Delivery Devices for Heart Valve Repair and Replacement Devices - Patent application

Abstract

A delivery system and method for delivering a device or implant (100, 200, 300, 402, 604, 8200, 9100) is disclosed. The device or implant may be configured as a valve repair or treatment device having gripping members that can be opened and closed to attach the device to the leaflets of a native heart valve. The delivery system is configured to position the device or implant and open and close the gripping members of the device or implant.

Description

[Background technology]

[0001] Related patent applications This application claims priority to U.S. Provisional Application No. 63 / 267,184, filed January 26, 2022, U.S. Provisional Application No. 63 / 352,635, filed June 15, 2022, and U.S. Provisional Application No. 63 / 399,041, filed August 18, 2022, which are incorporated herein by reference.

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

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

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

[0005] 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 conditions 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 leaflets can be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one of the commissures of the leaflets (i.e., where the leaflets meet) can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle, and therefore the valve does not close and regurgitation is present. Tricuspid regurgitation can be similar, except on the right side of the heart. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Pat. No. 8,449,599 [Patent Document 2] US Patent Application Publication No. 2014 / 0222136 [Patent Document 3] US Patent Application Publication No. 2014 / 0067052 [Patent Document 4] US Patent Application Publication No. 2016 / 0331523 [Patent Document 5] International Publication No. 2020 / 076898 Brochure [Patent Document 6] International Publication No. 2018 / 195215 Brochure [Patent Document 7] International Publication No. 2019 / 139904 Brochure [Patent Document 8] U.S. Pat. No. 10,653,862 [Patent Document 9] U.S. Pat. No. 10,646,342 [Patent Document 10] U.S. Provisional Patent Application No. 63 / 181,120 [Patent Document 11] U.S. Pat. No. 10,820,998 [Patent Document 12] International Publication No. 2020 / 112622 Brochure Summary of the Invention

[0007] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any features included in the examples of this summary are not required by the claims unless the claims explicitly recite those features. Also, features, components, steps, concepts, etc. described in the examples of this summary and elsewhere in this disclosure can be combined in various ways. Various features and steps described in relevant parts of this disclosure can be included in the examples summarized herein.

[0008] The present disclosure discloses components for a delivery system for a valve repair or replacement device. These components, while not required, can make the delivery system easier to use, more ergonomic, more intuitive, and more precise than conventional delivery systems. One or more of these components can be used in existing delivery systems. Any combination or subcombination of the disclosed components can be used together, but it is not a requirement that any component disclosed in this application be used with any other component disclosed in this application.

[0009] In some implementations, a device, such as a valve repair device, has anchors that are openable and closable to attach the device to the leaflets of a native heart valve. The anchors have an adjustable width. A delivery system is configured to position the device, open and close the anchors of the device, and adjust the width of the anchors of the device.

[0010] In some implementations, a handle assembly for controlling a transvascular device (e.g., an implantable device, a therapeutic device, a repair device, etc.) includes a handle housing, a sheath, an actuation element, a paddle actuation knob (or the like, e.g., a button, a switch, etc.), a paddle width adjustment element, and a paddle width control knob (or the like, e.g., a button, a switch, etc.). The sheath extends distally from the handle housing. The actuation element extends through the sheath and is configured to be coupled to the device. The paddle actuation knob is coupled to the actuation element. In some implementations, the paddle actuation knob is rotatable relative to the handle housing. Actuation of the paddle actuation knob (e.g., rotating, pushing, sliding, etc.) causes the actuation element to move (e.g., one or more of axial movement, rotational movement, translational movement, etc.) relative to the handle housing and the sheath. In some implementations, movement of the actuation element causes the device to move between a closed position and an open position.

[0011] In some implementations, the paddle width adjustment element extends through the actuation element. The paddle width adjustment element can be configured to be coupled to at least one of the pair of paddles of the device. A paddle width control knob is coupled to the paddle width adjustment element and is rotatable relative to the handle housing. In some implementations, actuation of the paddle width control knob (e.g., rotating, pressing, sliding, etc.) causes the paddle width adjustment element to move (e.g., one or more of axial movement, rotational movement, translational movement, etc.) relative to the handle housing and sheath. In some implementations, movement of the paddle width adjustment element causes the width of at least one of the pair of paddles of the device to move from a first width to a second width.

[0012] In some implementations, the paddle actuation knob is axially positioned between the handle housing and the paddle width control knob.

[0013] In some implementations, the distal end of the paddle actuation knob includes external threads configured to engage with the internal threads of the handle housing.

[0014] In some implementations, rotation of the paddle width control knob axially drives a frame that is attached to the actuation element. The paddle width control knob can be rotatable relative to the frame.

[0015] In some implementations, rotation of the paddle width control knob drives the paddle width control knob and paddle width adjustment element axially relative to the paddle actuation knob and actuation element.

[0016] In some implementations, a pair of clasp actuation lines extend through the sheath and are connected to a pair of clasp control members, each of which is movable relative to the handle housing to move the clasp between an open configuration and a closed configuration.

[0017] In some implementations, each clasp actuation line is coupled to a suture lock extending from the proximal end of the handle housing.

[0018] In some implementations, each suture lock is angled relative to a central axis extending through the handle assembly.

[0019] In some implementations, the paddle width control knob is coupled to the planetary gearbox, and rotation of the paddle width control knob is effective to cause rotation of the planetary gearbox.

[0020] In some implementations, the planetary gearbox comprises at least a ring gear, a pair of planetary gears, and an elongated central gear.

[0021] In some implementations, the elongated central gear is coupled to the paddle width adjustment element through a rotationally fixed follower such that rotation of the elongated central gear causes the rotationally fixed follower to move axially, which in turn causes the paddle width adjustment element to move axially relative to the housing.

[0022] In some implementations, the external teeth of the elongated central gear engage with the teeth of a pair of planetary gears.

[0023] In some implementations, the delivery system includes a steerable catheter assembly and a device catheter assembly (e.g., an implant catheter assembly, a control catheter assembly, a device control catheter assembly, etc.). The steerable catheter assembly has a handle and a sheath extending from the handle. The device catheter assembly has a handle and a sheath coaxially extendable through the sheath of the steerable catheter assembly. In some implementations, the handle of the device catheter assembly includes a handle housing, a sheath, an actuation element, a paddle actuation knob (or the like, e.g., a button, a switch, etc.), a paddle width adjustment element, and a paddle width control knob (or the like, e.g., a button, a switch, etc.). The sheath extends distally from the handle housing. The actuation element extends through the sheath and is configured to be coupled to a device (e.g., a treatment device, a repair device, an implant, an implantable device, a valve repair device, etc.).

[0024] In some implementations, a paddle actuation knob (or the like, e.g., a button, switch, etc.) is coupled (e.g., operably coupled) to the actuation element. In some implementations, the paddle actuation knob is rotatable relative to the handle housing. Actuation of the paddle actuation knob (e.g., rotating, pressing, sliding, etc.) causes the actuation element to move (e.g., one or more of axial movement, rotational movement, translational movement, etc.) relative to the handle housing and sheath. Movement of the actuation element causes the device to move between the open and closed positions. A paddle width adjustment element extends through the actuation element. The paddle width adjustment element is configured to be coupled to at least one of a pair of paddles of the device.

[0025] In some implementations, a paddle width control knob (or the like, e.g., a button, switch, etc.) is coupled (e.g., operably coupled) to the paddle width adjustment element. In some implementations, the paddle width control knob is rotatable relative to the handle housing. When the paddle width control knob is actuated (e.g., rotated, pressed, slid, etc.), the paddle width adjustment element moves (e.g., one or more of axial movement, rotational movement, translational movement, etc.) relative to the handle housing and sheath. When the paddle width adjustment element moves, the width of at least one of the pair of paddles of the device is moved from a first width to a second width.

[0026] In some implementations, the paddle actuation knob is axially positioned between the handle housing and the paddle width control knob.

[0027] In some implementations, the distal end of the paddle actuation knob includes external threads configured to engage with the internal threads of the handle housing.

[0028] In some implementations, rotation of the paddle width control knob axially drives a frame that is attached to the actuation element. The paddle width control knob can be rotatable relative to the frame.

[0029] In some implementations, rotation of the paddle width control knob drives the paddle width control knob and paddle width adjustment element axially relative to the paddle actuation knob and actuation element.

[0030] In some implementations, a pair of clasp actuation lines extend through the sheath and are connected to a pair of clasp control members, each of which is movable (e.g., one or more of axially movable, rotationally movable, etc.) relative to the handle housing to move a clasp between an open configuration and a closed configuration.

[0031] In some implementations, each clasp actuation line is coupled to a suture lock extending from the proximal end of the handle housing.

[0032] In some implementations, each suture lock is angled relative to a central axis extending through the handle assembly.

[0033] In some implementations, the paddle width control knob is coupled to the planetary gearbox, and rotation of the paddle width control knob is effective to cause rotation of the planetary gearbox.

[0034] In some implementations, the planetary gearbox comprises at least a ring gear, a pair of planetary gears, and an elongated central gear.

[0035] In some implementations, the elongated central gear is coupled to the paddle width adjustment element through a rotationally fixed follower such that rotation of the elongated central gear causes the rotationally fixed follower to move axially, which in turn causes the paddle width adjustment element to move axially relative to the housing.

[0036] In some implementations, the external teeth of the elongated central gear engage with the teeth of a pair of planetary gears.

[0037] In some implementations, the method includes delivering a device (e.g., a therapeutic device, a repair device, an implant, an implantable device, a valve repair device, etc.). In some implementations, the device is coupled to an actuation element, a paddle width adjustment element, and a sheath. The sheath is advanced to position the device at a delivery site. In some implementations, a paddle actuation knob (or the like, e.g., a button, a switch, etc.) is actuated (e.g., rotated, pressed, slid, etc.) to move an actuation element (e.g., one or more of an axial movement, a rotational movement, a translational movement, etc.) to move the device from a closed configuration to an open configuration. In some implementations, a paddle width control knob (or the like, e.g., a button, a switch, etc.) is actuated (e.g., rotated, pressed, slid, etc.) to move a paddle width adjustment element (e.g., one or more of an axial movement, a rotational movement, a translational movement, etc.) to adjust the width of the paddles of the device.

[0038] In some implementations, the paddle actuation knob is rotated to axially move the actuation element and move the device from an open configuration to a closed configuration.

[0039] As part of the method, the device may be decoupled from the actuation element, the paddle width adjustment element, and the sheath.

[0040] In some implementations, the paddle actuation knob is rotated to move the device from a fully extended configuration to an open configuration, and the paddle actuation knob is further rotated in the same direction to move the device from the open configuration to a closed configuration.

[0041] In some implementations, the paddle width adjustment element is coupled to at least one of the pair of paddles through an inner end, Axial movement of the paddle width adjustment element causes the inner end to move axially relative to the working portion of the device, and Axial movement of the inner end causes at least one of the pair of paddles to move relative to the working portion of the device effective to move a width of at least one of the pair of paddles from a first width to a second width.

[0042] In some implementations, rotating the paddle actuation knob is effective to move the paddle actuation knob and the paddle width control knob axially relative to the housing of the handle.

[0043] In some implementations, rotating the paddle width control knob causes the paddle width control knob and the paddle width adjustment element to move axially relative to a frame coupled to the paddle actuation knob.

[0044] In some implementations, the paddle width adjustment element is rotationally fixed during rotation of the paddle width control knob and the actuation element is rotationally fixed during rotation of the paddle actuation knob.

[0045] In some implementations, the devices are decoupled by pulling the adjustment through the actuation element and pulling the actuation element through the sheath.

[0046] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, a cadaver heart, an anthropomorphic phantom, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0047] In some implementations, a handle assembly for controlling a transvascular device (e.g., a treatment device, a repair device, an implant, an implantable device, a valve repair device, etc.) includes a handle housing, a sheath extending distally from the handle housing, an actuation element extending through the sheath and configured to be coupled to the device, and a paddle actuation control operably coupled to the actuation element. In some implementations, the handle assembly also includes a paddle width adjustment element extending through the actuation element and configured to be coupled to at least one of a pair of paddles of the device, and a paddle width control operably coupled to the paddle width adjustment element. In some implementations, the handle assembly also includes a release control operably coupled to the paddle width adjustment element.

[0048] In some implementations, the handle assembly is configured such that actuation of the paddle actuation control causes the actuation element to move axially relative to the handle housing and sheath Axial movement of the actuation element moves the device between the open and closed positions.

[0049] In some implementations, the handle assembly is configured such that actuation of the paddle width control causes the paddle width adjustment element to move axially relative to the handle housing and the sheath such that axial movement of the paddle width adjustment element moves the width of at least one of the pair of paddles of the device from a first width to a second width.

[0050] In some implementations, the handle assembly is configured such that actuation of the release control causes the paddle width adjustment element and the actuation element to move axially to uncouple the device from the sheath. Actuation of the paddle actuation control causes the release control to move axially.

[0051] In some implementations, a delivery system (e.g., a delivery system for an implantable device, a delivery system for a repair device, a delivery system for a therapeutic device, etc.) includes a steerable catheter assembly having a handle and a sheath extending axially from the handle, and a device catheter assembly (e.g., an implant catheter assembly, a control catheter assembly, a device control catheter assembly, etc.) having a handle and a sheath coaxially extendable through the sheath of the steerable catheter assembly. The handle of the device catheter assembly includes a handle housing, a sheath extending distally from the handle housing, an actuation element extending through the sheath and configured to be coupled to a device (e.g., a therapeutic device, a repair device, an implant, an implantable device, a valve repair device, etc.), and a paddle actuation control operably coupled to the actuation element. In some implementations, the delivery system also includes a paddle width adjustment element extending through the actuation element and configured to be coupled to at least one of a pair of paddles of the device, and a paddle width control operably coupled to the paddle width adjustment element. In some implementations, the delivery system also includes a release control operably coupled to the paddle width adjustment element.

[0052] In some implementations, the delivery system is configured such that actuation of the paddle actuation control causes an actuation element to move (e.g., one or more of axial movement, rotational movement, translational movement, etc.) relative to the handle housing and sheath. Movement of the actuation element moves the device between an open position and a closed position.

[0053] In some implementations, the delivery system is configured such that actuation of the paddle width control causes a paddle width adjustment element to move relative to the handle housing and the sheath such that movement of the paddle width adjustment element moves the width of at least one of the pair of paddles of the device from a first width to a second width.

[0054] In some implementations, the delivery system is configured such that actuation of the release control can move the paddle width adjustment element and the actuation element to uncouple the device from the sheath.

[0055] In some implementations, the delivery system is configured such that actuation of the paddle actuation control causes the release control to move axially.

[0056] In some implementations, delivering and / or using a device (e.g., a therapeutic device, a repair device, an implant, an implantable device, a valve repair device, etc.) includes obtaining the device coupled to an actuation element and a paddle width adjustment element extending from a distal end of a sheath of a catheter assembly (e.g., a device catheter assembly, an implant catheter assembly, a steerable catheter assembly, a control catheter assembly, a device control catheter assembly, etc.), advancing the sheath of the catheter assembly to position the device at a delivery site in an open configuration, actuating a paddle actuation control on the handle, thereby moving the actuation element to move the device from the open configuration to a closed configuration, actuating a paddle width control on the handle, thereby moving the paddle width adjustment element to move a width of at least one of the pair of paddles from a first width to a second width, and actuating a release control on the handle, thereby moving and actuating the paddle width adjustment element and the actuation element to uncouple the device from the sheath. In some implementations, actuation of the paddle actuation control causes the release control and the paddle width adjustment element to move axially.

[0057] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, a cadaver heart, an anthropomorphic phantom, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0058] In some implementations, a delivery system for a device (e.g., an implantable device, a repair device, a therapeutic device, etc.) has a handle and a sheath extending axially from the handle, the sheath having a distal end portion with a capture mechanism for attaching the sheath to the device (e.g., a valve repair device, including an implant, an implantable device, etc.) having a plurality of clasps for securing native leaflets of a heart valve. The delivery system includes a first clasp actuation line configured to move a first clasp of the plurality of clasps between a closed position and an open position, the first clasp actuation line extending from the handle, through the sheath, and through a first opening in the first clasp. A first distal end of the first clasp actuation line is attached to the capture mechanism when the capture mechanism is in the coupled position.

[0059] In some implementations, a method of using a device, such as, for example, a valve repair device, on a patient's heart valve includes closing a first clasp of the device to grasp a first leaflet of the heart valve by releasing tension on a first clasp actuation line, closing a second clasp of the device to grasp a second leaflet of the heart valve by releasing tension on a second clasp actuation line, and releasing the device from the capture mechanism and withdrawing the capture mechanism from the device. Releasing the device from the capture mechanism and withdrawing the capture mechanism from the device releases the first clasp actuation line from the first clasp and the capture mechanism, and releases the second clasp actuation line from both the second clasp and the capture mechanism.

[0060] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, a cadaver heart, an anthropomorphic phantom, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0061] In some implementations, a handle assembly for controlling a transvascular device having a plurality of clasps for securing native leaflets of a heart valve includes a handle housing, a sheath extending distally from the handle housing, a first clasp actuation line extending through the sheath and operably coupled to a first clasp of a plurality of clasps on the device, and a first clasp control member operably connected to the first clasp actuation line, the first clasp control member being movable relative to the housing between a first position associated with the first clasp in an open position and a second position associated with the clasp in a closed position, the first clasp control member being biased to the second position.

[0062] In some implementations, a method of using a device or implant, such as a valve repair device, having multiple clasps for securing the native leaflets of a heart valve includes delivering the device to the heart valve via a catheter assembly (e.g., a device catheter assembly, an implant catheter assembly, a steerable catheter assembly, a control catheter assembly, a device control catheter assembly, etc.) having a first clasp actuation line that holds a first clasp of the device in an open position and a second clasp actuation line that holds a second clasp of the device in an open position, closing a first clasp of the device to grasp a first leaflet of the heart valve by releasing tension on the first clasp actuation line, and closing a second clasp of the device to grasp a second leaflet of the heart valve by releasing tension on the second clasp actuation line. Releasing tension in the first clasp actuation line includes biasing the first clasp control member from the first position to the second position, and releasing tension in the second clasp actuation line includes biasing the second clasp control member from the third position to the fourth position.

[0063] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, a cadaver heart, an anthropomorphic phantom, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0064] In some implementations, a clasp actuation line for actuating a clasp of a device, such as a valve repair device, includes a braided body having a proximal end and a distal end opposite the proximal end, and a closed loop is formed at the distal end. In some implementations, the closed loop is formed by a bifurcated braided portion of the braided body. In some implementations, a distal end of the braided body extends axially through a portion of the braided body proximal to the closed loop to form a tucked portion. In some implementations, a distal end portion of the braided body extends laterally through a portion of the braided body proximal to the closed loop to form a threaded portion. In some implementations, a distal end portion of the braided body extends axially through a portion of the braided body proximal to the closed loop to form a tucked portion proximal to the threaded portion.

[0065] In some implementations, a method of forming a clasp actuation line for actuating a clasp of a device includes braiding an elongate body and forming a closed loop at a distal end of the elongate body. In some implementations, braiding the elongate body includes braiding a bifurcated portion to form the closed loop. In some implementations, braiding the elongate body further includes braiding a plurality of bifurcated portions separated by integral portions, and cutting the elongate body into sections having a single bifurcated portion adjacent a distal end of the section. In some implementations, forming the closed loop includes extending a distal end of the braided body axially through a portion of the braided body to form a tucked portion proximal to the closed loop. In some implementations, forming the closed loop includes extending a distal end portion of the braided body laterally through a portion of the braided body to form a threaded portion proximal to the closed loop.

[0066] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, a cadaver heart, an anthropomorphic phantom, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0067] In some implementations, a handle assembly (which may be the same as or similar to other handle assemblies described herein) for controlling a device (which may be the same as or similar to other devices described herein) is provided, the handle assembly comprising a handle housing, a sheath extending distally from the handle housing, and an actuation element (which may be the same as or similar to other actuation elements described herein) extending through at least a portion of the sheath, the actuation element being configured to be coupled to the device. In some implementations, the handle assembly also includes a width adjustment element (which may be the same as or similar to other width adjustment elements described herein) extending through at least a portion of the sheath, the width adjustment element being configured to be coupled to at least one of a pair of anchors (which may be the same as or similar to other anchors, paddles, clasps, etc. described herein) of the device. In some implementations, the handle assembly also includes an actuation control (which may be the same as or similar to other actuation controls described herein) coupled to the actuation element, where actuation of the actuation control moves the actuation element relative to the handle housing and / or sheath, and movement of the actuation element may move the device between an open configuration and a closed configuration.

[0068] In some implementations, the handle assembly further includes a width control (which may be the same as or similar to other width controls, such as the paddle width control described herein) coupled to the width adjustment element, such that actuation of the width control causes the width adjustment element to move relative to the handle housing and / or sheath, and movement of the width adjustment element may cause at least one of the pair of anchors of the device to transition between a first width and a second width.

[0069] In some implementations, the handle assembly further comprises one or more clasp actuation lines (which may be the same as or similar to other actuation lines described herein) extending through the sheath, the one or more clasp actuation lines being configured to be coupled to the device.

[0070] In some implementations, the handle assembly further comprises one or more clasp control members (which may be the same as or similar to other clasp control members described herein) that are movable relative to the handle housing, and movement of the one or more clasp control members causes one or more clasps of the device to move between an open configuration and a closed configuration.

[0071] In some implementations, the one or more clasp actuation lines are coupled to a suture lock extending from the proximal end of the handle housing.

[0072] In some implementations, the one or more clasp actuation lines include a braided body having a proximal end and a distal end opposite the proximal end, and a closed loop is formed at the distal end. In some implementations, the closed loop is formed by a bifurcated braided portion of the braided body. In some implementations, a distal end of the braided body extends axially through a portion of the braided body proximal to the closed loop to form a pushed portion. In some implementations, a distal end portion of the braided body extends laterally through a portion of the braided body proximal to the closed loop to form a threaded portion. In some implementations, a distal end portion of the braided body extends axially through a portion of the braided body proximal to the closed loop to form a pushed portion proximal to the threaded portion.

[0073] In some implementations, each suture lock is angled relative to a central axis extending through the handle assembly.

[0074] In some implementations, the width control is coupled to a planetary gearbox, and actuation of the width control is effective to cause rotation of the planetary gearbox. In some implementations, the planetary gearbox comprises at least a ring gear, a pair of planetary gears, and an elongated central gear. In some implementations, the elongated central gear is coupled to the width adjustment element through a rotationally fixed follower such that rotation of the elongated central gear causes the rotationally fixed follower to move axially, which in turn causes the width adjustment element to move axially relative to the housing. In some implementations, external teeth of the elongated central gear engage with teeth of the pair of planetary gears.

[0075] In some implementations, a handle assembly (which may be the same as or similar to other handle assemblies described herein) for controlling a transvascular device (e.g., a treatment device, a repair device, an implant, an implantable device, a valve repair device, etc.) includes a handle housing, a sheath, a first clasp actuation element, a first clasp control member, and a first biasing element. The sheath extends distally from the handle housing. The first clasp actuation element extends through the sheath and is operably coupled to a first clasp of a plurality of clasps on the device.

[0076] In some implementations, the first clasp control member is operably connected to the first clasp actuation element and is movable relative to the housing between a first position associated with the first clasp in an open position and a second position associated with the first clasp in a closed position.

[0077] In some implementations, the first biasing element is configured to apply a force to pull the first catch toward the open position.

[0078] The handle assembly may be part of a catheter assembly (e.g., a device catheter assembly, an implant catheter assembly, a steerable catheter assembly, a control catheter assembly, a device control catheter assembly, etc.) of a delivery system for the device. The delivery system may include a sheath extending axially from the handle assembly. The sheath may include a distal end portion that includes a capture mechanism for removably attaching the sheath to the device.

[0079] In some implementations, the first biasing element can apply a force to the first clasp actuation element. When the first biasing element applies the force, it can directly contact the first clasp actuation element. The force can be directed radially outward from a centerline of the handle housing.

[0080] In some implementations, when the first clasp control member is in the second position, no force is applied to pull the first clasp toward the open position.

[0081] In some implementations, the first biasing element can have an elongate body having a proximal end fixed relative to the handle housing and a free distal end. The elongate body can have a semi-elliptical shape. The elongate body can have an opening extending laterally through the elongate body, and the first clasp actuation element can extend through the opening. In some implementations, the opening can be positioned closer to the distal end than the proximal end.

[0082] In some implementations, the first clasp actuation element is a suture.

[0083] In some implementations, the first biasing element has a wide position in which a force is applied to pull the first clasp toward the open position and a narrow position in which no force is applied to pull the first clasp toward the open position. The first biasing element can be biased to the wide position. In some implementations, the first clasp control member holds the first biasing element in the narrow position when the first clasp control member is in the second position. In some implementations, the first clasp control member releases the first biasing element to the wide position when the first clasp control member is in the first position.

[0084] In some implementations, the first biasing element is positioned in series with the first clasp actuation element.

[0085] In some implementations, the first biasing element includes a resilient portion of the first clasp actuation element. The resilient portion may extend along the entire length of the first clasp actuation element or may extend along a partial length of the first clasp actuation element. The resilient portion of the first clasp actuation element may be positioned inside the handle housing.

[0086] In some implementations, the first biasing element does not exert a force to pull the first clasp toward the open position when the first clasp control member is in the second position.

[0087] In some implementations, the first clasp control member is axially movable relative to the housing between a first position and a second position.

[0088] In some implementations, the handle assembly includes a second clasp actuation element, a second clasp control member, and a second biasing element. The second clasp actuation element can extend through the sheath and can be operably coupled to a second clasp of a plurality of clasps on the device.

[0089] In some implementations, the second clasp control member may be operably connected to the second clasp actuation element and may be movable relative to the housing between a third position associated with the second clasp in an open position and a fourth position associated with the second clasp in a closed position.

[0090] The second biasing element may be configured to apply a second force to pull the second catch toward the open position.

[0091] In some implementations, the second biasing element is configured to apply the second force independent of the first biasing element.

[0092] In some implementations, a method of using a device, e.g., a valve repair device, having one or more clasps for securing the native leaflets of a heart valve includes delivering the device to the heart valve via a catheter assembly (e.g., a device catheter assembly, an implant catheter assembly, a steerable catheter assembly, a control catheter assembly, a device control catheter assembly, etc.), holding a first clasp of the device in an open position with a first clasp actuation element, and closing the first clasp of the device to grasp a first leaflet of the heart valve.

[0093] In some implementations, the first clasp control member is moved to a first position to hold a first clasp of the device in an open position and is moved to a second position to close the first clasp.

[0094] Holding the first clasp of the device in an open position may include applying a force to the first clasp actuation element after the first clasp control member is in the first position.

[0095] In some implementations, applying a force to the first clasp actuation element includes applying a force to the first clasp actuation element. The force may be directed radially outward from a centerline of the handle housing.

[0096] In some implementations, the first clasp actuation element is a suture.

[0097] In some implementations, applying a force to the first clasp actuation element after the first clasp control member is in the first position includes moving the biasing element to a wide position. Moving the biasing element to the wide position can include moving the first clasp control member to the first position.

[0098] In some implementations, moving the first clasp control member to the second position includes moving the biasing element to a narrow position. Moving the biasing element to the narrow position can include engaging the biasing element with the first clasp control member. In some implementations, the biasing element is held in the narrow position by the first clasp control member.

[0099] In some implementations, moving the first clasp control member to the second position includes axially moving the first clasp control member.

[0100] In some implementations, applying a force to the first clasp actuation element includes stretching a resilient portion of the first clasp actuation element.

[0101] In some implementations, the method includes holding a second clasp of the device in an open position with a second clasp actuation element, and closing the second clasp of the device to grasp a second leaflet of the heart valve.

[0102] In some implementations, the second clasp control member is moved to a third position to hold the second clasp of the device in an open position and moved to a fourth position to close the first clasp. Holding the second clasp of the device in an open position can include applying a second force to the second clasp actuation element after the second clasp control member is in the third position.

[0103] In some implementations, the first force is applied independently of the second force.

[0104] In some implementations, a clasp actuation line for actuating a clasp of a device via a clasp control member includes a braid having a first end configured to operably couple to the clasp control member and a second end opposite the first end, The braid can have a first portion having a first elasticity and a second portion having a second elasticity greater than the first elasticity.

[0105] In some implementations, a first portion of the braid has a first number of picks per inch and a second portion of the braid has a second number of picks per inch that is greater than the first number of picks per inch. Both the first and second portions may be formed from an ultra-high molecular weight polyethylene material.

[0106] In some implementations, the second portion can extend most of the total length of the clasp actuation line, hi some implementations, the second portion is adjacent the first end and extends less than half of the total length of the clasp actuation line.

[0107] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, a cadaver heart, an anthropomorphic phantom, a simulator, etc.). In a simulation, the body part may optionally be referred to as a "simulation" (e.g., a simulated heart, a simulated tissue, etc.) and may include, for example, a computerized and / or physical representation.

[0108] Any of the above systems, assemblies, devices, equipment, components, etc. may be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for patient use, and the above methods may include (or the additional methods may include or consist of) sterilization (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, equipment, components, etc. described herein.

[0109] 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:

[0110] To further clarify various aspects of the implementation of the present disclosure, certain embodiments and implementations will be described in more detail by referring to various aspects of the accompanying drawings. These drawings show only exemplary implementations of the present disclosure and therefore should not be considered as limiting the scope of the present disclosure. Moreover, while the drawings may be drawn to scale for some embodiments, the drawings are not necessarily drawn to scale for all embodiments. The embodiments and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0111] [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 leaflets when viewed from the atrial side of the mitral valve. [Figure 7] FIG. 7 shows the tricuspid valve as viewed from the atrial side of the tricuspid valve. [Figure 8] FIG. 8 shows one embodiment of a device or implant at various stages of deployment. [Figure 9] FIG. 9 shows one embodiment of a device or implant at various stages of deployment. [Figure 10] FIG. 10 shows one embodiment of a device or implant at various stages of deployment. [Figure 11] FIG. 11 shows one embodiment of a device or implant at various stages of deployment. [Figure 12] FIG. 12 shows one embodiment of a device or implant at various stages of deployment. [Figure 13] FIG. 13 shows one embodiment of a device or implant at various stages of deployment. [Figure 14] FIG. 14 shows one embodiment of a device or implant at various stages of deployment. [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] FIG. 16 shows the exemplary device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 17] FIG. 17 shows the exemplary device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 18] FIG. 18 shows the exemplary device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 19] FIG. 19 shows the exemplary device or implant of FIGS. 8-14 delivered and implanted within the native valve. [Figure 20] FIG. 20 shows the exemplary device or implant of FIGS. 8-14 delivered and implanted within a native valve. [Figure 21] FIG. 21 shows the exemplary device or implant of FIGS. 8-14 delivered and implanted within the native valve. [Figure 22] FIG. 22 shows a perspective view of an exemplary 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 top perspective view of the device or implant of FIG. 22 in the open position. [Figure 27] FIG. 27 shows a bottom perspective view of the device or implant of FIG. 22 in the open position. [Figure 28] FIG. 28 shows a clasp for use in a device or implant. [Figure 29] FIG. 29 shows a portion of native valve tissue grasped by a clasp. [Diagram 30] FIG. 30 shows a side view of an exemplary device or implant in a partially open position, with the clasp in the closed position. [Diagram 31] FIG. 31 shows a side view of an exemplary device or implant in a partially open position, with the clasp 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 semi-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 clasp in the open position. [Diagram 36] FIG. 36 shows 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 shows a side view of an exemplary device in a fully open or fully evacuation position, with the clasp in the open position. [Figure 38] FIG. 38 shows the exemplary device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 39] FIG. 39 shows the exemplary device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 40]FIG. 40 shows the exemplary device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 41] FIG. 41 shows the exemplary device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 42] FIG. 42 shows the exemplary device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 43] FIG. 43 shows the exemplary device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 44] FIG. 44 shows the exemplary device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Diagram 45] FIG. 45 shows the exemplary device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 46] FIG. 46 shows the exemplary device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 47] FIG. 47 shows the exemplary device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 48] FIG. 48 shows the exemplary device or implant of FIGS. 30-38, including a covering, delivered and implanted within a native valve. [Figure 49] FIG. 49 shows the exemplary device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 50] FIG. 50 is a schematic diagram showing the path of the native valve leaflets along each side of a coaptation element or spacer of an exemplary device or implant. [Figure 51] FIG. 51 is a top schematic view showing the path of the leaflets of a native valve around a coaptation element or spacer of an exemplary device or implant. [Figure 52]FIG. 52 shows a coaptation element or spacer within the native valve gap as viewed from the atrial side of the native valve. [Figure 53] FIG. 53 shows a device or implant attached to the native valve leaflets by coaptation elements or spacers 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 device or implant attached to the native valve leaflets by coaptation elements or spacers within the native valve gap when viewed from the ventricular side of the native valve. [Figure 55] FIG. 55 shows a perspective view of an exemplary device or implant in a closed position. [Figure 56] FIG. 56 illustrates a perspective view of an exemplary clasp of an exemplary device or implant in a closed position. [Figure 57] FIG. 57 shows the device with the paddles in the open position. [Figure 58] FIG. 58 shows the apparatus of FIG. 57 with the paddle in an open position and the gripping member moved to create a wider gap between the gripping member and the paddle. [Figure 59] FIG. 59 shows the device of FIG. 57 in the position shown in FIG. 57 with the valve tissue disposed between the grasping members and the paddles. [Figure 60] FIG. 60 shows the apparatus of FIG. 57 with the gripping member moved to reduce the gap between the gripping member and the paddle. [Figure 61] 61A and 61B show the paddle of the device of FIG. 57 moving from an open position to a closed position. [Figure 62] FIG. 62 shows the device of FIG. 57 in a closed position with the gripping members engaging the valve tissue. [Figure 63] FIG. 63 shows the device of FIG. 57 after being detached from the delivery device and attached to valve tissue, with the device in a closed and locked state. [Figure 64] FIG. 64 shows the distal end of an exemplary delivery assembly including a delivery device and an apparatus. [Figure 65] FIG. 65 shows the proximal end of the exemplary delivery assembly of FIG. [Figure 66] FIG. 66 shows an exemplary catheter assembly for use in a delivery assembly coupled to the device. [Figure 67] FIG. 67 shows a perspective view of one embodiment of a device having a paddle with adjustable width, illustrating some aesthetic features. [Figure 68] FIG. 68 is a cross-section of the device of FIG. 67 where the device is bisected, showing some aesthetic features. [Figure 69] FIG. 69 is another cross-section of the device of FIG. 67 where the device is bisected along a plane perpendicular to the plane shown in FIG. 68, illustrating some aesthetic features. [Figure 70] FIG. 70 is a schematic diagram of an exemplary catheter assembly coupled to a device, where an actuating element such as a tube is coupled to a paddle actuation control and driver head of the device, showing some aesthetic features. [Figure 71] FIG. 71 is a view of the assembly of FIG. 70 with the device rotated 90 degrees to show a paddle width adjustment element coupled to the inner end of the device and coupled to the paddle width control, illustrating some aesthetic features. [Figure 72] FIG. 72 illustrates an exemplary catheter assembly that may be used in conjunction with the handles of the various implementations described herein, showing some aesthetic features. [Figure 73] FIG. 73 is a perspective view of an exemplary handle of a catheter assembly showing some aesthetic features. [Figure 74] FIG. 74 is an enlarged portion of FIG. 73, showing some aesthetic features. [Figure 75] FIG. 75 is a cross-section of a portion of the handle of FIG. 73 showing some aesthetic features. [Figure 76] FIG. 76 is a schematic diagram of an exemplary catheter assembly coupled to a device, where each of the clasp actuation lines is coupled to a clasp control member positioned on the handle, and the actuation element is coupled to a knob positioned on the handle, showing some aesthetic features. [Figure 77] FIG. 77 is a perspective view of an exemplary handle of a catheter assembly showing some aesthetic features. [Figure 78]FIG. 78 is a cross section of the handle of FIG. 77 perpendicular to the plane defined by line AA, with one of the clasp control tubes bisected to show some aesthetic features. [Figure 79] FIG. 79 is another cross-section of the handle of FIG. 77 perpendicular to the plane defined by line BB, with the release knob bisected to show some aesthetic features. [Figure 80] FIG. 80 is an enlarged portion of FIG. 79, showing some aesthetic features. [Figure 81] FIG. 81 is another cross-section of the handle of FIG. 77 perpendicular to the plane defined by line CC, with the release knob and suture lock bisected to show some aesthetic features. [Figure 82] FIG. 82 is another perspective view of the handle of FIG. 77, where the housing includes a pair of detents for locking the clasp control member in place and shows some aesthetic features. [Figure 83] FIG. 83 is a perspective view of an exemplary proximal end of a handle with the release knob in a distal position, illustrating some aesthetic features. [Figure 84] FIG. 84 is a perspective view of an exemplary proximal end of a handle with the release knob in a proximal position and showing some aesthetic features. [Figure 85] FIG. 85 is a cutaway perspective view of a handle including an exemplary release knob with a ratchet mechanism, illustrating some aesthetic features. [Figure 86] FIG. 86 is a perspective view of the release knob of FIG. 85 with a ratchet mechanism, showing some aesthetic features. [Figure 87] FIG. 87 is a cross-sectional view of the release knob of FIGS. 85 and 86 perpendicular to the plane defined by line DD, with the pawl shown in cross-section to show some aesthetic features. [Figure 88] FIG. 88 is a cross-sectional view of an exemplary suture lock, where the clasp actuation line is secured to a post at one end and coupled to the device, and then extends between the suture lock body and a suture lock body receptacle at a second end. [Figure 89]FIG. 89 is a perspective view of an exemplary handle including a paddle width control knob and a cap over the suture lock, showing some aesthetic features. [Figure 90] FIG. 90 is an enlarged view of a portion of the handle of FIG. 89 without the cap, showing some aesthetic features. [Figure 91] FIG. 91 is a perspective view of an elongated central gear of a planetary gearbox coupled to a follower for use in one or more implementations shown and described herein, showing some aesthetic features. [Figure 92] FIG. 92 is another view of an elongated central gear and follower for use in one or more of the implementations shown and described herein, illustrating some aesthetic features. [Figure 93] FIG. 93 is a perspective view of the follower extending from the proximal end of the handle, showing some aesthetic features. [Figure 94] FIG. 94 is a perspective view of the frame that rotationally fixes the follower to the handle, showing some aesthetic features. [Figure 95] FIG. 95 is a perspective view of an elongated central gear extending from the proximal end of the handle, showing some of its aesthetic features. [Figure 96] FIG. 96 is a perspective view of a carrier and planetary gear of a planetary gear box for use in one or more implementations shown and described herein, showing some aesthetic features. [Figure 97] FIG. 97 is a perspective view of the planetary gearbox positioned within the handle, showing some of the aesthetic features. [Figure 98] FIG. 98 is an end view showing the planetary gearbox in the handle, illustrating some of the aesthetic features. [Figure 99] FIG. 99 is a perspective view of the handle including the housing without the cap, showing some of the aesthetic features. [Figure 100] FIG. 100 is a perspective view of an exemplary handle of a catheter assembly, showing some aesthetic features. [Figure 101] FIG. 101 is a partial cross-sectional view of the handle of FIG. 100 showing some aesthetic features. [Figure 102] FIG. 102 is a partial cross-sectional view of the handle of FIG. 100 showing some aesthetic features. [Figure 103] FIG. 103 is a partial cross-sectional view of a portion of the handle of FIG. 100 showing the clasp control member and illustrating some aesthetic features. [Figure 104] FIG. 104 is a cross-sectional view of a portion of the handle of FIG. 103 showing some aesthetic features. [Figure 105] FIG. 105 is a cross-sectional view of a portion of the handle of FIG. 103 showing some aesthetic features. [Fig. 106] FIG. 106 is a cross-sectional view of a portion of the handle of FIG. 100 showing the handle when the exemplary device is in an extended or fully open position, illustrating some aesthetic features. [Figure 107] FIG. 107 is a perspective view of an exemplary device in an extended or fully open state, illustrating some of the aesthetic features. [Figure 108] FIG. 108 is a cross-sectional view of a portion of the handle of FIG. 100 showing the handle as the device transitions from a fully open to a fully closed position, illustrating some aesthetic features. [Figure 109] FIG. 109 is a perspective view of the device in a partially open position, showing some of the aesthetic features. [Figure 110] FIG. 110 is a perspective view of the device in a fully closed state, showing some of the aesthetic features. [Figure 111] FIG. 111 is a cross-sectional view of a portion of the handle of FIG. 100 showing the handle when the paddles of the device are in an extended position, illustrating some aesthetic features. [Figure 112] FIG. 112 is a perspective view of the device with the paddles in an extended position, illustrating some of the aesthetic features. [Figure 113] FIG. 113 is a cross-sectional view of a portion of the handle of FIG. 100 showing the handle when the paddles of the device are in a constricted position, illustrating some aesthetic features. [Fig. 114] FIG. 114 is a perspective view of the device with the paddles in the constricted position, showing some of the aesthetic features. [Fig. 115]FIG. 115 is a cross-sectional view of a portion of the handle of FIG. 100 showing the implant release knob and illustrating some aesthetic features. [Fig. 116] FIG. 116 is a cross-sectional view of the handle portion of FIG. 115 showing the rotational movement of the release knob and illustrating some aesthetic features. [Figure 117] FIG. 117 is a cross-sectional view of the handle portion of FIG. 115 showing axial movement of the release knob and illustrating some aesthetic features. [Fig. 118] FIG. 118 is a perspective view of the device in an extended position showing one embodiment of the capture mechanism and routing of the clasp control member, and illustrating some aesthetic features. [Figure 119] FIG. 119 is a side view of an exemplary clasp actuation line showing some aesthetic features. [Figure 120] FIG. 120 is a schematic diagram of the device mounted on a delivery system showing the routing of the clasp actuation lines and illustrating some aesthetic features. [Figure 121] FIG. 121 is a schematic diagram of FIG. 120 with the device decoupled from the delivery system, showing some aesthetic features. [Figure 122] FIG. 122 is a schematic diagram of the device attached to a delivery system showing various stages of release of the device and illustrating some aesthetic features. [Figure 123] FIG. 123 is a schematic diagram of the device attached to a delivery system showing various stages of release of the device and illustrating some aesthetic features. [Figure 124] FIG. 124 is a schematic diagram of the device attached to a delivery system showing various stages of release of the device and illustrating some aesthetic features. [Fig. 125] FIG. 125 is a perspective view of one embodiment of a capture mechanism at various stages of release of the device, illustrating some aesthetic features. [Fig. 126] FIG. 126 is a perspective view of one embodiment of a capture mechanism at various stages of release of the device, illustrating some aesthetic features. [Figure 127] FIG. 127 is a perspective view of one embodiment of a capture mechanism at various stages of release of the device, illustrating some aesthetic features. [Figure 128] FIG. 128 is a side view of one embodiment of a clasp actuation line. [Figure 129] FIG. 129 is a side view of one embodiment of a clasp actuation line. [Fig. 130] FIG. 130 is a side view of one embodiment of a clasp actuation line. [Fig. 131] FIG. 131 is a side view of one embodiment of a clasp actuation line. [Fig. 132] FIG. 132 is a side view of one embodiment of a clasp actuation line. [Fig. 133] FIG. 133 is a side view of one embodiment of a clasp actuation line. [Fig. 134] FIG. 134 is a side view of one embodiment of a clasp actuation line. [Fig. 135] FIG. 135 is a side view of one embodiment of a clasp actuation line. [Fig. 136] FIG. 136 is a side view of one embodiment of a clasp actuation line. [Fig. 137] FIG. 137 is a side view of one embodiment of a clasp actuation line. [Figure 138] FIG. 138 is a schematic diagram of the device attached to a delivery system. [Fig. 139] FIG. 139 illustrates an embodiment of a device or implant shown in a partially open, ready to grasp state, with the clasps in a fully open position. [Fig. 140] FIG. 140 shows the device or implant of FIG. 139 with the clasps in a suspended position. [Fig. 141] FIG. 141 illustrates an embodiment of the device or implant shown in an extended state, with the clasps in a fully open position. [Fig. 142] FIG. 142 shows the device or implant of FIG. 141 with the clasps in a hanging position. [Fig. 143] FIG. 143 is a schematic diagram of an exemplary catheter assembly coupled to a device in which each of the clasp actuation lines is coupled to a clasp control member that is biased to eliminate clasp sagging. [Fig. 144]FIG. 144 is a schematic diagram of an exemplary catheter assembly coupled to a device, where each of the clasp actuation lines includes an elastic portion. [Fig. 145] FIG. 145 illustrates an exemplary clasp actuation portion of a catheter assembly apparatus with an exemplary clasp control member in a first position. [Fig. 146] FIG. 146 illustrates an exemplary clasp actuation portion of a catheter assembly apparatus with an exemplary clasp control member in a second position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0112] 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.

[0113] Exemplary implementations of the present disclosure are directed to systems, devices, methods, etc., for repairing defective heart valves. For example, various implementations of therapeutic devices, repair devices, valve repair devices, implantable devices, implants, and systems (including systems for delivering them) are disclosed herein, and any combination of these options may be implemented unless specifically excluded. In other words, individual components of the disclosed devices and systems may be combined unless mutually exclusive or physically impossible. Furthermore, the techniques and methods herein may be implemented on live animals or may be implemented on simulations, such as cadavers, cadaver hearts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0114] 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 reference to specific embodiments, the terms "gripping member" and / or "gripper arm" may be substituted and function in the same or similar manner, even if not configured in the same manner as a typical clasp.

[0115] 1 and 2 are cross-sectional views of a human heart H during diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, i.e., atrioventricular valves, respectively. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible leaflets (e.g., leaflets 20, 22 shown in Figs. 3-6 and leaflets 30, 32, 34 shown in Fig. 7) that extend inward across their respective openings, which come together or "coapt" in flow to form a unidirectional fluid occlusion surface. The native valve repair system of the present application is frequently described and / or illustrated with respect to the mitral valve MV. Accordingly, the anatomy of the left atrium LA and the left ventricle LV will be described in more detail. However, the devices described herein may also be used in the repair of other native valves, for example, the devices may be used in the repair of the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0116] The left atrium LA receives oxygen-rich blood from the lungs. During the expansion phase, or diastole, seen in FIG. 1, blood already collected in the left atrium LA (during the contraction phase) moves through the mitral valve MV to the left ventricle LV due to the expansion of the left ventricle LV. During the contraction phase, or systole, seen in FIG. 2, the left ventricle LV contracts to pump blood through the aortic valve AV and the ascending aorta AA into the body. During systole, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV into the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In some implementations, the device described in this application is used to restore the function of a defective mitral valve MV. That is, the device is configured to assist in the closing of the leaflets of the mitral valve to prevent, inhibit, or reduce blood from flowing back from the left ventricle LV into the left atrium LA. Many of the devices described in this application are designed to easily grasp and secure the native valve leaflets around a coaptation element or spacer that beneficially acts as a filler within the regurgitant opening to prevent or reduce backflow or reflux during systole, although this is not required.

[0117] Now, referring to Figures 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24 (see Figure 5), which is a variably dense fibrous ring of tissue that surrounds the leaflets 20, 22. Referring to Figures 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are chord-like tendons that connect the papillary muscles PM (i.e., muscles located in the wall of the left ventricle LV at the base of the chordae tendineae CT) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM function to limit the movement of the leaflets 20, 22 of the mitral valve MV and to prevent the mitral valve MV from everting. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Rather, the papillary muscles PM support or brace the leaflets 20, 22 against the high pressure required to circulate blood through the body. Together, the papillary muscles PM and chordae tendineae CT are known as the subvalvular apparatus, which function to keep the mitral valve MV from prolapsing into the left atrium LA when the mitral valve closes. As can be seen from the left ventricular outflow tract (LVOT) diagram shown in FIG. 3, the anatomy of the leaflets 20, 22 is such that the inner surfaces of the leaflets coapt at their free end portions and the leaflets 20, 22 begin to retract or spread apart from each other. The leaflets 20, 22 spread apart toward the atrium until each leaflet contacts the mitral valve annulus.

[0118] 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 heart 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.

[0119] In general, native valves can malfunction in different ways, including (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when a native valve does not open completely, thereby causing impaired blood flow. Typically, valve stenosis is due to the accumulation of calcified material on the leaflets of the valve, which thickens the leaflets and impairs the ability of the valve to open completely and allow forward blood flow. Valve regurgitation occurs when the leaflets of the valve do not close completely, causing blood to leak back into the previous heart chamber (e.g., blood leaks from the left ventricle into the left atrium).

[0120] There are three main mechanisms by which native valves become regurgitant or incompetent, including Carpentier's Type I, II, and III insufficiencies. Carpentier's Type I insufficiency involves dilatation of the valve annulus, so that normally functioning leaflets move apart and fail to form a tight seal (i.e., the leaflets do not coapt properly). Included in the insufficiency of the Type I mechanism is leaflet perforation, as occurs in endocarditis. Carpentier's Type II insufficiency involves prolapse of one or more leaflets of the native valve above the plane of coaptation. Carpentier's Type III insufficiency involves restricted movement of one or more leaflets of the native valve, so that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease or ventricular dilatation.

[0121] With reference to FIG. 5, when a healthy mitral valve MV is in a closed position, the anterior leaflet 20 and the posterior leaflet 22 are coapted, thereby preventing leakage of blood from the left ventricle LV to the left atrium LA. With reference to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV are displaced into the left atrium LA during systole, so that the edges of the leaflets 20, 22 do not contact each other. Such malcoaptation creates a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to flow regurgitantly from the left ventricle LV to the left atrium LA during systole, as shown by the mitral regurgitation MR flow path in FIG. 3. With reference to FIG. 6, the gap 26 may have a width W of about 2.5 mm to about 17.5 mm, about 5 mm to about 15 mm, about 7.5 mm to about 12.5 mm, or about 10 mm. In some circumstances, the gap 26 may have a width W of greater than 15 mm or even greater than 17.5 mm. As discussed above, there are several different ways in which a valve leaflet (e.g., the leaflets 20, 22 of the mitral valve MV) may become incompetent, causing valve regurgitation.

[0122] In any of the above-mentioned situations, a device (e.g., an implant, non-implantable device, therapeutic device, repair device, valve repair device, etc.) that can engage the anterior leaflets 20 and posterior leaflets 22 and close the gap 26 to prevent or inhibit the backflow of blood through the mitral valve MV is desirable. As can be seen from Figure 4, an abstract representation of a valve repair device, repair device, implantable device, or implant 10 is shown implanted between the leaflets 20, 22 such that backflow does not occur during systole (compare Figure 3 with Figure 4).

[0123] In some implementations, the coaptation elements (e.g., spacers, coaptation elements, gap fillers, membranes, sheets, plugs, wedges, balloons, etc.) of device 10 have a generally tapered or triangular shape that naturally matches the shape of the native valve and its propensity to expand (towards the annulus). In this application, terms such as spacer, coaption element, coaptation element, and gap filler are used interchangeably to refer to elements that fill a portion of the space between the native leaflets and / or are configured to engage or "coapt" the native leaflets (e.g., such that the native leaflets coapt not only to each other but also to the coaptation element, e.g., spacer, coaption element, gap filler, etc.).

[0124] 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 extremely 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.

[0125] Dysfunctional native heart valves may 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. Because the stenotic damage sustained by the valve leaflets is irreversible, treatment of a stenotic aortic valve or pulmonary valve may involve removal of the valve and replacing it with a surgically implanted heart valve, or may involve replacing the valve 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 to the atrium (e.g., deformation of the mitral valve MV may allow regurgitation or backflow from the left ventricle LV to 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 evert, resulting in blood flowing back into the left atrium LA. Problems caused by incompetent chordae tendineae CT can be ameliorated by repairing the structure of the chordae tendineae CT or the mitral valve MV (e.g., by fixing the leaflets 20, 22 at the affected portion of the mitral valve).

[0126] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it will be understood that the devices and concepts provided herein can be used to repair any native valve, as well as to repair any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or inhibit backflow of blood from the left ventricle to 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 inhibit backflow of blood from the right ventricle to the right atrium. In addition, any of the devices and concepts provided herein can be used on all three of the leaflets 30, 32, 34 together to prevent or inhibit backflow of blood from the right ventricle to the right atrium. That is, the valve repair device, treatment device, or other device and implant provided herein can be centrally located between the three leaflets 30, 32, 34.

[0127] An exemplary device or implant may optionally include an interface element (e.g., a spacer, interface element, gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, a device or implant may have any combination or subcombination of the features disclosed herein without an interface element.

[0128] When included, the coaptation element (e.g., coaptation element, spacer, etc.) may be configured to be positioned within the native heart valve orifice to help fill the space between the leaflets and form a more effective seal, thereby reducing or preventing or inhibiting the above-mentioned backflow. The coaptation element may be impermeable to blood (or resist blood flow therethrough) and may have a structure that allows the native leaflets to close around the coaptation element during ventricular systole, thereby blocking backflow of blood from the left or right ventricle into the left or right atrium, respectively. The device or implant may be configured to seal against two or three native leaflets, i.e., the device may be used with native mitral (bicuspid) and tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because the coaptation element may fill the space between dysfunctional native leaflets (e.g., mitral leaflets 20, 22 or tricuspid leaflets 30, 32, 34) that do not close completely.

[0129] The optional coaptation elements (spacers, coaptation elements, gap fillers, etc.) may have a variety of shapes. In some implementations, the coaptation elements may have an elongated cylindrical shape with a circular cross-sectional shape. In some implementations, the coaptation elements may have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or a variety of other non-cylindrical shapes. In some implementations, the coaptation elements may have an atrial portion positioned in or adjacent to the atrium, a ventricular or lower portion positioned in or adjacent to the ventricle, and a lateral surface extending between the native leaflets. In some implementations configured for use with a tricuspid valve, the atrial or upper portion is positioned in or adjacent to the right atrium, the ventricular or lower portion is positioned in or adjacent to the right ventricle, and the lateral surface extends between the native tricuspid leaflets.

[0130] In some implementations, the anchors can be configured to secure the device to one or both of the native leaflets such that the coaptation element is positioned between two native leaflets. In some implementations configured for use with a tricuspid valve, the anchors are configured to secure the device to one, two, or three of the tricuspid leaflets such that the coaptation element is positioned between three native leaflets. In some implementations, the anchors can be attached to the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some implementations, the anchors can be attached to an 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 can 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., an actuating shaft, actuating rod, actuating tube, actuating wire, etc.). In some implementations, the anchors and coaptation elements can be simultaneously positioned by moving the anchors and coaptation elements together along a longitudinal axis of the actuating element (e.g., a shaft, actuating wire, etc.). The anchors may be configured to be positioned behind the native leaflets when implanted such that the leaflets are grasped by the anchors.

[0131] 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, a device / 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 radially expanded away from the initially still compressed coaptation element to create a gap between the coaptation element and the anchor. The native leaflet may then be positioned within the gap. The coaptation element may be radially expanded to close the gap between the coaptation element and the anchor to capture the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to self-expand. The implantation methods for various implementations may vary and are described more fully below for each implementation. Additional information regarding these and other delivery methods can be found in U.S. Patent No. 8,449,599, U.S. Patent Application Publication No. 2014 / 0222136, U.S. Patent Application Publication No. 2014 / 0067052, U.S. Patent Application Publication No. 2016 / 0331523, and PCT Patent Application Publication No. WO2020 / 076898, which are incorporated by reference in their entirety for all purposes. These methods can be performed, mutatis mutandis, on 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.

[0132] The disclosed device or implant may be configured such that anchors are connected to the leaflets and utilize tension from the natural chordae tendineae to resist high systolic pressures that urge the device toward the left atrium. During diastole, the device may rely on compressive and retaining forces exerted on the leaflets that are gripped by the anchors.

[0133] 8-15, a schematic representation of a device or implant 100 (e.g., an implantable prosthetic device, a prosthetic spacer device, a valve repair device, an implantable device, etc.) is shown in various stages of deployment. The device or implant 100, as well as other similar devices / implants, are described in more detail in PCT Patent Application Publication Nos. WO2018 / 195215, WO2020 / 076898, and WO2019 / 139904, which are incorporated by reference in their entireties. The device 100 may include any other features of another device or implant described in this application or the applications cited above, and the device 100 may be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application or the applications cited above).

[0134] The device or implant 100 is deployed from a delivery system 102. The delivery system 102 may include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, a device / implant catheter, a tube, a channel, a passageway, combinations thereof, etc. The device or implant 100 includes an interface portion / region 104 and an anchor portion / region 106.

[0135] In some implementations, the interface portion 104 of the device or implant 100 is adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and includes an interface element 110 (e.g., a spacer, plug, filler, foam, sheet, membrane, interface element, etc.) that is 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 actuating element 112 (as well as other actuating means and elements disclosed herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, threads, sutures, lines, strips, combinations thereof, etc.), can be made from a variety of different materials, and can have a variety of configurations. As one example, the actuating element can be threaded such that when the actuating element is rotated, the anchor portion 106 moves relative to the interface portion 104. Alternatively, the actuating element can be unthreaded such that pushing or pulling the actuating element 112 moves the anchor portion 106 relative to the interface portion 104.

[0136] The anchor portion 106 and / or anchor of the device 100, in some implementations, includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the interface element 110 by portions 124, 126, 128. The portions 124, 126, 128 may be interfaced and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 120, inner paddle 122, interface element 110, and cap 114 by portions 124, 126, 128 may constrain the device to the positions and movements shown herein.

[0137] In some implementations, the delivery system 102 includes a steerable catheter, a device / implant catheter, and an actuating element 112 (e.g., an actuating wire, an actuating shaft, etc.), which may be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuating element 112 extends through the delivery catheter and the interface element 110 to a distal end (e.g., a cap 114 or other attachment portion at the distal connection of the anchor portion 106). Extending and retracting the actuating element 112 increases and decreases the spacing between the interface element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion), respectively. In some implementations, a collar or other attachment element (e.g., a clamp, clip, lock, suture, friction fit, buckle, snap fit, lasso, etc.) removably attaches, either directly or indirectly, the interface element 110 to the delivery system 102 such that the actuation element 112 slides through the collar or other attachment 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.

[0138] 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 integrally formed with fixed arm 132 and movable arm 134. Fixed arm 132 is attached to inner paddle 122 and remains stationary or substantially stationary relative to inner paddle 122 when movable arm 134 is in an open state, opening clasp 130 and exposing optional barbs, friction enhancing elements, or anchoring structures 136.

[0139] 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 a steerable catheter and / or a device / implant catheter). Other actuation mechanisms are also possible.

[0140] The actuation line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The clasp 130 can be spring loaded so that the clasp 130 continues to provide a clamping force to the grasped native leaflet in the closed position. Optional barbs, friction enhancing elements, or fixation structures 136 of the clasp 130 can grab, pinch, and / or pierce the native leaflet to further secure it.

[0141] During implantation, the paddles 120, 122 may be opened and closed, for example, to grip the native leaflets (e.g., leaflets of a native mitral valve, etc.) between the paddles 120, 122 and / or between the paddles 120, 122 and the coaptation element 110 (e.g., spacer, plug, membrane, gap filler, etc.). The clasps 130 may be used to grip and / or further secure the native leaflets by engaging the leaflets with optional barbs, friction enhancing elements or fixation structures 136 and clamping the leaflets between the movable arm 134 and the fixation 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 may increase friction with the leaflets or partially or completely puncture the leaflets. The actuation lines 116 may be actuated separately such that each clasp 130 may be opened and closed separately. By operating separately, one leaflet can be grasped at a time, or the clasp 130 can 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.

[0142] 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 apart from the interface element 110 such that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the interior of the outer paddle 120 and the inner paddle 122 is about 180 degrees. The clasp 130 can be kept closed during deployment 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.

[0143] 9, device 100 is shown in an extended state similar to 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 disentanglement or detachment from patient anatomical structures, such as chordae tendineae CT, during implantation of device 100.

[0144] 10, the device 100 is shown in a contracted or fully closed state. To move the device 100 from the extended state to the contracted state, the actuation element 112 is retracted to pull 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, so that the compressive force acting on the outer paddle 120 from the cap 114 retracted towards the interface element 110 moves the paddle or gripping element radially outward. The outer paddle 120 maintains an acute angle with the actuation element 112 during movement from the open position to the closed position. The outer paddle 120 can optionally be biased towards the closed position. The inner paddle 122 moves over a very large angle and crushes along the side of the closed interface element 110 because it is oriented away from the open interface element 110 during the same movement.

[0145] 11-13, the device 100 is shown in a partially open, ready-to-grasp state. To move from a fully closed state to a partially open state, an actuation element (e.g., actuation wire, actuation shaft, etc.) is extended to push the cap 114 away from the coaptation element 110, 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, so that the leaflets can be grasped. In some implementations, the pair of inner and outer paddles 122 and 120 are moved together, rather than independently, by a single actuation element 112. Also, the position of the clasp 130 depends on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 closes the clasp. In some implementations, the paddles 120, 122 can be independently controllable. In the embodiment shown in FIG. 15, the device 100 may have two actuating elements 111, 113 and two independent caps 115, 117 (or other mounting parts), such that one independent actuating element (e.g., a wire, shaft, etc.) and cap (or other mounting part) is used to control one paddle and the other independent actuating element and cap (or other mounting part) is used to control the other paddle.

[0146] 12, one of the actuation lines 116 may be extended to close one of the clasps 130. Now, referring to FIG. 13, the other actuation line 116 may be extended to close the other clasp 130. One or both of the actuation lines 116 may be repeatedly actuated to repeatedly open and close the clasps 130.

[0147] 14, the device 100 is shown in a fully closed and deployed state. The delivery system 102 and actuation element 112 are retracted and the paddles 120, 122 and clasp 130 remain in a fully closed position. Once deployed, the device 100 may be maintained in the fully closed position by a mechanical latch or may be biased to remain closed by the use of a spring material such as steel, other metals, plastics, composites, or a shape memory alloy such as Nitinol. For example, the connecting portions 124, 126, 128, the interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from a metal such as steel or from a shape memory alloy such as Nitinol that is fabricated into a wire, sheet, tube, or laser sintered powder and biased to hold the outer paddle 120 closed around the interface element 110 and the clasp 130 in a clamped state around the native leaflets. Similarly, the fixed and movable arms 132, 134 of the clasp 130 are biased to clamp the valve leaflets. In some implementations, the attachment or connecting portions 124, 126, 128, the interface portion 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) may be formed from metal or any other suitable resilient material, such as a polymeric material, to maintain the device 100 in a closed state after implantation.

[0148] 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 100 illustrated in Figure 11, except that the device 101 in 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 paddles 122 and outer paddles 120 are moved together, rather than independently, by a single actuation element 112.

[0149] 16-21, the device 100 of Figures 8-14 is shown 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.

[0150] As can be seen from Figure 18, the implant / device is moved into a position within the mitral valve MV and into the ventricle LV in a partially open state so as to grasp the leaflets 20, 22. For example, a steerable catheter can be advanced and steered or bent to position the steerable catheter 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.

[0151] 19, the implant / device may be stored in a steerable catheter and the mitral valve leaflets 20, 22 positioned 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 / device catheter, etc.), actuating element 112, and actuating line 116 are then stored and the device or implant 100 is fully closed and deployed within the native mitral valve MV.

[0152] Any of the features disclosed herein may be used in a wide variety of different devices or valve repair devices, which may be implantable or non-implantable. Figures 22-27, 55, 57-63, and 67-71 show examples of devices or 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 devices shown in Figures 22-27, 55, 57-63, and 67-71.

[0153] 22-27, 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 a device or implant 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 therapeutic device, an artificial spacer device, a valve repair device, or another type of device or implant that is attached to the leaflets of a native valve.

[0154] In some implementations, the device or implant 200 includes a coaptation portion 204, a proximal or attachment portion 209, an anchor portion 206, and a distal portion 207. In some implementations, the coaptation portion 204 of the device optionally includes a coaptation element 210 (e.g., a spacer, coaptation element, plug, membrane, sheet, etc.) for implantation between the leaflets of the native valve. In some implementations, the anchor portion 206 includes multiple anchors 208. The anchors may be configured in a variety of ways. In some implementations, each anchor 208 includes an outer paddle 220, an inner paddle 222, a paddle extension member or paddle frame 224, and a clasp 230. In some implementations, the attachment portion 209 includes a first or proximal collar 211 (or other attachment element) for engaging a capture mechanism 213 (FIGS. 43-49) of the delivery system 202 (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, a device / 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.

[0155] 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 any other suitable manner, or a flexible material that is laser cut or otherwise cut to provide shape setting capabilities. The material may be a fabric, a shape memory alloy wire such as Nitinol, or any other flexible material suitable for implantation in the human body.

[0156] 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.

[0157] 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, circular shape, although other shapes and configurations are possible. In some implementations, the coaptation element 210 has an elliptical shape or cross-section when viewed from above (e.g., FIG. 51), a tapered shape or cross-section when viewed from the front (e.g., FIG. 23), and a circular shape or cross-section when viewed from the side (e.g., FIG. 24). A mixture of these three geometries may result in the illustrated three-dimensional shape of the coaptation element 210 that achieves the advantages described herein. The round shape of the coaptation element 210 may also be seen to substantially follow or approximate the shape of the paddle frame 224 when viewed from above.

[0158] 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.

[0159] 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.

[0160] In some implementations, the inner paddle 222 is rigid, relatively rigid, stiff, has a stiff portion, and / or is stiffened by a stiffening member 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 shown and described 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.

[0161] In some implementations, the paddle frame 224 is attached to the cap 214 of the distal portion 207 and extends to a connection 223 between the inner paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is formed from a material that is stiffer and harder than the material forming the paddles 222, 220 such that the paddle frame 224 provides support to the paddles 222, 220.

[0162] The paddle frame 224 provides additional clamping force between the inner paddle 222 and the coaptation element 210, as can be seen in FIG. 51, and helps wrap the leaflets around the sides of the coaptation element 210 for a better seal between the coaptation element 210 and the leaflets. That is, the paddle frame 224 may be configured with a rounded three-dimensional shape that extends from the cap 214 to the connecting portion 223 of the anchor 208. The connections between the paddle frame 224, the outer and inner paddles 220 and 222, the cap 214, and the coaptation element 210 may constrain each of these members to the movements and positions described herein. In particular, the connecting portion 223 is constrained by its connections between the outer and inner paddles 220 and 222, and by its connections to the paddle frame 224. Similarly, the paddle frame 224 is constrained by its attachment to the connecting portion 223 (and thus the inner paddle 222 and the outer paddle 220 ) and by its attachment to the cap 214 .

[0163] 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 for easier grasping and fixation of the native leaflets. The increased surface area may also distribute the clamping force of the paddles 220 and paddle frame 224 on the native leaflets over a larger surface area of ​​the native leaflets to further protect the native leaflet tissue. Referring again to FIG. 51, the increased surface area of ​​the paddle frame 224 may also allow the native leaflets to be clamped against the device or implant 200 such that the native leaflets are generally coapted against the periphery of the coaptation member or element 210. This may, for example, improve sealing of the native leaflets 20, 22, thereby preventing, inhibiting, or further reducing mitral regurgitation.

[0164] In some implementations, the clasp comprises 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.

[0165] In some implementations, the fixed arm 232 is attached to the inner paddle 222 through a hole or slot 231 by 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 causing the movable arm 234 to articulate, pivot, and / or bend on the interface 238.

[0166] 29, a close-up view of one of the leaflets 20, 22 grasped by a clasp, such as clasp 230, is shown. The leaflets 20, 22 are grasped between a movable arm 234 and a fixed arm 232 of the clasp 230. The tissue of the leaflets 20, 22 is not pierced by the optional barbs, frictional enhancing elements, or fixation structures 236, although in some implementations the optional barbs 236 may partially or fully pierce the leaflets 20, 22. The angle and height of the optional barbs, frictional enhancing elements, or fixation structures 236 relative to the movable arms 234 helps to secure the leaflets 20, 22 within the clasp 230. In particular, the force pulling the implant away from the native leaflets 20, 22 encourages the optional barbs, frictional enhancing elements, or fixation structures 236 to further engage the tissue, thereby ensuring a better hold. Retention of the leaflets 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 anchoring 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 anchoring structures 236. Thus, the force pulling the leaflets 20, 22 away from the clasp 230 encourages the tissue to further engage the optional barbs, frictional enhancement elements, or anchoring structures 236 before the leaflets 20, 22 may prolapse. For example, tension on the leaflets during diastole encourages the optional barbs, frictional enhancement elements, or anchoring structures 236 to pull towards the end portions of the leaflets 20, 22. Thus, the S-shaped pathway may take advantage of the tension of the leaflets during diastole, forcing the leaflets 20, 22 to more firmly engage with the optional barbs, friction enhancing elements, or anchoring structures 236.

[0167] 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, inhibit, or reduce blood flow through the device or implant 200 and / or to promote natural tissue ingrowth. 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.

[0168] During implantation, the paddles 220, 222 of the anchor 208 are 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. The extension and retraction of 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 member) 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, 220 between different positions to grip the mitral valve leaflets 20, 22 during implantation.

[0169] To open and close the device 200, the pair of inner and outer paddles 222, 220 are moved together, not independently, by a single actuation element 212. Also, the position of the clasp 230 depends on the positions of the paddles 222, 220. For example, the clasp 230 is positioned such that closure of the anchor 208 causes the clasp 230 to close simultaneously. In some implementations, the device 200 can be made to allow the paddles 220, 222 to be independently controllable in the same manner (e.g., device 101 shown in FIG. 15).

[0170] In some implementations, the clasp 230 further secures the native leaflets 20, 22 by engaging the leaflets 20, 22 with optional barbs, friction enhancing elements, or fixation structures 236 and / or sandwiching the leaflets 20, 22 between the movable arm 234 and the fixation arm 232. In some implementations, the clasp 230 is a barbed clasp that includes barbs that can increase friction with the leaflets 20, 22 and / or partially or fully pierce the leaflets 20, 22. The actuation lines 216 (FIGS. 43-48) can be actuated separately such that each clasp 230 can be opened and closed separately. Actuating separately allows one leaflet 20, 22 to be gripped at a time, or the clasp 230 can be repositioned over a leaflet 20, 22 that was not adequately gripped without changing the good grip on the other leaflets 20, 22. The clasp 230 can be fully opened or closed when the inner paddle 222 is not closed, thereby allowing the leaflets 20, 22 to be grasped in various positions as the particular situation requires.

[0171] 22-25, the device 200 is shown in a closed position. The inner paddle 222 is disposed between the outer paddle 220 and the coaptation element 210 when closed. The clasp 230 is disposed between the inner paddle 222 and the coaptation element 210. Upon successfully capturing the native leaflets 20, 22, the device 200 is moved to and held in a closed position such that the leaflets 20, 22 are secured within the device 200 by the clasp 230 and pressed against the coaptation member 210 by the paddles 220, 222. The outer paddle 220 may have a wider curved shape that fits around the curved shape of the coaptation member 210 (e.g., as can be seen in FIG. 51) to more securely grip the leaflets 20, 22 when the device 200 is closed. The curved shape and circular edges of the outer paddle 220 also prevent or inhibit tearing of the leaflet tissue.

[0172] 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 each of the positions shown in FIGS. 30-37, from the closed position shown in FIGS. 22-25 to the extension of the actuating element 212 from a fully retracted position to a fully extended position.

[0173] 30 and 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. Because the proximal collar 211 (or other attachment member) and joint element 210 are held in place by the capture mechanism 213, the inner paddle 222 is caused to articulate, pivot, and / or bend in the open direction. The inner paddle 222, outer paddle 220, and paddle frame all bend to the positions shown in FIGS. 30 and 31. Opening the paddles 222, 220 and frame 224 creates a gap between the coaptation element 210 and the inner paddle 222, which may receive and grasp the native leaflets 20, 22. This movement also exposes the clasp 230, which may be moved between a closed position (FIG. 30) and an open position (FIG. 31) to create a second gap for grasping the native leaflets 20, 22. The extent of the gap between the fixed arm 232 and the movable arm 234 of the clasp 230 is limited to the extent that the inner paddle 222 extends away from the coaptation element 210.

[0174] 32 and 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 between the interface element 210 and the inner paddle 222 formed in the laterally extended or laterally open position allows the catch 230 to open further before engaging the interface element 210 (FIG. 33), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0175] 34 and 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 the extension of 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 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 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 between the joint element 210 and the inner paddle 222 formed in the laterally extended or laterally open position may allow 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.

[0176] 36 and 37, an 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. The inner and outer paddles 222, 220 are linearly extended in the fully extended position, forming an angle of about 180 degrees between the paddles 222, 220. The fully extended position of the device 200 provides the largest size gap between the coaptation element 210 and the inner paddle 222, and in some implementations, also allows the clasp 230 to fully open to approximately 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 position for extrication of the device 200 from an attempted implantation, or may be in a desired position for placement of the device into a delivery catheter or the like.

[0177] Configuring the device or implant 200 such that the anchors 208 may extend to 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 leaflets 20, 22 by providing a larger opening between the coaptation element 210 and the inner paddle 222 for grasping the native leaflets 20, 22. Additionally, the relatively narrow and straight configuration may prevent or reduce the likelihood of the device or implant 200 becoming entangled in natural anatomy (e.g., the chordae tendineae CT shown in FIGS. 3 and 4) when positioning and / or retrieving the device or implant 200 within the delivery system 202.

[0178] 38-49, an exemplary device 200 is shown being delivered and deployed within a native mitral valve MV of a heart H. As discussed above, the device 200 shown in FIGS. 38-49 includes an optional cover 240 (e.g., FIG. 25) over the coaptation member 210, the clasp 230, 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 a device / implant catheter extendable from a guide sheath) and is held by a capture mechanism 213 (see, for example, FIGS. 43 and 48) and actuated by extending and retracting an actuating element 212. Fingers of the capture mechanism 213 releasably attach a 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, removing the actuating element 212 causes the fingers of the capture mechanism 213 to open the collar 211 and release the collar 211, detaching the capture mechanism 213 from the device 200.

[0179] Now referring to FIG. 38, the delivery system 202 (e.g., its delivery catheter / sheath) is inserted through the septum into the left atrium LA, and the device / implant 200 is deployed from the delivery system 202 in a fully open state for the reasons described above with respect to the device 100 (e.g., the implant catheter holding the device / implant may be extended to deploy the device / implant out of the steerable catheter). The actuating element 212 is then retracted, moving the device 200 through a partially closed state (FIG. 39) to a fully closed state as shown in FIGS. 40 and 41. The delivery system or catheter then steers the device / implant 200 towards the mitral valve MV, as shown in FIG. 41. Now referring to FIG. 42, when the device 200 is aligned with the mitral valve MV, the actuating element 212 is extended to open the paddles 220, 222 to a partially open position, and the actuating lines 216 (FIGS. 43-48) are retracted, opening the clasps 230 to prepare for grasping the valve leaflets. Next, as shown in Figures 43 and 44, the partially open device 200 is inserted through the native valve (e.g., by advancing the device / implant catheter from the steerable catheter) until the leaflets 20, 22 are properly positioned between the inner paddle 222 and the coaptation element 210 and within the open clasp 230.

[0180] FIG. 45 illustrates the device 200 with both clasps 230 closed, but with the optional barb, friction enhancing element, or fixation structure 236 of one clasp 230 not engaged with one leaflet 22. As can be seen from FIGS. 45-47, the misaligned clasp 230 is again opened and closed to properly grasp the unengaged leaflet 22. When both leaflets 20, 22 are properly grasped, retracting the actuating element 212 moves the device 200 to the fully closed position shown in FIG. 48. With the device 200 fully closed and implanted in the native valve, the actuating element 212 is disengaged and withdrawn from the cap 214, releasing the capture mechanism 213 from the proximal collar 211 (or other attachment member) so that the capture mechanism 213 can 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 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 in a closed position around the inner paddle 222, the coaptation element 210, and / or the clasp 230 in a clamped position around the native leaflets 20, 22.

[0181] 50-54, once the device 200 is implanted in a native valve, the coaptation element 210 functions as a gap filler in a valve regurgitation opening, such as the gap 26 in the mitral valve MV shown in FIG. 6 or a gap in another native valve. In some implementations, when the device 200 is deployed between the leaflets 20, 22 of two opposing valves, 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 need to approach to close the native valve during systole, thereby facilitating the repair of functional valve disease that may cause valvular 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. Less or no reduction in the valve annulus may result in less reduction in valve opening area compared to a device without a coaptation element or spacer. In this manner, the coaptation element 210 may reduce transvalvular gradients.

[0182] In order to adequately fill the gap 26 between the leaflets 20, 22, the device 200 and its components may have a wide variety of different shapes and sizes. For example, the outer paddle 220 and paddle frame 224 may be configured to match 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 may mate with both the coaptation element 210 and the native valve leaflets 20, 22. In some implementations, when the leaflets 20, 22 are coapted against the coaptation element 210, the leaflets 20, 22 completely surround or "hugge" the coaptation element 210 with their entirety, and thus small leaks at the outer and inner surfaces 201, 203 of the coaptation element 210 may be prevented or inhibited. The interaction of the leaflets 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., from Fig. 52) that conforms to the geometry of the coaptation element 210. The opposing leaflets 20, 22 (whose ends also would not be visible from a true atrial view, e.g., from Fig. 52) are approximated by the paddle frame 224 to completely surround or "hug" the coaptation element 210.

[0183] This coaptation of the leaflets 20, 22 to 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 leaflets must approximate. However, the distance the leaflets 20, 22 must approximate is still minimized if the coaptation element 210 is precisely positioned in the regurgitation gap 26, and the regurgitation gap 26 is smaller than the width (medial minus lateral) of the coaptation element 210.

[0184] FIG. 50 shows 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 leaflets 20, 22 coapt and the coaptation element 210 is required to increase in size as it extends toward the atrium. Thus, the illustrated native valve geometry is accommodated by the tapered coaptation element shape. Still referring to FIG. 50, the tapered coaptation element geometry, in combination with the illustrated expanded paddle frame 224 shape (towards the annulus), may help achieve coaptation at the bottom of the leaflets, reduce stress, and minimize transvalvular gradients.

[0185] 54, the shapes of the coaptation element 210 and the paddle frame 224 may be defined based on the inner commissure view of the native valve and the device 200. Two factors in these shapes are the coaptation of the leaflets to the coaptation element 210 and the reduction of stress on the leaflets due to coaptation. With reference to FIG. 54 and FIG. 24, the coaptation member 210 may have a circular or round shape and the paddle frame 224 may have a full radius that spans almost the entirety of the paddle frame 224, both to coapt the leaflets 20, 22 to the coaptation member 210 and to reduce the stress that the coaptation member 210 and / or paddle frame 224 apply to the leaflets 20, 22. The round shape of the coaptation member 210 and / or the fully round shape of the paddle frame 224 shown distributes the stress on the leaflets 20, 22 over a large curved engagement region 205. For example, in FIG. 54, the force exerted by the paddle frame on the leaflets 20, 22 is spread along the entire rounded length of the paddle frame 224 as the leaflets 20 attempt to open during diastole.

[0186] 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 in Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215). 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 / US2018 / 028189 (International Publication No. WO2018 / 195215). Patent Cooperation Treaty International Application No. PCT / US2018 / 028189 (International Publication No. WO2018 / 195215) is incorporated herein by reference in its entirety.

[0187] 55, an embodiment of a device or implant 300 (e.g., an implantable prosthetic device, a prosthetic spacer device, a valve repair device, a repair device, a treatment device, etc.) is shown. Device 300 is one of many different configurations that device 100 may assume, as shown generally in FIGS. 8-14. 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).

[0188] 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 a coaptation portion / region 304, which may optionally include a coaptation element 310 (e.g., a spacer, plug, membrane, sheet, gap filler, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes a plurality of anchors 308. In some implementations, each anchor 308 may include one or more paddles, for example, an outer paddle 320, an inner paddle 322, a paddle extension, 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 member) 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).

[0189] The anchors 308 may be attached to other portions of the device and / or to each other in a variety of different manners (e.g., directly, indirectly, by welding, by sutures, by adhesive, by links, by latches, by integral formation, by combinations of some or all of these, etc.) In some implementations, the anchors 308 are attached to the interface element 310 by connecting portion 325 and to the cap 314 by connecting portion 321.

[0190] 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.

[0191] In implementations that include a joining member or element 310, the joining member or 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 piece 301 of braided or woven material, such as braided or interwoven 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 piece of fabric 301.

[0192] 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 straight 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.

[0193] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight in the direction of the longitudinal axis of the device. In some implementations, the connecting portion 323 of the anchor 308 is adjacent to the longitudinal axis of the joint 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 folded 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 midpoint or center of the device, the anchor 308 bends at the connecting portions 321, 323, 325, and the connecting portion 323 moves radially outward relative to the longitudinal axis of the device 300 and axially toward the midpoint and / or proximal end of the device (e.g., similar to the configuration of the device 200 shown in FIG. 34). As cap 314 continues to move toward the midpoint and / or toward the 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).

[0194] In some implementations, the clasp comprises a movable arm coupled to the anchor. In some implementations, the clasp 330 (as shown in detail in FIG. 56 ) includes a base or fixed arm 332, a movable arm 334 with optional barbs, a friction enhancing element or anchoring structure 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.

[0195] 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 the optional barb, friction enhancing element, or fixation structure 336. The clasp 330 is opened by applying tension to an actuation line (e.g., actuation line 216 shown in FIGS. 43-48 ) attached to the hole 335 of the movable arm 334, thereby allowing the movable arm 334 to articulate, pivot, and / or bend on the interface 338.

[0196] 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 piece of material 301. The continuous piece 301 can be a single layer of material or can include two or more layers. In some implementations, portions of the device 300 have a single layer of material 301 and other portions are formed from multiple overlapping or overlapping layers of the piece of material 301.

[0197] For example, Figure 55 shows a joining element 310 and inner paddle 322 formed from multiple overlapping layers of material strips 301. A single continuous piece of material 301 may start and end at various locations on the apparatus 300. The ends of the piece of material 301 may be at the same location or at different locations on the apparatus 300. For example, in the embodiment shown in Figure 55, the piece of material 301 starts and ends at the location of the inner paddle 322.

[0198] 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. Notably, by forming many of the components of the device 300 from a single piece of material 301, the device 300 may be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance at the top of the coaptation element 310 is less than 2 mm, and the medial-lateral distance at the device 300's widest point (i.e., the width of the paddle frame 324, which is wider than the coaptation element 310) is approximately 5 mm.

[0199] Additional features of the device 300, modified versions of the device, delivery systems for the device, and methods of using the device and delivery systems are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898). 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 / 055320 (International Publication No. WO2020 / 076898). Patent Cooperation Treaty International Application No. PCT / US2019 / 055320 (International Publication No. WO2020 / 076898) is incorporated herein by reference in its entirety.

[0200] The concepts disclosed herein may be used in a wide variety of different devices or valve repair devices, including implantable and non-implantable ones. Figures 57-63 show another example of one of many valve repair systems 400 for repairing a patient's native valve to which the concepts of the present application may be applied. Valve repair system 400 includes a delivery device 401 and a device 402 (e.g., exemplified herein as a valve repair device or a valve therapy device).

[0201] In some implementations, the valve repair or treatment device 402 includes a base assembly 404, a pair of paddles 406, and a pair of gripping members 408 (e.g., clasps, clasp arms, grippers, gripping arms, latches, etc.). In some implementations, the paddles 406 may be integrally formed with the base assembly. For example, the paddles 406 may be formed as an extension of a link of the base assembly. In the illustrated example, the base assembly 404 of the valve repair device 402 has a shaft 403, a coupler 405 configured to move along the shaft, and a lock 407 configured to lock the coupler in a stationary position on the shaft. The coupler 405 is mechanically connected to the paddles 406 such that moving the coupler 405 along the shaft 403 moves the paddles between an open position and a closed position. In this manner, coupler 405 serves as a means for mechanically coupling paddles 406 to shaft 403 and for moving paddles 406 between their open and closed positions as they move along shaft 403.

[0202] In some implementations, the gripping member 408 is pivotally connected to the base assembly 404 such that the gripping member can be moved to adjust the width of the opening 414 between the paddle 406 and the gripping member 408 (e.g., the gripping member 408 can be pivotally connected to the shaft 403 or any other suitable member of the base assembly). The gripping member 408 can include a gripping portion 409 (e.g., barbs, projections, ridges, grooves, textured surfaces, adhesives, etc.) for attaching the gripping member to valve tissue when the valve repair device 402 is attached to the valve tissue. The gripping member 408 forms a means for gripping valve tissue (particularly tissue of the leaflets of the valve) by an anchoring means or portion such as the gripping portion 409. When the paddle 406 is in the closed position, the paddle engages the gripping member 408 such that when the valve tissue is attached to the gripping portion 409 of the gripping member, the paddle acts as a retention or fixation means to hold the valve tissue with the gripping member and secure the valve repair device 402 to the valve tissue. In some implementations, the gripping member 408 is configured to engage the paddle 406 such that the gripping portion 409 engages the valve tissue member and the paddle 406 to secure the valve repair device 402 to the valve tissue member. For example, in certain circumstances it may be advantageous to have the paddle 406 maintain an open position and have the gripping member 408 move outwardly toward the paddle 406 to engage the valve tissue and the paddle 406.

[0203] Although the implementation shown in Figures 57-63 shows a pair of paddles 406 and a pair of gripping members 408, it will be understood that the valve repair device 402 can include any suitable number of paddles and gripping members.

[0204] In some implementations, the valve repair system 400 includes a placement shaft 413 that is removably attached to the shaft 403 of the base assembly 404 of the valve repair device 402. The placement shaft 413 is detached from the shaft 403 after the valve repair device 402 is secured to the valve tissue, removing the valve repair device 402 from the remainder of the valve repair system 400 such that the valve repair device 402 can remain attached to the valve tissue and the delivery device 401 can be removed from the patient's body.

[0205] The valve repair system 400 may also include a paddle control mechanism 410, a gripper control mechanism 411, and a lock control mechanism 412. The paddle control mechanism 410 is mechanically attached to the coupler 405 and moves the coupler along the shaft, thereby moving the paddle 406 between the open and closed positions. The paddle control mechanism 410 may take any suitable form and may include, for example, a shaft, wires, tubes, hypotubes, rods, sutures, lines, etc. For example, the paddle control mechanism may comprise a hollow shaft and a catheter tube or sleeve that fits over the mounting shaft 413 and shaft 403 and connects to the coupler 405.

[0206] Gripper control mechanism 411 is configured to move gripping member 408 such that the width of opening 414 between the gripping member and paddle 406 may be altered. Gripper control mechanism 411 may take any suitable form, such as, for example, a line, suture, wire, rod, catheter, tubing, hypotube, etc.

[0207] The lock control mechanism 412 is configured to lock and unlock the lock. The lock 407 serves as a locking means for locking the coupler 405 in a stationary position relative to the shaft 403 and can take a wide variety of different forms, and the type of lock control mechanism 412 can be dictated by the type of lock used. In some implementations, the lock 407 includes a pivotable plate having a hole, and the shaft 403 of the valve restoration device 402 is disposed within the hole of the pivotable plate. In this implementation, when the pivotable plate is in a tilted position, the pivotable plate engages the shaft 403 to maintain its position on the shaft 403, but when the pivotable plate is in a substantially non-tilted position, the pivotable plate can be moved along the shaft (which allows the coupler 405 to move along the shaft 403). In other words, the coupler 405 is prevented or inhibited from moving in direction Y (as shown in FIG. 61A ) along the shaft 403 when the pivotable plate of the lock 407 is in the tilted position (or locked position), and the coupler is allowed to move in direction Y along the shaft 403 when the pivotable plate is in the substantially non-tilted position (or unlocked position). In some implementations where the lock 407 includes a pivotable plate, the lock control mechanism 412 is configured to engage the pivotable plate to move the plate between the tilted position and the substantially non-tilted position. The lock control mechanism 412 can be, for example, a rod, a suture, a wire, or any other member that can move the pivotable plate of the lock 407 between the tilted position and the substantially non-tilted position. In some implementations, the pivotable plate of the lock 407 is biased to the tilted position (or locked position), and the lock control mechanism 412 is used to move the plate from the tilted position to the substantially non-tilted position (or unlocked position). In some implementations, the pivotable plate of the lock 407 is biased to a substantially non-tilted position (or unlocked position), and the lock control mechanism 412 is used to move the plate from the substantially non-tilted position to the tilted position (or locked position).

[0208] 61A and 61B show a valve repair or treatment device 402 moving from an open position (shown in FIG. 61A) to a closed position (shown in FIG. 61B). The base assembly 404 includes a first link 1021 extending from point A to point B, a second link 1022 extending from point A to point C, a third link 1023 extending from point B to point D, a fourth link 1024 extending from point C to point E, and a fifth link 1025 extending from point D to point E. The coupler 405 is movably attached to the shaft 403, which is fixed to the fifth link 1025. The first link 1021 and the second link 1022 are pivotally attached to the coupler 405 at point A, such that moving the coupler 405 along the shaft 403 moves the location of point A, which in turn moves the first link 1021 and the second link 1022. The first link 1021 and the third link 1023 are pivotally attached to each other at point B, and the second link 1022 and the fourth link 1024 are pivotally attached to each other at point C. One paddle 406a is attached to the first link 1021 such that moving the first link 1021 moves the paddle 406a, and the other paddle 406b is attached to the second link 1022 such that moving the second link 1022 moves the paddle 406b. In some implementations, the paddles 406a, 406b may be connected to the links 1023, 1024 or may be extensions of the links 1023, 1024.

[0209] To move the valve repair device from an open position (shown in FIG. 61A ) to a closed position (shown in FIG. 61B ), the coupler 405 is moved along the shaft 403 in direction Y, thereby moving the pivot point A for the first link 1021 and the second link 1022 to a new position. Moving the coupler 405 (and pivot point A) in direction Y causes a portion of the first link 1021 near point A to move in direction H, and a portion of the first link 1021 near point B to move in direction J. The paddle 406a is attached to the first link 1021 such that moving the coupler 405 in direction Y causes the paddle 406a to move in direction Z. In addition, the third link 1023 is pivotally attached to the first link 1021 at point B, such that moving the coupler 405 in direction Y causes the third link 1023 to move in direction K. Similarly, moving the coupler 405 (and pivot point A) in direction Y causes a portion of the second link 1022 near point A to move in direction L and a portion of the second link 1022 near point C to move in direction M. The paddle 406b is attached to the second link 1022 such that moving the coupler 405 in direction Y causes the paddle 406b to move in direction V. In addition, the fourth link 1024 is pivotally attached to the second link 1022 at point C such that moving the coupler 405 in direction Y causes the fourth link 1024 to move in direction N. FIG. 61B shows the final position of the valve repair device 402 after the coupler 405 has been moved as shown in FIG. 61A.

[0210] 58, the valve repair device 402 is shown in an open position (similar to the position shown in FIG. 61A) and the gripper control mechanism 411 is shown moving the gripping members 408 to provide a wider gap at the opening 414 between the gripping members and the paddle 406. In the illustrated embodiment, the gripper control mechanism 411 includes a line, such as a suture, wire, or the like, that is threaded through an opening in the end of the gripping members 408. Both ends of the line extend through a delivery opening 516 of the delivery device 401. When the line is pulled in direction Y through the delivery opening 516, the gripping members 408 move inward in direction X, causing the opening 414 between the gripping members and the paddle 406 to become wider.

[0211] 59, the valve repair device 402 is shown with the valve tissue 20, 22 positioned within the opening 414 between the gripping member 408 and the paddle 406. With reference to FIG. 60, after the valve tissue 20, 22 is positioned between the gripping member 408 and the paddle 406, the gripper control mechanism 411 is used to narrow the width of the opening 414 between the gripping member and the paddle. That is, in the illustrated embodiment, the line of the gripper control mechanism 411 is released or pushed out of the delivery member opening 516 in direction H such that the gripping member 408 can be moved in direction D to narrow the width of the opening 414. Although the gripper control mechanism 411 is shown moving the gripping member 408 to increase the width of the opening 414 between the gripping member and the paddle 406 (FIG. 59), it will be understood that the gripping member may not need to be moved to position the valve tissue within the opening 414. However, in certain circumstances, the opening 414 between the paddle 406 and the gripping member 408 may be wider to receive the valve tissue.

[0212] 62, the valve repair device 402 is in a closed position and secured to the valve tissue 20, 22. The valve repair device 402 is secured to the valve tissue 20 by the paddles 406a, 406b and the gripping members 408a, 408b. In particular, the valve tissue 20, 22 is attached to the valve repair device 402 by the gripping portions 409 of the gripping members 408a, 408b, and the paddles 406a, 406b engage the gripping members 408 to secure the valve repair device 402 to the valve tissue 20, 22.

[0213] To move the valve repair device 402 from the open position to the closed position, the lock 407 is moved to an unlocked state (as shown in FIG. 62 ) by the lock control mechanism 412. Once the lock 407 is in the unlocked state, the coupler 405 may be moved along the shaft 403 by the paddle control mechanism 410. In the illustrated embodiment, the paddle control mechanism 410 moves the coupler 405 along the shaft in direction Y, thereby moving one paddle 406a in direction X and the other paddle 406b in direction Z. Moving the paddle 406a in direction X and moving the paddle 406b in direction Z engages the gripping members 408a, 408b and secures the valve repair device 402 to the valve tissue 20, 22.

[0214] 63, after the valve repair device 402 is secured to the valve tissue 20, 22 by moving the paddle 406 to the closed position (as shown in FIG. 62), the lock 407 is moved to a locked state by the lock control mechanism 412 (FIG. 62) to maintain the valve repair device 402 in the closed position. After the valve repair device 402 is maintained in the locked state by the lock 407, the valve repair device 402 is removed from the delivery device 401 by decoupling the shaft 403 from the mounting shaft 413 (FIG. 62). Additionally, the valve repair device 402 is removed from the paddle control mechanism 410 (FIG. 62), the gripper control mechanism 411 (FIG. 62), and the lock control mechanism 412. By removing the valve repair device 402 from the delivery device 401, the valve repair device can remain secured to the valve tissue 20, 22 while the delivery device 401 is removed from the patient.

[0215] During delivery and / or implantation of 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 FIGS. 3 and 4) that extend to the valve leaflets. An exemplary device or implant 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 take on a wide variety of different configurations that may be configured to actively or passively constrict, thereby reducing the width of the paddle frame of the anchor portion of the device, thereby reducing the surface area of ​​the device, thereby facilitating movement of the device / implant over and / or through the CT.

[0216] The valve repair or treatment device 402 may include any other features described with respect to other devices discussed in this application, and the device 402 may be positioned to engage valve tissue as part of any suitable valve repair or treatment system (e.g., any valve repair or treatment system disclosed in this application). Additional features of the device 402, modified versions of the device, delivery systems for the device, and methods of using the device and delivery system are disclosed in Patent Cooperation Treaty International Application No. PCT / US2019 / 012707 (International Publication No. WO2019139904). Any combination or subcombination of 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).

[0217] In some implementations, the delivery device is configured to more easily move the device or implant between its various configurations and / or to more easily implant (and / or deliver) the device or implant into the native heart valve. For example, the controls of the handles used in the delivery assembly may be configured to allow for improved control of the device or implant, as described below.

[0218] 64 and 65 show an example of a delivery assembly 600 and its components. With reference to FIG. 64, the delivery assembly 600 may include a delivery device 602 and a device 604 (e.g., a treatment device, a repair device, an implant, an implantable device, a valve repair device, etc.). The delivery device 602 may include multiple catheter assemblies and optional catheter stabilizers (not shown in FIG. 64 and FIG. 65). For example, in the illustrated embodiment, the delivery device 602 includes a delivery catheter assembly 606, a steerable catheter assembly 608, and a device / implant catheter assembly 610 (e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.). The steerable catheter assembly 608 extends coaxially through the delivery catheter assembly 606, and the device / implant catheter assembly 610 extends coaxially through the steerable catheter assembly 608 and the delivery catheter assembly 606. The device 604 may be removably coupled to a distal portion of the device / implant catheter assembly 610, as described further below. It should be understood that the device 604 may be any device described herein.

[0219] 65, each of the delivery catheter assembly 606, the steerable catheter assembly 608, and the device / implant catheter assembly 610 includes a sheath or shaft 607, 609, 611, respectively, extending from a handle 612, 614, 616. The handles 612, 614, 616 are located at the proximal end of each of the corresponding sheaths or shafts and include one or more control members that allow a user to manipulate the catheter assembly (e.g., bend or rotate the sheath or shaft of the catheter assembly) or control a component coupled to the corresponding catheter assembly (e.g., a control wire extending through the shaft of the catheter assembly).

[0220] The delivery catheter assembly 606 and the steerable catheter assembly 608 may be used, for example, to access an implantation location (e.g., the native mitral valve region of the heart) and / or to position the device / implant catheter assembly 610 at the implantation location. Thus, in various implementations, the delivery catheter assembly 606 and the steerable catheter assembly 608 are configured to be steerable. The catheter assembly features disclosed by U.S. Pat. Nos. 10,653,862 and 10,646,342 may be used in the catheter assemblies 606, 608, 610. U.S. Pat. Nos. 10,653,862 and 10,646,342 are incorporated herein by reference in their entireties.

[0221] FIG. 66 illustrates one embodiment of a device / implant catheter assembly 610. FIG. 66 illustrates a generalized device / implant catheter assembly 610. In the embodiment illustrated in FIG. 66, the device / implant catheter assembly 610 may include an inner element or actuation element 112, a coupler 620, an outer shaft 611, a handle 616 (shown diagrammatically), and a clasp actuation line 624. A proximal end portion 622a of the outer shaft 611 may be coupled to extend distally from the handle 616, and a distal end portion 622b of the outer shaft 611 may be coupled to the coupler 620. The actuation element 112 may extend distally from an actuation control or knob 626 (shown diagrammatically in FIG. 66), through the handle 616, through the outer shaft 611, and further through the coupler 620. The actuation element 112 may be movable (e.g., axially and / or rotationally) relative to the outer shaft 611 and the handle 616. The clasp actuation line 624 may extend through the handle 616 and the outer shaft 611 and may be axially movable relative to the handle 616 and the outer shaft 611. The clasp actuation line 624 may also be axially movable relative to the actuation element 112.

[0222] In some implementations, the outer shaft 611 of the device / implant catheter assembly 610 can be configured to be steerable. For example, although not shown, the device / implant catheter assembly 610 can include a tension element, such as a wire, and a flexible sleeve, such as a flexible, axially incompressible tension wire sleeve (e.g., a helical coil).

[0223] As shown in FIG. 66 , the actuating element 112 (e.g., actuating rod, actuating tube, actuating shaft, actuating wire, etc.) of the device / implant catheter assembly 610 may be removably coupled to the cap 114 of the device 604. The actuating element extends from a proximal end portion 112a to a distal end portion 112b. In some implementations, the distal end portion 112b of the actuating element 112 may include male threads configured to removably engage with female threads of the cap 114 of the device 604. Thus, when the actuating element 112 is rotated in a first direction (e.g., clockwise) relative to the cap 114 of the device 604, the actuating element 112 releasably secures to the cap 114, while when the actuating element 112 is rotated in a second direction (e.g., counterclockwise) relative to the cap 114 of the device 604, the actuating element 112 is released from the cap 114.

[0224] In the embodiment of FIG. 66, the outer shaft 611 of the device / implant catheter assembly 610 is an elongate shaft extending axially between a proximal end portion 622a coupled to the handle 616 and a distal end portion 622b coupled to the coupler 620. The outer shaft 611 may also include an intermediate portion 622c disposed between the proximal end portion 622a and the distal end portion 622b. The outer shaft 611 may be formed from a variety of materials including metals and polymers. For example, in one particular implementation, the proximal end portion 622a may include stainless steel and the distal portion 622b and intermediate portion 622c may include polyether block amide (PEBA). The outer shaft 611 may also include an outer sheath or coating, such as a polymer, that is reflowed over the portions 622a, 622b, and 622c.

[0225] 66 , the clasp actuation lines 624 are coupled to the clasp 130 through holes 235 in the clasp 130 and extend axially through the outer shaft 611 between the clasp 130 and the handle 616. In some implementations, the clasp actuation lines 624 are each coupled to a clasp control member 628 at a proximal end portion of the clasp actuation line 624. Each clasp control member 628 can be, for example, an axially moving control or slider coupled to a corresponding clasp actuation line 624, and causes the clasp actuation line 624 to move axially relative to the outer shaft 611 and actuation element 112. Each of the clasp control members 628 may be operated independently of the other clasp control members such that each clasp actuation line 624 is moved relative to the outer shaft 611, the actuation element 112, and the other clasp actuation lines 624, or the clasp control members 628 may be fixed (e.g., locked) relative to one another such that the clasp actuation lines 624 are moved axially together relative to the outer shaft 611 and the actuation element 112. Additional information regarding exemplary clasp control members 628 and device / implant catheter assemblies including same can be found, for example, in U.S. Provisional Patent Application No. 63 / 181,120, filed April 28, 2021, which is incorporated herein by reference in its entirety.

[0226] In some implementations, the catheter assembly is used to deliver and / or operate a device, such as the device 8200 shown in FIG. 67 or other therapeutic or repair devices herein. FIGS. 67-71 show one of many valve repair or treatment systems for repairing or treating a patient's native valve to which the concepts of the present application may be applied. With reference to FIGS. 70 and 71, the valve repair or treatment system includes a delivery device 1611 and a device 8200, such as a therapeutic device, repair device, valve repair device, implantable valve repair device, implant, etc. With reference to FIGS. 67-69, the device 8200 includes a proximal or attachment portion 8205, a paddle frame 8224, an outer paddle portion 8120, an inner paddle portion 8122, and a distal portion 8207. The proximal portion 8205, the distal portion 8207, and the paddle frame 8224 may be configured in a variety of ways. The outer paddle portion 8120, the inner paddle portion 8122, and the paddle frame 8224 may open and close in the same or similar manner as the outer paddle portion 220, the inner paddle portion 222, and the paddle frame 224 described above.

[0227] 67, the paddle frame 8224 may be symmetrical along the longitudinal axis YY. However, in some implementations, the paddle frame 8224 is not symmetrical about the axis YY. Further, with reference to FIG. 67, the paddle frame 8224 includes an outer frame member 8256 and an inner frame member 8260.

[0228] In some implementations, the connector 8266 (e.g., a molded metal component, a molded plastic component, a tether, wire, post, line, cord, suture, etc.) is attached to the outer frame member 8256 at an outer end of the connector 8266 and to a coupler 8972 at an inner end 8968 of the connector 8266 ( FIG. 69 ). Between the connector 8266 and the proximal portion 8205, the outer frame member 8256 forms a curved shape. For example, in the illustrated embodiment, the shape of the outer frame member 8256 resembles an apple shape, with the outer frame member 8256 being wider toward the proximal portion 8205 and narrower toward the distal portion 8207. However, in some implementations, the outer frame member 8256 may be shaped in other ways.

[0229] The inner frame member 8260 extends from the proximal portion 8205 towards the distal portion 8207. The inner frame member 8260 then extends inwardly to form a retaining portion 8272 that is attached to the actuation cap 8214. The retaining portion 8272 and the actuation cap 8214 can be configured to be attached in any suitable manner.

[0230] In some implementations, the inner frame member 8260 is a rigid frame portion while the outer frame member 8256 is a flexible frame portion. The proximal end of the outer frame member 8256 connects to the proximal end of the inner frame member 8260, as shown in FIG.

[0231] A width adjustment element 8211 (e.g., a width adjustment wire, a width adjustment shaft, a width adjustment tube, a width adjustment line, a width adjustment cord, a width adjustment suture, a width adjustment screw or bolt, etc.) is configured to move the outer frame member 8256 from an expanded position to a constricted position by pulling the inner end 8968 ( FIG. 69 ) and a portion of the connector 8266 into the actuation cap 8214. An actuation element 8102 (e.g., a wire, a rod, a shaft, a tube, a screw, a suture, a line, a strip, combinations thereof, etc.) is configured to move the inner paddle frame portion 8260 to open or close the paddle according to some implementations disclosed herein.

[0232] As shown in FIGS. 68 and 69 , the paddle frame 8224 has an inner end 8968 that engages with the width adjustment element 8211 such that a user can move the inner end 8968 inside the receiver 8912 (e.g., an internally threaded element, a column, a conduit, a hollow member, a notched receiving portion, a tube, a shaft, a sleeve, a post, a housing, a raceway, a cylinder, etc.) to move the outer frame member 8256 between a constricted position and an expanded position. In the illustrated embodiment, the inner end 8968 comprises a post 8970 that is attached to the outer frame member 8256 and a coupler 8972 that extends from the post 8970. The coupler 8972 is configured to be attached to and detached from both the width adjustment element 8211 and the receiver 8912. When the coupler 8972 is attached to the width adjustment element 8211, the coupler is released from the receiver 8912. When the coupler 8972 is removed from the width adjustment element 8211, the coupler is secured to the tube. However, the inner end 8968 may be configured in a variety of ways. Any configuration may be used that can suitably attach the outer frame member 8256 to the coupler such that the width adjustment element 8211 can move the outer frame member 8256 between the constricted and expanded positions.

[0233] The width adjustment element 8211 allows a user to expand or contract the outer frame member 8256 of the implantable device 8200. In the embodiment shown in FIGS. 68 and 69 , the width adjustment element 8211 includes a male threaded end that screws into the coupler 8972. The width adjustment element 8211 moves the coupler into the receiver 8912 to adjust the width of the outer frame member 8256. When the width adjustment element 8211 is unscrewed from the coupler 8972, the coupler engages the inner surface of the receiver 8912 to set the width of the outer frame member 8256.

[0234] In some implementations, the receiver 8912 may be integrally formed with or fixedly connected to the distal cap 8214. Moving the cap 8214 relative to the body of the mounting portion 8205 opens and closes the paddle. In the illustrated embodiment, the receiver 8912 slides inside the body of the mounting portion 8205. When the coupler 8972 is removed from the width adjustment element 8211, the width of the outer frame member 8256 is fixed while the actuation element 8102 moves the receiver 8912 and cap 8214 relative to the body of the mounting portion 8205. Moving the cap may open and close the device in the same manner as other implementations disclosed above.

[0235] In the illustrated embodiment, the driver head 8916 is disposed at a proximal end of the actuation element 8102. The driver head 8916 removably couples the opening / closing control actuation element 8102 to the receiver 8912. In the illustrated embodiment, the width adjustment element 8211 extends through the actuation element 8102. The actuation tube is advanced axially in the opposite direction to the Y direction to move the distal cap 8214. As shown by the arrows in FIG. 68, movement of the distal cap 8214 relative to the mounting portion 8205 is effective to open and close the paddle. That is, when the distal cap 8214 is moved in the Y direction, the device is closed, and when the distal cap is moved in the opposite direction to the Y direction, the device is opened.

[0236] As also shown in FIGS. 68 and 69, the width adjustment element 8211 extends through the actuation element 8102 , the driver head 8916 , and the receiver 8912 and engages a coupler 8972 attached to the inner end 8968 .

[0237] When the outer frame member 8256 is moved to the stenotic position, the device or implant 8200 may be easily maneuvered into position for implantation into the heart by reducing contact and / or friction between the natural structures of the heart (e.g., chordae tendineae) and the device 8200. When the outer frame member 8256 is moved to the expanded position, the anchor portions of the device or implant 8200 are provided with a larger surface area to engage and capture the leaflets of the native heart valve.

[0238] 70 and 71, in implementations of a device / implant catheter assembly 1611 (e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.) in which the clasp actuation line 624 extends through the handle 1616, the actuation element 8102 is coupled to an actuation control 1626 (which may be referred to herein as an anchor actuation control or a paddle actuation control) and the width adjustment element 8211 is coupled to a width control 1628 (which may be referred to herein as an anchor width control, a paddle width control, etc.). A proximal end portion 1622a of the shaft or catheter of the device / implant catheter assembly 1611 may be coupled to the handle 1616 and a distal end portion 1622b of the shaft or catheter may be coupled to the device 8200. The actuating element 8102 may extend distally from the paddle actuation control 1626, through the handle 1616, through the shaft or catheter of the delivery device 1611, and through a proximal end of the device 8200 where it couples with the driver head 8916. The actuating element 8102 may be axially movable relative to the device / implant catheter assembly 1611 and the shaft of the handle 1616 to open and close the device.

[0239] The width adjustment element 8211 may extend distally from the paddle width control 1628, through the paddle actuation control 1626, through the actuation element 8102 (and, consequently, through the handle 1616, outer shaft 1611, and device 8200), where the width adjustment element couples with the movable coupler 8972. The width adjustment element 8211 may be axially movable relative to the actuation element 8102, outer shaft 1611, and handle 1616. The clasp actuation line 624 may extend through the handle 1616 and outer shaft 1611 and may be axially movable relative to the handle 1616 and outer shaft 1611. The clasp actuation line 624 may also be axially movable relative to the actuation element 8102.

[0240] 70 and 71, width adjustment element 8211 can be removably coupled to coupler 8972 of device 8200. Advancing and retracting width adjustment element 8211 via control 1628 widens and narrows the width of the paddle. Advancing and retracting actuation element 8102 via control 1626 opens and closes the paddle of the device.

[0241] 70 and 71, the catheter or shaft of the device / implant catheter assembly 1611 is an elongate shaft extending axially between a proximal end portion 1622a that is coupled to the handle 1616 and a distal end portion 1622b that is coupled to the device 8200. The outer shaft 1611 may also include an intermediate portion 1622c disposed between the proximal end portion 1622a and the distal end portion 1622b.

[0242] In various implementations, the handle 1616, including controls for adjusting the width of the paddle frame, may be incorporated into a control system having various forms. For example, the handle 1616 may be incorporated into the control system 1000 shown in FIG. 72. Features of the control system shown in FIG. 72 may be found in U.S. Patent No. 10,820,998, filed April 8, 2020, entitled "Valve Repair Device," the entire contents of which are incorporated herein by reference.

[0243] 73-75 show an exemplary implementation of a handle 7300 incorporating a paddle width adjustment control. The handle 7300 can be used to position the device / implant catheter 1622 to position the device, advance and retract the actuation element 8102 to open and close the device, and advance and retract the width adjustment element 8211 to widen and narrow the paddle frame (see FIG. 75). As shown in FIG. 73, the handle 7300 generally includes a paddle actuation control 7302, a paddle width control 7304, a paddle release clip 7306, and a width control element connection control 7308. FIG. 74 shows the paddle actuation control 7302, the paddle width control 7304, the paddle release clip 7306, and the control element connection control 7308 in more detail. FIG. 75 shows a cross section of the paddle actuation control 7302, the paddle width control 7304, the paddle release clip 7306, and the control element connection control 7308.

[0244] It should be understood that the handle 7300 may be an implementation of the handle 1616 of FIGS. 70 and 71. For example, the paddle actuation control or knob 7302 is an example of the paddle actuation control 1626 of FIGS. 70 and 71, and the paddle width control or knob 7304 is an example of the paddle width control 1628 of FIGS. 70 and 71. Different types of controls / controllers may be used for any of the controls or knobs described herein, for example, the knobs shown in many of the figures, or other controls such as buttons, switches, gears, etc. In the following, the term "knob" may be used to match the illustrated variations, but it should be understood that this is an example and that other types of controls or controls may be used in place of the knobs.

[0245] The paddle actuation knob 7302 is rotatable about an axis AA that extends longitudinally along the handle 7300. The actuation element 8102 extends through the paddle actuation knob 7302 and is secured to a ferrule 7312. The ferrule 7312 is secured to a frame 7310 that includes external threads for engaging with internal threads of the paddle width control knob 7304, as described in more detail below. A distal end of the paddle actuation knob 7302 includes external threads 7314 configured to engage with internal threads in a housing of the handle 7300. The paddle actuation knob 7302 is rotatable relative to both the housing of the handle 7300 and the frame 7310 and attached ferrule 7312. Thus, when the paddle actuation knob 7302 is rotated about axis AA relative to the handle 7300, the paddle actuation knob 7302 drives the frame 7310 and attached ferrule 7312 (and thus the actuation element 8102) axially relative to the handle 7300, which is effective to drive the actuation element 8102 axially relative to the device 8200.

[0246] The paddle width control knob 7304 is also rotatable about an axis AA that extends longitudinally along the handle 7300. A width adjustment element 8211 extends through the actuation element 8102, the paddle actuation knob 7302, the ferrule 7312, and the paddle width control knob 7304. The width adjustment element 8211 is fixedly attached to a ferrule 7316 that is connected to the inside of the control element connecting knob 7308. The ferrule 7316 rotationally and axially secures the width adjustment element 8211 to the control element connecting knob 7308. The paddle width control knob 7304 is rotatably coupled to the control element connecting knob 7308 and to the width adjustment element 8211.

[0247] In some implementations, the paddle width control knob 7304 is fixed or threadably connected to a threaded component that is part of the paddle actuation assembly. When the paddle width control knob 7304 is rotated, the threaded connection drives or pushes the paddle width control knob 7304 to couple with a control element 7316, such as the illustrated ferrule, away from the paddle actuation knob 7302 and associated actuation element 7312 or ferrule. For example, as shown in the implementation of FIG. 75, the width control knob 7304 (e.g., such as a paddle width control knob) includes female threads 7311 that engage with male threads 7313 of the frame 7310. Thus, rotation of the paddle width control knob 7304 is effective to move the paddle width control knob 7304 axially. Because the paddle width control knob 7304 is rotatably coupled to the control element connection knob 7308, when the paddle width control knob 7304 is rotated, the width adjustment element 8211 moves axially rather than rotatably relative to the paddle actuation knob 7302. This is effective to drive the width adjustment element 8211 axially relative to the mounting portion 8205 of the device 8200. The movement of the width adjustment element 8211 relative to the mounting portion 8205 is effective to adjust the width of the paddle, as described above.

[0248] The control element connection knob 7308 is coupled to a proximal end of the paddle width control knob 7304 and includes a ferrule 7316 to which the width adjustment element 8211 is affixed. In an implementation, the control element connection knob 7308 does not rotate about axis AA during implantation of the device 8200. The paddle release clip 7306 axially locks the control element connection knob 7308 and the paddle width control knob 7304 together while allowing rotation therebetween. Thus, to disengage the width adjustment element 8211 from the device 8200, the paddle release clip 7306 is removed and the control element connection knob 7308 is rotated relative to the paddle width control knob 7304. This rotates the width adjustment element 8211 relative to the device 8200, which is effective to uncouple the width adjustment element 8211 from the device 8200. The control element connection knob 7308 and the width adjustment element 8211 can then be pulled axially to remove the width adjustment element from the device 8200.

[0249] In some implementations, the device 8200 is released from the device / implant catheter 1622 by the following sequence of actions with the handle: The paddle release clip 7306 is removed and the control element connection knob 7308 is rotated, decoupling the width adjustment element 8211 from the device 8200. The control element connection knob 7308 and width adjustment element 8211 can then be pulled proximally past the distal end of the actuation element 8102, decoupling the actuation element 8102 from the driver head 8916 and a connected receiver, such as the illustrated tube. For example, in one implementation, the fingers at the distal end bend inward when the width adjustment element 8211 is pulled proximally past the distal end of the actuation element 8102, decoupling the actuation element 8102 from the driver head 8916. The paddle width control knob 7304 and the actuating element 8102 can then be pulled proximally past the distal end or coupler of the catheter 1622, decoupling the distal end or coupler of the catheter 1622 from the device 8200. For example, in one implementation, the fingers of the distal end or coupler bend outward when the actuating element 8102 is pulled proximally past the distal end or coupler of the catheter 1622, decoupling the catheter 1622 from the device 8200.

[0250] 77, an implementation of a handle 616 of a device / implant catheter assembly 610 (e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.) is shown. In FIG. 77, the handle 616 includes a housing 632 to which the various controls are coupled. The housing 632 may be formed from a variety of materials, including polymers such as polycarbonate, and may be formed as a unitary body (e.g., by injection molding) or may be fastened together in any of a variety of manners, including with fasteners, pins, adhesives, or the like. As shown in FIGS. 78-81, the housing 632 includes multiple lumens through which the clasp actuation lines 624 and actuation elements (e.g., actuation rods, actuation tubes, actuation wires, actuation shafts, etc.) 112 extend.

[0251] The handle 616 further includes a flushing port 638, as shown in Figures 77-79. The flushing port 638 is configured to flush the outer shaft 611 (e.g., with saline) prior to inserting the outer shaft 611 into the patient's vasculature. Additionally, the flushing port 638 may remove air present in the outer shaft 611 as fluid is drawn into the proximal end of the outer shaft 611. Additional information regarding flushing ports that may be used in the handle 616 may be found, for example, in WO 2020 / 112622, the entire contents of which are incorporated herein by reference.

[0252] As shown in FIGS. 77-79, the housing 632 includes an opening for receiving the marking pin 640. The marking pin 640 may be removably coupled to an opening in the housing 632 for storing the marking pin 640. In use, the marking pin 640 may be removed from the opening in the housing and inserted into an opening 641 (shown in FIG. 77) on one of the clasp control members 628. For example, the marking pin 640 may be inserted into an opening 641 on the clasp control member 628 that controls the clasp to be coupled to the posterior leaflet of the mitral valve. Thus, when the handle 616 is rotated in use, a user may easily identify the clasp control member 628 for controlling the clasp coupled to the posterior leaflet (e.g., the marked clasp control member 628) and the clasp control member 628 for controlling the clasp coupled to the anterior leaflet (e.g., the unmarked clasp control member 628). Although the marking pin 640 is described as being coupled to the clasp control member 628 that controls the clasp coupled to the posterior leaflet, it is envisioned that the marking pin 640 may be coupled to any clasp control member 628 to indicate any particular orientation of the device / implant catheter assembly.

[0253] Included in the handle 616 is a slide lock 642 configured to slide between a first position in which the slide lock 642 is coupled to one clasp control member 628 and a second position in which the slide lock 642 is coupled to both clasp control members 628. For example, each of the clasp control members 628 may include a flange 643 to which the slide lock 642 is slidably coupled. Thus, the slide lock 642 may be moved to a first position (indicated by the arrow shown in FIG. 77 ) in which the slide lock engages the flange 643 of one clasp control member 628 (e.g., to allow independent movement of each clasp actuation line relative to one another) and to a second position (as shown in FIG. 77 ) in which the slide lock engages the flange 643 of both clasp control members 628 (e.g., to allow simultaneous movement of the clasp actuation lines) to selectively control relative movement between the clasp control members 628. When the slide locks are in a first position, each of the clasp control members can move axially independently relative to the other clasp control members, and when the slide locks are in a second position, the clasp control members can move axially together. Although not shown, in some implementations, each flange 643 can include a stop to limit the position of the slide locks 642 along the flange 643.

[0254] In some implementations, each of the clasp control members 628 may include one or more tactile or visual indicators to allow a user to distinguish one clasp control member from the other with improved accuracy. For example, one clasp control member 628 may have a different color and / or a different texture (e.g., ribbed, smooth) compared to the other clasp control member 628. As shown in the figures, in some implementations, each of the clasp control members 628 is wrapped approximately 180 degrees around the periphery of the housing 632 such that together the clasp control members 628 surround and / or encircle the housing 632. Such an arrangement may allow, for example, the clasp control members 628 to be accessible from any angle by a user with one hand. Moreover, in the implementation shown in FIG. 68, the clasp control member 628 includes a recessed region 644 that is generally shaped to receive and cradle a user's thumb. Although the inclusion of such recessed areas is optional in some implementations, if included, the recessed areas may provide comfort to the user and may improve the ease of use of the clasp control member 628.

[0255] Each clasp control member 628 may further include one or more keyed projections or tongues configured to be received by and slide along a corresponding groove or slot in the housing 632. As shown most clearly in FIG. 82, in several implementations, the housing 632 further includes a pair of detents 645. The first detent 645 is located at a first axial position along one path of the clasp control member 628, and the second detent 645 is located at a second axial position along the path of the clasp control member 628. For example, in FIG. 82, one of the detents 645 protrudes from the housing 632 at a position that places the clasp control member 628 in a fully proximal position (e.g., fully open position), thereby maintaining the clasp control member 628 in a fully proximal position (e.g., fully open position) and preventing or inhibiting the clasp control member 628 from moving distally without the user's intention. A second detent 645 protrudes from the housing 632 at a position that places the clasp control member 628 in a fully distal position (e.g., a fully closed position), thereby maintaining the clasp control member 628 in a fully distal position (e.g., a fully closed position) and preventing or inhibiting the clasp control member 628 from moving proximally without the user's intention. To release the clasp control member 628 for operating the clasp, the user depresses the detent 645 and pushes the clasp control member 628 with enough force to slide over the detent 645. When the clasp control member 628 is moved to either the proximal position (open position) or the distal position (closed position), the corresponding detent 645 provides tactile and audible feedback to the user indicating that the clasp control member 628 is in the open or closed position.

[0256] 82, the clasp control member 628 may include a coupler 646 configured to attach the clasp control member 628 to a clasp control tube 648. As described in more detail below, the clasp control tube 648 is removably coupled to the clasp actuation line 624. Sliding the clasp control member 628 along the housing moves the clasp control tube 648 relative to the housing 632 to open and close the clasp.

[0257] In the embodiment shown in FIGS. 77 and 78, the coupler 646 includes at least one opening 647 within which a clasp control tube 648 is connected. The clasp control member 628 is slidably coupled to the housing 632, such as by an engagement channel 629 in the housing 632 and a protrusion 631 on the clasp control member 628 (see FIG. 77), and / or by the clasp control tube 648 extending through a guide passage 649 formed in the housing (see FIG. 81). The clasp control member, coupler 646, and clasp control tube 648 can slide axially together (i.e., distally and proximally) relative to the housing 632 to open and close the clasp. Only a single coupler 646 and clasp control tube 648 are visible in FIGS. 77 and 78. 81 illustrates that each clasp control member 628 is fixedly coupled to a corresponding clasp control tube 648 and slides together with such clasp control tube 648 in a similar manner. The clasp control tube 648 may be secured at its proximal end to a suture lock 650 that is used to secure the clasp actuation line 624 to the clasp control tube 648.

[0258] In some implementations, each clasp control tube 648 may include one or more optional keyed features 671 at various positions along the axial length of the clasp control tube 648 or at all. In some implementations, no keyed features are included. The optional keyed features 671, if included, are complementary to corresponding keyed features 675 formed in one or more components of the handle 616, such as in the handle housing 632. These keyed features 671, 675 may prevent or inhibit rotation of the clasp control tube 648 within the housing, thereby limiting movement of the clasp control tube to linear movement along the length of the housing 632. For example, the optional keyed feature 671 of the clasp control tube 648 may include a wire welded to the exterior surface of the clasp control tube 648 (see FIG. 78). In such implementations, one or more portions of the axial pathway defined by the handle for the clasp control tube 648 may include a corresponding groove configured to receive the wire and provide a pathway along which the wire may slide. The optional keyed features 671, 675 may enhance stabilization of the clasp control member 628 by preventing or inhibiting rotation or twisting of the clasp control tube 648 within the handle 616. For example, the optional features 671, 675 may prevent or inhibit rotation or twisting of the clasp control tube 648 within the handle 616 when a control line is pulled by and / or through the clasp control tube 648 to release the clasp.

[0259] The suture lock may take a variety of forms. In the embodiment shown in FIG. 88, the suture lock 650 comprises a post 658, a suture lock body 660, and a suture lock body receptacle 662. In the illustrated embodiment, the suture lock body 660 has external threads 665 that engage with internal threads 667 of the suture lock body receptacle 662, connecting the suture lock body and the suture lock body receptacle together. The suture lock body 660 includes a central bore that extends from a first end to a second end of the suture lock body 660. In some implementations, the central bore of the suture lock body 660 has a diameter that varies from the first end to the second end of the suture lock body 660. At least a portion of the central bore is sized to receive the post 658. Thus, the diameter of the central hole of the suture lock body 660 can vary to form a flange to limit the position of the post 658 within the hole of the suture lock body 660 while allowing the post 658 to be inserted into the first end of the suture lock body 660.

[0260] The suture lock body receptacle 662 includes a central bore extending from a first end to a second end of the suture lock body receptacle 662. The central bore of the suture lock body receptacle 662 is sized to receive the suture lock body 660 at the threaded end of the suture lock body receptacle 662 and is sized to receive and attach to the clasp control tube 648 at the second end of the suture lock body receptacle 662. An optional O-ring 664 is positioned around the suture lock body 660 and forms a fluid-tight seal between the suture lock body 660 and the suture lock body receptacle 662.

[0261] The clasp actuation line 624 is secured at one end of the clasp actuation line 624 to a post 658 that is inserted into the suture lock body 660, thereby coupling the clasp actuation line 624 to the suture lock body 660. In some implementations, the clasp actuation line 624 can be welded, glued, or otherwise fixedly coupled to the post 658.

[0262] The clasp actuation line 624 threads through a central bore in the suture lock body 660, through a central bore in the suture lock body receptacle 662, and through the clasp control tube 648. The clasp actuation line 624 threads through the interior of the handle 616 to guide and protect the clasp actuation line 624. The clasp actuation line 624 exits the clasp control tube 648 near the distal end of the handle 616 and extends through the outer shaft 611 of the device / implant catheter assembly 610. As described herein, the clasp actuation line 624 exits the outer shaft 611 at the distal end of the outer shaft and is coupled to the device, such as by passing through one or more holes 235 in the clasp 130 (see, e.g., FIGS. 66 and 76). The clasp actuation line 624 is then threaded back through the outer shaft 611 from the distal end to the proximal end and threaded through the clasp control tube 648 to form a loop within the clasp actuation line 624 extending from the distal end of the outer shaft 611. The clasp actuation line 624 then exits the clasp control tube 648, passes between the suture lock body 660 and the suture lock body receptacle 662, and exits through a central bore of the suture lock body receptacle 662. The threaded connections 665, 667 between the suture lock body 660 and the suture lock body receptacle 662 may be tightened to pinch the clasp actuation line 624 in position between the tapered nose 679 of the suture lock body 660 and the reduced diameter passage 681 of the suture lock body receptacle 662. Tightening the threaded connections 665, 667 also causes a seal, such as an O-ring, to be compressed between the suture lock body 660 and the suture lock body receptacle 662, forming a fluid-tight seal between the suture lock body 660 and the suture lock body receptacle 662.

[0263] To release the clasp from the clasp actuation line, the suture lock body 660 is removed (e.g., by unscrewing) from the suture lock body receptacle 662, releasing the end of the clasp actuation line 624 that is sandwiched between the suture lock body 660 and the suture lock body receptacle 662. Once the clasp actuation line 624 is released, the clasp actuation line may be pulled through the clasp control tube 648, the outer shaft 611, the clasp hole 235, and back through the outer shaft 611, the clasp control tube 648. Thus, the clasp actuation line 624 is no longer connected to the clasp and may be removed from the patient.

[0264] Returning to FIG. 78 , as the clasp control member 628 is moved proximally, the clasp control tube 648 also moves proximally, forcing the suture lock 650 proximally relative to the handle 616. As the suture lock 650 moves proximally, the loop of the clasp actuation line 624 extending from the distal end of the outer shaft 611 moves proximally, pulling the clasp 130. To release the clasp 130, such as gripping a leaflet, the clasp control member 628 is moved distally, which moves the clasp control tube 648 and the suture lock 650 distally, thereby moving the loop of the clasp actuation line 624 distally to allow the clasp 130 to move towards the inner paddle 122, gripping the leaflet between the clasp 130 and the inner paddle 122.

[0265] As mentioned above, the handle 616 further includes a knob 626 (or other control, e.g., a button, switch, gear, etc.) configured to control the position of the actuation element 112 relative to the handle 616 and outer shaft 611. In some implementations, the knob 626 is configured to rotate about an axis of the handle 616. As can be seen in FIGS. 78-81 , the knob 626 can be fixedly coupled to an internally threaded tube 652 positioned within a housing 632 of the handle 616.

[0266] In some implementations, when the knob 626 is rotated about the axis of the handle 616, the female threaded tube 652 rotates relative to the housing 632. The male threaded nut or retractor 654 is positioned within and engaged with the female threaded tube 652. The male threaded nut or retractor 654 is rotationally fixed relative to the housing 632. The male threaded nut or retractor 654 can be rotationally fixed in a variety of different manners. In the example shown in FIG. 79, a pair of guide rods 661 extend axially within the handle 616, and each of the pair of guide rods 661 is fixed to the housing 632 at both ends of the pair of guide rods 661. A mounting bracket 663 couples the pair of guide rods 661 to the housing 632 at a distal end of each of the pair of guide rods 661. Thus, as the female threaded tube 652 is rotated, the male threaded retractor 654 is linearly advanced axially (ie, distally and proximally) along the pair of guide rods 661 .

[0267] The threaded retractor 654 is connected to the actuation element 112 such that linear movement of the threaded retractor 654 causes linear movement of the actuation element 112, thereby moving the device between a fully extended configuration, an open configuration, and a closed configuration, as described herein. Translating the rotational movement of the knob 626 into linear movement of the actuation element 112 improves control and precision, thereby increasing accuracy when opening and closing the device.

[0268] The female threaded tube 652 includes a non-threaded portion 657. A clutch spring 656 is positioned around the non-threaded proximal portion 659 of the retractor 654. The clutch spring presses against a proximal end face 655 of the threaded portion of the retractor 654. Proximal movement of the actuating element 112 after closure of the device 604 may result in over-closure or compression of the valve repair device or treatment device. The location of the non-threaded portion 657 is selected to prevent or inhibit over-retraction of the actuating element 112, thereby preventing or inhibiting over-closure of the valve repair device. That is, the male threaded retractor 654 is no longer driven proximally when the male threaded nut or retractor 654 reaches the non-threaded portion 657. The clutch spring is configured to bias the male threaded retractor 654 distally (e.g., toward the threads of the female threaded tube 652) when the male threaded retractor 654 reaches the end of the threads of the female threaded tube 652. Continued rotation of the knob 626 after the male threads of the male threaded retractor 654 and the female threads of the female threaded tube 652 are disengaged provides an audible indication that the device is in the closed position. Biasing the male threaded retractor 654 may also reduce tilt in the threaded connection, thereby improving the stability of the paddle angle. Biasing the male threaded retractor 654 toward the female threads of the female threaded tube 652 ensures that the male threaded retractor 654 is reengaged by the female threaded tube 652 when the knob 626 is rotated in the opposite direction corresponding to the advancement of the actuation element 112.

[0269] As shown in FIGS. 79, 80, and 81, the male threaded retractor 654 includes a central passage 683. A crimp assembly 668 is coupled within the central passage 683. The crimp assembly attaches the actuation element 112 (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.) within the actuation tube 669 to the paddle release knob 630. The crimp assembly 668 can take a variety of different forms. In the illustrated embodiment, the crimp assembly 668 includes a collet 687 and a nut 670. The collet 687 includes male threads and the nut includes female threads. The collet and nut each have a central bore sized to receive the actuation tube 669 that surrounds the actuation element 112. The actuation element 112 can be secured to the actuation tube 669 near a proximal end of the actuation tube 669. The actuation tube 669 is secured to a crimp assembly 668, which is secured to the male threaded retractor 654. Male threads on the exterior of the collet 687 engage with the female threads of a nut 670. The collet 687 and nut 670, when tightened, secure the crimp assembly to both the actuation tube 669 and a shoulder 689 at the proximal end of the retractor 654. The nut is positioned within a central bore 683 of the male threaded retractor 654. A spring 672 is also positioned within a central bore 683 of the male threaded retractor 654 such that the nut 670 is biased against the shoulder 689. Positioning the nut 670 against the shoulder 689 allows the collet 687 to be easily attached to the nut 670.

[0270] In some implementations, in use, the knob 626 is rotated, which rotates the female threaded tube 652 relative to the housing 632, thereby axially driving the male threaded retractor 654. Axial movement of the male threaded retractor 654 axially moves the actuation element 112, which moves the device between a fully extended, open, and closed configuration. Axial movement of the male threaded retractor 654 also moves the release knob 630 axially between a proximal or extended position (shown in FIG. 84 ) and a distal or retracted position (shown in FIG. 83 ). Thus, in several implementations, the axial position of the release knob 630 relative to the housing 632 is a visual indicator of the configuration of the device 604.

[0271] When the device 604 is in a closed configuration (e.g., as shown in FIG. 21 ), the release knob 630 is in a proximal position extending from the housing 632, as shown in FIG. 84. To release the device from the device / implant catheter assembly 610, the release knob 630 is rotated in an unscrewing or unscrewing direction, which rotates the crimp assembly 668, the actuation tube 669, and the actuation element 112. Rotating the actuation element 112 extends the length of the actuation element to the distal end portion 112b of the actuation element, thereby unscrewing the actuation element 112 from the cap 114 of the device 604.

[0272] As shown in FIGS. 85-87, in some implementations, the release knob 630 includes an elongate shaft 673 and a number of teeth 674 extending from an outer surface of the elongate shaft 673. Each of the teeth 674 is uniform but asymmetric in shape, with each of the teeth 674 having a moderate slope on one edge and a much steeper slope on the other edge. A ratchet insert 676 is positioned within the housing 632 of the handle 616 between the elongate shaft 673 and the housing 632. The ratchet insert 676 includes one or more pawls 678 flexibly attached to a ratchet frame 680. In some implementations, the pawls 678 and the ratchet frame 680 are fabricated from a unitary strip of material that allows the pawls 678 to flex relative to the ratchet frame 680.

[0273] Each of the pawls 678 contacts the outer surface of the elongate shaft 673. Thus, as the release knob 630 is rotated in an unscrewing or loosening direction, each pawl 678 slides over the edge of the moderately sloped tooth 674 and bounces into the area between the tooth and the adjacent tooth. In some implementations, the bouncing of the pawl into the area between the teeth generates an audible indication that the tooth has been passed. The steeper sloped edge of the tooth 674 captures the pawl 678 and prevents or inhibits the release knob 630 from being rotated in the opposite tightening direction. By allowing the release knob 630 to rotate in a single direction, any twist that may have accumulated as a result of the actuation element 112 being twisted upon release of the device 604 prevents or inhibits the release knob 630 from unwinding in the tightening direction.

[0274] Once the working element 112 has been decoupled from the device 604, the working element 112 can be withdrawn into the device / implant catheter assembly 610, which can be withdrawn through the steerable catheter assembly 608 and the delivery catheter assembly 606.

[0275] In some implementations, a cap 634 (shown in FIG. 89 ) is removably coupleable to the proximal end of the handle and covers the release knob 630 and the suture lock 650. Thus, the cap 634 can be positioned over the release knob 630 and the suture lock 650 to prevent or inhibit the release knob 630 and the suture lock 650 from accidentally contacting or getting caught during operation of the device, and can be removed to access the release knob 630 and the suture lock 650.

[0276] In several implementations, the handle 616 shown and described in FIGS. 77-88 can be modified to include a width control element as described above (e.g., the paddle width control 1628 of FIGS. 70 and 71). As described above, the width or paddle width control element can take any one of a variety of forms, and in the implementation shown in FIGS. 89-99, the paddle width control element is in the form of a paddle width control knob 890. In the implementation shown in FIGS. 89-99, the paddle width control knob 890 is configured as a rotatable knob that rotates about a central axis extending through the handle 616 without interfering with the clasp control tube and / or clasp control line 624 (shown in FIGS. 77 and 78) that extend to the suture lock 650 positioned at the end of the handle 616.

[0277] 90, the suture lock 650 is angled relative to the central axis to accommodate components associated with the paddle width control, while in some implementations, such as the implementation shown in Fig. 99, the suture lock 650 is parallel to the central axis. Thus, it should be understood that various modifications may be made to the handle 616 to incorporate a paddle width control.

[0278] FIG. 90 illustrates various components of an exemplary anchor or paddle width control incorporated into the handle 616. As shown in FIG. 90, a width control or knob 890 is coupled to a planetary gear box that includes a ring gear 892, a pair of planetary gears 894 (as shown in FIG. 90), and an elongated central gear 896. Thus, rotation of the width control knob 890 relative to the handle 616 is effective to cause rotation of the elongated central gear 896, which in turn is effective to axially move a width adjustment element (not shown in FIG. 90) and thereby adjust the width of the anchor or paddle, as described above.

[0279] The ring gear 892 is housed within a barrel 898 that is fixed to the width control or knob 890 such that as the width control or knob 890 rotates, the barrel 898 and the ring gear 892 fixed within the barrel 898 rotate. In the illustrated embodiment, the axis of each planetary gear 894 is fixed. The teeth of the ring gear 892 engage with the teeth of a pair of planetary gears 894 such that as the ring gear 892 rotates, the planetary gears 894 rotate on their fixed axis. The teeth of the pair of planetary gears 894 also engage with the teeth of an elongated central gear 896 such that as the pair of planetary gears 894 rotate, the elongated central gear 896 rotates.

[0280] 90, the paddle release knob 630 extends from the end of the elongated central gear 896. In implementations in which the handle 616 includes a paddle width control knob 890, the paddle release knob 630 can function as a control element connection knob 7308 (shown and described in FIGS. 73-75) to allow the device to be disengaged from an implant delivery system that includes the handle 616.

[0281] FIG. 91 shows the planetary gears 894 and the elongated central gear 896 in more detail. As shown in FIG. 91, the paddle release knob 630 is disposed at one end of the shaft 900. A second end of the shaft 900 is coupled to a follower 902. The follower 902 includes male threads configured to engage with the female threads of the elongated central gear 896. However, the follower 902 is rotationally fixed such that as the elongated central gear 896 rotates, the follower 902 is driven axially relative to the elongated central gear 896. The follower 902 is further fixedly coupled to a width adjustment element 8211. Thus, axial movement of the follower 902 causes axial movement of the width adjustment element 8211, which is effective to adjust the width of the paddle, as described above.

[0282] An elongated central gear 896 is positioned within the handle 616 adjacent the threaded retractor 654 and receives a shaft 904 extending from one end of the threaded retractor 654. The shaft 904 is rotatably coupled to the elongated central gear 896 adjacent the follower 902. A width adjustment element 8211 extends through a central passage of the shaft 904 and the threaded retractor 654. A clip 906 axially secures the shaft 904 to the elongated central gear 896. As described above, the threaded retractor 654 is rotationally fixed to a housing of the handle 616 and is configured to open and close a device coupled to the handle 616 when driven axially. The extended configuration allows the elongated central gear 896 to maintain mesh contact with the planetary gears 894 as the elongated central gear moves axially with the threaded retractor 654. Rotation of the elongated central gear 896 is effective to drive the follower 902 axially relative to the externally threaded retractor 654. Movement of the follower 902 relative to the externally threaded retractor 654 is effective to move the width adjustment element 8211 relative to the actuating portion of the device, thereby adjusting the width of the paddle.

[0283] FIG 93 shows a barrel 898 that extends from the handle 616 and surrounds various other components housed within the handle 616. The follower 902 extends from the end of the barrel 898 and can be viewed in place unobstructed by the elongated central gear 896. As shown in FIG 94, a guide 908 extends around the follower 902 and is configured to prevent or inhibit the follower 902 from rotating. The guide 908 is rotationally fixed relative to the handle 616.

[0284] In FIG. 95, an elongated central gear 896 is shown extending from one end of a barrel 898. A guide 908 and follower 902 extend through a central passage of the elongated central gear 896. As described above, rotation of the elongated central gear 896 is effective to axially drive the follower 902 because rotation of the follower 902 is prevented or inhibited by the guide 908. The external teeth of the elongated central gear 896 engage with the teeth of a pair of planetary gears 894, one of which is shown in FIG.

[0285] FIG. 96 also shows a carrier 910 that is part of the planetary gearbox. The carrier 910 is fixedly coupled to a portion of the handle 616, such as the housing 632, and provides support to the shafts and gears (e.g., the pair of planetary gears 894). To facilitate coupling to the handle 616, the carrier 910 is attached to a coupler 912. In the illustrated implementation, the coupler 912 is configured to receive a screw (e.g., the screw 914 in FIG. 99). However, in some implementations, the coupler 912 may take other forms or may be omitted, provided that the carrier 910 is otherwise coupled to the handle 616.

[0286] 97 shows the carrier and pair of planetary gears in place within a barrel 898. A ring gear 892 is positioned within the barrel 898 for engagement with a pair of planetary gears 894. An elongated central gear 896 extends between and engages the pair of planetary gears 894.

[0287] FIG. 98 is an end view of the handle 616 showing the planetary gear box. More specifically, FIG. 98 shows the control or knob 626, catch control member 628, and paddle width control 890, in addition to the ring gear 892, pair of planetary gears 894, and elongated central gear 896. As the arrows indicate, counterclockwise rotation of the paddle width control 890 rotates the ring gear 892 counterclockwise, which in turn rotates the pair of planetary gears 894 counterclockwise. Counterclockwise rotation of the pair of planetary gears 894 rotates the elongated central gear 896 clockwise. As described above, rotation of the elongated central gear 896 is effective to axially drive the width adjustment element 8211, thereby adjusting the width of the paddle of the device.

[0288] 99 shows the housing 632 positioned about the barrel 898. As described above, the screw 914 extends through the housing 632 and is received by the coupler 912 to secure the carrier 910 to the handle 616. In some implementations, the housing 632 includes a mechanism that allows a cap 634 ( FIG. 89 ) to be coupled to the housing 632.

[0289] FIG. 100 illustrates an implementation of a handle 3616 of a device / implant catheter assembly 3610 (e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.) and / or a delivery system used to deliver a device or implant such as device 8200 (FIG. 67). The handle 3616 is described with respect to delivery of device 8200, but may be used to deliver any suitable device or implant, such as any of the devices described herein. In the example of FIG. 100, the handle 3616 has a distal end 3617 and a proximal end 3619 opposite the distal end 3617. The handle 3616 may include some or all of a housing 3632, a paddle actuation portion 3625 having a paddle actuation control 3626, a clasp actuation portion 3631 having one or more clasp control members 3628, a paddle width control portion 3627 having a paddle width control 3629, and a release control 3630 (FIG. 101).

[0290] 100-102 and discussed below, in some implementations of the handle 3616, the clasp actuation portion 3631, the paddle actuation portion 3625, the paddle width control portion 3627, and the release control 3630 are disposed in series in the handle 3616. For example, in some implementations, the clasp actuation portion 3631 is positioned distally from the paddle actuation portion 3625, which is positioned distally from the paddle width control portion 3627, which is positioned in series within the handle 3616 distally from the release control 3630.

[0291] The housing 3632 may be formed from a variety of materials, including polymers such as polycarbonate, and may be formed as a unitary body (e.g., by injection molding) or may be fastened together in any one of a variety of manners, including with fasteners, pins, adhesives, or the like. As shown in FIGS. 101 and 102, the housing 3632 includes multiple lumens through which the clasp actuation lines 3624, actuation elements (e.g., actuation rods, actuation tubes, actuation wires, actuation shafts, etc.) 8102, and width control elements 8211 extend.

[0292] The handle 3616 may further include a flushing port 3638 similar to the flushing port 638 of the handle 616 of FIG. 77. Additional information regarding flushing ports that may be used in the handle 3616 may be found, for example, in International Publication No. WO 2020 / 112622, the entire contents of which are incorporated herein by reference. The housing 3632 may additionally include an opening for receiving a marking pin 3640 that may be removably coupled with an opening in the housing 3632 to accommodate the marking pin 3640. The opening in the marking pin 3640 may be similar to the opening in the marking pin 640 of the handle 616 of FIG.

[0293] In some implementations, the paddle actuation control 3626 is configured to control the position of the actuation element 8102 relative to the handle 3616 and the catheter of the delivery assembly. The paddle actuation control 3626 may be configured in a variety of ways, such as, for example, a knob, a button, a switch, one or more gears, etc. In some implementations, the paddle actuation control 3626 may be a lead screw mechanism that converts rotary motion to linear motion. For example, in some implementations, the paddle actuation control 3626 is configured to rotate about the longitudinal axis B of the handle 3616 to control the movement of a mechanism (e.g., a line, a shaft, a screw, an internally threaded component, an externally threaded component, a lever, a pulley, or any combination thereof) within the handle 3616 to control the position of the actuation element 8102. In some implementations, the paddle actuation control 3626 may include one or more linear actuators (e.g., electric actuators, manual actuators, pneumatic actuators, and / or hydraulic actuators) to control the movement of a mechanism (e.g., a line, a shaft, a screw, an internally threaded component, an externally threaded component, a lever, a pulley, or any combination thereof) within the handle 3616. A user interface, such as one or more actuation buttons, a touch screen, a voice command interface, or other suitable interface, may be provided (e.g., mounted on and / or within the handle housing) and operably connected to the linear actuators to enable a user to control the position of the actuation element 8102.

[0294] In the illustrated embodiment of FIGS. 101 and 102 , the paddle actuation control 3626 may be fixedly coupled to a first female threaded tube 3652 positioned within the housing 3632 of the handle 3616. In some implementations, when the paddle actuation control 3626 is rotated about the longitudinal axis B of the handle 3616, the first female threaded tube 3652 rotates relative to the housing 3632. In some implementations, an externally threaded nut or retractor 3654 is positioned within and engaged with the first female threaded tube 3652. The externally threaded nut or retractor 3654 may be rotationally fixed relative to the housing 3632. The externally threaded nut or retractor 3654 may be rotatably fixed in a variety of different manners. 101 , the pair of guide rods 3661 extend axially within the handle 3616, with each of the pair of guide rods 3661 secured to the housing 3632 at both ends of each of the guide rods 3661. In some implementations, a mounting bracket 3663 may be optionally included to couple the pair of guide rods 3661 to the housing 3632 at a distal end of each of the pair of guide rods 3661, and a collar 3666 couples the pair of guide rods 3661 to the housing 3632 at a proximal end of each of the pair of guide rods 3661. In some implementations, the system is configured such that as the first female-threaded tube 3652 is rotated, the male-threaded retractor 3654 is linearly advanced axially (i.e., distally and proximally) along the pair of guide rods 3661.

[0295] In some implementations, the male-threaded retractor 3654 is connected to a proximal end of the actuating element 8102 such that linear movement of the male-threaded retractor 3654 causes linear movement of the actuating element 8102, thereby moving the device 8200 between an open configuration and a closed configuration, as described herein. The proximal end of the actuating element 8102 may be connected to the male-threaded retractor 3654 in any suitable manner. In the illustrated example, the proximal end of the actuating element 8102 is secured to the male-threaded retractor 3654. The proximal end of the actuating element 8102 may be secured to the male-threaded retractor 3654 in any suitable manner, such as by a ferrule 3612 or other crimp connection positioned within a distal portion of a central longitudinal passage 3683 extending through the male-threaded retractor 3654. Converting the rotational movement of the paddle actuated control 3626 into linear movement of the actuating element 8102 may improve control and precision, thereby improving accuracy when opening and closing the device 8200.

[0296] The first female-threaded tube 3652 includes a proximal non-threaded portion 3657. Proximal movement of the actuating element 8102 after closure of the device 8200 can result in over-closure or compression of the device. The location of the non-threaded portion 3657 is selected to prevent or inhibit over-retraction of the actuating element 8102, thereby preventing or inhibiting over-closure of the device 8200. That is, the male-threaded retractor 3654 is no longer driven proximally when the male-threaded nut or retractor 3654 reaches the non-threaded portion 3657.

[0297] In some implementations, one or more optional springs 3656 or other suitable biasing elements may be positioned to press against one or more proximally facing surfaces 3655 of the male-threaded retractor 3654. As shown in FIG. 101 , the illustrated embodiment includes a pair of springs 3656, each received around a corresponding one of a pair of guide rods 3661. The springs 3656 are configured to bias the male-threaded retractor 3654 distally (e.g., toward the threads of the first female-threaded tube 3652) when the male-threaded retractor 3654 reaches the end of the threads of the first female-threaded tube 3652. In some implementations, the system and handle are configured such that continued rotation of the paddle actuated control or knob 3626 after the male threads of the male-threaded retractor 3654 and the female threads of the first female-threaded tube 3652 disengage provides an audible indication that the device is in the closed position. Biasing the male-threaded retractor 3654 may also reduce tilt in the threaded connection, thereby improving the stability of the paddle angle. Biasing the male-threaded retractor 3654 toward the female threads of the first female-threaded tube 3652 ensures that the male-threaded retractor 3654 will be re-engaged by the first female-threaded tube 3652 when the paddle actuation knob 3626 is rotated in the opposite direction corresponding to advancement of the actuation element 8102.

[0298] As shown in FIGS. 101 and 102 , in some implementations, the male-threaded retractor 3654 includes a proximally extending stem 3682 having a radial shoulder 3684 in a central longitudinal passage 3683 that acts as a stop. In some implementations, the width adjustment element 8211 extends through the interior of the actuating element 8102, through the central longitudinal passage 3683, and out from the proximal end of the stem 3682. In some implementations, an annular stop 3686 is attached to the exterior of the width adjustment element 8211 in the central passage 3683, such as the optional illustrated stiffening tube 8212 that is secured to a proximal portion of the width adjustment element. The annular stop 3686 is movable within the central longitudinal passage 3683 and configured to engage the radial shoulder 3684 to prevent or inhibit further proximal movement of the width adjustment element 8211 relative to the actuating element 8102. Thus, when the annular stop 3686 reaches the radial shoulder 3684, the width adjustment element 8211, the externally threaded retractor 3654, and the actuation element 8102 all move together as the width adjustment elements are moved closer together.

[0299] In some implementations, the handle 3616 includes an extension or link 3688 configured to transfer proximal movement of the male-threaded retractor 3654 to the width control portion 3627. The link 3688 may be configured in a variety of ways. In the illustrated embodiment of FIGS. 101 and 102, the link 3688 is formed as an elongated tube having a distal end 3690, a proximal end 3692 opposite the distal end 3690, and a central longitudinal passage 3694 extending through the link 3688. The width adjustment element 8211 extends through the central longitudinal passage 3694. The central longitudinal passage 3694 includes a counterbore 3696 at the distal end 3690 and a radial flange 3698 at the proximal end 3692. The counterbore 3696 is configured to receive the proximal end of the stem 3682 within the central longitudinal passage 3694. The radial flange 3698 defines a proximally-facing engagement surface 3699 .

[0300] The width control 3629 is configured to control the width of a portion of the anchor of the device, for example, to control the width of the outer paddle 8120 of the device 8200. The width control 3629 can be configured in a variety of ways, for example, as a knob, a button, a switch, one or more gears, etc. In some implementations, the width control 3629 can be a lead screw mechanism that converts rotary motion to linear motion. For example, in some implementations, the width control 3629 is configured as a knob that rotates about the longitudinal axis B of the handle 3616 to control the movement of a mechanism (e.g., a line, a shaft, a screw, a female threaded component, a male threaded component, a lever, a pulley, or any combination thereof) within the handle 3616 to control the position of the width control element 8211. In some implementations, the width control 3629 may include one or more linear actuators (e.g., electric actuators, manual actuators, pneumatic actuators, and / or hydraulic actuators) to control movement of a mechanism (e.g., a line, a shaft, a screw, an internally threaded component, an externally threaded component, a lever, a pulley, or any combination thereof) in the handle 3616. A user interface, such as one or more width control inputs, one or more actuation buttons, a touch screen, a voice command interface, or other suitable interface, may be provided (e.g., mounted on and / or within the handle housing) and operably connected to the linear actuators to enable a user to control the position of the width control element 8211.

[0301] As can be seen in the examples of FIGS. 101 and 102, in some implementations, the width control 3629 is fixed to a rotatable barrel 3700 such that rotation of the width control 3629 rotates the barrel 3700 about the longitudinal axis B of the handle 3616. The barrel 3700 has a distal end 3702 rotatably coupled to the housing 3632 and a proximal end 3704 defining a cavity 3706 in which the release control 3630 is received. In some implementations, the barrel 3700 is operably coupled via the width control 3629 to a second female threaded tube 3708 positioned within the housing 3632 of the handle 3616 such that rotation of the barrel 3700 about the longitudinal axis B rotates the second female threaded tube 3708 relative to the housing 3632. In the illustrated example, the second female threaded tube 3708 may also move axially relative to the housing 3632. The distal end of the second female threaded tube 3708 abuts a proximally facing engagement surface 3699 of a radial flange 3698 of the link 3688 such that axial movement of the link 3688 causes the second female threaded tube 3708 to move proximally. The proximal end of the second female threaded tube 3708 abuts an end cap 3710.

[0302] The connection between the barrel 3700 and the second female threaded tube 3708 can be any suitable connection that provides for rotational movement of the second female threaded tube 3708 while also allowing axial movement of the second female threaded tube 3708 in response to rotation of the barrel 3700. In the illustrated embodiment, the barrel 3700 connects to the second female threaded tube 3708 via a splined connection.

[0303] The second female threaded tube 3708 includes a central longitudinal passage 3712. Positioned within the central longitudinal passage 3712 are an externally threaded drive member 3714 and a cap 3715. The externally threaded drive member 3714 is configured to engage the internal threads of the second female threaded tube 3708. The cap is positioned on a distal end of the externally threaded drive member 3714.

[0304] In some implementations, the male threaded drive member 3714 is rotationally fixed relative to the housing 3632. The male threaded drive member 3714 may be rotationally fixed in a variety of different manners. In the example illustrated by FIGS. 101 and 102, a pair of guide rods 3716 extend axially through a central longitudinal passage 3712 of the second female threaded tube 3708. Each of the pair of guide rods 3716 is fixed relative to the housing 3632 at both ends of the guide rods 3716. The pair of guide rods 3716 are attached to the housing 3632 at a distal end of each of the pair of guide rods 3716, and a proximal end of each of the guide rods 3716 is fixed to the end cap 3710. Thus, as the barrel 3700 is rotated, the male threaded drive member 3714 is linearly advanced axially (i.e., distally and proximally) along the pair of guide rods 3716. In some implementations, the male threaded drive member 3714 may include longitudinal grooves (not shown) that receive a pair of guide rods 3716 .

[0305] In the illustrated example, the male threaded drive member 3714 is configured as a tube having a central longitudinal passage 3718 extending therethrough. The central longitudinal passage 3718 includes a threaded nut 3720 adjacent a proximal end of the male threaded drive member 3714. In some implementations, instead of a threaded nut, a female thread may be integrally formed within the passage 3718 of the male threaded drive member 3714. A biasing member, such as a coil spring 3722, may be positioned within the central longitudinal passage 3718 between the threaded nut 3720 and the cap 3715 to bias the threaded nut 3720 toward the proximal end of the central longitudinal passage 3718.

[0306] The release control 3630 is configured to release the device 8200 from the device / implant catheter assembly 3610. The release control 3630 may be configured in a variety of ways, such as, for example, a knob, a button, a switch, one or more gears, etc. In some implementations, the release control 3630 may be a lead screw mechanism that converts rotary motion to linear motion. In some implementations, the release control 3630 may be a release button configured to release the device upon depression of the button. In some implementations, the release control 3630 may include one or more linear actuators (e.g., electric actuators, manual actuators, pneumatic actuators, and / or hydraulic actuators) to control movement of mechanisms (e.g., lines, shafts, screws, female threaded components, male threaded components, levers, pulleys, or any combination thereof) within the handle 3616. A user interface, such as one or more buttons, a touch screen, a voice command interface, or other suitable interface, may be provided (e.g., mounted on and / or within the handle housing) and operably connected to the linear actuators to enable a user to release the device.

[0307] In the illustrated embodiment, the release control 3630 is configured as a knob that rotates about the longitudinal axis B of the handle 3616. As can be seen in FIGS. 101 and 102 , the release control 3630 is positioned at a proximal end 3619 of the handle 3616 and is received within a cavity 3706 of the barrel 3700. In some implementations, the handle 3616 includes a stem 3724 that is proximally attached to the release control 3630 and extends distally toward the male threaded drive member 3714. The release screw 3726 is threadably received within a threaded nut 3720 of the male threaded drive member 3714. A distal end of the stem 3724 is configured to engage a head of the release screw 3726 such that the release screw 3726 may be threaded into or unthreaded from the threaded nut 3720 by rotational movement of the release control 3630.

[0308] In some implementations, the width adjustment element 8211 extends through the length of the handle 3616 from the distal end 3617 to the release control 3630, and the width adjustment element is fixed such that movement of the release control 3630 results in corresponding movement of the width adjustment element 8211. In some implementations, at least a portion of the width adjustment element 8211 is received within a support tube 8212 (e.g., a hypotube) in the handle 3616. The support tube 8212 may be fixed to the release control 3630 along with the width adjustment element 8211. The support tube 8212 is configured to stiffen a portion of the width adjustment element 8211 within the handle 3616. The handle 3616 may also include a cover or cap 3728 over the release control 3630 to prevent or inhibit unintended release of the device 8200.

[0309] 103-105 show an exemplary clasp actuation portion 3631 of the handle 3616. The illustrated clasp actuation portion 3631 includes a clasp control member 3628 configured to move a clasp of the device (e.g., clasp 8134 of device 8200 via actuation line 8102 shown in FIGS. 122-124) via a clasp actuation line. The clasp 8134 may be configured in the same manner as any of the clasps described herein. The clasp actuation portion 3631 may be configured in a variety of ways. In some implementations, the device / implant catheter assembly 3610 includes two clasp actuation lines 3624 (FIGS. 120 and 121), each coupled to a corresponding clasp control member 3628 at a proximal end of the clasp actuation line 3624. Each clasp control member 3628 may be, for example, an axially movable control or slider coupled to a corresponding clasp actuation line 3624 to move the clasp actuation line 3624 axially relative to the actuation element 8102. Each of the clasp control members 3628 may be manipulated independently of the other clasp control members such that each clasp actuation line 3624 is moved relative to the actuation element 8102 and the other clasp actuation lines 3624. The clasp control members 3628 may be fixed (e.g., locked) relative to one another such that the clasp actuation lines 3624 are moved axially together relative to the actuation element 8102.

[0310] The clasp control member 3628 may be configured in a variety of ways, including any of the clasp control members disclosed herein. In the implementation shown in FIG. 103, the clasp control member 3628 is similar to the clasp control member 628 of FIG. 77, and thus the previous description of the clasp control member 3628 applies equally to the clasp control member 3628 shown in FIG. 103. The handle 3616 includes a pair of line engagement members 3730 configured to engage the clasp actuation lines 3624 to move the lines in response to movement of the clasp control member 3628. The line engagement members 3730 may be configured in a variety of ways. In the illustrated embodiment, each line engagement member 3730 is configured as an elongated rod having a proximal end secured to the corresponding clasp control member 3628 and a distal end configured to engage the corresponding clasp actuation line 3624. In the illustrated embodiment, the distal end of each line engagement member 3730 includes a laterally extending passage 3732 through which the clasp actuation line 3624 may extend.

[0311] In some implementations, the handle 3616 may include a fluid body housing 3734 positioned within the housing 3632 of the handle 3616. The fluid body housing includes a distal stem 3736 defining a passageway 3738, a body portion 3740 defining an interior space 3742, and a proximal cap 3744. The proximal cap 3744 includes a plurality of openings 3746 configured to allow the actuation element 8102 and the width adjustment element 8211 to extend through the proximal cap 3744. Additionally, each of the pair of line engagement members 3730 extends distally from the clasp control member 3628 through a corresponding opening 3746 in the proximal cap 3744 into the interior space 3742. The body portion 3740 further includes a line anchor 3748 to which a proximal end of the clasp actuation line 3624 is attached. The line anchor 3748 can be configured in a variety of ways, including location, orientation, and anchoring means. In the illustrated embodiment, the line anchor 3748 includes a passageway 3750 from the interior space 3742 to the exterior of the body portion 3740, and a boss 3752 surrounds the passageway 3750 to which the clasp actuation line 3624 is attached.

[0312] 106-114 show various stages of an exemplary deployment of an exemplary device 8200 with the handle 3616. The handle 3616 may be used to deploy any of the devices disclosed herein, such as the repair or treatment devices 8200, 100, 200, 300, 402, 9100. As shown in FIG. 107, the device 8200 is in a fully extended position with the outer paddle 8120 and inner paddle 8122 fully extended and the clasp 8134 in a fully open position. Additionally, the outer paddle 8120 is in an extended position.

[0313] As shown in FIG. 106, when the device 200 is in the fully open position, the male-threaded retractor 3654 is in its distal-most position within the first female-threaded tube 3652, the radial flange 3698 is positioned near or adjacent to the collar 3666, and the release control 3630 is positioned within the cavity 3706 of the barrel 3700.

[0314] To move the device 200 through the partially closed position (FIG. 109) to the fully closed position (FIG. 110), the actuating element 8102 is retracted, moving the paddle radially outward, as shown in FIG. 109, so that in the fully closed position it is positioned along the clasp 8134.

[0315] To retract the actuating element 8102, the paddle actuation control 3626 is rotated which rotates the first female threaded tube 3652 relative to the housing 3632, thereby axially driving the male threaded retractor 3654 in the proximal direction, as shown in FIG. 108. Axial movement of the male threaded retractor 3654 causes axial movement of the actuating element 8102, which moves the device 8200 between the fully extended configuration (FIG. 107) and the closed configuration (FIG. 110).

[0316] Axial movement of the male threaded retractor 3654 also causes axial movement of the second female threaded tube 3708 via the link 3688. Axial movement of the second female threaded tube 3708 causes axial movement of the release control 3630 between a position within the cavity 3706 of the barrel 3700 (shown in FIG. 106 ) and an extended position (shown in FIG. 108 ) in which the release control 3630 extends proximally from the cavity 3706 of the barrel 3700. Thus, in some implementations, the axial position of the release control 3630 relative to the housing 3632 is a visual indicator as to the configuration of the device 8200.

[0317] 112, the device 8200 is in a fully closed position and the outer paddle 8120 is in an extended or expanded position. In this position, the link 3688, the release control 3630, the second female threaded tube 3708, and the components within the second female threaded tube 3708 (e.g., the male threaded drive member 3714) have moved axially such that the radial flange 3698 of the link 3688 is located within the distal end 3702 of the barrel 3700, as shown in FIG.

[0318] To move the outer paddle 8120 from the expanded position (FIG. 112) to the constricted position (as shown by arrow N in FIG. 114), the width adjustment element 8211 is retracted. While FIGS. 111 and 113 show the device 8200 in a fully closed position when the outer paddle 8120 is moved from the expanded position to the constricted position, the outer paddle 8120 can also be moved between the expanded and constricted positions while the device 8200 is in the fully expanded position, the open position, or any partially closed position. Retracting the width adjustment element 8211 pulls the inner end 8968 (FIG. 69) of the paddle frame 8224 and a portion of the connector 8266 against the actuation cap 8214 (as shown by arrow C in FIG. 114).

[0319] To accommodate the width adjustment element 8211, the width control 3629 is rotated, which causes the barrel 3700 and the second female threaded tube 3708 to rotate relative to the housing 3632, thereby axially driving the male threaded drive member 3714 in a proximal direction, as shown in FIG. 113. Axial movement of the male threaded drive member 3714 causes axial movement of the release control 3630, via the stem 3724. Because the width adjustment element 8211 is attached to the release control 3630, axial movement of the release control 3630 causes the width adjustment element 8211 to move axially, moving the outer paddle 8120 of the device 8200 to a constricted position. Axial movement of the width adjustment element 8211 causes the annular stop 3686 to move axially within the central longitudinal passage 3683 of the male threaded retractor 3654 (e.g., move axially relative to the male threaded retractor 3654).

[0320] 115-117 show the handle 3616 in various stages of release of the device 8200. In FIG. 115, the handle 3616 is shown in the same position as in FIG. 113 (e.g., the device 8200 is in a fully closed position and the outer paddle 8120 is in a constricted position) with the cover 3728 on the release control 3630. To release the device 8200, the width adjustment element 8211 is decoupled from the coupler 8972 of the device 8200 (FIGS. 68 and 69). To decouple the width adjustment element 8211 from the coupler 8972, the cover 3728 is removed from over the release control 3630, as shown by arrow R in FIG. 116, and the release control 3630 is rotated. Rotating the release control 3630 rotates the release screw 3726, disengaging the release screw 3726 from the threaded nut 3720 in the handle 3616, while rotating the width adjustment element 8211 disengages the width adjustment element 8211 from the coupler 8972 in the device 8200. Removing the release screw 3726 from the threaded nut 3720 also uncouples the width adjustment element 8211 from the width control 3629.

[0321] Once the release screw 3726 and width adjustment element 8211 are disengaged from the threaded nut 3720 and coupler 8972, respectively, the release control 3630 can be pulled axially away from the barrel 3700, as shown by arrow B in FIG. 117. As the release control 3630 is pulled axially away, the width adjustment element 8211 is pulled along with the release control 3630, causing the annular stop 3686 to move axially within the central longitudinal passage 3683.

[0322] In the embodiment shown in FIG. 118, the device 8200 is coupled to the device / implant catheter assembly by a capture mechanism 3760. The actuating element 8102 extends through the device / implant catheter assembly, through the capture mechanism 3760, and is attached to the device 8200 by a coupler 8213. In FIG. 118, the device 8200 is shown in an open state to provide an unobstructed view of the coupler 8213. However, during release of the device 8200, the device 8200 is in a fully closed position. In the illustrated embodiment of FIG. 118, the distal end of the actuating element 8102 is received within the coupler 8213 and includes two longitudinally extending legs 8215 separated by a slot 8216. The longitudinally extending legs 8215 may be configured (e.g., shaped) to be biased inwardly toward one another. A width adjustment element 8211 (not shown in FIG. 118 ) extends coaxially within the actuation element 8102 and urges the longitudinally extending legs 8215 outwardly and away from one another, coupling the actuation element 8102 to the coupler 8213. A variety of different capture mechanisms are possible that function in similar or different ways, e.g., threaded portions, snap fit connections, locks, clasps, sutures, loops, etc.

[0323] In some implementations, after the release screw 3726 and width adjustment element 8211 are unscrewed from the threaded nut 3720 and coupler 8972, respectively, when the release control 3630 is pulled axially in the proximal direction, the width adjustment element 8211 is withdrawn relative to the actuation element 8102. Once the width adjustment element 8211 is withdrawn past the coupler 8213, the two longitudinally extending legs 8215 move inwardly to uncouple the actuation element 8102 from the coupler 8213.

[0324] 117, sufficient axial movement of the annular stop 3686 within the central longitudinal passage 3683 may cause the annular stop 3686 to engage a radial shoulder 3684 at a proximal end of the central longitudinal passage 3683. As a result, because the male threaded retractor 3654 is within the proximal unthreaded portion 3657 of the first female threaded tube 3652 (e.g., not engaged with the female threads of the first female threaded tube 3652), the male threaded retractor 3654 is pulled by the release control 3630 and the width adjustment element 8211 is pulled by further axial movement of the release control 3630. Because the actuating element 8102 is attached to the male threaded retractor 3654 and removed from the coupler 8213, the actuating element 8102 is also pulled axially relative to the housing 3632. The actuating element 8102 can be pulled until the proximal end of the actuating element dislodges the coupler 3760, releasing the coupler from the device.

[0325] FIG. 119 illustrates an exemplary clasp actuation line 3624. The clasp actuation line 3624 can be configured in a variety of ways, including but not limited to the material used, the construction (e.g., braid), length, and diameter. In the illustrated example of FIG. 119, the clasp actuation line 3624 includes a proximal or terminal end 3754, a distal end 3756 opposite the proximal end 3754, and a closed opening 3758, such as a loop or lacing hole, formed in the distal end 3756. The distance between the proximal end 3754 and the distal end 3756 defines a length L of the clasp actuation line 3624. In some implementations, the length L is less than 100 inches or less than 80 inches. In some implementations, the length ranges from 65 inches to 75 inches, or from 68 inches to 72 inches.

[0326] 120-124 show simplified or schematic (FIGS. 120 and 121) and more detailed (FIGS. 122-124) views of an exemplary device / implant catheter assembly 3610 coupled to a device 8200, with each of the clasp actuation lines 3624 coupled to a corresponding clasp control member 3628 positioned on the handle 3616. The device 8200 is coupled to the device / implant catheter assembly 3610 by a capture mechanism 3760 through which the actuation element 8102 (e.g., FIG. 120) extends.

[0327] In some implementations, the proximal end of each clasp actuation line 3624 is attached to a line anchor 3748. Each clasp actuation line 3624 extends from the line anchor 3748, passes through a passage 3732 at the distal end of each line engagement member 3730, and extends distally through the device / implant catheter assembly 3610 (e.g., into the catheter / sheath) to the device 8200. In the device, each clasp actuation line 3624 extends through an opening 8235 in a corresponding one of the clasps 8134 of the device 8200, and the closed loop 3758 is attached to a capture mechanism 3760. The capture mechanism 3760 is configured to removably attach the device 8200 to the device / implant catheter assembly 3610. The closed loop 3758 can be attached to any suitable portion of the capture mechanism 3760 that allows the clasp actuation line 3624 to be released when the capture mechanism 3760 releases the device 8200.

[0328] The capture mechanism 3760 can be configured in a variety of ways. In the embodiment illustrated in FIGS. 120-124, the capture mechanism 3760 includes a plurality of flexible arms 8228 configured to pivot between a first or released configuration (FIGS. 121, 123, and 124) and a second or coupled configuration (FIGS. 120 and 122). The flexible arms 8228 are held in the coupled configuration by the actuating element 8102. When the actuating element 8102 is retracted from the capture mechanism 3760, the flexible arms 8228 pivot open to release the device 8200 from the device / implant catheter assembly 3610 (FIGS. 121 and 123 and 124). When the flexible arm 3672 pivots open, the closed loop 3758 at the distal end 3756 of the clasp actuation line 3624 is released from the capture mechanism 3760 and the clasp actuation line 3624 can be pulled through the opening 8235 in the clasp 8134 and removed from the device / implant catheter assembly 3610.

[0329] 125-127 show an exemplary capture mechanism 3760 through various stages of releasing the device 8200. The capture mechanism 3760 may be removably coupled to a proximal collar 8251 of the device 8200. The capture mechanism 3760 includes a plurality of flexible arms 8228 and a plurality of stabilizer members 8230. The flexible arms 8228 and stabilizer members 8230 may be configured in a variety of ways. In the illustrated embodiment, the stabilizer members 8230 are formed as longitudinally projecting fingers or prongs having a distal end. The flexible arms 8228 may include an aperture 8232 and a lacing hole 8234. The flexible arms 8228 may be configured to pivot between a first or released configuration (FIGS. 126 and 127) and a second or coupled configuration (FIG. 125). In the first configuration, the flexible arms 8228 extend radially outward relative to the stabilizer member 8230. In the second configuration, the flexible arms 8228 extend axially parallel to the stabilizer member 8230 and the lacing holes 8234 radially overlap. The flexible arms 8228 can be configured (e.g., shaped) to be biased into the first configuration.

[0330] The proximal collar 8251 of the device 8200 may include a central opening 8252 configured to slidably receive the actuating element 8102. The proximal collar 8251 may also include a plurality of bosses or protrusions 8254 and a plurality of guide openings 8255. The protrusions 8254 may extend radially outward and may be offset circumferentially (e.g., by about 90 degrees) relative to the guide openings 8255. The guide openings 8255 may be disposed radially outward from the central opening 8252. The protrusions 8254 and guide openings 8255 of the proximal collar 8251 may be configured to releasably engage a capture mechanism 3760 for attaching the device 8200 to a device / implant catheter assembly, as shown in FIG. 125. In particular, as shown in FIG. 125 , when the capture mechanism 3760 is in the coupled configuration, the plurality of bosses or protrusions 8254 are received within the openings 8232 of the flexible arms 8228, the plurality of stabilizer extensions or stabilizer members 8230 are received within the guide openings 8255, and the actuation element 8102 is received through the radially overlapping lacing holes 8234. Further, the clasp actuation lines 3624 are attached to the capture mechanism 3760 by receiving each of the stabilizer extensions / members 8230 through a closed loop 3758 of a corresponding clasp actuation line 3624 before the stabilizer extensions / members 8230 are received within the guide openings 8255. Thus, the closed loop 3758 is captured between the proximal collar 8251 of the device 8200 and the capture mechanism 3760.

[0331] 126 and 127 , in some implementations, the device 8200 may be released from the device / implant catheter assembly by retracting the actuation shaft 8102 proximally relative to the capture mechanism 3760 such that a distal end portion of the actuation shaft 8102 is withdrawn from the lacing hole 8234 of the capture mechanism 3760. This allows the flexible arms 8228 of the capture mechanism 3760 to move radially outwardly, away from the projections 8254 of the proximal collar 8251. The stabilizer extensions or stabilizer members 8230 of the capture mechanism 3760 may then be withdrawn from the guide openings 8255 of the proximal collar 8251 by pulling the capture mechanism 3760 proximally, as shown by arrow Y in FIG. With the stabilizer member 8230 withdrawn from the guide opening 8255, the closed loop 3758 is no longer trapped on the stabilizer extension / member 8230 by the proximal collar 8251. As a result of pulling the capture mechanism 3760 proximally, the stabilizer member 8230 is withdrawn from the closed loop 3758, releasing the clasp actuation line 3624. The clasp actuation line 3624 can then be retracted through the opening 8235 of the clasp 8134, as shown in FIG. 127, thereby releasing the device 8200 from the device / implant catheter assembly.

[0332] 128-137 show various implementations of the clasp actuation line 3624 of FIG. 119, including various configurations of the distal end 3756 of the clasp actuation line 3624. The clasp actuation line 3624 can be configured in a variety of ways, including but not limited to the material used, the construction (e.g., braid), the length of the line, the line diameter, the shape, and the diameter of the closed loop 3758. In some implementations, the clasp actuation line 3624 is braided. The braided clasp actuation line 3624 can include any suitable number and size of yarns. For example, the clasp actuation line 3624 can be braided with 4-100 ends using 10-400 dtex yarns. In some implementations, the clasp actuation line 3624 is a 16 end braid of 25 dtex yarns, a 32 end braid of 10 dtex yarns, an 8 end braid of 55 dtex yarns, or a 4 end braid of 110 dtex yarns.

[0333] In some implementations, the clasp actuation line 3624 has a tensile strength in the range of 20N to 100N, or 30N to 70N, or 30N to 50N. In some implementations, the clasp actuation line 3624 is made from an ultra-high molecular weight polyethylene material, such as, for example, Dyneema® fiber. In some implementations, the closed loop 3758 of the clasp actuation line 3624 has a nominal loop diameter in the range of 0.0275 inches to 0.0425 inches, or 0.03 inches to 0.04 inches, or 0.0325 inches to 0.0375 inches, and a circumference in the range of 0.07 inches to 0.15 inches, or 0.09 inches to 0.13 inches. In some implementations, the clasp actuation line 3624 has a diameter in the range of 0.003 inches to 0.008 inches, or 0.004 inches to 0.006 inches. In some implementations, the clasp actuation line 3624 has a permanent deformation of less than 0.5% under a cyclic load of 0N to 10N, or less than 0.3% under a cyclic load of 0N to 10N.

[0334] 128 and 129, the illustrated embodiment of the clasp actuation line 3624 has an elongated braided body 3767 having a bifurcated section 3762 that forms a closed loop 3758 and an integral section 3764 that forms the remainder of the clasp actuation line 3624. The bifurcated section 3762 may be formed as part of the braiding process, rather than forming a loop in the integral section of the braided line after the line has been braided. In some implementations, the clasp actuation line 3624 may be made in a continuous process in which multiple clasp actuation lines are formed into a single continuous braided line 3766 with alternating bifurcated and integral sections, and then cut into multiple clasp actuation lines. However, in some implementations, only a single clasp actuation line 3624 may be formed.

[0335] The clasp actuation line 3624 is formed from a single continuous braided wire 3766. A section of the single continuous braided wire 3766 having a desired length and one bifurcated section 3762 is cut from the continuous braided wire 3766 such that the bifurcated section 3762 is proximate to the end (e.g., near where the continuous braided wire 3766 is cut). The end proximate to the bifurcated section 3762 forms the distal end 3756 of the clasp actuation line 3624. The distal end 3756 may be heat sealed or treated, or sealed or treated in another manner to prevent or inhibit separation of the threads at the distal end 3756.

[0336] 130 and 131, the illustrated embodiment of the clasp actuation line 3624 has an elongated braided body 3767 with a distal end portion 3768 of the braided body 3767 tucked back into a more proximal portion of the braided body 3767 forming a closed loop 3758 and a tucked portion 3771. The end portion 3768 can be tucked into the braided body 3767 in a number of ways. In the illustrated embodiment, a pull wire or needle 3770 is tied or connected to the end portion 3768 as shown in FIG. 131. The pull wire 3770 is inserted axially through a portion of the braided body 3767 proximal to the end portion 3768. For example, a needle or other piercing device (not shown) can be attached to the pull wire 3770 and used to thread the pull wire 3770 axially along a portion of the braided body 3767 to form the closed loop 3758. In some implementations, the distal portion 3768 may be attached directly to a needle or other puncture device. The pushed portion 3771 has a pushed length TL (FIG. 131) that may vary in different implementations. In some implementations, the pushed length TL is 0.25 inches or more, 0.5 inches or more, 1.0 inches or more, or 1.5 inches or more. In some implementations, the pushed length is in the range of 0.25 inches to 1.5 inches.

[0337] 132 and 133, the illustrated embodiment of the clasp actuated line 3624 has a braid 3767 using a Blummellock splice or other method of threading a distal end portion 3768 of the braid 3767 through a more proximal portion of the braid 3767 to form a closed loop 3758 at the distal end 3756. The distal end portion 3768 may be attached to a piercing device 3769, such as a splicing needle. As shown in FIG. 132, the piercing device 3769 with the distal end portion 3768 attached may be inserted laterally through a more proximal portion of the braid 3767 to form a threaded portion 3773 proximal to the closed loop 3758, as shown in FIG. The distal end portion 3768 may be threaded back and forth through the braid 3767 at locations adjacent to one another along the braid 3767 any suitable number of times to lock the closed loop 3758 in place and secure the distal end portion 3768. After being woven back and forth through the braid 3767, the exposed distal end portion 3768 may be cut off, secured to the braid 3767 in any suitable manner, or tucked into a portion of the braid 3767.

[0338] 134 and 135, the illustrated embodiment of the clasp actuation line 3624 has an elongated braided body 3767 and forms a closed loop 3758 at a distal end 3756 through a combination of weaving a distal end portion 3768 of the braided body 3767 through a more proximal portion of the braided body 3767 to form a threaded portion 3773, and forcing the distal end portion 3768 axially into the braided body 3767 to form a tucked portion 3771 (e.g., a combination of the methods described for the clasp actuation line 3624 of FIGS. 130-133). In the illustrated embodiment, the tucked portion 3771 is proximal to the threaded portion 3773.

[0339] In particular, the distal end portion 3768 may be attached to a piercing device 3769, such as a bonded needle. As shown in FIG. 134, the piercing device 3769 with the distal end portion 3768 attached may be inserted laterally through a more proximal portion of the braid 3767 to form a closed loop 3758, as shown in FIG. 133. The distal end portion 3768 may be threaded back and forth through the braid 3767 at adjacent locations along the braid 3767 any suitable number of times to lock the closed loop 3758 in place and secure the distal end portion 3768. After being woven laterally through the braid 3767 one or more times, the piercing device 3769 may be inserted axially through a portion of the braid 3767 and retracted to retract the distal end portion 3768 axially along a portion of the braid 3767 into the braid 3767 to lock the closed loop 3758 in place and secure the distal end portion 3768. The tucked portion 3771 has a tucked length TL, which may vary in different implementations. In some implementations, the tucked length TL is 0.25 inches or more, 0.5 inches or more, 1.0 inches or more, or 1.5 inches or more. In some implementations, the tucked length is in the range of 0.25 inches to 1.5 inches.

[0340] 136 and 137, the illustrated embodiment of the clasp actuation line 3624 has a braid 3767 having a closed loop 3758 formed at a distal end portion 3768. In the illustrated embodiment, the closed loop 3758 is formed by laterally piercing the distal end portion 3768 with any suitable piercing device 3769, such as a needle or pin, to form a lateral hole 3772 in the distal end portion 3768. Thus, the braid 3767 is divided by the piercing device 3769 to form the hole 3772 and form the closed loop 3758. The distal end 3768 of the braid may be heat sealed or otherwise sealed to prevent or inhibit separation of the threads at the distal end 3768.

[0341] FIG. 138 illustrates an implementation of a device / implant catheter assembly 610 (e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.). In the example illustrated in FIG. 138, the device / implant catheter assembly 610 may include an inner element or actuation element 112, a coupler or capture mechanism 620, an outer shaft 611, a handle 616 (shown diagrammatically), and a clasp actuation line 624. A proximal end portion 622a of the outer shaft 611 may be coupled to extend distally from the handle 616, and a distal end portion 622b of the outer shaft 611 may be coupled to the coupler or capture mechanism 620. The actuation element 112 may extend distally from an actuation control 626 (shown diagrammatically in FIG. 138), through the handle 616, through the outer shaft 611, and further through the coupler or capture mechanism 620. The actuation element 112 may be movable (e.g., axially and / or rotationally) relative to the outer shaft 611 and the handle 616. The clasp actuation line 624 may extend through the handle 616 and the outer shaft 611 and may be axially movable relative to the handle 616 and the outer shaft 611. The clasp actuation line 624 may also be axially movable relative to the actuation element 112.

[0342] As shown in FIG. 138 , the actuating element 112 (e.g., actuating rod, actuating tube, actuating shaft, actuating wire, etc.) of the device / implant catheter assembly 610 may be removably coupled to the cap 114 of the device 604. The actuating element 112 extends from a proximal end portion 112a to a distal end portion 112b. In some implementations, the distal end portion 112b of the actuating element 112 may include male threads configured to removably engage with female threads of the cap 114 of the device 604. Thus, when the actuating element 112 is rotated in a first direction (e.g., clockwise) relative to the cap 114 of the device 604, the actuating element 112 releasably secures to the cap 114, while when the actuating element 112 is rotated in a second direction (e.g., counterclockwise) relative to the cap 114 of the device 604, the actuating element 112 is released from the cap 114.

[0343] 138, the outer shaft 611 of the device / implant catheter assembly 610 is an elongate shaft extending axially between a proximal end portion 622a coupled to the handle 616 and a distal end portion 622b coupled to the coupler 620. The outer shaft 611 may also include an intermediate portion 622c disposed between the proximal end portion 622a and the distal end portion 622b. The outer shaft 611 may be formed from a variety of materials including metals and polymers. For example, in one particular implementation, the outer shaft may include an outer covering or coating such as stainless steel, polyether block amide (PEBA), and / or a polymer that is reflowed over the outer portion.

[0344] 138, the clasp actuation lines 624 are coupled to the clasps 130a, 130b on the device 604 through holes 235 in the clasps 130a, 130b and extend axially through the outer shaft 611 between the clasps 130a, 130b and the handle 616. In some implementations, the clasp actuation lines 624 are each coupled to a clasp control member 628a, 628b at a proximal end portion of the clasp actuation line 624. Each clasp control member 628a, 628b can be, for example, an axially moving control or slider coupled to a corresponding clasp actuation line 624, causing the clasp actuation line 624 to move axially relative to the outer shaft 611 and actuation element 112. Each of the clasp control members 628a, 628b may be operated independently of the other clasp control members such that each clasp actuation line 624 is moved relative to the outer shaft 611, the actuation element 112, and the other clasp actuation line 624, or the clasp control members 628a, 628b may be fixed (e.g., locked) relative to one another such that the clasp actuation lines 624 are moved axially together relative to the outer shaft 611 and the actuation element 112.

[0345] In the illustrated embodiment of FIG. 138, each clasp control member 628a, 628b is movable between a first position, as indicated by the clasp control member 628b in FIG. 138, and a second position, as indicated by the clasp control member 628a in FIG. 138. The first position of each clasp control member 628a, 628b is associated with an open position of the corresponding clasp 130, and the second position is associated with a closed position of the corresponding clasp 130. For example, in the illustrated embodiment, moving one of the clasp control members 628a, 628b to the first position retracts the corresponding clasp 130 to the open position, and moving one of the clasp control members 628a, 628b to the second position releases the corresponding clasp 130, allowing the clasp to move to the closed position.

[0346] In the illustrated embodiment of FIG. 138, each clasp control member 628a, 628b is biased to the second position. Each clasp control member 628a, 628b may be biased to the second position in a variety of ways, such as by a spring, a magnet, and an elastic material. In the illustrated embodiment of FIG. 138, each clasp control member 628a, 628b is spring loaded. In particular, the handle 616 includes a pair of springs 627. Each spring 627 is coupled to a corresponding one of the clasp control members 628a, 628b in a manner that biases the clasp control members 628a, 628b to the second position. Each of the clasp control members 628a, 628b may further include a removable retention device 633, such as, for example, a locking mechanism, associated with each clasp control member 628a, 628b. The removable retaining devices 633 may be configured in any suitable manner capable of retaining the corresponding clasp control member 628a, 628b in a first position against the bias of the spring 627 until removed. Each of the retaining devices 633 may include a manual interface for a user to actuate to release the clasp control member 628a, 628b and allow the spring 627 to move the clasp control member 628a, 628b to the second position.

[0347] The clasp control members 628a, 628b may be biased to the second position with sufficient force to cause the clasp control members 628a, 628b to move rapidly from the first position to the second position and close the clasp quickly. In some implementations, the clasp control members 628a, 628b move from the first position to the second position in less than 500 milliseconds (ms), less than 100 ms, less than 75 ms, or less than 50 ms.

[0348] 139, a schematic representation of a device or implant 9100 (e.g., an implantable prosthetic device, prosthetic spacer device, valve repair device, treatment device, etc.) is shown in a partially open, grasp-ready configuration. The device or implant 9100 corresponds to the previously described device 100 of FIGS. 8-14, and the description of device 100 applies equally to device 9100. However, device 9100 may be any of the valve repair or treatment devices disclosed herein. The device or implant 9100 is deployed from a delivery system 9102. The delivery system 9102 may include one or more of a catheter, a sheath, a guide catheter / sheath, a delivery catheter / sheath, a steerable catheter, a device / implant catheter, a tube, a channel, a pathway, combinations thereof, and the like. The device or implant 9100 includes an optional interface portion / region 9104 and an anchor portion / region 9106.

[0349] In some implementations, the interface portion 9104 of the device or implant 9100 includes an interface member 9110 (e.g., a spacer, interface element, plug, membrane, sheet, membrane, etc.) that is adapted to be implanted between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and is slidable relative to an actuating element 9112 (e.g., a drive wire, drive shaft, actuating tube, etc.).

[0350] The anchor portion 9106 includes one or more anchors 9108 that are actuable between an open and closed state and can take a variety of forms, such as, for example, paddles, gripping elements, or the like. Actuation of the actuation element 9112 opens and closes the anchor portion 9106 of the device 9100. The actuation element 9112 (as well as other actuation means and elements disclosed herein) can take a variety of different forms (e.g., wires, rods, shafts, tubes, threads, sutures, lines, strips, combinations thereof, etc.), can be made from a variety of different materials, and can have a variety of configurations. As one example, the actuation element can be threaded such that rotating the actuation element moves the anchor portion 9106 relative to the interface portion 9104. Alternatively, the actuation element can be unscrewed such that pushing or pulling the actuation element 9112 moves the anchor portion 9106 relative to the interface portion 9104.

[0351] The anchor portion 9106 and / or anchor of the device can take a variety of different forms. For example, the anchor portion 9106 can have any of the features of any of the anchor portions disclosed herein. In the illustrated example, in some implementations, the anchor portion 9106 and / or anchor of the device 9100 includes an outer paddle 9120 and an inner paddle 9122 connected between the cap 9114 and the interface element 9110 by portions 9124, 9126, 9128. The portions 9124, 9126, 9128 can be interfaced and / or flexible to move between all of the positions described below. The interconnection of the outer paddle 9120, inner paddle 9122, interface element 9110, and cap 9114 by portions 9124, 9126, 9128 can constrain the device to the positions and movements shown herein.

[0352] In some implementations, the delivery system 9102 includes a steerable catheter, a device / implant catheter, and an actuating element 9112 (e.g., an actuating wire, an actuating shaft, etc.), which may be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the actuating element 9112 extends through the delivery catheter to or through the coaptation element 9110. Extending and retracting the actuating element 9112 increases and decreases, respectively, the spacing between the coaptation element 9110 and the distal end of the device (e.g., cap 9114 or other attachment portion). In some implementations, a collar or other attachment element removably attaches, either directly or indirectly, the interface element 9110 to the delivery system 9102 such that the actuation element 9112 slides through the collar or other attachment member, and in some implementations, through the interface element 9110 during actuation, to open and close the paddles 9120, 9122 of the anchor portion 9106 and / or anchor 9108.

[0353] In some implementations, the anchor portion 9106 and / or the anchor 9108 may include an attachment portion or a gripping member. The gripping member may take a variety of different forms. For example, the gripping member may have any of the features of any of the gripping members disclosed herein. The illustrated gripping member may include a base or fixed arm 9132, a movable arm 9134, a catch 9130 including optional friction enhancing elements or other fastening structures 9136 (e.g., barbs, projections, ridges, grooves, textured surfaces, adhesives, etc.), and an interface portion 9138. The fixed arm 9132 is attached to the inner paddle 9122. In some implementations, the fixed arm 9132 is attached to the inner paddle 9122 with the interface portion 9138 disposed proximate to the interface element 9110. The interface portion 9138 provides a spring force between the fixed arm 9132 and the movable arm 9134 of the catch 9130. The interface 9138 can be any suitable joint, such as a flexible joint, a spring joint, a pivot joint, or the like. In some implementations, the interface 9138 is a flexible piece of material integrally formed by the fixed arm 9132 and the movable arm 9134. The fixed arm 9132 is attached to the inner paddle 9122 and remains stationary or substantially stationary relative to the inner paddle 9122 when the movable arm 9134 is in an open state, opening the clasp 9130 and exposing the optional barb, friction enhancing element, or fixation structure 9136.

[0354] In some implementations, the clasp 9130 is opened by applying tension to an actuation line 9116 attached to the movable arm 9134, thereby causing the movable arm 9134 to articulate, bend or pivot on an articulation 9138. The actuation line 9116 extends through the delivery system 9102 (e.g., through a steerable catheter and / or a device / implant catheter). Other actuation mechanisms are also possible.

[0355] The actuation line 9116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, or the like. The clasp 9130 can be spring loaded such that the clasp 9130 continues to provide a clamping force to the grasped native leaflet in the closed position. Optional barbs, friction enhancing elements, or fixation structures 9136 of the clasp 9130 can grasp, pinch, and / or pierce the native leaflet to further secure the native leaflet.

[0356] During implantation, the paddles 9120, 9122 may be opened and closed, for example, to compress the native leaflets (e.g., native mitral leaflets, etc.) between the paddles 9120, 9122 and / or between the paddles 9120, 9122 and the coaptation element 9110 (e.g., spacer, plug, membrane, gap filler, etc.). The clasp 9130 may be used to grasp and / or further secure the native leaflets by engaging the leaflets with optional barbs, friction enhancing elements or fixation structures 9136 and clamping the leaflets between the movable arm 9134 and the fixed arm 9132. The optional barbs, friction enhancing elements or other fixation structures 9136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesives, etc.) of the clasp 9130 may increase friction with the leaflets or partially or fully puncture the leaflets. The actuation lines 9116 may be actuated separately such that each clasp 9130 may be opened and closed separately. Actuating separately allows one leaflet to be grasped at a time, or the clasp 9130 may be repositioned on a leaflet that was not adequately grasped without changing the good grip on the other leaflets. The clasp 9130 may be opened and closed relative to the position of the inner paddle 9122 (when the inner paddle is in an open or at least partially open position), thereby allowing the leaflets to be grasped in various positions as the particular situation requires.

[0357] In FIG. 139, the device 9100 is shown in a partially open, ready to grip state, with the clasp 9130 in a fully open position such that the movable arm 9134 of the clasp 9130 contacts the outer surface 9135 of the interface element 9110. With reference to FIG. 140, the device 9100 is shown in a partially open, ready to grip state, but with the clasp 9130 in a drooping position. The drooping position is an undesirable clasp position that may occur with some devices. In the drooping position, the clasp 9130 is actuated to be in the fully open position shown in FIG. 139, but instead of being or remaining in the fully open position, the movable arm 9134 is positioned away from the outer surface of the interface element 9110 or moves faster than normal (e.g., the angle between the fixed arm 9132 and the movable arm 9134 is smaller in the drooping position than in the fully open position). In the drooping position, there may be slack in the actuation line 9116 such that the actuation line 9116 does not hold the clasp 9130 in the fully open position. The clasp 9130 may be positioned in the drooping position or down to the drooping position sooner than normal if, for example, the actuation element 9112 stretches during implant extension, the implant extension length setting procedure is incorrect, or the length of the actuation line 9116 is incorrect.

[0358] 141, the device 9100 is shown in an extended state with the clasp 9130 in a fully open position (e.g., approximately 180 degrees between the fixed arm 9132 and the movable arm 9134 of the clasp 9130). FIG. 142 shows that the clasp 9130 can be in a hanging position when the device 9100 is also in an extended state. As shown in FIG. 142, instead of being in the fully open position, the movable arm 9134 is positioned or moved away from the interface element 9110 (e.g., the angle between the fixed arm 9132 and the movable arm 9134 is smaller in the hanging position than it is in the fully open position).

[0359] FIG. 143 is a schematic diagram of an exemplary device / implant catheter assembly 9610 (e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.) configured to compensate for clasp sagging. The device / implant catheter assembly can take a variety of different forms. For example, the device / implant catheter assembly can have any of the features of any of the device / implant catheter assemblies disclosed herein. In the illustrated embodiment, the device / implant catheter assembly 9610 corresponds to the previously disclosed device / implant catheter assembly 610, and the description of the device / implant catheter assembly 9610 applies equally to the device / implant catheter assembly 9610. The device / implant catheter assembly 9610 can include any of the features of the device / implant catheter assembly 9610 described in this application or in the applications cited above.

[0360] 142, the device / implant catheter assembly 9610 may include an inner or actuating element 9112, a coupler or capture mechanism 9620, an outer shaft 9611, a handle 9616 (shown diagrammatically), and a clasp actuating element 9624 (e.g., a clasp actuating line, a clasp actuating wire, a clasp actuating shaft, a clasp actuating rod, a clasp actuating tube, etc.). A proximal end portion 9622a of the outer shaft 9611 may be coupled to extend distally from the handle 9616, and a distal end portion 9622b of the outer shaft 9611 may be coupled to the coupler or capture mechanism 9620. The actuating element 9112 may extend distally from an actuation control 9626 (shown diagrammatically in FIG. 143), through the handle 9616, through the outer shaft 9611, and further through the coupler or capture mechanism 9620. The actuating element 9112 can be movable (e.g., axially and / or rotationally) relative to the outer shaft 9611 and the handle 9616. The clasp actuating element 9624 can extend through and be axially movable relative to the handle 9616 and the outer shaft 9611. The clasp actuating element 9624 can also be axially movable relative to the actuating element 9112.

[0361] 143, an actuating element 9112 (e.g., actuating rod, actuating tube, actuating shaft, actuating wire, etc.) of the device / implant catheter assembly 9610 can be removably coupled to a cap 9114 of the device 9604, either directly or through one or more intermediate components. The actuating element 9112 extends from a proximal end portion 9112a to a distal end portion 9112b. In some implementations, the distal end portion 9112b of the actuating element 9112 can include male threads configured to removably engage female threads of the cap 9114 or intermediate component of the device 9604. Thus, by rotating the actuating element 9112 in a first direction (e.g., clockwise) relative to the cap 9114 of the device 9604, the actuating element 9112 is releasably secured to the cap 9114 or intermediate component, while by rotating the actuating element 9112 in a second direction (e.g., counterclockwise) relative to the cap 9114 of the device 9604, the actuating element 9112 is released from the cap 9114 or intermediate component. However, the actuating element 9112 may be coupled to the cap or intermediate component in a wide variety of different ways. For example, the actuating element may be coupled to the cap or intermediate component in any manner in which any of the actuating elements disclosed herein are coupled (see, e.g., FIGS. 67-71).

[0362] In the example of FIG. 143, the outer shaft 9611 of the device / implant catheter assembly 9610 is an elongate shaft extending axially between a proximal end portion 9622a coupled to the handle 9616 and a distal end portion 9622b coupled to the coupler 9620. The outer shaft 9611 may also include an intermediate portion 9622c disposed between the proximal end portion 9622a and the distal end portion 9622b. The outer shaft 9611 may be formed from a variety of materials including metals and polymers. For example, in one implementation, the outer shaft may include an outer covering or coating, such as stainless steel, polyether block amide (PEBA), and / or a polymer reflowed over the outer portion.

[0363] 143, the clasp actuation elements 9624 are coupled to the clasps 9130a, 9130b on the device 9604 through holes 9235 in the clasps 9130a, 9130b and extend axially through the outer shaft 9611 between the clasps 9130a, 9130b and the handle 9616. In some implementations, the clasp actuation elements 9624 are each coupled to a clasp control member 9628a, 9628b at a proximal end of the clasp actuation element 9624. Each clasp control member 9628a, 9628b can be, for example, an axially moving control or slider coupled to a corresponding clasp actuation element 9624 to move the clasp actuation element 9624 axially relative to the outer shaft 9611 and actuation element 9112. Each of the clasp control members 9628a, 9628b may be operated independently of the other clasp control members such that each clasp actuating element 9624 is moved relative to the outer shaft 9611, the actuating element 9112, and the other clasp actuating elements 9624, or the clasp control members 9628a, 9628b may be fixed (e.g., locked) relative to one another such that the clasp actuating elements 9624 are moved axially together relative to the outer shaft 9611 and the actuating element 9112.

[0364] In the illustrated embodiment of FIG. 143, each clasp control member 9628a, 9628b is movable proximally to a first position to pull the corresponding clasp 9130a, 9130b to an open position and movable distally to a second position to release the corresponding clasp 9130a, 9130b to allow the clasp to move to a closed position. In the illustrated embodiment of FIG. 143, the handle 9616 includes a droop compensation mechanism 9630 configured to prevent or reduce sagging of the clasps 9130a, 9130b. The droop compensation mechanism 9630 may prevent or reduce sagging of the clasps in a variety of ways.

[0365] 143, the droop compensation mechanism 9630 includes one or more biasing elements 9632 configured to apply a force to each of the clasp actuation elements 9624, each of the clasp control members 9628a, 9628b, or both, such that the clasp actuation elements 9624 move the clasps 9130a, 9130b to the fully open position. For example, in some implementations, the one or more biasing elements 9632 can engage the clasp actuation elements 9624 and / or each of the clasp control members 9628a, 9628b, causing each of the clasp actuation elements 9624 to pull the clasps 9130a, 9130b from the drooping position to the fully open position.

[0366] In some implementations, the one or more biasing elements 9632 are configured to remove slack from the clasp actuation element 9624 (e.g., when the clasp actuation element 9624 is configured as a suture). The one or more biasing elements 9632 can be configured to apply a force during movement of the clasp control members 9628a, 9628b from the second position to the first position and after the clasp control members 9628a, 9628b are in the fully proximal first position. Thus, even when the clasp control members 9628a, 9628b reach the fully proximal first position (e.g., the clasp control members cannot further pull the clasp actuation element 9624 to move the clasp 9630), the one or more biasing elements 9632 continue to apply a force to pull the first clasp toward the open position. For example, one or more biasing elements 9632 can be configured to accommodate (e.g., elastically stretch and return to its original length) a distance equal to or greater than the maximum expected clasp sag. For example, one or more biasing elements 9632 can be configured to accommodate a sag between 0.1 mm and 10 mm, e.g., a sag between 0.2 and 5 mm, e.g., a sag between 0.3 and 2 mm, or any subrange of these ranges.

[0367] The one or more biasing elements 9632 may be configured in a variety of ways. In some examples, the one or more biasing elements 9632 may be a spring, a resilient element capable of applying a suitable force to the clasp actuation element 9624 and / or clasp control members 9628a, 9628b, a resilient portion of the clasp actuation element 9624, a clasp actuation element 9624 made entirely of a resilient material, clasp control members 9628a and / or 9628b having a spring or resilient element, etc. In some examples, the sag compensation mechanism 9630 may compensate for the sag of one clasp 9130a independently of the other clasp 9130b (e.g., the clasp actuation element and / or clasp control member associated with one clasp may move independently of the clasp actuation control element and / or clasp actuation element associated with the other clasp).

[0368] FIG. 144 is a schematic diagram of an exemplary device / implant catheter assembly 9710 (e.g., a control catheter assembly, a device control catheter assembly, an implant control catheter assembly, an implant delivery catheter assembly, etc.) configured to compensate for clasp sag. The device / implant catheter assembly 9710 corresponds to the previously disclosed device / implant catheter assembly 9610, and the description of the device / implant catheter assembly 9610 applies equally to the device / implant catheter assembly 9710, with reference numbers of similar elements kept the same. The device / implant catheter assembly 9710 may include any of the features of any of the device / implant catheter assemblies described in this application or the applications cited above. In the embodiment illustrated by FIG. 144, the sag compensation mechanism 9630 incorporates one or more biasing elements 9632 as part of each of the clasp actuation elements 9624.

[0369] In some embodiments, each clasp actuation element 9624 may be made elastic along the entire clasp actuation element 9624 or along one or more sections of the clasp actuation element 9624. For example, the entire elastic clasp actuation line or an elastic portion of the clasp actuation line may be configured to accommodate a distance equal to or greater than the maximum expected clasp sag (e.g., elastically stretch and return to its original length). For example, the entire elastic clasp actuation line or an elastic portion of the clasp actuation line may be configured to accommodate a sag of 0.1 mm to 10 mm, such as a sag of 0.2 to 5 mm, such as a sag of 0.3 mm to 2 mm, or any subrange within these ranges. The elastic clasp actuation element 9624, or a portion thereof, may function as one or more biasing elements 9632. For example, in the embodiment shown in FIG. 144, each clasp actuation element 9624 may include a portion near or adjacent to each corresponding clasp control member 9628a, 9628b in the handle 9616 that functions as the biasing element 9632. However, the resilient portion or portions of the clasp actuation element 9624 may be located along the clasp actuation element 9624 at any suitable location.

[0370] When the clasp actuation element 9624 is configured as a suture in some embodiments, it may be made as a braided suture. To increase the elasticity of the braided suture or a portion of th...

Claims

1. 1. A handle assembly for controlling a transvascular device, comprising: A handle housing; a sheath extending distally from the handle housing; an actuation element configured to extend through the sheath and be coupled to the device; a paddle actuated control operably coupled to the actuation element, the actuation of which moves the actuation element relative to the handle housing and the sheath, the movement of the actuation element moving the device between an open position and a closed position; and a paddle width adjustment element extending through the actuation element and configured to be coupled to at least one of a pair of paddles of the device; a paddle width control operably coupled to the paddle width adjustment element, wherein actuation of the paddle width control causes the paddle width adjustment element to move relative to the handle housing and the sheath, and movement of the paddle width adjustment element causes a width of at least one of the pair of paddles of the device to move from a first width to a second width.

2. 2. The handle assembly of claim 1, further comprising a release control operably coupled to the paddle width adjustment element, wherein actuation of the release control moves the paddle width adjustment element and an actuation element to uncouple the device from the sheath.

3. 3. A handle assembly according to claim 1 or 2, wherein actuation of the paddle width control and / or actuation of the paddle actuation control may cause the release control to move axially.

4. A handle assembly as described in any one of claims 1 to 3, wherein the paddle actuation control is operably coupled to a retractor and moves the actuation element, and the paddle width control is operably coupled to a drive member and moves the paddle width adjustment element, and when the paddle actuation control is actuated, both the retractor and the drive member move.

5. The handle assembly of claim 4 , wherein the paddle actuated control is configured as a paddle actuated control knob, and rotation of the paddle actuated control knob drives the retractor axially.

6. 6. A handle assembly according to claim 4 or 5, wherein the paddle width control is configured as a paddle width control knob, and rotation of the paddle width control knob drives the drive member axially.

7. A handle assembly according to any one of claims 4 to 6, wherein the retractor is positioned within the handle distally from the drive member.

8. The handle assembly of any one of claims 4 to 7, wherein the paddle actuated control is operably coupled to a first female-threaded tube, and when the paddle actuated control is actuated, the first female-threaded tube rotates and moves the retractor.

9. 9. The handle assembly of claim 4, wherein the paddle width control is operably coupled to a second female-threaded tube, and actuation of the paddle width control causes the second female-threaded tube to rotate and move the drive member.

10. The handle assembly of claim 9 , wherein the handle assembly is configured such that movement of the retractor causes the second internally threaded tube to move axially.

11. A handle assembly according to any one of claims 1 to 10, wherein the release control is configured as a release control knob, and rotation of the release control knob decouples the paddle width adjustment element from the paddle width control.

12. 12. The handle assembly of claim 11, further comprising a release nut operably coupled to the paddle width control such that when the paddle width control is actuated, the release nut moves axially, and when the release control is rotated, a release screw is disengaged from the release nut to decouple the paddle width adjustment element from the paddle width control.

13. 13. A handle assembly as claimed in claim 11 or 12, wherein movement of the release control after the release control decouples the paddle width adjustment element from the paddle width control causes movement of both the paddle actuation element and the paddle width adjustment element.

14. A delivery system for a device, comprising: a steerable catheter assembly having a handle and a sheath extending axially from the handle, the sheath of the steerable catheter assembly having a distal end portion with a steerable section; a device / implant catheter assembly having a handle with a handle housing and a sheath extending distally from the handle housing, the sheath of the device / implant catheter assembly being extendable coaxially through the sheath of the steerable catheter assembly, the handle of the device / implant catheter assembly comprising: an actuation element configured to extend through the sheath and be coupled to the device; a paddle actuated control operably coupled to the actuation element, the actuation of which moves the actuation element relative to the handle housing and the sheath, the movement of the actuation element moving the device between an open position and a closed position; and a paddle width adjustment element extending through the actuation element and configured to be coupled to at least one of a pair of paddles of the device; and a paddle width control operatively coupled to the paddle width adjustment element, wherein actuation of the paddle width control causes the paddle width adjustment element to move relative to the handle housing and the sheath, and movement of the paddle width adjustment element causes a width of at least one of the pair of paddles of the device to move from a first width to a second width.

15. 15. The delivery system of claim 14, wherein the device / implant catheter assembly further comprises a release control operably coupled to the paddle width adjustment element, wherein actuation of the release control moves the paddle width adjustment element and an actuation element to uncouple the device from the sheath.

16. 16. The delivery system of claim 14 or 15, wherein the device / implant catheter assembly is configured such that actuation of the paddle width control and / or actuation of the paddle actuation control causes the release control to move axially and / or rotationally.

17. 17. The delivery system of any one of claims 14 to 16, wherein the paddle actuation control is operably coupled to a retractor to move the actuation element, and the paddle width control is operably coupled to a drive member to move the paddle width adjustment element, and actuation of the paddle actuation control may move both the retractor and the drive member.

18. 20. The delivery system of claim 17, wherein the paddle actuated control is configured as a paddle actuated control knob, and rotation of the paddle actuated control knob drives the retractor axially.

19. 19. The delivery system of claim 17 or 18, wherein the paddle width control is configured as a paddle width control knob, and rotation of the paddle width control knob drives the drive member axially.

20. The delivery system of any one of claims 17 to 19, wherein the retractor is positioned within the handle distal to the drive member.

21. 21. The delivery system of any one of claims 17 to 20, wherein the paddle actuation control is operably coupled to a first female threaded tube, and actuation of the paddle actuation control rotates the first female threaded tube and causes axial and / or rotational movement of the retractor.

22. 22. The delivery system of any one of claims 17 to 21, wherein the paddle width control is operably coupled to a second female threaded tube, and actuation of the paddle width control causes the second female threaded tube to rotate and the drive member to move.

23. 23. The delivery system of claim 22, wherein the device / implant catheter assembly is configured such that movement of the retractor causes axial movement of the second female threaded tube.

24. 24. A delivery system according to any one of claims 14 to 23, wherein the release control is configured as a release control knob, and when the release control knob is rotated, the paddle width adjustment element is decoupled from the paddle width control.

25. 25. The delivery system of claim 24, further comprising a release nut operably coupled to the paddle width control such that when the paddle width control is actuated, the release nut moves axially, and when the release control is rotated, a release screw is disengaged from the release nut to decouple the paddle width adjustment element from the paddle width control.

26. 26. The delivery system of claim 24 or 25, wherein axial movement of the release control after the release control decouples the paddle width adjustment element from the paddle width control moves both the paddle actuation element and the paddle width adjustment element.

27. A method of using an apparatus, comprising: obtaining a device coupled to an actuation element and a paddle width adjustment element extending from a distal end of a sheath of a catheter assembly, the sheath being coupled to a handle of the catheter assembly at a proximal end of the sheath; advancing the sheath of the catheter assembly to position the device at a delivery site in an open configuration; activating the paddle actuated control on the handle, thereby moving the actuation element to move the device from the open configuration to a closed configuration; activating a paddle width control on the handle, thereby moving or actuating the paddle width adjustment element to move a width of at least one of a pair of paddles from a first width to a second width; and actuating a release control on the handle, thereby moving the paddle width adjustment element and the actuation element to decouple the device from the sheath; The method, wherein actuation of the paddle actuation control may cause axial movement of the release control and the paddle width adjustment element.

28. 1. A delivery system for a device having multiple clasps for securing native leaflets of a heart valve, comprising: a catheter assembly having a handle and a sheath extending axially from the handle, the sheath having a distal end portion including a capture mechanism for attaching the sheath to the device, the capture mechanism configured to move between a coupled position in which the capture mechanism is secured to the device and a released position in which the capture mechanism is uncoupled from the device; a first clasp actuation line configured to move a first clasp of the plurality of clasps between a closed position and an open position, the first clasp actuation line extending from the handle, through the sheath, and through a first opening in the first clasp; A delivery system, wherein a first distal end of the first clasp actuation line is attached to the capture mechanism when the capture mechanism is in the bound position.

29. 1. A method of treating a heart valve with a valve treatment device, comprising: closing a first clasp of the valve therapy device, the first clasp grasping a first leaflet of the heart valve by releasing tension on a first clasp actuation line coupled to the first clasp; closing a second clasp of the valve therapy device, the second clasp grasping and closing a second leaflet of the heart valve by releasing tension on a second clasp actuation line coupled to the second clasp; and releasing the valve treatment device from a capture mechanism and withdrawing the capture mechanism from the valve treatment device; The method, wherein the step of releasing the valve therapy device from the capture mechanism and withdrawing the capture mechanism from the valve therapy device includes the steps of decoupling the first clasp actuation line from the first clasp and decoupling the second clasp actuation line from both of the second clasps.

30. 1. A handle assembly for controlling a transvascular device having a plurality of clasps for securing native leaflets of a heart valve, comprising: A handle housing; a sheath extending distally from the handle housing; a first clasp actuation line extending through the sheath and operably coupled to a first clasp of the plurality of clasps on the device; a first clasp control member operably connected to the first clasp actuation line and movable relative to the housing between a first position associated with the first clasp being an open position and a second position associated with the first clasp being a closed position; The first clasp control member is biased to the second position.

31. 1. A method for repairing a heart valve with a valve repair device having a plurality of clasps for securing native leaflets of the heart valve, comprising: delivering the valvular therapy device to the heart valve via a catheter assembly having a first clasp actuation line that holds a first clasp of the valvular therapy device in an open position and a second clasp actuation line that holds a second clasp of the valvular therapy device in an open position; closing the first clasp of the valve therapy device to grasp a first leaflet of the heart valve by releasing tension on the first clasp actuation line; and closing the second clasp of the valve therapy device to grasp a second leaflet of the heart valve by releasing tension on the second clasp actuation line; Releasing tension on the first clasp actuation line includes biasing a first clasp control member from a first position to a second position; The method, wherein releasing tension on the second clasp actuation line includes biasing a second clasp control member from a third position to a fourth position.

32. A clasp actuation line for actuating a clasp of a valve therapy device, A clasp actuation line comprising a proximal end, a distal end opposite the proximal end, and a braid having a closed loop formed at the distal end.

33. 1. A method of forming a clasp actuation line for actuating a clasp of a valvular therapy device, comprising: braiding the elongate body; and forming a closed loop at a distal end of the elongate body.

34. 1. A handle assembly for controlling a transvascular device, comprising: A handle housing; a sheath extending distally from the handle housing; an actuation element configured to extend through the sheath and be coupled to the device; a paddle actuated control operably coupled to the actuation element, the actuation of which moves the actuation element relative to the handle housing and the sheath, the movement of the actuation element moving the device between an open position and a closed position; and a paddle width adjustment element extending through the actuation element and configured to be coupled to at least one of a pair of paddles of the device; a paddle width control operably coupled to the paddle width adjustment element, wherein actuation of the paddle width control causes the paddle width adjustment element to move relative to the handle housing and the sheath, and movement of the paddle width adjustment element causes a width of at least one of the pair of paddles of the device to move from a first width to a second width.

35. A delivery system comprising: a steerable catheter assembly having a handle and a sheath extending axially from the handle, the sheath of the steerable catheter assembly having a distal end portion with a steerable section; a catheter assembly having a handle and a sheath coaxially extendable through the sheath of the steerable catheter assembly, the handle of the catheter assembly comprising: A handle housing comprising: a handle housing, the sheath of the catheter assembly extending distally from the handle housing; an actuation element configured to extend through the sheath and be coupled to a treatment device; a paddle actuated control operably coupled to the actuation element, the actuation of which moves the actuation element relative to the handle housing and the sheath, the movement of the actuation element moving the device between an open configuration and a closed configuration; and a paddle width adjustment element extending through the actuation element and configured to be coupled to at least one of a pair of paddles of the device; a paddle width control coupled to the paddle width adjustment element, wherein actuation of the paddle width control causes the paddle width adjustment element to move relative to the handle housing and the sheath, and movement of the paddle width adjustment element causes a width of at least one of the pair of paddles of the device to move from a first width to a second width.

36. 1. A method of delivering a device, comprising: obtaining a device coupled to an actuation element and a paddle width adjustment element extending from a distal end of a sheath of a device / implant catheter assembly, the sheath being coupled to a handle of the device / implant catheter assembly at a proximal end of the sheath; advancing the sheath of the device / implant catheter assembly to position the device at a delivery site; activating a paddle actuated control on the handle, thereby moving the actuation element to move the device from a closed configuration to an open configuration; activating a paddle width control on the handle, thereby moving the paddle width adjustment element to move the width of at least one of the pair of paddles from a first width to a second width; activating the paddle actuated control on the handle, thereby moving the actuation element to move the device from the open configuration to a closed configuration; and decoupling the device from the actuation element and the paddle width adjustment element.

37. 1. A handle assembly for controlling a transvascular device, comprising: A handle housing; a sheath extending distally from the handle housing; an actuation element configured to extend through the sheath and be coupled to the device; a paddle width adjustment element extending through the actuation element and configured to be coupled to at least one of a pair of paddles of the device; a paddle actuated control coupled to the actuation element, the actuation of which moves the actuation element relative to the handle housing and the sheath, the movement of the actuation element moving the device between an open configuration and a closed configuration; and a paddle width control coupled to the paddle width adjustment element, wherein actuation of the paddle width control causes the paddle width adjustment element to move relative to the handle housing and the sheath, and movement of the paddle width adjustment element causes a width of at least one of the pair of paddles of the device to move from a first width to a second width; a pair of clasp actuation lines extending through the sheath, each clasp actuation line of the pair of clasp actuation lines configured to be coupled to the device; a pair of clasp control members, each of the pair of clasp control members being movable relative to the handle housing, and movement of each clasp control member moving a clasp of the device between an open configuration and a closed configuration.

38. A delivery system comprising: a steerable catheter assembly having a handle and a sheath extending axially from the handle, the sheath of the steerable catheter assembly having a distal end portion with a steerable section; and a device / implant catheter assembly having a handle and a sheath coaxially extendable through the sheath of the steerable catheter assembly, the handle of the device / implant catheter assembly comprising: A handle housing comprising: a handle housing, the sheath of the device / implant catheter assembly extending distally from the handle housing; an actuation element configured to extend through the sheath and be coupled to a treatment device; a paddle width adjustment element extending through the actuation element and configured to be coupled to at least one of a pair of paddles of the device; a paddle actuated control coupled to the actuation element, the actuation of which moves the actuation element relative to the handle housing and the sheath, the movement of the actuation element moving the device between an open configuration and a closed configuration; and a paddle width control coupled to the paddle width adjustment element, wherein actuation of the paddle width control causes the paddle width adjustment element to move relative to the handle housing and the sheath, and movement of the paddle width adjustment element causes a width of at least one of the pair of paddles of the device to move from a first width to a second width; a pair of clasp actuation lines extending through the sheath, each clasp actuation line of the pair of clasp actuation lines configured to be coupled to the device; a pair of clasp control members, each of the pair of clasp control members being movable relative to the handle housing, such that movement of each clasp control member moves a respective clasp of the device between an open configuration and a closed configuration; Each clasp actuation line of the pair of clasp actuation lines is coupled to a suture lock extending from a proximal end of the handle housing.

39. A handle assembly for controlling the device, comprising: A handle housing; a sheath extending distally from the handle housing; an actuation element extending through at least a portion of the sheath and configured to be coupled to the device; a width adjustment element extending through at least a portion of the sheath and configured to be coupled to at least one of a pair of anchors of the device; an actuation control coupled to the actuation element, the actuation control causing the actuation element to move relative to the handle housing and / or the sheath, the actuation control causing the device to move between an open configuration and a closed configuration; and a width control coupled to the width adjustment element, wherein actuation of the width control causes the width adjustment element to move relative to the handle housing and / or the sheath, and movement of the width adjustment element causes at least one of the pair of anchors of the device to transition between a first width and a second width.

40. 1. A handle assembly for controlling a transvascular device having a plurality of clasps for securing native leaflets of a heart valve, comprising: A handle housing; a sheath extending distally from the handle housing; a first clasp actuation element extending through the sheath and operably coupled to a first clasp of the plurality of clasps on the device; a first clasp control member operatively connected to the first clasp actuation element and movable relative to the housing between a first position associated with the first clasp being an open position and a second position associated with the first clasp being a closed position; a first biasing element configured to apply a first force to pull the first clasp toward the open position.

41. 1. A method of repairing a heart valve with a valve repair device having a plurality of clasps for securing native leaflets of the heart valve, comprising: delivering the valve repair device to the heart valve via a catheter assembly; moving a first clasp control member to a first position to hold a first clasp of the valve repair device in an open position with a first clasp actuation element; and moving the first clasp control member to a second position to close the first clasp of the valve repair device to grasp a first leaflet of the heart valve; The method, wherein the step of holding the first clasp of the valve repair device in an open position further comprises applying a first force to the first clasp actuation element after the first clasp control member is in the first position.

42. 1. A delivery system for a device having multiple clasps for securing native leaflets of a heart valve, comprising: a catheter assembly having a handle assembly for controlling the device and a sheath extending axially from the handle assembly; the sheath having a distal end portion including a capture mechanism for removably attaching the sheath to the device; The handle assembly includes: A handle housing; a sheath extending distally from the handle housing; a first clasp actuation element extending through the sheath and operably coupled to a first clasp of the plurality of clasps on the device; a first clasp control member operatively connected to the first clasp actuation element and movable relative to the housing between a first position associated with the first clasp being an open position and a second position associated with the first clasp being a closed position; a first biasing element configured to apply a force to pull the first clasp toward the open position.

43. a clasp actuation line for actuating a clasp of the valve repair device via a clasp control member, a braid having a first end configured to operably couple to the clasp control member and a second end opposite the first end; The braid has a first portion having a first elasticity and a second portion having a second elasticity greater than the first elasticity.

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