40556 along the shaft 40356 moves the location of point A and therefore the first link 102156 and the second link 102256. The first link 102156 and the third link 102356 are pivotally attached to one another at point B, and the second link 102256 and the fourth link 102456 are pivotally attached to one another at point C. One paddle 40656a is attached to the first link 102156 such that movement of the first link 102156 moves the paddle 40656a, and the other paddle 40656b is attached to the second link 102256 such that movement of the second link 102256 moves the paddle 40656b. In some implementations, the paddles 40656a, 40656b may be connected to the links 102356, 102456 or may be extensions of the links 102356, 102456.

[0257] To move the valve repair device from an open position (shown in FIG. 56E) to a closed position (shown in FIG. 56F), the coupler 40556 is moved along the shaft 40356 in direction Y, which moves the pivot point A for the first link 102156 and the second link 102256 to a new position. Moving the coupler 40556 (and pivot point A) in direction Y moves the portion of the first link 102156 located near point A to direction H and moves the portion of the first link 102156 located near point B to direction J. The paddle 40656a is attached to the first link 102156 such that moving the coupler 40556 in direction Y moves the paddle 40656a in direction Z. In addition, the third link 102356 is pivotally attached to the first link 102156 at point B such that moving the coupler 40556 in direction Y moves the third link 102356 to orientation K. Similarly, moving the coupler 40556 (and pivot point A) in direction Y moves a portion of the second link 102256 located near point A to orientation L and moves a portion of the second link 102256 located near point C to orientation M. The paddle 40656b is attached to the second link 102256 such that moving the coupler 40556 in direction Y moves the paddle 40656b to orientation V. Additionally, the fourth link 102456 is pivotally attached to the second link 102256 at point C such that moving the coupler 40556 in direction Y moves the fourth link 102456 in orientation N. Figure 56F illustrates the final position of the valve repair device 40256 after the coupler 40556 has been moved as shown in Figure 56E.

[0258] 56B, the valve repair device 40256 is shown in an open position (similar to the position shown in FIG. 56E) and the gripper control mechanism 41156 is shown moving the gripping members 40856 to provide a wider gap at the opening 41456 between the gripping members and the paddle 40656. In the illustrated example, the gripper control mechanism 41156 includes a line, such as a suture, wire, etc., that is attached through an opening in the end of the gripping member 40856. Both ends of the line extend through a delivery opening 51656 of the delivery device 40156. When the line is pulled through the delivery opening 51656 in direction Y, the gripping members 40856 are moved inward in direction X to provide a wider opening 41456 between the gripping members and the paddle 40656.

[0259] 56C, the valve repair device 40256 is shown with the valve tissue 20, 22 disposed into the opening 41456 between the gripping member 40856 and the paddle 40656. With reference to FIG. 56D, after the valve tissue 20, 22 is disposed between the gripping member 40856 and the paddle 40656, the gripper control mechanism 41156 is used to narrow the opening 41456 between the gripping member and the paddle. That is, in the illustrated example, the line of the gripper control mechanism 41156 is released or pushed out of the opening 51656 of the delivery member (e.g., tube, shaft, conduit, etc.) in the direction H, allowing the gripping member 40856 to move in the direction D, thereby narrowing the opening 41456. Although the gripper control mechanism 41156 is shown moving the gripping member 40856 to widen the opening 41456 between the gripping member and the paddle 40656 ( FIG. 56C ), it will be understood that there may be cases where the gripping member does not need to be moved to place valve tissue within the opening 41456. However, in certain circumstances, the opening 41456 between the paddle 40656 and the gripping member 40856 may need to be made wider to receive the valve tissue.

[0260] 56G, the valve repair device 40256 is in a closed position and secured relative to the valve tissue 20, 22. The valve repair device 40256 is secured relative to the valve tissue 20 by the paddles 40656a, 40656b and the gripping members 40856a, 40856b. In particular, the valve tissue 20, 22 is attached to the valve repair device 40256 by the gripping portions 40956 of the gripping members 40856a, 40856b, and the paddles 40656a, 40656b engage the gripping members 40856 to secure the valve repair device 40256 relative to the valve tissue 20, 22.

[0261] To move the valve repair device 40256 from the open position to the closed position, the lock 40756 is moved to an unlocked state by the lock control mechanism 41256 (as shown in FIG. 56G). After the lock 40756 is in the unlocked state, the coupler 40556 can be moved along the shaft 40356 by the paddle control mechanism 41056. In the illustrated example, the paddle control mechanism 41056 moves the coupler 40556 along the shaft in a direction Y to move one paddle 40656a in a direction X and the other paddle 40656b in a direction Z. Moving the paddle 40656a in a direction X and the paddle 40656b in a direction Z engages the paddles with the gripping members 40856a, 40856b and secures the valve repair device 40256 to the valve tissue 20, 22.

[0262] 56H, after the paddle 40656 is moved to the closed position to secure the valve repair device 40256 to the valve tissue 20, 22 (as shown in FIG. 56G), the lock 40756 is moved to a locked state by the lock control mechanism 41256 (FIG. 56G) 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 (FIG. 56G). Additionally, the valve repair device 40256 is decoupled from the paddle control mechanism 41056 (FIG. 56G), the gripper control mechanism 41156 (FIG. 56G), and the lock control mechanism 41256. Detachment of the valve repair device 40256 from the delivery device 40156 allows the valve repair device to remain fixed relative to the valve tissue 20, 22 while the delivery device 40156 is removed from the patient.

[0263] The 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 may be combined with any combination or subcombination of the features 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 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 / 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.

[0264] 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.

[0265] When implanting a device or implant into a native heart valve, movement of the device to the implantation location may be inhibited or impeded by native heart structures. For example, the articulating portion of the device or implant (such as the paddle portion of the anchor used to secure the device to the native heart valve tissue) may rub, be temporarily caught, or be temporarily blocked by the chordae tendineae CT (shown in Figures 3 and 4) extending to the leaflets. Exemplary devices or implants may be configured to reduce the likelihood that the device or implant will be temporarily caught or blocked by the CT. For example, the device or implant may have a wide variety of different configurations that are configured to actively or passively constrict to reduce the width of the paddle frame at the anchor portion of the device, thereby reducing the surface area of ​​the device and facilitating movement of the device / implant over and / or through the CT.

[0266] The valve repair device 40256 may include any other features for a valve repair device discussed elsewhere 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). The described therapeutic methods can be performed mutatis mutandis on a living animal or a simulation such as a cadaver, cadaver heart, simulator (e.g., where a body part, heart, tissue, etc. is simulated), applying the concepts herein mutatis mutandis.

[0267] 57-68, various configurations of embodiments of the device or implant 400 are shown. The device / implant 400 is configured to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device / implant 400 and native structures of the heart, such as ligaments. The device / implant 400 may include any other features of devices or implants discussed in this application or in the applications and patent documents incorporated herein by reference, and the device 400 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additionally, any device or implant described herein may include the features of the device / implant 400.

[0268] The device / implant 400 can include an interface portion or interface 404 and an anchor portion 406. The anchor portion can include two or more anchors 408. In some implementations, the interface portion 404 optionally includes one or more interface elements 410 (e.g., spacers, coupling members, gap fillers, etc.). The spacers, interface elements, interface elements, etc. 410 can take any suitable form, such as any of the forms described herein.

[0269] Each of the anchors 408 includes a plurality of paddles 420 (e.g., three in each of the illustrated examples) and one or more clasps 430 (e.g., three in the illustrated examples shown in FIGS. 57-59). The clasps 430 may take any suitable form, such as any of the forms described herein.

[0270] Although the illustrated example shows anchors 408 each including three paddles 420, it will be understood that anchors 408 may include any suitable number of paddles 420, such as, for example, two or more paddles, three or more paddles, four or more paddles, five or more paddles, etc.

[0271] In some implementations, each of the anchors 408 can include a corresponding clasp 430 for each of the paddles 420 (as shown in FIGS. 57-59), or each anchor 408 can include only a single clasp 430 corresponding to only a single paddle of the plurality of paddles 420 (e.g., as shown in FIGS. 60-68). However, it will be understood that each anchor 408 can include any number of paddles 420 that include a corresponding clasp 430, and any number of paddles 420 that do not include a corresponding clasp 430.

[0272] The interface elements 410 and anchors 408 can be coupled together in a variety of ways. For example, as shown in the illustrated example, the interface elements 410 and anchors 408 can be optionally coupled together by integrally forming the interface elements 410 and anchors 408 as a single, unitary component. This can be accomplished, for example, by forming the interface elements 410 and anchors 408 from a continuous strip of braided or woven material, such as braided or woven Nitinol wire. In some implementations, multiple components are formed separately and attached to one another.

[0273] The device or implant 400 may also include an attachment portion 405 for attaching the device 400 to a delivery system 402 (FIGS. 69-73). The delivery system 402 may be the same as or similar to other delivery systems described herein, such as 102, 202, and 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 pathway, combinations thereof, and the like. The attachment portion 405 may include a proximal collar 411 for engaging the delivery system 402 (e.g., to an implant catheter of the delivery system). For example, the proximal collar 411 may be configured to engage a capture mechanism (e.g., capture mechanism 213 shown in FIGS. 43-49) of the delivery system 402 (e.g., a capture mechanism of an implant catheter).

[0274] The anchor 408 is configured to reduce contact and / or friction between the anchor 408 and a native structure of the heart, such as a tether, thereby allowing the device or implant 400 to be more easily maneuvered into position for implantation within the heart. The anchor 408 includes a plurality of paddles 420 such that one or more gaps G are formed between the paddles 420. Contact between the native structure of the heart and the anchor 408 is reduced because the native structure of the heart may extend into the gaps G as the device 400 is moved through the heart. This allows the device or implant 400 to be more easily maneuvered within the heart. Additionally, the gaps G allow the paddles to flex towards each other upon contact between the anchor 408 and a native structure of the heart, such as a tether. This flexing also allows the device / implant 400 to be more easily maneuvered through the heart. The device / implant can also be configured to open and close the paddles 420 to move the paddles towards each other. This movement relative to the paddles, towards each other, also allows the device / implant 400 to be more easily maneuvered through the heart.

[0275] The anchor 408 may have a total width TW of 4 mm to 20 mm, such as, for example, about 10 mm, such as, for example, 6 mm to 15 mm, such as, for example, 8 mm to 12 mm. Each of the paddles 420 may have a width W of 0.2 mm to 2 mm, such as, for example, 0.5 mm to 1 mm, such as, for example, 0.3 mm to 1.5 mm. Although each of the paddles 420 is shown as having the same width W, it will be understood that the width W of any paddle 420 may not be equal to the width W of any other paddle 420. The ratio of the total width TW to the width W may be 5 / 1 to 20 / 1, such as, for example, about 10 / 1, such as, for example, 7 / 1 to 15 / 1. The ratio of the total width to the sum of the widths W for the paddles 420 may be about 2 / 1 to 15 / 1, such as, for example, about 4 / 1, such as, for example, 3 / 1 to 10 / 1.

[0276] In the illustrated example, an inner paddle axis IPA for an inner paddle 420 of the plurality of paddles 420 is substantially aligned with a central axis CA of the apparatus 400, and an outer paddle axis OPA of one or more outer paddles 420 extends at an angle α away from the inner paddle axis IPA of the inner paddle 420. The angle α may be between 5 degrees and 60 degrees, such as between 20 degrees and 35 degrees, such as between 15 degrees and 45 degrees.

[0277] 57-62, each of the paddles 420 has a length L between 6 mm and 18 mm, such as between 8 mm and 16 mm, such as between 10 mm and 14 mm, such as about 12 mm. Although each of the paddles 420 is shown as having the same length L, it will be understood that the length L of any paddle 420 may not be equal to the length L of any other paddle (see, e.g., FIGS. 63-68).

[0278] 60-62 illustrate an exemplary implementation of the device or implant 400 shown in FIGS. 57-59. In this example, the device or implant 400 is the same as the embodiment shown in FIGS. 57-59, except that each anchor 408 includes only a single clasp 430 connected to one of the paddles 420. In the illustrated example, the clasp 430 is connected to the inner paddle 420 of each anchor 408, and the outer paddle of each anchor 408 does not include a corresponding clasp. In some implementations, each of the outer paddles 420 may include a corresponding clasp 430, and the inner paddle 420 may not include a corresponding clasp. It will be understood that any number of the paddles 420 may include a corresponding clasp 430, and any number of the paddles 420 may not include a corresponding clasp 430.

[0279] 63-65 illustrate an exemplary implementation of the device or implant 400 shown in FIGS. 60-62. In this example, the device 400 is the same as the embodiment shown in FIGS. 60-62, except that the inner paddle 420 of each anchor 408 has a length IL that is longer than the length OL of the outer paddle 420. The length IL can be 6 mm to 18 mm, such as, for example, about 12 mm, such as, for example, 8 mm to 16 mm, such as, for example, 10 mm to 14 mm. The length OL can be 4 mm to 16 mm, such as, for example, about 10 mm, such as, for example, 8 mm to 12 mm, such as, for example, 6 mm to 14 mm. The ratio of the length IL to the length OL can be 10 / 9 to 2 / 1, such as, for example, about 6 / 5, such as, for example, 8 / 7 to 3 / 2.

[0280] 66-68 illustrate an exemplary implementation of the device or implant 400 shown in FIGS. 60-62. In this example, the device 400 is the same as the embodiment shown in FIGS. 60-62, except that the inner paddle 420 of each anchor 408 has a length IL that is shorter than the length OL of the outer paddle 420. The length OL can be between 6 mm and 18 mm, such as between 10 mm and 14 mm, such as between 8 mm and 16 mm, such as between 10 mm and 14 mm, such as between 4 mm and 16 mm, such as between 8 mm and 12 mm, such as between 6 mm and 14 mm, such as between 4 mm and 16 mm, such as between 8 mm and 12 mm, such as between 6 mm and 14 mm, such as between 10 mm and 2 / 1, such as between 8 mm and 3 / 2, such as between 6 mm and 14 mm ...

[0281] Although the embodiment shown in Figures 63-68 illustrates each anchor 408 having a single clasp 430 corresponding to the inner paddle 420, it will be understood that each paddle 420 of the anchor 408 may include a corresponding clasp 430 (e.g., as shown in Figures 57-59), or any number of the paddles 420 may include a corresponding clasp 430 or any number of the paddles 420 may not include a corresponding clasp 430.

[0282] 69-73, the device 400 is shown at various stages in its deployment from a delivery system 402. The delivery system 402 may take any suitable form, such as any of those described herein. Although the example of the device / implant 400 depicted in FIGS. 57-59 is shown with reference to FIGS. 69-73, it will be understood that the deployment of the device / implant 400 from the delivery system 402 also applies to the example of the device / implant 400 depicted in FIGS. 60-68.

[0283] 69, the device / implant 400 is shown in a compressed position within the delivery system 402. The coaptation elements 410 and paddles 420 are formed from a compressible material that allows the device 400 to be in a compressed position as the device 400 is moved to a desired location within the patient's heart. A capture mechanism 413 is connected to the collar 411 of the device / implant 400 while the device / implant 400 is located within the delivery system 402 and until the device / implant 400 is implanted onto a native heart valve (e.g., native mitral valve, native tricuspid valve, etc.) after the device / implant 400 is deployed from the delivery system 402.

[0284] 70 shows the device or implant 400 in a deployed, closed position. Upon deployment of the device / implant 400 from the delivery system 402, the joint elements 410 expand in an outward direction M and the outer paddles 420 of each anchor 408 pivot or articulate outwardly in an orientation N to a normal position such that a gap G (FIGS. 57 and 59) exists between the inner paddle 420 and each outer paddle 420.

[0285] The actuation shaft 412 extends from the delivery system 402 to engage the paddle 420 and move it from a closed position to an open position. With reference to FIG. 71 , moving the actuation shaft 412 in direction Y engages the paddle 420 and provides a force to the paddle 420 to move the paddle 420 in an outward direction X to an open position. That is, the paddle 420 can be pivotally or flexibly connected to the coaptation element 410 at a connection point 470 such that when a force is provided to the paddle 420, the paddle 420 can pivot, bend, and / or articulate outwardly relative to the coaptation element 410. With reference again to FIG. 71 , the clasp 430 is maintained in an open position relative to the paddle 420 by a corresponding actuation line 416 applying a tension force F onto the clasp 430 such that a tissue capture area exists between the paddle 420 and the clasp 430.

[0286] 72, after the pointed tissue is positioned within the tissue capture area between the clasp 430 and the paddle 420, the clasp 430 is moved in a direction Z to capture the tissue and secure the device 400 relative to the tissue. The clasp 430 can be biased toward the closed position by releasing tension F (FIG. 71) from the actuation line 416 to move the clasp 430 to the closed position, or the actuation line 416 can be actively controlled by a user to move the clasp 430 to the closed position.

[0287] 73, after the device 400 is secured to the apicated tissue by the paddles 420 and clasps 430, the actuation shaft 412 is decoupled from the paddles 420 and moved back into the delivery system 402, which moves the paddles 420 back to their normal closed position. After the device 400 is secured to the tissue and the anchors 408 are in the closed position, the capture mechanism 413 is detached from the collar 411 such that the device 400 is no longer attached to the delivery system 402, and the delivery system 402 can be removed from the patient.

[0288] 74-85, various configurations of embodiments of the device or implant 500 are shown. The device or implant 500 is configured to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device or implant 500 and native structures of the heart, such as, for example, ligaments. The device or implant 500 may include any other features of the device or implant discussed in this application or in the applications and patent documents incorporated herein by reference, and the device 500 may be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). Additionally, any device or implant described herein may include the features of the device / implant 500.

[0289] The device or implant 500 includes an interface portion 504 (e.g., a spacer, interface element, gap filler, etc.), a proximal or attachment portion 505, an anchor portion 506, and a distal portion 507. In some implementations, the interface portion 504 includes an interface element 510 (e.g., a spacer, a coupling member, a gap filler, etc.) that can be used to implant, for example, between the cusps 20, 22 in the native mitral valve MV. The interface element 510 can take any suitable form, such as, for example, any form described herein. The attachment portion 205 includes a first or proximal collar 511 for engaging with a capture mechanism 513 of a delivery sheath or delivery system 202 (see FIGS. 86A, 86B, 87A, 87B, 88, and 89). The proximal collar 511 can take any suitable form, such as, for example, any form described herein.

[0290] The anchor portion 506 can include two or more anchors 508, each of which includes a plurality of paddle members 519 (e.g., three in each of the illustrated examples) and one or more clasps 530 (e.g., three in the illustrated examples shown in FIGS. 74-76). The clasps 530 can take any suitable form, such as any of the forms described herein. The distal portion 507 includes a cap 514 attached to the paddle portion 519 such that moving the cap 514 can move the paddle portion 519 between an open position and a closed position. The cap 514 can take any suitable form, such as any of the forms described herein.

[0291] The paddle members 519 may include an outer paddle 520 and an inner paddle 522, respectively. The paddle members 519 may be formed, for example, from a metal fabric such as a mesh, a woven fabric, a braid, or any other suitable formed, 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 in the human body. In some implementations, the paddle members 519 further include a paddle frame (not shown) that supports the inner paddle 522 and the outer paddle 520. The paddle frame may take any suitable form, such as any of the forms for paddle frames described in this application.

[0292] The interface element 510 is optional. In the illustrated example, the interface element 510 and the paddle member 519 are formed from a continuous strip of material. The material can be, for example, any of the materials described herein for the paddle member 519. In some implementations, multiple components are formed separately and attached to one another. The interface element 510 extends from the proximal collar 511 to the inner paddle 522.

[0293] The interface element 510 has a generally elongated, rounded shape. In particular, the interface element 510 can have an oval shape or cross-section when viewed from above (e.g., as shown in FIG. 74), a tapered shape or cross-section when viewed from the front (e.g., as shown in FIG. 75), and a round shape or cross-section when viewed from the side (e.g., as shown in FIG. 76). A mixture of these three geometries can result in a three-dimensional shape for the illustrated interface element 510 that achieves the advantages described herein.

[0294] Although the illustrated example shows anchors 508 each including three paddle members 519, it will be understood that anchors 508 may include any suitable number of paddle members 519, e.g., two or more paddle members, three or more paddle members, four or more paddle members, five or more paddle members, etc. Additionally, each of anchors 508 may include a corresponding clasp 530 for each of paddle members 519 (as shown in FIGS. 74-76), or each anchor 508 may include only a single clasp 530 corresponding to only a single paddle member of the plurality of paddle members 519 (as shown in FIGS. 77-79, for example). However, it will be understood that each anchor 508 may include any number of paddle members 519 including corresponding clasps 530, and any number of paddle members 519 without corresponding clasps 530.

[0295] The anchor 508 is configured to reduce contact and / or friction between the anchor 508 and a native structure of the heart, such as a tether, thereby allowing the device 500 to be more easily maneuvered into position for implantation within the heart. The anchor 508 includes a plurality of paddles 520 such that one or more gaps G are formed between the paddles 520. Contact between the native structure of the heart and the anchor 508 is reduced because the native structure of the heart may extend into the gaps G as the device 500 is moved through the heart. This allows the device 500 to be more easily maneuvered within the heart. Additionally, the gaps G allow the paddles to flex toward one another upon contact between the anchor 508 and a native structure of the heart, such as a tether. This flexing also allows the device 500 to be more easily maneuvered through the heart. The device can also be configured to move the paddles 520, 522 toward one another by opening and closing the paddles 520, 522. This movement of the paddles toward each other also allows the device 500 to be more easily maneuvered through the heart.

[0296] The anchor 508 may have a total width TW of 4 mm to 20 mm, such as, for example, about 10 mm, such as, for example, 6 mm to 15 mm, such as, for example, 8 mm to 12 mm. Each of the paddles 519 may have a width W of 0.2 mm to 2 mm, such as, for example, 0.5 mm to 1 mm, such as, for example, 0.3 mm to 1.5 mm. Although each of the paddles 519 is shown as having the same width W, it will be understood that the width W of any paddle 519 may not be equal to the width W of any other paddle 519. The ratio of the total width TW to the width W may be from 5 / 1 to 20 / 1, such as, for example, about 10 / 1, such as, for example, 7 / 1 to 15 / 1. The ratio of the total width to the sum of the widths W for the paddles 519 may be from, for example, about 2 / 1 to 15 / 1, such as, for example, about 4 / 1, such as, for example, 3 / 1 to 10 / 1.

[0297] 74-79, each of the inner paddles 522 has a length L between 6 mm and 18 mm, such as between 8 mm and 16 mm, such as between 10 mm and 14 mm, such as about 12 mm. Although each of the inner paddles 522 is shown as having the same length L, it will be understood that the length L of any one of the inner paddles 522 may not be equal to the length L of any other of the inner paddles (see, e.g., FIGS. 63-68).

[0298] 77-79 illustrate an embodiment of the device or implant 500 shown in FIGS. 74-76. In this embodiment, the device 500 is the same as the embodiment shown in FIGS. 74-76, except that each anchor 508 includes only a single clasp 530 attached to one of the paddle members 519. In the illustrated example, the clasp 530 is aligned with a central one of the inner paddle members 522 of each anchor 508, and the outer one of the inner paddle members 522 does not include a corresponding clasp. In some implementations, the outer one of the paddle members 519 may include a corresponding clasp 530 and the inner one of the paddle members 519 may not include a corresponding clasp. It will be understood that any number of the paddle members 519 may include a corresponding clasp 530, and any number of the paddle members 519 may not include a corresponding clasp 530.

[0299] 80-82 illustrate an example implementation of the device or implant 500 shown in FIGS. 77-79. In this example, the device / implant 500 is the same as the embodiment shown in FIGS. 77-79, except that the inner one of the paddles 519 of the anchor 508 has a length IL that is longer than the length OL for the outer one of the paddles 519. The length IL can be 6 mm to 18 mm, such as, for example, about 12 mm, such as, for example, 8 mm to 16 mm, such as, for example, 10 mm to 14 mm. The length OL can be 4 mm to 16 mm, such as, for example, about 10 mm, such as, for example, 8 mm to 12 mm, such as, for example, 6 mm to 14 mm. The ratio of the length IL to the length OL can be 10 / 9 to 2 / 1, such as, for example, about 6 / 5, such as, for example, 8 / 7 to 3 / 2.

[0300] 83-85 illustrate an exemplary implementation of the device or implant 500 shown in FIGS. 77-79. In this embodiment, the device 500 is the same as the embodiment shown in FIGS. 77-79, except that the inner paddle member 519 (e.g., strap, link, etc.) of each anchor 508 has a length IL that is shorter than the length OL of the outer paddle member 519 (e.g., strap, link, etc.). The length OL can be 6 mm to 18 mm, such as, for example, about 12 mm, such as, for example, 8 mm to 16 mm, such as, for example, 10 mm to 14 mm. The length IL can be 4 mm to 16 mm, such as, for example, about 10 mm, such as, for example, 8 mm to 12 mm, such as, for example, 6 mm to 14 mm. The ratio of the length OL to the length IL can be 10 / 9 to 2 / 1, such as, for example, about 6 / 5, such as, for example, 8 / 7 to 3 / 2.

[0301] Although the embodiment shown in Figures 80-85 illustrates each anchor 508 having a single clasp 530 corresponding to the inner paddle member 519, it will be understood that each paddle member 519 of an anchor 508 may include a corresponding clasp 530 (e.g., as shown in Figures 74-76), or any number of paddle members 519 may include a corresponding clasp 530, or any number of paddle members 519 may not include a corresponding clasp 530.

[0302] 86A, 87A, and 88-90, a device or implant 500 is shown at various stages in its deployment from a delivery system 502. The delivery system 502 may take any suitable form and may be the same or similar to other delivery systems herein, such as 102, 202, 402, etc., and may further include one or more of a catheter, sheath, guide catheter / sheath, delivery catheter / sheath, steerable catheter, implant catheter, tube, channel, pathway, combinations thereof, etc. Although the example of the device or implant 500 illustrated in FIGS. 74-76 is shown with reference to FIGS. 86A, 87A, and 88-90, it will be understood that the deployment of the device / implant 500 from the delivery system 502 also applies to the example of the device / implant 500 shown in FIGS. 77-85.

[0303] 86A, the device or implant 500 is shown in a compressed position within a delivery system 502. The coaptation elements 510 and paddle members 519 are formed from a compressible material that allows the device 500 to be in a compressed position as the device 500 is moved to a desired location within the patient's heart. A capture mechanism 513 is connected to the collar 511 of the device 500 while the device 500 is within the delivery system 502 and until the device 500 is implanted onto the native mitral valve MV (or other native heart valve) after the device 500 is deployed from the delivery system 502.

[0304] 87A shows device 500 in a deployed, closed position. Upon deployment of device 500 from delivery system 502, coaptation elements 510 expand in outward direction M and outer members 519 of each anchor 508 rotate outward in orientation N to a normal position such that a gap G (FIGS. 74 and 76) exists between inner and outer paddle members 519.

[0305] Figure 86B shows an embodiment similar to that of Figure 86A with the paddle members 519 in an extended position within the delivery system 502. This allows the device / implant 500 to be compressed to a smaller size compared to the example of Figure 86A since the paddles are not positioned around the outside of the coaptation element 510. As a result, the example illustrated in Figure 86B allows the same size device to be delivered using a smaller delivery system 502 (compared to the delivery system used in the example illustrated in Figure 86A).

[0306] Figure 87B illustrates the device or implant 500 in the configuration of Figure 86B being extracted from the delivery system 502. Upon deployment of the device / implant 500 from the delivery system 502, the coaptation elements 510 expand in the outward direction M and the paddle members 519 remain in an elongated state. After exiting the delivery system, the paddle members 519 can be occluded (e.g., moved to the position illustrated in Figure 87A).

[0307] An actuation element 512 (e.g., actuation wire, actuation shaft, etc.) extends from the delivery system 502 to engage the cap 514 and move the paddle member 519 from the closed position to the open position. With reference to FIG. 88 , moving the actuation element 512 engages the cap 514 and moving the cap 514 in direction Y moves the paddle member 519 in outward direction X to the open position (e.g., similar to the engagement between the actuation element 212 and the cap 214 to move the anchor 208 shown in FIGS. 22-37 ). The clasp 530 is maintained in the open position relative to the paddle member 519 by the corresponding actuation line 516 applying tension F on the clasp 530 such that a tissue capture region exists between the paddle member 519 and the clasp 530.

[0308] 89, after the pointed tissue is positioned within the tissue capture area between the clasp 530 and the paddle member 519, the clasp 530 is moved in a direction Z to capture the tissue and secure the device / implant 500 relative to the tissue. The clasp 530 can be biased toward the closed position by releasing tension F (FIG. 88) from the actuation line 516 to move the clasp 530 to the closed position, or the actuation line 516 can be actively controlled by a user to move the clasp 530 to the closed position.

[0309] 90, after the device or implant 500 is secured to the apical tissue by the paddle members 519 and clasp 530, the actuating element 512 moves the cap 514 back to the normal position toward D, thereby moving the paddle members 519 to the closed position, and the actuating element 512 is disengaged from the cap 514 and moved back into the delivery system 502. After the device 500 is secured to the tissue and the anchor 508 is in the closed position, the capture mechanism 513 is detached from the collar 511 such that the device 500 is no longer attached to the delivery system 502, and the delivery system 502 can be removed from the patient.

[0310] 91-95, an exemplary implementation of device or implant 600 (FIG. 94) includes an anchor portion 606 having one or more paddle frames 624. The paddle frames 624 are configured to more easily maneuver the device or implant 600 into position for implantation within the heart by reducing contact and / or friction between the device 600 and native structures of the heart, such as cords. That is, the paddle frames 624 are configured to be moved between an expanded position (when the device 600 is in a closed position) and a constricted position (when the device 600 is in an open position), such that when the paddle frames 624 are in the constricted position, contact between the device 600 and native structures of the heart is reduced. The device or implant 600 may include any other features of the devices or implants discussed in this application or in the applications and patent documents incorporated herein by reference, and the device 600 may be positioned to engage valve tissues 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 or implants described herein may include the features of the device or implant 600.

[0311] 94, device or implant 600 includes a coaptation portion 604, a proximal or attachment portion 605, an anchor portion 606, and a distal portion 607. Coaptation portion 604, attachment portion 605, and distal portion can take any suitable form, such as, for example, those for these portions of device 200 shown in FIGS. 22-37, or any other form described herein. In some implementations, coaptation portion 604 optionally includes a coaptation element 610 (e.g., a spacer, a coupling member, a gap filler, etc.) that can be used, for example, for implantation between cusps 20, 22 in a native mitral valve MV. Coaptation element, etc. 610 can take any suitable form, such as, for example, any form described herein.

[0312] The attachment portion 605 includes a first or proximal collar 611 for engaging a capture mechanism (e.g., capture mechanism 213 shown in FIGS. 44-49) of a delivery sheath or delivery system (e.g., delivery system 202 shown in FIGS. 38-49). The proximal collar 611 can take any suitable form, such as any of the forms described herein.

[0313] Distal portion 607 includes a cap 614 attached to anchor 608 of anchor portion 606 such that moving cap 614 may move anchor 608 between open and closed positions. Cap 614 may take any suitable form, such as any of the forms described herein. Cap 614 may be moved by extending and retracting an actuating element 612, such as an actuating wire, actuating shaft, or the like (e.g., as described herein with respect to device 200 and actuating element 212 shown in FIGS. 22-37).

[0314] The anchor portion 606 of the device 600 may take any suitable form, such as, for example, that of the anchor portion 206 in the device 200 shown in Figures 22-37 (except that the paddle frame 224 is replaced by a paddle frame 624 as shown in Figures 91-95 and described in more detail below), or any other form described herein that may include a paddle frame 624. The anchor portion 606 may include a plurality of anchors 608, each anchor 608 including an outer paddle 620, an inner paddle 622, a paddle extension or paddle frame 624, and a clasp (e.g., clasp 230 shown in Figures 22-37).

[0315] The outer paddle 620 is joinably attached to the inner paddle 622 by a connecting portion 623 and to the cap 614 of the distal portion 607, and the inner paddle 622 is joinably attached to the joining element 610. In this manner, the anchor 608 is configured similar to a leg, in that the inner paddle 622 is like an upper portion of a leg, the outer paddle 620 is like a lower portion of a leg, and the connecting portion 623 is like a knee portion of a leg.

[0316] The paddle frame 624 has a first connection member 601 (mating surface, connector, notch, fastener, etc.) (FIGS. 91 and 95) for attaching the paddle frame 624 to the distal portion 607 of the cap 614 such that the paddle frame 624 is fixedly connected to the cap 614. The connection member 601 can be, for example, a notch that engages with a corresponding notch in the cap. The paddle frame 624 has one or more second connection members 603 (FIGS. 91 and 95) that connect to a connection portion 623 between the inner paddle 622 and the outer paddle 620 such that the paddle frame 624 is fixedly connected to the anchor 608. The connection member 603 can be, for example, an eyelet that allows the paddle frame 624 to be sewn to the cover and also to the inner and outer paddles 622, 620. In some implementations, the paddle frame 624 is formed from a stiffer and more rigid material as compared to the material forming the paddles 622,620 such that the paddle frame 624 provides support for the paddles 622,620.

[0317] The paddle frame 624 provides additional clamping force between the inner paddle 622 and the interface element 610. The paddle frame helps wrap the cusps around the sides of the interface element 610 for better sealing between the interface element 610 and the cusps. That is, the paddle frame 624 can be configured with a rounded three-dimensional shape that extends from the cap 614 to the connection portion 623 of the anchor 608. The connections between the paddle frame 624, the outer and inner paddles 620 and 622, the cap 614, and the interface element 610 can constrain the movement of each of these members (e.g., to the movements and positions described with reference to Figures 22-37). In particular, the connection portion 623 is constrained by its connections between the outer and inner paddles 620 and 622 and by its connections to the paddle frame 624. Similarly, the paddle frame 624 is constrained by its attachment to the connecting portion 623 (and thus the inner paddle 622 and the outer paddle 620 ) and by its attachment to the cap 614 .

[0318] Configuring the paddle frame 624 in this manner provides an increased surface area compared to the inner paddle 622 alone, which may, for example, allow easier grasping and fixation of the natural cusp. The increased surface area may also distribute the clamping force of the paddle 620 and paddle frame 624 on the natural cusp over a larger surface area of ​​the natural cusp to further protect the natural cusp tissue. In some implementations, the increased surface area of ​​the paddle frame 624 may also allow the natural cusp to be clamped against the device or implant 200 such that the natural cusp fully coapts against the periphery of the coaptation element 610. This may, for example, improve the sealing of the natural cusp, thereby preventing or further reducing mitral regurgitation.

[0319] The paddle frame 624 is configured to be moved between an expanded position (e.g., as shown in FIG. 91 ) and a stenotic position (e.g., as shown in FIGS. 92 and 95 ). When in the expanded position, the paddle frame 624 has an increased surface area that provides the above-mentioned advantages for securing the device 600 against the native valve of the heart. When in the stenotic position, the paddle frame 624 has a reduced width compared to the paddle frame in the expanded position, which allows the device 600 to be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device 600 and native structures of the heart, such as cords. Moving the anchors 608 between the open and closed positions moves the paddle frame 624 between the expanded and stenotic positions.

[0320] In the illustrated example, an actuation element 612 (e.g., an actuation wire, actuation shaft, etc.) extends from a delivery system (e.g., any delivery system described herein) and engages the cap 614 to allow movement of the device 600 by moving the cap 614 in the direction Y relative to the interface element or spacer 610. The actuation element 612 may engage and move the cap by any suitable means, such as any of the means provided herein. Moving the cap 614 away from the interface element 610 moves the anchor 608 to an open position (as shown in FIG. 94 ) and moving the interface element 610 towards the interface element 610 moves the anchor to a closed position.

[0321] Based on the configuration of the paddle frame 624 and its connection to the cap 614 and to the connecting portion 623 of the anchor 608, the paddle frame 624 is in an expanded position when the anchor 608 is in a closed position and in a constricted position when the anchor 608 is in an open position. That is, referring to FIG. 91, moving the anchor 608 to the open position applies a tension force F to the paddle frame 624 due to the cap 614 being moved in the direction Y (FIG. 94) away from the joint element 610 and due to the fixed connection of the paddle frame 624 to the cap 614 and to the connecting portion 623 of the anchor 608.

[0322] 91 and 92, the paddle frame 624 has a width W and a thickness T that is greater than the width W. Having the thickness T greater than the width W increases the degree to which the paddle frame 624 is compressed in the direction X when tension F is applied to the paddle frame 624. This is because the paddle frame is less stiff in the direction of the width W than in the direction of the thickness T. In some implementations, the ratio of the thickness T to the width W is between 10 / 9 and 3 / 1, such as between 4 / 3 and 3 / 2, such as between 5 / 4 and 2 / 1.

[0323] Referring to FIG. 95, the paddle frame 624 has a length L2 and an overall width W2 when in the constricted position. The length L2 can be 9 mm to 21 mm, such as about 15 mm, such as 12 mm to 18 mm. The width W2 can be 3 mm to 12 mm, such as about 8 mm, such as 7 mm to 9 mm, such as 5 mm to 10 mm. The ratio of the overall width (not shown) of the paddle frame 624 in the expanded position to the overall width W2 can be 10 / 9 to 3 / 1, such as 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2. The ratio of the length (not shown) of the paddle frame 624 in the expanded position to the length L2 of the paddle frame 624 can be 10 / 9 to 3 / 1, such as 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2.

[0324] 93, the paddle frame 624 is shown in a compressed position within the delivery system 602. The delivery system 602 may take any suitable form, for example, the same as or similar to other delivery systems herein, such as 102, 202, 402, 502, etc., and may 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, etc. The configuration of the paddle frame 624 allows the paddle frame to more easily maintain a compressed position within the delivery system 602. That is, because the paddle frame 624 has a thickness T (FIG. 91) that is greater than its width W (FIG. 91), the paddle frame 624 may be more easily compressed because the paddle frame is less stiff in the direction of the width W than in the direction of the thickness T.

[0325] 96-98, 101, and 104, an embodiment of a paddle frame 724 for a device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or other suitable device) includes a main support section 785, a first connecting member 701 (e.g., a notch, a complementary surface, a connector, a fastener, etc.) for attachment to a cap of the device or implant, a second connecting member 703 for attachment to an anchor of the device, and a transition portion 771 extending between the first connecting member 701 and the main support section 785. The paddle frame 724 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as, for example, any of the means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0326] The connecting member 701 of the paddle frame 724 includes an extension portion 773 configured to extend into the cap of a device or implant to connect the paddle frame 724 to the cap. In this example, an outer surface 775 of the main support section 785, an outer surface 777 of the transition portion 771, and an outer surface 779 of the connecting member 701 are substantially aligned such that each of these outer surfaces faces in the same direction Z (FIG. 104).

[0327] With reference to Fig. 98, the paddle frame 724 is shown in a closed position relative to the coaptation element or spacer 710 of the device or implant. With reference to Figs. 101 and 104, the paddle frame is shown in an open position relative to the coaptation element 710. The coaptation element 710 can take any suitable form, such as, for example, any of the forms described in this application.

[0328] 99, 102, 105, an embodiment of a paddle frame 824 for a device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or other suitable device) includes a main support section 885, a first connecting member 801 (e.g., a notch, a complementary surface, a connector, a fastener, etc.) for attachment to a cap of the device or implant, a second connecting member (e.g., connecting member 603 shown in FIG. 91) for attachment to an anchor of the device, and a transition portion 871 extending between the first connecting member 801 and the main support section 885. The paddle frame 824 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as, for example, any of the means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0329] Connecting member 801 of paddle frame 824 includes an extension portion 873 configured to extend into the cap of a device or implant to connect paddle frame 824 to the cap. In this example, outer surface 879 of connecting member 801 is disposed at an angle of approximately 45 degrees from outer surface 875 of main support section 885 such that transition portion 871 is twisted about its axis.

[0330] The paddle frame can be shape set with the twist illustrated in Figures 99 and 102. In some implementations, the paddle frame can be shape set in the shape shown in Figures 96, 98, and 101, and the connecting members 801 can be twisted into the position illustrated in Figures 99 and 102 and held in the twisted orientation by attachment to the cap. In some implementations, the paddle frame 824 can be shape set with the connecting members 801 set in the position illustrated in Figures 99 and 102, but can be shape set in a twisted state back to the position illustrated in Figures 96, 98, and 101 by connection to the cap.

[0331] With reference to Fig. 99, the paddle frame 724 is shown in a closed position relative to the coaptation element or spacer 810 of the device or implant. With reference to Figs. 102 and 105, the paddle frame is shown in an open position relative to the coaptation element 810. The coaptation element 810 can take any suitable form, such as, for example, any of the forms described in this application.

[0332] The angle between the outer surface 879 of the connecting member 801 and the outer surface 875 of the main support section 885 (and the corresponding twisted transition portion 871) creates torque and stress in the material of the paddle frame 824 when the paddle frame is moved from the closed position to the open position. This torque and stress in the material of the paddle frame is due to the paddle frame being fixedly connected to both the inner and outer paddles (at the transitions between them) and to the cap of the device or implant. When the cap pulls on the outer paddle, the twist in the transition portion 871 propagates along the length of the paddle frame. As a result, the paddle frame 824 becomes narrower when the cap pulls on the paddle to the open position compared to a paddle frame that does not include the twisted translation portion 871. This additional reduction in the width of the paddle frame 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 heart's native structures, such as cords.

[0333] Although the illustrated example shows outer surface 879 disposed at an angle of approximately 45 degrees from outer surface 875, it will be understood that outer surface 879 may be disposed at any other suitable angle relative to outer surface 875 such that the paddle frame torques and moves to a more constricted position (compared to a paddle frame not having a twisted translation portion) when the paddle frame is moved from a closed position to an open position.

[0334] Generally, the greater the amount of twist, the greater the torque and stress that will be generated, resulting in greater constriction of the paddle. For example, in Figs. 100, 103, and 106, the embodiment of paddle frame 924 has a 90 degree twist. In the embodiment shown in Figs. 100, 103, and 106, the device or implant (e.g., device 200 shown in Figs. 22-37, device 600 shown in Fig. 94, or other suitable device) includes a main support section 985, a first connecting member 901 (e.g., a notch, a complementary surface, a connector, a fastener, etc.) for attachment to a cap of the device or implant, a second connecting member (e.g., connecting member 603 shown in Fig. 91) for attachment to an anchor of the device, and a transition portion 971 extending between the first connecting member 901 and the main support section 985. The paddle frame 924 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in Figures 91-95), or the width can be greater than the thickness.

[0335] The connecting member 901 of the paddle frame 924 includes an extension portion 973 configured to extend into the cap of a device or implant to connect the paddle frame 924 to the cap. In this example, an outer surface 979 of the connecting member 901 is disposed at an angle of approximately 90 degrees from an outer surface 975 of the main support section 985 such that the transition portion 971 is twisted about its axis.

[0336] The paddle frame can be shape set with the twist illustrated in Figs. 100 and 103. In some implementations, the paddle frame can be shape set in the shape shown in Figs. 96, 98, and 101, and the connecting members 901 can be twisted into the position illustrated in Figs. 100 and 103 and held in the twisted orientation by attachment to the cap. In some implementations, the paddle frame 924 can be shape set with the connecting members 901 set in the position illustrated in Figs. 100 and 103, but can be shape set twisted back to the position illustrated in Figs. 96, 98, and 101 by connection to the cap.

[0337] With reference to Fig. 100, the paddle frame 924 is shown in a closed position relative to the coaptation element or spacer 910 of the device or implant. With reference to Figs. 103 and 106, the paddle frame is shown in an open position relative to the coaptation element 910. The coaptation element 910 can take any suitable form, such as, for example, any of the forms described in this application.

[0338] The angle between the outer surface 979 of the connecting member 901 and the outer surface 975 of the main support section 985 (and the corresponding twisted transition portion 971) creates torque and stress in the material of the paddle frame 924 as the paddle frame is moved from the closed position to the open position. This torque and stress in the material of the paddle frame is due to the paddle frame being fixedly connected to both the inner and outer paddles (at the transitions between them) and to the cap of the device or implant. When the cap pulls on the outer paddle, the twist in the transition portion 971 propagates along the length of the paddle frame. As a result, the paddle frame 924 becomes narrower when the cap pulls on the paddle to the open position compared to a paddle frame that does not include the twisted translation portion 971. This additional reduction in the width of the paddle frame 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 heart's native structures, such as cords.

[0339] 107 and 108, an embodiment of a paddle frame 1024 for a device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or other suitable device) includes a main support section 1085, a first connection member 1001 (e.g., notch, complementary surface, connector, fastener, etc.) for attachment to a cap of the device or implant, and a second connection member 1003 for attachment to an anchor of the device. The paddle frame 1024 can be attached to the connection portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0340] The main support section 1085 includes an inner frame portion 1072 and an outer frame portion 1074. The inner frame portion 1072 is connected to connecting member 1001 at connection point 1076 and to connecting member 1003 at connection point 1078. The inner frame portion 1072 is configured to move the paddle frame 1024 from a normally expanded position (FIG. 107) when the anchors of the device or implant are in a closed position to a constricted position (FIG. 108) when the anchors of the device are moved to an open position. The outer frame portion 1074 is connected to the inner frame portion at connection point 1080 and defines an overall width of the paddle frame 1024 (e.g., expanded width EW shown in FIG. 107 and constricted width NW shown in FIG. 108).

[0341] In the illustrated example, the inner frame portion 1072 of the main support section 1085 is diamond shaped. Referring to FIG. 108, when the anchor of the device or implant is moved to the open position, the paddle frame 1024 is subjected to a tension force F due to the paddle frame 1024 being fixedly connected to the cap and to the transition between the inner and outer paddles of the device. This tension force F applied to the paddle frame 1024 moves the connection points 1076, 1078 in the outward direction OD, which moves the connection point 1080 in the inward direction ID. Moving the connection point 1080 in the inward direction ID moves the outer frame portion 1074 in the inward direction ID, which moves the overall width of the paddle frame 1024 from the expanded width EW (FIG. 107) to the narrowed width NW (FIG. 108). By moving the paddle frame 1024 to the constriction position, the device or implant can be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device and the heart's natural structures, such as cords.

[0342] The expansion width EW of the paddle frame 1024 can be 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, such as about 10 mm. The narrowing width NW of the paddle frame 1024 can be 3 mm to 12 mm, such as 7 mm to 9 mm, such as about 8 mm, such as 5 mm to 10 mm. The ratio of the expansion width EW to the narrowing width NW can be 10 / 9 to 3 / 1, such as 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2.

[0343] Although the illustrated example shows the inner frame portion 1072 of the main support section 1085 to be diamond shaped, it will be understood that the inner frame portion 1072 may take any form that can move the paddle frame 1024 to a constricted position when tension F is applied to the paddle frame 1024 so that the paddle frame can more easily maneuver a device or implant into position for implantation within the heart.

[0344] 109 and 110, an embodiment of a paddle frame 1124 for a device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or other suitable device) includes a main support section 1185, a first connection member 1101 (e.g., notch, complementary surface, connector, fastener, etc.) for attachment to a cap of the device or implant, and a second connection member 1103 for attachment to an anchor of the device. The paddle frame 1124 can be attached to the connection portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0345] The main support section 1185 includes an inner frame portion 1172 and an outer frame portion 1174. The inner frame portion 1172 is connected to the connecting member 1103 at a connection point 1178. The outer frame portion 1174 is connected to the inner frame portion 1172 at a connection point 1180, with the outer frame portion 1174 extending to the connecting member 1101. The outer frame portion 1174 defines the overall width of the paddle frame 1124 (e.g., an expanded width EW as shown in FIG. 109 and a narrowed width NW as shown in FIG. 110). The inner frame portion 1172 is configured to move the paddle frame 1124 from a normally expanded position ( FIG. 109 ) when the anchors of the device or implant are in a closed position to a narrowed position ( FIG. 110 ) when the anchors of the device are moved to an open position.

[0346] In the illustrated example, the inner frame portion 1172 of the main support section 1185 includes arms 1182 that extend inwardly from connection point 1180 and meet at connection point 1178 such that the inner frame portion 1172 has a triangular shape. Referring to FIG. 110, when the device or implant anchor is moved to the open position, the paddle frame 1124 is subjected to a tension force F due to the paddle frame 1124 being fixedly connected to the cap and to the transition portion between the inner and outer paddles of the device. This tension force F applied to the paddle frame 1124 moves the connection point 1178 and connecting member 1101 in an outward direction OD, which in turn moves the connection point 1080 in an inward direction ID. Moving connection point 1080 in the inward direction ID moves outer frame portion 1174 in the inward direction ID, which moves the overall width of paddle frame 1124 from an expanded width EW (FIG. 109) to a constricted width NW (FIG. 110). Moving the paddle frame 1124 to a 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 native structures of the heart, such as cords.

[0347] The expansion width EW of the paddle frame 1124 can be 5 mm to 15 mm, such as, for example, 7 mm to 12 mm, such as, for example, 9 mm to 11 mm, such as, for example, about 10 mm. The narrowing width NW of the paddle frame 1124 can be 3 mm to 12 mm, such as, for example, 7 mm to 9 mm, such as, for example, 5 mm to 10 mm, such as, for example, about 8 mm. The ratio of the expansion width EW to the narrowing width NW can be 10 / 9 to 3 / 1, such as, for example, 5 / 4 to 2 / 1, such as, for example, 4 / 3 to 3 / 2.

[0348] Although the illustrated example shows the inner frame portion 1172 of the main support section 1185 having arms 1182 extending inwardly from connection point 1180 and meeting each other at connection point 1178 such that the inner frame portion 1172 has a triangular shape, it will be understood that the inner frame portion 1072 may take any form that can move the paddle frame 1124 to a constricted position when tension F is applied to the paddle frame 1124 such that the paddle frame can more easily maneuver the device or implant into position for implantation within the heart.

[0349] In the illustrated example, the inner frame portion 1172 of the main support section 1185 includes arms 1182 that extend inwardly from a connection point 1180 and meet at a connection point 1178 such that the inner frame portion 1172 has a triangular shape. Referring to FIG. 110, when the anchor of the device or implant is moved to the open position, the paddle frame 1124 is subjected to a tension force F due to the paddle frame 1124 being fixedly connected to the cap and to the anchor of the device. This tension force F applied to the paddle frame 1124 moves the connection point 1178 and the connecting member 1101 in an outward direction OD, which moves the connection point 1180 in an inward direction ID. Moving the connection point 1180 in an inward direction ID moves the outer frame portion 1174 in an inward direction ID, which moves the overall width of the paddle frame 1124 from an expanded width EW (FIG. 109) to a narrowed width NW (FIG. 110). By moving the paddle frame 1124 to the constriction position, the device or implant can be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device and the heart's natural structures, such as cords.

[0350] Although the illustrated example shows the inner frame portion 1172 of the main support section 1185 having arms 1182 extending inwardly from connection point 1180 and meeting each other at connection point 1178 such that the inner frame portion 1172 has a triangular shape, it will be understood that the inner frame portion 1172 may take any form that can move the paddle frame 1124 to a constricted position when tension F is applied to the paddle frame 1124 such that the paddle frame can more easily maneuver the device or implant into position for implantation within the heart.

[0351] 111, an embodiment of a paddle frame 1224 for a device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or other suitable device) includes a main support section 1285, a first connecting member 1201 (e.g., notch, complementary surface, connector, fastener, etc.) for attachment to a cap of the device or implant, and a second connecting member 1203 (e.g., notch, complementary surface, connector, fastener, etc.) for attachment to an anchor of the device. The paddle frame 1224 can be attached to the connecting portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0352] The main support section 1285 includes an inner frame portion 1272 and an outer frame portion 1274. The inner frame portion 1272 is connected to the connecting member 1203 at a connection point 1278. The outer frame portion 1274 is connected to the inner frame portion 1272 at a connection point 1280, with the outer frame portion 1274 extending to the connecting member 1201. The outer frame portion 1274 defines an overall width TW of the paddle frame 1224. The inner frame portion 1272 is configured to move the paddle frame 1224 from a normally expanded position (FIG. 111) when the anchors of the device or implant are in a closed position to a constricted position when the anchors of the device are moved to an open position.

[0353] In the illustrated example, the inner frame portion 1272 of the main support section 1185 includes arms 1282 and round members 1284 (e.g., round metal pieces, round metal wires, etc.). The arms 1282 extend inwardly from connection points 1280, and the round members 1284 are connected to each of the arms 1282 and to connection points 1278. When the device or implant anchor is moved to the open position, the paddle frame 1224 is under tension (e.g., tension force F shown in FIGS. 108 and 110) due to the paddle frame 1224 being fixedly connected to the cap and to the device anchor. This tension force F on the paddle frame 1224 causes the connection points 1278 and the connection members 1201 (e.g., notches, complementary surfaces, connectors, fasteners, etc.) to move outwardly, which in turn causes the connection points 1280 to move inwardly. Moving the connection point 1280 inwardly moves the outer frame portion 1274 inwardly, thereby moving the overall width TW of the paddle frame 1224 to a narrowed position, thereby allowing 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 heart's native structures, such as cords.

[0354] The overall width TW of the paddle frame 1224 in the normal expanded position can be 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, such as about 10 mm. The constriction width of the paddle frame 1124 can be 3 mm to 12 mm, such as 7 mm to 9 mm, such as about 8 mm, such as 5 mm to 10 mm. The ratio of the overall width TW to the constriction width can be 10 / 9 to 3 / 1, such as 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2.

[0355] Although the illustrated example shows inner frame portion 1272 of main support section 1285 having arms 1282 extending inwardly from connection point 1280 and connected to round members 1284 connected to connection point 1278, it will be understood that inner frame portion 1272 may take any form that can move paddle frame 1224 to a constricted position when tension force F is applied to paddle frame 1224 so that the paddle frame can more easily maneuver a device or implant into position for implantation within the heart.

[0356] 112-114, an embodiment of a paddle frame 1324 for a device or implant (e.g., device 200 shown in FIGS. 22-37, device 600 shown in FIG. 94, or other suitable device) includes a main support section 1385, a first connection member 1301 (e.g., notch, complementary surface, connector, fastener, etc.) for attachment to a cap of the device or implant, and a second connection member 1303 (e.g., protrusion, notch, complementary surface, connector, fastener, etc.) for attachment to an anchor of the device. The paddle frame 1324 can be attached to the connection portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in FIGS. 91-95), or the width can be greater than the thickness.

[0357] The main support section 1385 includes an inner frame portion 1372 and an outer frame portion 1374. The inner frame portion 1372 is connected to the connecting member 1303 at a connection point 1378. The outer frame portion 1374 is connected to the inner frame portion 1372 at a connection point 1380, with the outer frame portion 1374 extending to the connecting member 1301. The outer frame portion 1374 defines an overall width TW of the paddle frame 1324. The inner frame portion 1372 is configured to move the paddle frame 1324 from a normally expanded position (FIGS. 112-114) when the anchors of the device or implant are in a closed position to a constricted position when the anchors of the device are moved to an open position.

[0358] In the illustrated example, inner frame portion 1372 of main support section 1385 includes arms 1382 and round member 1384. Arms 1382 extend inwardly from connection points 1380, and round member 1384 is connected to each of the arms 1382 and to connection points 1378. The configurations of paddle frame 1324 shown in Figures 112-114 are similar to each other, except that connection points 1380 between inner frame portion 1372 and outer frame portion 1374 of paddle frame 1324 are located at different locations from connecting member 1301 for each of these configurations. For example, the connection points 1380 for the paddle frame 1324 configuration shown in FIG. 112 are located farther from the connecting member 1301 compared to the paddle frame configuration shown in FIG. 113, and the connection points 1380 for the paddle frame 1324 configuration shown in FIG. 113 are located farther from the connecting member 1301 compared to the paddle frame configuration shown in FIG. 114. These different configurations cause the width Z between the connection points 1380 to be different for each configuration. For example, the width Z for the paddle 1324 configuration shown in FIG. 112 is larger compared to the width Z for the paddle 1324 configuration shown in FIG. 113, and the width Z for the paddle 1324 configuration shown in FIG. 113 is larger compared to the width Z for the paddle 1324 configuration shown in FIG. 114.

[0359] When the anchors of the device or implant are moved to the open position, the paddle frame 1324 is under tension (e.g., tension F shown in FIGS. 108 and 110) due to the paddle frame 1324 being fixedly connected to the cap and to the transition between the inner and outer paddles of the device. This tension F applied to the paddle frame 1324 moves the connection point 1378 and the connection member 1301 in an outward direction, which moves the connection point 1380 in an inward direction. Moving the connection point 1380 in an inward direction moves the outer frame portion 1374 in an inward direction, which moves the overall width TW of the paddle frame 1324 to a constricted position, which allows 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 native structures of the heart, such as cords.

[0360] The overall width TW of the paddle frame 1324 in the normal expanded position may be 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, such as about 10 mm. The constriction width of the paddle frame 1124 may be 3 mm to 12 mm, such as 7 mm to 9 mm, such as about 8 mm, such as 5 mm to 10 mm. The ratio of the overall width TW to the constriction width may be 10 / 9 to 3 / 1, such as 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2.

[0361] Although the illustrated example shows inner frame portion 1372 of main support section 1385 having arms 1382 extending inwardly from connection point 1380 and connected to round members 1384 connected to connection point 1378, it will be understood that inner frame portion 1372 may take any form that can move paddle frame 1324 to a constricted position when tension force F is applied to paddle frame 1324 so that the paddle frame can more easily maneuver a device or implant into position for implantation within the heart.

[0362] 115-116, a paddle frame 1424 of a device or implant (e.g., device 200 shown in Figs. 22-37, device 600 shown in Fig. 94, or any other suitable device) includes a main support section 1485, a first connection member 1401 (e.g., protrusions, notches, complementary surfaces, connectors, fasteners, etc.) for attachment to a cap of the device or implant, and a second connection member 1403 (e.g., protrusions, notches complementary surfaces, connectors, fasteners, etc.) for attachment to an anchor of the device. The paddle frame 1424 can be attached to the connection portion of the anchor and to the cap by any suitable means, such as any of the means described herein. The thickness and width of the paddle frame can take any suitable form, for example, the thickness can be substantially the same as the width, the thickness can be greater than the width (as shown in Figs. 91-95), or the width can be greater than the thickness.

[0363] The main support section 1485 includes an inner frame portion 1472 and an outer frame portion 1474. The inner frame portion 1472 of the main support section 1485 includes an arm 1482 extending inwardly from a connection point 1480 and connected to a connection point 1478. The outer frame portion 1474 is connected to the inner frame portion 1472 at the connection point 1480 and is connected to the connection point 1478 by a biasing member 1484 (e.g., a spring), which extends to the connecting member 1401 (e.g., a protrusion, notch, complementary surface, connector, fastener, etc.). The biasing member 1484 curves at least a portion of the outer frame portion 1474 such that the paddle has curved lateral edges 1486 (FIG. 16). The curved lateral edges 1486 can be configured to form against the outer shape of a spacer or abutment element in the device or implant (e.g., any of the abutment elements described herein). The biasing member 1484 can be, for example, a spring member or any other member that can cause the paddle frame 1474 to have curved lateral edges 1486.

[0364] The outer frame portion 1474 defines an overall width TW of the paddle frame 1424. The inner frame portion 1472 and the biasing member 1484 are configured to move the paddle frame 1424 from a normally expanded position (FIGS. 115-116) when the anchors of the device or implant are in a closed position to a constricted position when the anchors of the device are moved to an open position.

[0365] When the anchor of the device or implant is moved to the open position, the paddle frame 1424 is under tension (e.g., tension F shown in Figs. 108 and 110) due to the fixed connection of the paddle frame 1424 to the cap and to the transition between the inner and outer paddles of the device. This tension F applied to the paddle frame 1424 moves the connection point 1478 and the connection member 1401 in an outward direction, which moves the connection point 1480 in an inward direction. Moving the connection point 1380 in an inward direction moves the outer frame portion 1474 in an inward direction, which moves the overall width TW of the paddle frame 1424 to the narrowed position. Additionally, moving the connection point 1478 in an outward direction causes the biasing member 1484 to curve the curved lateral edge 1486 in a direction B (Fig. 116), which moves the overall width TW of the paddle frame 1424 to the narrowed position. By moving the paddle frame 1424 to the constriction position, the device or implant can be more easily maneuvered into position for implantation within the heart by reducing contact and / or friction between the device and the heart's natural structures, such as cords.

[0366] The overall width TW of the paddle frame 1424 in the normal expanded position can be 5 mm to 15 mm, such as 7 mm to 12 mm, such as 9 mm to 11 mm, such as about 10 mm. The constriction width of the paddle frame 1124 can be 3 mm to 12 mm, such as 7 mm to 9 mm, such as about 8 mm, such as 5 mm to 10 mm. The ratio of the expansion width TW to the constriction width can be 10 / 9 to 3 / 1, such as 5 / 4 to 2 / 1, such as 4 / 3 to 3 / 2.

[0367] In some implementations, the biasing member 1484 can passively allow the anchors of the device or implant to be more open when needed, and can also cooperate with the movement of the apex to assist in coaptation when the device or implant is attached against the natural apex of the heart.

[0368] Although the illustrated example shows inner frame portion 1472 of main support section 1485 having arms 1482 extending inwardly from connection point 1480 and connected to connection point 1478, it will be understood that inner frame portion 1472 may take any form that can move paddle frame 1424 to a constricted position when tension force F is applied to paddle frame 1424 so that the paddle frame can more easily maneuver a device or implant into position for implantation within the heart.

[0369] 117-121, an embodiment of a 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 native 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 frame portions that flex inwardly to reduce the width of the paddles when the flexible outer frame portions contact native heart structures, such as, for example, tethers.

[0370] When the paddle frame 1524 is in the stenosis position, friction between the heart's native structure and the device 1500 is reduced. The device 1500 may include any other features of devices or implants discussed in this application or in the applications and patent documents incorporated herein by reference, and the device 1500 may be positioned to engage valve tissues 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 features of the device 1500.

[0371] The device or implant 1500 includes a coaptation portion 1504 (e.g., a spacer, coaptation element, gap filler, etc.), a proximal or attachment portion 1505, an anchor portion 1506, and a distal portion 1507. The coaptation portion 1504, attachment portion 1505, and distal portion 1507 can take any suitable form, such as, for example, those for these portions of the device 200 shown in FIGS. 22-37, 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, for implantation between the cusps 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 woven wire.

[0372] The attachment portion 1505 includes a first or proximal collar 1511 for engaging a capture mechanism 1513 (FIG. 119) of a delivery system (e.g., delivery system 502 shown in FIGS. 86A, 87A, 88, and 89). The proximal collar 1511 can take any suitable form, such as, for example, any form described herein. The capture mechanism 1513 can take any suitable form, such as, for example, any form described herein.

[0373] 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 enable actuation of the device 1500 by moving the cap 1514...

Claims

1. 1. An actuation mechanism for an implantable device, comprising: an outer tube including a plurality of openings; a latch tube attached to the adjustable member, the latch tube including a latch member and a threaded opening; a drive member having a threaded portion threadably attachable to the threaded opening of the latch tube and a tapered distal end; when the threaded portion of the drive member is threaded into the threaded opening of the latch tube, the tapered distal end engages the latch member and holds the latch member in an unlatched condition so that the latch tube can be moved to a desired location within the outer tube; an actuation mechanism wherein the drive member is unscrewed from the threaded opening in the latch tube to disengage the tapered distal end from the latch member and facilitate movement of the latch member to a latched state in which the latch member engages one of the plurality of openings in the outer tube.

2. The actuation mechanism of claim 1 , wherein the latch member is laser cut from the latch tube.

3. The actuation mechanism of claim 1 or 2, wherein the latch member is biased toward the latched state.

4. The actuation mechanism of claim 1 or 2, wherein the latch tube further includes an orientation tab extending through an orientation slot in the outer tube to prevent relative rotation of the latch tube and the outer tube.

5. An actuation mechanism according to claim 1; a deployment system comprising a handle; A system comprising: The system wherein the handle includes a mechanism for facilitating disengagement and removal of an actuation member of the actuation mechanism from an implantable device and a deployment system.

6. The system of claim 5, wherein the mechanism that facilitates disengagement and removal of the actuating member of the actuating mechanism from the implantable device and deployment system is a handle release assembly.

7. The actuating element extends from a distal end for engaging the implantable device to a proximal end secured to an actuating element adapter; The system of claim 6 , wherein the actuation member of the actuation mechanism extends within the actuation element from the tapered distal end to a proximal end, the proximal end being secured to a width adjustment element adapter.

8. The system described in claim 7, wherein the handle release assembly comprises a connector body having a central lumen through which the actuating element and the actuating member extend.

9. The connector body is a coupling portion including one, some, or all of the retention grooves; an inner body including a mounting member for engaging the coupling portion and the retention groove of the connector body, a recess for receiving the actuation element adapter, a catch, and a side slot; an outer body having a proximal stop, a latch arm having a protrusion that engages a catch on the inner body to inhibit relative movement between the outer body and the inner body, and a side slot; The system of claim 8 , comprising:

10. The width adjustment element adapter extends through the side slot of the inner body and the side slot of the outer body; a gripping portion slidably attached to the outer body; The system of claim 9 , wherein sliding the grip portion proximally exposes the latch arm on the outer body, allowing the latch arm to disengage from a catch on the inner body.

11. The system described in claim 10, wherein after the latch arm is disengaged, further proximal force is applied to the gripping portion to move the outer body proximally, causing the side slot to engage with the width adjustment element adapter and move the actuating member proximally.

12. The system described in claim 11, wherein further proximal movement of the gripping portion and the outer body exposes the mounting member of the inner body, the width adjustment element adapter engages with the side slot of the inner body, the mounting member disengages from the retaining groove of the coupling portion of the connector body, and the actuating element is pulled in the proximal direction.

13. The connector body is a coupling portion including one, some, or all of the retention grooves; a movable body including a mounting member for engaging the coupling portion and the retention groove of the connector body, a recess for receiving the actuation element adapter, and a side slot; The system of claim 8 , comprising:

14. The width adjustment element adapter extends through a side slot of the inner body and a side slot of the outer body; The system of claim 9 , wherein the grip portion is slidably attached to the outer body.

15. The system described in claim 14, wherein the handle release assembly is configured to engage with the width adjustment element adapter by sliding the gripping portion proximally to move the actuating member proximally.

Images